EDGAR 10-K Filing

Company CIK: 1522860
Filing Year: 2025
Filename: 1522860_10-K_2025_0001628280-25-014559.json

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ITEM 1. BUSINESS
Item 1. Business.
Overview
Historically, we designed, manufactured and marketed a range of tools for catheter-based ablation procedures to treat various arrhythmias. Our product portfolio included novel access sheaths, diagnostic and mapping catheters, conventional and contact ablation catheters, mapping and imaging consoles and accessories, as well as supporting algorithms and software programs. Our foundational product was our AcQMap Imaging and Mapping System, which was designed to rapidly and accurately identify ablation targets and to confirm both ablation success and procedural completion.
In April 2022, we announced that we agreed to sell our left-heart access product portfolio to Medtronic pursuant to an Asset Purchase Agreement with Medtronic (the "Asset Purchase Agreement") and refinance existing debt with a new longer-term credit facility to recapitalize our business and fund our strategic growth priorities. Pursuant to the sale transaction, Medtronic paid upfront cash consideration of $50.0 million (of which $4.0 million was paid into an indemnity escrow account for a period of 18 months), and we became eligible for contingent cash consideration of up to $37.0 million (of which we earned $20.0 million on October 31, 2022 and $17.0 million on December 31, 2022) plus a portion of Medtronic’s future net sales of the left-heart access product portfolio. In conjunction with the sale of our left-heart access product portfolio, we executed a distribution agreement with Medtronic (the “Distribution Agreement”), pursuant to which we agreed to manufacture and supply these left-heart access products to Medtronic as exclusive distributor of the product line for an initial term of up to four years at specified transfer prices. We will also continue to be eligible for earnout payments on Medtronic’s net sales of the left-heart access product portfolio through 2027.
In November 2023, we announced, following an extensive strategic review by our board of directors, and in light of the current financing environment and the capital investments required to achieve leadership in the electrophysiology market, that we had determined to reallocate capital from our mapping and ablation business to the manufacturing of left-heart access products for Medtronic under the Distribution Agreement, which we believe will maximize the potential for future contingent cash consideration and cash flow. As part of this restructuring (the "Strategic Restructuring"), we wound down our mapping and ablation businesses and no longer manufacture or distribute our AcQMap Mapping System, AcQMap 3D Mapping Catheter, AcQBlate Force-Sensing Ablation Catheter, AcQGuide Max 2.0 Steerable Sheath, or associated accessories, though we continue to explore strategic alternatives for these businesses (including a potential sale of related assets).
As a result of this restructuring, we have relied solely on our strategic partnership with Medtronic to generate revenue through (i) the manufacture of the left-heart access product portfolio for Medtronic at transfer prices specified under our Distribution Agreement and (ii) potential earnouts from Medtronic’s sales of the left-heart access product portfolio to end-users.
In November 2024, our board of directors approved a realignment of resources and operational downsizing of the company to reduce the size of our organization while complying with our remaining obligations to Medtronic for the production of left-heart access products under the Distribution Agreement and Asset Purchase Agreement (the “Operational Downsizing”). As a result of the Operational Downsizing, we have reduced operations to a scale designed solely to support the manufacturing and distribution of Medtronic’s left-heart access products under the Distribution Agreement through the transition of the production of these products to Medtronic pursuant to the terms of the Asset Purchase Agreement and the Distribution Agreement, which would occur at a Second Closing under the Asset Purchase Agreement as described under “-Left-Heart Access Portfolio Sale and Distribution Agreement” below. As part of the Operational Downsizing, we announced a reduction in workforce of approximately 61 employees, representing approximately 70% of our employees. Upon the occurrence of the Second Closing, we anticipate that our sole source of revenue would be potential earnouts from Medtronic’s sales of the left-heart access product portfolio to end-users pursuant to the Asset Purchase Agreement, and to further wind down operations to minimize costs while continuing to capture the value associated with potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027.
In January 2025, our board determined to effect the deregistration of our common stock with the SEC, including the suspension of our reporting obligations under the Exchange Act. We filed a Form 15 with the SEC to voluntarily effect such deregistration. The filing of the Form 15 immediately suspended our reporting obligations under Section 13(a) of the Exchange Act, subject only to our obligation to file a Form 10-K for our fiscal year ended December 31, 2024. We expect the deregistration to become effective 90 days after filing the Form 15 with the SEC.
Left-Heart Access Portfolio Sale and Distribution Agreement
On June 30, 2022, we completed the first closing (the “First Closing”) of the sale of our left-heart access portfolio in accordance with the Asset Purchase Agreement, pursuant to which we sold to Medtronic our AcQCross® line of sheath-compatible septal crossing devices, the AcQGuide® MINI integrated crossing device and sheath, the AcQGuide FLEX steerable introducer with integrated transseptal dilator and needle and the AcQGuide® VUE steerable sheaths (the “Products”). Pursuant to the Asset Purchase Agreement, Medtronic paid cash consideration of $50.0 million at the First Closing, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing, and acquired from us, among other things, intellectual property rights to the Products and certain equipment used in the manufacturing of the Products. A second closing would occur on a date determined by Medtronic, but no later than the fourth anniversary of the First Closing, subject to the satisfaction of customary closing conditions (the “Second Closing”). At the Second Closing, Medtronic would acquire certain additional assets relating to the Products, primarily supplier agreements and permits and design and specification files required for Medtronic to become the manufacturer of record of the Products, for no additional consideration.
Under the Asset Purchase Agreement, we also became eligible to receive contingent cash consideration of up to $37.0 million plus a portion of Medtronic’s future net sales from the Products, as follows:
(i) $20.0 million upon our completion, to the reasonable satisfaction of Medtronic, of certain conditions set forth in the Asset Purchase Agreement relating to our becoming a qualified supplier of Medtronic for the Products, including demonstration of ISO 14971:2019 compliance, completion of certain test method validations and compliance with certain other reporting requirements (the “OEM Earnout”);
(ii) $17.0 million upon the earlier of (A) the Second Closing or (B) our initial submission for Conformité Européenne Mark, or CE Mark, certification of the Products under the European Union Medical Devices Regulation, or MDR, to the reasonable satisfaction of a third-party regulatory consultant, subject to certain other conditions as set forth in the Asset Purchase Agreement (the “Transfer Earnout”); and
(iii) amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the Products achieved by Medtronic over each year over a four-year period beginning on the first full quarter after Medtronic’s first commercial sale of a Product and achievement of the OEM Earnout (the “Net Sales Earnouts”).
On October 31, 2022, we achieved the OEM Earnout, and payment of $20.0 million from Medtronic was received in November 2022. Further, on December 1, 2022, Medtronic qualified us as an original equipment manufacturer (“OEM”) and accordingly, we began to manufacture the Products exclusively for Medtronic under the Distribution Agreement. The Distribution Agreement has an initial term ending on the date of the Second Closing. If the Second Closing has not occurred on or prior to the fourth anniversary of the First Closing, then the Distribution Agreement will automatically renew thereafter for successive one-year periods, unless either we or Medtronic provides notice of non-renewal at least 180 days before the end of the then current term.
On December 31, 2022, we achieved the Transfer Earnout for our submission for CE Mark certification of the Products under the European Union MDR, to the reasonable satisfaction of a third-party regulatory consultant, and payment of $17.0 million was received from Medtronic on January 14, 2023.
The quarterly measurement period for the Net Sales Earnouts began on January 30, 2023, and such earnout payments began in January 2024 and will continue quarterly each quarter thereafter until 2027. In 2024, we earned $11.1 million related to Net Sales Earnouts and received $18.7 million in related payments. In 2023, we earned $9.4 million related to the Net Sales Earnouts, with $7.3 million paid in January 2024.
Strategic Realignment and Restructuring
In November 2023, our board of directors approved the Strategic Restructuring. We implemented a shift in our business model to solely support the manufacturing and distribution of Medtronic’s left-heart access product portfolio under the Distribution Agreement, including to earn potential Net Sales Earnouts. As part of the Restructuring, we wound down our mapping and ablation businesses and no longer manufacture or distribute our AcQMap Mapping System, AcQMap 3D Mapping Catheter, AcQBlate Force-Sensing Ablation Catheter, AcQGuide Max 2.0 Steerable Sheath or associated accessories and are exploring strategic alternatives for these businesses (including a potential sale of related assets). In addition, we reduced our workforce by approximately 160 employees, representing approximately 65% of our employees at the time. The restructuring was substantially completed in the first quarter of 2024.
As of December 31, 2024, we have recognized $26.8 million of the estimated $21.0 million to $32.0 million of pre-tax restructuring and exit-related charges, of which $1.0 million of the estimated $2.0 million to $3.0 million represented cash expenditures for the payment of severance and related benefit costs, $2.9 million of the estimated
$3.0 million to $4.0 million represented cash expenditures for the payment of retention bonuses to certain employees that are assisting with the Restructuring, less than $3.7 million of the estimated $2.0 million to $5.0 million represented cash expenditures for other restructuring costs, and $19.2 million of the estimated $14.0 million to $20.0 million represented non-cash pre-tax impairment charges in connection with the disposition of certain assets, including inventory, fixed assets and intangibles. A majority of the non-cash charges were incurred in the fourth quarter of 2023, while the majority of the cash expenditures charges were incurred in the first quarter of 2024.
Operational Downsizing
In November 2024, our board of directors approved the Operational Downsizing, in which we are reducing the size of our organization while complying with our remaining obligations to Medtronic for the production of left-heart access products. As part of the Operational Downsizing, we announced a reduction in our current workforce of approximately 61 employees, representing approximately 70% of the Company’s employees, that is expected to be completed by the first quarter of 2025. In compliance with the Worker Adjustment and Retraining Notification Act, we provided pre-termination notices to affected employees and government authorities where required. We entered into retention arrangements with certain employees who are expected to remain with us to assist with the downsizing and operation of our left-heart access manufacturing and distribution business.
We estimate we will incur approximately $1.4 million to $1.8 million of pre-tax downsizing and exit-related charges, of which approximately $0.3 million represents future cash expenditures for the payment of monetary consideration and related benefit costs, approximately $1.2 million represents future cash expenditures for the payment of retention bonuses to certain employees that will assist with the Operational Downsizing, and potentially up to $0.3 million estimated as future cash expenditures for contract closing costs. We expect that a majority of the future cash expenditures charges will be incurred in the first quarter of 2025, and that the Operational Downsizing will be substantially complete in the first quarter of 2025.
As of December 31, 2024, we have recognized $1.4 million of the pre-tax downsizing and exit-related charges.
Amendment to Debt Documents
On January 21, 2025, we and Deerfield Partners, L.P. and Deerfield Private Design Fund III, L.P. (collectively, the “Deerfield Funds”) entered into Amendment No. 5 (“Amendment No. 5”) to the Amended and Restated Credit Agreement, dated as of June 30, 2022 (as amended, restated, supplemented or otherwise modified from time to time, the “2022 Credit Agreement”), among us, the Deerfield Funds and Wilmington Trust, National Association, as Administrative Agent.
Pursuant to Amendment No. 5, the 2022 Credit Agreement was amended to allow us to effect the deregistration of our common stock with the SEC, including the termination of our periodic reporting obligations under the Exchange Act (the “Deregistration”) and, among other things: (i) provided that the Deerfield Funds would receive a consent fee in the form of a contingent value right payable upon certain triggering events in an amount equal to the lesser of $300,000 or 5.0% of the aggregate amount of total value that would otherwise be available to our equityholders (the “Consent Fee”); (ii) modified the financial reporting requirements under the 2022 Credit Agreement, including requiring delivery of cash flow forecasts to the Deerfield Funds; (iii) required the appointment of a Chief Restructuring Officer; and (iv) modified the negative covenants to limit our business activities and required us to maintain minimum liquidity of $5 million. The effectiveness of Amendment No. 5 was conditioned upon the occurrence of the Deregistration on or prior to January 31, 2025 (or such other date as agreed to by the Deerfield Funds in their sole discretion).
In connection with entry into Amendment No. 5 and the Deregistration, we also entered into certain other agreements, including: (i) a contingent value rights agreement to provide for payment of the Consent Fee by us to the Deerfield Funds (the “Contingent Value Rights Agreement”); (ii) a warrant termination agreement to terminate (a) warrants to purchase 224,118 shares of our common stock pursuant to that certain Warrant to Purchase Shares of Common Stock of the Company dated as of June 7, 2018 (the “2018 Warrants”), (b) warrants to purchase 209,996 shares of our common stock pursuant to that certain Warrant dated as of May 20, 2019 (the “2019 Warrants”) and (c) warrants to purchase 3,779,018 shares of our common stock pursuant to that certain Warrant to Purchase Shares of Common Stock of the Company dated June 30, 2022 (the “2022 Warrants”) for a fee equal to $250,000 in the aggregate paid by us to the Deerfield Funds (the “Warrant Termination Agreement”) and (iii) a registration rights termination agreement to terminate the registration rights agreement, dated June 30, 2022, among us and the Deerfield Funds and withdraw the registration statement on Form S-3 filed with the SEC (File No. 333-266804) in
connection with the sale from time to time of our securities held by the Deerfield Funds and terminate the offer and/or sale of securities under such registration statement (the “Registration Rights Termination Agreement”).
Deregistration and “Going Dark”
As previously disclosed, Nasdaq suspended trading in our common stock on May 9, 2024, due to noncompliance with Nasdaq Listing Rule 5550(a)(2) and 5550(b). On May 15, 2024, Nasdaq announced that it would formally delist our common stock that was previously suspended. On May 16, 2024, Nasdaq filed a Form 25 Notification of Delisting with the SEC to complete the delisting and remove such securities from registration under Section 12(b) of the Exchange Act, and such delisting took effect on May 26, 2024. The deregistration of our common stock under Section 12(b) of the Exchange Act was effective 90 days after the Form 25 filing. On May 9, 2024, our common stock began trading over the counter on the OTC Pink Market under the trading symbol “AFIB.”
In January 2025, our board determined to effect the deregistration of our common stock with the SEC, including the suspension of our reporting obligations under the Exchange Act (the “Deregistration”). We filed a Form 15 with the SEC to voluntarily effect the Deregistration. The filing of the Form 15 immediately suspended our reporting obligations under Section 13(a) of the Exchange Act, subject only to our obligation to file a Form 10-K for our fiscal year ended December 31, 2024. We expect the Deregistration to become effective 90 days after filing the Form 15 with the SEC.
Our board of directors has determined that “going dark” is in the best interests of our company and our stockholders as a result of the substantial cost savings from the elimination of accounting and other expenses relating to maintaining our status as a public reporting company. In coming to this decision, our board of directors, among other factors, considered the advantages and disadvantages of being an Exchange Act reporting company, the number of stockholders and the relatively low level of trading in our common stock.
Overview of the Products We Manufacture
Historical Products
Historically, we designed, manufactured and marketed a range of tools for catheter-based ablation procedures to treat various arrhythmias. Our foundational and most highly differentiated product was our AcQMap Imaging and Mapping System which offered a non-contact map paradigm-shifting approach to mapping the drivers and maintainers of arrhythmias with unmatched speed and precision. We established a broad portfolio of electrophysiology products that complemented our AcQMap System. In addition to our AcQMap System, our commercial product portfolio included a suite of access devices and full product lines of diagnostic and, in our European markets, ablation catheters. We also launched the AcQBlate Force Sensing Ablation System following the December 2020 receipt of CE Mark approval in Europe.
As part of the Strategic Restructuring, we wound down our mapping and ablation businesses and no longer manufacture or distribute our AcQMap Mapping System, AcQMap 3D Mapping Catheter, AcQBlate Force-Sensing Ablation Catheter, AcQGuide Max 2.0 Steerable Sheath or associated accessories.
Current Products
Following the Strategic Restructuring and the shift in our business model to solely supporting the manufacturing and distribution of the Products to Medtronic, we manufacture transseptal crossing devices and associated accessories, such as integrated transseptal dilators and needles, fixed-curve or steerable introducers, and steerable sheaths (i.e., the Products). These Products are used to access the left side, or left atrium, of the cardiac anatomy and are used in a range of medical applications, including in electrophysiology and structural heart procedures. The technology supports physicians during a critical component of an ablation or structural heart procedure.
The transseptal crossing devices that we manufacture for Medtronic include versions that are length-, diameter- and tip-matched and designed to lock into the hub of sheaths used in many left-heart procedures. These devices enable mechanical septal crossing with a spring-loaded needle that can also be enhanced with concurrent delivery of radiofrequency energy. They streamline the procedural workflow by eliminating the need for wire and needle exchanges, as they incorporate a retained guidewire within the hollow crossing needle.
The fixed-curve and steerable introducers are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. They are designed to facilitate vascular access to the heart and then provide catheter positioning (fixed or variable) within the cardiac anatomy.
The steerable sheaths are designed to facilitate handling and deliverability of interventional devices.
We previously obtained U.S. Food and Drug Administration, or FDA, clearance for the Products in April 2021 and for additional configurations of the Products in June 2022 and submitted an application for CE Mark under the European Union MDR for the Products in December 2022.
We believe the unique attributes of the Products that we manufacture for Medtronic offer significant clinical benefits relative to the current standard of care. The Products are designed for patient safety and procedural efficiency, allowing for fewer steps than a traditional transseptal access workflow.
The transseptal crossing devices contain a spring-tensioned safety needle that only deploys when actuated. The matched integrated dilator and needle lock together with introducers as one unit for control and ease of use.
The transseptal crossing devices incorporate a retained guidewire within the hollow crossing needle. This design reduces exchanges and allows physicians to reposition without requiring wire and needle exchanges. The elimination of guidewire and needle exchanges facilitates transseptal crossing procedures, as the optimal septal crossing location and angle differ depending on the procedure so the ability to easily reposition without cumbersome catheter withdrawals and exchanges is important.
Market and Industry
Electrophysiology involves the diagnosing and treating of abnormal electrical activities of the heart. Electrophysiology products include devices used by electrophysiologists and interventional cardiologists for the treatment of cardiac arrhythmias, or heart rhythm disorders, which are common and can occur when the heart beats too rapidly, too slowly or irregularly. If left untreated, arrhythmias can result in debilitating symptoms, heart failure, stroke and sudden cardiac death. Atrial fibrillation, or AF, is the most common arrhythmia and is characterized by rapid and irregular activation of the heart. This irregular behavior increases the potential to develop blood clots within the upper chambers of the heart, which can then circulate to other organs, leading to reduced blood flow and strokes.
Structural heart conditions involve defects or disorders in the heart’s structure-its valves, walls, chambers or muscles. Structural heart products include those used by interventional cardiologists to treat defects of the heart, such as valve stenosis (stiffness) and valve regurgitation (leaky valve). Surgical repair of the valve may be required in such circumstances.
The Products we manufacture for Medtronic are used in electrophysiology and structural heart procedures. An estimated several hundred thousand transseptal crossings are performed annually during these procedures. The Products support the challenging and critical step of accessing the left atrium during electrophysiology and structural heart procedures such as atrial fibrillation ablation procedures, left atrial appendage occlusions, and transcatheter mitral valve repairs. They simplify transseptal crossing for electrophysiologists and interventional cardiologists to improve workflow, add procedural efficiencies and help alleviate complexity during left heart procedures.
Our Strategy
Following the Operational Downsizing, our strategy is to reduce our operations to a scale designed solely to support the manufacturing and distribution of Medtronic’s left-heart access products under the Distribution Agreement through the transition of the production of these products to Medtronic pursuant to the terms of the Asset Purchase Agreement and the Distribution Agreement, which would occur at a Second Closing under the Asset Purchase Agreement. Upon the occurrence of the Second Closing, we anticipate that our sole source of revenue would be potential earnouts from Medtronic’s sales of the left-heart access product portfolio to end-users pursuant to the Asset Purchase Agreement, and to further wind down operations to minimize costs while continuing to capture the value associated with potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027. We have also, and may continue to, explore opportunities for the sale of our remaining intellectual property assets relating to our former mapping and ablation business.
Competition
The medical device industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants.
Because our revenue following the Operational Downsizing is primarily dependent on our ability to capture the value associated with potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027, which is dependent on Medtronic’s ability to sell the Products, we face indirect competition from
Medtronic’s competitors for heart access products in the electrophysiology field, which we believe to include Abbott Laboratories, Biosense Webster Inc. (a Johnson & Johnson Company), and Boston Scientific Corporation.
Many competitors in the manufacturing services industry and the electrophysiology field are large, well-capitalized companies with significantly greater market share and resources. We believe that the principal competitive factors in the electrophysiology field are: name recognition; relations with healthcare professionals, customers and third-party payors; quality and depth of distribution networks; breadth of product lines and the ability to offer rebates or bundle products to offer discounts or other incentives; capabilities in research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for products; and financial and human resources for product development, manufacturing, sales and marketing and patent prosecution.
Intellectual Property
We rely on a combination of patent, trademark, trade secret, copyright and other intellectual property rights and measures to protect our technology and the continued commercialization of the Products by Medtronic.
As of December 31, 2024, our patent portfolio included 40 solely owned or exclusively licensed U.S. patents and 20 solely owned or exclusively licensed pending U.S. patent applications (including one solely owned Patent Cooperation Treaty, or PCT, application and zero solely owned provisional U.S. patent applications). In addition, we solely owned or exclusively licensed 56 issued patents and 42 pending patent applications in jurisdictions outside the United States. Of our 62 pending patent applications (U.S. and outside the U.S.), zero have been allowed. Our patents are scheduled to expire between 2027 and 2042. Further, pursuant to our sale of the Products to Medtronic, we no longer retain rights to any patents covering the Products.
For more information regarding the risks related to our intellectual property, please see the section titled “Risk Factors-Risks Related to Our Intellectual Property.”
Manufacture and Supply
We manufacture the Products for Medtronic at our approximately 50,800 square foot facility in Carlsbad, California. This facility provides approximately 15,750 square feet of space for our production operations, including manufacturing, quality control and storage. We believe our existing facility is sufficient to meet our current manufacturing needs and we believe that adequate additional space will be available if we require it. We also subleased out unused portions of the facility.
We stock inventory of raw materials, components and finished goods at our facility in Carlsbad. We rely on a single or limited number of suppliers for certain raw materials and components, and we generally have no long-term supply arrangements with our suppliers, as we generally order on a purchase order basis.
Government Regulation
Our manufacturing operations are subject to regulatory requirements of the FDA’s Quality System Regulation, or QSR, for medical devices sold in the United States, set forth in 21 CFR part 820, and the European Medical Device Directive 93/42/EEC and amendments, and the Products comply to ISO 13485 for manufacturing for medical devices marketed in the European Union. In addition, the Carlsbad facility is licensed by the California Food and Drug Branch.
We have registered with the FDA as a medical device manufacturer and have obtained a manufacturing license from the California Department of Public Health, or CDPH. The FDA and CDPH have broad post-market and regulatory enforcement powers. We are subject to unannounced inspections by the FDA and the Food and Drug Branch of CDPH to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our suppliers. Additionally, our Notified Body, DQS-MED, regularly inspects our manufacturing and operational facilities to ensure ongoing ISO 13485 compliance in order to maintain CE Mark.
We are also subject to applicable local regulations relating to the environment, waste management and health and safety matters including measures relating to the release, use, storage, treatment, transportation, discharge, disposal, sale, labeling, collection, recycling, treatment and remediation of hazardous substances. As of December 31, 2024, there were no material capital expenditures for environmental control facilities. Although there is no assurance that existing or future environmental laws applicable to our operations or the Products we manufacture will not have a material adverse effect on our operations, cash flows or financial condition, we do not currently anticipate material capital expenditures for environmental control facilities.
Human Capital Resources
As part of the Restructuring, we reduced our workforce by approximately 160 employees, representing approximately 65% of our employees at the time, that was completed by the first quarter of 2024. As part of the Operational Downsizing, we further reduced our workforce by 61 employees, representing approximately 70% of our employees, that is expected to be completed by the first quarter of 2025. In compliance with the Worker Adjustment and Retraining Notification Act, we have provided pre-termination notices to affected employees and government authorities where required. As of December 31, 2024, we had 85 employees, of which 85 are full-time employees.
As of December 31, 2024, we have paid $0.0 million of the estimated $1.4 million to $1.8 million in downsizing and exit-related charges, which includes approximately $0.3 million for the payment of severance and related benefit costs and $1.2 million for the payment of retention bonuses to certain employees that will assist with the Operational Downsizing. A majority of the cash expenditures charges was incurred in the first quarter of 2025, and we expect the Operational Downsizing to be substantially complete in the first quarter of 2025
Company Information
We were incorporated in Delaware on March 25, 2011 as Acutus Medical, Inc. Our principal executive offices and manufacturing facilities are located at 2210 Faraday Ave., Suite 100, Carlsbad, CA 92008, and our telephone number is (442) 232-6080. Our website address is www.acutusmedical.com. The information on, or that may be accessed through, our website is not a part of this report and the inclusion of our website address in this report is an inactive textual reference only.
“Acutus,” the “Acutus” logo, “Acutus Medical,” the “Acutus Medical” logo, “AcQMap,” the “AcQMap” logo, “AcQBlate,” the “AcQBlate” logo, “AcQGuide,” the “AcQGuide” logo], “AcQRef,” the “AcQRef” logo, “SuperMap,” the “SuperMap” logo, “UNCOVER AF” and the “UNCOVER AF” logo are trademarks or registered trademarks of our company. Our logo and our other trade names, trademarks and service marks appearing in this report are our property. Solely for convenience, our trademarks and trade names referred to in this report appear without the ™ or ® symbol, but those references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks and trade names. Other trade names, trademarks and service marks appearing in this report are the property of their respective owners.
We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports available free of charge at our website as soon as reasonably practicable after they have been filed with the SEC.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As such, we are eligible for exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation, and an exemption from the requirements to obtain a non-binding advisory vote on executive compensation or golden parachute arrangements.
In addition, an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this provision of the JOBS Act. As a result, we will not be subject to new or revised accounting standards at the same time as other public companies that are not emerging growth companies. Therefore, our consolidated financial statements may not be comparable to those of companies that comply with new or revised accounting pronouncements as of public company effective dates.
We will remain an emerging growth company until the earliest of: (i) December 31, 2025; (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion; (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; or (iv) the
date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
We are also a smaller reporting company as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

