Anika: FDA says current Hyalofast application not approvable
Anika expects $8.0 million in distributor payments; the FDA notified the company that Hyalofast’s current PMA application is not approvable.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Anika Therapeutics, Inc. (ANIK) reported third-quarter 2026 revenue of $30.6 million, up 10% from $27.8 million a year earlier; nine-month revenue was $92.8 million, up 13% from $82.2 million. Gross profit rose to $18.8 million from $15.6 million for the quarter and to $59.1 million from $44.6 million for nine months. Net loss narrowed to $0.3 million from $2.3 million for the quarter and to $2.1 million from $11.2 million for nine months.
The FDA notified the company that its current Hyalofast PMA application is not approvable, primarily based on clinical data; Anika continues discussions with the FDA about evidence that may support future approval. Anika targets a Cingal NDA submission by December 31, 2027; Chemistry, Manufacturing and Controls activities remain a key milestone, and approval remains subject to development and regulatory requirements.
Cash was $45.0 million at September 30, 2026, and nine-month operating cash flow was $2.8 million, versus $6.6 million a year earlier. An extended distributor agreement effective January 1, 2027 through December 31, 2036 carries expected payments of $8.0 million, including $4.0 million upfront in the first quarter of 2027 and $4.0 million tied to commercial volumes.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointNine-month revenue increased 13% to $92.8 million.
- Moderate pointNine-month net loss narrowed to $2.1 million from $11.2 million.
Negative
- Major pointFDA notified Anika that Hyalofast’s current PMA application is not approvable.
- Moderate pointNine-month operating cash flow: $2.8 million versus $6.6 million.
Filing Explained
At September 30, 2026, no borrowing was outstanding and any increase above the $50 million base remained conditional.
By
The
Key Figures
Key Terms
Premarket Approval regulatory
bioequivalence study medical
Chemistry, Manufacturing and Controls technical
adjusted EBITDA financial
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much revenue did ANIK report in the third quarter of 2026?
Why was Anika’s Hyalofast PMA application not approvable?
When does Anika expect to submit the Cingal NDA?
What payments does Anika expect under its extended distributor agreement?
What percentage of ANIK revenue came from DePuy Synthes?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of October 30, 2026, there were
ANIKA THERAPEUTICS, INC.
TABLE OF CONTENTS
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Page |
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Part I |
Financial Information |
3 |
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Item 1. |
Condensed Consolidated Financial Statements (unaudited): |
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Condensed Consolidated Balance Sheets at September 30, 2026 and December 31, 2025 |
3 |
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Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2026 and 2025 |
4 |
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Condensed Consolidated Statement of Stockholders’ Equity for the three and nine months ended September 30, 2026 and 2025 |
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Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2026 and 2025 |
6 |
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Notes to Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
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Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
26 |
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Item 4. |
Controls and Procedures |
26 |
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Part II |
Other Information |
26 |
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Item 1. |
Legal Proceedings |
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Item 1A. |
Risk Factors |
26 |
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Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
26 |
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Item 3. |
Defaults Upon Senior Securities |
26 |
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Item 4. |
Mine Safety Disclosures |
26 |
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Item 5. |
Other Information |
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Item 6. |
Exhibits |
27 |
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Signatures |
28 |
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References in this Quarterly Report on Form 10-Q to “we,” “us,” “our,” “our company,” and other similar references refer to Anika Therapeutics, Inc. and its subsidiaries unless the context otherwise indicates.
Trademarks, trade names and service marks owned by us, as well as certain trademarks, trade names and service marks licensed to us, may appear in this report. HYALOFAST is a trademark of Fidia Farmaceutici S.p.A. that is licensed to us. Any other trademarks, trade names or service marks appearing in this report are the property of their respective owners. Our use or display of third-party trademarks, trade names or service marks does not imply any relationship with, or endorsement or sponsorship of us by, their respective owners.
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PART I: |
FINANCIAL INFORMATION |
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ITEM 1. |
FINANCIAL STATEMENTS |
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
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September 30, |
December 31, |
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ASSETS |
2026 |
2025 |
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Current assets: |
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Accounts receivable, net |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Right-of-use assets |
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Other long-term assets |
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Notes receivable |
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Deferred tax assets |
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Intangible assets, net |
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Goodwill |
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Total assets |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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Accrued expenses and other current liabilities |
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Total current liabilities |
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Other long-term liabilities |
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Lease liabilities |
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Commitments and contingencies (Note 10) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in-capital |
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Accumulated other comprehensive loss |
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Retained earnings |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | |||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share data)
(unaudited)
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For the Three Months Ended |
For the Nine Months Ended |
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2025 |
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Revenue |
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Cost of revenue |
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Operating expenses: |
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Total operating expenses |
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Loss from operations |
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Interest and other income, net |
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Loss before income taxes |
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(Benefit from) provision for income taxes |
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Loss from continuing operations |
( |
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Income from discontinued operations, net of tax |
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Net loss |
$ | ( |
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Loss per share: |
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Basic |
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Continuing operations |
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Discontinued operations |
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Diluted |
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Continuing operations |
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Discontinued operations |
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Weighted average common shares outstanding: |
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Basic |
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Diluted |
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Net loss |
$ | ( |
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Foreign currency translation adjustment |
( |
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Comprehensive loss |
$ | ( |
) | $ | ( |
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) | $ | ( |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders' Equity
(in thousands, except per share data)
(unaudited)
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Nine Months Ended September 30, 2026 |
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Common Stock |
Accumulated |
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Number of |
$.01 Par |
Additional |
Retained |
Other |
Total |
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Shares |
Value |
in Capital |
Earnings |
Loss |
Equity |
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Balance, January 1, 2026 |
$ | $ | $ | $ | ( |
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Vesting of restricted stock units |
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Stock-based compensation expense |
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Retirement of common stock for minimum tax withholdings |
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( |
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( |
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Repurchase of common stock |
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Net loss |
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( |
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Other comprehensive loss |
- | ( |
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Balance, March 31, 2026 |
$ | $ | $ | $ | ( |
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Issuance of common stock for equity awards |
||||||||||||||||||||||||
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Vesting of restricted stock units |
( |
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Issuance of ESPP shares |
||||||||||||||||||||||||
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Stock-based compensation expense |
- | |||||||||||||||||||||||
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Retirement of common stock for minimum tax withholdings |
( |
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) | ||||||||||||||||||
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Repurchase of common stock |
( |
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Net income |
- | |||||||||||||||||||||||
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Other comprehensive loss |
- | ( |
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Balance, June 30, 2026 |
$ | $ | $ | $ | ( |
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Vesting of restricted stock units |
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Stock-based compensation expense |
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Retirement of common stock for minimum tax withholdings |
( |
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Net loss |
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Other comprehensive loss |
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Balance, September 30, 2026 |
$ | $ | $ | $ | ( |
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Nine Months Ended September 30, 2025 |
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Common Stock |
Accumulated |
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Number of |
$.01 Par |
Additional |
Retained |
Other |
Total |
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Shares |
Value |
in Capital |
Earnings |
Loss |
Equity |
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Balance, January 1, 2025 |
$ | $ | $ | $ | ( |
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$ | |||||||||||||||||
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Vesting of restricted stock units |
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Stock-based compensation expense |
- | |||||||||||||||||||||||
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Retirement of common stock for minimum tax withholdings |
( |
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( |
