# EDGAR Filing Document

**Accession Number:** 0000898437
**File Stem:** 0001171843-25-007003
**Filing Date:** 2025-11
**Character Count:** 41846
**Document Hash:** 07a1c2ada17523f050fca7a8ab6378fa
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-25-007003.hdr.sgml**: 20251105

**ACCESSION NUMBER**: 0001171843-25-007003

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20251105

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

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251105

**DATE AS OF CHANGE**: 20251105

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Anika Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0000898437
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 043145961
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-14027
- **FILM NUMBER:** 251451767

**BUSINESS ADDRESS:**
- **STREET 1:** 32 WIGGINS AVENUE
- **CITY:** BEDFORD
- **STATE:** MA
- **ZIP:** 01730
- **BUSINESS PHONE:** (781) 457-9000

**MAIL ADDRESS:**
- **STREET 1:** 32 WIGGINS AVENUE
- **CITY:** BEDFORD
- **STATE:** MA
- **ZIP:** 01730

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ANIKA THERAPEUTICS INC
- **DATE OF NAME CHANGE:** 19970114

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ANIKA RESEARCH INC
- **DATE OF NAME CHANGE:** 19930309

?xml version='1.0' encoding='ASCII'? Form 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

### Washington, D.C. 20549
_________________

### FORM 8-K
_________________

#### CURRENT REPORT

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

#### Date of Report (Date of earliest event reported): November 5, 2025
_______________________________

#### Anika Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

_______________________________

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-14027** | **04-3145961** |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |

---

#### 32 Wiggins Avenue

#### Bedford, Massachusetts 01730
(Address of Principal Executive Offices) (Zip Code)

(781) 457-9000

(Registrant's telephone number, including area code)

#### Not Applicable
(Former name or former address, if changed since last report)

_______________________________

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:

---

| | |
|:---|:---|
| Title of each class | Name of each exchange on which registered |
| Common Stock, par value $0.01 per share ANIK | NASDAQ Global Select Market |

---

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. ☐

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

The following information, including the exhibit attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

On November 5, 2025, Anika Therapeutics, Inc. ("Anika") issued a press release announcing its financial results for the third quarter ended September 30, 2025. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

**Item 8.01. Other Events.**

On November 5, 2025, Anika also issued a press release announcing that it filed the third and final module of its Premarket Approval application for Hyalofast, its resorbable, hyaluronic acid-based scaffold used with autologous bone marrow aspirate concentrate for treating articular cartilage defects in the knee, and reporting results from its U.S. pivotal Phase III FastTRACK clinical trial evaluating Hyalofast (the "Press Release"). A copy of the Press Release is attached hereto as Exhibit 99.2 and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

**Item 9.01. Financial Statements and Exhibits.**

***(d) Exhibits.***

---

| | |
|:---|:---|
| **<u>Exhibit Number</u>** | **<u>Description</u>** |
| [99.1](exh_991.htm) | [Press Release of Anika Therapeutics, Inc. dated November 5, 2025, furnished herewith.](exh_991.htm) |
| [99.2](exh_992.htm) | [Press Release of Anika Therapeutics, Inc. dated November 5, 2025, filed herewith.](exh_992.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

#### SIGNATURE
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.

---

| | | |
|:---|:---|:---|
|  | **Anika Therapeutics, Inc.** | **Anika Therapeutics, Inc.** |
| Date: November 5, 2025 | By: | <u>/s/ Cheryl R. Blanchard&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  |  | Cheryl R. Blanchard |
|  |  | President and Chief Executive Officer |

---

## Exhibit 99.1

**EXHIBIT 99.1**

**Anika Reports Third Quarter 2025 Financial Results**

*Commercial Channel revenue up 22% with continued strong Integrity*<sup>*™*</sup> *Implant System and Hyalofast<sup>®</sup> growth, and double-digit International OA Pain Management growth*

*Third and final Hyalofast PMA module filed and data released*

*Cingal<sup>®</sup> achieved commercial milestone of more than one million injections worldwide since 2016*

*Reaffirming Fiscal 2025 guidance and long-term outlook and commencing a $15 million 10b5-1 share repurchase*

BEDFORD, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (Nasdaq: ANIK), a global leader in the osteoarthritis ("OA") pain management and regenerative solutions spaces focused on early intervention orthopedics, today announced financial results for the third quarter ended September 30, 2025.