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ITEM 1A. RISK FACTORS
Item 1A. Risk Factors.
Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other information in this Annual Report on Form 10-K, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes before deciding whether to invest in shares of our common stock. The risks described below are not the only ones facing us. The occurrence of any of the following risks or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition, results of operations and future prospects. Please also see the section titled “Cautionary Note Regarding Forward-Looking Statements.”
Risks Related to our Business
We are dependent on Medtronic for all of our revenue, with no sales or marketing capabilities of our own, and following the completion of the Operational Downsizing and occurrence of the Second Closing, we will have no manufacturing capabilities of our own, and our business will rely solely on our ability to capture the value associated with potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027.
Following the Restructuring, we have no sales or marketing capabilities of our own, and we have relied solely on our strategic partnership with Medtronic to generate revenue through (i) the manufacture of the left-heart access product portfolio for Medtronic at transfer prices specified under our Distribution Agreement and (ii) potential earnouts from Medtronic’s sales of the left-heart access product portfolio to end-users. As a result of the Operational Downsizing, we further reduced operations to a scale designed solely to support the manufacturing and distribution of Medtronic’s left-heart access products under the Distribution Agreement through the transition of the production of these products to Medtronic pursuant to the terms of the Asset Purchase Agreement and the Distribution Agreement, which would occur at a Second Closing under the Asset Purchase Agreement as described under “Business-Left-Heart Access Portfolio Sale and Distribution Agreement”. Upon the occurrence of the Second Closing, we anticipate that our sole source of revenue would be potential earnouts from Medtronic’s sales of the left-heart access product portfolio to end-users pursuant to the Asset Purchase Agreement until 2027. Moreover, we do not expect further demand for our production of the Products from Medtronic under the Distribution Agreement after June 30, 2025 and, following the completion of the Operational Downsizing and occurrence of the Second Closing, we will have no manufacturing capabilities and no material operations. Accordingly, our success depends on Medtronic performing its obligations under the Distribution Agreement and the Asset Purchase Agreement and continuing to market and successfully sell the Products to end-users in order for us to achieve earnout payments under the Asset Purchase Agreement. There can be no assurance that Medtronic will be able to, or will, perform its obligations under the Distribution Agreement or the Asset Purchase Agreement, or continue to market and successfully sell the Products.
We believe that the factors that may effect Medtronic’s ability to continue to market and successfully sell the Products include, among other things:
•acceptance by Medtronic’s customers of the Products as safe, effective and, with respect to providers, cost-effective, and their level of demand for the Products;
•Medtronic’s ability to increase physician awareness of the Products and on the willingness of hospitals, physicians, patients or payors to adopt them;
•the coverage and reimbursement policies with respect to the procedures using the Products and current and future products that compete with the Products;
•defects or failures associated with the Products, including any that result in product recalls or other safety or end-user satisfaction issues relating to the Products;
•the medical device industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants, and many competitors in the electrophysiology field are large, well-capitalized companies that may invest greater resources than Medtronic in manufacturing, marketing and sales of current and future products that compete with the Products;
•the cost of manufacturing the Products, which may vary depending on the quantity of production and the terms of Medtronic’s agreements with third-party suppliers;
•the occurrence of natural disasters, outbreaks of disease or public health crises such as the COVID-19 pandemic; and
•economic uncertainty and capital markets disruption, including due to the ongoing military conflict between Russia and Ukraine and Israel and Hamas.
If Medtronic is unable to successfully market and sell the Products, or if Medtronic decided to no longer market and sell the Products, it would have a significantly negative effect on the potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027, and have a material adverse effect on our business, results of operation, cash flows and financial condition.
There are continued risks associated with the Restructuring and Operational Downsizing, including our ability to manage the transition costs to realize the anticipated benefits.
As part of the Restructuring and Operational Downsizing, we have recognized $27.1 million out of an estimated $22.4 million - 33.8 million of pre-tax restructuring and exit-related charges, for associated employee severance and benefits, retention bonuses, other restructuring costs and the disposition of certain assets. As part of our Operational Downsizing, we have incurred $0.3 million out of an estimated $1.8 million of pre-tax downsizing and exit-related charges, payment of monetary consideration and related benefit costs, retention bonuses and other contract closing costs. The amount of actual restructuring, downsizing, transition and impairment charges may materially exceed our estimates, when determined, due to various factors outside of our control. Moreover, we may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our realignment and downsizing efforts due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from the Restructuring and Operational Downsizing, our business, results of operations and financial condition would be adversely affected, and we may be forced to seek bankruptcy protection. The Restructuring and Operational Downsizing involve numerous risks, including but not limited to:
▪the inability of our remaining business to retain qualified personnel necessary to run the remaining business;
▪potential disruption of the operations of our remaining business and diversion of management’s attention from such business and operations;
▪exposure to unknown, contingent or other liabilities, including litigation arising in connection with the Restructuring or Operational Downsizing; and
▪unintended negative consequences from changes to our business profile.
Our ability to continue to have the liquidity necessary to service our debt, meet contractual payment obligations and fund our operations depends on many factors, including our ability to generate sufficient cash flow from operations or obtain other financing.
Our ability to continue to have the liquidity necessary to service our debt and meet financial covenants under our 2022 Credit Agreement depends on us generating sufficient cash, either through cash flows from operations or other financings. If we are unable to service our debt, we would be in default under the 2022 Credit Agreement, which would result in all amounts outstanding under such facility becoming immediately due and payable unless we are able to refinance such indebtedness or obtain a waiver or amendment of the 2022 Credit Agreement from our lenders, which may not be available to us on acceptable terms or at all. While we believe that cash on hand, remaining distribution revenue from left-heart access Products to Medtronic and future earnouts under the Asset Purchase Agreement will generate sufficient cash flows to service our debt and meet our obligations for the next twelve months; however, the foregoing expectation is dependent on a number of factors, including our ability to generate sufficient cash flow from operations, our ongoing ability to manage our operating obligations and the potential borrowing restrictions imposed by the Deerfield Funds based on their credit judgment.
In the event that we are unable to timely service our debt or fund our other liquidity needs, we may need to refinance all or a portion of our indebtedness before maturity, seek waivers of or amendments to our contractual obligations for payment, sell material assets, file for bankruptcy protection and/or liquidate our business, or seek other financing opportunities, none of which may be available to us on acceptable terms or at all.
Our board of directors may decide to pursue a liquidation and dissolution of our business prior to or following the conclusion of the Net Sales Earnout period. In such an event, the amount of cash available for distribution to our stockholders, if any, will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, including under our 2022 Credit Agreement.
Our board of directors may decide to pursue an assignment for the benefit of creditors, a reorganization or a dissolution of the Company and liquidation of all our remaining assets prior to or following the completion of the Net Sales Earnout period under the Asset Purchase Agreement. In such an event, the amount of cash available for distribution to our stockholders, if any, will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations. The process of liquidation may be lengthy, and we cannot make any assurances regarding the timing of completing such a process. If our board of directors were to approve and recommend, and our stockholders were to approve, a dissolution and liquidation, we would be required under Delaware corporate law to pay our outstanding obligations, including any under our 2022 Credit Agreement, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders. Further, upon our liquidation, dissolution, winding up, bankruptcy, receivership, general assignment for the benefit of creditors or other insolvency event, the Deerfield Funds would be entitled to a consent fee under Amendment No. 5 to the 2022 Credit Agreement in an amount equal to the lesser of $300,000 or 5.0% of the aggregate amount of total value that would otherwise be available to our equityholders. There is a substantial likelihood that no cash will be available to distribute to stockholders after paying our debts and other obligations and setting aside funds for reserves. In addition to our obligations to the Deerfield Funds and other creditors, our financial commitments and contingent liabilities may include: (i) personnel costs, including severance; (ii) contractual obligations to third parties; (iii) non-cancelable lease obligations; and (iv) potential litigation against us.
As a result of the requirement to reserve for contingencies, a portion of our assets may need to be reserved pending the resolution of such obligations and the timing of any such resolution is uncertain. In addition, we may be subject to litigation or other claims related to a dissolution and liquidation. If a dissolution and liquidation were pursued, our board of directors, in consultation with our advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of our common stock would likely lose all or a significant portion of their remaining investment in the event of a liquidation, dissolution or winding up.
Defects or failures associated with the Products we have manufactured for Medtronic under the Distribution Agreement may have a material adverse effect on our business, financial condition, cash flows and results of operations.
Under the Distribution Agreement, we provide a limited warranty that the Products are free of material defects and conform to specifications, and we offer to repair, replace or refund the purchase price of defective products. As a result, we bear the risk of potential warranty claims on the Products. Furthermore, in the event that a recall is caused by a Product due to our non-conformance with the Product specifications or quality requirements, we would be solely responsible for all costs and expenses reasonably incurred by Medtronic in connection with the recall. The circumstances giving rise to recalls are unpredictable, and any recalls of existing or future products could have a material adverse effect on our business, financial condition and results of operations. In the event that we attempt to recover some or all of the expenses associated with a warranty claim against us from our suppliers or vendors, we may not be successful in claiming recovery and any recovery from such vendor or supplier may not be adequate.
The medical device industry has historically been subject to extensive litigation over product liability claims. We may be subject to product liability claims if the Products cause, or merely appear to have caused, an injury or death, even if due to physician error. In addition, an injury or death that is caused by the activities of our suppliers such as those that provide us with components and raw materials, or by an aspect of a treatment used in combination with the Products such as a complementary drug or anesthesia, may be the basis for a claim against us by patients, hospitals, physicians or others purchasing or using the Products, even if the Products were not the actual cause of such injury or death. An adverse outcome of any such claim involving one of the Products could result in our incurring substantial liabilities to Medtronic under the Distribution Agreement.
Although we carry product liability insurance, we can give no assurance that such coverage will be available or adequate to satisfy any claims. Product liability insurance is expensive, subject to significant deductibles and exclusions, and may not continue to be available on acceptable terms, if at all. Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, harm our reputation, significantly increase our expenses and reduce sales of the Products. If we are unable to obtain or maintain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we could be exposed to significant liabilities. Product liability claims could cause us to incur significant legal fees and deductibles, and claims in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and operating results. Defending a suit regardless of its merit or eventual outcome could be costly, could divert management’s attention from our business and might result in adverse publicity, which could result in reduced acceptance of the Products in the market, in product recalls or in market withdrawals.
We are required to file adverse event reports under MDR regulations with the FDA which are publicly available on the FDA’s website. We are required to file MDRs if the Products we manufacture may have caused or contributed to a serious injury or death or malfunctioned in a way that could likely cause or contribute to a serious injury or death if it were to recur. Any such MDR that reports a significant adverse event could result in negative publicity, which could harm our reputation and Medtronic’s future sales. See “-Risks Related to Government Regulation-If any of the Products we manufacture cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.”
If we are unable to comply with our remaining obligations to Medtronic, it could have a material adverse effect on our business, results of operation, cash flows and financial position.
If we are unable to comply with our remaining obligations to Medtronic under the Distribution Agreement and the Asset Purchase Agreement, including but not limited to our obligations to meet Medtronic demand for manufacture of the Products (if any) or transfer to Medtronic certain assets relating to the Products required for Medtronic to become manufacturer of record of the Products at the Second Closing, we could be in breach or default under these agreements and face liability. If we fail to comply with our obligations under these agreements, Medtronic may have the right to terminate these agreements, which would negatively impact our ability to earn the earnouts we are potentially eligible to receive under the Asset Purchase Agreement and prevent us from meeting the Second Closing conditions. We would be in default under our 2022 Credit Agreement, which would result in all amounts
outstanding under such facility becoming immediately due and payable unless we are able to refinance such indebtedness or obtain a waiver or amendment of the 2022 Credit Agreement from our lenders. Thus, failure to comply with our remaining obligations to Medtronic could have a material adverse effect on our business, results of operations, cash flows and financial position.
If we underestimate Medtronic demand for the Products, or if the Second Closing does not occur or does not occur on the timeline we anticipate, we may encounter substantial difficulties managing the ramp up of our operations given our Operational Downsizing. If we are unable to meet Medtronic demand, we may be in violation of our obligations under the Distribution Agreement and Asset Purchase Agreement and lose the earnouts we are eligible to receive under these agreements.
We have effectuated an Operational Downsizing to reduce our operations to a scale designed solely to support the manufacturing and distribution of Medtronic’s Products under the Distribution Agreement through the transition of the production of these Products to Medtronic pursuant to the terms of the Asset Purchase Agreement and the Distribution Agreement, which would occur at a Second Closing under the Asset Purchase Agreement. However, if we underestimate Medtronic demand for the Products, or if the Second Closing does not occur or does not occur on the timeline we anticipate, we may encounter substantial difficulties and incur significant costs to quickly ramp up our operations and resume hiring of skilled personnel to ensure we have sufficient manufacturing capabilities to meet our obligations under the Distribution Agreement and the Asset Purchase Agreement. We may be unable to meet our obligations under these agreements, which would cause us to be in breach or default of such agreements and negatively impact our ability to earn the earnouts we are potentially eligible to receive under the Asset Purchase Agreement and cause us to lose significant revenue opportunities.
The terms of our 2022 Credit Agreement, require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
On June 30, 2022, we amended and restated our prior debt facility under the 2019 credit agreement with the 2022 Credit Agreement, which provided us with a senior term loan facility in aggregate principal amount of $35 million.
On August 4, 2023, we entered into Amendment No. 1 (“Amendment No.1”) to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 1, the 2022 Credit Agreement was amended to decrease the amount of cash we are required to maintain pursuant to the minimum liquidity covenant in the 2022 Credit Agreement to $5,000,000 for a period of 18 months, at which point the amount required under the minimum liquidity covenant shall increase to $20,000,000 (or, if certain conditions are met, $10,000,000), in exchange for a fee paid by us.
On November 8, 2023, we entered into Amendment No. 2 (“Amendment No. 2”) to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 2, the 2022 Credit Agreement was amended to, among other things: (i) adjust and increase the amortization schedule such that payments commence on June 30, 2024 and are made 12, 24 and 36 months (i.e., the scheduled maturity date) following June 30, 2024; (ii) limit the business activities the Company may engage in; and (iii) require us to maintain a minimum liquidity of $10,000,000 at all times, in exchange for fees paid by us.
On March 4, 2024, we entered into Waiver and Amendment No. 3 (“Amendment No. 3”) to the 2022 Credit Agreement with the Deerfield Funds. Previously, on February 16, 2024, the Biotronik Parties filed a demand (the "Demand") against us with the American Arbitration Association, alleging that we breached our contractual obligations under five agreements relating to the licensing, manufacturing, distribution and development of medical devices as a result of the wind down of our businesses. Pursuant to Amendment No. 3, Deerfield has agreed to waive any Default or Event of Default (each defined in the 2022 Credit Agreement) that has arisen or may arise in connection with the Demand. In addition, pursuant to Amendment No. 3, among other things, (i) the 2022 Credit Agreement was amended such that (x) a Change in Control (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement would not be deemed to occur in the event our common stock ceases to be listed on Nasdaq (without a comparable re-listing) (a “Delisting”) and (y) exposure incurred in excess of $3.0 million in respect of proceedings in relation to the Demand and/or related proceedings and/or between such parties is deemed an Event of Default (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement.
On November 13, 2024, we entered into Amendment No. 4 (“Amendment No. 4”) to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 4, the 2022 Credit Agreement was amended to (i) adjust the amortization schedule of the 2022 Credit Agreement such that the $7.5 million installment payment of principal due on June 30, 2025 would be made over three equal installments of $2.5 million on each of June 30, 2025, September
30, 2025 and December 31, 2025 and (ii) increase the exit fee associated with prepayment or repayment of the loans from 5.0% to 6.0% of the principal amount of the loans prepaid or repaid.
On January 21, 2025, we entered into Amendment No. 5 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 5, the 2022 Credit Agreement was amended to allow us to effect the Deregistration and, among other things: (i) provided that the Deerfield Funds would receive a Consent Fee in the form of a contingent value right payable upon certain triggering events in an amount equal to the lesser of $300,000 or 5.0% of the aggregate amount of total value that would otherwise be available to our equityholders; (ii) modified the financial reporting requirements under the 2022 Credit Agreement, including requiring delivery of cash flow forecasts to the Deerfield Funds; (iii) required the appointment of a Chief Restructuring Officer; and (iv) modified the negative covenants to limit our business activities and required us to maintain minimum liquidity of $5 million.
Our payment obligations under the 2022 Credit Agreement reduced cash available to fund working capital, capital expenditures, manufacturing and general corporate needs. In addition, indebtedness under the 2022 Credit Agreement bears interest at a variable rate, making us vulnerable to increases in market interest rates. If market rates increase, we will have to pay additional interest on this indebtedness, which would further reduce cash available for our other business needs.
Our obligations under the 2022 Credit Agreement are secured by substantially all of our assets and the assets of our wholly-owned subsidiary. The security interest granted over our assets could limit our ability to obtain additional debt financing. In addition, the 2022 Credit Agreement contains customary affirmative and negative covenants restricting our activities, including limitations on:
◦dispositions, mergers or acquisitions; encumbering our intellectual property;
◦incurring indebtedness or liens;
◦paying dividends or redeeming stock or making other distributions;
◦making certain investments;
◦liquidating our company;
◦modifying our organizational documents;
◦entering into sale-leaseback arrangements; and,
◦engaging in certain other business transactions.
In addition, we are required to maintain a minimum liquidity amount of $5.0 million. Failure to comply with the covenants in the 2022 Credit Agreement, including the minimum liquidity covenant, could result in the acceleration of our obligations under the 2022 Credit Agreement, and, if such acceleration were to occur, would materially and adversely affect our business, financial condition and results of operations.
We may not have sufficient funds, and may be unable to arrange for additional financing, to pay the amounts due under our debt arrangement. The obligations under the 2022 Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to regulatory approvals and a material adverse change in our business, operations or other financial condition. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, Wilmington Trust may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. The 2022 Credit Agreement also provides for final payment fees that are due upon prepayment, on the maturity date or upon acceleration, as well as prepayment penalties.
Our outstanding indebtedness and any future indebtedness combined with our other financial obligations could increase our vulnerability to adverse changes in general economic, industry and market conditions, limit our flexibility in planning for, or reacting to, changes in our business and the industry and impose a competitive disadvantage compared to our competitors that have less debt or better debt servicing options.
Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, gross receipts, value added or similar taxes and may successfully impose additional obligations on us, and any such assessments or obligations could adversely affect our business, financial condition and results of operations.
We have not historically collected sales and use, gross receipts, value added or similar taxes, although we may be subject to such taxes in various jurisdictions. One or more jurisdictions may seek to impose additional tax collection obligations on us, including for past sales. A successful assertion by a state, country or other jurisdiction that we should have been or should be collecting additional sales, use or other taxes on our services could, among other things, result in substantial tax liabilities for past sales, create significant administrative burdens for us or otherwise harm our business, results of operations and financial condition.
Our ability to utilize our net operating loss carryforwards may be limited.
As of December 31, 2024, we had U.S. federal and state net operating loss, or NOL, carryforwards of approximately $458.7 million and $150.1 million, respectively. We may use these NOLs to offset against taxable income for U.S. federal and state income tax purposes. If not utilized, our U.S. federal NOLs (and our state NOLs in conforming states) arising in taxable years beginning before 2018 will begin to expire in 2031. Deductibility of U.S. federal NOLs arising in taxable years beginning after 2017 may be carried forward 20 years and are limited to 80% of our taxable income before the deduction for such NOLs. Additionally, Section 382 of the Internal Revenue Code of 1986, as amended, may limit the NOLs we may use in any year for U.S. federal income tax purposes in the event of certain changes in ownership of our company. A Section 382 “ownership change” generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. Similar rules may apply under state tax laws. In addition, future issuances or sales of our stock, including certain transactions involving our stock that are outside of our control, could result in future “ownership changes.” “Ownership changes” that have occurred in the past or that may occur in the future could result in the imposition of an annual limit on the amount of pre-ownership change NOLs and other tax attributes we can use to reduce our taxable income, potentially increasing and accelerating our liability for income taxes, and also potentially causing those tax attributes to expire unused. Any limitation on using NOLs could, depending on the extent of such limitation and the NOLs previously used, result in our retaining less cash after payment of U.S. federal and state income taxes during any year in which we have taxable net income than we would be entitled to retain if such NOLs were available as an offset against such income for U.S. federal and state income tax reporting purposes, which could adversely impact operating results.
If we experience significant disruptions in our information technology systems, our business may be adversely affected.
We depend on our information technology systems for the efficient functioning of our business, including the manufacture, distribution and maintenance of the Products, as well as for accounting, data storage, compliance, purchasing and inventory management. We do not have redundant information technology systems at this time. Our information technology systems may be subject to computer viruses, ransomware or other malware, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, damage or interruption from fires or other natural disasters, hardware failures, telecommunication failures and user errors, among other malfunctions. We could be subject to any number of unintentional events that could involve a third party gaining unauthorized access to our systems, which could disrupt our operations, corrupt our data or result in release of our confidential information. Technological interruptions could disrupt our operations, including our ability to timely ship and track product orders, project inventory requirements, manage our supply chain and otherwise adequately service Medtronic’s ability to use the Products for treatments. In the event we experience significant disruptions, we may be unable to repair our systems in an efficient and timely manner. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse effect on our business, financial condition and results of operations. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or result in inappropriate disclosure of confidential or proprietary information, we could incur liability.
Currently, we carry business interruption coverage to mitigate certain potential losses, but this insurance is limited in amount and may not be sufficient in type or amount to cover us against claims related to security breaches, cyber-attacks and other related data and system disruptions. We cannot be certain that such potential losses will not exceed our policy limits, whether insurance will continue to be available to us on economically reasonable terms, or at all, or whether any insurer will not deny coverage as to any future claim. In addition, we may be subject to changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements. We are increasingly dependent on complex information technology to manage our infrastructure. Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance our
existing systems. Failure to maintain or protect our information systems and data integrity effectively could have a material adverse effect on our business, financial condition and results of operations.
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
The information we stored historically includes sensitive data, including procedure-based information, and legally protected health information, insurance information and other potentially personally identifiable information. We also store sensitive intellectual property and other proprietary business information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology, or IT, and infrastructure, and that of our third-party billing and collections provider and other technology partners, may be vulnerable to cyber-attacks by hackers or viruses or breached due to employee error, malfeasance, social engineering (including phishing), ransomware, supply chain attacks and vulnerabilities through our third-party partners, credential stuffing, efforts by individuals or groups of hackers and sophisticated organizations including state-sponsored organizations, bug or security vulnerabilities in the software or systems on which we rely or other disruptions. We rely extensively on IT systems, networks and services including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided and/or used by third parties or their vendors to assist in conducting our business. A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or infrastructure by our workforce, by others with authorized access to our systems or by unauthorized persons could negatively impact operations. The ever-increasing use and evolution of technology including cloud-based computing creates opportunities for the unintentional dissemination or intentional destruction of confidential information stored in our or our third-party providers’ systems, in portable media or in storage devices. We could also experience a business interruption, a theft of confidential information or the reputational damage from industrial espionage attacks, malware or other cyber-attacks, which may compromise our system infrastructure or lead to data leakage either internally or at our third-party providers. Although the aggregate impact on our operations and financial condition has not been material to date, we have been the target of events of this nature and expect them to continue as cybersecurity threats have been rapidly evolving in sophistication and becoming more prevalent in the industry. We are investing in protections and monitoring practices of our data and IT to reduce these risks and we continue to monitor our systems on an ongoing basis for any current or potential threats. There can be no assurance, however, that our efforts will prevent breakdowns or breaches to our or our third-party providers’ databases or systems that could materially and adversely affect our business, financial condition and results of operations.
Additionally, we cannot be certain that any insurance coverage that we may maintain will be adequate or otherwise protect us with respect to claims, expenses, fines, penalties, business loss, data loss, litigation, regulatory actions or other impacts arising out of security breaches or other disruptions, or that such coverage will continue to be available on acceptable terms or at all. Any of these results could adversely affect our business, financial condition and results of operations.
Risks Related to Government Regulation
Regulatory compliance is expensive, complex and uncertain, and failure to comply could lead to enforcement actions against us and other negative consequences for our business.
The current Products that we manufacture are subject to extensive regulation by the FDA in the United States, our Notified Body in the European Union and certain other non-U.S. regulatory agencies. Complying with these regulations is costly, time-consuming, complex and uncertain. Government regulations specific to medical devices are wide-ranging and include, among other things, oversight of:
◦product design, development, manufacture (including our suppliers) and testing;
◦product safety and effectiveness;
◦product labeling;
◦product storage and shipping;
◦record keeping;
◦product sales and distribution;
◦product changes;
◦product recalls; and
◦post-market surveillance and reporting of deaths or serious injuries and certain malfunctions.
In order to sell the Products in member countries of the EEA, the Products must comply with the essential requirements of the Medical Device Directive, or MDD. Compliance with these requirements is a prerequisite to be able to affix the CE Mark to the Products, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with the essential requirements, we must undergo a conformity assessment procedure which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I non-sterile, non-measuring devices) where the manufacturer can issue an European Commission Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the MDD, a conformity assessment procedure requires the intervention by a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. The Notified Body issues a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements. This certificate entitles the manufacturer to affix the CE Mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. If we fail to be in compliance with applicable European laws and directives, we would be unable to affix the CE Mark to the Products, which would prevent Medtronic from selling them within the EEA.
Further, failure to comply with applicable U.S. requirements regarding, for example, manufacturing or labeling the Products, may subject us to a variety of administrative or judicial actions and sanctions, such as Form 483 observations, warning letters, untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.
Any enforcement action by the FDA and other comparable non-U.S. regulatory agencies could have a material adverse effect on our business, financial condition and results of operations. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state or international agencies, which may include any of the following actions:
◦untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
◦unanticipated expenditures to address or defend such actions;
◦customer notifications for repair, replacement or refunds;
◦recall, detention or seizure of the Products;
◦operating restrictions or partial suspension or total shutdown of production;
◦refusing or delaying requests for 510(k) clearance or Premarket Approval, or PMA, of modified products;
◦operating restrictions;
◦withdrawing 510(k) clearances or PMA that have already been granted;
◦refusal to grant export approval for the Products; or
◦criminal prosecution.
If any of these events were to occur, it would have a material and adverse effect on our business, financial condition and results of operations.
Our operations are subject to pervasive and continuing FDA regulatory requirements.
Medical devices regulated by the FDA are subject to controls which include: registration with the FDA; listing commercially distributed products with the FDA; complying with current Good Manufacturing Processes under QSR; filing reports with the FDA, and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation; assuring that device labeling complies with device labeling requirements; and reporting certain device field removals and corrections to the FDA.
The medical device industry is now experiencing greater scrutiny and regulation by federal, state and foreign governmental authorities. Companies in our industry are subject to more frequent and more intensive reviews and investigations, often involving the marketing, business practices and product quality management. Such reviews and
investigations may result in civil and criminal proceedings; the imposition of substantial fines and penalties; the receipt of warning letters, untitled letters, demands for recalls or the seizure of the Products; the requirement to enter into corporate integrity agreements, stipulated judgments or other administrative remedies; and could result in our incurring substantial unanticipated costs and the diversion of key personnel and management’s attention from their regular duties, any of which may have a material and adverse effect on our business, financial condition and results of operations, and may result in greater and continuing governmental scrutiny of our business in the future.
If we fail to comply with the FDA’s QSR, or other FDA or European Union requirements, the FDA or the competent European Union authority could take various enforcement actions including halting our manufacturing operations, and our business would suffer.
In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of medical devices. The FDA enforces the QSR through periodic inspections and unannounced “for cause” inspections.
We are subject to periodic FDA inspections to determine compliance with QSR and pursuant to the Bioresearch Monitoring Program, which may in the future result in the FDA issuing Form 483s. Outside the United States, the Products we manufacture and our operations are also often required to comply with standards set by industrial standards bodies such as the International Organization for Standardization. Foreign regulatory bodies may evaluate the Products or the testing that the Products undergo against these standards. The specific standards, types of evaluation and scope of review differ among foreign regulatory bodies. Our failure to comply with FDA or local requirements that pertain to clinical trials/investigations, including GCP requirements and the QSR (in the United States), or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing the Products, refusal to permit the import or export of the Products, prohibition on sales of the Products, a recall or seizure of the Products, fines, injunctions, civil or criminal penalties or other sanctions, any of which could cause our business and operating results to suffer.
The Products may be subject to recalls after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation and adversely affect our business.
The FDA and similar foreign governmental authorities have the authority to require the recall of the Products because of any failure to comply with applicable laws and regulations or because of defects in design or manufacture. A government mandated or voluntary product recall by us or Medtronic could occur because of, for example, component failures, device malfunctions or other adverse events such as serious injuries or deaths or quality-related issues such as manufacturing errors or design or labeling defects. Any future recalls of the Products could divert managerial and financial resources, harm our reputation and adversely affect our business.
If we initiate a correction or removal for one of the Products we manufacture to reduce a risk to health posed by such product, we would be required to submit a publicly available Correction and Removal report to the FDA and, in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA as a product recall which could lead to increased scrutiny by the FDA, other international regulatory agencies and Medtronic regarding the quality and safety of the Products. Furthermore, the submission of these reports has been and could be used by competitors against us in competitive situations and cause Medtronic to delay purchase decisions or cancel orders from us and would harm our reputation.
If any of the Products we manufacture cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable MDR regulations, which can result in voluntary corrective actions or agency enforcement actions.
Under FDA MDR regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. If we fail to report events required to be reported to the FDA within the required timeframes, or at all, the FDA could take enforcement action and impose sanctions against us. Any such adverse event involving the Products also could result in future voluntary corrective actions such as recalls or customer notifications, or agency action such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, would require our time and capital, distract management from operating our business and may harm our reputation and have a material adverse effect on our business, financial condition and results of operations.
Our strategic partner, employees, independent contractors, consultants, and vendors may engage in misconduct or other improper activities including noncompliance with regulatory standards and requirements.
We are exposed to the risk that our strategic partner, employees, independent contractors, consultants and vendors may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the laws of the FDA and other similar foreign regulatory bodies including those laws requiring the reporting of true, complete and accurate information to such regulators; (ii) manufacturing standards; (iii) healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (iv) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact, among other things, future sales. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally.
We have adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, additional integrity reporting and oversight obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against any such actions or investigations, we could incur substantial costs including legal fees and the diversion of the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition and results of operations.
Compliance with environmental laws and regulations could be expensive, and failure to comply with these laws and regulations could subject us to significant liability.
Our manufacturing operations involve the use of hazardous substances and are subject to a variety of federal, state, local and foreign environmental laws and regulations relating to the storage, use, discharge, disposal, remediation of, and human exposure to, hazardous substances and the sale, labeling, collection, recycling, treatment and disposal of products containing hazardous substances. Liability under environmental laws and regulations can be joint and several and without regard to fault or negligence. Compliance with environmental laws and regulations may be expensive, and noncompliance could result in substantial liabilities, fines and penalties, personal injury and third-party property damage claims and substantial investigation and remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of these laws and regulations will not occur in the future, or have not occurred in the past, as a result of human error, accidents, equipment failure or other causes. The expense associated with environmental regulation and remediation could harm our financial condition and results of operations.
Risks Related to Our Intellectual Property
We are a contract manufacturer, and our lack of any meaningful registered intellectual property means we rely solely on our manufacturing processes for our success.
We are a contract manufacturer of the Products for Medtronic, and our business is largely dependent upon our manufacturing processes and know-how. Pursuant to our sale of the Products to Medtronic, we no longer retain any patents covering the Products, and we no longer have an intellectual property position that is protected by meaningful registered intellectual property. The lack of strong patent and other intellectual property protection increases our vulnerability and sole dependence on our manufacturing processes for our success.
We are required to indemnify Medtronic for intellectual property claims in respect of the Products under the Asset Purchase Agreement, and as a result we may become a party to intellectual property litigation or
administrative proceedings that could be costly and could interfere with our ability to sell the Products to Medtronic and Medtronic’s ability to sell the Products to end-users.
The medical device industry has been characterized by extensive litigation regarding patents, trademarks, trade secrets and other intellectual property rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. It is possible that U.S. and foreign patents and pending patent applications or trademarks controlled by third parties may be alleged to cover the Products. Additionally, the Products include components that we purchase from vendors, and may include design components that are outside of our direct control. Our competitors, many of which have substantially greater resources and have made substantial investments in patent portfolios, trade secrets, trademarks and competing technologies, may have applied for or obtained, or may in the future apply for or obtain, patents or trademarks that will prevent, limit or otherwise interfere with our ability to make, use, sell and/or export the Products to Medtronic, or Medtronic’s ability to sell and/or export the Products to end-users. Because patent applications can take years to issue and are often afforded confidentiality for some period of time, there may currently be pending applications, unknown to us, that later result in issued patents that could cover one or more of the Products. Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that our products and business operations infringe or violate the intellectual property rights of others. The defense of these matters can be time consuming, costly to defend in litigation, divert management’s attention and resources, damage our reputation and brand and cause us to incur significant expenses or make substantial payments. Vendors from whom we purchase hardware or software may not indemnify us in the event that such hardware or software is accused of infringing a third party’s patent or trademark or of misappropriating a third party’s trade secret, or any indemnification granted by such vendors may not be sufficient to address any liability and costs we incur as a result of such claims. Additionally, we may be obligated to indemnify our business partners in connection with litigation and to obtain licenses or refund fees, which could further exhaust our resources.
For example, under our Asset Purchase Agreement with Medtronic, we are required to indemnify Medtronic against the risk of intellectual property claims related to the Products. We may be responsible for claims that the Products we supply use, infringe, misappropriate or otherwise violate third party intellectual property rights.
Even if we believe a third party’s intellectual property claims are without merit, there is no assurance that a court would find in our favor, including on questions of infringement, validity, enforceability or priority of patents. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect our ability to sell the Products to Medtronic and Medtronic’s ability to sell the Products to end-users. In order to successfully challenge the validity of any such U.S. patent in federal court, the presumption of validity must be overcome. This burden is a high one requiring clear and convincing evidence as to the invalidity of any such U.S. patent claim, and there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof.
Further, if patents, trademarks or trade secrets are successfully asserted against us or Medtronic, this may harm our business and result in injunctions preventing us from developing, manufacturing or selling the Products to Medtronic or them from selling the Products to end-users, or result in obligations to pay license fees, damages, attorney fees and court costs, which could be significant. In addition, if a party is found to willfully infringe third-party patents or trademarks or to have misappropriated trade secrets, that party could be required to pay treble damages in addition to other penalties.
Our rights to develop, manufacture and distribute the Products to Medtronic are subject, in part, to the terms and conditions of licenses granted to us by Medtronic.
We rely, in part, upon licenses to certain patent rights and proprietary technology from Medtronic that are important or necessary to the development, manufacturing and distribution of the Products to Medtronic. We may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications covering such technology. Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced and defended in a manner consistent with the best interests of our business. If our licensor, Medtronic, fails to prosecute, maintain, enforce and defend such patents, or loses rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop, manufacture or distribute any of the Products that are the subject of such licensed rights could be adversely affected.
If we are unable to protect the confidentiality of our other proprietary information covering the Products, our business and competitive position may be harmed.
We also rely on other proprietary rights, including protection of trade secrets and other proprietary information that is not patentable or that we elect not to patent. However, trade secrets can be difficult to protect and some courts are less willing or are unwilling to protect trade secrets. To maintain the confidentiality of our trade secrets and proprietary information, we rely heavily on confidentiality provisions that we have in contracts with our employees, consultants, contractors, collaborators and others upon the commencement of their relationship with us. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by such third parties despite the existence generally of these confidentiality restrictions. These contracts may not provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use, misappropriation or disclosure of such trade secrets, know-how or other proprietary information. There can be no assurance that such third parties will not breach their agreements with us, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known or independently developed by competitors. Despite the protections we do place on our intellectual property or other proprietary rights, monitoring unauthorized use and disclosure of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property or other proprietary rights will be adequate. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. The laws of many foreign countries will not protect our intellectual property or other proprietary rights to the same extent as the laws of the United States. Consequently, we may be unable to prevent our proprietary technology from being exploited in the United States and abroad, which could require costly efforts to protect the technology.
To the extent our intellectual property or other proprietary information protection is incomplete, we are exposed to a greater risk of direct competition. A third party could, without authorization, copy or otherwise obtain and use the Products, or develop similar technology. Our competitors could purchase the Products from Medtronic and attempt to replicate some or all of the competitive advantages derived the design around any protected technology. Our failure to secure, protect and enforce our intellectual property rights could substantially harm the value of the Products and our business. The theft or unauthorized use or publication of our trade secrets and other confidential business information could reduce the differentiation of the Products and harm our business.
We also seek to preserve the integrity and confidentiality of our data and other confidential information by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and detecting the disclosure or misappropriation of confidential information and enforcing a claim that a party illegally disclosed or misappropriated confidential information is difficult, expensive and time-consuming, and the outcome is unpredictable. Further, we may not be able to obtain adequate remedies for any breach. Any of the foregoing could materially and adversely affect our business, financial condition and results of operations.
Maintaining patent protection for the Products depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection for the Products could be reduced or eliminated by Medtronic’s non-compliance with these requirements, which could have a material adverse effect on our business, financial condition and results of operations.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees on issued patents and patent applications will be due to the USPTO and foreign patent agencies over the lifetime of such patents or patent applications. We rely on Medtronic to pay these fees due to U.S. and non-U.S. patent agencies for patents in respect of the Products. While an unintentional lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If Medtronic fails to maintain the patents covering the Products, we may not be able to stop a competitor from marketing products that are the same as or similar to the Products, which could have a material adverse effect on our business, financial condition and results of operations.
We may be subject to claims that we or our employees, consultants or contractors have wrongfully used, disclosed or otherwise misappropriated the intellectual property of a third party, including trade secrets or know-how, or
are in breach of non-competition or non-solicitation agreements with our competitors or claims asserting an ownership interest in intellectual property we regard as our own or otherwise transferred to Medtronic.
Many of our employees, consultants and contractors were previously employed at or engaged by other medical device, biotechnology or pharmaceutical companies, including our competitors or potential competitors. Some of these employees, consultants and contractors may have executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Although we try to ensure that our employees, consultants and contractors do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may be subject to claims that we or these individuals have, inadvertently or otherwise, used, disclosed or otherwise misappropriated intellectual property, including trade secrets or other proprietary information of their former employers or our competitors or potential competitors. Additionally, we may be subject to claims from third parties challenging our ownership interest in intellectual property we regard as our own or transferred to Medtronic based on claims that our employees, consultants or contractors have breached an obligation to assign inventions to another employer, to a former employer or to another person or entity.
Litigation may be necessary to defend against such claims, and it may be necessary to enter into a license to settle any such claim; however, there can be no assurance that a license would be obtained on commercially reasonable terms, if at all. If our defense to those claims fails, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. For example, a court could prohibit us from using technologies or features that are essential to the Products if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employer. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.
An inability to incorporate technologies or features that are important or essential to the Products could have a material adverse effect on our business, financial condition and results of operations, and may prevent us from selling the Products to Medtronic or Medtronic from selling the Products to end-users. Any litigation or the threat thereof may adversely affect our ability to maintain employees. A loss of key personnel or their work product could hamper or prevent our ability to manufacture the Products for Medtronic, which could have an adverse effect on our business, financial condition and results of operations.
We may be subject to claims challenging the inventorship of the patents we transferred to Medtronic and other intellectual property in respect of the Products.
We or Medtronic may be subject to claims that former consultants, contractors or other third parties have an interest in the patents, trade secrets or other intellectual property in respect of the Products that we transferred to Medtronic as an inventor or co-inventor. While it is our policy to require our employees, consultants and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and we or Medtronic may be forced to bring claims against third parties or defend claims that they may bring against us or Medtronic to determine the ownership the intellectual property. Under our Asset Purchase Agreement with Medtronic, we are required to indemnify Medtronic against the risk of intellectual property claims related to the Products. We may be responsible for claims that the Products we supply use, infringe, misappropriate or otherwise violate third party intellectual property rights. If we or Medtronic fail in defending any such claims, in addition to paying monetary damages, we or Medtronic may lose valuable intellectual property rights such as exclusive ownership of, or right to use, intellectual property that is important to the Products. Any such events could have a material adverse effect on our business, financial condition and results of operations.
Risks Related to Our Common Stock
Our common stock has been delisted from Nasdaq, and we have undertaken actions to effect a “going dark” transaction, including the deregistration of our common stock with the SEC, including the suspension of our reporting obligations under Exchange Act.
As previously disclosed, Nasdaq suspended trading in our common stock on May 9, 2024, due to noncompliance with Nasdaq Listing Rule 5550(a)(2) and 5550(b). On May 15, 2024, Nasdaq announced that it would formally delist our common stock that was previously suspended. On May 16, 2024, Nasdaq filed a Form 25 Notification of Delisting with the SEC to complete the delisting and remove such securities from registration under Section 12(b) of the Exchange Act, and such delisting took effect on May 26, 2024. The deregistration of our common stock under Section 12(b) of the Exchange Act was effective 90 days after the Form 25 filing. On May 9, 2024, our common stock began trading over the counter on the OTC Pink Market under the trading symbol “AFIB.”
In January 2025, our board determined to effect the Deregistration. We filed a Form 15 with the SEC to voluntarily effect the Deregistration. The filing of the Form 15 immediately suspended our reporting obligations under Section 13(a) of the Exchange Act, subject only to our obligation to file a Form 10-K for our fiscal year ended December 31, 2024. We expect the Deregistration to become effective 90 days after filing the Form 15 with the SEC.
These actions have the following effect:
◦Except for the filing this Form 10-K, we have ceased filing annual, quarterly, current, and other reports and documents with the SEC, and our stockholders will have significantly less information about us and our business, operations, and financial performance than they previously had.
◦We are no longer listed on Nasdaq, which may have an adverse effect on the liquidity of our common stock. Any trading in our common stock will only occur in privately negotiated sales and on the OTC, but only if one or more brokers chooses to make a market for our common stock on the OTC and complies with applicable regulatory requirements, which may adversely affect the liquidity of our common stock and result in a significantly increased spread between the bid and asked prices of our common stock, and there is no guarantee that a broker will continue to make a market in our common stock and that trading of our common stock will continue on the OTC or otherwise. Additionally, the overall price of our stock may be significantly reduced due to the potential that investors may view the investment as inherently riskier given the fact that publicly available information about us will be significantly more limited, as well as due to possible limited liquidity of our common stock.
◦We will no longer be subject to the reporting requirements under the Exchange Act or other requirements applicable to a public company, including requirements under the Sarbanes-Oxley Act and the listing standards of any national securities exchange.
◦Our executive officers, directors and 10% stockholders will no longer be required to file reports relating to their transactions in our common stock with the SEC. In addition, our executive officers, directors and 10% shareholders will no longer be subject to the recovery of profits provision of the Exchange Act, and persons acquiring 5% of our common stock will no longer be required to report their beneficial ownership under the Exchange Act.
◦We will have no ability to access the public capital markets or to use public securities in attracting and retaining executives and other employees, and we will have a decreased ability to use stock to acquire other companies.
Since our common stock was delisted from Nasdaq and is traded over-the-counter, your ability to trade and the market price of our shares of common stock may be negatively impacted.
Since our common stock was delisted from Nasdaq and is traded on the over-the-counter market, the application of the “penny stock” rules could adversely affect the market price of our common stock and increase the transaction costs to sell those shares. The SEC has adopted regulations which generally define a “penny stock” as any equity security not listed on a national securities exchange or quoted on Nasdaq that has a market price of less than $5.00 per share, subject to certain exceptions. Since our common stock was delisted from Nasdaq and is traded on the over-the-counter market at a price of less than $5.00 per share, our common stock is considered a penny stock. Unless otherwise exempted, the SEC’s penny stock rules require a broker-dealer, before a transaction in a penny stock, to deliver a standardized risk disclosure document that provides information about penny stock and the risks in the penny stock market, the current bid and offer quotations for the penny stock, the compensation of the broker-dealer and the salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. Further, prior to a transaction in a penny stock, the penny stock rules require the broker-dealer to provide a written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s agreement to the transaction. The penny stock rules restrict the ability of
brokers-dealers to sell our common stock and may affect the ability of investors to sell their shares, until our common stock is no longer a penny stock.
We have in the past and may be in the future subject to securities litigation, which is expensive and could divert management attention.
We and certain of our current officers have been named as defendants in two putative securities class action lawsuits filed by putative stockholders in the United States District Court for the Southern District of California on February 15, 2022 and March 23, 2022 (case numbers 22CV206 and 22CV0388). The plaintiffs allege that the defendants violated Section 10(b) of the Exchange Act and Rule 10b-5 and Section 20(a) of the Exchange Act. The complaints allege that the defendants made false and misleading statements about our business, prospects and operations. The putative claims are based upon statements made in filings made by us with the SEC, press releases and on earnings calls between May 13, 2021 and November 11, 2021. The lawsuits seek, among other relief, a determination that the alleged claims may be asserted on a class-wide basis, unspecified compensatory damages, attorney’s fees, other expenses and costs. On July 19, 2022, the court consolidated the two actions, appointed a lead plaintiff and appointed lead counsel for the proposed class. On September 16, 2022, the lead plaintiff filed a consolidated amended complaint. The defendants thereafter filed a motion to dismiss. On September 27, 2023, the court granted the defendant’s motion to dismiss in its entirety, but gave plaintiffs leave to file an amended complaint. On October 27, 2023, the plaintiffs filed a second amended complaint asserting similar claims. The defendants thereafter filed a motion to dismiss. On March 26, 2024, the court granted the defendant’s motion and, on April 29, 2024, dismissed the case and entered judgment. On May 29, 2024, plaintiff filed a notice of appeal. On June 28, 2024, plaintiff voluntarily dismissed the appeal with prejudice, and we consider this matter closed.
We may also be the target of this type of litigation in the future. Securities litigation against us, including the putative class actions described above, could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.
We currently do not intend to declare dividends on our common stock in the foreseeable future and, as a result, your only opportunity to achieve a return on your investment is if the price of our common stock appreciates.
We currently do not expect to declare any dividends on our common stock in the foreseeable future. Instead, we anticipate that all of our earnings, if any, in the foreseeable future will be used to provide working capital to support our operations. Any determination to declare or pay dividends in the future will be at the discretion of our board of directors, subject to applicable laws and dependent upon a number of factors including our earnings, capital requirements and overall financial condition. In addition, our ability to pay dividends on our common stock is currently limited by the covenants of our 2022 Credit Agreement and may be further restricted by the terms of any future debt or preferred securities. Accordingly, your only opportunity to achieve a return on your investment in our company may be if the market price of our common stock appreciates and you sell your shares at a profit. The market price for our common stock may never exceed, and may fall below, the price that you pay for such common stock.
Our directors, executive officers and principal stockholders and their respective affiliates have substantial influence over us and could delay or prevent a change in corporate control; our principal stockholders may have interests that conflict with your interests as an investor in our common stock.
As of December 31, 2024, our directors, executive officers and holders of more than 5% of our common stock beneficially owned, as a group, approximately 18.1% of our common stock. As of December 31, 2024, funds affiliated with certain of our directors also held all of the 6,666 outstanding shares of our Series A Common Equivalent Preferred Stock, convertible into up to 6,665,841 shares of our common stock (which conversion is subject to certain beneficial ownership limitations set forth in our Certificate of Designation of Preferences, Rights and Limitations of the Series A Common Equivalent Preferred Stock). In addition, as of December 31, 2024, we had $32.5 million remaining in aggregate principal amount of outstanding long-term debt under our 2022 Credit Agreement with certain entities affiliated with Deerfield Management Company, L.P., of which one entity is a 9.1% holder of our common stock. Our principal stockholders, in the aggregate, will continue to have substantial influence over the outcome of matters submitted to our stockholders for approval including the election of directors and any matter related to the merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, in the aggregate, will continue to have significant influence over the management and affairs of our company. Accordingly, this concentration of ownership may have the effect of:
◦delaying, deferring or preventing a change in corporate control;
◦impeding a merger, consolidation, takeover or other business combination involving us; or
◦discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
The interests of our principal stockholders may conflict with your interests as a stockholder. You should carefully consider these potential conflicts of interest before deciding whether to invest in shares of our common stock.
Provisions in our organizational documents and agreements with third parties could delay or prevent a change of control.
Certain provisions of our amended and restated certificate of incorporation and amended and restated bylaws may have the effect of delaying or preventing a merger, acquisition, tender offer, takeover attempt or other change of control transaction that a stockholder might consider to be in its best interest, including attempts that might result in a premium over the market price of our common stock.
These provisions include the following:
◦establish a classified board of directors so that not all members of our board of directors are elected at one time;
◦authorize the issuance of “blank check” preferred stock that our board of directors could use to implement a stockholder rights plan;
◦permit the board of directors to establish the number of directors and fill any vacancies and newly-created directorships;
◦provide that directors may only be removed for cause;
◦require super-majority voting to amend some provisions in our certificate of incorporation and bylaws;
◦eliminate the ability of our stockholders to call special meetings of stockholders;
◦prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
◦provide that the board of directors is expressly authorized to make, alter or repeal our bylaws;
◦restrict the forum for certain litigation against us to Delaware; and
◦establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon by stockholders at annual stockholder meetings.
These provisions could make it more difficult for a third party to acquire us, even if the third party’s offer may be considered beneficial by many of our stockholders. As a result, our stockholders may be limited in their ability to obtain a premium for their shares.
In addition, our Settlement Agreement with the Biotronik Parties contains provisions that may have the effect of delaying, deterring or preventing a change in control transaction involving us. Under the Settlement Agreement, we must pay to Biotronik contingent payments of (x) in the event of a Qualifying Asset Sale (as defined in the Settlement Agreement), an amount equal to 50% of the aggregate cash consideration received; (y) in the event of a Change of Control (as defined in the Settlement Agreement) of the Company involving a Competitive Company (as defined in the Settlement Agreements), (A) initial amounts of $8 million and 5% of the aggregate upfront consideration received, with the latter not to exceed approximately $25 million (“Agreed Upfront Consideration”) and (B) additional amounts if additional consideration is received, up to approximately $25 million in aggregate (including the Agreed Upfront Consideration); and (z) in the event of a Change of Control not involving a Competitive Company, with certain exceptions, an amount equal to 25% of the aggregate cash consideration received.
Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between
us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another state court in Delaware or the federal district court for the District of Delaware) is the exclusive forum for the following (except for any claim as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within 10 days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than such court or for which such court does not have subject matter jurisdiction:
◦any derivative action or proceeding brought on our behalf;
◦any action asserting a claim of breach of fiduciary duty;
◦any action asserting a claim against us arising under the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; and
◦any action asserting a claim against us that is governed by the internal-affairs doctrine.
This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction.
Our amended and restated bylaws further provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or Securities Act.
These exclusive-forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees. Any person or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to these provisions. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings. It is possible that a court could find these types of provisions to be inapplicable or unenforceable, and if a court were to find either exclusive-forum provision in our amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business. For example, under the Securities Act, federal courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.
Our board of directors is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.
Our amended and restated certificate of incorporation authorizes our board of directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated certificate of incorporation, as shares of preferred stock in series, to establish from time to time the number of shares to be included in each such series and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations or restrictions thereof. The powers, preferences and rights of these additional series of preferred stock may be senior to or on parity with our common stock, which may reduce its value.
General Risk Factors
Market conditions and changing circumstances, some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to timely pay key vendors and others.
Market conditions and changing circumstances, some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to timely pay key vendors and others. For example, on March 10, 2023, Silicon Valley Bank (SVB), where we maintain certain accounts, was placed into receivership with the Federal Deposit Insurance Corporation (FDIC), which resulted in all funds held at SVB being temporarily inaccessible by SVB’s customers. If other banks and financial institutions with whom we have banking relationships enter receivership or become insolvent in the future, we may be unable to access, and we may lose, some or all of our existing cash, cash equivalents and investments to the extent those funds are not insured or otherwise protected by the FDIC. In addition, in such circumstances we might not be able to timely pay key vendors
and others. We regularly maintain cash balances that are not insured or are in excess of the FDIC’s insurance limit. Any delay in our ability to access our cash, cash equivalents and investments (or the loss of some or all of such funds) or to timely pay key vendors and others could have a material adverse effect on our operations and cause us to need to seek additional capital sooner than planned.
Litigation and other legal proceedings may adversely affect our business.
From time to time, we may become involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee claims, tort or contract claims, federal regulatory investigations, securities class action and other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. For example, we and certain of our current officers have been named as defendants in two putative securities class action lawsuits filed by putative stockholders in the United States District Court for the Southern District of California on February 15, 2022 and March 23, 2022 (case numbers 22CV206 and 22CV0388). Plaintiffs allege that the defendants violated Section 10(b) of the Exchange Act and Rule 10b-5, and Section 20(a) of the Exchange Act. The complaints allege that the defendants made false and misleading statements about our business, prospects and operations. The putative claims are based upon statements made in filings made by us with the SEC, press releases and on earnings calls between May 13, 2021 and November 11, 2021. The lawsuits seek, among other relief, a determination that the alleged claims may be asserted on a class-wide basis, unspecified compensatory damages, attorney’s fees, other expenses and costs. On July 19, 2022, the court consolidated the two actions, appointed a lead plaintiff and appointed lead counsel for the proposed class. On September 16, 2022, the lead plaintiff filed a consolidated amended complaint. We thereafter filed a motion to dismiss. On September 27, 2023, the court granted the defendant’s motion to dismiss in its entirety, but gave plaintiffs leave to file an amended complaint. On October 27, 2023, the plaintiffs filed a second amended complaint asserting similar claims. The defendants thereafter filed a motion to dismiss. On March 26, 2024, the court granted the defendant’s motion and, on April 29, 2024, dismissed the case and entered judgment. On May 29, 2024, plaintiff filed a notice of appeal. On June 28, 2024, plaintiff voluntarily dismissed the appeal with prejudice, and we consider this matter closed.
In addition, on February 2, 2024, Biotronik sent a Notice to us. The Notice provides that Biotronik rescinds and terminates the Bi-Lateral Distribution Agreements, effective immediately, based on the alleged repudiation of our contractual obligations under the Bi-Lateral Distribution Agreements, and alleges damages in an amount to be quantified by Biotronik. Biotronik has separately alleged that we breached our contractual obligations to it under the LDA, as a result of the wind down of our mapping and ablation businesses and alleges further damages.
On February 16, 2024, the Biotronik Parties filed the Demand against Acutus with the American Arbitration Association (who notified us of the Demand on February 29, 2024), alleging that we breached our contractual obligations under five agreements relating to the licensing, manufacturing, distribution and development of medical devices as a result of the wind down of our businesses. The Biotronik Parties allege that we breached, among other things, our obligations (i) to develop, manufacture, use and commercialize certain product lines under the LDA and the MSA; (ii) to distribute Biotronik products and manufacture and supply Acutus products under the Bi-Lateral Distribution Agreements, as applicable; and (iii) to use commercially reasonable efforts to perform and complete our responsibilities under the F&DA. The claim seeks, among other relief, $38.0 million in damages, attorney’s fees, other expenses and costs.
On October 15, 2024, we and the Biotronik Parties entered into a Settlement Agreement terminating the LDA, MSA, the Bi-Lateral Distribution Agreements and the F&DA (except for certain surviving obligations specified therein), settling the arbitration relating to such agreements, and releasing and discharging each party of all claims against the other, including any claims that were or could have been asserted in the arbitration. Pursuant to the Settlement Agreement, we must pay to Biotronik (i) an initial settlement payment of approximately $2.5 million; (ii) contingent payments of (x) in the event of a Qualifying Asset Sale (as defined in the Settlement Agreement), an amount equal to 50% of the aggregate cash consideration received; (y) in the event of a Change of Control (as defined in the Settlement Agreement) of the Company involving a Competitive Company (as defined in the Settlement Agreements), (A) initial amounts of $8 million and 5% of the aggregate upfront consideration received, with the latter not to exceed approximately $25 million (“Agreed Upfront Consideration”) and (B) additional amounts if additional consideration is received, up to approximately $25 million in aggregate (including the Agreed Upfront Consideration); and (z) in the event of a Change of Control not involving a Competitive Company, with certain exceptions, an amount equal to 25% of the aggregate cash consideration received.
Litigation is inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation, undermine Medtronic or our end-user’s confidence and reduce long-term demand for the Products, even if the regulatory or legal action is unfounded or not material to our operations.