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Repurchase of common stock |
( |
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Net loss |
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( |
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Other comprehensive income |
- | |||||||||||||||||||||||
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Balance, March 31, 2025 |
$ | $ | $ | $ | ( |
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$ | |||||||||||||||||
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Vesting of restricted stock units |
( |
) | ||||||||||||||||||||||
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Issuance of ESPP shares |
||||||||||||||||||||||||
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Stock-based compensation expense |
- | |||||||||||||||||||||||
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Retirement of common stock for minimum tax withholdings |
( |
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) | ( |
) | ||||||||||||||||||
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Net loss |
- | ( |
) | ( |
) | |||||||||||||||||||
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Other comprehensive income |
- | |||||||||||||||||||||||
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Balance, June 30, 2025 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
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Vesting of restricted stock units |
||||||||||||||||||||||||
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Stock-based compensation expense |
- | |||||||||||||||||||||||
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Retirement of common stock for minimum tax withholdings |
( |
) | ( |
) | ( |
) | ||||||||||||||||||
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Net loss |
- | ( |
) | ( |
) | |||||||||||||||||||
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Other comprehensive loss |
- | ( |
) | ( |
) | |||||||||||||||||||
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Balance, September 30, 2025 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
| Nine Months Ended September 30, | ||||||||
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2026 |
2025 |
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Cash flows from operating activities: |
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Net loss |
$ | ( |
) |
$ | ( |
) |
||
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
||||||||
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Amortization of acquisition related intangible assets |
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Non-cash operating lease cost |
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Stock-based compensation expense |
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Deferred income taxes |
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Provision for credit losses |
( |
) | ||||||
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Provision for inventory |
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Interest income on notes receivable |
( |
) | ( |
) | ||||
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Loss (gain) on sale of assets |
( |
) | ||||||
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Changes in operating assets and liabilities: |
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Accounts receivable |
( |
) | ||||||
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Inventories |
( |
) | ||||||
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Prepaid expenses, other current and long-term assets |
( |
) | ||||||
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Accounts payable |
( |
) | ( |
) | ||||
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Operating lease liabilities |
( |
) |
( |
) | ||||
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Accrued expenses, other current and long-term liabilities |
( |
) | ||||||
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Income taxes |
( |
) | ||||||
|
Net cash provided from operating activities |
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Cash flows from investing activities: |
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Proceeds from sale of Parcus |
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Proceeds from sale of intangible assets |
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Notes receivable |
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Purchases of property and equipment |
( |
) | ( |
) | ||||
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Net cash used in investing activities |
( |
) | ( |
) | ||||
|
Cash flows from financing activities: |
||||||||
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Proceeds from employee stock purchase program |
||||||||
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Cash paid for tax withheld on vested restricted stock awards |
( |
) | ( |
) | ||||
|
Proceeds from exercises of equity awards |
||||||||
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Repurchases of common stock |
( |
) |
( |
) | ||||
|
Net cash used in financing activities |
( |
) | ( |
) | ||||
|
Exchange rate impact on cash |
( |
) | ||||||
|
(Decrease) increase in cash and cash equivalents |
( |
) | ||||||
|
Cash and cash equivalents at beginning of period |
||||||||
|
Cash and cash equivalents at end of period |
$ | $ | ||||||
|
Supplemental disclosure of cash flow information: |
||||||||
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Non-cash investing activities: |
||||||||
|
Purchases of property and equipment included in accounts payable and accrued expenses |
$ | $ | ||||||
| Right-of-use assets obtained in exchange for operating lease liabilities | $ | |||||||
The cash flows related to discontinued operations and held-for-use assets and liabilities have not been segregated and remain included in the major classes of assets and liabilities. Accordingly, the Consolidated Statements of Cash Flows include the results of continuing and discontinued operations. See Note 3 for selected financial information related to significant operating and investing cash flow items from discontinued operations.
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Anika Therapeutics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(amounts in thousands, except share and per share amounts or as otherwise noted)
(unaudited)
|
1. |
Nature of Business |
Anika Therapeutics, Inc. (the “Company”) is a global leader in the design, development, manufacturing and commercialization of hyaluronic acid (HA) innovations. In partnership with clinicians, the Company’s primary focus is dedicated to delivering and advancing osteoarthritis (OA) pain management and orthopedic regenerative solutions.
In early 2020, the Company expanded its overall technology platform through its acquisitions of Parcus Medical, LLC (“Parcus Medical”), a sports medicine implant and instrumentation company, and Arthrosurface Incorporated (“Arthrosurface”), a company specializing in less invasive, bone preserving partial and total joint replacement solutions. These acquisitions broadened the Company's product portfolio, developed over its 30 years of expertise in HA technology, into joint preservation and restoration, increased its commercial capabilities, diversified its revenue base, and expanded its research and development product pipeline.
In October 2024, the Company announced a strategic shift to focus on its OA pain management and regenerative solutions businesses. This strategic decision resulted in the sale of Arthrosurface on October 31, 2024, and the sale of Parcus Medical on March 7, 2025.
The Company is subject to risks common to companies in the life sciences industry including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, commercialization of existing and new products, and compliance with U.S. Food and Drug Administration (“FDA”) and foreign regulations and approval requirements, as well as the ability to grow the Company’s business through appropriate commercial strategies.
|
2. |
Basis of Presentation |
The accompanying unaudited condensed consolidated financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The financial statements include the accounts of Anika Therapeutics, Inc. and its subsidiaries. Inter-company transactions and balances have been eliminated. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to SEC rules and regulations relating to interim financial statements. The December 31, 2025, balances reported herein were derived from the audited consolidated financial statements. In the opinion of management, these unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to fairly state the condensed consolidated financial statements.
The accompanying unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s annual financial statements filed with its Annual Report on Form 10-K for the year ended December 31, 2025. The results of operations for the three and nine-month periods ended September 30, 2026, are not indicative of the results to be expected for the year ending December 31, 2026.
Recent Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), and in January 2025, the FASB issued ASU No. 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date (“ASU 2025-01”). ASU 2024-03 requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement. ASU 2024-03, as clarified by ASU 2025-01, is effective for public companies for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is evaluating the impact of ASU 2024-03 on its disclosures in future years as a result of the adoption of ASU 2024-03.
In December 2025, the FASB issued ASU 2025‑11 — Interim Reporting (Topic 270): Narrow‑Scope Improvements to clarify and reorganize the U.S. GAAP guidance on interim financial reporting consistent with Accounting Standards Codification (“ASC”) Topic 270. This new pronouncement will require registrants to use a comprehensive list of interim disclosure requirements compiled in accordance with ASC 270 and recognize this list as the complete population of required interim GAAP disclosures. ASU 2025-11 is effective for public companies with interim periods beginning after December 15, 2027. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
|
3. |
Discontinued Operations |
In October 2024, the Company announced a strategic shift to focus on its OA pain management and regenerative solutions businesses. This strategic decision resulted in the sale of Arthrosurface on October 31, 2024, and the sale of Parcus Medical on March 7, 2025.
Arthrosurface
On October 31, 2024 (the “Closing Date”), the Company completed the sale of all of the outstanding equity interests of Arthrosurface, a Delaware corporation and former wholly-owned subsidiary of the Company, which held the Company’s Arthrosurface business, to Phoenix Brio, Incorporated, a Delaware corporation (the “Buyer”), pursuant to the terms and conditions of a Share Purchase Agreement, dated as of the Closing Date (the “Purchase Agreement”), by and among the Company, Arthrosurface and Buyer (the “Arthrosurface Transaction”).
As consideration for the Arthrosurface Transaction, at the closing, the Buyer delivered to the Company a ten-year non-interest-bearing promissory note in the principal amount of $
Parcus Medical
On March 7, 2025, the Company completed the sale of all outstanding equity interests of Parcus Medical, to Medacta Americas Manufacturing, Inc. (“Medacta”), pursuant to the terms and conditions of a Membership Interest Purchase Agreement (the “Parcus Transaction”). As consideration for the Parcus Transaction, at closing, Medacta paid $
The components of net income from discontinued operations for the three and nine months ended September 30, 2026, and 2025, consist of the following (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Revenue |
$ | $ | $ | $ | ||||||||||||
|
Costs and expenses |
||||||||||||||||
|
Loss from discontinued operations before income taxes |
( |
) | ||||||||||||||
|
Benefit from income taxes |
( |
) | ( |
) | ||||||||||||
|
Net income from discontinued operations |
$ | $ | $ | $ | ||||||||||||
Selected financial information related to significant operating and investing cash flow items from discontinued operations (excluding working capital impacts) are as follows (in thousands):
| Nine Months Ended September 30, | ||||||||
|
2026 |
2025 |
|||||||
|
Depreciation |
$ | $ | ||||||
|
Non-cash operating lease cost |
$ | $ | ||||||
|
Stock-based compensation expense |
$ | $ | ||||||
|
Purchases of property and equipment |
$ | $ | ||||||
|
4. |
Accounts Receivable |
The Company estimates an allowance for credit losses with its accounts receivable resulting from the inability of its customers to make required payments, which is included in selling, general and administrative expenses in the accompanying consolidated statements of operations. In determining the adequacy of the allowance, management specifically analyzes individual accounts receivable, historical bad debts, customer concentrations, customer creditworthiness, current and reasonable and supportable forecasts of future economic conditions, accounts receivable aging trends, and changes in the Company’s customer payment terms.
