# EDGAR Filing Document

**Accession Number:** 0001407973
**File Stem:** 0000950170-23-000393
**Filing Date:** 2023-1
**Character Count:** 25159
**Document Hash:** ed232549c756dba90a53abdce61a6fe9
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-23-000393.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0000950170-23-000393

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 37

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Sonendo, Inc.
- **CENTRAL INDEX KEY:** 0001407973
- **STANDARD INDUSTRIAL CLASSIFICATION:** DENTAL EQUIPMENT & SUPPLIES [3843]
- **IRS NUMBER:** 205041718
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40988
- **FILM NUMBER:** 23516391

**BUSINESS ADDRESS:**
- **STREET 1:** 26061 MERIT CIRCLE
- **STREET 2:** SUITE 101
- **CITY:** Laguna Hills
- **STATE:** CA
- **ZIP:** 92653
- **BUSINESS PHONE:** (949) 766-3636

**MAIL ADDRESS:**
- **STREET 1:** 26061 MERIT CIRCLE
- **STREET 2:** SUITE 101
- **CITY:** Laguna Hills
- **STATE:** CA
- **ZIP:** 92653

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Dentatek CORP
- **DATE OF NAME CHANGE:** 20070726

?xml version="1.0" encoding="ASCII"? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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**FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** January 09, 2023<br>

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Sonendo, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-40988 | 20-5041718 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 26061 Merit Circle, Suite 102 |  |  |
| Laguna Hills**,** California |  | 92653 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (949) 766-3636<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, par value $0.001 per share | SONX | New York Stock Exchange |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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**Item 2.02 Results of Operations and Financial Condition.**

Sonendo, Inc. (the "Company") intends to participate in certain investor meetings during the week of January 9, 2023, at which the Company will discuss its business and strategy, and expects to affirm its prior guidance for fiscal year 2022, as set forth below.

As previously disclosed, the Company expects full year 2022 total revenue to be in the range of $40.5 million to $42.5 million, representing annual growth between 22% and 28%.

The financial guidance provided by the Company is based on information available to the Company as of January 9, 2023 and is subject to completion of the Company's year-end financial closing procedures and audit by the Company's independent registered public accounting firm, which have not yet been performed. These customary closing procedures could cause actual results to differ materially from management's guidance. You are cautioned not to rely on management's guidance being achieved when making an investment decision in the Company's securities. The Company expects to publish its financial results for the fiscal year ended December 31, 2022 in March 2023.

**Item 7.01 Regulation FD Disclosure.**

A copy of the presentation to be used during the investor meetings is attached hereto as Exhibit 99.1 and is incorporated herein by reference. From time to time after the date of this Current Report on Form 8-K, the Company may use the presentation with investors, analysts and others.

The presentation materials will be available online on the Company's corporate website at www.sonendo.com under the "Investor Relations – Latest Events & Presentation" section.

The information contained in Items 2.02 and 7.01 and Exhibit 99.1 hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

**Forward Looking Statements**

In addition to background and historical information, this Current Report on Form 8-K contains "forward-looking statements" based on the Company's current expectations, forecasts and beliefs, including the Company's expectations with respect to financial information for fiscal year 2022. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including risks related to the preliminary nature of the Company's fiscal year 2022 financial information, which is subject to completion of the Company's year-end closing procedures, and other risks and uncertainties described more fully in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) on March 23, 2022 under the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation", as well as any reports that we may file with the SEC in the future. Forward-looking statements contained in this report are based on information available to the Company as of the date hereof. The Company undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of the Company.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [<u>Sonendo, Inc. presentation dated January 9, 2023</u>](sonx-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | SONENDO, INC. |
| Date: | January 9, 2023. | By:  | /s/ Bjarne Bergheim |
|  |  |  | Bjarne Bergheim<br>President and Chief Executive Officer |

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## Exhibit 99.1

![Slide 1](sonx-ex99_1s1.jpg)

Sonendo Overview January 2023

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![Slide 2](sonx-ex99_1s2.jpg)