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ITEM 1B. UNRESOLVED STAFF COMMENTS
Item 1B. Unresolved Staff Comments.
None.

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ITEM 2. PROPERTIES
Item 2. Properties.
As of December 31, 2024, we lease approximately 50,800 square feet of office space for our corporate headquarters and manufacturing facility located in Carlsbad, California under a noncancelable operating lease that expires on December 31, 2027, with the option to renew for a period of an additional five years upon the expiration date of this lease. We also leased approximately 3,900 square feet of office space in Brussels, Belgium under a noncancelable operating lease that expired on December 31, 2024. We did not renew this contract. We believe that the Carlsbad facility is sufficient to meet our current and anticipated needs in the near term and that any unused space can be subleased on commercially reasonable terms.

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ITEM 3. LEGAL PROCEEDINGS
Item 3. Legal Proceedings.
From time to time, we are involved in legal proceedings, including litigation arising from the normal course of our business activities. We have also received, and may from time to time receive, letters from third parties alleging patent infringement, violation of employment practices or trademark infringement, and we may in the future participate in litigation to defend ourselves. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Other than the matters listed below, we are not currently party to any pending legal proceedings that we believe would, individually or in the aggregate, have a material adverse effect on our financial condition, cash flows or results of operations.
We and certain of our current officers have been named as defendants in two putative securities class action lawsuits filed by putative stockholders in the United States District Court for the Southern District of California on February 15, 2022 and March 23, 2022 (case numbers 22CV206 and 22CV0388). Plaintiffs allege violations of Section 10(b) of the Exchange Act and Rule 10b-5, and Section 20(a) of the Exchange Act. The complaints allege that the defendants made false and misleading statements about our business, prospects and operations. The putative claims are based upon statements made in filings made by us with the SEC, press releases and on earnings calls between May 13, 2021 and November 11, 2021. The lawsuits seek, among other relief, a determination that the alleged claims may be asserted on a class-wide basis, unspecified compensatory damages, attorney’s fees, other expenses and costs. On July 19, 2022, the court consolidated the two actions, appointed a lead plaintiff and appointed lead counsel for the proposed class. On September 16, 2022, the lead plaintiff filed a consolidated amended complaint. We thereafter filed a motion to dismiss. On September 27, 2023, the court granted the defendant’s motion to dismiss in its entirety, but gave plaintiffs leave to file an amended complaint. On October 27, 2023, the plaintiffs filed a second amended complaint asserting similar claims. The defendants thereafter filed a motion to dismiss. On March 26, 2024, the court granted the defendant’s motion and, on April 29, 2024, dismissed the case and entered judgment. On May 29, 2024, plaintiff filed a notice of appeal. On June 28, 2024, plaintiff voluntarily dismissed the appeal with prejudice, and we consider this matter closed.
In addition, on February 2, 2024, Biotronik sent a Notice to us. The Notice provides that Biotronik rescinds and terminates the Bi-Lateral Distribution Agreements, effective immediately, based on the alleged repudiation of our contractual obligations under the Bi-Lateral Distribution Agreements, and alleges damages in an amount to be quantified by Biotronik. Biotronik has separately alleged that we breached our contractual obligations to it under the LDA, as a result of the wind down of our mapping and ablation businesses and alleges further damages.
On February 16, 2024, the Biotronik Parties filed the Demand against Acutus with the American Arbitration Association (who notified us of the Demand on February 29, 2024), alleging that we breached our contractual obligations under five agreements relating to the licensing, manufacturing, distribution and development of medical devices as a result of the wind down of our businesses. The Biotronik Parties allege that we breached, among other things, our obligations (i) to develop, manufacture, use and commercialize certain product lines under the LDA and the MSA; (ii) to distribute Biotronik products and manufacture and supply Acutus products under the Bi-Lateral Distribution Agreements, as applicable; and (iii) to use commercially reasonable efforts to perform and complete our responsibilities under the F&DA. The claim seeks, among other relief, $38.0 million in damages, attorney’s fees, other expenses and costs.
On October 15, 2024, we and the Biotronik Parties entered into a Settlement Agreement terminating the LDA, MSA, the Bi-Lateral Distribution Agreements and the F&DA (except for certain surviving obligations specified therein), settling the arbitration relating to such agreements, and releasing and discharging each party of all claims against the
other, including any claims that were or could have been asserted in the arbitration. Pursuant to the Settlement Agreement, we must pay to Biotronik (i) an initial settlement payment of approximately $2.5 million; (ii) contingent payments of (x) in the event of a Qualifying Asset Sale (as defined in the Settlement Agreement), an amount equal to 50% of the aggregate cash consideration received; (y) in the event of a Change of Control (as defined in the Settlement Agreement) of the Company involving a Competitive Company (as defined in the Settlement Agreements), (A) initial amounts of $8 million and 5% of the aggregate upfront consideration received, with the latter not to exceed approximately $25 million (“Agreed Upfront Consideration”) and (B) additional amounts if additional consideration is received, up to approximately $25 million in aggregate (including the Agreed Upfront Consideration); and (z) in the event of a Change of Control not involving a Competitive Company, with certain exceptions, an amount equal to 25% of the aggregate cash consideration received.

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ITEM 4. MINE SAFETY DISCLOSURE
Item 4. Mine Safety Disclosures.
Not applicable.
PART II

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ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Common Stock Market Prices and Dividends
On May 16, 2024, Nasdaq filed a Form 25 to delist our common stock and remove such securities from registration under Section 12(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and such delisting took effect on May 26, 2024. The deregistration of our common stock under Section 12(b) of the Exchange Act was effective 90 days after the Form 25 filing. Our common stock currently trades on the OTC Pink Market under the symbol “AFIB.” The closing price of our stock on December 31, 2024 and 2023 was $.06 and $.20, respectively.
The approximate number of record holders of our common stock on January 2, 2025 was 129. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
Unregistered Sales of Equity Securities
We had no sales of unregistered equity securities during the period covered by this report that were not previously reported in a Quarterly Report on Form 10-Q or Current Report on Form 8-K.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
Stock Performance Graph
As a smaller reporting company as defined by Item 10 of Regulation S-K, we are not required to provide this information.
Dividend Policy
We have never declared or paid, and do not anticipate declaring or paying in the foreseeable future, any cash dividends on our capital stock. Any future determination as to the declaration and payment of dividends, if any, will be at the discretion of our board of directors, subject to applicable laws and will depend on then existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant.

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ITEM 6. SELECTED FINANCIAL DATA
Item 6. Reserved.

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Overview
Historically, we designed, manufactured and marketed a range of tools for catheter-based ablation procedures to treat various arrhythmias. Our product portfolio included novel access sheaths, diagnostic and mapping catheters, conventional and contact ablation catheters, mapping and imaging consoles and accessories, as well as supporting algorithms and software programs. Our foundational product was our AcQMap imaging and mapping system, which was designed to rapidly and accurately identify ablation targets and to confirm both ablation success and procedural completion.
In April 2022, we announced that we agreed to sell our left-heart access product portfolio to Medtronic and refinance existing debt with a new longer-term credit facility to recapitalize our business and fund our strategic growth priorities. Pursuant to the sale transaction, Medtronic paid upfront cash consideration of $50.0 million (of which $4.0 million was paid into an indemnity escrow account for a period of 18 months), and we became eligible for contingent cash consideration of up to $37.0 million (of which we earned $20.0 million on October 31, 2022 and $17.0 million on December 31, 2022) plus a portion of Medtronic’s future net sales of the left-heart access product portfolio. In conjunction with the sale of our left-heart access product portfolio, we executed a Distribution Agreement with Medtronic, pursuant to which we agreed to manufacture and supply these left-heart access products to Medtronic as exclusive distributor of the product line for an initial term of up to four years at specified transfer prices. We will also continue to be eligible for earnout payments on Medtronic’s net sales of the left-heart access product portfolio through 2027.
In November 2023, we announced the Strategic Realignment and Restructuring, following an extensive strategic review by our board of directors, and in light of the current financing environment and the capital investments required to achieve leadership in the electrophysiology market, that we had determined to reallocate capital from our mapping and ablation business to the manufacturing of left-heart access products for Medtronic under the Distribution Agreement, which we believe will maximize the potential for future contingent cash consideration and cash flow. As part of this restructuring, we wound down our mapping and ablation businesses and no longer manufacture or distribute our AcQMap Mapping System, AcQMap 3D Mapping Catheter, AcQBlate Force-Sensing Ablation Catheter, AcQGuide Max 2.0 Steerable Sheath, or associated accessories, though we continue to explore strategic alternatives for these businesses (including a potential sale of related assets).
In November 2024, we announced the Operational Downsizing, in which we will further reduce the size of our organization while complying with our remaining obligations to Medtronic for the production of left-heart access products. We will reduce operations to a scale designed solely to support the manufacturing and distribution of Medtronic’s left-heart access products through the transition of the production of these products to Medtronic pursuant to the terms of the Asset Purchase Agreement and Distribution Agreement. We will continue contract manufacturing for Medtronic until it has fulfilled its obligations under the Asset Purchase Agreement and the Distribution Agreement. We expect to continue to minimize costs while capturing the value associated with potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027.
Left-Heart Access Portfolio Sale and Distribution Agreement
On June 30, 2022, we completed the First Closing of the sale of our left-heart access portfolio in accordance with the Asset Purchase Agreement, pursuant to which we sold to Medtronic our AcQCross® line of sheath-compatible septal crossing devices, the AcQGuide® MINI integrated crossing device and sheath, the AcQGuide FLEX steerable introducer with integrated transseptal dilator and needle and the AcQGuide® VUE steerable sheaths (i.e., the Products). Pursuant to the Asset Purchase Agreement, Medtronic paid cash consideration of $50.0 million at the First Closing, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing, and acquired from us, among other things, intellectual property rights to the Products and certain equipment used in the manufacturing of the Products. A Second Closing would occur on a date determined by Medtronic, but no later than the fourth anniversary of the First Closing, subject to the satisfaction of customary closing conditions. At the Second Closing, Medtronic would acquire certain additional assets relating to the Products, primarily supplier agreements and permits and design and specification files required for Medtronic to become the manufacturer of record of the Products, for no additional consideration.
Under the Asset Purchase Agreement, we also became eligible to receive contingent cash consideration of up to $37.0 million plus a portion of Medtronic’s future net sales from the Products, as follows:
(i) $20.0 million upon our completion, to the reasonable satisfaction of Medtronic, of certain conditions set forth in the Asset Purchase Agreement relating to our becoming a qualified supplier of Medtronic for the Products, including demonstration of ISO 14971:2019 compliance, completion of certain test method validations and compliance with certain other reporting requirements (i.e., the OEM Earnout);
(ii) $17.0 million upon the earlier of (A) the Second Closing or (B) our initial submission for CE Mark certification of the Products under the European Union MDR, to the reasonable satisfaction of a third-party regulatory consultant, subject to certain other conditions as set forth in the Asset Purchase Agreement (i.e., the Transfer Earnout); and
(iii) amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the Products achieved by Medtronic over each year over a four-year period beginning on the first full quarter after Medtronic’s first commercial sale of a Product and achievement of the OEM Earnout (i.e., the Net Sales Earnouts).
On October 31, 2022, we achieved the OEM Earnout, and payment of $20.0 million from Medtronic was received in November 2022. Further, on December 1, 2022, Medtronic qualified us as an OEM and accordingly, we began to manufacture the Products exclusively for Medtronic under the Distribution Agreement. The Distribution Agreement has an initial term ending on the date of the Second Closing. If the Second Closing has not occurred on or prior to the fourth anniversary of the First Closing, then the Distribution Agreement will automatically renew thereafter for successive one year periods, unless either we or Medtronic provides notice of non-renewal at least 180 days before the end of the then current term.
On December 31, 2022, we achieved the Transfer Earnout for our submission for CE Mark certification of the Products under the European Union MDR, to the reasonable satisfaction of a third-party regulatory consultant, and payment of $17.0 million was received from Medtronic on January 14, 2023.
The quarterly measurement period for the Net Sales Earnouts began on January 30, 2023, and such earnout payments began in January 2024 and will continue quarterly each quarter thereafter until 2027. In 2024, we earned $11.1 million related to the Nets Sales Earnounts and received a $18.7 million in related payments. In 2023, we earned $9.4 million related to the Net Sales Earnouts, with $7.3 million paid in January 2024.
We were incorporated in the state of Delaware on March 25, 2011 and are headquartered in Carlsbad, California.
For the years ended December 31, 2024 and 2023, we generated total revenue of $20.2 million and $7.2 million, respectively. Since our inception, we have generated significant losses. Net loss from continuing operations was $4.5 million and $11.9 million for the years ended December 31, 2024 and 2023, respectively. Discontinued operations generated net loss of $5.0 million and $69.7 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and 2023, we had an accumulated deficit of $609.5 million and $600.0 million, respectively, and working capital of $13.1 million and $27.3 million, respectively.
Investments in manufacturing and distribution, if any, will be focused on the left-heart access Products. Additionally, we will continue to incur costs as a public company that we did not incur prior to our IPO or incurred prior to our IPO at lower rates, including increased costs for employee-related expenses, director and officer insurance premiums, audit and legal fees, investor relations fees, fees to members of our board of directors and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC, as well as Nasdaq rules. Because of these and other factors, we may continue to incur net losses and negative cash flows from operations for at least the next couple years.
Delisting from Nasdaq
As previously disclosed, Nasdaq suspended trading in our common stock on May 9, 2024, due to noncompliance with Nasdaq
Listing Rule 5550(a)(2) and 5550(b). On May 15, 2024, Nasdaq announced that it would formally delist our common stock that
was previously suspended. On May 16, 2024, Nasdaq filed a Form 25 Notification of Delisting with the SEC to complete the
delisting and remove such securities from registration under Section 12(b) of the Exchange Act, and such delisting took effect
on May 26, 2024. The deregistration of our common stock under Section12(b) of the Exchange Act was effective 90 days after the Form 25 filing.
On May 9, 2024, our common stock began trading over the counter on the OTC Pink Market under the trading symbol “AFIB.”
Factors Affecting Our Performance Following the Restructuring
There are a number of factors that we believe will impact our results of operations.
Medtronic Partnership
Following the Restructuring, we have relied solely on our strategic partnership with Medtronic to generate revenue through (i) sales of the Products to Medtronic at transfer prices specified under the Distribution Agreement and (ii) potential earnouts from Medtronic’s sales of the Products to end-users that we may become eligible to receive under the Asset Purchase Agreement. We have relied solely on Medtronic to market and sell the Products as we have no marketing and sales capabilities on our own. This strategy leaves us largely dependent upon the success of Medtronic. If Medtronic stops buying Products from us, or stops marketing or selling the Products or is unsuccessful in its efforts to sell the Products to end users, our business, results of operations and financial condition would be materially and adversely affected.
Manufacture and Supply
Our ability to perform as a business depends on the proper functioning of our manufacturing and supplier operations. Following Medtronic’s qualification of us as their OEM supplier, we have manufactured the Products for Medtronic at our approximately 50,800 square foot facility in Carlsbad, California. This facility provides approximately 15,750 square feet of space for our production operations, including manufacturing, quality control and storage. Following the Restructuring, our business model has focused exclusively on manufacturing the Products for Medtronic and achieving potential earnout payments. Our manufacturing operations require timely delivery of sufficient amounts of materials and components. We rely on a single or limited number of suppliers for certain materials and components, and we generally have no long-term supply arrangements with our suppliers, as we generally order on a purchase order basis. In the future, we may face unanticipated interruptions and delays in manufacturing through our supply chain. Manufacturing or supplier disruptions could result in product shortages, declining production, reputational damage or significant costs. Our ability to manufacture the Products for Medtronic full-time and produce at optimal capacity when and as planned could affect our revenue and operating expenses.
Strategic Restructuring
In November 2023, we announced our plans for the Restructuring, designed to simplify our operational footprint and cut costs while maximizing free cash flow. As part of the Restructuring, we have winded down our mapping and ablation businesses. We also immediately implemented the corporate restructuring plan, which resulted in reducing our workforce by approximately 65% across different areas and functions. We may not achieve the anticipated cost savings, operating efficiencies or other benefits of such activities anticipated from the Restructuring. We will continue to review our operations to optimize our business.
Operational Downsizing
In November 2024, our board of directors approved the reduction in size of our organization while complying with our remaining obligations to Medtronic for the production of left-heart access products. As part of the Operational Downsizing, we announced a reduction in our current workforce of approximately 61 employees, representing approximately 70% of the Company’s employees, which is expected to be completed by the first quarter of 2025. In compliance with the Worker Adjustment and Retraining Notification Act, we provided pre-termination notices to affected employees and government authorities where required. We entered into retention arrangements with certain employees who are expected to remain with us to assist with the downsizing and operation of our left-heart access manufacturing and distribution business.
Manufacturing Costs
Our financial results, including our gross margins, may fluctuate from period to period due to a variety of factors, including: the cost of direct materials; manufacturing costs; product yields; headcount and cost-reduction strategies (including the Restructuring and Operational Downsizing).
Future gross margins for the Products may fluctuate due to a variety of other factors, including the introduction by others of competing products or the attempted integration by third parties of capabilities similar to ours into their existing products, and Medtronic’s demand for the Products, including due to seasonality.
Competition
Our industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants. Because our revenue following the Operational Downsizing is primarily dependent on our ability to capture the value associated with potential earnout payments we are eligible to receive under the Asset Purchase Agreement until 2027, which is dependent on Medtronic’s ability to sell the Products, we face indirect competition from Medtronic’s competitors for heart access products in the electrophysiology field, which we believe to include Abbott Laboratories, Biosense Webster Inc. (a Johnson & Johnson Company), and Boston Scientific Corporation.
Many competitors in the manufacturing services industry and the electrophysiology field are large, well-capitalized companies with significantly greater market share and resources. We believe that the principal competitive factors in the electrophysiology
field are: name recognition; relations with healthcare professionals, customers and third-party payors; quality and depth of distribution networks; breadth of product lines and the ability to offer rebates or bundle products to offer discounts or other incentives; capabilities in research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for products; and financial and human resources for product development, manufacturing, sales and marketing and patent prosecution.
Components of Results of Operations
Revenue
Following the Strategic Restructuring, we generate revenue solely under our Distribution Agreement with Medtronic, as Medtronic’s exclusive OEM supplier of the left-heart access Products sold to Medtronic under the Asset Purchase Agreement and potential earnouts from Medtronic’s sales of the Products to end-users that we may become eligible to receive under the Asset Purchase Agreement.
All sales from continuing operations were from the United States for the years ended December 31, 2024 and 2023, respectively.
Costs and Operating Expenses
Cost of Products Sold
Cost of products sold consist primarily of raw materials, direct labor (including stock-based compensation), manufacturing overhead associated with the production and sale of our products. Cost of products sold also includes expenditures for warranty and inventory reserve provisions. We expect cost of products sold to increase in absolute dollars in future periods as our revenue increases.
Research and Development Expenses
Historically, research and development expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel directly engaged in research and development activities, clinical trial expenses, equipment costs, materials costs, allocated rent and facilities costs and depreciation.
Research and development expenses related to possible future products are expensed as incurred. We also accrue and expense costs for activities associated with clinical trials performed by third parties as incurred. All other costs relative to setting up clinical trial sites are expensed as incurred. Clinical trial site costs related to patient enrollment are accrued as patients are entered into the trials.
Due to our shift in business model as part of the Strategic Restructuring, we expect our research and development expenses to significantly decrease in absolute dollars in the upcoming years.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel in executive, finance and other administrative functions, allocated rent and facilities costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs, and additionally, prior to the Strategic Restructuring, salaries and employee-related costs for personnel in sales, marketing, and other administrative functions.
To align resources with our current strategic direction, we implemented an organizational workforce reduction and are implementing the Operational Downsizing. Due to this downsizing, we expect our selling, general and administrative expenses to decrease in absolute dollars in the upcoming years.
Restructuring Expenses
In 2023, we undertook a strategic realignment of resources and corporate restructuring (i.e., the Strategic Restructuring), including an organizational workforce reduction and additional cost reduction measures. Our restructuring and exit-related charges consist of severance expenses and related benefit costs for employees affected by the organizational workforce reduction, retention bonuses for certain employees that assisted with the Strategic Restructuring, other restructuring costs and
impairment charges in connection with the disposition of certain assets, including inventory, fixed assets and intangibles. The Strategic Restructuring is complete as of December 31, 2024. Refer to Note 3 - Discontinued Operations, Assets Held for Sale and Restructuring for additional details.
In 2024, we announced a downsizing of our organization while complying with our remaining obligations to Medtronic for the production of left-heart access products (i.e., the Operational Downsizing). Our downsizing costs will consist of charges to reduce our workforce to an appropriate scale to support the operation of our left-heart access manufacturing and distribution business and other exit related costs. For the year ended December 31, 2024, all Restructuring expenses relate to downsizing accruals.
Change in Fair Value of Contingent Consideration
The change in fair value of contingent consideration relates to our June 2019 acquisition of Rhythm Xience. The acquisition included potential earn-out considerations based on the achievement of certain regulatory and revenue milestones. The value of such contingencies is estimated and recorded on the consolidated balance sheets and are adjusted to fair value each period with increases and decreases of in the estimated fair value of the contingent consideration earn-out recognized in the statement of
operations and comprehensive loss. The earnout period under the Rhythm Xience acquisition agreement concluded on June 19, 2023. Accordingly, no contingent consideration liability was recorded at fair value on the condensed consolidated balance sheet as of December 31, 2023.
Gain on Sale of Business
Gain on sale of business consists of the value of consideration received by us in excess of the book value of assets transferred to the buyer and net of direct selling costs. In 2022, we completed the First Closing of the sale of certain assets to Medtronic whereby the value received was in excess of the book value of the assets transferred, resulting in a recognized gain of $79.5 million. Gain on sale of business also consists of consideration contingent upon the satisfaction of certain contractual conditions. Associated with the sale and included in the above recognized gain, in 2022, we achieved both an OEM Earnout entitling us to $20.0 million and a Transfer Earnout entitling us to $17.0 million in contingent consideration.
Additionally, over the next four years, we expect to receive a percentage of Medtronic's quarterly commercial sales of the Products, ranging from 100% in the first year to 50% in the fourth year. In 2024, we have recognized an estimated gain (earned sales less transaction costs) of $10.8 million related to the Net Sales Earnouts. Refer to Note 4 - Sale of Business for more information.
Other Income (Expense)
Change in Fair Value of Warrant Liability
Warrants meeting specific conditions are required to be recorded as liabilities at fair value on the condensed consolidated balance sheets. We issued warrants associated with various recorded transactions, some of which meet these specific conditions. The change in fair value of warrant liability recorded on our consolidated results of operations and comprehensive loss reflect changes in the fair value of these recorded liabilities.
Under the terms of our 2022 Credit Agreement effective June 30, 2022, we issued warrants meeting the conditions for treatment as a liability. The recorded fair value of the liability associated with such warrants is adjusted each reporting period with an entry to the consolidated statements of operations and comprehensive loss. Refer to Note 13 - Warrants for more information.
Interest Income
Interest income consists primarily of interest earned on our cash, cash equivalents and marketable securities.
Interest Expense
Interest expense primarily relates to interest paid on our 2022 Credit Agreement. Refer to Note 10 - Debt for more information.
Results of Operations for the Years ended December 31, 2024 and 2023
The results of operations presented below should be reviewed in conjunction with our consolidated financial statements and related notes. The following table sets forth our results of operations for the years ended December 31, 2024 and 2023:
Change
(dollars in thousands) 2024 2023 $ %
Revenue(1)
$ 20,157 $ 7,164 $ 12,993 181 %
Costs of products sold(2)
19,144 10,301 8,843 86 %
Gross profit (loss) 1,013 (3,137) 4,150 (132) %
Operating expenses (income):
Research and development(2)
- 3,482 (3,482) (100) %
Selling, general and administrative(2)
10,436 14,066 (3,630) (26) %
Restructuring 1,448 - 1,448 100 %
Change in fair value of contingent consideration - 123 (123) (100) %
Gain on sale of business (10,814) (9,080) (1,734) 19 %
Total operating expenses
1,070 8,591 (7,521) (88) %
Loss from operations
(57) (11,728) 11,671 (100) %
Other income (expense):
Change in fair value of warrant liability 215 2,937 (2,722) (93) %
Interest income 763 2,588 (1,825) (71) %
Interest expense (5,758) (5,655) (103) 2 %
Other revenue
301 - 301 100 %
Total other expense, net (4,479) (130) (4,349) 3345 %
Loss from continuing operations before income taxes
(4,536) (11,858) 7,322 (62) %
Income tax expense
- 63 (63) *
Net loss from continuing operations
(4,536) (11,921) 7,385 (62) %
Discontinued Operations:
Loss from discontinued operations before income taxes (4,999) (69,530) 64,531 (93) %
Income taxes - discontinued operations 12 212 (200) (94) %
Loss from discontinued operations (5,011) (69,742) 64,731 (93) %
Net loss $ (9,547) $ (81,663) $ 72,116 (88) %
Other comprehensive income (loss):
Unrealized gain on marketable securities - 7 (7) (100) %
Foreign currency translation adjustment 98 (4) 102 (2550) %
Comprehensive loss $ (9,449) $ (81,660) $ 72,211 (88) %
(1)The following table sets forth our continuing revenue for disposables and service/other for the years ended December 31, 2024 and 2023 (in thousands):
Year Ended December 31,
2024 2023
Disposables $ 19,629 $ 6,315
Service/Other 528 849
Total revenue $ 20,157 $ 7,164
Continuing revenue is all US-based for the years ended December 31, 2024 and 2023, respectively.
(2)The following table sets forth the stock-based compensation expense included in our results of operations of our continuing business for the years ended December 31, 2024 and 2023 (in thousands):
2024 2023
Cost of products sold $ 78 $ 288
Research and development - 46
Selling, general and administrative 381 2,698
Total stock-based compensation $ 459 $ 3,032
For information regarding our discontinued operations, please see the section titled "Discontinued Operations-Loss on Discontinued Operations" below.
Revenue of Continuing Operations
Revenue was $20.2 million for the year ended December 31, 2024, compared to $7.2 million for the year ended December 31, 2023. This increase of $13.0 million, or 181%, was primarily attributable to increased sales from left-heart access products through our partner Medtronic.
Costs and Operating Expenses of Continuing Operations
Cost of Products Sold
Cost of products sold was $19.1 million for year ended December 31, 2024, compared to $10.3 million for the year ended December 31, 2023. The increase of $8.8 million was primarily due to an increase in standard product costs, offset by a decrease in absorption. Gross margin was 5% for the year ended December 31, 2024, compared to negative 44% for the year ended December 31, 2023. The improvement in gross margin is primarily due to an increase in product sales price at a higher rate than the increase in product costs.
Research and Development Expenses
Research and development expenses were $- for the year ended December 31, 2024, compared to $3.5 million for the year ended December 31, 2023. This decrease of $3.5 million, or 100%, was attributable to the curtailment of research and development due to the Strategic Restructuring.
Selling, General and Administrative Expenses
SG&A expenses were $10.5 million for the year ended December 31, 2024, as compared to $14.1 million for the year ended December 31, 2023. This decrease of $3.5 million, or 25%, was primarily attributable to a decrease in compensation and related costs due to the reduction in work force resulting from the Strategic Restructuring and a decrease in insurance premiums.
Restructuring Expenses
Restructuring expenses were $1.4 million for the year ended December 31, 2024, an increase of $1.4 million from the year ended December 31, 2023. The increase is directly attributable to compensation-related accruals for severance and retention payments, and other costs related to the Operational Downsizing. During the year ended December 31, 2023, restructuring costs related to the Strategic Restructure were charged to discontinued operations.
Change in Fair Value of Contingent Consideration
For the year ended December 31, 2023, we recorded $0.1 million for the change in the fair value of the contingent consideration for the acquisition of Rhythm Xience. The earnout period under the Rhythm Xience acquisition agreement concluded on June 19, 2023. Accordingly, there is no change in fair value recorded during the year ended December 31, 2024.
Gain on Sale of Business
Gain on sale of business was $10.8 million during the year ended December 31, 2024 and $9.1 million during the year ended December 31, 2023. The increase in gain on sale of business is a result of the increased revenue related to the sale of left-heart access products by Medtronic.
Other Expense (Income) of Continuing Operations
Change in Fair Value of Warrant Liability
For the year ended December 31, 2024 the fair value of the warrant liability decreased by $0.2 million, as compared to a decrease in fair value of warrant liability of $2.9 million for the year ended December 31, 2023. The decline in fair value of the warrants during the year ended December 31, 2024 was less than the decline during the year ended December 31, 2023 as the Company's stock price decline was less steep.
Interest Income and Interest Expense, Net
Our interest income and interest expense are a direct reflection of amounts we hold for investment and amounts we owe to debtholders, respectively, both of which change according to our cash requirements. Additionally, as both our holdings and our debt bear interest at variable market rates, both are subject to market factors outside our immediate control. During the year ended December 31, 2024, interest income was $0.8 million, compared to $2.6 million during the year ended December 31, 2023, resulting from decreased cash and marketable securities balances. During the years ended December 31, 2024 and 2023, interest expense was $5.8 million and $5.7 million, respectively, with the increase in interest expense primarily resulting from higher interest rates charged on our debt.
Other Revenue
Other revenue was $0.3 million for the year ended December 31, 2024, compared to $- for the year ended December 31, 2023. This increase of $0.3 million is attributable to the sublease rent received from the two subleases that were in effect as of the second quarter of 2024. There were no subleases in 2023.
Discontinued Operations
Loss on Discontinued Operations
Loss on discontinued operations was $5.0 million for the year ended December 31, 2024, compared to $69.7 million for the year ended December 31, 2023. This decrease of $64.7 million was primarily attributable to a reduction in research & development expenses of $18.5 million, a reduction in selling, general and administrative expenses of $18.3 million, a reduction in restructure and discontinued operations charges for impairment of assets and loss on assets held for sale of $19.6 million and a decrease in gross loss of $8.1 million, resulting from the winding down of the mapping and ablation business pursuant to the Strategic Restructuring.
Liquidity and Capital Resources
We have limited revenue and have incurred significant operating losses and negative cash flows from operations since our inception, and, if we are unable to realize the expected benefits of the Restructuring, we anticipate that we will incur significant losses for at least the next several years. As of December 31, 2024, and December 31, 2023, we had cash, cash equivalents, restricted cash and marketable securities of $14.0 million and $29.4 million, respectively. For the year ended December 31, 2024, we incurred net loss of $4.6 million from continuing operations and net loss of $5.0 million from discontinued operations. For the year ended December 31, 2023, we incurred net loss of $11.9 million from continuing operations and net loss of $69.7 million from discontinued operations. Net cash used in operating activities for continuing operations was $17.2 million and $19.9 million for the years ended December 31, 2024 and 2023, respectively. Net cash used in operating activities for discontinued operations was $14.5 million and $43.3 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, and December 31, 2023, we had an accumulated deficit of $609.5 million and $600.0 million, respectively, and working capital of $13.1 million and $27.3 million, respectively.
The Strategic Restructuring was intended to reduce our operating expenses and optimize our cash resources by focusing exclusively on the manufacturing and distribution of the left-heart access Products to Medtronic to continue to generate revenue
from such sales and potentially earn the associated earnout payments. The Operational Downsizing is intended to scale the Company solely to support the manufacturing and distribution of the left-heard access Products. Following these restructurings, our primary uses of capital are to support the manufacture and distribution of the left-heart access Products to Medtronic and related expenses, raw materials and supplies, legal and other regulatory expenses, minimal general administrative costs and working capital.
On June 30, 2022, Medtronic paid us $50.0 million at the First Closing of the sale of our left-heart access portfolio to Medtronic, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing to secure our indemnification obligations under the Asset Purchase Agreement. We achieved a $20.0 million OEM Earnout as set forth in the Asset Purchase Agreement on October 31, 2022, which was paid to us in the fourth quarter of 2022. Additionally, we achieved a $17.0 million Transfer Earnout as set forth under the Asset Purchase Agreement on December 21, 2022. Accordingly, $17.0 million was recorded as a receivable for the year ended December 31, 2022 and payment was received in January 2023. As part of the Restructuring, we will focus exclusively on the manufacturing and distribution of the left-heart access Products to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments.
Since inception, we have recorded no impairments to or write-offs of our accounts receivable. Accounts receivable for the years ended December 31, 2024 and 2023 consists of the following (in thousands):
2024 2023
Trade accounts receivable $ 6,040 $ 1,993
Net Sales Earnout receivable 1,838 9,360
Total accounts receivable $ 7,878 $ 11,353
Management believes our current cash, cash equivalents and marketable securities and anticipated cash earnouts generated from Medtronic’s sales of the Products are sufficient to fund operations for at least the next 12 months. To ensure that we have sufficient resources to fulfill our obligations under the Distribution Agreement with Medtronic, management implemented the Operational Downsizing to reduce expenses and cash burn.
Our future liquidity and capital funding requirements will depend on numerous factors, including:
•Medtronic’s success in selling Products and our ability to achieve earnouts pursuant to the Asset Purchase Agreement with Medtronic;
•the emergence and effect of competing or complementary products; and
•debt service requirements.
Under Accounting Standards Codification Subtopic 205-40, Presentation of Financial Statements-Going Concern, we have the responsibility to evaluate whether conditions and/or events could raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date that the financial statements are issued. Going concern matters are more fully discussed in Note 1 - Organization and Description of Business - Liquidity and Capital Resources of our consolidated financial statements attached hereto.
Debt Obligations
On June 30, 2022, we entered into the 2022 Credit Agreement with related parties Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P. The 2022 Credit Agreement provided us with a term loan facility in an aggregate principal amount of $35.0 million. The 2022 Credit Agreement bears interest at the one-month adjusted term Secured Overnight Financing Rate, with a floor of 2.50% per annum, plus 9.00% per annum. The principal amount of the term loan will be paid in installments with the final principal payment due on June 30, 2027. The 2022 Credit Agreement can be prepaid but is subject to prepayment penalties. The 2022 Credit Agreement provides for final payment fees of an additional $1.8 million that are due upon prepayment, on the maturity date or upon acceleration. Proceeds from the 2022 Credit Agreement, along with cash on hand, were used to repay the 2019 Credit Agreement and to pay related fees and expenses and for working capital purposes.
The 2022 Credit Agreement contains certain customary negative covenants, including, but not limited to, restrictions on our ability and that of our subsidiaries to merge and consolidate with other companies, incur indebtedness, grant liens or security interests on assets, pay dividends or make other restricted payments, sell or otherwise transfer assets or enter into transactions with affiliates. The 2022 Credit Agreement provides that, upon the occurrence of certain events of default, our obligations thereunder may be accelerated. Such events of default include payment defaults to the Lenders, material inaccuracies of
representations and warranties, covenant defaults, cross-defaults to certain other indebtedness, voluntary and involuntary bankruptcy proceedings, certain money judgments, change of control events and other customary events of default.
Our obligations under the 2022 Credit Agreement are secured by substantially all of our assets, including our intellectual property.
On August 4, 2023, we entered into Amendment No. 1 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 1, the 2022 Credit Agreement was amended to decrease the amount of cash we are required to maintain pursuant to the minimum liquidity covenant in the 2022 Credit Agreement to $5,000,000 for a period of 18 months, at which point the amount required under the minimum liquidity covenant shall increase to $20,000,000 (or, if certain conditions are met, $10,000,000), in exchange for a fee paid by us.
On November 8, 2023, we entered into Amendment No. 2 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 2, the 2022 Credit Agreement was amended to, among other things: (i) adjust and increase the amortization schedule such that payments commence on June 30, 2024 and are made 12, 24 and 36 months (i.e., the scheduled maturity date) following June 30, 2024; (ii) limit the business activities the Company may engage in; and (iii) require us to maintain a minimum liquidity of $10,000,000 at all times, in exchange for fees paid by us.
On March 4, 2024, we entered into Amendment No. 3 to the 2022 Credit Agreement with the Deerfield Funds. Previously, on February 16, 2024, the Biotronik Parties filed the Demand against us with the American Arbitration Association, alleging that we breached our contractual obligations under five agreements relating to the licensing, manufacturing, distribution and development of medical devices as a result of the wind down of our businesses. Pursuant to Amendment No. 3, the Deerfield Funds have agreed to waive any Default or Event of Default (each defined in the 2022 Credit Agreement) that has arisen or may arise in connection with the Demand. In addition, pursuant to Amendment No. 3 among other things, (i) the 2022 Credit Agreement was amended such that (x) a Change in Control (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement would not be deemed to occur in the event our common stock ceases to be listed on Nasdaq (without a comparable re-listing) (a "Delisting") and (y) exposure incurred in excess of $3.0 million in respect of proceedings in relation to the Demand and/or related proceedings and/or between such parties is deemed an Event of Default (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement.
On November 13, 2024, we and Deerfield entered into Amendment No. 4 (“Amendment No. 4”) to the 2022 Credit Agreement. Pursuant to Amendment No. 4, the Credit Agreement was amended to (i) adjust the amortization schedule of the Credit Agreement such that the $7.5 million installment payment of principal due on June 30, 2025 would be made over three equal installments of $2.5 million on each of June 30, 2025, September 30, 2025 and December 31, 2025 and (ii) increase the exit fee associated with prepayment or repayment of the loans from 5% to 6% of the principal amount of the loans prepaid or repaid. Except as amended by Amendment No. 4, the remaining terms of the amended and restated 2022 Credit Agreement remain in full force and effect.
On January 21, 2025, we entered into Amendment No. 5 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 5, the 2022 Credit Agreement was amended to allow us to effect the Deregistration and, among other things: (i) provided that the Deerfield Funds would receive a Consent Fee; (ii) modified the financial reporting requirements under the 2022 Credit Agreement, including requiring delivery of cash flow forecasts to the Deerfield Funds; (iii) required the appointment of a Chief Restructuring Officer; and (iv) modified the negative covenants to limit our business activities and required us to maintain minimum liquidity of $5 million. The effectiveness of Amendment No. 5 was conditioned upon the occurrence of the Deregistration on or prior to January 31, 2025 (or such other date as agreed to by the Deerfield Funds in their sole discretion).
As of December 31, 2024, we repaid $2.6 million of debt, inclusive of $0.13 million in fees.
In connection with the 2022 Credit Agreement, we entered into a warrant purchase agreement (the “2022 Warrant Purchase Agreement”) with Deerfield, pursuant to which we issued warrants to purchase up to an aggregate 3,779,018 shares of our common stock, par value $0.001 per share common stock, at an exercise price of $1.1114 per warrant share for a period of eight years following the issuance thereof (the “2022 Warrants”).
On March 4, 2024, we entered into an amendment (the “Warrant Amendment”) to the 2022 Warrants and 2022 Warrant Purchase Agreement with Deerfield. Pursuant to the Warrant Amendment, (i) the 2022 Warrants were amended to remove Deerfield’s option to require us to repurchase the 2022 Warrants from Deerfield upon a Delisting, and to modify the volatility rate that would be used to calculate the Black-Scholes value of the 2022 Warrants that would apply to certain other transactions involving us pursuant to the 2022 Warrants, and (ii) the Warrant Purchase Agreement was amended to remove our obligation to
take all commercially reasonable actions necessary to cause our common stock to remain listed on Nasdaq at all times during the term of the 2022 Warrants.
On January 21, 2025, in connection with entry into Amendment No. 5 and the Deregistration, we also entered into certain other agreements, including: (i) a Contingent Value Rights Agreement; (ii) a “Warrant Termination Agreement and (iii) a Registration Rights Termination Agreement.
Cash Flows
The following table shows a summary of our cash flows from continuing operations for the years ended December 31, 2024 and 2023 (in thousands):
2024 2023
Net cash used in operating activities - continuing operations
$ (17,185) $ (19,850)
Net cash provided by investing activities -continuing operations
$ 21,810 $ 59,766
Net cash used in financing activities - continuing operations
$ (2,850) $ (2,384)
Effect of exchange rate changes on cash, cash equivalents and restricted cash $ 221 $ 2,079
Net change in cash, cash equivalents and restricted cash $ (12,181) $ (5,148)
Operating Activities
During the year ended December 31, 2024, operating activities of continuing operations used $17.2 million of cash, a decrease of $2.7 million from the year ended December 31, 2023. This decrease was primarily attributable to favorable changes in operating assets and liabilities of $4.9 million, offset by an unfavorable change in non-cash items of $0.2 million and stock-based compensation of $2.6 million.
Investing Activities
During the year ended December 31, 2024, investing activities of continuing operations provided $21.8 million of cash, a decrease of $38.0 million from the year ended December 31, 2023. This decrease was attributable to a decrease of $79.3 million in marketable securities maturities, offset by the change in purchases of marketable securities of $39.8 million, an increase net sales earnout of $1.7 million and a decrease in the purchase of property and equipment of $0.1 million.
Financing Activities
During the year ended December 31, 2024, financing activities of continuing operations used $2.9 million of cash, an increase of $0.5 million from the year ended December 31, 2023. This increase is primarily attributable to the required $2.6 million debt repayment (inclusive of fees) made during the year ended December 31, 2024, whereas during the year ended December 31, 2023, $1.9 million in contingent consideration payments were made related to the Rhythm acquisition earnout and $0.5 million in debt restructuring fees were paid.
The following table shows a summary of our cash flows from discontinued operations for the years ended December 31, 2024 and 2023 (in thousands):
2024 2023
Net cash used in operating activities - discontinued operations
$ (14,475) $ (43,268)
Net cash provided by (used in) investing activities - discontinued operations
$ 339 $ (1,211)
Net cash used in financing activities - discontinued operations
$ (41) $ (280)
Operating Activities
During the year ended December 31, 2024, operating activities of discontinued operations used $14.5 million of cash, a decrease of $28.8 million from the year ended December 31, 2023. This decrease was primarily attributable to the payment of
accounts payable of $1.9 million, accrued liabilities of $2.8 million and restructure liabilities of $6.9 million, in addition to change in non-cash items of $15.1 million.
During the year ended December 31, 2024, investing activities of discontinued operations provided $0.3 million of cash, compared to cash used of $1.2 million during the year ended December 31, 2023. This increase in cash provided was attributable to the sale of equipment. Following the sale or disposal of the mapping and ablation business property and equipment, we believe that there would be a cash benefit to the company resulting from the disposition of these assets. (See the section titled "Biotronik" below for further information)
Financing Activities
During the year ended December 31, 2024, financing activities of discontinued operations used $0.0 million of cash, a decrease of $0.2 million from the year ended December 31, 2023. This decrease was due to minimal repurchase of common shares to cover employee stock purchase withholding taxes.
Contractual Obligations and Commitments
Rhythm Xience
The agreement to acquire Rhythm Xience requires us to pay the former owners of Rhythm Xience up to $17.0 million in additional cash earn-out consideration based on the achievement of certain regulatory and revenue milestones. In February 2020, we issued to the former owners of Rhythm Xience 119,993 shares of our Series D convertible preferred stock valued at $2.2 million and paid them $2.5 million in the first quarter of 2020, an additional $3.4 million and $1.3 million in 2021 and 2022, respectively, in connection with the regulatory and revenue milestones earned. The earnout period under the Rhythm Xience acquisition agreement concluded on June 19, 2023 and the final earnout payment under the agreement, totaling $1.9 million, was made to Rhythm Xience in July 2023.
Biotronik
Pursuant to the LDA with Biotronik, we issued to Biotronik $5.0 million in shares of our Series D convertible preferred stock in February 2020, and we may be required to pay the Biotronik Parties up to $10.0 million, of which $2.0 million has been paid as of December 31, 2023, upon the achievement of various regulatory and sales-related milestones, as well as unit-based royalties on any sales of Force Sensing Catheters.
On October 15, 2024, we and the Biotronik Parties entered into a Settlement Agreement terminating the (i) the License and Distribution Agreement with the Biontronik Parties entered into on July 2, 2019 (the “LDA”); (ii) the Global Alliance for Biotronik Product Distribution Agreement with Biotronik entered into on May 11, 2020 and the Global Alliance for Acutus Product Distribution Agreement, as amended, with Biotronik entered into on May 25, 2020 (collectively, the “Distribution Agreements”); (iii) the Feasibility and Development Agreement with Biotronik entered into on June 3, 2021 (the “F&D Agreement”); and (iv) the Manufacturing and Supply Agreement with Biotronik entered into on April 19, 2022 (the “MSA”, and together with the LDA, the Distribution Agreements and the F&D Agreement, the "Relevant Agreements"), (except for certain surviving obligations specified therein), settling the arbitration relating to the Relevant Agreements and releasing and discharging each party of all claims against the other, including any claims that were or could have been asserted in the arbitration. Pursuant to the Settlement Agreement, we must pay to Biotronik (i) an initial settlement payment of approximately $2.5 million; (ii) contingent payments of (x) in the event of a Qualifying Asset Sale (as defined in the Settlement Agreement), an amount equal to 50% of the aggregate cash consideration received; (y) in the event of a Change of Control (as defined in the Settlement Agreement) of the Company involving a Competitive Company (as defined in the Settlement Agreement), (A) initial amounts of $8 million and 5% of the aggregate upfront consideration received, with the latter not to exceed approximately $25 million (“Agreed Upfront Consideration”) and (B) additional amounts if additional consideration is received, up to approximately $25 million in aggregate (including the Agreed Upfront Consideration); and (z) in the event of a Change of Control not involving a Competitive Company, with certain exceptions, an amount equal to 25% of the aggregate cash consideration received. During the year ended December 31, 2024, we recorded $2.5M in discontinued operations restructure liability related to the Biotronik settlement. Additionally, we booked $1.7 million as contingent consideration (additional cost to sell) in the event of a Qualifying Asset Sale based on the carrying value of the assets held for sale. Subsequent to December 31, 2024, we received a letter of intent from a third-party that would qualify as a Qualifying Asset Sale and we adjusted the contingent consideration to $1.3 million, pursuant to the offer in the letter of intent.
Off-Balance Sheet Arrangements
As of December 31, 2024 and December 31, 2023, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined in the SEC rules and regulations.
Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue and expenses. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.
While our significant accounting policies are more fully described in Note 2-Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Item 8, Financial Statements and Supplementary Data of this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of operations and which require our most difficult, subjective and complex judgments.
Revenue from Contracts with Customers
We account for revenue earned from contracts with customers under ASC 606, Revenue from Contracts with Customers (“ASC 606”), and ASC 842, Leases (“ASC 842”). The core principle of ASC 606 is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
Step 1: Identify the contract with the customer.
Step 2: Identify the performance obligations in the contract.
Step 3: Determine the transaction price.
Step 4: Allocate the transaction price to the performance obligations in the contract.
Step 5: Recognize revenue when, or as, the company satisfies a performance obligation
.
ASC 842 provides guidance on determining if an agreement contains a lease. ASC 842 defines a lease as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment for a period of time in exchange for consideration.
Prior to the Restructuring, we usually placed our AcQMap System at customer sites under evaluation agreements and we generated revenue from the sale of disposable products used with the AcQMap System. Disposable products primarily included AcQMap Catheters and AcQGuide Steerable Sheaths. Outside of the U.S., we also had the Qubic Force Device which generated revenue from the sale of the AcQBlate FORCE Ablation Catheters. We provided the disposable products in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposables at the agreed upon prices in the invoice. Generally, customers purchased disposable products using separate purchase orders after the equipment has been provided to the customer for free with no binding agreement or requirement to purchase any disposable products. We have elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation.
We sold the AcQMap System to customers along with software updates on a when-and-if-available basis, as well as the Qubic Force Device and a transseptal crossing line of products which can be used in a variety of heart procedures and does not need to be accompanied with an AcQMap System or Qubic Force Device.
We also entered into deferred equipment agreements that were generally structured such that we agreed to provide an AcQMap System at no up-front charge, with title of the device transferring to the customer at the end of the contract term, in exchange for the customer’s commitment to purchase disposables at a specified price over the term of the agreement, which generally ranges from two to four years. We determined that the deferred equipment agreements included an embedded sales-type lease. We allocated contract consideration under deferred equipment agreements containing fixed annual disposable purchase commitments to the underlying lease and non-lease components at contract inception. We expensed the cost of the device at the inception of the agreement and recorded a financial lease asset equal to the gross consideration allocated to the lease. The lease asset was reduced by payments for minimum disposable purchases that were allocated to the lease.
Lastly, we entered into short-term operating leases, for the rental of the system after an evaluation. These lease agreements imposed no requirement on the customer to purchase the equipment and the equipment was not transferred to the customer at
the end of the lease term. The short-term nature of the lease agreements did not result in lease payments accumulating to an amount that equals the value of the equipment nor is the lease term reflective of the economic life of the equipment.
Following the Restructuring, we manufacture and sell left-heart access transseptal crossing Products to Medtronic under a Distribution Agreement. Under our Distribution Agreement with Medtronic, we expect to produce and sell these products to Medtronic for a period of up to four years. Revenue is recognized when the title to the products are transferred to Medtronic, which occurs when the Products are shipped from our facility (FOB shipping point).
Fair Value Measurements
Accounting guidance regarding fair value measurements addresses how companies should measure fair value when they are required to use a fair value measure for recognition or disclosure purposes under GAAP, and provides a common definition of fair value to be used throughout GAAP. It defines fair value as the price that would be received when selling an asset or paid to transfer a liability in an orderly fashion between market participants at the measurement date. In addition, it establishes a three-level valuation hierarchy for the disclosure of fair value measurements. The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability as of the measurement date. The level in the hierarchy within which a given fair value measurement falls is determined based on the lowest level input that is significant to the measurement (Level 1 being the highest and Level 3 being the lowest).
In connection with certain of our acquisitions, additional contingent consideration can be earned by the sellers upon achievement of certain milestones and revenue-based targets in certain years. We classify our contingent consideration liability as Level 3. The initial fair value of the revenue-based contingent consideration was therefore calculated through the use of a Monte Carlo simulation utilizing revenue projections for the respective earn-out period, corresponding targets and approximate timing of payments as outlined in the purchase agreement. The analyses used the following assumptions: (i) expected term; (ii) risk-adjusted net sales; (iii) risk-free interest rate; and (iv) expected volatility of net sales.
Estimated contingent consideration payments, as determined through the respective model, were further discounted by a credit spread assumption to account for credit risk. The fair value of the milestones-based contingent consideration was determined by probability weighting and discounting to the respective valuation date at our cost of debt. Our cost of debt was determined by performing a synthetic credit rating for us and selecting yields based on companies with a similar credit rating. The contingent consideration is revalued to fair value each period, and any increase or decrease is recorded in operating loss. The fair value of the contingent consideration may be impacted by certain unobservable inputs, most significantly with regard to discount rates, expected volatility and historical and projected performance. Significant changes to these inputs in isolation could result in a significantly different fair value measurement.
In connection with our shift in business model, certain assets met the classification for held for sale. The fair value of the assets held for sale are based on significant inputs that are unobservable and thus represent Level 3 measurements. Such unobservable significant inputs include an estimated marketplace transaction sales price for the disposal group, hypothetical projected revenues, costs and expenses, and cash flows that could potentially be generated by the assets held for sale, discounted at an estimated weighted average cost of capital. We also considered how the estimated value of the assets held for sale compared to the company’s overall market capitalization with a control premium. Significant changes to the inputs could result in a significantly different fair value measurement.
Recent Accounting Pronouncements
For a description of recently issued and adopted accounting pronouncements, including the respective dates of adoption and expected effects on our results of operations and financial condition, see Note 2-Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Item 8, Financial Statements and Supplementary Data of this Annual Report on Form 10-K, which is incorporated by reference in response to this item.
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company, as defined in the JOBS Act. As such, we are eligible for exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation, and an exemption from the requirements to obtain a non-binding advisory vote on executive compensation or golden parachute arrangements. We have elected to take advantage of certain of the reduced disclosure obligations and may elect to take advantage of other reduced reporting requirements in our future filings with the SEC. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.
In addition, an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We elected to avail ourselves of this provision of the JOBS Act. As a result, we will not be subject to new or revised accounting standards at the same time as other public companies that are not emerging growth companies. Therefore, our consolidated financial statements may not be comparable to those of companies that comply with new or revised accounting pronouncements as of public company effective dates.
We will remain an emerging growth company until the earliest of: (i) December 31, 2025; (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion; (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
We are also a smaller reporting company as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information required by this item.