The components of the Company’s accounts receivable are as follows:
|
As of |
As of |
|||||||
|
September 30, |
December 31, |
|||||||
|
2026 |
2025 |
|||||||
|
Accounts Receivable |
$ | |||||||
|
Less: Allowance for credit losses |
||||||||
|
Net balance, end of period |
$ | |||||||
A summary of activity in the allowance for credit losses is as follows:
|
As of September 30, |
||||||||
|
2026 |
2025 |
|||||||
|
Balance, beginning of the period |
$ | $ | ||||||
|
Amounts provided |
||||||||
|
Amounts recovered |
( |
) |
( |
) |
||||
|
Amounts written off |
( |
) | ( |
) | ||||
|
Translation adjustments |
( |
) | ||||||
|
Balance, end of period |
$ | $ | ||||||
|
5. |
Fair Value Measurements |
The Company has certain cash equivalents in money market funds that are classified within Level 1 of the fair value hierarchy and are valued based on quoted prices in active markets. For cash, accounts receivables, accounts payable, and accrued interest, the carrying amounts approximate fair value, because of the short maturity of these instruments, and therefore fair value information is not included in the table below. There were no transfers between fair value levels during the nine-month periods ended September 30, 2026, and the year ended December 31, 2025, respectively.
The classification of the Company’s cash equivalents within the fair value hierarchy was as follows:
|
September 30, |
Active |
Significant |
Significant |
Amortized |
||||||||||||||||
|
2026 |
(Level 1) |
(Level 2) |
(Level 3) |
Cost |
||||||||||||||||
|
Cash equivalents: |
||||||||||||||||||||
|
Money Market Funds |
$ | $ | $ | $ | $ | |||||||||||||||
|
December 31, |
Active |
Significant |
Significant |
Amortized |
||||||||||||||||
|
2025 |
(Level 1) |
(Level 2) |
(Level 3) |
Cost |
||||||||||||||||
|
Cash equivalents: |
||||||||||||||||||||
|
Money Market Funds |
$ | $ | $ | $ | $ | |||||||||||||||
|
6. |
Inventories |
Inventories consist of the following:
|
September 30, |
December 31, |
|||||||
|
2026 |
2025 |
|||||||
|
Raw materials |
$ | $ | ||||||
|
Work-in-process |
||||||||
|
Finished goods |
||||||||
|
Total |
$ | $ | ||||||
|
Inventories |
$ | $ | ||||||
|
Other long-term assets |
||||||||
|
Total |
$ | $ | ||||||
Inventories are stated net of inventory reserves of approximately $
|
7. |
Property and Equipment |
Property and equipment are stated at cost and consists of the following:
|
September 30, |
December 31, |
|||||||
|
2026 |
2025 |
|||||||
|
Equipment and software |
$ | $ | ||||||
|
Furniture and fixtures |
||||||||
|
Leasehold improvements |
||||||||
|
Construction in progress |
||||||||
|
Subtotal |
||||||||
|
Less accumulated depreciation |
( |
) | ( |
) | ||||
|
Total |
$ | $ | ||||||
Depreciation expense was $
|
8. |
Goodwill and Intangible Assets |
The Company assesses goodwill for impairment annually, or, under certain circumstances, more frequently, such as when events or changes in circumstances indicate there may be impairment.
Changes in the carrying value of goodwill for the nine-month period ended September 30, 2026 were as follows:
|
Nine Months Ended |
||||
|
2026 |
||||
|
Balance, beginning of period |
$ | |||
|
Effect of foreign currency adjustments |
( |
) | ||
|
Balance, ending of period |
$ | |||
The Company has intangible assets of $
|
9. |
Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consist of the following:
|
September 30, |
December 31, |
|||||||
|
2026 |
2025 |
|||||||
|
Compensation and related expenses |
$ | $ | ||||||
|
Stock-based compensation |
||||||||
|
Operating lease liability – current |
||||||||
|
Professional fees |
||||||||
|
Clinical trial costs |
||||||||
|
Deferred revenue |
||||||||
|
Other |
||||||||
|
Total |
$ | $ | ||||||
|
10. |
Commitments and Contingencies |
In certain of its contracts, the Company warrants to its customers that the products it manufactures conform to the product specifications as in effect at the time of delivery of the specific product. The Company may also warrant that the products it manufactures do not infringe, violate, or breach any U.S. or international patent or intellectual property right, trade secret, or other proprietary information of any third party. On occasion, the Company contractually indemnifies its customers against any and all losses arising out of, or in any way connected with, any claim or claims of breach of its warranties or any actual or alleged defect in any product caused by the negligent acts or omissions of the Company. The Company maintains a products liability insurance policy that limits its exposure to these risks. Based on the Company’s historical activity, in combination with its liability insurance coverage, the Company believes the estimated fair value of these indemnification agreements is immaterial. The Company had no accrued warranties as of September 30, 2026, or December 31, 2025, and has no history of claims paid.
The Company is also involved from time-to-time in various legal proceedings arising in the normal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these occasional legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flow.
|
11. |
Revenue and Geographic Information |
Revenue by product classification is as follows:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Original Equipment Manufacturer (“OEM”) Channel |
$ | $ | $ | $ | ||||||||||||
|
Commercial Channel |
||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
Revenue from the Company’s sole significant customer, DePuy Synthes, formerly Johnson & Johnson MedTech, as a percentage of the Company’s total revenue was
Total revenue by geographic location based on the location of the customer in total and as a percentage of total revenue were as follows:
|
Three Months Ended September 30, |
||||||||||||||||
|
2026 |
2025 |
|||||||||||||||
|
Percentage of |
Percentage of |
|||||||||||||||
|
Revenue |
Revenue |
Revenue |
Revenue |
|||||||||||||
|
Geographic Location: |
||||||||||||||||
|
United States |
$ |
% |
$ |
% |
||||||||||||
|
Europe |
% |
% |
||||||||||||||
|
Other |
% |
% |
||||||||||||||
|
Total |
$ |
% |
$ |
% |
||||||||||||
|
Nine Months Ended September 30, |
||||||||||||||||
|
2026 |
2025 |
|||||||||||||||
|
Percentage of |
Percentage of |
|||||||||||||||
|
Revenue |
Revenue |
Revenue |
Revenue |
|||||||||||||
|
Geographic Location: |
||||||||||||||||
|
United States |
$ | % | $ | % | ||||||||||||
|
Europe |
% | % | ||||||||||||||
|
Other |
% | % | ||||||||||||||
|
Total |
$ | % | $ | % | ||||||||||||
|
12. |
Equity Incentive Plans |
Equity Incentive Plans
The Anika Therapeutics, Inc. 2017 Omnibus Incentive Plan (the “2017 Plan”) was approved by the Company’s stockholders on June 13, 2017, and subsequently amended most recently on June 18, 2026. On June 18, 2026, the Company’s stockholders approved a seventh amendment and restatement of the 2017 Plan increasing the number of shares by
The Anika Therapeutics, Inc. 2021 Inducement Plan (the “Inducement Plan”) was adopted by the Company’s board of directors on November 4, 2021, and subsequently amended on December 22, 2023, and May 2, 2024. On May 2, 2024, the Company’s board of directors approved an amendment to the Inducement Plan increasing the number of shares by
The Anika Therapeutics, Inc. 2021 Employee Stock Purchase Plan (the “ESPP”) was adopted by the Company’s board of directors on March 17, 2021, and approved by the Company’s stockholders on June 16, 2021, and subsequently amended on June 18, 2026. On June 18, 2026, the Company’s stockholders approved an amendment to the ESPP to increase the number of shares of common stock reserved for issuance by
The Company may satisfy share-settled awards upon exercise, or upon fulfillment of the vesting requirements for other equity-based awards, with either newly issued shares or shares reacquired by the Company. Stock-based awards are granted with an exercise price equal to or greater than the market price of the Company’s stock on the date of grant. Awards contain service conditions or service and performance conditions, and they generally become exercisable ratably over three years with a maximum contractual term of ten years.