**Third Quarter 2025 Results**

Anika reported third quarter revenue from continuing operations of $27.8 million, a 6% decrease compared to the same period in 2024. Commercial Channel revenue increased 22% year over year, while OEM Channel revenue, which includes U.S. OA Pain Management, was down 20% in line with expectations. The OEM Channel decline was driven by lower U.S. pricing for Monovisc<sup>®</sup> and Orthovisc<sup>®</sup>, sold by our commercial partner, Johnson & Johnson MedTech.

Cheryl Blanchard, President and CEO of Anika Therapeutics, commented: "We continue to see strength in our Commercial Channel with Regenerative Solutions revenue increasing 25% in the quarter driven by Integrity's outperformance, continued strong international Hyalofast growth, and double-digit International OA Pain Management revenue growth. Third quarter pricing for U.S. OA Pain Management products was in line with expectations, and we anticipate the full year to be in line with our prior guidance. In addition, J&J MedTech has exercised its option to continue our license and supply agreement for Monovisc for another 5-year term through December 2031. During the quarter, Cingal reached a significant commercial milestone, surpassing 1 million injections globally since launch. Finally, we continued to take actions to improve our operating expense profile, with Selling, General and Administrative expenses down 12% year over year, and overall operating expenses down 3%, as we continue to work to improve our profitability and free cash flow."

**Strong Integrity Commercial Performance** 

Integrity procedures grew for the sixth consecutive quarter and continues to outpace the overall growth of the U.S. soft tissue augmentation market. The strong growth keeps Integrity on pace to more than double procedures and revenue in 2025 compared to 2024. The recently cleared larger shapes and sizes of the Integrity Implant System, tailored for Achilles repair in the foot and other large tendon applications in the knee and hip, entered limited release with first sales and cases completed during the quarter. These additions are expected to accelerate adoption and support sustained commercial momentum into 2026.

**Double Digit Growth in International OA Pain Management**

Anika's International Sales organization continues to be a strong contributor to overall performance, delivering third-quarter revenue growth of 21% year over year. This increase was primarily driven by the timing of distributor orders. Year-to-date revenue is up 6%, reflecting solid growth in both Cingal and Orthovisc, partially offset by delayed Monovisc orders stemming from earlier production-related challenges. International Sales remains a key driver of our revenue strength, as we expand market share in established regions and accelerate growth in new markets with our current product portfolio.

**Hyalofast PMA Submission Filed and Clinical Data Released**

On October 31, 2025, Anika submitted the third and final module of the Hyalofast Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA"). In addition, data from the U.S. pivotal Phase III FastTRACK clinical trial has been released, demonstrating statistically significant improvements in key secondary endpoints such as KOOS Sports and Recreation Function, Quality of Life, and Total KOOS. Anika is encouraged by the strength and consistency of the overall data submitted to FDA for review, including positive clinical findings from independent studies conducted outside the U.S. over the past 15 years, which have demonstrated the consistent safety and efficacy of Hyalofast. For additional details, please see Anika's press release dated November 5, 2025 regarding the Hyalofast PMA filing and the Phase III FastTRACK clinical data.

**Progress on Final Steps to Cingal NDA Filing**

During the quarter, Anika advanced key activities toward filing the NDA for Cingal, its next-generation, non-opioid, single-injection OA Pain Management product, consisting of Anika's proprietary cross-linked hyaluronic acid combined with a fast-acting steroid. Anika completed the first of two toxicity studies and initiated patient screening for the bioequivalence study, which remains on track to begin before year-end. Upon completion of these two studies, requirements for the NDA submission in the U.S. will be complete.