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 8. Financial Statements and Supplementary Data.
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
Acutus Medical, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Acutus Medical, Inc. and subsidiary (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2024, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KPMG LLP
We have served as the Company’s auditor since 2015.
San Diego, California
March 24, 2025
Acutus Medical, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts) December 31,
2024 December 31,
ASSETS
Current assets:
Cash and cash equivalents $ 14,019 $ 19,170
Marketable securities, short-term - 3,233
Restricted cash, short-term - 7,030
Accounts receivable 7,878 11,353
Inventory 1,790 4,278
Prepaid expenses and other current assets 641 678
Current assets of discontinued operations (Note 3) 1,250 510
Total current assets 25,578 46,252
Property and equipment, net 517 825
Right-of-use assets, net 2,459 3,189
Other assets 94 94
Non-current assets of discontinued operations (Note 3) - 3,600
Total assets $ 28,648 $ 53,960
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Current liabilities:
Accounts payable 1,276 2,761
Accrued liabilities 3,006 2,887
Operating lease liabilities, short-term 957 718
Long-term debt, current portion 7,005 1,864
Warrant liability 194 409
Current liabilities of discontinued operations (Note 3) - 10,303
Total current liabilities 12,438 18,942
Operating lease liabilities, long-term 2,238 3,243
Long-term debt 25,564 32,654
Total liabilities 40,240 54,839
Commitments and contingencies (Note 12)
Stockholders' (deficit) equity
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 6,666 shares of the preferred stock, designated as Series A Common Equivalent Preferred Stock, are issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
- -
Common stock, $0.001 par value; 260,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 29,912,305 and 29,313,667 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
30 29
Additional paid-in capital 598,670 599,935
Accumulated deficit (609,524) (599,977)
Accumulated other comprehensive loss (768) (866)
Total stockholders' deficit (11,592) (879)
Total liabilities and stockholders' deficit $ 28,648 $ 53,960
The accompanying notes are an integral part of these consolidated financial statements.
Acutus Medical, Inc.
Consolidated Statements of Operations and Comprehensive Loss
Year Ended December 31,
(in thousands, except share and per share amounts) 2024 2023
Revenue $ 20,157 $ 7,164
Cost of products sold 19,144 10,301
Gross profit (loss) 1,013 (3,137)
Operating expenses (income):
Research and development - 3,482
Selling, general and administrative 10,436 14,066
Restructuring 1,448 -
Change in fair value of contingent consideration - 123
Gain on sale of business (10,814) (9,080)
Total operating expenses 1,070 8,591
Loss from operations (57) (11,728)
Other income (expense):
Change in fair value of warrant liability 215 2,937
Interest income 763 2,588
Interest expense (5,758) (5,655)
Other revenue 301 -
Total other expense, net (4,479) (130)
Loss from continuing operations before income taxes (4,536) (11,858)
Income tax expense
- 63
Net loss from continuing operations (4,536) (11,921)
Discontinued operations:
Loss from discontinued operations before income taxes (4,999) (69,530)
Income tax expense - discontinued operations
12 212
Loss from discontinued operations (5,011) (69,742)
Net loss $ (9,547) $ (81,663)
Other comprehensive income (loss):
Unrealized gain on marketable securities - 7
Foreign currency translation adjustment 98 (4)
Comprehensive loss $ (9,449) $ (81,660)
Net loss per share, basic and diluted:
Loss from continuing operations $ (0.15) $ (0.41)
Loss from discontinued operations $ (0.17) $ (2.40)
Net loss per common share, basic $ (0.32) $ (2.81)
Weighted average number of common shares outstanding, basic and diluted 29,768,208 29,095,294
The accompanying notes are an integral part of these consolidated financial statements.
Acutus Medical, Inc.
Consolidated Statements of Stockholders’ Equity (Deficit)
(in thousands, except share amounts) Preferred Stock Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive Income (Loss) Total
Stockholders'
Equity (Deficit)
Shares Amount Shares Amount
Balance as of December 31, 2022 6,666 $ - 28,554,656 $ 29 $ 594,173 $ (518,314) $ (869) $ 75,019
Unrealized loss on marketable securities - - - - - - 7 7
Foreign currency translation adjustment - - - - - - (4) (4)
Stock option exercises and RSU releases
- - 3,218 - 4 - - 4
Stock-based compensation - - 710,631 - 5,733 - - 5,733
Employee stock purchase plan shares issued - - 45,162 - 25 - - 25
Net loss - - - - - (81,663) - (81,663)
Balance as of December 31, 2023 6,666 $ - 29,313,667 $ 29 $ 599,935 $ (599,977) $ (866) $ (879)
(in thousands, except share amounts) Preferred Stock Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive Income (Loss) Total
Stockholders'
Deficit
Shares Amount Shares Amount
Balance as of December 31, 2023 6,666 $ - 29,313,667 $ 29 $ 599,935 $ (599,977) $ (866) $ (879)
Unrealized gain on marketable securities - - - - - - - -
Foreign currency translation adjustment - - - - - - 98 98
Stock option exercises and RSU releases
- - - 1 - - - 1
Stock-based compensation - - 598,638 - (1,265) - - (1,265)
Employee stock purchase plan shares issued - - - - - - - -
Net loss - - - - - (9,547) - (9,547)
Balance as of December 31, 2024 6,666 $ - 29,912,305 $ 30 $ 598,670 $ (609,524) $ (768) $ (11,592)
The accompanying notes are an integral part of these consolidated financial statements.
Acutus Medical, Inc.
Consolidated Statements of Cash Flows
(in thousands) 2024 2023
Cash flows from operating activities
Net loss $ (9,547) $ (81,663)
Less: Loss on discontinued operations 5,011 69,742
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense 297 191
Non-cash stock-based compensation expense 459 3,032
Accretion of discounts on marketable securities, net
(28) (1,428)
Amortization of debt issuance costs 931 571
Amortization of operating lease right-of-use assets 730 683
Gain on sale of business, net (10,814) (9,080)
Change in fair value of warrant liability (215) (2,937)
Change in fair value of contingent consideration - 123
Changes in operating assets and liabilities:
Accounts receivable (4,048) (1,074)
Inventory 2,488 (2,484)
Employer retention credit receivable - 4,703
Prepaid expenses and other current assets 48 656
Accounts payable (1,485) 288
Accrued liabilities (246) (700)
Operating lease liabilities (766) (461)
Other long-term liabilities - (12)
Net cash used in operating activities - continuing operations (17,185) (19,850)
Net cash used in operating activities - discontinued operations (14,475) (43,268)
Net cash used in operating activities (31,660) (63,118)
Cash flows from investing activities
Proceeds from sale of business 18,672 17,000
Purchases of available-for-sale marketable securities - (39,765)
Sales of available-for-sale marketable securities 500 750
Maturities of available-for-sale marketable securities 2,750 82,000
Purchases of property and equipment (112) (219)
Net cash provided by investing activities - continuing operations 21,810 59,766
Net cash provided by (used in) investing activities - discontinued operations
339 (1,211)
Net cash provided by investing activities 22,149 58,555
Cash flows from financing activities
Repayment of debt (2,625) -
Payment of amendment consent fees
(225) -
Payment of debt issuance costs - (490)
Proceeds from the exercise of stock options - 4
Proceeds from employee stock purchase plan - 25
Payment of contingent consideration - (1,923)
Net cash used in financing activities - continuing operations (2,850) (2,384)
Net cash used in financing activities - discontinued operations (41) (280)
Net cash used in financing activities (2,891) (2,664)
Effect of exchange rate changes on cash, cash equivalents and restricted cash 221 2,079
Net change in cash, cash equivalents and restricted cash (12,181) (5,148)
Cash, cash equivalents and restricted cash, at the beginning of the period 26,200 31,348
Cash, cash equivalents and restricted cash, at the end of the period $ 14,019 $ 26,200
Supplemental disclosure of cash flow information:
Cash paid for interest $ 4,544 $ 5,012
Supplemental disclosure of noncash investing and financing activities:
Changes between assets and liabilities in discontinued operations $ - $ 5,445
Accounts receivable from sale of business $ 1,838 $ 9,360
Change in unrealized (gain) loss on marketable securities $ - $ (7)
The accompanying notes are an integral part of these consolidated financial statements.
Acutus Medical, Inc.
Notes to Consolidated Financial Statements
Note 1-Organization and Description of Business
Acutus Medical, Inc. (the “Company”) historically designed, manufactured and marketed a range of tools for catheter-based ablation procedures to treat various arrhythmias. Prior to November 2023, the Company’s product portfolio included novel access sheaths, diagnostic and mapping catheters, ablation catheters, mapping and imaging consoles and accessories, as well as supporting algorithms and software programs.
In November 2023, the Company’s Board of Directors approved a strategic realignment of resources and corporate restructuring (the “Strategic Restructuring”). The Company began implementation of a shift in its business model to solely support the manufacturing and distribution of Medtronic Inc.’s (“Medtronic”) left-heart access ("LHA") product portfolio, including to potentially earn earnout payments from Medtronic pursuant to its manufacturing and distribution arrangements with Medtronic. As part of the Restructuring, the Company wound down its mapping and ablation businesses and no longer manufactures or distributes the AcQMap Mapping System, the AcQMap 3D Mapping Catheter, the AcQBlate Force-Sensing Ablation Catheter, the AcQGuide Max 2.0 Steerable Sheath or associated accessories, and are exploring strategic alternatives for these businesses (specifically a potential sale of related assets). The Strategic Restructuring was substantially complete in the first quarter of 2024.
In November 2024, the Company announced a further realignment of resources and operational downsizing of the Company, in which the Company further reduced the size of its organization while complying with its remaining obligations to Medtronic for the production of left-heart access products (the "Operational Downsizing"). The Company reduced operations to a scale designed solely to support the manufacturing and distribution of Medtronic’s left-heart access products through the transition of the production of these products to Medtronic pursuant to the terms of the Asset Purchase Agreement, dated April 26, 2022, with Medtronic (the “Asset Purchase Agreement”) and the Distribution Agreement, dated June 30, 2022, with Medtronic (the “Distribution Agreement”). The Company will continue contract manufacturing for Medtronic until it has fulfilled its obligations under the Asset Purchase Agreement and the Distribution Agreement. The Company expects to continue to minimize costs while capturing the value associated with potential earnout payments it is eligible to receive under the Asset Purchase Agreement until 2027.
The Company was incorporated in the state of Delaware on March 25, 2011, and is located in Carlsbad, California.
Liquidity and Capital Resources
The Company has limited revenue, and has incurred significant operating losses and negative cash flows from operations since its inception, and if it is unable to realize the expected benefits of the Restructuring, anticipates that it could incur significant losses for at least the next several years. As of December 31, 2024 and December 31, 2023, the Company had cash, cash equivalents, restricted cash and marketable securities of $14.0 million and $29.4 million, respectively. For the year ended December 31, 2024, net loss was $4.5 million from continuing operations and net loss was $5.0 million from discontinued operations. For the year ended December 31, 2023, net loss was $11.9 million from continuing operations and net loss was $69.7 million from discontinued operations. For the years ended December 31, 2024 and 2023, net cash used by operating activities for continuing operations was $17.2 million and $19.9 million, respectively. For the years ended December 31, 2024 and 2023, net cash used by operating activities for discontinued operations was $14.5 million and $43.3 million, respectively. As of December 31, 2024 and December 31, 2023, the Company had an accumulated deficit of $609.5 million and $600.0 million, respectively, and working capital of $13.1 million and $27.3 million, respectively.
The Strategic Restructuring announced in November 2023 was intended to reduce the Company’s operating expenses and optimize its cash resources by focusing exclusively on the manufacturing and distribution of the Products (as defined in Note 4 - Sale of Business, below) to Medtronic to continue to generate revenue from such sales in addition to the associated earnout payments discussed further below. Following the Restructuring, the Company's primary uses of capitalare investments in manufacturing and distributing the Products to Medtronic and related expenses, raw materials and supplies, legal and other regulatory expenses, general administrative costs and working capital.
On June 30, 2022, Medtronic paid the Company $50.0 million at the first closing (the "First Closing") of the sale of the Company's left-heart access portfolio to Medtronic, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing to secure the Company's indemnification obligations under the asset purchase agreement ("Asset Purchase Agreement") entered into with Medtronic on April 26, 2022. The OEM Earnout (as defined in Note 4 - Sale of Business, below) under the Asset Purchase Agreement with Medtronic was achieved on October 31, 2022, with $20.0 million paid by Medtronic to the Company in November 2022. Additionally, the Transfer Earnout (as defined in Note 4 - Sale of Business, below) under the Asset Purchase Agreement with Medtronic was achieved on December 21, 2022, with $17.0
million paid by Medtronic to the Company in January 2023. Beginning in February 2023, following Medtronic's first commercial sale of the Products after the Company's achievement of the OEM Earnout (as defined in Note 4 - Sale of Business, below), the Company became eligible to earn amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) of the Products achieved by Medtronic each year over four years. During the year ended December 31, 2024, the Company earned $11.1 million (before transaction costs), with $1.8 million recorded in accounts receivable as of December 31, 2024.
Management believes the Company’s current cash, cash equivalents and marketable securities are sufficient to fund operations for at least the next 12 months from the date of this filing.
Note 2-Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Principles of Consolidation
The consolidated financial statements include the accounts of Acutus Medical, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Discontinued Operations
In accordance with Accounting Standards Codification ("ASC") 205, Presentation of Financial Statements, under subtopic 205-20 Discontinued Operations, a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results when the components of an entity meets the criteria in paragraph 205-20-45-10. In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities are reported as components of total assets and liabilities separate from those balances of the continuing operations. At the same time, the results of all discontinued operations, less applicable income taxes, are reported as components of net loss separate from the net loss of continuing operations.
The strategic shift approved by the Company's Board of Directors (discussed in Note 1 - Organization and Description of Business above) met the definition of a discontinued operation at December 31, 2024 and 2023. Accordingly, the major current assets, non-current assets, current liabilities, and non-current liabilities are reported as components of total assets and liabilities separate from those balances of the continuing operations as of December 31, 2024 and 2023, and the operating results of the components disposed are reported as loss from discontinued operations in the accompanying consolidated statement of operations and comprehensive loss for the years ended December 31, 2024 and 2023. For additional information, see Note 3 - Discontinued Operations, Assets Held for Sale and Restructuring.
Use of Estimates and Assumptions
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and disclosures of contingent assets and liabilities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates.
Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company's determined based on the regularly reviewed and provided financial package to its Chief Executive Officer & Chief Financial Officer ("CEO & CFO"), that the CEO & CFO was its singular Chief Operating Decision Maker. Additionally, the Company determined that due to its sole focus on the manufacture and distribution of Medtronic's left heart access products, the Company views its operations and manages its business as one operating and reportable segment focused
on the manufacture and distribution of Medtronics LHA portfolio products pursuant to the Distribution Agreement (or, "OEM LHA").
Cash and Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposits and other accounts, the balances of which, at times and as of December 31, 2024 and December 31, 2023, exceeded federally insured limits.
Restricted cash consists of (i) deposited cash collateral for the Company’s corporate credit card program and (ii) cash received for the sale of business to Medtronic held in an indemnity escrow account until certain terms of sale are met.
The following table reconciles cash, cash equivalents and restricted cash in the consolidated balance sheets to the total balances as of December 31, 2024 and December 31, 2023 (in thousands):
2024 2023
Cash and cash equivalents $ 14,019 $ 19,170
Restricted cash - 7,030
Total cash, cash equivalents and restricted cash $ 14,019 $ 26,200
Marketable Securities
The Company’s marketable securities portfolio consists of investments in money market funds, commercial paper, U.S. treasury securities, Yankee debt securities, and asset-backed securities.
The Company considers its debt securities to be available-for-sale securities. Available-for-sale securities are classified as cash equivalents or short-term or long-term marketable securities based on the maturity date at time of purchase and their availability to meet current operating requirements. Marketable securities that mature in three months or less from the date of purchase are classified as cash equivalents. Marketable securities, excluding cash equivalents, that mature in one year or less are classified as short-term available-for-sale securities and are reported as a component of current assets.
Securities that are classified as available-for-sale are measured at fair value with temporary unrealized gains and losses reported in other comprehensive income (loss), and as a component of stockholders’ equity until their disposition or maturity. See Fair Value Measurements, below. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s current intent and ability to sell the security if it is required to do so. Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific-identification method.
Marketable securities are subject to a periodic impairment review. The Company may recognize an impairment charge when a decline in the fair value of investments below the cost basis is determined to be other-than-temporary. In determining whether a decline in market value is other-than-temporary, various factors are considered, including the cause, duration of time and severity of the impairment, any adverse changes in the investee’s financial condition and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. Declines in value judged to be other-than-temporary are included in the Company’s consolidated statements of operations and comprehensive loss. The Company recorded not impairements any other-than-temporary impairments related to marketable securities in the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023.
Concentrations of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents, restricted cash, accounts receivable and marketable securities. The Company has not experienced losses on these accounts, and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
Revenue from Contracts with Customers
The Company accounts for revenue earned from contracts with customers under ASC 606, Revenue from Contracts with Customers (“ASC 606”), and ASC 842, Leases ("ASC 842"). The core principle of ASC 606 is that a company should
recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
•Step 1: Identify the contract with the customer.
•Step 2: Identify the performance obligations in the contract.
•Step 3: Determine the transaction price.
•Step 4: Allocate the transaction price to the performance obligations in the contract.
•Step 5: Recognize revenue when, or as, the company satisfies a performance obligation.
ASC 842 provides guidance on determining whether an agreement contains a lease. ASC 842 defines a lease as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment for a period of time in exchange for consideration.
The below description applies to products that will no longer be manufactured and sold by the Company upon completion of the Restructuring. See Note 1 - Organization and Description of Business - Liquidity and Capital Resources, above.
For new customers, the Company places its medical diagnostic equipment, the AcQMap System, at customer sites under evaluation agreements and generates revenue from the sale of disposable products used with the AcQMap System. Disposable products primarily include AcQMap Catheters and AcQGuide Steerable Sheaths. Outside of the United States, the Company also has the Qubic Force Device which generates revenue from the sale of the AcQBlate Force Ablation Catheters. The Company provides the disposable products in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposables at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment has been provided to the customer for free with no binding agreement or requirement to purchase any disposable products. The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation.
Additionally, the Company sells the AcQMap System to customers along with software updates on a when-and-if-available basis, as well as the Qubic Force Device and a transseptal crossing line of products which can be used in a variety of heart procedures and does not need to be accompanied with an AcQMap System or Qubic Force Device. Included in the transseptal crossing line of products are primarily the AcQRef Introducer Sheath, the AcQGuide Sheaths and the AcQCross Transseptal Dilator/Needle.
The Company also enters into deferred equipment agreements that are generally structured such that the Company agrees to provide an AcQMap System at no up-front charge, with title of the device transferring to the customer at the end of the contract term, in exchange for the customer’s commitment to purchase disposables at a specified price over the term of the agreement, which generally ranges from two to four years. The Company has determined that such deferred equipment agreements include an embedded sales-type lease. The Company allocates contract consideration under deferred equipment agreements containing fixed annual disposable purchase commitments to the underlying lease and non-lease components at contract inception. The Company expenses the cost of the device at the inception of the agreement and records a financial lease asset equal to the gross consideration allocated to the lease. The lease asset is reduced by payments for minimum disposable purchases that are allocated to the lease.
Lastly, the Company enters into short-term operating leases for the rental of the AcQMap System after an evaluation. These lease agreements impose no requirement on the customer to purchase the equipment, and the equipment is not transferred to the customer at the end of the lease term. The short-term nature of the lease agreements does not result in lease payments accumulating to an amount that equals the value of the equipment nor is the lease term reflective of the economic life of the equipment.
The Company’s contracts primarily include fixed consideration. Generally, there are no discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 to 60 days.
The delivery of disposable products are performance obligations satisfied at a point in time. The disposable products are shipped Free on Board (“FOB”) shipping point or FOB destination. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products
leave the Company’s shipping facilities, at which point the customer obtains control and thus revenue is recognized at that point in time. Revenue is recognized on delivery for disposable products shipped FOB destination.
For direct customers, the installation and delivery of the AcQMap System is satisfied at a point in time when the installation is complete, which is when the customer can benefit and has control of the system. For AcQMap Systems sold to Biotronik SE & Co. KG (“Biotronik”), the installation is not a performance obligation as it is performed by Biotronik, and therefore the AcQMap System is satisfied at a point in time when they have control of the system. The Company’s software updates and equipment service performance obligations are satisfied evenly over time as the customer simultaneously receives and consumes the benefits of the Company’s performance for these services throughout the service period.
The Company allocates the transaction price to each performance obligation identified in the contract based on the relative standalone selling price (“SSP”). The Company determines SSP for the purposes of allocating the transaction price to each performance obligation based on the adjusted market assessment approach that maximizes the use of observable inputs, which include, but are not limited to, sales transactions where the specific performance obligations are sold separately, Company list prices and specific offers to customers.
Except for the deferred equipment agreements noted above, the Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative ("SG&A") expense as incurred due to the short duration of the Company’s contracts. The Company’s contract balances consisted solely of accounts receivable as of December 31, 2024 and December 31, 2023.
In May 2020, the Company entered into bi-lateral distribution agreements (the “Bi-Lateral Distribution Agreements”) with Biotronik. Pursuant to the Bi-Lateral Distribution Agreements, the Company obtained a non-exclusive license to distribute a range of Biotronik’s products and accessories in the United States, Canada, China, Hong Kong and multiple Western European countries under the Company’s private label. Moreover, if an investigational device exemption (“IDE”) clinical trial is required for these products to obtain regulatory approval in the United States, or a clinical trial is required for these products to obtain regulatory approval in China, the Company will obtain an exclusive distribution right in such territories for a term of up to five years commencing on the date of regulatory approval if the Company covers the cost of the IDE or other clinical trial and the Company conducts such study within a specified period. Biotronik also agreed to distribute the Company’s products and accessories in Germany, Japan, Mexico, Switzerland and multiple countries in Asia-Pacific, Eastern Europe, the Middle East and South America. The Company also granted Biotronik a co-exclusive right to distribute these products in Hong Kong. Each party will pay to the other party a specified transfer price on the sale of the other party’s products and, accordingly, will earn a distribution margin on the sale of the other party’s products.
In 2022, the Company sold its left-heart access transseptal crossing business to Medtronic. In connection with the sale, the Company entered into a distribution agreement (the "Distribution Agreement") with Medtronic, pursuant to which the Company acts as the original equipment manufacturer ("OEM") supplier of these products. The Company will produce and sell the products to Medtronic for a period of up to four years. Revenue is recognized when the title to the products are transferred to Medtronic, which occurs when the products are shipped from our facility (or FOB shipping point). See Note 4 - Sale of Business, below, for further details. As part of the Restructuring, the Company will focus exclusively on the manufacturing and distribution of the left-heart access Products to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments.
The following table sets forth the Company’s continuing revenues (primarily sales to Medtronic) for disposables and service/other (transitional services for Medtronic) for the years ended December 31, 2024 and 2023 (in thousands):
2024 2023
Disposables $ 19,629 $ 6,315
Service/Other 528 849
Total revenue $ 20,157 $ 7,164
Revenue from continuing operations is primarily US-based.
Inventory
Inventory is stated at the lower of cost (first-in, first-out basis) or net realizable value. The Company recorded write-downs for excess and obsolete inventory of $1.1 million and $3.2 million for the years ended December 31, 2024 and 2023, respectively, based on management’s review of inventories on hand, comparisons to estimated future usage and sales, observed shelf-life and assumptions about the likelihood of obsolescence.
Accounts Receivable
Trade accounts receivable are recorded net of allowances for uncollectible accounts. The Company evaluates future credit losses based on various factors including historical experience, the length of time the receivables are past due and the financial health of the customer. The Company reserves specific receivables if collectability is no longer reasonably assured. Based upon the assessment of these factors, the Company did not record an allowance for uncollectible accounts as of December 31, 2024 or December 31, 2023.
Accounts receivable recorded on the consolidated balance sheets as of December 31, 2024 and December 31, 2023 consists of the following (in thousands):
2024 2023
Trade accounts receivable $ 6,040 $ 1,993
Earnouts receivable from Medtronic 1,838 9,360
Total accounts receivable $ 7,878 $ 11,353
Property and Equipment, Net
Property and equipment are recorded at cost. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets, generally 3 to 5 years, or, in the case of leasehold improvements, over the lesser of the useful life of the related asset or the lease term.
Foreign Currency Translation and Transactions
The assets, liabilities and results of operations of Acutus Medical N.V. and Acutus Medical UK Limited are measured using their functional currency, the Euro and British Pound Sterling, respectively, which is the currency of the primary foreign economic environment in which the subsidiaries operate. Upon consolidating these entities with the Company, their assets and liabilities are translated to U.S. dollars at currency exchange rates as of the balance sheet date and their revenues and expenses are translated at the weighted average currency exchange rates during the applicable reporting periods. Translation adjustments resulting from the process of translating the entities’ financial statements are reported in accumulated other comprehensive loss in the consolidated balance sheets and foreign currency translation adjustment in the consolidated statements of operations and comprehensive loss.
Lease Property
The Company leases office space in Carlsbad, California as its corporate headquarters and for manufacturing operations. The Company accounts for its lease property under ASC 842. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases, and are recorded on the consolidated balance sheets as both a right-of-use asset and a lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate, which is the rate for collateralized borrowings based on the current economic environment, credit history, credit rating, value of leases, currency in which the lease obligation is satisfied, rate sensitivity, lease term and materiality. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset results in straight-line rent expense over the lease term. Variable lease expenses are recorded when incurred.
The Zaventem, Belgium lease expired December 31, 2024 and was not renewed.
In calculating the right-of-use asset and lease liability, the Company elected to combine lease and non-lease components. The Company adopted the policy election to exclude short-term leases having initial terms of twelve months from the initial recognition provisions of ASC 842. See Note 11 - Operating Leases for additional details.
Cost of Products Sold
Cost of products sold includes raw materials, direct labor, manufacturing overhead, shipping and receiving costs and other less significant indirect costs related to the production of the Company’s products.
Research and Development
Prior to the Restructuring, the Company was actively engaged in new product research and development efforts. Research and development expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel directly engaged in research and development activities, clinical trial expenses, equipment costs, material costs, allocated rent and facilities costs and depreciation.
Research and development expenses relating to possible future products are expensed as incurred. The Company also accrues and expenses costs for activities associated with clinical trials performed by third parties as incurred. All other costs relative to setting up clinical trial sites are expensed as incurred. Clinical trial site costs related to patient enrollment are accrued as patients are entered into the trials.
Selling, General and Administrative
Selling, general, and administrative expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel in executive, finance and other administrative functions, allocated rent and facilities costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs, and additionally, prior to the Restructuring, salaries and employee-related costs for personnel in sales, marketing, and other administrative functions.
Fair Value Measurements
Financial Instruments
Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy is used in determining the inputs for measuring fair value:
Level 1-Quoted prices in active markets for identical assets or liabilities.
Level 2-Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3-Unobservable inputs which are supported by little or no market activity and consist of financial instruments valued using pricing models, discounted cash flow methodologies or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. There were no transfers made among the three levels in the fair value hierarchy for the years ended December 31, 2024 and 2023.
As of December 31, 2024 and December 31, 2023, the Company’s cash (excluding cash equivalents which are recorded at fair value on a recurring basis), restricted cash, accounts receivable, accounts payable and accrued expenses were carried at cost, which approximates the fair values due to the short-term nature of each instrument. The carrying amount of the Company’s long-term debt approximates fair value (using Level 2 assumptions) due to its variable market interest rate and management’s opinion that current rates and terms that would be available to the Company with the same maturity and security structure would be essentially equivalent to that of the Company’s long-term debt.
The following tables classify the Company’s financial assets and liabilities measured at fair value on a recurring basis into the fair value hierarchy as of December 31, 2024 and December 31, 2023 (in thousands):
Fair Value Measurements as of December 31, 2024
Quoted
Prices
in Active
Markets for
Identical
Assets
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3) Total
Assets included in:
Cash and cash equivalents
Money market securities $ 10,160 $ - $ - $ 10,160
Total fair value $ 10,160 $ - $ - $ 10,160
Liabilities included in:
Warrant liability - - 194 194
Total fair value $ - $ - $ 194 $ 194
Fair Value Measurements as of December 31, 2023
Quoted
Prices
in Active
Markets for
Identical
Assets
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3) Total
Assets included in:
Cash and cash equivalents
Money market securities $ 16,911 $ - $ - $ 16,911
Marketable securities at fair value
U.S. treasury securities - - - -
Commercial paper - 1,978 - 1,978
Asset-backed securities - 497 - 497
Yankee debt securities - 758 - 758
Total fair value $ 16,911 $ 3,233 $ - $ 20,144
Liabilities included in:
Warrant liability - - 409 409
Contingent consideration - - - -
Total fair value $ - $ - $ 409 $ 409
The fair value of the Company’s money market securities is determined using quoted market prices in active markets for identical assets.
The fair value for the available-for-sale marketable securities is determined based on valuation models using inputs that are observable either directly or indirectly (Level 2 inputs) such as quoted prices for similar assets, yield curve, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments, broker and dealer quotes, as well as other relevant economic measures.
Financial Obligations
The following table presents changes in Level 3 liabilities measured at fair value for the year ended December 31, 2024 (in thousands):
Warrant Liability
Balance, December 31, 2023 $ 409
Change in fair value of warrant liability (215)
Balance, December 31, 2024 $ 194
As of December 31, 2024, the fair value of the common stock warrants was estimated using the Black-Scholes option pricing model. The fair value was estimated to be $0.0514 per warrant as of December 31, 2024 and the significant inputs used in the estimation of the fair value were as follows:
December 31, 2024
Risk-free interest rate 4.78 %
Expected term in years 5.5
Expected volatility 200 %
Stock-Based Compensation
The Company accounts for all stock-based payments to employees and non-employees, including grants of stock options, restricted stock units ("RSUs"), and restricted stock awards ("RSAs"), to be recognized in the consolidated financial statements based on their respective grant date fair values. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The RSUs and RSAs are valued based on the fair value of the Company’s common stock on the date of grant. The Company expenses stock-based compensation related to stock options, RSUs and RSAs over the requisite service period. All stock-based compensation costs are recorded in cost of products sold, research and development expense or SG&A expense in the consolidated statements of operations and comprehensive loss based upon the respective employee’s or non-employee’s roles within the Company. Forfeitures are recorded as they occur. See Note 15-Stock-Based Compensation for additional details.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse, and net operating loss (“NOL”) carryforwards and research and development tax credit carryforwards. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits.
Warrant Liability
The Company accounts for certain common stock warrants outstanding as a liability at fair value, determined using the Black-Scholes option pricing model, on the consolidated balance sheets in accordance with ASC 815, Derivatives and Hedging (“ASC
815”). The liability is subject to re-measurement at each reporting period and any change in fair value is recognized in the consolidated statements of operations and comprehensive loss. See Note 14-Warrants for additional details.
Business Combinations
The Company accounts for business acquisitions using the acquisition method of accounting based on ASC 805, Business Combinations (“ASC 805”), which requires recognition and measurement of all identifiable assets acquired and liabilities assumed at their fair value as of the date control is obtained. The Company determines the fair value of assets acquired and liabilities assumed based upon its best estimates of the acquisition-date fair value of assets acquired and liabilities assumed in the acquisition. Goodwill is calculated as the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) ("ASU 2023-07"), which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. Additionally, the amendments enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, provide new segment disclosure requirements for entities with a single reportable segment, and contain other disclosure requirements. ASU 2023-07 is effective for public entities with annual periods beginning after December 15, 2023, with early adoption permitted. The Company adopted this new standard effective December 31, 2024. (See Note 8, Segments, for disclosures related to the adoption of ASU 2023-07.)
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-04, Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments ("ASU 2024-04"), which clarifies the requirements for determining whether to account for certain early settlements of convertible debt instruments as induced conversions or extinguishments. ASI 2024-04 is effective for fiscal years beginning after December 15, 2025 with early adoption permitted for entities that have adopted ASU 2020-06. The Company is evaluating the impact of this guidance on its consolidated financial statements.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Recognition Disclosures ("ASU 2024-03"), which requires disclosure of disaggregated information about specific categories underlying certain income statement expense line items in the footnotes of the financial statements for both annual and interim periods. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is evaluating the impact of this guidance on the related disclosures.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes: Improvements to Income Tax Disclosures (Topic 740) ("ASU 2023-09"), which requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company is evaluating the impact of this guidance on its consolidated financial statements.
Note 3-Discontinued Operations, Assets Held for Sale and Restructuring
In November 2023, with approval of the “Strategic Restructuring”, the Company began implementation of its business model shift to solely support the manufacturing and distribution of Medtronic’s left-heart access product portfolio. As part of the Restructuring, the Company is no longer manufacturing or distributing the AcQMap Mapping System, the AcQMap 3D Mapping Catheter, the AcQBlate Force-Sensing Ablation Catheter, the AcQGuide Max 2.0 Steerable Sheath, and associated accessories. Additionally, the Company has halted any further research and development related to this suite of products.
Discontinued operations comprise those activities that were disposed of during the period, abandoned or which were classified as held for sale at the end of the period and relate to the Company's mapping and ablation business, which it substantially wound-down at the end of the first quarter of 2024.
Assets Held for Sale
The Company considers assets to be held for sale when management approves and commits to a plan to actively market the assets for sale at a reasonable price in relation to its fair value, the assets are available for immediate sale in their present condition, an active program to locate a buyer and other actions required to complete the sale have been initiated, the sale of the assets is expected to be completed within one year and it is unlikely that significant changes will be made to the plan. Upon
designation as held for sale, the Company ceases to record depreciation and amortization expenses and measures the assets at the lower of their carrying value or estimated fair value less costs to sell. At December 31, 2024, assets held for sale are included as current assets in the Company’s consolidated balance sheet, as any proceeds from disposal will be used for the payment of debt that is due in less than one year. At December 31, 2023, assets held for sale were included as non-current assets in the Company’s consolidated balance sheet and the loss recognized on classification of assets held for sale was included in the Company’s restructuring expenses. At December 31, 2023, the assets held for sale were determined to be non-current assets as any proceeds from disposal would be used to pay down the Company's long-term debt.
The major assets and liabilities (at carrying value) associated with discontinued operations included in the Company's consolidated balance sheets are as follows (in thousands):
December 31, 2024 December 31, 2023
Carrying amounts of major classes of assets included as part of discontinued operations
Accounts receivable $ - $ 510
Inventory 12,780 *
12,780
Prepaid expenses and other current assets 165 *
Property and equipment, net 4,508 *
4,871
Intangible assets, net 1,416 *
1,416
Other assets - -
Less: Impairment on classification as held for sale
(17,619) *
(16,369)
Total assets of the disposal group classified as discontinued operations in the statement of financial position
$ 1,250 $ 4,110
* These comprise assets held for sale, at their carrying value of $1.25 million as of December 31, 2024. The Company recorded the impairment on classification of held for sale as a valuation allowance on the group of assets held for sale, without allocation to the individual assets within the group.
Carrying amounts of major classes of liabilities included as part of discontinued operations
Accounts payable - 1,892
Accrued restructure
- 5,649
Accrued liabilities - 2,762
Total liabilities of the disposal group classified as discontinued operations in the statement of financial position
$ - $ 10,303
Inventory in discontinued operations consisted of the following (in thousands):
December 31,
2024 December 31,
Raw materials $ 8,020 $ 8,020
Work in process 2,211 2,211
Finished goods 2,549 2,549
Total inventory transferred to held for sale $ 12,780 $ 12,780
Property and equipment, net, in discontinued operations consisted of the following (in thousands):
December 31,
2024 December 31,
Furniture and fixtures $ 20 $ 20
Laboratory equipment and software 17,506 18,295
Construction in process 1,141 1,141
Total property and equipment 18,667 19,456
Less: accumulated depreciation (14,159) (14,585)
Total property and equipment, net, related to discontinued operations $ 4,508 $ 4,871
Depreciation expense was $0 million and $3.6 million for the years ended December 31, 2024 and 2023, respectively. Assets transferred to held for sale are no longer depreciated.
Intangibles, net, consists solely of licensed intangible assets acquired from Biotronik relating to the force sensing ablation catheter, which is part of the Company's operations that it intends to sell. The Company recorded amortization expense related to the above intangible assets of $0 million and $0.17 million for the years ended December 31, 2024 and 2023, respectively. Intangible assets held for sale are no longer amortized.
The revenues and expenses associated with discontinued operations included in the Company's consolidated statements of operations and comprehensive loss were as follows (in thousands):
December 31, 2024 December 31, 2023
Major line items constituting pretax loss of discontinued operations
Revenue $ - $ 10,937
Cost of product sold - (19,002)
Research and development 189 (18,335)
Selling, general and administrative (520) (18,852)
Restructuring (3,418) (6,324)
Impairment of inventory - (384)
Impairment of prepaid assets and other current assets - (580)
Impairment of property and equipment - (621)
Impairment from held for sale classification (1,250) (16,369)
Loss from discontinued operations before income taxes (4,999) (69,530)
Income tax expense 12 212
Net loss from discontinued operations $ (5,011) $ (69,742)
The following table sets forth the breakdown of Company’s discontinued operations revenue for disposables, systems and service/other for the years ended December 31, 2024 and 2023 (in thousands):
2024 2023
Disposables $ - $ 8,082
Systems - 1,254
Service/Other - 1,601
Total revenue $ 10,937
The following table provides discontinued operations revenue by geographic location for the years ended December 31, 2024 and 2023 (in thousands):
2024 2023
United States $ - $ 4,450
Outside the United States - 6,487
Total revenue $ - $ 10,937
Impairment of Inventory
For the year ended December 31, 2023, certain inventory was impaired as a result of the strategic decision to wind down the mapping and ablation business. The Company determined that certain non-left-heart access inventories needed to be destroyed or that the net realizable value for certain inventories was lower than cost, resulting in an impairment expense recognition of approximately $0.4 million related to its inventory for the year ended December 31, 2023. The balance of remaining inventory in discontinued operations at December 31, 2024 and 2023 was $12.8 million and $12.8 million, respectively. At December 31, 2024, the Company determined that all inventory was unexpired, useable, sellable and at its net realizable value.
Impairment of Prepaid Assets and Other Current Assets
For the year ended December 31, 2023, certain prepaid assets and other current assets were impaired as a result of the strategic decision to wind down the mapping and ablation business. The Company determined that for these prepaid assets and other current assets it could not seek a refund, however, the service related to the respective asset was no longer required due to the business shift, resulting in an impairment expense recognition of approximately $0.6 million related to its prepaid assets and other current assets for the year ended December 31, 2023. The remaining balance of prepaid assets and other current assets in discontinued operations at December 31, 2024 and 2023 was $0.2 and $0.9 million, respectively.
Impairment of Property and Equipment
For the year ended December 31, 2023, certain property and equipment were impaired as a result of the strategic decision to wind down the mapping and ablation business. The Company determined that certain property and equipment that had been tailored or integrated in ways specific to the Company, had no salvage value or the efforts to separate and/or transfer/sell the property and equipment was cost prohibitive, resulting in an impairment expense recognition of approximately $0.6 million related to property and equipment for the year ended December 31, 2023. The remaining balance of property and equipment in discontinued operations at December 31, 2024 and 2023 was $4.5 and $4.9 million, respectively. During the year ended December 31, 2024, $0.4 million of net assets held for sale were sold.
Impairment of Assets Classified as Held for Sale
For the year ended December 31, 2023, certain intangible assets, inventory and property and equipment were impaired as a result of meeting the criteria to be classified as held for sale. The Company engaged an independent third-party to determine the fair value of the assets held for sale (“disposal group”.) The Company determined that the carrying value of $3.6 million (fair value of $3.8 million less estimated costs to sell of $0.2 million) of the disposal group was less than the book values of the disposal group, thus, the Company recorded an impairment charge related to the held for sale classification of $16.4 million for the year ended December 31, 2023. With the Biotronik settlement during the third quarter of 2024, the Company recognized additional contingent consideration of $1.7 million related to the cost to sell the mapping and ablation business, which was
adjusted in the fourth quarter of 2024 to $1.25 million based on a letter of intent received by the Company for the purchase of certain assets of the discontinued operation. Due to the nature of estimates, the actual amounts realized upon sale may be more than or less than the estimated carrying value of the disposal group. Any difference will be recognized as a gain or loss in discontinued operations of future financial statements. The fair value measurements of the assets held for sale are based on significant inputs that are unobservable and thus represents Level 3 measurements.
Restructuring Activities
In connection with the strategic decision to wind down the ablation and mapping business, restructuring actions were taken related to this shift in business model, resulting in the realignment of resources, including an organizational workforce reduction and corporate restructure. Restructuring and exit-related charges consisting of severance expenses and related benefit costs for employees affected by the organizational workforce reduction, retention bonuses for certain employees that are assisting with the Restructuring, contract termination costs and other restructuring costs were recorded as restructuring expense, cost of product sold or selling, general administrative expense and is included in the loss from discontinued operations.