The Company presents the expenses related to stock-based compensation awards in the same expense line items as cash compensation paid to each of its employees as follows (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Cost of revenue |
$ | $ | $ | $ | ||||||||||||
|
Research & development |
||||||||||||||||
|
Selling, general & administrative |
||||||||||||||||
|
Total stock-based compensation expense |
$ | $ | $ | $ | ||||||||||||
Stock Options and Stock Appreciation Rights
Stock options and stock appreciation rights (“SARs”) are granted to purchase common shares at prices that are equal to the fair market value of the shares on the date the options/SARs are granted or, in the case of premium options, are granted with an exercise price at
The following summarizes the activity under the Company’s stock option and SAR plans:
|
Weighted |
||||||||||||||||
|
Average |
||||||||||||||||
|
Weighted |
Remaining |
Aggregate |
||||||||||||||
| Average |
Contractual |
Intrinsic |
||||||||||||||
| Number of Shares |
Exercise |
Term |
Value |
|||||||||||||
|
(Options/SARs) |
Price |
(in years) |
(in thousands) |
|||||||||||||
|
Outstanding as of December 31, 2025 |
$ | $ | ||||||||||||||
|
Granted |
$ | |||||||||||||||
|
Exercised |
( |
) |
$ | $ | ||||||||||||
|
Forfeited and canceled |
( |
) |
$ | |||||||||||||
|
Outstanding as of September 30, 2026 |
$ | $ | ||||||||||||||
|
Vested, September 30, 2026 |
$ | $ | ||||||||||||||
|
Vested or expected to vest, September 30, 2026 |
$ | $ | ||||||||||||||
There were
The Company granted
Listed below are the assumptions used in the Black-Scholes pricing model for options and SARs granted during the nine months ended September 30, 2026.
The assumptions were as follows:
|
Nine Months Ended |
||||||||||||||||||||||||
| September 30, | ||||||||||||||||||||||||
|
2026 |
2025 |
|||||||||||||||||||||||
|
Risk free interest rate |
% | - | % | % | - | % | ||||||||||||||||||
|
Expected volatility |
% | - | % | % | - | % | ||||||||||||||||||
| Expected life (years) & dividend yield | % | % | ||||||||||||||||||||||
|
Fair value per option/SARs |
$ | $ | ||||||||||||||||||||||
As of September 30, 2026, there was $
Restricted Stock Units
RSUs generally vest in equal annual installments over a three-year period. The grant-date fair value of RSUs is recognized as expense on a straight-line basis over the requisite service period, which is generally the vesting period. The Company determines the fair value of RSUs based on the closing price of its common stock on the date of grant.
RSU activity for the nine-month period ended September 30, 2026, was as follows:
|
Weighted Average |
||||||||
|
Number of |
Grant Date |
|||||||
|
Shares |
Fair Value |
|||||||
|
Outstanding as of December 31, 2025 |
$ | |||||||
|
Granted |
$ | |||||||
|
Vested |
( |
) |
$ | |||||
|
Forfeited and cancelled |
( |
) |
$ | |||||
|
Outstanding as of September 30, 2026 |
$ | |||||||
The weighted-average grant-date fair value per share of RSUs granted was $
The Company’s annual grants of RSU awards in March 2025 and 2026 can be settled at vesting in cash or shares at the Company’s election. The Company has recorded these RSUs as a liability due to the expectation that the Company will settle the vesting of these RSU awards in cash due to a potential shortage of shares in the 2017 Plan at the time of vesting. As a result, these RSUs will be subject to change in value at the time of each reporting period. The first tranche of the March 2025 RSU awards,
Performance Stock Units
PSU activity for the nine-month period ended September 30, 2026, was as follows:
|
Weighted Average |
||||||||
|
Number of |
Grant Date |
|||||||
|
Shares |
Fair Value |
|||||||
|
Outstanding as of December 31, 2025 |
$ | |||||||
|
Granted |
$ | |||||||
|
Vested |
( |
) | $ | |||||
|
Forfeited and cancelled |
( |
) | $ | |||||
|
Outstanding as of September 30, 2026 |
$ | |||||||
On March 14, 2025, the Company granted
The Company’s grants of PSU awards can be settled at vesting in cash or shares at the Company’s election. The Company has recorded these PSUs as a liability due to the expectation that the Company will settle the vesting of these PSU awards in cash due to a potential shortage of shares in the 2017 Plan at the time of vesting. As a result, these PSUs will be subject to change in value at the time of each reporting period. The PSU awards that vested in March totaled
There were no PSUs granted in the nine-month period ended September 30, 2026.
|
13. |
Restructuring |
During 2026, the Company initiated actions to reduce general and administrative and regulatory expenses to reflect a more focused cost structure following the recent strategic divestitures. This included a workforce reduction resulting in the recognition of severance and employee‑related costs, which primarily consist of cash severance payments, employer‑paid benefits during the severance period, and payroll‑related taxes. These costs were recognized in accordance with ASC 420, Exit or Disposal Cost Obligations. The Company incurred approximately $
The following table is a summary of the changes in the severance liability, included with accrued expenses on the consolidated balance sheets related to the workforce reduction:
|
Nine-Months Ended |
||||
|
2026 |
||||
|
Balance, beginning of period |
$ | |||
|
Severance and other personnel costs |
||||
|
Cash payments during the period |
( |
) | ||
|
Balance, ending of period |
$ | |||
In addition, the Company announced a leadership transition in January 2026 in which its former Chief Executive Officer became Executive Chair of the Company’s Board of Directors. The Company and Dr. Cheryl Blanchard, its former Chief Executive Officer, entered into a Transitional Services and Separation Agreement (the “Transition Agreement”). Pursuant to the Transition Agreement, Dr. Blanchard stepped down from her role as the Company’s President and Chief Executive Officer, effective January 31, 2026. Dr. Blanchard will continue to serve on the Board of Directors through January 31, 2028. Pursuant to the Transition Agreement, Dr. Blanchard will be entitled to receive her base salary rate and related employee benefits for 18 months immediately at the time of transition, which will be paid over 24 months through January 31, 2028. Dr. Blanchard will also continue to serve on the Board of Directors through the Company’s 2028 annual stockholders meeting. Her equity awards granted under the Company’s 2017 Omnibus Incentive Plan and any other equity plan shall continue to vest throughout her service relationship, in accordance with the terms of the applicable award agreements and equity plans.
With this change in Dr. Blanchard’s role, the Company determined that the unrecognized stock-based compensation associated with her equity awards at the time of transition should be expensed immediately during the three-month period ended March 31, 2026, based on the premise that Dr. Blanchard would no longer be providing substantive services after January 31, 2026, commensurate with the value of the equity awards. As a result, the Company recorded $
|
14. |
Income Taxes |
There was a small income tax benefit for the three-month period ended September 30, 2026, and $
The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, carryback potential if permitted under the tax law, and results of recent operations. The Company has incurred operating losses in recent years. As a result, the Company anticipates that deferred tax assets will exceed the availability of reversing taxable temporary differences. Due to significant negative evidence, including the Company’s prior year operating losses, the Company concluded its anticipated net deferred tax assets in the U.S. are not more likely than not to be realizable. Accordingly, the income tax provision for the nine-month period ended September 30, 2026, includes an adjustment for the valuation allowance required against the U.S. deferred tax assets. As of September 30, 2026, the Company continues to believe its foreign deferred tax assets are realizable based upon future reversals of existing taxable temporary differences and projected future taxable income.