**Third Quarter 2025 Continuing Operations Financial Summary** (compared to the third quarter of 2024, where applicable)

* Revenue $27.8 million, decreased 6% OEM Channel revenue $15.8 million, decreased 20%Commercial Channel revenue $12.0 million, increased 22% 

* Gross margin 56%

* Operating expenses $18.8 million, decreased 3%

* Loss from continuing operations ($3.2) million, ($0.22) per share

* Adjusted net income from continuing operations<sup>1</sup>$0.7 million, $0.04 per share

* Adjusted EBITDA<sup>1</sup> $0.9 million

* Cash provided by operating activities for total Company $6.9 million

* Cash balance $58.0 million

<sup>1</sup> See description of non-GAAP financial information contained in this release.

**Maintaining Fiscal 2025 Guidance** 

Anika maintains 2025 revenue ranges by channel as follows:

* Commercial Channel, unchanged, of $47 to $49.5 million, up 12% to 18% year over year

* OEM Channel, unchanged, of $62 to $65 million, down 16% to 20% year over year

Anika maintains Adjusted EBITDA as a percent of revenue of positive 3% to negative 3%.

**Company Commencing $15 Million 10b5-1 Share Repurchase**

In accordance with Anika's commitment to return capital to shareholders while maintaining the flexibility to execute on strategic growth objectives, the Company is commencing a $15 million 10b5-1 share repurchase which it expects to complete by June 2026.

**Conference Call and Webcast Information**

Anika's management will hold a conference call and webcast to discuss its financial results and business highlights today, Wednesday, November 5, 2025, at 8:30 am ET. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) and providing the conference ID number 53754. A live audio webcast will be available in the Investor Relations section of Anika's website, www.anika.com. A slide presentation with highlights from the conference call will be available in the Investor Relations section of the Anika website. A replay of the webcast will be available on Anika's website approximately two hours after the completion of the event.

**About Anika**

Anika Therapeutics, Inc. (NASDAQ: ANIK), is the global leader in the design, development, manufacturing, and commercialization of hyaluronic acid innovations. In partnership with clinicians, our sole focus is dedicated to delivering and advancing osteoarthritis pain management and orthopedic regenerative solutions. At our core is a passion to deliver a differentiated portfolio that improves patient outcomes around the world. Anika's global operations are headquartered outside of Boston, Massachusetts. For more information about Anika, please visit www.anika.com.

ANIKA, ANIKA THERAPEUTICS, CINGAL, HYALOFAST, INTEGRITY, MONOVISC, ORTHOVISC, and the Anika logo are trademarks of Anika Therapeutics, Inc. or its subsidiaries or are licensed to Anika Therapeutics, Inc. for its use.

**Non-GAAP Financial Information<sup>1</sup>**

Non-GAAP financial measures should be considered supplemental to, and not a substitute for, the Company's reported financial results prepared in accordance with GAAP. Furthermore, the Company's definition of non-GAAP measures may differ from similarly titled measures used by others. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, Anika strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. The Company presents these non-GAAP financial measures because it uses them as supplemental measures in internally assessing the Company's operating performance, and, in the case of Adjusted EBITDA, it is set as a key performance metric to determine executive compensation. The Company also recognizes that these non-GAAP measures are commonly used in determining business performance more broadly and believes that they are helpful to investors, securities analysts, and other interested parties as a measure of comparative operating performance from period to period.

*Adjusted EBITDA* 

Adjusted EBITDA is defined by the Company as GAAP net income (loss) from continuing operations excluding depreciation and amortization, interest and other income (expense), income taxes, stock-based compensation expense, and shareholder activism costs.

*Adjusted Net Income (Loss) from Continuing Operations and Adjusted EPS from Continuing Operations*

Adjusted net income (loss) is defined by the Company as GAAP net income from continuing operations, on a tax effected basis, excluding stock-based compensation. Adjusted diluted EPS from continuing operations is defined by the Company as GAAP diluted EPS from continuing operations excluding stock-based compensation.

A reconciliation of adjusted EBITDA to adjusted net income (loss) from continuing operations to net income (loss) from continuing operations and adjusted diluted EPS from continuing operations to diluted EPS from continuing operations, the most directly comparable financial measures calculated and presented in accordance with GAAP, is shown in the tables at the end of this release.