The Company identified three major types of restructuring activities related to the disposal of the mapping and ablation business, in addition to, the asset impairments detailed above. These three types of activities are employee termination costs, contract termination costs, and other costs. For the year ended December 31, 2023, the Company recorded $4.2 million for employee termination costs within restructure expenses of discontinued operations. Additionally, the Company estimated $2.2 million in contract termination costs, which were recorded in restructuring expense of discontinued operations, as these contract termination costs were deemed probable and estimable.
The restructuring activities related to employee termination and contract termination activities were substantially completed by the end of the first quarter of 2024. However, due to the Biotronik settlement, an additional $2.5 million of restructuring expense was accrued related to other restructuring cost; and, was paid as of December 31, 2024. Additionally, an additional $1.25 million of loss recognized on assets held for sale was recorded as December 31, 2024, to account for additional contingent consideration on a qualifying sale of assets, in which subsequent to December 31, 2024, the Company received a letter of intent from a third party. (See Footnote 12, Commitments and Contingencies, for further information.)
The following summarizes the restructuring activities and their related accruals as of December 31, 2024:
Employee
Contract
Termination Costs
Termination Costs Other Costs
Total
Restructure Accrual Balance at 12/31/2023 $ 3,493 $ 2,156 $ - $ 5,649
Payments (3,272) (1,171) (2,510) (6,953)
Accrual release (non-cash) (221) (985) - (1,206)
Biotronik settlement - - 2,510 2,510
Restructure Accrual Balance at 12/31/24 $ - $ - $ - $ -
Note 4-Sale of Business
On June 30, 2022, the Company completed the First Closing in accordance with the Asset Purchase Agreement with Medtronic, pursuant to which the Company agreed to sell to Medtronic certain transseptal access and sheath assets which make up the Company's left-heart access portfolio (and which comprised the Rhythm Xience, Inc. ("Rhythm Xience") product line acquired as part of the Rhythm Xience acquisition). The assets transferred to Medtronic upon the First Closing (the “Assets”) include patents, trademarks, patent and trademark applications, know-how, copyrights, prototypes and other intellectual property owned or licensed by the Company, business records and documents (including regulatory and clinical materials) and manufacturing equipment related to the AcQCross® line of sheath-compatible septal crossing devices, AcQGuide® MINI integrated crossing device and sheath, AcQGuide® FLEX Steerable Introducer with integrated transseptal dilator and needle, and AcQGuide® VUE steerable sheaths (the “Products”).
Pursuant to the Asset Purchase Agreement, Medtronic paid $50.0 million at the First Closing, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing to secure indemnification obligations of the Company under the Asset Purchase Agreement, which the Company has recorded as restricted cash on its condensed consolidated balance sheets.
The Company is also eligible to receive the following contingent cash consideration pursuant to the Asset Purchase Agreement:
(i) $20.0 million upon the Company’s completion, to the reasonable satisfaction of Medtronic, of certain conditions set forth in the Asset Purchase Agreement relating to the Company becoming a qualified supplier of Medtronic for the Products, including demonstration of ISO 14971:2019 compliance, completion of certain test method validations and compliance with certain other reporting requirements (the “OEM Earnout”);
(ii) $17.0 million upon the earlier of (A) the Second Closing (as defined below) or (B) the Company’s initial submission for CE Mark certification of the Products under the European Union Medical Devices Regulation, to the reasonable satisfaction of a third-party regulatory consultant, subject to certain other conditions as set forth in the Asset Purchase Agreement (the “Transfer Earnout”); and
(iii) amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the Products achieved by Medtronic over each year over a four-year period beginning on the first full quarter after Medtronic’s first commercial sale of a Product and achievement of the OEM Earnout.
The $20.0 million OEM Earnout was achieved in October 2022 and payment was received in November 2022, of which $1.6 million is held in escrow and recorded as restricted cash on the consolidated balance sheets. The $17.0 million Transfer Earnout was achieved in December 2022 and payment was received in January 2023, of which $1.4 million is held in escrow and recorded as restricted cash on the consolidated balance sheets. Following the termination of the escrow account in accordance with the Asset Purchase Agreement, the amounts in escrow were released. December 31, 2024, the Company has no restricted cash recorded on the consolidated balance sheet. During the year ended December 31, 2024, $11.1 million was earned under item (iii) and $1.8 million was recorded as a receivable on the consolidated balance sheet as of December 31, 2024.
With the achievement of the OEM Earnout Conditions (as defined in the Asset Purchase Agreement) and upon notice from Medtronic, Medtronic became the Company's exclusive distributor of the Products under the Distribution Agreement.
The Company recorded a net gain of $79.5 million during the year ended December 31, 2022 related to the sale of business to Medtronic, calculated as the difference between the non-contingent consideration received, less direct transaction costs and the net carrying amount of the assets sold.
For the year ending December 31, 2024, the Company recorded the following amounts, resulting in a net gain of $10.8 million related to the sale of business to Medtronic, calculated as the difference between the non-contingent consideration earned, less direct transaction costs (in thousands):
December 31, 2024
Net Sales Earnout as of December 31, 2024 $ 11,149
Transaction costs (335)
Gain on sale of business, net $ 10,814
The net gain on sale will be adjusted in future periods by the contingent consideration, based on the achievement of the predetermined milestones mentioned above. The sale was accounted for as a derecognition of a group of assets that is a business pursuant to ASC 810 - Consolidation, with the resulting gain classified as operating income within loss from operations on the consolidated statements of operations and comprehensive loss. The sale did not represent a strategic shift having a major effect on the Company's operations and financial results and, consequently, did not qualify as a discontinued operation.
Note 5-Marketable Securities
As of December 31, 2024. the Company did not hold any marketable securities held for sale.
Marketable securities consisted of the following as of December 31, 2023 (in thousands):
December 31, 2023
Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
Available-for-sale securities - short-term:
Commercial paper $ 1,978 $ - $ - $ 1,978
Asset-backed securities 497 - - 497
Yankee debt securities 758 - - 758
Total available-for-sale securities - short-term 3,233 - - 3,233
Total available-for-sale securities $ 3,233 $ - $ - $ 3,233
As of December 31, 2023, the Company’s available-for-sale securities classified as short-term of $3.2 million mature in 1 year or less and there were none held long-term.
Note 6-Inventory
Inventory as of December 31, 2024 and December 31, 2023 consisted of the following (in thousands):
December 31,
2024 December 31,
Raw materials $ 1,186 $ 3,428
Work in process 583 319
Finished goods 21 531
Total inventory $ 1,790 $ 4,278
Inventory is recorded net of write-downs and manufacturing scrap of $1.1 million and $3.2 million or the for the years December 31, 2024 and 2023, respectively.
Note 7-Property and Equipment, Net
The Company’s property and equipment, net, consisted of the following as of December 31, 2024 and December 31, 2023 (in thousands):
December 31,
2024 December 31,
Furniture and fixtures $ 432 $ 432
Office equipment 1,537 1,537
Laboratory equipment and software 1,274 1,494
Leasehold improvements 949 979
Construction in process 41 7
Total property and equipment 4,233 4,449
Less: accumulated depreciation (3,716) (3,624)
Property and equipment, net $ 517 $ 825
Depreciation expense was $0.3 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively.
Note 8-Segments
The Company operates in one segment focused on the manufacture and distribution of Medtronic's LHA portfolio products pursuant to the Distribution Agreement. The LHA portfolio products segment recognizes revenue when title to the LHA products are transferred to Medtronic, which occurs when the LHA products are shipped from the Company's facility (or via FOB shipping point). Revenues are primarily from the United States.
The CEO & CFO who is the chief operating decision maker ("CODM") manages the business based on non-GAAP operating expenses and consolidated EBITDA for the purposes of assessing performance and making operating decisions.
The CODM uses non-GAAP operating expenses to monitor budget versus actual results, which facilitates the assessment of the Company's performance. Consolidated EBITDA is used by the CODM to determine the overall spending of the Company. The measurement of segment assets is reported on the balance sheet as consolidated assets.
The Company does not have any significant segment expenses that are not already reported on the Company's consolidated statement of operations. Additionally, the Company does not have intra-entity sales or transfers.
The accounting policies of the Company's one reportable segment are those described in the summary of significant accounting policies.
The table below presents segment reporting and a reconciliation to the consolidated statement of operations for the years ended December 31, 2024 and 2023:
December 31, 2024 December 31, 2023
OEM LHA Segment Reporting:
Revenue $ 20,157 $ 7,164
Cost of product sold 19,066 10,013
Gross profit (loss) 1,091 (2,849)
Operating expenses:
Research and development - 3,436
Selling, general and administrative 10,055 11,368
Non-GAAP operating expenses 10,055 14,804
Non-GAAP operating loss (8,964) (17,653)
Less depreciation and amortization 297 191
EBITDA (8,667) (17,462)
Reconciliation to consolidated net loss:
Interest expense, net
(4,995) (3,067)
Depreciation (297) (191)
Stock-based compensation (459) (3,032)
Change in fair value of contingent consideration - (123)
Restructure (1,448) -
Other income 301 -
Change in fair value of warrant liability 215 2,937
Gain on sale from business 10,814 9,080
Loss from continuing operations before taxes (4,536) (11,858)
Income tax (benefit) expense - 63
Loss from continuing operations (4,536) (11,921)
Discontinued operations:
Loss from discontinued operations before taxes
(4,999) (69,530)
Income tax expense
12 212
Loss from discontinued operations
(5,011) (69,742)
Net loss $ (9,547) $ (81,663)
Note 9-Accrued Liabilities
Accrued liabilities related to continuing operations consisted of the following as of December 31, 2024 and December 31, 2023 (in thousands):
December 31,
2024 December 31,
Compensation and related expenses $ 983 $ 2,225
Professional fees 624 378
Other*
1,399 284
Total accrued liabilities $ 3,006 $ 2,887
*For the year ended December 31, 2024, other is principally comprised of accruals related to the downsizing restructuring.
Note 10-Debt
Outstanding debt as of December 31, 2024 and December 31, 2023 consisted of the following (in thousands):
December 31,
2024 December 31,
2022 Credit Agreement(1)
$ 34,450 $ 36,792
Total outstanding debt, gross 34,450 36,792
Less: Unamortized debt discount and fees (1,881) (2,274)
Total outstanding debt
$ 32,569 $ 34,518
(1)With Amendment No.4 (see further discussion below), the 2022 Credit Agreement includes an increase in the final payment fees to $2.0 million.
2022 Amended and Restated Credit Agreement
On June 30, 2022, the Company amended and restated its prior debt facility. The amended and restated credit agreement is with related parties Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P. (collectively referred to as “Deerfield”, the "Deerfield Funds" or "Lenders") and is for an aggregate principal amount of $35.0 million and has a 5-year term. Proceeds from the 2022 Credit Agreement, along with cash on hand, were used to repay the prior debt facility and to pay related fees and expenses.
The 2022 Credit Agreement bears an annual interest of 9% plus the one-month adjusted term Secured Overnight Financing Rate (applying a 2.50 % minimum rate). From date of closing, amortization payments were originally due as follows,:
•$2,500,000 of the principal due at the end of month 24;
•$7,500,000 of the principal due at the end of month 36;
•$10,000,000 of the principal due at the end of month 48; and
•$15,000,000 due at the end of month 60.
The 2022 Credit Agreement is subject to prepayment penalties and originally provided for final payment fees of an additional $1.8 million due upon prepayment, on the maturity date or upon acceleration.
The 2022 Credit Agreement is secured by a first-priority perfected lien on and security interest in substantially all of the Company’s existing and after-acquired tangible and intangible assets, subject to certain exceptions noted therein.
The 2022 Credit Agreement is subject to certain customary affirmative covenants, representations and warranties and other terms and conditions. It also contains certain customary negative covenants, including, but not limited to, restrictions on the Company’s ability and that of its subsidiaries to merge and consolidate with other companies, incur indebtedness, grant liens or security interests on assets, pay dividends or make other restricted payments, sell or otherwise transfer assets or enter into transactions with affiliates.
In addition, the 2022 Credit Agreement includes customary events of default and other provisions that could require all amounts due thereunder to become immediately due and payable, either automatically or at the option of the Lenders, if the Company fails to comply with the terms.
On August 4, 2023, the Company and Deerfield entered into that certain Amendment No. 1, dated August 4, 2023 (“Amendment No.1”) to the 2022 Credit Agreement. Pursuant to Amendment No. 1, the 2022 Credit Agreement was amended to decrease the amount of cash the Company is required to maintain pursuant to the minimum liquidity covenant in the 2022 Credit Agreement to $5,000,000 for a period of 18 months, at which point the amount required under the minimum liquidity covenant shall increase to $20,000,000 (or, if certain conditions are met, $10,000,000), in exchange for a fee paid by the Company.
On November 8, 2023, the Company and Deerfield entered into that certain Amendment No. 2, dated November 8, 2023 (“Amendment No. 2”) to the 2022 Credit Agreement. Pursuant to Amendment No. 2, the 2022 Credit Agreement was amended to, among other things: (i) adjust and increase the amortization schedule such that payments commence on June 30, 2024 and are made 12, 24 and 36 months (i.e., the scheduled maturity date) following June 30, 2024; (ii) limit the business activities the Company may engage in; and (iii) require the Company to maintain a minimum liquidity of $10,000,000 at all times, in exchange for fees paid by the Company.
On March 4, 2024, the Company entered into Waiver and Amendment No. 3 ("Amendment No. 3") to the 2022 Credit Agreement. Previously, on February 16, 2024, the Biotronik Parties filed the Demand against Acutus with the American Arbitration Association (who notified the Company of the Demand on February 29, 2024), alleging that the Company breached its contractual obligations under five agreements relating to the licensing, manufacturing, distribution and development of medical devices as a result of the wind down of its businesses. Pursuant to Amendment No. 3, Deerfield has agreed to waive any Default or Event of Default (each defined in the 2022 Credit Agreement) that has arisen or may arise in connection with the Demand. In addition, pursuant to Amendment No. 3 among other things, (i) the 2022 Credit Agreement was amended such that (x) a Change in Control (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement would not be deemed to occur in the event the Company's common stock ceases to be listed on Nasdaq (without a comparable re-listing) (a "Delisting") and (y) exposure incurred in excess of $3.0 million in respect of proceedings in relation to the Demand and/or related proceedings and/or between such parties is deemed an Event of Default (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement.
On November 13, 2024, the Company and Deerfield entered into Amendment No. 4 (“Amendment No. 4”) to the 2022 Credit Agreement. Pursuant to Amendment No. 4, the Credit Agreement was amended to (i) adjust the amortization schedule of the Credit Agreement such that the $7.5 million installment payment of principal due on June 30, 2025 would be made over three equal installments of $2.5 million on each of June 30, 2025, September 30, 2025 and December 31, 2025 and (ii) increase the exit fee associated with prepayment or repayment of the loans from 5% to 6% of the principal amount of the loans prepaid or repaid. Except as amended by Amendment No. 4, the remaining terms of the amended and restated 2022 Credit Agreement remain in full force and effect.
As of December 31, 2024, $2.6 million has been paid, inclusive of $0.13 million in fees.
In connection with entering into the 2022 Credit Agreement, the Company entered into a warrant purchase agreement (the "2022 Warrant Purchase Agreement") with Deerfield, pursuant to which the Company issued to Deerfield warrants to purchase up to an aggregate 3,779,018 shares of the Company's common stock at an exercise price of $1.1114 per warrant share for a period of 8 years following issuance (the "2022 Warrants").
On March 4, 2024, the Company entered into an amendment (the “Warrant Amendment”) to the 2022 Warrants and 2022 Warrant Purchase Agreement with Deerfield. Pursuant to the Warrant Amendment, (i) the 2022 Warrants were amended to remove Deerfield’s option to require the Company to repurchase the 2022 Warrants from Deerfield upon a Delisting, and to modify the volatility rate that would be used to calculate the Black-Scholes value of the 2022 Warrants that would apply to certain other transactions involving the Company pursuant to the 2022 Warrants, and (ii) the Warrant Purchase Agreement was amended to remove the Company obligation to take all commercially reasonable actions necessary to cause the Company's common stock to remain listed on Nasdaq at all times during the term of the 2022 Warrants.
The 2022 Warrants represent a freestanding financial instrument and are conditionally puttable at the holder’s option upon an event that is outside of the Company’s control. Therefore, the 2022 Warrants are classified as liability pursuant to ASC 480, Distinguishing Liabilities from Equity, initially and subsequently recognized at fair value, with changes in fair value recognized in the consolidated statements of operations and comprehensive loss. Refer to Fair Value Measurements in Note 2 - Summary of Significant Accounting Policies and Note 14 - Warrants for more information.
Note 11-Operating Leases
The Company leases approximately 50,800 square feet of office space for its corporate headquarters and manufacturing facility in Carlsbad, California under a non-cancelable operating lease that expires on December 31, 2027. The lease is subject to variable charges for common area maintenance and other costs that are determined annually based on actual costs. The base rent is subject to an annual increase each year. The Company has a renewal option for an additional five-year term upon the expiration date of the lease, which has been excluded from the calculation of the right-of-use asset as it is not reasonably certain to be exercised.
Additionally, the Company had leased approximately 3,900 square feet of office space in Zaventem, Belgium under a non-cancelable operating lease that expired on December 31, 2024 and was not renewed. The lease was subject to variable charges that were determined annually for common area maintenance and other costs based on actual costs, and base rent was subject to an annual increase each year based on an index rate.
During the second quarter of 2024, the Company entered into two subleases with unrelated third parties at the Carlsbad property. The Company was not relieved of its primary obligations under the Carlsbad lease ("head lease") and, therefore, became the intermediate lessor of the subleases. Pursuant to ASC 842, the subleases are operating leases related to property, plant and equipment. The Company determined that the sublease income was more than the remaining lease cost on the head lease, and as such, there was no impairment of the head lease's right-to-use assets. The Company also determined that the
head lease did not need to be remeasured as the lease term of the subleases was not longer than the remaining term of the head lease. Additionally, there are no residual value guarantees on the subleases. The Company recorded the sublease income as other revenue in the other income (expense) section of the condensed consolidated statements of operations and comprehensive income (loss). For the year ended December 31, 2024, sublease income was less than $0.3 million.
The following table summarizes quantitative information about the Company’s operating leases for the year ended December 31, 2024 and 2023 (dollars in thousands):
2024 2023
Operating cash flows from operating leases $ 290 $ 756
Weighted average remaining lease term - operating leases (in years) 3.0 4.0
Weighted average discount rate - operating leases 7.0% 7.0%
The following table provides the components of the Company’s operating lease expense for the year ended December 31, 2024 and 2023 (in thousands):
2024 2023
Operating leases
Operating lease cost $ 1,020 $ 1,006
Variable lease cost 378 324
Total operating lease expense $ 1,398 $ 1,330
As of December 31, 2024, future minimum payments under the non-cancelable operating leases under ASC 842 were as follows (in thousands):
Year ending December 31, 2025 1,151
Year ending December 31, 2026 1,185
Year ending December 31, 2027 1,221
Total 3,557
Less: present value discount (362)
Operating lease liabilities $ 3,195
Note 12-Commitments and Contingencies
Securities Litigation
The Company and certain of its current and former officers were named as defendants in two putative securities class action lawsuits filed in the United States District Court for the Southern District of California on February 14, 2022 and March 23, 2022. On July 19, 2022, the court consolidated the two actions, appointed a lead plaintiff and appointed lead counsel for the proposed class. On September 16, 2022, the lead plaintiff filed a consolidated amended complaint. The defendants thereafter filed a motion to dismiss. On September 27, 2023, the court granted the defendant’s motion to dismiss in its entirety, but gave plaintiffs leave to file an amended complaint. On October 27, 2023, the plaintiffs filed a second amended complaint asserting similar claims. The defendants thereafter filed a motion to dismiss. On March 26, 2024, the court granted the defendant’s motion and, on April 29, 2024, dismissed the case and entered judgment. On May 29, 2024, plaintiff filed a notice of appeal. On June 28, 2024, plaintiff voluntarily dismissed the appeal with prejudice, and the Company considers this matter closed.
Biotronik Arbitration
On October 15, 2024, the Company and Biotronik SE & Co. KG (“Biotronik”) and VascoMed GmbH (“VascoMed”, and together with Biotronik, the “Biotronik Parties”) entered into a Settlement Agreement and Release (the “Settlement Agreement”) terminating the Relevant Agreements (as defined below) (except for certain surviving obligations specified therein), settling the Arbitration (as defined below) relating to the Relevant Agreements and releasing and discharging each party of all claims against the other, including any claims that were or could have been asserted in the Arbitration. Pursuant to the Settlement Agreement, the Company must pay to Biotronik (i) an initial settlement payment of approximately $2.5 million; (ii) contingent payments of (x) in the event of a Qualifying Asset Sale (as defined in the Settlement Agreement), an amount equal to 50% of the aggregate cash consideration received; (y) in the event of a Change of Control (as defined in the Settlement Agreement) of the Company involving a Competitive Company (as defined in the Settlement Agreement), (A) initial amounts of $8.0 million and 5% of the aggregate upfront consideration received, with the latter not to exceed approximately $25.0 million (“Agreed Upfront Consideration”) and (B) additional amounts if additional consideration is received, up to approximately $25.0 million in aggregate (including the Agreed Upfront Consideration); and (z) in the event of a Change of Control not involving a Competitive Company, with certain exceptions, an amount equal to 25% of the aggregate cash consideration received.
At September 30, 2024, the Company recorded $2.5 million in discontinued operations restructuring liability related to the Biotronik settlement. A Qualifying Asset Sale per the Settlement Agreement can be triggered by an asset only sale which is a lower threshold than a business combination. The Company has already designated certain assets as held for sale on its balance sheet (see Footnote 3, Discontinued Operations, Assets Held for Sale and Restructuring, for further details), which such disposal transaction would give rise to a Qualifying Asset Sale but not a Change of Control. The Company determined that the contingent payment as a result of a potential Qualifying Asset Sale represents an additional cost to sell. As such, the Company adjusted its valuation allowance against the assets held for sale by $1.7 million, based on the formula prescribed in the Settlement Agreement, to account for the contingent payment to the Biotronik Parties.
As of December 31, 2024, the Company has paid the $2.5 million related to the Biotronik settlement. Additionally, at December 31, 2024, the Company reduced the valuation allowance against the assets held for sale to $1.25 million based on a letter of intent received in January 2025 from a buyer for the purchase of assets related to the Biotronik settlement for $2.5 million. The sale of the assets held for sale, however, has not yet been finalized, and, as such, it is possible that the contingent payment amount could differ from the amount recorded. With regard to a Change of Control event, the Company determined a Change of Control event cannot be considered probable and, therefore, should not be accrued until such transaction has occurred.
Note 13-Warrants
As of December 31, 2024 and December 31, 2023, the outstanding warrants to purchase the Company’s common stock consisted of the following:
Exercise Price Expiration Date December 31,
2024 December 31,
Warrants issued in 2015 $ 5.25 1/30/25 3,808 3,808
Warrants issued with 2018 Convertible Notes $ 0.10 6/7/28 346,689 346,689
Warrants issued with 2018 Term Loan $ 16.67 7/31/28 26,998 26,998
Warrants issued with 2019 Credit Agreement $ 16.67 5/20/29 419,992 419,992
Warrants issued with 2022 Credit Agreement $ 1.11 6/30/30 3,779,018 3,779,018
Total Warrants 4,576,505 4,576,505
There was no warrant activity during the year ended December 31, 2024.
The Company’s warrants provide the holder the option to purchase a specified number of shares for a specified price within a specified duration or upon the occurrence of a specific event. The holder may exercise the warrant either by cash payment or by exercise pursuant to a cashless exercise whereby a calculated number of shares are withheld upon exercise to satisfy the exercise price. The warrants do not provide the holder any voting rights until the warrants are exercised.
In accordance with ASC 480, the 2022 Warrants are recorded at fair value on the consolidated balance sheets as a warrant liability. Changes in fair value are recognized as a change in fair value of warrant liability in the consolidated statements of operations and comprehensive loss. For the year ended December 31, 2024, a favorable fair value change of $0.2 million was recognized.
In connection with the Series A Common Equivalent Preferred Stock Exchange Agreements (as defined below), four warrant holders are limited to exercising their warrants such that following any such exercise, the number of shares of common stock beneficially owned by such holder cannot exceed 4.9% of the outstanding common stock of the Company (two of the holders may, at their option and upon sufficient prior written notice to the Company, increase such percentage to 9.9%). In the event the common share limit has been met and the holder chooses to exercise their warrants, the holder can sell any common stock they hold. Therefore, the amendment to the warrant agreements does not restrict the holder from fully exercising the warrants under the original terms of the warrant agreements.
Note 14-Stockholders’ Equity
Series A Common Equivalent Preferred Stock
In August 2021, the Company entered into exchange agreements (the “Exchange Agreements”) with four investors pursuant to which the investors exchanged 6,665,841 shares of the Company’s common stock for 6,666 shares of a new series of non-voting convertible preferred stock of the Company designated as “Series A Common Equivalent Preferred Stock,” par value $0.001 per share (the "Preferred Stock"). In connection with the issuance of the Preferred Stock pursuant to the Exchange Agreements, on August 23, 2021, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Common Equivalent Preferred Stock of the Company with the Secretary of State of the State of Delaware. The Preferred Stock ranks senior to the common stock with respect to rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company, having a liquidation preference equal to its par value of $0.001 per share. The Preferred Stock will participate equally and ratably on an as-converted basis with the holders of common stock in all cash dividends paid on the common stock. The Preferred Stock is non-voting.
Upon election, each holder may convert each share of Preferred Stock into 1,000 shares of common stock, except to the extent that following such conversion the number of shares of common stock held by such holder, its affiliates and any other persons whose beneficial ownership of common stock would be aggregated with such holder’s for purposes of Section 13(d) of the Exchange Act including shares held by any “group” (as defined in Section 13(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act") and applicable regulations of the Securities and Exchange Commission ("SEC")) of which such holder is a member, but excluding shares beneficially owned by virtue of the ownership of securities or rights to acquire securities that have limitations on the right to convert, exercise or purchase similar to the limitation set forth in the Series A Certificate of Designation, exceeds 4.9% (or, at the election of the holders, OrbiMed Private Investments IV, LP or OrbiMed
Royalty Opportunities II, LP, made by delivering at least 61 days advance written notice to the Company of its intention to increase the beneficial ownership cap applicable to such holder, 9.9%) of the total number of shares of common stock then issued and outstanding.
Common Stock
During the December 31, 2024 and 2023, stock options to acquire 0 shares and 3,218 shares, respectively, were exercised for shares of the Company's common stock with proceeds of $0 million and less than $0.1 million and respectively. Additionally in conjunction with the 2020 Employee Stock Purchase Plan (the "2020 ESPP"), during the December 31, 2024 and 2023, 0 shares and 45,162 shares, respectively, of common stock were issued for consideration of less than $0.0 million and $0.1 million, respectively. During the December 31, 2024 and 2023, the Company issued 598,638 shares and 710,631 shares, respectively, of common stock upon vesting of RSUs.
Note 15-Stock-Based Compensation
2022 Inducement Equity Incentive Plan
The 2022 Inducement Equity Incentive Plan (the “2022 Plan”), which permits the granting of nonstatutory stock options, RSUs, RSAs, stock appreciation rights, performance share units ("PSUs"), performance shares and other equity-based awards to employees, directors and consultants, became effective on March 30, 2022. As of December 31, 2024, 6,000,000 shares of common stock were authorized for issuance under the 2022 Plan, of which 5,958,365 remain available for issuance under the 2022 Plan.
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the “2020 Plan”), which permits the granting of nonstatutory stock options, RSAs, RSUs, stock appreciation rights, PSUs, performance shares and other equity-based awards to employees, directors and consultants became effective on August 5, 2020. As of December 31, 2024, 4,431,305 shares of common stock were authorized for issuance under the 2020 Plan and 5,887,381 shares remain available for issuance under the 2020 Plan.
2011 Equity Incentive Plan
The Company’s 2011 Equity Incentive Plan (the “2011 Plan”) permits the granting of incentive stock options, non-statutory stock options, RSAs, RSUs and other stock-based awards to employees, directors, officers and consultants. As of December 31, 2024,16,902 shares of common stock were authorized for issuance under the 2011 Plan and 0 shares remain available for issuance under the 2011 Plan. No additional awards will be granted under the 2011 Plan. Shares that become available for issuance from the outstanding awards under the 2011 Plan due to forfeiture, or otherwise, will become available for issuance from future awards under the 2020 Plan.
Stock Options
Stock options granted generally vest over four years and have a 10-year contractual term. The fair value of each employee and non-employee stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The Company's common stock became publicly traded in August 2020 and lacks company-specific historical and implied volatility information. Therefore, the Company estimates its expected stock volatility based on the historical volatility of a set of publicly traded peer companies. Due to the lack of historical exercise history, the expected term of the Company’s stock options has been determined using the “simplified” method for awards. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
There were no stock options awards granted during the year ended December 31, 2024. The following assumptions were used to estimate the fair value of stock options for the for the year ended December 31, 2023:
Risk-free interest rate 3.91% - 4.27%
Expected dividend yield -
Expected term in years 5.5 - 5.6
Expected volatility 75% - 85%
The Company's stock option activity for the year ended December 31, 2024 was as follows:
Stock
Options Weighted
Average
Exercise
Price Weighted
Average
Remaining
Contractual
Life (in years) Aggregate
Intrinsic
Value
(in thousands)
Outstanding as of December 31, 2023 1,904,723 $ 1.98 7.8 $ -
Options granted - -
Options exercised - - $ -
Options forfeited (1,395,921) 1.34
Outstanding as of December 31, 2024 508,802 $ 3.72 7.6 $ -
Options vested and expected to vest December 31, 2024 508,802 $ 3.72 7.6 $ -
Options exercisable December 31, 2024 508,802 $ 3.72 7.6 $ -
For options in the money, the aggregate intrinsic value for options outstanding in the above table represents the product of the number of options outstanding multiplied by the difference between the per share fair value of the Company’s common stock on the last day of the fiscal period, which was $0.06 and $0.20 as of December 31, 2024 and December 31, 2023, respectively, and the exercise price. The aggregate intrinsic value for options exercised in the above table represents the product of the number of options exercised multiplied by the difference between the per share fair value of the Company’s stock on the date of exercise and the exercise price. As of December 31, 2024, all outstanding stock options were approved by the Company's board of directors for accelerated vesting, and therefore, total unrecognized compensation related to unvested stock option awards granted was $-, which the Company expects to recognize over a weighted-average period of approximately 0.00 years.
Restricted Stock Units (RSUs)
The Company’s RSU activity for the year ended December 31, 2024 was as follows:
Number
of Shares Weighted
Average
Grant Price
Unvested as of December 31, 2023 2,185,330 $ 2.18
Granted - -
Forfeited (1,286,853) 2.51
Vested (898,477) 1.70
Unvested as of December 31, 2024 - $ -
As of December 31, 2024, all outstanding RSUs were approved by the Company's board of directors for accelerated vesting and, therefore, at December 31, 2024, there was zero of unrecognized compensation related to unvested RSUs.
Total Stock-Based Compensation
The following table summarizes the total stock-based compensation expense for the stock options, RSUs and RSAs recorded in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023 (in thousands):
Year Ended December 31, Year Ended December 31, 2024 Year Ended December 31, 2023
2024 2023 Continuing Operations Discontinued Operations Continuing Operations Discontinued Operations
Cost of products sold $ (64) $ 454 $ 78 $ (142) $ 288 $ 166
Research and development (558) 1,167 - (558) 46 1,121
Selling, general and administrative (642) 4,112 381 (1,023) 2,698 1,414
Total stock-based compensation $ (1,264) $ 5,733 $ 459 $ (1,723) $ 3,032 $ 2,701
The employee terminations in conjunction with the Strategic Restructuring resulted in the credit to stock-based compensation for the year ended December 31, 2024. Forfeitures due to the Strategic Restructuring comprised $1.0 million the credit and Type III equity modifications related to accelerated RSU vesting comprised $0.5 million of the credit, with the credit resulting from the decrease in RSU fair value due to the decline in the Company's stock price. The Type I modifications related to the Company's board of directors approving accelerated vesting on remaining unvested stock options and RSUs resulted in de minimis incremental stock-based compensation.
Note 16-Net Loss Per Common Share
Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per common share includes the potential impact of the Company’s convertible preferred stock, common stock options, RSUs, RSAs, intended ESPP purchases and warrants when such shares are not anti-dilutive. In accordance with ASC 260, Earnings Per Share, if a Company had discontinued operations, the Company uses income from continuing operations, adjusted for preferred dividends and similar adjustments, as its control number to determine whether potential common shares are dilutive. For the years ended December 31, 2024 and 2023, the Company reported loss from continuing operations, discontinued operations and net loss per common share, and, therefore, basic and diluted net loss per common share are the same.
The table below provides potentially dilutive securities not included in the calculation of diluted loss per common share for loss from continuing operations, loss from discontinued operations and net loss because to do so would be anti-dilutive:
Year Ended December 31, Year Ended December 31,
2024 2023
Shares issuable upon:
Conversion of Series A Common Equivalent Preferred Stock 6,665,841 6,665,841
Exercise of common stock warrants 4,576,505 4,576,505
Exercise of stock options - 1,039,564
Vesting of RSUs and RSAs 898,477 2,185,330
Total potentially dilutive securities 12,140,823 14,467,240
Note 17-401(k) Retirement Plan
The Company has a 401(k) retirement savings plan that provides retirement benefits to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations. The Company provided no contributions to the 401(k) retirement savings plan for the for the years ended December 31, 2024 and 2023.
Note 18-Income Taxes
The components of pretax loss from continuing operations for the years ended December 31, 2024 and 2023 are as follows (in thousands):
December 31,
2024 2023
U.S. $ (4,536) $ (11,858)
Foreign - -
Pretax loss from continuing operations
$ (4,536) $ (11,858)
The components of income tax expense for continuing operations are as follows (in thousands):
December 31,
2024 2023
Federal $ - $ -
State - 63
Foreign - -
Total provision for income taxes $ - $ 63
A provision for state and foreign income taxes was less than $0.0 and $0.1 million for the years ended December 31, 2024 and 2023, respectively. Current income taxes are based upon the year’s income taxable for federal, state and foreign tax reporting purposes. Deferred income taxes are provided for certain income and expenses which are recognized in different periods for tax and financial reporting purposes. Deferred tax assets and liabilities are computed for differences between the consolidated financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the period in which the differences are expected to affect taxable income, and NOL carryforwards and R&D tax credit carryforwards.
The following table presents a reconciliation of income tax computed at the U.S. federal statutory tax rate to the total income tax expense for the years ended December 31, 2024 and 2023 (dollars in thousands):
Year Ended December 31,
2024 2023
Amount Tax Rate Amount Tax Rate
Income tax benefit at federal statutory rate $ (970) 21.0 % $ (2,490) 21.0 %
Adjustments for tax effects of:
State taxes, net (263) 5.7 % (271) 2.3 %
Permanent adjustments (205) 4.5 % (750) 6.3 %
Stock based compensation expense - - % 2,616 (22.1) %
Research and development credit - - % (1,720) 14.5 %
Unrecognized tax benefit - - % 626 (5.3) %
Rate change
(612) 13.3 % - - %
Return to provision (543) 11.8 % (1,959) 16.5 %
Valuation allowance 2,593 (56.2) % 4,012 (33.8) %
Income tax expense $ - - % $ 63 (0.5) %
Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2024 and 2023 are as follows (in thousands):
December 31,
2024 2023
Deferred tax assets:
Net operating losses $ 105,760 $ 96,679
Stock-based compensation 439 1,031
Research and development credit 11,733 11,733
Capitalized research costs 10,320 12,679
Intangible assets 394 93
Accrued compensation 69 733
Debt
549 623
Lease liability 801 929
Inventory 3,274 6,811
Other 1,995 1,241
Total gross deferred tax assets 135,334 132,552
Valuation allowance (134,335) (131,395)
Net deferred tax asset $ 999 $ 1,157
Deferred tax liabilities:
Property and equipment (163) (249)
Right of use assets (617) (747)
Prepaid expenses (108) (47)
Other (111) (115)
Total deferred tax liabilities (999) (1,157)
Net deferred tax assets (liabilities) $ - $ -
In assessing the realizability of deferred tax assets as of December 31, 2024 and 2023, management considered whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible or the NOL carryforwards and R&D credit carryforwards will be used. The Company determined it is more likely than not that its net deferred tax assets will not be realized. Accordingly, a valuation allowance was recorded as of December 31, 2024 and 2023 to fully offset the net deferred tax assets of $134.3 million and $131.4 million, respectively.
The following table presents NOLs and tax credit carryforwards as of December 31, 2024 (in thousands):
Amount Expiration Years
NOLs, federal (post-December 31, 2017) $ 365,646 Indefinite (1)
NOLs, federal (pre-January 1, 2018) $ 93,096 2031 - 2037
NOLs, state $ 131,140 2026 - 2044
NOLs, state (post-December 31, 2017) $ 19,006 Indefinite (1)
Research and development tax credits, federal $ 11,087 2031 - 2043
Research and development tax credits, California $ 7,183 Indefinite
____________________
(1) NOL carryforwards generated after 2017 can be carried forward indefinitely and can generally be used to offset up to 80%of future taxable income.
NOL carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be used annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50% of the outstanding stock of a company by certain stockholders. The
Company believes it has experienced certain ownership changes in the past and has recorded the deferred tax assets related to NOL and R&D credit carryforwards net of any previous limitations due to sections 382 and 383.
The Company had conducted intensive research and experimentation activities, generating R&D tax credits for federal and state purposes under Section 41 of the Code. The Company has not performed a formal study validating these credits claimed in the tax returns. Once a study is prepared, the amount of R&D tax credits available could vary from what was originally claimed on the tax returns.
The following table summarizes the changes to unrecognized tax benefits as of December 31, 2024 and 2023 (in thousands):
December 31,
2024 2023
Balance at beginning of year $ 5,481 $ 4,795
Gross increases - tax positions in current period - 556
Gross increases - tax positions in prior period
- 130
Gross decreases - tax positions in prior period - -
Balance at end of year $ 5,481 $ 5,481
As of December 31, 2024, the Company has unrecognized tax benefits of $5.5 million of which $5.5 million will affect the effective tax rate if recognized when the Company no longer has a valuation allowance offsetting its deferred tax assets.
The Company does not anticipate that there will be a significant change in unrecognized tax benefits over the next 12 months.
The Company is subject to U.S. federal and various state tax as well as Belgium, and the UK tax jurisdictions. Since the Company formed in 2011, all filed tax returns are subject to examination. Generally, the tax years remain open for examination by the federal statute under a three-year statute of limitation; however, states generally keep their statutes open between three and four years. However, the Company’s tax years from inception are subject to examination by the United States and various state taxing authorities due to the carry forward of unused NOLs and R&D credits.
The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest and penalties on its consolidated balance sheets and has not recognized interest and/or penalties in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023.
The Tax Cuts and Jobs Act enacted in 2017 requires taxpayers to capitalize and amortize R&D expenditures for tax purposes incurred in tax years beginning after December 31, 2021. The rule resulted in the Company's capitalization of R&D expenditures of approximately $0.0 million and $20.6 million incurred during 2024 and 2023, respectively. For R&D performed in the U.S., the Company will amortize costs capitalized for tax purposes over 5 years and for R&D performed outside the U.S, the Company will amortize costs capitalized for tax purposes over 15 years.
Note 19-Related Party Transactions
Consulting Agreement
The Company had a consulting agreement with the chairman of the Company’s board of directors. The Company recorded approximately $0 and less than approximately $0.1 million for the years ended December 31, 2024 and 2023, respectively.
Credit Agreements
The Company's prior credit agreement (the "2019 Credit Agreement") was between the Company and related parties OrbiMed Royalty Opportunities II, LP and Deerfield Private Design Fund II, L.P., and provided for a loan of up to $70.0 million with a maturity date of May 20, 2024. On June 30, 2022, the loan balance of $40.0 million was repaid in full out of the proceeds of the 2022 Credit Agreement. The 2022 Credit Agreement with related parties Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P. replaced the 2019 Credit Agreement and provides for an aggregate principal amount of $35.0 million and a maturity date five years from the closing of the loan. Refer to Note 9 - Debt for additional details.
The liability for the loan balance related to the 2022 Credit Agreement recorded on the Company's consolidated balance sheets was $32.6 million and $34.5 million as of December 31, 2024 and 2023, respectively. The Company recorded interest expense related to the debt on the consolidated statements of operations and comprehensive loss of $5.8 million and $5.7 million for the years ended December 31, 2024 and 2023, respectively.
Warrants
In connection with the 2022 Credit Agreement, the Company entered into the 2022 Warrant Purchase Agreement with Deerfield, pursuant to which the Company issued warrants for the purchase up to an aggregate 3,779,018 shares of the Company’s common stock at an exercise price of $1.1114 per share for a period of eight years following issuance. Refer to Note 13 - Warrants for additional details.
Registration Rights Agreement
On June 30, 2022, in connection with the issuance of the 2022 Warrants, the Company also entered into a registration rights agreement (the “Registration Rights Agreement”) with Deerfield, pursuant to which the Company filed a shelf registration statement on Form S-3 with the SEC to register the resale of certain securities held by Deerfield and their affiliates (the “Registrable Securities”). In addition, for a period of five years following the execution of the Registration Rights Agreement, or until all Registrable Securities are registered or no longer subject to restrictions on transfer (whichever is earlier), Deerfield will hold certain “piggy-back” registration rights with respect to registration statements filed during such period. The Company will generally pay all reasonable expenses incidental to its obligations and performance under the Registration Rights Agreement, other than underwriting discounts and commissions and such other charges.
Note 20-Subsequent Events
2022 Credit Agreement Amendment No.5
On January 21, 2025, the Company and Deerfield entered into Amendment No. 5 (“Amendment No. 5”) to the 2022 Credit Agreement (as amended and restated.) Pursuant to Amendment No. 5, the 2022 Credit Agreement is being amended to allow the Company to effect the deregistration of its common stock, par value 0.001 per share, with the U.S. Securities and Exchange Commission (the “SEC”), including the termination of the Company’s periodic reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (the “Deregistration”) and, among other things: (i) provides that Deerfield will receive a consent fee in the form of a contingent value right payable upon certain triggering events in an amount equal to the lesser of $300,000 or 5.0% of the aggregate amount of total value that would otherwise be available to the Company’s equityholders (the “Consent Fee”); (ii) modifies the financial reporting requirements under the 2022 Credit Agreement, including requiring delivery of cash flow forecasts to Deerfield; (iii) requires the appointment of a Chief Restructuring Officer of the Company; and (iv) modifies the negative covenants to limit the Company’s business activities and requires the Company to maintain minimum liquidity of $5 million. The effectiveness of Amendment No. 5 was conditioned upon the occurrence of the Deregistration on or prior to January 31, 2025 (or such other date as agreed to by Deerfield in their sole discretion).
In connection with entry into Amendment No. 5 and the Deregistration, the Company also entered into certain other agreements, including: (i) a contingent value rights agreement to provide for payment of the Consent Fee by the Company to Deerfield (the “Contingent Value Rights Agreement”); (ii) a warrant termination agreement to terminate (a) warrants to purchase 224,118 shares of Common Stock pursuant to that certain Warrant to Purchase Shares of Common Stock of the Company dated as of June 7, 2018 (the “2018 Warrants”), (b) warrants to purchase 209,996 shares of Common
Stock pursuant to that certain Warrant dated as of May 20, 2019 (the “2019 Warrants”) and (c) warrants to purchase 3,779,018 shares of Common Stock pursuant to that certain Warrant to Purchase Shares of Common Stock of the Company dated June 30, 2022 (the “2022 Warrants”) for a fee equal to $250,000 in the aggregate paid by the Company to Deerfield (the “Warrant Termination Agreement”) and (iii) a registration rights termination agreement to terminate the registration rights agreement, dated June 30, 2022, among the Company and Deerfield and withdraw the registration statement on Form S-3 filed with the SEC (File No. 333-266804) in connection with the sale from time to time of the Company’s securities held by
Deerfield and terminate the offer and/or sale of securities under such registration statement (the “Registration Rights Termination Agreement” and,together with Amendment No. 5, the Contingent Value Rights Agreement and the Warrant Termination Agreement, the “Transaction Documents”).
Notice of Securities Registration Termination
On January 24, 2025, the Company filed with SEC certification and notice of termination of registration under Section 12(g) of the Securities and Exchange Act of 1934 under Rule 15d-6.