Disclaimer and Confidentiality Notice This presentation contains forward-looking statements with respect to the Company. These forward-looking statements, by their nature, require the Company to make certain assumptions and necessarily involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these forward-looking statements, including without limitation the successful and timely completion and the commercialization of the products referred to herein, addressable markets, entering other markets and any plans and objectives of management for future operations and future results. Forward-looking statements are not guarantees of performance. These forward-looking statements, including financial outlooks and strategies or deliverables stated herein, may involve, but are not limited to, comments with respect to the Company's business or financial objectives, its strategies or future actions, its targets, expectations for financial condition or outlook for operations. Words such as "may", "will", "would", "could", "expect", "believe", "plan", "anticipate", "intend", "estimate", "continue", or the negative or comparable terminology, as well as terms usually used in the future and conditional, are intended to identify forward-looking statements. Information contained in forward-looking statements is based upon certain material assumptions that were applied in drawing a conclusion or making a forecast or projection, including perceptions of historical trends, current conditions and expected future developments, as well as other considerations that are believed to be appropriate in the circumstances. These assumptions are considered to be reasonable based on currently available information, but the reader is cautioned that these assumptions regarding future events, many of which are beyond its control, may ultimately prove to be incorrect since they are subject to risks and uncertainties that affect the Company and its business. The forward-looking information set forth therein reflects expectations as of the date hereof and is subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Undue reliance should not be placed on forward-looking statements. We operate in a very competitive and rapidly changing environment. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances described in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements contained in this presentation. The forward-looking statements contained in this presentation are expressly qualified by this cautionary statement. Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys, and other data obtained from third party sources and Sonendo's own internal estimates and research. While Sonendo believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy, or completeness of, any information obtained from third party sources. While Sonendo believes its internal research is reliable, such research has not been verified by any independent source. Sonendo's estimates are derived from publicly available information, management's knowledge of the Sonendo's industry and management's assumptions based on such information and knowledge, which they believe to be reasonable. This data involves a number of assumptions and limitations which are necessarily subject to a high degree of uncertainty and risk due to a variety of factors. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy our securities. All amounts are in U.S. dollars unless otherwise indicated.

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![Slide 3](sonx-ex99_1s3.jpg)

OUR MISSION Saving Teeth. Improving Lives. WHAT THIS MEANS Establish the GentleWave procedure as the standard of care for tooth decay, with an initial focus on transforming root canal therapy.

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![Slide 4](sonx-ex99_1s4.jpg)

Introducing the Team Strong and Experienced Leadership Team MichaelWatts Chief FinancialOfficer MichaelSmith Chief CommercialOfficer AndrewKirkpatrick Chief OperatingOfficer BjarneBergheim President& CEO RoyChen Chief TalentOfficer

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![Slide 5](sonx-ex99_1s5.jpg)

Paradigm-Shifting Platform Technology for Tooth Decay 1 Large Market Opportunity with Significant Need for Innovation 2 Compelling and Growing Body of Clinical and Real-World Evidence 3 Attractive Value Proposition for Dental Practitioners and Patients 4 Transformative R&D Capabilities and a Robust Intellectual Property Portfolio 5 Established and Growing Digital Infrastructure 6 Recurring Revenue Business Model 7 Key Success Factors for Sonendo

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![Slide 6](sonx-ex99_1s6.jpg)

Large Market for Root Canal Therapy (RCT) ~17M Root Canal Procedures Performed Annually in the U.S. and Canada Global prevalence of additional 30+ million procedures annually outside of the U.S. and Canada $1.9 Billion Endodontists (~5,000) Non-Referring General Practitioners (GPs) (~50,000) Remaining GeneralPractitioners (GPs) (~126,000) Sonendo's Potential Annual Addressable Market Opportunity for Root Canal Procedures in the U.S. and Canada ~4M Annual Root Canal Procedures ~9M Annual Root Canal Procedures ~4M Annual Root Canal Procedures

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![Slide 7](sonx-ex99_1s7.jpg)

Unique for each person, root and tooth Exhibit unpredictable three-dimensional curvature Include branches and connections between canals May bifurcate into multiple canals or converge into one canal The Root Canal System is Complex Root canals are complex… …making them difficult toeffectively and efficiently clean Endodontic Biofilm Root Canal Dentin Dentin Bacteria are smaller than anatomical features in the tooth Canals are increasingly complicated in hardest to reach areas Bacteria penetrates the microscopic spaces in the root canal system The Problem

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![Slide 8](sonx-ex99_1s8.jpg)

Limitations in Clinical Outcomes Limitations in Clinical Workflow Ng YL. et al. Outcome of primary root canal treatment: systematic review of the literature -part 1. Effects of study characteristics on probability of success. Int Endod J. 2007; 40(12):921-39. POOR CLINICAL OUTCOMES, EXPERIENCES RCT treatment failure ranges from 15% to 32%1 29% to 70% of patients report post-operative pain LACK OF STANDARDIZED PROTOCOLS Lack of standardized protocols for most critical steps of RCT Contributes to unpredictable procedure times and outcomes INEFFECTIVE CLEANING Files only touch 35% to 65% of the surface of the root canal >74% of canals show signs of residual tissue and bacteria EXTENSIVE USE OF INSTRUMENTATION Weakens tooth and impacts long-term survival Increases likelihood of procedural errors and other complications COMPLEX PROCEDURE Difficult procedure relies heavily on clinician skills Uses aerosol-generating devices NEED FOR MULTIPLE VISITS Approximately half of root canal procedures require multiple visits Causes patient inconvenience and impacts practice economics Limitations of Conventional RCT