The Company files income tax returns in the United States on a federal basis, in certain U.S. states, and in certain foreign jurisdictions. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate, which varies by jurisdiction.
|
15. |
Earnings Per Share (“EPS”) |
Basic EPS is calculated by dividing net income (loss) by the weighted average number of shares outstanding during the period. Unvested restricted shares, although legally issued and outstanding, are not considered outstanding for purposes of calculating basic EPS. Diluted EPS is calculated by dividing net income by the weighted average number of shares outstanding plus the dilutive effect, if any, of outstanding share-based awards using the treasury stock method. Due to the Company’s loss position, the share-based payment awards are anti-dilutive.
The Company had a net loss during the three- and nine-month periods ended September 30, 2026, and 2025, respectively, and therefore all potential common shares would have been anti-dilutive and accordingly were excluded from the computation of diluted EPS. Stock options of
|
16. |
Share Repurchase |
In May 2024, the Company implemented a share repurchase program for an aggregate purchase price of up to $
|
17. |
Segment Information |
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company operates in one business segment. The Company’s CODM is its President and Chief Executive Officer, who reviews financial information presented on a consolidated basis. The CODM’s financial review is focused on the consolidated financial results of the Company which is used as the basis for financial performance assessment and allocation of resources.
The following table presents financial information with respect to the Company’s single operating segment for the three and nine months ended September 30, 2026, and 2025 (in thousands):
|
For the Three Months Ended |
For the Nine Months Ended |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Revenue |
$ | $ | $ | $ | ||||||||||||
|
Cost of revenue |
||||||||||||||||
|
Gross profit |
||||||||||||||||
|
Operating expenses: |
||||||||||||||||
|
Research & development |
||||||||||||||||
|
Selling, general & administrative |
||||||||||||||||
|
Total operating expenses |
||||||||||||||||
|
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
Interest and other income, net |
||||||||||||||||
|
Loss before income taxes |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
(Benefit from) provision for income taxes |
( |
) | ||||||||||||||
|
Loss from continuing operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
Income from discontinued operations, net of tax |
||||||||||||||||
|
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
18. |
Subsequent Event |
On November 5, 2026, the Company extended its license and distribution agreement with one of its non-orthopedic distributors effective January 1, 2027, through December 31, 2036. The agreement provides an increase in selling price, a royalty on end-market sales, higher contractual purchases and upfront and milestone payments. The Company expects to receive $
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
You should read the following discussion in conjunction with our financial statements and related notes appearing elsewhere in this report and our audited consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2025, or our 2025 Form 10-K. In addition to historical information, this report contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, concerning our business, consolidated financial condition, and results of operations. The Securities and Exchange Commission, or the SEC, encourages companies to disclose forward-looking statements so that investors can better understand a company’s future prospects and make informed investment decisions. Forward-looking statements are subject to risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by words such as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical matters. All statements other than statements of historical facts included in this report regarding our strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Examples of forward-looking statements include, among others, express or implied statements regarding expected future operating results, expectations regarding the timing and receipt of regulatory results, anticipated levels of capital expenditures, and expectations of the effect on our financial condition of claims, litigation, and governmental and regulatory proceedings.
Please also refer to “Item 1A. Risk Factors” of our 2025 Form 10-K for important factors that we believe could cause actual results to differ materially from those in our forward-looking statements. Any forward-looking statement made by us in this report is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Management Overview
We are a global leader in the design, development, manufacturing and commercialization of hyaluronic acid, or HA, innovations. In partnership with our clinicians, our primary focus is dedicated to delivering and advancing osteoarthritis, or OA, pain management, orthopedic regenerative solutions and non-orthopedic products. At our core is a passion to deliver a differentiated portfolio that improves patient outcomes around the world.
We have over 30 years of global expertise developing, manufacturing and commercializing products based on our HA, technology platform. HA is a naturally occurring polymer found throughout the body that is vital for proper joint health and tissue function. Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to multiple uses, including enabling longer residence time to support OA pain management and creating a solid form of HA called Hyaff, which is a platform utilized in our regenerative solutions portfolio.
As we look forward to the future, our business is positioned to capture value within our target markets of OA pain management and regenerative solutions. We believe our future success will be driven by our:
|
● |
Over 30 years of experience in HA and HA-based regenerative solutions and early intervention orthopedics, combined with seasoned leadership with a strong financial foundation for future investment in meaningful solutions for our customers and their patients; |
|
● |
Utilizing proprietary HA-based technology and manufacturing expertise to provide new and differentiated solutions in next generation OA pain management (e.g., Cingal) and regenerative (e.g., Integrity Implant System and Hyalofast) markets; |
|
● |
Growth of the Integrity Implant System, our HA-based scaffold for rotator cuff and other tendon repairs, with first commercial cases in 2023; |
|
● |
Targeting to introduce key HA-based products into the U.S. market upon U.S. Food and Drug Administration, or FDA approval/clearance, such as Cingal and Hyalofast, and developing additional products that leverage our proprietary Hyaff regenerative platform; |
|
● |
Robust network of stakeholders in our target markets to identify evolving unmet patient treatment needs; |
|
● |
Global commercial expertise, which we will leverage to drive growth across our product portfolio, including continued international expansion; |
|
● |
Opportunity to pursue strategic inorganic growth opportunities, including potential partnerships and smaller acquisitions, technology licensing, and leveraging our strong financial foundation and operational capabilities; and |
|
● |
Energized and experienced team focused on strong values, talent, and culture. |
Products
OA Pain Management
Our OA pain management product family consists of Monovisc and Orthovisc, our injectable, HA-based OA pain management offerings that are indicated to provide pain relief from osteoarthritis conditions; and Cingal, our novel, single-injection OA pain management product consisting of our proprietary cross-linked HA material combined with a fast-acting steroid.
Cingal is our next generation fast-acting, long-lasting, non-opioid, clinically proven OA pain product that is designed to provide both short- and long-term pain relief through at least six months. It is currently sold outside the United States in over 35 countries. In 2022, we completed a third Phase 3 clinical trial for Cingal, which achieved its primary endpoint. We have been actively engaging with the FDA, on next steps for U.S. regulatory approval. We continue to work towards addressing the FDA's requirements for Cingal's approval and are continuing to advance New Drug Application or NDA, preparation activities and are working towards a submission to the FDA. In September 2026, we completed enrollment in the bioequivalence study, which was one of the key FDA requirements. Chemistry, Manufacturing and Controls, or CMC, activities required for approval of HA as a drug also remain a key milestone in the regulatory pathway and are expected to be a primary focus as we advance toward filing. We are targeting to make the NDA submission by December 31, 2027. Regulatory approval remains subject to the completion of these development and regulatory requirements. We are committed to bringing this revolutionary pain management therapy to the approximate $1 billion U.S. addressable market.
Regenerative Solutions
Our regenerative solutions product family consists of: (a) our portfolio of orthopedic regenerative solutions products utilizing HA, including Integrity, our hyaluronic acid-based scaffold for rotator cuff repair and other tendon procedures, Tactoset, an HA-enhanced, flowable, injectable and settable bone void filler used to facilitate bone regeneration and augment hardware in poor quality bone, and Hyalofast, a hyaluronic acid scaffold for cartilage repair, sold outside of the United States in over 30 countries.
Hyalofast is not currently approved for commercial use in the United States and is not available for commercial sale. We submitted a Premarket Approval, or PMA, application to the FDA on October 31, 2025, following completion of a pivotal Investigational Device Exemption, or IDE, clinical trial. In October 2026, we received formal notification from the FDA that our current Hyalofast PMA application is not approvable, primarily based on the clinical data included in the submission. We continue to believe strongly in Hyalofast’s potential in the U.S. market, and we will continue discussions with the FDA regarding the evidence that may be required to support future approval.
Non-Orthopedic Products
Our Non-Orthopedic product family consists of legacy HA-based products that are marketed principally for non-orthopedic applications. These products include: Hyvisc, our high molecular weight injectable HA veterinary product for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine OA; Hyalobarrier, an anti-adhesion barrier indicated for use after abdominal-pelvic surgeries; Hyalomatrix, our HA-based scaffold used in the treatment of complex wounds; and ophthalmic products, including injectable, high molecular weight HA products such as Anikavisc and Nuvisc, used as viscoelastic agents in ophthalmic surgical procedures such as cataract extraction and intraocular lens implantation. These Non-Orthopedic products are sold through commercial sales and marketing partners around the world.