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.

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ITEM 9A. CONTROLS AND PROCEDURES
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation and supervision of our Chief Executive Officer and Chief Financial Officer, have evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
As of December 31, 2024, there were no material changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarterly period ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitation on the Effectiveness of Internal Control Processes
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Management’s Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting for the Company (as defined in Exchange Act Rule 13a-15(f)). Management conducted an evaluation of the effectiveness of internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, management concluded that the Company’s internal control over financial reporting was effective as of December 31, 2024.
Attestation Report of Independent Registered Public Accounting Firm
This Annual Report on Form 10-K does not include an attestation report of our registered independent public accounting firm regarding internal control over financial reporting due to an exemption established by the JOBS Act for emerging growth companies.

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ITEM 9B. OTHER INFORMATION
Item 9B. Other Information.
There were no Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements adopted, modified or terminated by our directors and executive officers during the quarter ended December 31, 2024.

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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Item 10. Directors, Executive Officers and Corporate Governance.
Information about Our Executive Officers
The following table sets forth certain information concerning our executive officers as of February 28, 2025:
Name
Age
Position
Takeo Mukai
44 Chief Executive Officer and Chief Financial Officer
There are no family relationships between any of our directors and any of our executive officers.
Takeo Mukai. Mr. Mukai has served as our Chief Executive Officer and Chief Financial Officer since January 2024. Mr. Mukai previously served as our Senior Vice President, Chief Financial Officer from January 2023 to January 2024 and as the Company’s interim Chief Financial Officer from August 2022 to January 2023 and as Vice President, Finance from July 2021 to August 2022. Prior to his service with the Company, Mr. Mukai served in various roles of increasing responsibility with Medtronic from 2007 to 2021, including: Finance Director, Neurovascular and Cerebrospinal Fluid Business Units, from July 2019 to July 2021; Finance Director, Global Growth Platforms, from May 2018 to July 2019; and Finance Director, Type 2 Diabetes Business Unit, from August 2014 to May 2018. Mr. Mukai received a B.S. in Business Administration from the Carnegie Mellon University and an M.B.A. from the University of Southern California, Marshall School of Business.
Information about Our Board of Directors
The following table sets forth certain information concerning our board of directors as of February 28, 2025:
Name Age
Director Since
Independent
Audit Committee
Compensation Committee
Nominating and Corporate Governance Committee
John Sheridan
69 2021
✓
Chair
Niamh Pellegrini
58 2021
✓
✓
✓
Shaden Marzouk, M.D.*
54 2020
✓
✓
✓
Andrew ElBardissi,
M.D.
43 2017
✓
✓
✓
Jason Garland
51 2022
✓
Chair
David P. Bonita, M.D.
49 2016
✓
Chair
*Board Chair
Board Biographies
A brief biography of each director is also set forth below, which includes information, as of February 28, 2025, regarding specific and particular experience, qualifications, attributes or skills of each director e that led the Nominating and Corporate Governance Committee and the board of directors to believe that the director should serve on the Board.
John Sheridan. Mr. Sheridan has served as a member of our board of directors since March 2021. Mr. Sheridan has been a member of the executive management team of Tandem Diabetes Care, Inc. (“Tandem”), a medical device company dedicated to improving the lives of people with diabetes, since April 2013, including as President and Chief Executive Officer since March 2019 and as a member of Tandem’s board of directors since June 2019. He previously served as Chief Operating Officer of Rapiscan Systems, Inc., a provider of security equipment and systems, from March 2012 to February 2013, and as Executive Vice President of Research and Development and Operations for Volcano Corporation, a medical technology company, from November 2004 to March 2010. Mr. Sheridan holds a B.S. in Chemistry from the University of West Florida and an M.B.A. from Boston University.
We believe Mr. Sheridan is qualified to serve on our board of directors due to his background as a public company Chief Executive Officer and his extensive experience coupled with his leadership of successful medical technology organizations.
Niamh Pellegrini. Ms. Pellegrini has served as a member of our board of directors since August 2021. Previously, from July 2019 to June 2023, she served as the Chief Commercial Officer of Nevro, Inc., a medical device company dedicated to helping patients suffering from chronic pain achieve lasting relief. From September 2018 to June 2019, Ms. Pellegrini served as Vice President of Global Commercial Operations for Abbott Laboratories, and from April 2016 to September 2018, she served as Chief Executive Officer and President at Autonomic Technologies, Inc. Ms. Pellegrini has also held positions in leadership, global business development, strategy and commercial with Thoratec Corporation and Johnson & Johnson. She earned both a B.S. and an M.B.A. from Santa Clara University.
We believe Ms. Pellegrini is qualified to serve on our board of directors due to her extensive background in commercial operations as well as her experience in global business development.
Shaden Marzouk, M.D. Dr. Marzouk has served on our board of directors since August 2020 and as Chairperson since January 2024. Dr. Marzouk is currently the U.S. Chief Executive Officer of GenesisCare, a position she has held since August 2022. From July 2021 to June 2022, Dr. Marzouk was Chief Executive Officer, Health, of Hudson’s Bay Company. From March 2020 to July 2021, Dr. Marzouk was President and Chief Executive Officer of CareMore Health and Aspire Health, subsidiaries of Anthem, Inc. From September 2018 to February 2020, Dr. Marzouk was Managing Director, Health and Global Health Innovation, of AXA S.A.’s (“AXA”) health insurance and health services business in Asia. Prior to AXA, Dr. Marzouk served as Cardinal Health, Inc.’s Medical Segment Chief Medical Officer from November 2016 to August 2018, its Senior Vice President, Clinical Operations from April 2015 to August 2016 and its Vice President, Clinical Operations from February 2012 to April 2015. From September 2016 to October 2016, Dr. Marzouk also briefly served as Chief Medical Officer at Oscar Insurance Corp. Dr. Marzouk previously served in the U.S. Army on active duty from July 2006 to July 2009, where she practiced as a neurosurgeon and served in Iraq as a Major. Dr. Marzouk obtained a B.A. from the Washington University in St. Louis, an M.D. from St. Louis University School of Medicine and an M.B.A. from The Fuqua School of Business at Duke University.
We believe Dr. Marzouk is qualified to serve on our board of directors due to her background in leading health technology companies as well as her international experience.
Andrew ElBardissi, M.D. Dr. ElBardissi has served as a member of our board of directors since July 2017. Dr. ElBardissi has been a Partner at Deerfield Management Company, L.P. (“Deerfield Management”) since 2017. Previously, he served as a Principal at Longitude Capital Management Co., LLC, a private investment firm that focuses on venture growth investments in drug development and medical technology, from January 2014 to January 2017. Prior to that, Dr. ElBardissi served as an Associate in J.P. Morgan Chase & Co.’s Healthcare Investment
Banking practice from June 2011 to July 2013. Dr. ElBardissi received a B.S. in biology (Phi Beta Kappa) from the Schreyer Honors College at the Pennsylvania State University, an M.P.H. in quantitative methods from Harvard University, an M.B.A. from Harvard Business School and an M.D. from the Mayo Clinic College of Medicine.
We believe Dr. ElBardissi’s extensive experience as a venture capital investor and a member of the boards of directors of multiple private medical technology companies qualify him to serve on our board of directors.
David P. Bonita, M.D. Dr. Bonita has served as a member of our board of directors since June 2013. Dr. Bonita is a member at OrbiMed Advisors LLC, an investment firm, where he has served in various roles of increasing responsibility since June 2004. Dr. Bonita currently serves on the boards of directors of Ikena Oncology, Inc. (NASDAQ: IKNA) since March 2016, Prelude Therapeutics, Inc. (NASDAQ: PRLD) since June 2016, Repare Therapeutics Inc. (NASDAQ: RPTX) since September 2019, and Third Harmonic Bio, Inc. (NASDAQ: THRD) since July 2020, as well as several private companies. Dr. Bonita also previously served on the boards of directors of IMARA Inc. from March 2019 to February 2023, and Tricida, Inc. from January 2014 to January 2023. Prior to OrbiMed, Dr. Bonita worked as a corporate finance analyst in the healthcare investment banking groups of Morgan Stanley and UBS. He received his B.A. in biology from Harvard University and his joint M.D./M.B.A. from Columbia University.
We believe Dr. Bonita is qualified to serve on our board of directors due to his extensive experience as a venture capital investor and as a member of the boards of directors of multiple private and public medical technologies companies.
Jason Garland. Mr. Garland has served as a member of our board of directors since August 2022. Mr. Garland has served as Chief Financial Officer of Repligen Corporation since September 2023. Previously, Mr. Garland served as Executive Vice President & Chief Financial Officer of Integer Holdings Corporation from October 2018 to May 2023. Prior to that, Mr. Garland served as Divisional Vice President & Chief Financial Officer, Global Sales, at Tiffany & Co. from October 2017 to October 2018 and Divisional Vice President & Chief Financial Officer, Diamond & Jewelry Supply, at Tiffany & Co. from July 2015 to October 2017. Prior to Tiffany & Co., since the late-1990s, Mr. Garland served in various financial and accounting roles of increasing responsibility with affiliates of General Electric Company, including with GE Energy Management, GE Aviation Services and GE Oil & Gas Global Services. Mr. Garland received a B.S. in Chemical Engineering from the University of New Hampshire, Durham.
We believe Mr. Garland is qualified to serve on our board of directors due to his background as a public company Chief Financial Officer as well as his previous extensive experience in various finance and accounting roles.
Delinquent Section 16(a) Reports
The Company’s directors, executive officers and 10% percent stockholders file reports with the SEC indicating the number of shares of any class of the Company’s equity securities that they owned when they became a director, executive officer or 10% percent stockholder and, after that, any changes in their ownership of the Company’s equity securities. The Company believes that all reporting persons filed on a timely basis the reports required by Section 16(a) of the Exchange, during the most recent fiscal year.
Information Regarding Committees of the Board of Directors
The board of directors has a number of committees that perform certain functions for the board. The current committees of the board of directors are the Audit Committee, the Compensation Committee and the Nominating and Corporate Governance Committee. Below is a description of each committee of the board. Each of the committees has authority to engage legal counsel or other experts or consultants, as it deems appropriate to carry out its responsibilities. The board of directors has determined that each member of each committee meets the applicable Nasdaq listing standards and relevant securities and other laws, rules and regulations regarding “independence” and that each member is free of any relationship that would impair his or her individual exercise of independent judgment with regard to our Company.
Audit Committee
The board of directors has a separately designated standing Audit Committee established in accordance with Section 3(a)(58) of the Exchange Act. The Audit Committee was established by the board to assist the board in its oversight
of the integrity of our financial statements and internal controls, and our compliance with legal and regulatory requirements. In addition, the Audit Committee assists the board in its oversight of the qualification, independence and performance of our independent registered public accounting firm and recommends to the board the appointment of our independent registered public accounting firm.
The members of our Audit Committee are Jason Garland, Niamh Pellegrini and Shaden Marzouk. Mr. Garland is the chair of our Audit Committee. The composition of our Audit Committee meets the requirements for independence under the current Nasdaq listing standards and SEC rules and regulations, including independence requirements specific to members of the audit committee of the board of directors of a listed company. Each member of our Audit Committee is financially literate. In addition, our board of directors has determined that all three members of our Audit Committee, Jason Garland, Shaden Marzouk and Niamh Pellegrini, are “audit committee financial experts” as defined in Item 407(d)(5)(ii) of Regulation S-K promulgated under the Securities Act of 1933, as amended (the “Securities Act”). In making that determination, the board relied on the past business experience of Mr. Garland, Dr. Marzouk and Ms. Pellegrini. Please see the description of their business experience under the heading “Board Biographies.”
This designation does not impose any duties, obligations or liabilities that are greater than are generally imposed on members of our Audit Committee and our Board of Directors. Our Audit Committee is directly responsible for, among other things:
•selecting a firm to serve as the independent registered public accounting firm to audit our financial statements;
•ensuring the independence of the independent registered public accounting firm;
•discussing the scope and results of the audit with the independent registered public accounting firm and reviewing, with management and that firm, our interim and year-end operating results;
•establishing procedures for employees to anonymously submit concerns about questionable accounting or audit matters;
•considering the adequacy of our internal controls;
•reviewing material related party transactions or those that require disclosure;
•approving or, as permitted, pre-approving all audit and non-audit services to be performed by the independent registered public accounting firm; and
•reviewing key cybersecurity, privacy and other information technology risks.
Our Audit Committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards of Nasdaq. In 2024, the Audit Committee met four times. The Audit Committee charter, most recently updated in June 2023, can be found in the Corporate Governance section of the Investors section of our website at https://ir.acutusmedical.com. Information on or accessible through our website is not incorporated by reference in this Form 10-K. The Audit Committee charter grants the Audit Committee authority to obtain, at our expense, advice and assistance from internal and external legal, accounting or other advisors and consultants and other external resources that the Audit Committee considers necessary or appropriate in the performance of its duties.
As required by its charter, the Audit Committee reviews and assesses the adequacy of its charter at least annually and recommends any proposed changes to the board for its consideration.
The board annually reviews the Nasdaq listing standards’ definition of independence for Audit Committee members and has determined that all members of our Audit Committee are “independent” and “financially literate” under Nasdaq listing standards and that members of the Audit Committee received no compensation from the Company other than for service as a director.
Compensation Committee
The members of our Compensation Committee are John Sheridan, Niamh Pellegrini and Andrew ElBardissi. Mr. Sheridan is the chair of our Compensation Committee. Each member of this committee is a non-employee director, as defined by Rule 16b-3 promulgated under the Exchange Act, and meets the requirements for independence under the current Nasdaq listing standards and SEC rules and regulations, including independence requirements specific to
members of the compensation committee of the board of directors of a listed company. Our Compensation Committee is responsible for, among other things:
•reviewing and approving, or recommending that our board of directors approve, the compensation of our executive officers;
•reviewing and recommending to our board of directors the compensation of our directors;
•administering our stock and equity incentive plans and compensation recoupment policy;
•reviewing and approving, or making recommendations to our board of directors with respect to, incentive compensation and equity plans; and
•reviewing our overall compensation philosophy.
Our Compensation Committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards of the Nasdaq. During 2024, the Compensation Committee met three times. The Compensation Committee charter can be found in the Corporate Governance section of the Investors section of our website at https://ir.acutusmedical.com. Information on or accessible through our website is not incorporated by reference in this Form 10-K. The Compensation Committee charter grants the Compensation Committee sole authority to retain or obtain the advice of a compensation consultant, legal counsel or other adviser, including the authority to approve the consultant’s reasonable compensation. The Compensation Committee may select such advisers, or receive advice from any other adviser, only after taking into consideration all factors relevant to that person’s independence from management, including those independence factors enumerated by Nasdaq rules.
Under the Compensation Committee charter, the Compensation Committee may, in its discretion, delegate its duties to a subcommittee.
As required by its charter, the Compensation Committee annually reviews and assesses the adequacy of its charter and recommends any proposed changes to the board for its consideration.
Compensation Committee Processes and Procedures
The implementation of our compensation philosophy is carried out under the supervision of the Compensation Committee. The Compensation Committee charter requires that the Compensation Committee meet as often as it determines is appropriate to carry out its responsibilities under the charter. The agenda for each meeting is usually developed by the chair of the Compensation Committee, in consultation with other Compensation Committee members, management and the Compensation Committee’s independent advisors. The Compensation Committee also meets regularly in executive session. However, our Chief Executive Officer and Chief Financial Officer, in addition to the Compensation Committee’s independent advisors, may attend portions of the Compensation Committee meetings for the purpose of providing analysis and information to assist management with their recommendations on various compensation matters. Management does not participate in the executive sessions of the Compensation Committee.
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee is generally responsible for identifying qualified board candidates, recommending director nominees and appointments to board committees, evaluating board performance and overseeing the Company’s Corporate Governance Guidelines. The members of our Nominating and Corporate Governance Committee are David Bonita, Andrew ElBardissi and Shaden Marzouk. Dr. Bonita is the chair of our Nominating and Corporate Governance Committee. David Bonita, Andrew ElBardissi and Shaden Marzouk all meet
the requirements for independence under the current Nasdaq listing standards. Our Nominating and Corporate Governance Committee is responsible for, among other things:
•identifying and recommending candidates for membership on our board of directors;
•reviewing and recommending our Code of Business Conduct and Ethics and Corporate Governance Guidelines and policies;
•reviewing proposed waivers of the Corporate Governance Guidelines and the Code of Business Conduct and Ethics for directors and executive officers;
•overseeing the process of evaluating the performance of our board of directors; and
•assisting our board of directors on corporate governance matters.
During 2024, the Nominating and Corporate Governance Committee met two times. Our Nominating and Corporate Governance Committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards of Nasdaq. A detailed discussion of the Nominating and Corporate Governance Committee’s procedures for recommending candidates for election as a director appears below under the caption “Procedures of the Nominating and Corporate Governance Committee.”
The Nominating and Corporate Governance Committee charter, most recently updated in May 2023, can be found in the Corporate Governance section of the Investors section of our website at https//ir.acutusmedical.com. The Nominating and Corporate Governance Committee charter complies with the guidelines established by Nasdaq. Information on or accessible through our website is not incorporated by reference in this Form 10-K. The charter of the Nominating and Corporate Governance Committee grants the Nominating and Corporate Governance Committee authority to retain and terminate any advisers, including search firms to identify director candidates, compensation consultants as to director compensation and legal counsel, including sole authority to approve all such advisers’ fees and other retention terms.
Procedures of the Nominating and Corporate Governance Committee
In connection with nominating directors for election at the Annual Meeting and periodically throughout the year, the Nominating and Corporate Governance Committee considers the composition of the board and each committee of the board to evaluate its effectiveness and whether changes should be considered to either the board or any of the committees. In support of this process, the board has determined that the Board as a whole must have the right diversity, mix of characteristics and skills for the optimal functioning of the board in its oversight of our Company. The board considers the following factors and qualifications, without limitation:
•the appropriate size and the diversity of the board;
•the needs of the board with respect to the particular talents and experience of its directors;
•the knowledge, skills and experience of nominees, including experience in the industry in which the Company operates, business, finance, management or public service, in light of prevailing business conditions and the knowledge, skills and experience already possessed by other members of the board;
•familiarity with domestic and international business matters;
•familiarity and experience with legal and regulatory requirements; and
•experience with accounting rules and practices.
Pursuant to the Nominating and Corporate Governance Committee charter, the Nominating and Corporate Governance Committee intends to periodically review the composition of the board in light of current challenges and needs of the board and the Company and determine whether it may be appropriate to add or remove individuals after considering issues of judgment, diversity, skills, background and experience. Although the Nominating and Corporate Governance Committee does not have a formal policy regarding diversity on the board, the Nominating and Corporate Governance Committee is sensitive to the importance of nominating persons with different perspectives and experience to enhance the deliberation and decision-making processes of the board.
Once the Nominating and Corporate Governance Committee and the board determine that it is appropriate to add a new director, either as a replacement or as a new position, the Nominating and Corporate Governance Committee uses a flexible set of procedures in selecting individual director candidates. This flexibility allows the Nominating and Corporate Governance Committee to adjust the process to best satisfy the objectives it is attempting to accomplish in any director search. The first step in the general process is to identify the type of candidate the Nominating and Corporate Governance Committee may desire for a particular opening, including establishing the specific target skill areas, experiences and backgrounds that are to be the focus of a director search. The Nominating and Corporate Governance Committee may consider candidates recommended by management, by members of the Nominating and Corporate Governance Committee, by the board, by stockholders or by a third party it may engage to conduct a search for possible candidates. In considering candidates submitted by stockholders, the Nominating
and Corporate Governance Committee will take into consideration the needs of the Board and the qualifications of the candidate.
In order for a stockholder to have a candidate considered by the Nominating and Corporate Governance Committee, a stockholder should submit a written recommendation that includes (A) as to each person whom the stockholder proposes to nominate for election or reelection as director, (1) all information relating to such person that is required to be disclosed in solicitations of proxies for election of directors, or is otherwise required, in each case pursuant to Regulation 14A under the Exchange Act, including such person’s written consent to being named in the proxy statement and form of proxy as a nominee and to serving as a director if elected, and (2) a reasonably detailed description of any compensatory, payment or other financial agreement, arrangement or understanding that such person has with any other person or entity other than the Company including the amount of any payment or payments received or receivable thereunder, in each case in connection with candidacy or service as a director of the Company, and (B) as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the proposal is made, (1) the name and address of such stockholder (as they appear on the Company’s books) and any such beneficial owner; (2) for each class or series, if any, the number of shares of capital stock of the Company that are held of record or are beneficially owned by such stockholder and by any such beneficial owner; (3) a description of any agreement, arrangement or understanding between or among such stockholder and any such beneficial owner, any of their respective affiliates or associates, and any other person or persons (including their names) in connection with the proposal of such nomination or other business; (4) a description of any agreement, arrangement or understanding (including, regardless of the form of settlement, any derivative, long or short positions, profit interests, forwards, futures, swaps, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions and borrowed or loaned shares) that has been entered into by or on behalf of, or any other agreement, arrangement or understanding that has been made, the effect or intent of which is to create or mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such stockholder or any such beneficial owner or any such nominee with respect to the Company’s securities; (5) a representation that the stockholder is a holder of record of stock of the Company entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to bring such nomination or other business before the meeting; (6) a representation as to whether such stockholder or any such beneficial owner intends or is part of a group that intends to (i) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the voting power of the Company’s outstanding capital stock required to approve or adopt the proposal or to elect each such nominee and/or (ii) otherwise to solicit proxies from stockholders in support of such proposal or nomination; and/or (iii) solicit holders of shares representing at least 67% of the outstanding securities of the Company generally entitled to vote on the election of directors in support of director nominees other than the Company’s nominees in accordance with Rule 14a-19 promulgated under the Exchange Act, (7) any other information relating to such stockholder, beneficial owner, if any, or director nominee or proposed business that would be required to be disclosed in a proxy statement or other filing required to be made in connection with the solicitation of proxies in support of such nominee or proposal pursuant to Section 14 of the Exchange Act; and (8) such other information relating to any proposed item of business as the Company may reasonably require to determine whether such proposed item of business is a proper matter for stockholder action.
Stockholder recommendations should be addressed to the Nominating and Corporate Governance Committee in care of our Chief Executive Officer at 2210 Faraday Ave., Suite 100, Carlsbad, CA 92008.
Once candidates are identified, the Nominating and Corporate Governance Committee conducts an evaluation of qualified candidates. The evaluation generally includes interviews and background and reference checks. There is no difference in the evaluation process of a candidate recommended by a stockholder as compared to the evaluation process of a candidate identified by any of the other means described above. In identifying and evaluating potential nominees to serve as directors, the Nominating and Corporate Governance Committee will examine each nominee on a case-by-case basis regardless of who recommended the nominee and take into account all factors it considers appropriate.
If the Nominating and Corporate Governance Committee determines that a candidate should be nominated as a candidate for election to the board, the candidate’s nomination is then recommended to the board, and the directors may in turn conduct their own review to the extent they deem appropriate. When the board has agreed upon a candidate, such candidate is recommended to the stockholders for election at an annual meeting of stockholders or appointed as a director by a vote of the board as appropriate.
Code of Business Conduct and Ethics
Our board of directors has adopted a Code of Business Conduct and Ethics that applies to all of our employees, officers and directors, including our principal executive officer, principal financial officer, principal accounting officer and other executive and senior financial officers. The full text of our Code of Business Conduct and Ethics is available in the Corporate Governance section of the Investors section of our website at https://ir.acutusmedical.com. Information on or accessible through our website is not incorporated by reference in this Form 10-K. We intend to disclose future amendments to our Code of Business Conduct and Ethics, or any waivers of such code, on our website or in public filings.
Compensation Recoupment Policy
On May 17, 2023, the board adopted a Compensation Recoupment Policy. The Compensation Recoupment Policy, adopted in compliance with Exchange Act Rule 10D and the corresponding Nasdaq listing standards, applies to current and former executive officers of the Company. In the event the Company is required to restate its financial statements as a result of events described in the Nasdaq listing standards effective October 2, 2023, the Compensation Committee is authorized to recover incentive compensation awarded to a covered executive in accordance with its Compensation Recoupment Policy.
Anti-Hedging and Anti-Pledging
The board has adopted a formal anti-hedging and anti-pledging policy for our employees, officers and directors. Under our Insider Trading Policy, which was adopted by the board in August 2020 and most recently updated in May 2023, our employees, officers and directors are prohibited from engaging in transactions in publicly-traded options, such as puts and calls, and other derivative securities with respect to the Company’s securities. This prohibition extends to any hedging or similar transaction designed to decrease the risks associated with holding Company securities. In addition, employees, officers and directors may not pledge Company securities under any circumstances, including by purchasing Company securities on margin or holding Company securities in a margin account, or pledging securities as collateral for loans.
Insider Trading
We maintain insider trading policies and procedures governing the purchase, sale, and/or other dispositions of our company’s securities by directors, officers, and employees that we believe are reasonably designed to promote compliance with insider trading laws, rules, and regulations. A copy of our insider trading policy is filed as exhibit 19 to our annual report on Form 10-K.

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ITEM 11. EXECUTIVE COMPENSATION
Item 11. Executive Compensation.
Our named executive officers (“NEOs”) for fiscal year 2024, who consist of our current and former principal executive officers serving at any time during fiscal year 2024, and the two individuals who served as executive officers during fiscal year 2024 and would have been the next two most highly compensated executive officers (other than the principal executive officers) had they remained executive officers through the end of the fiscal year, are:
◦Takeo Mukai, our current Chief Executive Officer and Chief Financial Officer;
◦David Roman, our former President and Chief Executive Officer;
◦Kevin Mathews, our former Senior Vice President, Commercial; and
◦Tom Sohn, our former Chief Administrative Officer, General Counsel and Secretary.
As an emerging growth company, we have opted to comply with the executive compensation disclosure rules applicable to emerging growth companies pursuant to the JOBS Act, which require compensation disclosure for each individual serving as our principal executive officer during fiscal year 2024, the two most highly compensated executive officers other than such principal executive officers and up to two additional individuals who would have been included had they remained executive officers through the end of fiscal year 2024.
During fiscal year 2024, we had two individuals serve as principal executive officer. David Roman served as the Company’s President and Chief Executive Officer through January 7, 2024. Takeo Mukai, the Company’s Chief Financial Officer, was appointed as Chief Executive Officer on January 8, 2024, while continuing to serve as the
Company’s Chief Financial Officer. In February 2025, Mr. Mukai’s employment was terminated but he remained with the Company as a consultant, continuing to serve as Chief Executive Officer and Chief Financial Officer. No other executive officers served through the end of fiscal year 2024. Kevin Mathews, Senior Vice President, Commercial, and Tom Sohn, Chief Administrative Officer, General Counsel and Secretary, departed effective as of January 7, 2024 and February 6, 2024, respectively.
Summary Compensation Table
The following table discloses compensation earned by our NEOs for each of the last three fiscal years during which they served as NEOs.
Name and Principal Position Year Salary ($) Bonus ($)
Stock Awards ($) (1)
Option Awards ($) (2)
Non-Equity Incentive Plan Compensation ($) (3)
All Other Compensation ($) Total ($)
Takeo Mukai........................
2024 371,970 231,000(4)
- - 204,474 1,539(5)
808,983
Chief Executive Officer and Chief Financial Officer 2023 323,438 60,000 66,975 44,859 - $1,575 496,847
David Roman.......................
2024 28,381 300,000(6)
- - - 503,987(7)
832,368
Former President and Chief Executive Officer 2023 491,667 140,000 190,350 127,494 - 1,575 951,086
2022 419,667 - 291,810 133,030 184,000 1,225 1,029,732
Kevin Mathews.....................
2024 17,596 38,000(8)
- - - 236,652(9)
292,249
Former SVP, Commercial 2023 310,000 - 59,925 40,137 - $198,661 608,723
Tom Sohn..........................
2024 52,689 188,000(10)
- - - 384,399(11)
625,088
Former Chief Administrative Officer, General Counsel and Secretary
(1) These figures reflect the aggregate grant date fair value of restricted stock units granted in the fiscal year, computed in accordance with the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718. See Note 16 of the Notes to our Consolidated Financial Statements contained in the Company’s report on Form 10-K for the applicable fiscal year for assumptions used in the valuation of these awards and related disclosures. As required by SEC rules, the amounts shown exclude the impact of estimated forfeitures related to service-based vesting conditions.
(2) These figures reflect the aggregate grant date fair value of stock options granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. See Note 16 of the Notes to the Consolidated Financial Statements contained in the Company’s report on Form 10-K for the applicable fiscal year for assumptions used in the valuation of these awards and related disclosures. As required by SEC rules, the amounts shown exclude the impact of estimated forfeitures related to service-based vesting conditions.
(3) For Mr. Mukai only includes $204,474 for quarterly bonuses paid in 2024. In 2023, in conjunction with the Company’s announcement of a realignment of resources and corporate restructuring, the Company ceased the short-term cash incentive bonus program. For 2022, represents bonuses paid to our NEOs under our short-term cash incentive bonus program for executives, as described under “-Short-Term Cash Incentive Program,” below. Annual bonuses are paid during the first quarter of the year following the year during which the bonuses are earned.
(4) Includes $231,000 for a retention bonus granted on November 08, 2023 and paid in 2024.
(5) Includes $1,539 in life insurance, internet and mobile device benefits.