**Forward-Looking Statements** 

*This press release may contain forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements about the launch of new shape and sizes and the potential growth of the Integrity Implant System, statements in Dr. Blanchard's quote about anticipated pricing of Monovisc and Orthovisc in the U.S., statements about the clinical and regulatory pathway and launch of Hyalofast in the U.S., statements about the anticipated regulatory pathway for the NDA filing for Cingal, statements regarding the timing of the share repurchase program, and statements in the section titled "Maintaining Fiscal 2025 Guidance". These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support, or to timely file domestic and international pre-market approval applications, 510(k) applications, or new drug applications, including the PMA for Hyalofast and the NDA for Cingal; (iii) that the FDA or other regulatory bodies may not approve or clear the Company's applications, including the Hyalofast PMA because of the failure to achieve the pre-defined primary endpoints or because the FDA may determine that achievement of secondary endpoints and/or post hoc data analyses are not sufficient to support approval; (iii) that such approvals or clearances will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at* ***www.sec.gov****. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.*

**For Investor Inquiries:**

Anika Therapeutics, Inc.

Matt Hall, 781-457-9554

Director, Corporate Development and Investor Relations

investorrelations@anika.com

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** |
| **Consolidated Statements of Operations** | **Consolidated Statements of Operations** | **Consolidated Statements of Operations** | **Consolidated Statements of Operations** | **Consolidated Statements of Operations** |
| **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** | **For the Nine Months Ended September 30,** | **For the Nine Months Ended September 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Revenue | $27817 | $29559 | $82204 | $89305 |
| Cost of Revenue | 12233 | 10151 | 37576 | 30433 |
| &nbsp;&nbsp;&nbsp;&nbsp;Gross Profit | 15584 | 19408 | 44628 | 58872 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 6946 | 5946 | 19318 | 19037 |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling, general and administrative | 11871 | 13543 | 37007 | 44231 |
| Total operating expenses | 18817 | 19489 | 56325 | 63268 |
| Loss from operations | (3233) | (81) | (11697) | (4396) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest and other income (expense), net | 997 | 406 | 1626 | 1593 |
| Loss before income taxes | (2236) | 325 | (10071) | (2803) |
| &nbsp;&nbsp;&nbsp;&nbsp;Provision for income taxes | 939 | 2170 | 1709 | 3539 |
| Loss from continuing operations | (3175) | (1845) | (11780) | (6342) |
| Income (loss) from discontinued operations, net of tax | 846 | (28073) | 608 | (28178) |
| Net loss | $(2329) | $(29918) | $(11172) | $(34520) |
| Net loss per share: |  |  |  |  |
| Basic |  |  |  |  |
| &nbsp;&nbsp;Continuing Operations | $(0.22) | $(0.13) | $(0.82) | $(0.43) |
| &nbsp;&nbsp;Discontinued Operations | $0.06 | $(1.90) | $0.04 | $(1.91) |
|  | $(0.16) | $(2.03) | $(0.78) | $(2.34) |
| Diluted |  |  |  |  |
| &nbsp;&nbsp;Continuing Operations | $(0.22) | $(0.12) | $(0.82) | $(0.43) |
| &nbsp;&nbsp;Discontinued Operations | $0.06 | $(1.90) | $0.04 | $(1.91) |
|  | $(0.16) | $(2.02) | $(0.78) | $(2.34) |
| Weighted average common shares outstanding: |  |  |  |  |
| &nbsp;&nbsp;Basic | 14419 | 14768 | 14361 | 14769 |
| &nbsp;&nbsp;Diluted | 14419 | 14768 | 14361 | 14769 |