Results of Operations
Three and Nine Months Ended September 30, 2026 Compared to Three and Nine Months Ended September 30, 2025
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
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|
2026 |
2025 |
$ Change |
% Change |
2026 |
2025 |
$ Change |
% Change |
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|
(in thousands, except percentages) |
(in thousands, except percentages) |
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Revenue |
$ | 30,594 | $ | 27,817 | $ | 2,777 | 10 | % | $ | 92,816 | $ | 82,204 | $ | 10,612 | 13 | % | ||||||||||||||||
|
Cost of revenue |
11,757 | 12,233 | (476 | ) | (4 | %) | 33,738 | 37,576 | (3,838 | ) | (10 | %) | ||||||||||||||||||||
|
Gross profit |
18,837 | 15,584 | 3,253 | 21 | % | 59,078 | 44,628 | 14,450 | 32 | % | ||||||||||||||||||||||
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Gross margin |
62 | % | 56 | % | 64 | % | 54 | % | ||||||||||||||||||||||||
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Operating expenses: |
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Research & development |
7,895 | 6,946 | 949 | 14 | % | 21,949 | 19,318 | 2,631 | 14 | % | ||||||||||||||||||||||
|
Selling, general & administrative |
11,654 | 11,871 | (217 | ) | (2 | %) | 40,375 | 37,007 | 3,368 | 9 | % | |||||||||||||||||||||
|
Total operating expenses |
19,549 | 18,817 | 732 | 4 | % | 62,324 | 56,325 | 5,999 | 11 | % | ||||||||||||||||||||||
|
Loss from operations |
(712 | ) | (3,233 | ) | 2,521 | (78 | %) | (3,246 | ) | (11,697 | ) | 8,451 | (72 | %) | ||||||||||||||||||
|
Interest and other income, net |
390 | 997 | (607 | ) | (61 | %) | 1,483 | 1,626 | (143 | ) | (9 | %) | ||||||||||||||||||||
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Loss before income taxes |
(322 | ) | (2,236 | ) | 1,914 | (86 | %) | (1,763 | ) | (10,071 | ) | 8,308 | (82 | %) | ||||||||||||||||||
|
(Benefit from) Provision for income taxes |
(11 | ) | 939 | (950 | ) | (101 | %) | 295 | 1,709 | (1,414 | ) | (83 | %) | |||||||||||||||||||
|
Loss from continuing operations |
(311 | ) | (3,175 | ) | 2,864 | (90 | %) | (2,058 | ) | (11,780 | ) | 9,722 | (83 | %) | ||||||||||||||||||
|
Income from discontinued operations, net of tax |
- | 846 | (846 | ) | (100 | %) | - | 608 | (608 | ) | (100 | %) | ||||||||||||||||||||
|
Net loss |
$ | (311 | ) | $ | (2,329 | ) | $ | 2,018 | (87 | %) | $ | (2,058 | ) | $ | (11,172 | ) | $ | 9,114 | (82 | %) | ||||||||||||
Revenue
The following table presents revenue by product family for the three and nine-month periods ended September 30, 2026, and 2025:
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Three Months Ended September 30, |
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|
2026 |
2025 |
$ Change |
% Change |
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|
(in thousands, except percentages) |
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Original Equipment Manufacturer (“OEM”) Channel |
$ | 16,601 | $ | 15,844 | $ | 757 | 5 | % | ||||||||
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Commercial Channel |
13,993 | 11,973 | 2,020 | 17 | % | |||||||||||
| $ | 30,594 | $ | 27,817 | $ | 2,777 | 10 | % | |||||||||
|
Nine Months Ended September 30, |
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|
2026 |
2025 |
$ Change |
% Change |
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|
(in thousands, except percentages) |
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|
Original Equipment Manufacturer (“OEM”) Channel |
$ | 52,341 | $ | 47,093 | $ | 5,248 | 11 | % | ||||||||
|
Commercial Channel |
40,475 | 35,111 | 5,364 | 15 | % | |||||||||||
| $ | 92,816 | $ | 82,204 | $ | 10,612 | 13 | % | |||||||||
Revenue for the three- and nine-month periods ended September 30, 2026 were $30.6 million and $92.8 million, respectively, representing increases of $2.8 million and $10.6 million, or 10% and 13%, respectively, compared to the same period in 2025. The increase was primarily driven by higher Commercial Channel revenue due to international OA pain management revenues and Integrity product sales as well as higher OEM revenue through our OEM Channel partners, primarily DePuy Synthes.
Revenue from our OEM Channel product family increased 5% and 11% for the three- and nine-month periods ended September 30, 2026, respectively, compared to the same periods in 2025. For the three-month period ended September 30, 2026, the $0.8 million increase was due to a $0.5 million increase in non-orthopedic revenues primarily from the relaunch of Hyalomatrix and higher veterinary revenue; and a $0.3 million increase in DePuy Synthes revenues due to a $1.3 million increase in volume, primarily on Monovisc sales, offset by a $1.0 million decrease due to lower pricing. For the nine-month period September 30, 2026, the $5.2 million increase in OEM Channel revenue was primarily attributable to a $4.4 million increase in DePuy Synthes revenue, due to a $10.1 million increase in sales volume, offset by a $5.7 million decrease due to lower pricing and a $0.8 million increase in non-orthopedic revenues from higher Hyvisc, Hyalomatrix and Hyalobarrier product sales.
Revenue from our Commercial Channel product family increased 17% and 15% for the three- and nine-month periods ended September 30, 2026, respectively, compared to the same periods in 2025. For the three-month period ended September 30, 2026, Commercial Channel revenue increased by $2.0 million, driven by a $1.6 million increase in international OA Pain Management revenues, primarily from higher sales of Monovisc and Cingal and a $0.4 million increase in regenerative revenue, primarily from sales of Integrity products. For the nine-month period ended September 30, 2026, Commercial Channel revenue increased by $5.4 million, driven by a $3.9 million increase in international OA Pain Management revenues, primarily from higher sales volume of Monovisc and Cingal and a $1.4 million increase in regenerative revenue, primarily from sales of Integrity and Hyalofast products.
Gross Profit and Margin
Gross profit for the three- and nine-month periods ended September 30, 2026, was $18.8 million and $59.1 million, respectively. Gross profit for the three- and nine-month periods ended September 30, 2025, was $15.6 million and $44.6 million, respectively. The increase in gross profit for the three- and nine-month periods ended September 30, 2026, was primarily related to higher sales volumes and manufacturing productivity.
Gross margin for the three- and nine-month periods ended September 30, 2026, was 62% and 64%, respectively. Gross margin was 56% and 54% for the three- and nine-month periods ended September 30, 2025, respectively. The increase in gross margin was due to higher sales volume, increased manufacturing production, lower inventory reserves and improved product sales mix, primarily from higher DePuy Synthes revenues.