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![Slide 9](sonx-ex99_1s9.jpg)

First and only FDA-cleared system for RCT that employs a sterilized, single-use procedure instrument to automate the cleaning of root canals Superior cleaning and disinfection of microscopic spaces independent of root canal complexity and tooth structure Intuitive touchscreen interface simplifies procedure setup and treatment delivery Wireless connectivity capabilities enables automatic software updates, remote monitoring of the system and real-time tracking of system utilization GentleWave System: Transforming RCT

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![Slide 10](sonx-ex99_1s10.jpg)

Conventional Root Canal Therapy GentleWave Procedure Mechanism of Action Produces Tissue Dissolution Throughout the Root Canal System GentleWave System: Proprietary Mechanism of Action Degassing 1 Concentration Adjustments 2 Broad-Spectrum Acoustic Energy 3 Advanced Fluid Dynamics 4 Gen3 System

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![Slide 11](sonx-ex99_1s11.jpg)

GentleWave System: Proprietary Mechanism of Action

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![Slide 12](sonx-ex99_1s12.jpg)

Conventional RCT GentleWave Procedure VS GentleWave Procedure Enables Superior Cleaning

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![Slide 13](sonx-ex99_1s13.jpg)

Clinical and Commercial Validation of the GentleWave Procedure Strong Clinical Outcomes & Superior Cleaning in a Less Invasive Procedure Enhanced Procedure Efficiency + In-Vivo and In-Vitro in… In Real-World, Clinical Practice with… 2 Prospective, Multi-Center Clinical Studies 30+ Peer-Reviewed Journal Publications 900K+ Patients Treated with the GentleWave System ~935 GentleWave System Installed Base The clinical benefits of the GentleWave system have been demonstrated… …and has been clinically proven to provide…

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![Slide 14](sonx-ex99_1s14.jpg)

Strong Clinical Outcomes PURE Study: Single-Arm, Multi-Center, Prospective, Non-Significant Risk Clinical Study Note: Data for GentleWave and conventional RCT is from separate studies. Clinical data is not head-to-head. Ng YL. et al. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007; 40(12):921-39. Sigurdsson A, Garland RW, Le KT, Woo SM. 12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. J Endod. 2016; 42(7):1040-8. Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009;3(4):273-9. Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013;4(1):152-5. Wong AW, Zhang S, Li SK, Zhu X, Zhang C, Chu CH. Incidence of post-obturation pain after single-visit versus multiple-visit non-surgical endodontic treatments. BMC Oral Health. 2015;15:96. High and Rapid Rates of Healing1 Minimal to No Post-Operative Pain2,3,4,5 GentleWave Procedure: 97% Success Rate Conventional RCT: Estimated 68-85% Success Rate GentleWave Procedure: Minimal to No Post-Op Pain Conventional RCT: 29-70% of Patients Report Post-Op Pain GentleWave Ince Gambarini Wong 68%-85% Range

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![Slide 15](sonx-ex99_1s15.jpg)

Enhanced Procedure Efficiency Proven, Real-World Results Supported by Clinical Studies and Commercial Experience GentleWave Procedure Customer Survey1 Clinical Study Results Includes data from Sonendo's GentleWave Procedure customer survey conducted in October 2020 (n=33) where users were polled about percent of single-visit RCT cases and impact on per patient file costs before/after adopting the GentleWave System Sigurdsson A, Garland RW, Le KT, Woo SM. 12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. J Endod. 2016; 42(7):1040-8. Sigurdsson A, Garland RW, Le KT & Rassoulian SA. Healing of Periapical Lesions After Endodontic Treatment with the GentleWave Procedure: A Prospective Multicenter Clinical Study. Journal of Endodontics. 2018;44(3):510-517. 92% 89% Patients Treated in a Single Visit Using the GentleWave System2 Patients with Periapical Lesions Treated in a Single Visit Using the GentleWave System3 Before After Total Single Visit Procedures BEFORE / AFTER GentleWave 41% Reduction in File Cost/Usage with GentleWave 90% 57% C-Shaped Canal Retreatment Calcified Canal Sinus Tract 94% 89% 93% 92% 45% 40% 66% 59% +