(6) Includes $300,000 in a retention bonus granted on November 08, 2023 and paid in 2024.
(7) Includes $500,000 in severance, $2,809 in Cobra payments, $1,050 in consulting, and $128 in life insurance, internet and mobile device benefits.
(8) Includes $38,000 in a retention bonus granted on November 08, 2023 and paid in 2024.
(9) Includes $232,500 in severance, $3,974 in Cobra payments, and $178 in life insurance, internet and mobile device benefits.
(10) Includes $188,000 in a retention bonus granted on November 08, 2023 and paid in 2024.
(11) Includes $281,250 in severance, $22,491 in Cobra payments, $80,401 in consulting fees, and $257 in life insurance, internet and mobile device benefits.
Cash Compensation
Base Salary
The NEOs receive base salaries to compensate them for services rendered to the Company. The base salaries are intended to provide a fixed component of compensation that is commensurate with each executive’s experience, role and responsibilities. The amount that each NEO received in base salary for 2024 is set forth in the Summary Compensation Table above.
In connection with his appointment as Chief Executive Officer, our Board of Directors, on recommendation by the Compensation Committee, increased Mr. Mukai’s base salary for 2024 from $325,000 to $375,000 based on the Compensation Committee’s review of available market information. See the “Salary” column in the 2024 Summary Compensation Table for the base salary amounts earned by the named executive officers in 2024. None of our other NEOs received any increases in base salary prior to his or her departure.
Short-Term Cash Incentive Program
Historically, we maintained an annual bonus program that rewarded each of our NEOs for our performance against business goals, and for the officer’s performance against his or her individual goals.
Equity Awards
We have historically granted stock options and restricted stock units (“RSUs”) to our executive officers. Options are granted with an exercise price per share that is no less than the fair market value of the Company’s common stock on the date of grant of such award. Options and RSUs generally vest over a 4 year-period from the date of grant with 25% of each award subject to one-year cliff-vesting. However, in 2022 and 2023, the Company granted options and RSUs that vest over a 2 year-period from the date of grant with 50% of each award subject to one-year cliff vesting and the remainder vesting over the subsequent year. None of our NEOs received equity or equity-based awards in 2024. See the “Outstanding Equity Awards at Fiscal Year End” table below for a description of the vesting schedule of option and RSU awards held by our NEOs as of December 31, 2024. Option and RSU awards may be subject to acceleration of vesting under certain termination and change of control events, as further described below under the section titled “Potential Payments upon Termination or Change of Control.” The terms of the 2020 Equity Incentive Plan (the “2020 Plan”) and the 2011 Equity Incentive Plan (the “2011 Plan”) are described under the section titled “Employee Benefit and Stock Plans” below.
Executive Officer Offer Letters and Employment Arrangements
We have entered into employment agreements with each of our NEOs, the key terms of which are described below. In addition, as a condition of employment, each of our NEOs has also entered into our standard, at-will employment, confidential information, invention assignment and arbitration agreements. Under these agreements, each officer is subject to a covenant not to solicit our employees, both during the officer’s employment and for the 12-month period following termination of employment for any reason.
Takeo Mukai
We are party to an employment agreement dated as of January 9, 2023 with Mr. Mukai, our Chief Executive Officer and Chief Financial Officer. This agreement does not have a specific term and provides that Mr. Mukai is an at-will employee. Mr. Mukai’s current base salary is $375,000, and his annual target under our annual cash incentive program was 60% of his annual base salary. Under his employment agreement, Mr. Mukai was eligible for severance benefits under his employment agreement, subject to his execution of a general release in our favor, as more fully described in “Potential Payments upon Termination or Change of Control.”
On November 30, 2024, in connection with the realignment of resources and operational downsizing of the Company, Mr. Mukai’s employment with the Company terminated effective as of February 1, 2025, at which time Mr. Mukai remains with the Company as a consultant, serving as the Company’s Chief Executive Officer and Chief Financial Officer. Upon Mr. Mukai’s separation from the Company on February 1, 2025, and receipt of his general release of the Company and its affiliates, he received the following severance payments for which he was entitled under his employment agreement upon an involuntary termination without Cause: $281,250 representing 9 months of his base salary, paid in a lump sum following his termination, plus 9 months of reimbursement for COBRA continuation premiums.
Further, on November 30, 2024, the Board also approved a one-time retention bonus of $56,250 for Mr. Mukai, subject to his continued service through February 1, 2025 with the Company.
On December 2, 2024, in connection with his transition to consultant on February 1, 2025, Mr. Mukai entered into a consulting agreement with the Company, which became effective February 1, 2025. Pursuant to the consulting agreement, Mr. Mukai agreed to provide all reasonable assistance to the Company with respect to the role of the Company’s Chief Executive Officer and Chief Financial Officer and will receive compensation equal to $10,000 per month, for up to 40 hours of services in the applicable month.
David Roman
We were party to an employment agreement dated as of March 1, 2021, as amended on July 20, 2022 with David Roman, our former President and Chief Executive Officer. This agreement did not have a specific term and provided that Mr. Roman was an at-will employee. Mr. Roman’s base salary was $500,000 and his annual target under our annual cash incentive program was 60% of his annual base salary. On November 8, 2023, the Company announced a realignment of resources and corporate restructuring, including a reduction in the workforce. As part of the reduction in workforce, Mr. Roman separated from the Company, effective January 7, 2024. Upon his separation, Mr. Roman received a cash retention bonus equal to $300,000, which was granted to him on November 6, 2023 and payable to him as a lump sum on January 7, 2024, subject to his continued service through such payment date.
On January 7, 2024, Mr. Roman entered into a separation agreement with the Company. Pursuant to the separation agreement (as contemplated by his employment agreement), in consideration of a customary release of claims, Mr. Roman received cash severance equal to one year of Mr. Roman’s annual base salary ($500,000) payable as a lump sum as well as the accelerated vesting of 67,500 shares underlying RSUs.
Pursuant to a consulting agreement entered into with the Company on January 8, 2024, Mr. Roman provided reasonable assistance to the Company with respect to the transition of the Company’s chief executive officer role and provided advisory services related to the Company’s corporate restructuring. Pursuant to his consulting agreement, Mr. Roman was entitled, during the term of the consulting agreement, to compensation equal to $200 per
hour of service. The consulting agreement was terminated by mutual agreement on January 26, 2024 upon Mr. Roman’s commencement of subsequent employment.
Kevin Mathews
We were party to an employment agreement dated as of May 1, 2022 with Mr. Mathews, our former Senior Vice President, Commercial. This agreement did not have a specific term and provided that Mr. Mathews was an at-will employee. Mr. Mathew’s base salary was $310,000 and his annual target under our annual cash incentive program was 50% of his annual base salary. On November 8, 2023, the Company announced a realignment of resources and corporate restructuring, including a reduction in the workforce. As part of the reduction in workforce, Mr. Mathews separated from the Company, effective January 7, 2024. Upon his separation, Mr. Mathews received a cash retention bonus equal to $38,000, which was granted to him on November 6, 2023 and payable to him as a lump sum on February 6, 2024, subject to his continued service through such payment date.
On January 7, 2024, Mr. Mathews entered into a separation agreement with the Company. Pursuant to the separation agreement (as contemplated by his employment agreement), in consideration of a customary release of claims, Mr. Mathews received cash severance equal to nine months of Mr. Mathews’ annual base salary ($232,500) payable as a lump sum as well as the accelerated vesting of 21,500 shares underlying RSUs.
Tom Sohn
We were party to an employment agreement dated as of August 5, 2020 with Mr. Sohn, our former Chief Administrative Officer, General Counsel, Secretary, and Chief Compliance Officer. This agreement did not have a specific term and provided that Mr. Sohn was an at-will employee. Mr. Sohn’s base salary was $375,000 and his annual target under our annual cash incentive program was 50% of his annual base salary. On November 8, 2023, the Company announced a realignment of resources and corporate restructuring, including a reduction in the workforce. As part of the reduction in workforce, Mr. Sohn separated from the Company, effective February 6, 2024. Upon his separation, Mr. Sohn received a cash retention bonus equal to $188,000, which was granted to him on November 6, 2023 and payable to him as a lump sum on February 6, 2024, subject to his continued service through such payment date.
On February 6, 2024, Mr. Sohn entered into a separation agreement with the Company. Pursuant to the separation agreement (as contemplated by his employment agreement), in consideration of a customary release of claims, Mr. Roman received cash severance equal to nine months of Mr. Sohn’s annual base salary ($281,500) payable as a lump sum as well as the accelerated vesting of 21,250 shares underlying RSUs.
Pursuant to a consulting agreement entered into with the Company on February 7, 2024, Mr. Sohn provided reasonable assistance to the Company with respect to the transition of the Company’s General Council and provided advisory services related to the Company’s corporate restructuring. Pursuant to his consulting agreement, Mr. Sohn was entitled, during the term of the consulting agreement, to compensation equal to $200 per hour of service. The consulting agreement was terminated by mutual agreement on September 27, 2024 upon Mr. Sohn’s commencement of subsequent employment.
Takeo Mukai
We were party to an employment agreement dated as of January 9, 2023 with Mr. Mukai, our Chief Executive Officer and Chief Financial Officer. On November 30, 2024, in connection with the realignment of resources and operational downsizing of the Company, Mr. Mukai’s employment with the Company terminated effective as of February 1, 2025, at which time Mr. Mukai would remain with the Company as a consultant, serving as the Company’s Chief Executive Officer and Chief Financial Officer. Upon Mr. Mukai’s separation from the Company on February 1, 2025, and receipt of his general release of the Company and its affiliates, he received the following severance payments for which he was entitled under his employment agreement upon an involuntary termination without Cause: $281,250 representing 9 months of his base salary, paid in a lump sum following his termination, plus 9 months of reimbursement for COBRA continuation premiums.
David Roman, Kevin Mathews and Tom Sohn
None of Messrs. Roman, Mathews and Sohn were employed as of December 31, 2024 and would not be entitled to any additional payments upon a termination of employment or change in control as of December 31, 2024. For more information on the payments received by Messrs. Roman, Mathews and Sohn in connection with their separations in 2024, see the descriptions set forth in the section titled “Executive Officer Offer Letters and Employment Arrangements” above.
Outstanding Equity Awards at Fiscal Year End
The following table sets forth information concerning unexercised options, stock that has not vested and equity incentive plan awards for our NEOs as of the end of our fiscal year ended December 31, 2024.
Outstanding Equity Awards at 2024 Fiscal Year End
Option Awards
Name Vesting Commencement Date Numbers of Securities Underlying Unexercised Options (#) Exercisable Number of Securities Underlying Unexercised Options (#) Unexercisable
Option Exercise Price (1) ($) Option Expiration Date
Takeo Mukai.... 8/2/2021 $ 20,566.00 - 1.34 8/2/2031
2/1/2022 13,000 - 1.34 2/1/2032
3/1/2023 47,500 - 1.41 3/1/2033
(1) Effective July 25, 2022, and in accordance with the terms of the 2011 Plan and the 2020 Plan, the Board of Directors reduced the exercise price of outstanding “underwater” options to purchase our common stock held by employees who were employed on July 25, 2022 (and who had not provided a notice of resignation prior to such date) to $1.34 per share, which was the closing price for our common stock on July 25, 2022. The exercise price for each option in the table shown above is the post-repricing exercise price.
(2) This option vests over four years from the vesting commencement date, with 1/4 vesting on the first anniversary of the vesting commencement date, and the remainder vesting in 36 equal monthly installments, subject to continued service through each such vesting date.
(3) This option vests over two years from the vesting commencement date, with 1/2 vesting on the first anniversary of the vesting commencement date, and the remainder vesting in 12 equal monthly installments, subject to the continued service through each such vesting date.
Employee Benefit and Stock Plans
Our NEOs are entitled to participate in our compensation and benefits plans as described below.
2020 Plan
In August 2020, our Board of Directors adopted, and our stockholders approved, our 2020 Plan, which became effective in connection with our initial public offering in August 2020. Our 2020 Plan replaced our 2011 Plan. Following the effectiveness of the 2020 Plan, no further equity awards may be granted under our 2011 Plan. The 2020 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock, RSUs, performance units, performance shares and other equity-based awards. ISOs may be granted only to employees. All other awards may be granted to employees, directors and consultants.
Our Board of Directors, or one or more duly authorized committees thereof, have the authority to administer the 2020 Plan. Unless the terms of an optionholder’s stock option agreement provide otherwise, if an optionholder’s
service relationship with us ceases for any reason other than disability or death, the optionholder may generally exercise any vested options for a period of three months following the cessation of service. In the event of certain corporate transactions specified in our 2020 Plan, including a merger or change of control, as defined in our 2020 Plan, the administrator may, in its discretion, take certain actions with respect to outstanding awards, including the continuation or assumption of awards.
Defined Contribution Plan
We currently maintain a 401(k)-retirement savings plan (the “401(k) plan”) for our employees, including our NEOs, who satisfy certain eligibility requirements. The 401(k) plan is intended to qualify as a tax-qualified plan under Section 401(k) of the Internal Revenue Code (the “Code”). Our NEOs are eligible to participate in the 401(k) plan on the same basis as our other employees. The Code allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions to the 401(k) plan. We reserve the right to make discretionary matching contributions or non-elective contributions under the 401(k) plan. Similar to prior years, in fiscal year 2024, we did not provide a matching contribution or a non-elective contribution under the 401(k) plan.
We do not maintain any defined benefit pension plans.
Director Compensation
Our directors play a critical role in guiding our strategic direction and overseeing the management of Acutus. The many responsibilities and risks and the substantial time commitment of being a director require that we provide adequate compensation commensurate with our directors’ workload and opportunity costs. Independent Directors receive a combination of annual cash retainers and annual grants of options or RSUs, as described further below.
Prior to his resignation in 2024, our one employee director, Mr. Roman, did not receive additional compensation for his services as a director. For more information on Mr. Roman’s compensation as an officer, see the section titled “Executive Compensation.” For more information on our non-employee director compensation, see the section titled “Director Compensation in 2024.”
Equity Compensation
Under the Company’s Outside Director Compensation Policy, as in effect prior to February 13, 2023, newly appointed non-employee directors received an initial stock option award with a grant date value of $140,000 as well as an RSU award with a grant date value of $60,000, and each incumbent non-employee director who served as such as of the date of our annual meeting, received a stock option award with a grant date value of $84,000 and an RSU award with a grant date value of $36,000, except that the annual grant for 2022 consisted of a stock option and an RSU award with respect to a fixed number of shares of Company stock in the amount of 13,595 and 9,000 respectively. In February 2023, the Board amended the policy to provide newly appointed non-employee directors an initial stock option award of 32,500 shares as well as an RSU award of 14,000 shares, and each incumbent non-employee director who served as such as of the date of our annual meeting, received a stock option award of 19,600 shares and an RSU award of 8,400 shares. In addition, an outside director serving in the capacity of Board Chair received an additional stock option award of 5,880 shares and an additional RSU award of 2,520 shares.
Each initial option grant and each initial RSU grant vests ratably over a three-year period following the commencement of the non-employee director’s services. In the case of the initial option grant, 1/3 of the shares vest on the first anniversary of the non-employee director’s commencement date, and the remaining two-thirds vest in equal monthly installments, and, in the case of the initial RSU grant, 1/3 of the shares vest on each anniversary of the non-employee director’s commencement date, in each case, subject to the non-employee director’s continuous service with us on each applicable vesting date. Each annual option and RSU grant vests on the first anniversary of the grant date, subject to the non-employee director’s continuous service with us through the vesting date. All then outstanding awards held by non-employee directors will vest upon a “Change in Control” (as defined in the 2020 Plan), subject to the non-employee director’s continuous service with us through the date of such Change in Control.
On February 13, 2023, our Compensation Committee approved an amendment to the Company’s Outside Director Compensation Policy, following which, upon being appointed to our Board of Directors, any new non-employee director will receive a stock option award with respect to 32,500 shares as well as an RSU award with respect to 14,000 shares, and each incumbent non-employee director who is serving as such as of the date of our
annual meeting will receive a stock option award with respect to 19,600 shares and an RSU award with respect to 8,400 shares. Under the amended policy, a non-employee director serving in the capacity of Chair will receive an additional stock option award with respect to 5,880 shares and an RSU award with respect to 2,520 shares. All other terms of the Company’s Outside Director Compensation Policy remain as in effect prior to the amendment.
Cash Compensation
The following table is a summary of the annual cash compensation provided for under the Company’s Outside Director Compensation Policy other than for Mr. Roman, who was an executive officer and did not receive any additional compensation for services provided as a director, and for Mr. Huennekens, who was paid cash compensation under his Chairperson Agreement described below:
Position Annual Cash Retainer
Chairperson...............................................................................................................................
$ 65,000
Lead Independent Director...........................................................................................................
$ 50,000
Board Member...........................................................................................................................
$ 40,000
Committee Chair
Audit....................................................................................................................................
$ 20,000
Compensation........................................................................................................................
$ 14,000
Nominating and Corporate Governance.......................................................................................
$ 10,000
Committee Member
Audit....................................................................................................................................
$ 10,000
Compensation........................................................................................................................
$ 7,000
Nominating and Corporate Governance......................................................................................
$ 5,000
Chairperson Agreement
We entered into a Chairperson Agreement with Mr. Huennekens under which we agreed to pay him at a rate of $500 per hour for his service as Chair. Pursuant to this agreement, we granted Mr. Huennekens an RSU award on June 30, 2019 with respect to 567,509 shares of our common stock. The vesting of this award was subject to Mr. Huennekens’ continued service through designated vesting dates over a period ending on March 1, 2022 and the occurrence of an initial public offering or change in control with respect to the Company within ten years of the date of grant.
Mr. Huennekens’ Chairperson Agreement provided that in the event that Mr. Huennekens’ service is terminated by us without “cause” or by Mr. Huennekens with “good reason” (each as defined in such agreement), then, subject to Mr. Huennekens’ waiver and release in a form reasonably satisfactory to the Company, his equity compensation awards, all of which had already vested as of March 1, 2022, would become vested and exercisable to the extent they would have become vested and exercisable if he had continued service to the Company for the 12-month period
following the date of termination. The agreement also provided that in the event of a change in control (as defined in our 2011 Plan), Mr. Huennekens’ equity compensation awards would become fully vested and exercisable. Mr. Huennekens resigned from Board effective January 15, 2024.
Director Compensation in 2024
The following table presents the total compensation each of our non-employee directors received during the year ended December 31, 2024.
The following table presents the total compensation each of our non-employee directors received during the year ended December 31, 2024.
Fees Earned or Paid in Cash ($) Total ($)
R. Scott Huennekens (3).....
David Bonita, M.D............
50,000 50,000
Andrew ElBardissi, M.D....
52,000 52,000
Niamh Pellegrini..............
57,000 57,000
John Sheridan...................
56,500 56,500
Shaden Marzouk, M.D. (5).
73,750 73,750
Jason Garland...................
60,000 60,000
(1) These figures reflect the aggregate grant date fair value of RSUs granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. The assumptions used to calculate the grant-date fair value of the awards reported in this column are set forth in Note 15 to our Consolidated Financial Statements above. As required by SEC rules, the amounts shown exclude the impact of estimated forfeitures related to service-based vesting conditions.
(2) These figures reflect the aggregate grant date fair value of stock options granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. The assumptions used to calculate the grant-date fair value of the awards reported in this column are set forth in Note 15 to our Consolidated Financial Statements above. As required by SEC rules, the amounts shown exclude the impact of estimated forfeitures related to service-based vesting conditions.
(3) Mr. Huennekens resigned from the Board of Directors, effective as of January 15, 2024, and did not receive any fees in 2024.
(4) Mr. Marzouk was appointed as independent chairperson effective as of January 15, 2024.
As of December 31, 2024, our directors held the following number of RSUs and stock options in the aggregate:
Stock Options (#)
R. Scott Huennekens (1)..
David Bonita, M.D.........
58,676
Andrew ElBardissi, M.D..
58,676
Jason Garland................... 52,100
John Sheridan................... 50,082
Niamh Pellegrini............
54,391
Shaden Marzouk, M.D.....
58,676
(1) Mr. Huennekens resigned from the Board of Directors, effective as of January 15, 2024. As of December 31, 2024, he did not hold any stock options.
Equity Compensation Plan Information
The following table provides certain information with respect to all of our equity compensation plans as of December 31, 2024:
Plan Number of securities to be issued upon exercise of outstanding options, warrants and rights Weighted average exercise price of outstanding options (3) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (4)
(a) (b) (c)
Equity compensation plans approved by stockholders (1).................................................
508,802 $ 3.72 5,887,381
Equity compensation plans not approved by stockholders (2)..........................................
- $ - 5,958,365
Total......................................................................................................................................
508,802 $ 3.72 11,845,746
(1) Includes our 2020 Plan, our 2011 Plan and our ESPP. Our ESPP was terminated, effective November 8, 2023.
(2) In March 2022, our Board of Directors approved our 2022 Inducement Equity Incentive Plan (the “2022 Plan”). The 2022 Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock, RSUs, performance units, performance shares and other equity-based awards. Only individuals not previously an employee or director of the Company (other than following a bona fide period of non-employment) are eligible for grants under the 2022 Plan and only as an inducement material to the individual’s entering into employment with the Company. Our Board of Directors, or one or more duly authorized committees thereof, have the authority to administer the 2022 Plan to new employees. Unless the terms of an optionholder’s stock option agreement provides otherwise, if an optionholder’s service relationship with us ceases for any reason other than disability or death, the optionholder may generally exercise any vested options for a period of three months following the cessation of service. In the event of certain corporate transactions specified in our 2022 Plan, including a merger or change of control, as defined in our 2022 Plan, the administrator may, in its discretion, take certain actions with respect to outstanding awards, including the continuation or assumption of awards.
(3) The weighted average exercise price is calculated based solely on outstanding stock options. It does not take into account shares issuable upon vesting of outstanding RSUs, which have no exercise price.
(4) Includes shares available for issuance under our 2022 Plan, our 2020 Plan and our ESPP. Our 2011 Plan was discontinued in connection with our initial public offering and there are no shares remaining available for issuance under the 2011 Plan. The number of shares available for issuance under our 2020 Plan increases automatically on
the first day of each fiscal year of the Company beginning with the 2021 fiscal year and ending with the 2029 fiscal year, in an amount equal to the least of (i) 2,193,360 shares; (ii) 4% of the outstanding shares of our common stock on the last business day of the immediately preceding fiscal year or (iii) such number of shares determined by our Board. Our ESPP was terminated, effective November 8, 2023.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth certain information known to us regarding beneficial ownership of our common stock as of February 1, 2025 by:
•each person whom we know to own beneficially more than 5% of our common stock;
•each of our directors and director nominees and named executive officers individually; and
•all of our directors and executive officers as a group.
In accordance with the rules of the SEC, beneficial ownership includes voting or investment power with respect to securities and includes the shares issuable pursuant to stock options and other awards that are exercisable within 60 days of February 1, 2025. Shares issuable pursuant to stock options and other awards are deemed outstanding for computing the percentage of the person holding such options or awards but are not outstanding for computing the percentage of any other person. The percentage ownership of our common stock in the “Shares Beneficially Owned” column in the table is based on 29,313,667 shares of our common stock issued and outstanding as of February 1, 2025.
Unless otherwise indicated, the mailing address of each of the stockholders below is c/o Acutus Medical, Inc., 2210 Faraday Ave., Suite 100, Carlsbad, CA 92008. To our knowledge, except as indicated in the footnotes to this table and pursuant to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all shares of common stock.
Name of Beneficial Owner
Shares Beneficially Owned
Shares
Percentage
5% and Greater Stockholders:
Entities affiliated with OrbiMed Advisors, LLC(1)
$ 6,961,450 8.9 %
Entities affiliated with Deerfield Management Company, L.P.(2)
5,492,725
8.9 %
Laurence W. Lytton(3)
2,078,030
7.0 %
Named Executive Officers and Directors:
Takeo Mukai(4)
116,805 *
David Roman(5)
155,466 ]
*
Kevin Mathews(6)
28,437 *
Tom Sohn(7)
54,359 *
David Bonita, M.D(8)
79,498 *
Andrew ElBardissi, M.D.(9)
79,498 ]
*
Jason Garland(10)
74,500 *
Niamh Pellegrini(11)
75,363 ]
*
Shaden Marzouk, M.D(12)
79,498 *
John Sheridan(13)
70,029 ]
*
All executive officers and directors as a group (7 persons)(14)
575,191 1.96 %
*Represents less than 1% of Acutus’ outstanding common stock.
(1) Based on the Schedule 13D/A filed with the SEC on November 18, 2021 by OrbiMed Advisors and its affiliates. Consists of: (i)(A) 2,076,139 shares of outstanding common stock, (B) 60,339 shares underlying warrants and (C) 2,795,886 shares issuable upon conversion of 2,795.8860 shares of our Series A Common Equivalent Preferred Stock, in each case, held by OrbiMed Private Investments IV, LP (“OPI IV”); (ii)(A) 572,247 shares of outstanding common stock, (B) 272,227 shares underlying warrants and (C) 1,105,114 shares issuable upon conversion of 1,105.1140 shares of our Series A Common Equivalent Preferred Stock, in each case, held by OrbiMed Royalty Opportunities II, LP (“ORO II”); and (iii) 20,822 shares of common stock and 58,676 shares underlying stock options held by David Bonita which are exercisable or will become exercisable or otherwise vest within 60 days, which shares and options are held for the benefit and at the direction of OPI IV. OrbiMed Capital GP IV LLC (“GP IV”) is the general partner of OPI IV. OrbiMed Advisors is the managing member of GP IV. By virtue of such relationships, GP IV and OrbiMed Advisors may be deemed to have voting and investment power with respect to the shares held by OPI IV and as a result may be deemed to have beneficial ownership of such shares. OrbiMed ROF II LLC (“ROF II”) is the general partner of ORO II and OrbiMed Advisors is the managing member of ROF II. By virtue of such relationships, ROF II and OrbiMed Advisors may be deemed to have voting and investment power with respect to the shares held by ORO II and as a result may be deemed to have beneficial ownership of such shares. David Bonita, a member of OrbiMed Advisors, is a member of the Company’s Board of Directors. By virtue of such relationship, OrbiMed Advisors may be deemed to beneficially own the securities held by David Bonita. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Each of GP IV, ROF II, OrbiMed Advisors, Carl L. Gordon, Sven H. Borho, W. Carter Neild and David Bonita disclaims beneficial ownership of the shares held by OPI IV and ORO II, except to the extent of its or his pecuniary interest therein if any. The address for each of OPI IV and ORO II is c/o OrbiMed Advisors LLC, 601 Lexington Avenue, 54th Floor, New York, New York 10022.
(2) Based on the Schedule 13D/A filed with the SEC on January 28, 2025 by Deerfield Management. Consists of: (i)(A) 1,026,243 shares of common stock and (B) 948,395 shares of common stock issuable upon conversion of 948.3950 shares of Series A Common Equivalent Preferred Stock, in each case, held by Deerfield Partners, L.P. (“Deerfield Partners”); (ii)(A) 1,622,143 shares of common stock and (B) 1,816,446 shares of common stock issuable upon conversion of 1,816.4460 shares of Series A Common Equivalent Preferred Stock, in each case, held by Deerfield Private Design Fund III, L.P. (“DPD III”); and (iii) 20,822 shares of common stock and 58,676 shares underlying stock options held by Andrew ElBardissi which are exercisable or will become exercisable or otherwise vest within 60 days, which shares and options are held for the benefit and at the direction of Deerfield Management. The terms of the Series A Common Equivalent Preferred Stock and provisions of the warrants restrict the conversion of such shares or the exercise of such warrants, as applicable, to the extent that, upon such conversion or exercise, the number of shares of common stock then beneficially owned by the holder and its affiliates and any other person or entities with which such holder would constitute a Section 13(d) “group” would exceed 4.9% of the total number of shares of common stock then outstanding (the “Ownership Cap”). Accordingly, notwithstanding the number of shares reported, the selling stockholder disclaims beneficial ownership of the shares of common stock issuable upon conversion of the Series A Common Equivalent Preferred Stock and the exercise of such warrants to the extent that upon such conversion or exercise the number of shares beneficially owned by all reporting persons hereunder, in the aggregate, would exceed the Ownership Cap. Deerfield Mgmt, L.P. is the general partner of Deerfield Partners. Deerfield Management is the investment manager of Deerfield Partners. James E. Flynn is the sole member of the general partner of each of Deerfield Mgmt, L.P. and Deerfield Management. Each of Deerfield Mgmt, L.P., Deerfield Management and James E. Flynn may be deemed to beneficially own the securities held by Deerfield Partners. Deerfield Mgmt III, L.P. is the general partner of DPD III. Deerfield Management is the investment manager of DPD III. James E. Flynn is the sole member of the general partner of each of Deerfield Mgmt III, L.P. and Deerfield Management. Each of Deerfield Mgmt III, L.P., Deerfield Management and James E. Flynn may be deemed to beneficially own the securities held by DPD III. The address of Deerfield Partners, DPD III and Deerfield Management is c/o Deerfield Management Company, L.P., 345 Park Avenue South, 12th Floor, New York, NY 10010.
(3) Number of shares based solely on information reported on Schedule 13G filed with the SEC on November 14, 2024 by Laurence W. Lytton, reporting beneficial ownership as of September 30, 2024. According to the Schedule 13G, Laurence W. Lytton has sole investment and voting power with respect to all of such shares. The address for Laurence W. Lytton is 467 Central Park West, New York, NY 10025.
(4) Consists of (i) 35,749 shares owned directly by Mr. Mukai, (ii) 81,056 shares underlying options exercisable within 60 days of February 1, 2025 and (iii) 0 restricted stock units vesting within 60 days of February 1, 2025.
(5) Consists of (i) 155,466 shares owned directly by Mr. Roman, (ii) 0 shares underlying options exercisable within 60 days of February 1, 2025 and (iii) 0 restricted stock units vesting within 60 days of February 1, 2025.
(6) Consists of (i) 28,437 shares owned directly by Mr. Mathews, (ii) 0 shares underlying options exercisable within 60 days of February 1, 2025 and (iii) 0 restricted stock units vesting within 60 days of February 1, 2025.
(7) Consists of (i) 54,359 shares owned directly by Mr. Sohn, (ii) 0 shares underlying options exercisable within 60 days of February 1, 2025 and (iii) 0 restricted stock units vesting within 60 days of February 1, 2025.
(8) Consists of (i) 20,822 shares owned directly by Dr. Bonita and (ii) 58,676 shares underlying options exercisable within 60 days of February 1, 2025.
(9) Consists of (i) 20,822 shares owned directly by Dr. ElBardissi and (ii) 58,676 shares underlying options exercisable within 60 days of February 1, 2025, which shares and options are held for the benefit and at the direction of Deerfield Management. Dr. ElBardissi disclaims beneficial ownership of the shares of our common stock except to the extent of any pecuniary interest therein.
(10) Consists of (i) 22,400 shares owned directly by Mr. Garland and (ii) 52,100 shares underlying options exercisable within 60 days of February 1, 2025.
(11) Consists of (i) 20,972 shares owned directly by Ms. Pellegrini and (ii) 54,391 shares underlying options exercisable within 60 days of February 1, 2025.
(12) Consists of (i) 20,822 shares owned directly by Dr. Marzouk and (ii) 58,676 shares underlying options exercisable within 60 days of February 1, 2025.
(13) Consists of (i) 19,947 shares owned directly by Mr. Sheridan and (ii) 50,082 shares underlying options exercisable within 60 days of February 1, 2025.
(14) Includes 161,534 shares directly owned by our executive officers and directors, 413,657 shares underlying options exercisable within 60 days of February 1, 2025 and 0 restricted stock units vesting within 60 days of February 1, 2025