Research and Development
Research and development expenses for the three- and nine-month periods ended September 30, 2026, and 2025 were as follows:
|
Three Months Ended September 30, |
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|
2026 |
2025 |
$ Change |
% Change |
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|
(in thousands, except percentages) |
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|
External costs by program |
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|
Hyalofast clinical study |
$ | 176 | $ | 671 | $ | (495 | ) | (74 | %) | |||||||
|
Integrity development costs |
322 | 286 | 36 | 13 | % | |||||||||||
|
Cingal clinical study |
830 | 1,058 | (228 | ) | (22 | %) | ||||||||||
|
Regulatory external costs |
390 | 118 | 272 | 230 | % | |||||||||||
|
Other early programs and unallocated expenses |
1,290 | 1,118 | 172 | 15 | % | |||||||||||
|
Total external costs |
3,008 | 3,251 | (243 | ) | (8 | %) | ||||||||||
|
Internal costs: |
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|
Employee compensation and benefits |
4,300 | 3,171 | 1,129 | 36 | % | |||||||||||
|
Facility and other |
587 | 524 | 63 | 12 | % | |||||||||||
|
Total internal costs |
4,887 | 3,695 | 1,192 | 32 | % | |||||||||||
|
Total research and development expense |
$ | 7,895 | $ | 6,946 | $ | 949 | 14 | % | ||||||||
|
Nine Months Ended September 30, |
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|
2026 |
2025 |
$ Change |
% Change |
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|
(in thousands, except percentages) |
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|
External costs by program |
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|
Hyalofast clinical study |
$ | 790 | $ | 1,812 | $ | (1,022 | ) | (56 | %) | |||||||
|
Integrity development costs |
957 | 1,017 | (60 | ) | (6 | %) | ||||||||||
|
Cingal clinical study |
2,415 | 2,096 | 319 | 15 | % | |||||||||||
|
Regulatory external costs |
989 | 675 | 314 | 47 | % | |||||||||||
|
Other early programs and unallocated expenses |
3,310 | 2,766 | 544 | 20 | % | |||||||||||
|
Total external costs |
8,461 | 8,366 | 95 | 1 | % | |||||||||||
|
Internal costs: |
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|
Employee compensation and benefits |
11,773 | 9,495 | 2,278 | 24 | % | |||||||||||
|
Facility and other |
1,715 | 1,457 | 258 | 18 | % | |||||||||||
|
Total internal costs |
13,488 | 10,952 | 2,536 | 23 | % | |||||||||||
|
Total research and development expense |
$ | 21,949 | $ | 19,318 | $ | 2,631 | 14 | % | ||||||||
Research and development external costs were $3.0 million and $8.5 million for the three- and nine-month periods ended September 30, 2026, respectively, compared to $3.3 million and $8.4 million for the corresponding periods in 2025. The decrease in external research and development costs for the three-month period ended September 30, 2026 was primarily driven by lower spending on the Hyalofast and Cingal clinical studies. For the nine-month period ended September 30, 2026, external research and development costs increased slightly by $0.1 million, primarily from higher clinical spending on Cingal and an increase in regulatory and new product development costs, offset by a decrease in Hyalofast clinical expenditures related to PMA submission to the FDA in late 2025.
Research and development internal costs were $4.9 million and $13.5 million for the three- and nine-month periods ended September 30, 2026, respectively, compared to $3.7 million and $11.0 million for the corresponding periods in 2025. The increase in the three-month period ended September 30, 2026, was primarily driven by higher employee-related costs, mostly related to higher stock-based compensation expense and investments to support Cingal CMC efforts. The increase in the nine-month period ended September 30, 2026, was primarily driven by higher employee-related costs, mostly related to higher stock-based compensation expense and investments to support Cingal CMC efforts and, to support product development and clinical programs.
Selling, General and Administrative
Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2026, were $11.7 million and $40.4 million, respectively. Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2025 were $11.9 million and $37.0 million, respectively. The decrease for the three-month period ended September 30, 2026 was due primarily to a $0.7 million decrease in legal expenses and lower employee-related costs due to a reduction in headcount offset by a $1.4 million increase in stock-based compensation. The increase for the nine-month period ended September 30, 2026, was primarily due to $2.5 million in severance costs and a $3.9 million increase in stock-based compensation primarily related to a charge during the three-month period ended March 31, 2026, for the transition of our former Chief Executive Officer, which was partially offset by a $1.2 million decrease in legal expense and lower headcount costs.
Loss from Continuing Operations
For the three- and nine-month periods ended September 30, 2026, loss from continuing operations was $0.3 million and $2.1 million, respectively. For the three- and nine-month periods ended September 30, 2025, loss from continuing operations was $3.2 million and $11.8 million, respectively. The decrease in loss from continuing operations was primarily due to higher revenue and improved gross margin driven by higher manufacturing production and efficiencies.
Income Taxes
We had a small income tax benefit for the three-month period ended September 30, 2026, and $0.3 million in income tax expense for the nine-month period ended September 30, 2026, resulting in effective tax rates of 3.4% and (16.7)%, respectively. We had income tax expense of $0.9 million and $1.7 million for the three- and nine-month periods ended September 30, 2025, resulting in an effective tax rate of (42.0)% and (17.0)%, respectively. Our effective tax rate for the three-month and nine-month periods ended September 30, 2026, was primarily driven by the full valuation on our deferred tax assets in the United States and our projected taxable income resulting in current tax expense in 2026.
Non-GAAP Financial Measures
We present certain information with respect to adjusted Earnings Before Interest, Tax, Depreciation and Amortization, or EBITDA, adjusted net income from continuing operations, and adjusted diluted earnings per share or adjusted EPS from continuing operations, which are financial measures not based on any standardized methodology prescribed by accounting principles generally accepted in the United States, or GAAP, and are not necessarily comparable to similarly titled measures presented by other companies.
We have presented adjusted EBITDA, adjusted net income from continuing operations, and adjusted EPS from continuing operations, because they are key measures used by our management and board of directors to understand and evaluate our operating performance and to develop operational goals for managing our business. We believe these financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude. In particular, we believe that the exclusion of these items in calculating these measures can provide a useful tool for period-to-period comparisons of our core operating performance. Accordingly, we believe that these measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects and allowing for greater transparency with respect to key financial metrics used by our management in their financial and operational decision-making.
Adjusted EBITDA
We present information below with respect to adjusted EBITDA, which we define as our net loss from continuing operations excluding interest and other income, net, income tax benefit (provision), depreciation and amortization, stock-based compensation expense, non-recurring professional fees and severance costs.
Adjusted EBITDA is not prepared in accordance with GAAP, and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of adjusted EBITDA rather than net loss from continuing operations, which is the nearest GAAP equivalent. Some of these limitations are:
|
● |
adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; |
|
● |
we exclude stock-based compensation expense from adjusted EBITDA although (a) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy and (b) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; |
|
● |
the expenses and other items that we exclude in our calculation of adjusted EBITDA may differ from the expenses and other items, if any, that other companies may exclude from adjusted EBITDA when they report their operating results; |
The following is a reconciliation of adjusted EBITDA, a non-GAAP metric, to net loss from continuing operations, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2026, and 2025, respectively:
|
For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
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|
2026 |
2025 |
2026 |
2025 |
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|
Net loss from continuing operations |
$ | (311 | ) | $ | (3,175 | ) | $ | (2,058 | ) | $ | (11,780 | ) | ||||
|
Interest and other income, net |
(390 | ) | (997 | ) | (1,483 | ) | (1,626 | ) | ||||||||
|
(Benefit from) provision for income taxes |
(11 | ) | 939 | 295 | 1,709 | |||||||||||
|
Depreciation and amortization |
1,439 | 1,403 | 4,351 | 4,263 | ||||||||||||
|
Stock-based compensation expense |
4,244 | 2,215 | 12,718 | 7,758 | ||||||||||||
|
Non-recurring professional fees |
- | 480 | 169 | 480 | ||||||||||||
|
Severance costs |
127 | - | 2,486 | - | ||||||||||||
|
Adjusted EBITDA |
$ | 5,098 | $ | 865 | $ | 16,478 | $ | 804 | ||||||||
Adjusted EBITDA for the three-month period ended September 30, 2026 increased by $4.2 million compared to the same period in 2025. The increase was primarily driven by higher revenue as well as higher gross profit resulting from manufacturing efficiencies and favorable product mix.
Adjusted EBITDA in the nine-month period ended September 30, 2026, increased $15.7 million compared to the same period in 2025. The increase was primarily driven by higher revenue and higher gross profit from manufacturing efficiencies, favorable product mix and lower inventory-related reserves.
Adjusted Net Income (Loss) From Continuing Operations and Adjusted EPS From Continuing Operations
We present information below with respect to adjusted net income (loss) from continuing operations and adjusted EPS. We define adjusted net income (loss) from continuing operations as our net loss from continuing operations excluding, stock-based compensation expense, non-recurring professional fees and severance costs, all on a tax-effected basis. We define adjusted EPS as GAAP diluted earnings per share excluding the above adjustments to net loss from continuing operations used in calculating adjusted net income (loss) from continuing operations, each on a per share and tax effected basis.