---

---

| | | |
|:---|:---|:---|
| **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** |
| **Consolidated Balance Sheets** | **Consolidated Balance Sheets** | **Consolidated Balance Sheets** |
| **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **September 30,** | **December 31,** |
| **ASSETS** | **2025** | **2024** |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $57990 | $55629 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable, net | 22187 | 23594 |
| &nbsp;&nbsp;&nbsp;&nbsp;Inventories, net | 16284 | 23809 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 5129 | 5494 |
| &nbsp;&nbsp;&nbsp;&nbsp;Current assets held for sale | - | 5126 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 101590 | 113652 |
| Property and equipment, net | 40684 | 38994 |
| Right-of-use assets | 24226 | 25685 |
| Other long-term assets | 5507 | 5656 |
| Notes receivable | 6478 | 5935 |
| Deferred tax assets | 1251 | 1177 |
| Intangible assets, net | 1650 | 2490 |
| Goodwill | 8051 | 7125 |
| Non-current assets held for sale | - | 2026 |
| Total assets | $189437 | $202740 |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $4732 | $5617 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | 14357 | 13567 |
| &nbsp;&nbsp;&nbsp;&nbsp;Current liabilities held for sale | - | 4122 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 19089 | 23306 |
| Other long-term liabilities | 761 | 772 |
| Lease liabilities | 22782 | 24014 |
| Non-current liabilities held for sale |  | 659 |
| Stockholders' equity: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Common stock, $0.01 par value | 144 | 144 |
| &nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in-capital | 91105 | 88961 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss | (4939) | (6783) |
| &nbsp;&nbsp;&nbsp;&nbsp;Retained earnings | 60495 | 71667 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 146805 | 153989 |
| Total liabilities and stockholders' equity | $189437 | $202740 |

---

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| | | |
|:---|:---|:---|
| **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** |
| **Reconciliation of GAAP Net Loss from Continued Operations to Adjusted EBITDA** | **Reconciliation of GAAP Net Loss from Continued Operations to Adjusted EBITDA** | **Reconciliation of GAAP Net Loss from Continued Operations to Adjusted EBITDA** |
| **(in thousands)** | **(in thousands)** | **(in thousands)** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** |
|  | **2025** | **2024** |
| Net loss from continuing operations | $(3175) | $(1845) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest and other (income) expense, net | (997) | (406) |
| &nbsp;&nbsp;&nbsp;&nbsp;Provision for income taxes | 939 | 2171 |
| &nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | 1403 | 1504 |
| &nbsp;&nbsp;&nbsp;&nbsp;Non-recurring professional fees | 480 | - |
| Adjusted EBITDA | $865 | $4542 |
| **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** |
| **Reconciliation of GAAP Net Income from Continuing Operations to Adjusted Net Income from Continuing Operations** | **Reconciliation of GAAP Net Income from Continuing Operations to Adjusted Net Income from Continuing Operations** | **Reconciliation of GAAP Net Income from Continuing Operations to Adjusted Net Income from Continuing Operations** |
| **(in thousands)** | **(in thousands)** | **(in thousands)** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** |
|  | **2025** | **2024** |
| Loss from continuing operations | $(3175) | $(1845) |
| &nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation, tax effected | 3145 | 2913 |
| &nbsp;&nbsp;&nbsp;&nbsp;Non-recurring professional fees, tax effected | 682 | - |
| Adjusted net income (loss) from continuing operations | $652 | $1068 |
| **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** |
| **Reconciliation of GAAP Diluted Earnings from Continuing Operations Per Share to Adjusted Diluted Earnings from Continuing Operations Per Share** | **Reconciliation of GAAP Diluted Earnings from Continuing Operations Per Share to Adjusted Diluted Earnings from Continuing Operations Per Share** | **Reconciliation of GAAP Diluted Earnings from Continuing Operations Per Share to Adjusted Diluted Earnings from Continuing Operations Per Share** |
| **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** |
|  | **2025** | **2024** |
| Diluted loss from continuing operations per share | $(0.22) | $(0.12) |
| &nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation, tax effected | 0.21 | 0.19 |
| &nbsp;&nbsp;&nbsp;&nbsp;Non-recurring professional fees, tax effected | 0.05 | - |
| Adjusted diluted net income (loss) from continuing operations per share | $0.04 | $0.07 |