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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Item 13. Certain Relationships and Related Transactions, and Director Independence.
We describe below transactions and series of similar transactions, since January 1, 2023 or currently proposed, to which we were a party or will be a party, in which:
•the amount involved exceeds the lesser of $120,000 or 1% of the average of the Company’s total assets at year-end for the last two completed fiscal years; and
•any of our directors, director nominees, executive officers or beneficial holders of more than 5% of any class of our capital stock, or any immediate family member of the foregoing persons, had or will have a direct or indirect material interest.
Other than as described below, there have not been, nor are there any currently proposed, transactions or series of similar transactions meeting these criteria to which we have been or will be a party other than compensation arrangements, which are described where required under the sections titled “Director Compensation” and “Executive Compensation.”
2019 Credit Agreement
On May 20, 2019, we entered into a credit agreement (the “2019 Credit Agreement”) with the lenders party thereto from time to time, ORO II as origination agent and Wilmington Trust, National Association as administrative agent.
The 2019 Credit Agreement provided us with a senior term loan facility in aggregate principal amount of $70.0 million and generally bore interest at a variable rate. We recorded $5.7 million and $2.8 million in interest expense related to this debt agreement for the year ended December 31, 2021 and the six months ended June 30, 2022, respectively. As of December 31, 2021, we had $40.0 million in aggregate principal amount of long-term debt outstanding under the 2019 Credit Agreement. On June 30, 2022, we fully repaid the $40.0 million in aggregate principal amount outstanding under the 2019 Credit Agreement (see “2022 Credit Agreement” below).
The lenders under the 2019 Credit Agreement were ORO II and DPD III. Each of ORO II and DPD III, together with their respective affiliates, are holders of 5% or more of our capital stock (see “Material Relationships” below).
2022 Credit Agreement
On June 30, 2022, we entered into a new debt facility with certain the Deerfield Funds. The amended and restated credit agreement (i.e., the 2022 Credit Agreement) is for an aggregate principal amount of $35.0 million (the “Term Loan”) and amends and restates our 2019 Credit Agreement. The proceeds from the Term Loan were, among other things, used to refinance the term loan under the 2019 Credit Agreement.
The Term Loan has a five-year term and bears interest at one-month adjusted Term SOFR, with a floor of 2.50% per annum, plus 9.00% per annum (subject to increase following the occurrence of an event of default).
On August 4, 2023, we entered into Amendment No.1 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 1, the 2022 Credit Agreement was amended to decrease the amount of cash we are required to maintain pursuant to the minimum liquidity covenant in the 2022 Credit Agreement to $5,000,000 for a period of 18 months, at which point the amount required under the minimum liquidity covenant shall increase to $20,000,000 (or, if certain conditions are met, $10,000,000), in exchange for a fee paid by us.
On November 8, 2023, we entered into Amendment No. 2 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 2, the 2022 Credit Agreement was amended to, among other things: (i) adjust and increase the amortization schedule such that payments commence on June 30, 2024 and are made 12, 24 and 36 months (i.e., the scheduled maturity date) following June 30, 2024; (ii) limit the business activities we may engage in; and (iii) require us to maintain a minimum liquidity of $10,000,000 at all times, in exchange for fees paid by us.
On March 4, 2024, we entered into Amendment No. 3 to the 2022 Credit Agreement with the Deerfield Funds. Previously, on February 16, 2024, the Biotronik Parties filed a Demand against us with the American Arbitration Association (who notified us of the Demand on February 29, 2024), alleging that we breached our contractual
obligations under five agreements relating to the licensing, manufacturing, distribution and development of medical devices as a result of the wind down of our businesses. Pursuant to Amendment No. 3, Deerfield has agreed to waive any Default or Event of Default (each defined in the 2022 Credit Agreement) that has arisen or may arise in connection with the Demand. In addition, pursuant to Amendment No. 3 among other things, (i) the 2022 Credit Agreement was amended such that (x) a Change in Control (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement would not be deemed to occur in the event our common stock undergoes a Delisting and (y) exposure incurred in excess of $3.0 million in respect of proceedings in relation to the Demand and/or related proceedings and/or between such parties is deemed an Event of Default (as defined in the 2022 Credit Agreement) under the 2022 Credit Agreement.
On November 13, 2024, we entered into Amendment No. 4 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 4, the 2022 Credit Agreement was amended to (i) adjust the amortization schedule of the 2022 Credit Agreement such that the $7.5 million installment payment of principal due on June 30, 2025 would be made over three equal installments of $2.5 million on each of June 30, 2025, September 30, 2025 and December 31, 2025 and (ii) increase the exit fee associated with prepayment or repayment of the loans from 5.0% to 6.0% of the principal amount of the loans prepaid or repaid.
On January 21, 2025, we entered into Amendment No. 5 to the 2022 Credit Agreement with the Deerfield Funds. Pursuant to Amendment No. 5, the 2022 Credit Agreement was amended to allow us to effect the Deregistration and, among other things: (i) provided that the Deerfield Funds would receive a consent fee in the form of a contingent value right payable upon certain triggering events in an amount equal to the lesser of $300,000 or 5.0% of the aggregate amount of total value that would otherwise be available to our equityholders (the “Consent Fee”);
(ii) modified the financial reporting requirements under the 2022 Credit Agreement, including requiring delivery of cash flow forecasts to the Deerfield Funds; (iii) required the appointment of a Chief Restructuring Officer; and (iv) modified the negative covenants to limit our business activities and requires us to maintain minimum liquidity of $5 million.
In the fiscal year ended December 31, 2024, we recorded $5.8 million in interest expense related to the 2022 Credit Agreement. As of December 31, 2024, we had $32.5 million in aggregate principal amount of long-term debt outstanding under this debt agreement.
2022 Warrant Agreement
On June 30, 2022, in connection with entering into the 2022 Credit Agreement, we entered into a warrant purchase agreement with the Deerfield Funds, pursuant to which we issued to the Deerfield Funds warrants to purchase up to an aggregate 3,779,018 shares (the “2022 Warrant Shares”) of our common stock, par value $0.001 per share, at an exercise price of $1.1114 per 2022 Warrant Share for a period of eight years following the issuance thereof, on and subject to the terms and conditions set forth in the warrants evidencing such rights (the “Warrants”).
On March 4, 2024, we entered into an amendment (the “Amendment”) to the 2022 Warrants and 2022 Warrant Purchase Agreement with the Deerfield Funds. Pursuant to the Amendment, (i) the 2022 Warrants were amended to remove the Deerfield Funds’ option to require us to repurchase the 2022 Warrants from Deerfield upon a Delisting, and to modify the volatility rate that would be used to calculate the Black-Scholes value of the 2022 Warrants that would apply to certain other transactions involving us pursuant to the 2022 Warrants, and (ii) the Warrant Purchase Agreement was amended to remove our obligation to take all commercially reasonable actions necessary to cause our common stock to remain listed on Nasdaq at all times during the term of the 2022 Warrants.
2022 Registration Rights Agreement
On June 30, 2022, in connection with the issuance of the Warrants, we also entered into a registration rights agreement (the “Registration Rights Agreement”) with the Deerfield Funds, pursuant to which we filed a shelf registration statement on Form S-3 (the “Registration Statement”) with the SEC to register the resale of certain
securities held by the Deerfield Funds and their affiliates (the “Registrable Securities”). In addition, for a period of five years following the execution of the Registration Rights Agreement, or until all Registrable Securities are registered or no longer subject to restrictions on transfer (whichever is earlier), the Deerfield Funds will hold certain “piggy-back” registration rights with respect to registration statements filed during such period. We will generally pay all reasonable expenses incidental to its obligations and performance under the Registration Rights Agreement, other than underwriting discounts and commissions and such other charges.
Contingent Value Rights Agreement, Warrant Termination Agreement and Registration Rights Termination Agreement
In connection with entry into Amendment No. 5 and the Deregistration, we also entered into certain other agreements, including: (i) a contingent value rights agreement to provide for payment of the Consent Fee by us to the Deerfield Funds (the “Contingent Value Rights Agreement”); (ii) a warrant termination agreement to terminate (a) warrants to purchase 224,118 shares of common stock pursuant to that certain Warrant to Purchase Shares of Common Stock of the Company dated as of June 7, 2018 (the “2018 Warrants”), (b) warrants to purchase 209,996 shares of common stock pursuant to that certain Warrant dated as of May 20, 2019 (the “2019 Warrants”) and (c) warrants to purchase 3,779,018 shares of common stock pursuant to that certain Warrant to Purchase Shares of Common Stock of the Company dated June 30, 2022 (the “2022 Warrants”) for a fee equal to $250,000 in the aggregate paid by us to the Deerfield Funds (the “Warrant Termination Agreement”) and (iii) a registration rights termination agreement to terminate the registration rights agreement, dated June 30, 2022, among us and the Deerfield Funds and withdraw the registration statement on Form S-3 filed with the SEC (File No. 333-266804) in connection with the sale from time to time of our securities held by the Deerfield Funds and terminate the offer and/or sale of securities under such registration statement (the “Registration Rights Termination Agreement”).
Material Relationships
Dr. Bonita, a member of our board of directors, serves as General Partner at OrbiMed Advisors, of which certain affiliates are an initial lender under the 2019 Credit Agreement (the amounts owed thereunder being repaid in connection with the execution of the 2022 Credit Agreement) and principal stockholders of the Company.
Dr. ElBardissi, a member of our Board of Directors, is a member of the private transaction team of Deerfield Management, of which certain affiliates are an initial lender under the 2019 Credit Agreement (the amounts owed thereunder being repaid in connection with the execution of the 2022 Credit Agreement), lenders under the 2022 Credit Agreement, parties to the Contingent Value Rights Agreement, Warrant Termination Agreement and Registration Rights Termination Agreement, and principal stockholders of the Company.
Consulting Agreements
On December 2, 2024, Mr. Mukai entered into a Consulting Agreement with the Company, which will become effective February 1, 2025. Pursuant to the Consulting Agreement, Mr. Mukai agreed to provide all reasonable assistance to the Company with respect to the role of the Company’s Chief Executive Officer and Chief Financial Officer and will receive compensation equal to $10,000 per month, for up to 40 hours of services in the applicable month.
On December 2, 2024, Mr. Hollister entered into a Consulting Agreement with the Company, which will become effective April 1, 2025. Pursuant to the Consulting Agreement, Mr. Hollister agreed to provide all reasonable assistance to the Company with respect to the role of the Company’s Secretary and will receive compensation equal to $200 per hour.
Director and Officer Indemnification
We have entered into an indemnification agreement with each of our directors and executive officers. These indemnification agreements and our amended and restated certificate of incorporation and bylaws indemnify each of our directors and executive officers to the fullest extent permitted by the Delaware General Corporation Law.
Equity Grants to Executive Officers and Directors
We have granted options to our NEOs and certain of our non-employee directors as more fully described in the sections titled “Director Compensation” and “Executive Compensation.”
Policies and Procedures for Related Party Transactions
Our board of directors adopted a written related party transaction policy in connection with our initial public offering, setting forth the policies and procedures for the review and approval or ratification of related party transactions. This policy covers any transaction, arrangement or relationship or any series of similar transactions, arrangements or relationships, in which we were or are to be a participant and a related party had or will have a direct or indirect material interest, as determined by the Audit Committee of our board of directors, including, without limitation, purchases of goods or services by or from the related party or entities in which the related party has a material interest, and indebtedness, guarantees of indebtedness or employment by us of a related party.
Transactions described in this section entered into during our fiscal year ended December 31, 2024 and December 31, 2023 were reviewed and approved pursuant to these policies and procedures. Certain other related party transactions described in this section occurred prior to adoption of this policy and as such, these transactions were not subject to the approval and review procedures set forth in the policy. However, these transactions were reviewed and approved by our board of directors.
Director Independence
The board of directors conducts an annual review to verify director independence. As a result of its most recent review, the Board has determined that the following directors are independent, as defined in the listing standards of the Nasdaq: David Bonita, M.D.; Andrew ElBardissi, M.D.; Jason Garland; Niamh Pellegrini; Shaden Marzouk, M.D.; and John Sheridan. None of the independent directors, to the Company’s knowledge, has any business,
financial, familial or other type of relationship with the Company or its management that would impact the director’s ability to exercise independent judgment.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Item 14. Principal Accountant Fees and Services.
On April 12, 2024, the board of directors selected and approved of KPMG as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2024. KPMG has served as our independent registered public accounting firm since 2015.
Independent Registered Public Accounting Firm
The following is a summary of the fees and services provided by KPMG to the Company for fiscal years 2024 and 2023:
Fiscal Year Ended December 31,
Description of Services Provided by KPMG
Audit Fees(1)
$
630,000 $
991,271
Audit-Related Fees
$
- $
-
Tax Fees(2)
$
144,020 $
350,136
All Other Fees
$
- $
-
]
TOTAL
$
774,020 $
1,341,407
(1)
Audit fees for KPMG for 2024 and 2023 were for professional services rendered for the audits of our financial statements, review of interim financial statements, assistance with registration statements filed with the SEC and services that are normally provided by KPMG in connection with statutory and regulatory filings or engagements.
(2)
Tax fees for KPMG for 2024 and 2023 were for tax advice and compliance.
The Audit Committee or delegate thereof pre-approves the scope of the audit, audit-related and tax services provided by our independent registered public accounting firm, as well as all associated fees and terms, pursuant to pre-approval policies and procedures established by the Audit Committee. The Audit Committee evaluates the independent registered public accounting firm’s qualifications, performance and independence, and presents its conclusions to the full Board on at least an annual basis.
All of the services provided by KPMG for fiscal years 2024 and 2023, and fees for such services, were pre-approved by the Audit Committee in accordance with these standards.
PART IV

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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
Item 15. Exhibits, Financial Statement Schedules.
1. The following consolidated financial statements of Acutus Medical, Inc. included in Item 8 are filed as part of this Annual Report on Form 10-K:
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 2024 and 2023
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2024 and 2023
Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2024 and 2023
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
Notes to the Consolidated Financial Statements for the Years Ended December 31, 2024 and 2023
2. Financial Statement Schedule: All schedules have been omitted because they are not required or because the required information is given in the consolidated financial statements or notes thereto.
3. Exhibits: The exhibits listed in the accompanying index to exhibits are filed or incorporated by reference as part of this Annual Report on Form 10-K.
Exhibit Index
Exhibit
Number
Description Incorporation by Reference
Form File No. Exhibit Filing Date
2.1+ Acquisition Agreement, dated May 31, 2019, among the Registrant, Rhythm Xience, Inc., the sellers listed on Schedule I thereto and Harold Wodlinger, as the Sellers’ Agent
S-1 333-239873 2.1 July 15, 2020
2.2+ Asset Purchase Agreement dated April 26, 2022, by and among Medtronic, Inc. and the Registrant
8-K 001-39430 2.1 April 27, 2022
3.1 Amended and Restated Certificate of Incorporation of the Registrant
8-K 001-39430 3.1 August 10, 2020
3.2 Amended and Restated Bylaws of the Registrant
8-K 001-39430 3.2 August 10, 2020
3.3 Certificate of Designation of Preferences, Rights and Limitations of the Series A Common Equivalent Preferred Stock, par value $0.001 per share, of the Registrant.
8-K 001-39430 3.1 August 23, 2021
4.1 Specimen Common Stock Certificate of the Registrant
S-1/A 333-239873 4.2 July 30, 2020
4.2+ Amended and Restated Investors’ Rights Agreement, dated June 12, 2019, among the Registrant and certain of its stockholders
S-1 333-239873 4.1 July 15, 2020
4.3* Description of the Registrant’s Securities
4.4+ Form of warrant to purchase common stock dated January 30, 2015, issued by the Registrant to various parties, together with a schedule of material differences
S-1 333-239873 4.3 July 15, 2020
4.5+ Form of warrant to purchase convertible preferred stock, dated June 7, 2018, issued by the Registrant to various parties, together with a schedule of material differences
S-1 333-239873 4.4 July 15, 2020
4.6+ Form of warrant to purchase convertible preferred stock, dated July 31, 2018, issued by the Registrant to various parties, together with a schedule of material differences
S-1 333-239873 4.5 July 15, 2020
4.7+ Form of warrant to purchase convertible preferred stock, dated May 20, 2019, issued by the Registrant to various parties, together with a schedule of material differences
S-1 333-239873 4.6 July 15, 2020
4.8+ Form of Warrant for the issuance of warrants dated June 30, 2022
8-K 001-39430 10.3 July 1, 2022
10.1+ Amended and Restated Credit Agreement dated June 30, 2022, by and among the Registrant, the lenders from time to time party thereto, Wilmington Trust, National Association, as Administrative Agent
8-K 001-39430 10.1 July 1, 2022
10.2 Amendment No. 1 to Amended and Restated Credit Agreement, dated as of August 4, 2023, by and between the Registrant and the Lenders party thereto
10-Q 001-39430 10.1 August 7, 2023
10.3 Amendment No. 2 to Existing Credit Agreement dated as of November 8, 2023, by and among the Company and the Lenders party thereto, and acknowledged by Wilmington Trust, National Association, as Administrative Agent
8-K 001-39430 10.1 November 13, 2023
10.4 Waiver and Amendment No. 3 to Amended and Restated Credit Agreement and Amendment to Lender Warrants and Warrant Purchase Agreement
8-K 001-39430 10.1 March 5, 2024
10.5+ Warrant Purchase Agreement dated June 30, 2022, by and among the Registrant and the purchasers named therein
8-K 001-39430 10.2 July 1, 2022
10.6+ Registration Rights Agreement dated June 30, 2022, by and among the Registrant, Deerfield Partners, L.P. and Deerfield Private Design Fund III
8-K 001-39430 10.4 July 1, 2022
10.7+ License and Distribution Agreement, dated July 2, 2019, among the Registrant, Biotronik SE & Co. KG and VascoMed GmbH
S-1 333-239873 10.3 July 15, 2020
10.8+ License Agreement, dated May 10, 2011, between the Registrant and Dr. Christoph Scharf
S-1 333-239873 10.6 July 15, 2020
10.9 First Amendment to License Agreement, dated September 30, 2011, between the Registrant and Dr. Christoph Scharf
S-1 333-239873 10.7 July 15, 2020
10.10+ Master License Agreement, dated March 11, 2014, between the Registrant and Biotectix, LLC
S-1 333-239873 10.8 July 15, 2020
10.11+ Exclusive Patent License Agreement, dated April 21, 2014, between the Registrant and Regents of the University of Minnesota
S-1 333-239873 10.9 July 15, 2020
10.12 First Amendment to Exclusive Patent License Agreement, dated October 20, 2014, between the Registrant and Regents of the University of Minnesota
S-1 333-239873 10.10 July 15, 2020
10.13+ Distribution Agreement, dated June 30, 2022, among the Registrant and Medtronic, Inc.
8-K 001-39430 10.1 December 5, 2022
10.14+ Lease Agreement, dated January 22, 2015, as amended, between the Registrant and Carlsbad 2210, LLC
S-1 333-239873 10.11 July 15, 2020
10.15† Form of Indemnification Agreement between the Registrant and each of its directors and executive officers
S-1 333-239873 10.12 July 15, 2020
10.16† 2011 Equity Incentive Plan, as amended, and forms of agreement thereunder
S-1 333-239873 10.13 July 15, 2020
10.17† 2020 Equity Incentive Plan and forms of agreement thereunder
S-1/A 333-239873 10.14 July 30, 2020
10.18† Executive Incentive Compensation Plan
S-1 333-239873 10.16 July 15, 2020
10.19† Employment Agreement between Registrant and David Roman
10-K 001-39430 10.22 March 19, 2021
10.20† Amendment No. 1 to Employment Agreement by and between Registrant and David Roman, dated July 20, 2022
8-K 001-39430 10.1 July 21, 2022
10.21† Consulting Agreement between the Registrant and David Roman
8-K 001-39430 10.1 January 11, 2024
10.22† Employment Agreement by and between Registrant and Takeo Mukai, dated January 9, 2023
8-K 001-39430 10.1 January 9, 2023
10.23† Employment Agreement by and between Registrant and Tom Sohn, dated August 5, 2020
10-Q 001-39430 10.1 May 11, 2023
10.24† Employment Agreement by and between Registrant and Kevin Matthews, dated May 1, 2022
10-Q 001-39430 10.3 May 11, 2023
10.25+ Limited Consent dated April 26, 2022, by and between Registrant, the lenders party to the Credit Agreement and Wilmington Trust, National Association, as Administrative Agent
8-K 001-39430 10.1 April 27, 2022
10.26 Commitment Letter dated April 26, 2022, by and between Registrant and the Commitment Parties
8-K 001-39430 10.2 April 27, 2022
10.27+ Exchange Agreement, dated as of August 23, 2021, by and among the Registrant, Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P.
8-K 001-39430 10.1 August 23, 2021
10.28+ Exchange Agreement, dated as of August 23, 2021, by and among the Registrant, OrbiMed Private Investments IV, LP and OrbiMed Royalty Opportunities II, LP
8-K 001-39430 10.2 August 23, 2021
10.29 Feasibility and Development Agreement, by and between Biotronik SE & Co. KG and Registrant
S-1 333-257844 10.24 July 12, 2021
10.30 2022 Inducement Equity Plan and forms of agreement thereunder
S-8 333-264004 99.1 March 31, 2022
10.31 Settlement Agreement and Release, dated October 15, 2024, by and among the Biotronik Parties and the Registrant
8-K
001-39430
10.1
October 17, 2024
10.32
Consulting Agreement between the Registrant and Takeo Mukai
8-K
001-39430
10.1
December 4, 2024
10.33† Amendment No. 4 to Amended and Restated Credit Agreement, dated as of November 13, 2024, by and among the Registration and the Lenders party
8-K
001-39430
10.1
November 15, 2024
10.34
Amendment No. 5 to the Amended and Restated Credit Agreement, dated as of January 21, 2025, by and among the Registrant and the Deerfield Funds
8-K
001-39430
10.1
January 21, 2025
10.35
Contingent Value Rights Agreement, dated as of January 21, 2025, by and among the Registrant and the Deerfield Funds
8-K
001-39430
10.2
January 21, 2025
10.36
Warrant Termination Agreement, dated as of January 21, 2025, by and among the Registrant and the Deerfield Funds
8-K
001-39430
10.3
January 21, 2025
10.37
Registration Rights Termination Agreement, dated as of January 21, 2025, by and among the Registrant and the Deerfield Funds
8-K
001-39430
10.4
January 21, 2025
19.1*
Insider Trading Policy
21.1* Subsidiaries of the Registrant
24.1* Power of Attorney (included on signature page)
31.1* Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2* Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1** Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2** Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97.1* Acutus Medical, Inc. Compensation Recoupment Policy
101.INS XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
101.LAB XBRL Taxonomy Extension Label Linkbase Document
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
104* Cover Page Interactive Data File (formatted as iXBRL with applicable taxonomy extension information contained in Exhibit 101)
________________________________
* Filed herewith.
** These certifications are being furnished solely to accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of Acutus Medical, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
† Indicates management contract or compensatory plan.
+ The schedules and exhibits to the exhibited agreements have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. The Company will furnish copies of any such schedules and exhibits to the SEC upon request.