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![Slide 16](sonx-ex99_1s16.jpg)

U.S. and Canada Commercial Strategy Establishing the GentleWave Procedure as the Standard of Care for RCT Increase GentleWave Procedure Utilization Grow GentleWave Installed Base Drive Patients to GentleWave Providers How? Increase Referrals Targeted Direct-to-Patient Marketing Increase Awareness and Education Increase Team of Capital Sales Reps to Drive GentleWave Console Sales Expand Team of Consumable Sales Reps to Drive Utilization Partner with Clinicians Core Pillars of Sonendo'sCommercial Strategy 1 3 2

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![Slide 17](sonx-ex99_1s17.jpg)

How We Structure Our Sales Team KEY RESPONSIBILITIES Increase utilization in existing GentleWave practices Onboarding, clinical education and training Improve practice efficiency Drive patient referral volumes CONSUMABLESALES REP Drive Account Utilization KEY RESPONSIBILITIES Win new business Establish customer relationships Target key opportunities Focus on GentleWave Console placements Grow installed base of GentleWave Consoles CAPITALSALES REP Increase Market Penetration

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![Slide 18](sonx-ex99_1s18.jpg)

CleanFlow PI Our Next Generation Procedure Instrument TM CONFIDENTIAL

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![Slide 19](sonx-ex99_1s19.jpg)

Molar PI CleanFlow PI CleanFlow Procedure Instrument: Driving Procedure Simplicity Cleans inside of tooth from outside Reduces procedure steps Easier and less technique-sensitive Confidence to use on more cases Fewer parts and easier to assemble Improved customer utilization Easier to teach procedure Expect to have positive impact on gross margins of single-use PIs Positive clinical and usability feedback Fully commercialized April 2022 Expected future expansion of indications Simplified & Intuitive Value for Sonendo Commercial Status No components placed inside tooth CLEANFLOW PROCEDURE INSTRUMENT

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![Slide 20](sonx-ex99_1s20.jpg)

DESIGNED FOR OPTIMIZED PERFORMANCE REFINED FOR A SIMPLIFIED WORKFLOW ENHANCED TO DELIVER AN ELEVATED EXPERIENCE Geared to support future software and evolving features Expanded Connectivity with both 2.4 and 5Ghz Wi-Fi compatibility Thermo-Electric Cooler enables system to operate over wider temperature environment 1 prime per 6 procedures reduces system preparation time between procedures Battery backup decreases downtime between procedures High-capacity reservoirs allow up to six treatments before refilling procedure fluids Multi-operatory connectivity communicates real-time status of your GentleWave G4 Systems to enable concurrent procedures and oversight for improved efficiency Intuitive, user-friendly interface provides step-by-step guidance through the procedure Auditory cues improve procedure awareness without looking at the screen Ergonomic handles, accessory basket, and large wheels make transport between operatories simple User replaceable parts improve console up-time

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![Slide 21](sonx-ex99_1s21.jpg)

Our Key Growth Strategies Focused on Driving Long-Term, Sustainable Growth Strategy Execute U.S.and Canada Commercial Strategy Reduce Costs and Improve Production Efficiencies Investin R&DInitiatives Expand into InternationalMarkets Key Elements Expand sales and marketing teams Grow installed base Increase utilization Drive patients to providers Launch CleanFlow Realize operating leverage Implement lean manufacturing methods Reduce material costs Enhance usability, efficiency and predictability Perform additional elements of the root canal procedure Expand beyond RCT to treat cavities Pursue regulatory approvals and related certifications Engage in market access initiatives in attractive international markets

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![Slide 22](sonx-ex99_1s22.jpg)

Financial Highlights Installed Base ~935 Consoles Placed Revenue Sales Territories 25 (Covering US and Canada) (3) As of September 30, 2022 2 $40.5M – $42.5M $33.2M $23.4M 3 (1) 2022 financial guidance issued on November 9, 2022 (2) Implied growth at the mid-point of guidance +25% +42% 3 1

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![Slide 23](sonx-ex99_1s23.jpg)

Paradigm-Shifting Platform Technology for Tooth Decay 1 Large Market Opportunity with Significant Need for Innovation 2 Compelling and Growing Body of Clinical and Real-World Evidence 3 Attractive Value Proposition for Dental Practitioners and Patients 4 Transformative R&D Capabilities and a Robust Intellectual Property Portfolio 5 Established and Growing Digital Infrastructure 6 Recurring Revenue Business Model 7 Key Success Factors for Sonendo

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![Slide 24](sonx-ex99_1s24.jpg)

THANK YOU