---

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** | **Anika Therapeutics, Inc. and Subsidiaries** |
| **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** | **Revenue by Product Family** |
| **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** | **(in thousands, except percentages)** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** | **For the Three Months Ended September 30,** | **For the Nine Months Ended September 30,** | **For the Nine Months Ended September 30,** | **For the Nine Months Ended September 30,** | **For the Nine Months Ended September 30,** |
|  | **2025** | **2024** | **$ change** | **% change** | **2025** | **2024** | **$ change** | **% change** |
| &nbsp;&nbsp;OEM Channel | $15844 | $19764 | $(3920) | -20% | $47093 | $58101 | $(11008) | -19% |
| &nbsp;&nbsp;Commercial Channel | 11973 | 9795 | 2178 | 22% | 35111 | 31204 | 3907 | 13% |
| &nbsp;&nbsp;Revenue | $27817 | $29559 | $(1742) | -6% | $82204 | $89305 | $(7101) | -8% |

---

## Exhibit 99.2

**EXHIBIT 99.2**

**Anika Therapeutics Reports Filing of Final PMA Module for Hyalofast® Cartilage Repair Scaffold and Data from U.S. Pivotal FastTRACK Phase III Study**

BEDFORD, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global leader in joint preservation and regenerative solutions, announced that it filed the third and final module of its Premarket Approval application (PMA) for Hyalofast—its resorbable, hyaluronic acid-based scaffold used with autologous bone marrow aspirate concentrate (BMAC) for treating articular cartilage defects in the knee. The Company also reported results from its U.S. pivotal Phase III FastTRACK clinical trial evaluating Hyalofast.

On October 31, 2025, Anika submitted the third and final module of its Hyalofast PMA to the U.S. Food and Drug Administration (FDA). The PMA includes FastTRACK 24-month data and incorporates additional post-hoc analyses and real-world data.

"We are pleased to announce the filing of the PMA for Hyalofast and to provide the results of the pivotal FastTRACK Phase III study. We believe the comprehensive results of the FastTRACK study reinforce Hyalofast's potential as a transformative, single-stage, off-the-shelf cartilage repair solution for patients in the U.S.," said Cheryl Blanchard, President and CEO of Anika Therapeutics. "We are proud of the robust clinical data that we presented to the FDA and we look forward to working with the FDA on our goal of bringing Hyalofast to patients in the U.S."

**Key Findings from U.S. Pivotal Phase III FastTRACK Clinical Trial**

Initiated in 2015, the FastTRACK study was a prospective, randomized, active treatment-controlled, evaluator-blinded, multicenter clinical trial designed to establish superiority of Hyalofast combined with BMAC in the treatment of articular knee cartilage defect lesions in comparison to microfracture, an active control arm that was considered the standard of care at the time. The study enrolled patients with symptomatic cartilage lesions and monitored outcomes for two years following treatment.

**Primary Endpoints (24-month data):**

As previously reported, the study did not meet its pre-specified co-primary endpoints under the original statistical framework. The two co-primary endpoints were the percent change in baseline at 24 months for Knee injury and Osteoarthritis Outcomes Score pain (KOOS Pain) and International Knee Documentation Committee Subjective Knee Evaluation Score (IKDC Function), a measure of function. The results are reported as the relative difference between the Hyalofast arm compared to the microfracture arm. At 24 months, KOOS Pain scores showed an 8.11% difference between the arms favoring microfracture (p=0.81), while IKDC Function scores showed a 4.84% difference favoring Hyalofast (p=0.34); neither result was statistically significant. These percent changes were influenced by high variability in baseline scores, particularly in the microfracture arm. To provide additional context, absolute changes from baseline were also analyzed on a post-hoc basis. For KOOS Pain, Hyalofast demonstrated an average improvement of 4.54 points over microfracture (p=0.15). Hyalofast demonstrated an improvement in IKDC score of 2.19 points over microfracture (p=0.28).

The number of subject dropouts for the microfracture arm was nearly double that of the Hyalofast arm, resulting in more missing data in the microfracture arm. The missing data was in part due to missed visits during COVID, as well as dissatisfaction with microfracture as a treatment. The original pre-specified endpoint analysis assumed data would be normally distributed and missing at random. Therefore, on a post-hoc basis, the company also prepared the results without imputation (observed data) using a non-parametric statistical t-test, which is used for data sets with skewed distributions. In that analysis, at the same 24-month timepoint, Hyalofast demonstrated a 23.37% improvement over microfracture in the KOOS Pain score (p=0.02) and showed superiority in KOOS Pain with an absolute difference of 4.54 points (p=0.02) over microfracture. Both of these results were statistically significant.

**Key Secondary Endpoints Demonstrated Statistically Significant Improvements with Hyalofast:**

Hyalofast demonstrated statistically significant improvements in key secondary endpoints. Compared to microfracture, Hyalofast showed a 12.19-point gain in KOOS Sports and Recreation scores (p=0.01) and a 9.52-point improvement in KOOS Quality of Life scores (p=0.03) over microfracture. Additionally, Hyalofast outperformed microfracture in Total KOOS—a composite measure of both pain and function—by 6.57 points (p=0.02). These results underscore the broader functional and quality-of-life benefits observed with Hyalofast. All other secondary endpoints showed consistent benefit of Hyalofast over microfracture, however, without statistical significance over the active control microfracture arm.

**Post-Hoc Responder Analysis Demonstrated a Significantly Greater Proportion of Patients Treated with Hyalofast Achieved Clinically Meaningful Improvements of KOOS Pain** 

A responder analysis provides a picture of how many patients achieve clinically significant improvement. This approach is widely recognized by clinicians and regulators as a meaningful measure of treatment benefit. At 24 months, a significantly greater proportion of patients treated with Hyalofast achieved clinically meaningful improvements in KOOS Pain.

Compared to microfracture, Hyalofast demonstrated statistically significant advantages at higher improvement thresholds, with 87.4% of Hyalofast patients achieving at least a 10-point improvement versus 75.3% of microfracture patients (p=0.050). At a 15-point improvement, the gap widened in favor of Hyalofast to 83.5% vs. 60.8% (p=0.004). And, at an even higher threshold of 20 points improvement, 72.8% of Hyalofast patients responded, compared to 52.6% in the microfracture group (p=0.029).

These findings underscore the consistency and depth of pain relief achieved with Hyalofast, with statistically significant advantages over microfracture at higher improvement thresholds.

**Clinical and Regulatory Implications**

While the study did not meet its pre-specified co-primary endpoints under the original statistical framework, Anika attributes this outcome to several study dynamics, including COVID-related disruptions, a shift in the standard of care away from microfracture since study initiation, and higher dropout rates in the microfracture active control arm due to patient dissatisfaction with that treatment —which collectively impacted statistical power. Despite these challenges, the Company remains confident in the clinical value of Hyalofast. Hyalofast showed statistically significant improvements in key pre-defined secondary endpoints including KOOS Sports and Recreation, and Quality of Life. In addition, Hyalofast demonstrated statistically significant improvement in Total KOOS, a composite pain and function measure. These measures have supported prior FDA approvals for cartilage repair products. Additionally, Anika has real world experience with Hyalofast, having treated over 35,000 patients globally since 2009, with positive long-term (to 15 years) outcomes from international published studies, and has also received Breakthrough Device Designation from the FDA.

**About Hyalofast®**

Hyalofast is an off-the-shelf, single-stage scaffold designed to support regeneration of hyaline-like cartilage. It is currently marketed in over 35 countries and has demonstrated safety and efficacy in multiple clinical trials.

**Forward-Looking Statements** 

*This press release may contain forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements about the clinical potential of Hyalofast, the timing of the FDA's review of regulatory submissions for Hyalofast and the outcome of such review. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support, or to timely file domestic and international pre-market approval applications, 510(k) applications, or new drug applications, including the PMA for Hyalofast; (iii) that the FDA or other regulatory bodies may not approve or clear the Company's applications, including the Hyalofast PMA, because of the failure to achieve the pre-defined primary endpoints or because the FDA may determine that achievement of secondary endpoints and/or post hoc data analyses are not sufficient to support approval; (iii) that such approvals or clearances will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at* ***www.sec.gov****. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.*

**For Investor Inquiries:**

Anika Therapeutics, Inc.

Matt Hall, 781-457-9554

Director, Corporate Development and Investor Relations

investorrelations@anika.com