The following is a reconciliation of adjusted net income (loss) from continuing operations, a non-GAAP metric, to net loss from continuing operations, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2026, and 2025, respectively:
|
For the Three Months Ended |
For the Nine Months Ended |
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|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Net loss from continuing operations |
$ | (311 | ) | $ | (3,175 | ) | $ | (2,058 | ) | $ | (11,780 | ) | ||||
|
Stock-based compensation, tax effected |
4,099 | 3,145 | 14,846 | 9,075 | ||||||||||||
|
Non-recurring professional fees, tax effected |
- | 682 | 197 | 561 | ||||||||||||
|
Severance costs, tax effected |
123 | - | 2,902 | - | ||||||||||||
| Adjusted net income (loss) from continuing operations | $ | 3,911 | $ | 652 | $ | 15,887 | $ | (2,144 | ) | |||||||
The following is a reconciliation of adjusted diluted EPS from continuing operations, a non-GAAP metric, to diluted EPS from continuing operations, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2026, and 2025, respectively:
|
For the Three Months Ended |
For the Nine Months Ended |
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|
2026 |
2025 |
2026 |
2025 |
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|
Diluted loss from continuing operations per share |
$ | (0.02 | ) | $ | (0.22 | ) | $ | (0.15 | ) | $ | (0.82 | ) | ||||
|
Share based compensation, tax effected |
0.30 | 0.21 | 1.11 | 0.63 | ||||||||||||
|
Non-recurring professional fees, tax effected |
- | 0.05 | - | 0.04 | ||||||||||||
|
Severance costs, tax effected |
0.01 | - | 0.22 | - | ||||||||||||
|
Adjusted diluted income (loss) from continuing operations per share |
$ | 0.29 | $ | 0.04 | $ | 1.18 | $ | (0.15 | ) | |||||||
Adjusted net income from continuing operations and adjusted diluted EPS in the three-month period ended September 30, 2026, increased $3.2 million and $0.25 respectively compared to the same period in 2025. The increase for the period was primarily due to higher revenue and improved gross profit from favorable product mix and improved manufacturing efficiencies.
Adjusted net income from continuing operations and adjusted diluted EPS in the nine-month period ended September 30, 2026, increased $18.0 million and $1.33, respectively, compared to the same period in 2025. The increase for the period was primarily due higher revenue and improved gross profit driven by manufacturing efficiencies, favorable product mix and lower inventory-related reserves as well as lower operating expenses, excluding stock-based compensation and depreciation and amortization.
Liquidity and Capital Resources
We require cash to fund our operating activities and to make capital expenditures and other investments in our business. We expect that our requirements for cash to fund these uses will increase as our operations expand. We continue to generate cash from operating activities and believe that our operating cash flows, cash currently on our balance sheet and availability under our credit facility will be sufficient to allow us to continue to invest in our existing business, to manage our capital structure on a short and long-term basis, and to meet our anticipated operating cash needs. Cash and cash equivalents aggregated $45.0 million and $57.5 million, and working capital totaled $76.3 million and $81.5 million, at September 30, 2026 and December 31, 2025, respectively.
On July 10, 2026, we entered into a Fifth Amendment to Credit Agreement with Bank of America N.A. as administrative agent, which amended our existing revolving line of credit agreement dated October 24, 2017, which provides up to $50.0 million in the form of a senior revolving line of credit. Subject to certain conditions, we may request up to an additional $50.0 million for a maximum aggregate commitment of $100.0 million. As of September 30, 2026, and December 31, 2025, there were no outstanding borrowings, and we are in compliance with the terms of the credit facility.
Summary of Cash Flows (in thousands):
|
Nine Months Ended September 30, |
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|
2026 |
2025 |
|||||||
|
Cash (used in) provided by |
||||||||
|
Operating activities |
$ | 2,847 | $ | 6,551 | ||||
|
Investing activities |
(4,275 | ) | (599 | ) | ||||
|
Financing activities |
(11,075 | ) | (5,272 | ) | ||||
|
Effect of exchange rate changes on cash |
(21 | ) | 151 | |||||
|
Net (decrease) increase in cash and cash equivalents |
$ | (12,524 | ) | $ | 831 | |||
The following changes contributed to the net change in cash and cash equivalents in the nine-month period ended September 30, 2026, as compared to the same period in 2025.
Operating Activities
Cash provided by operating activities was $2.8 million for the nine-month period ended September 30, 2026, compared to cash provided by operating activities of $6.6 million for the same period in 2025. The decrease in cash provided by operating activities was primarily due to higher inventory levels resulting in unfavorable working capital, partially offset by improved earnings and higher non-cash charges including stock-based compensation expense and depreciation of fixed assets.
Investing Activities
Cash used in investing activities was $4.3 million for the nine-month period ended September 30, 2026 compared to cash used in investing activities of $0.6 million for the same period in 2025. The change was primarily due to $4.5 million received from the sale of Parcus Medical in March 2025. Capital expenditure was $4.6 million in the nine-month period ended September 30, 2026, compared to $6.2 million for the same period in 2025. The decrease in capital expenditure was due to timing of purchases related to our continued manufacturing capacity expansion at our facility in Bedford, Massachusetts.
Financing Activities
Cash used in financing activities was $11 million for the nine-month period ended September 30, 2026, compared to cash used in financing activities of $5.3 million for the same period in 2025. The change was primarily due to increased repurchases of common stock and an increase in cash paid for withholding tax on employee restricted stock award vestings.
Critical Accounting Policies and Estimates
The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. We believe that our accounting policies for revenue recognition, accounts receivable and allowance for credit losses, goodwill, acquired in-process research and development, inventory and contingencies are based on, among other things, judgments and assumptions made by management that include inherent risks and uncertainties. There have been no significant changes to the above critical accounting policies or in the underlying accounting assumptions and estimates used in such policies from those disclosed in our annual consolidated financial statements and accompanying notes included in our 2025 Form 10-K. We monitor our estimates on an ongoing basis for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are recorded in the period in which they become known. We base our estimates on historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.
Recent Accounting Pronouncements
A discussion of Recent Accounting Pronouncements is included in our 2025 Form 10-K and is updated in the Notes to the condensed consolidated financial statements included in this report.
|
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Our market risks and the ways we manage them are summarized in the section captioned “Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our 2025 Form 10-K. There have been no material changes in the first nine months of 2026 to our market risks or to our management of such risks.
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ITEM 4. |
CONTROLS AND PROCEDURES |
(a) Evaluation of disclosure controls and procedures.
Under the supervision and with the participation of our management, including our chief executive officer (who is also our principal financial officer), we have evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined by Rules 13a-15(e) and 15d-15(e) of the Exchange Act, as of the end of the period covered by this report. Based upon that evaluation, the chief executive officer (who is also our principal financial officer) concluded as of September 30, 2026, that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in SEC rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. On an on-going basis, we review and document our disclosure controls and procedures, and our internal control over financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
(b) Changes in internal control over financial reporting.
There were no material changes in our internal control over financial reporting during the quarter ended September 30, 2026, that have materially affected, or were reasonably likely to materially affect, our internal control over financial reporting.
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PART II: |
OTHER INFORMATION |
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ITEM 1. |
LEGAL PROCEEDINGS |
We are involved from time-to-time in various legal proceedings arising in the normal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, we do not expect the resolution of these occasional legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flow. There have been no material changes to the information provided in the section captioned “Part I, Item 3. Legal Proceedings” in our 2025 Form 10-K.
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ITEM 1A. |
RISK FACTORS |
There have been no material changes to the risk factors described in the section captioned “Part I, Item 1A. Risk Factors” in our 2025 Form 10-K. In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section captioned “Part I, Item 1A. Risk Factors” in our 2025 Form 10-K, which could materially affect our business, financial condition, or future results. The risks described in our 2025 Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may have a material adverse effect on our business, financial condition, and/or operating results.
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ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Issuer Purchases of Equity Securities
None.
Recent Sales of Unregistered Securities
None.
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ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES |
None.
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ITEM 4. |
MINE SAFETY DISCLOSURES. |
Not applicable.
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ITEM 5. |
OTHER INFORMATION. |
Rule 10b5-1 Trading Plans
During the fiscal quarter ended September 30, 2026, none of our directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.”
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ITEM 6. |
EXHIBITS |
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Exhibit No. |
Description |
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3.1 |
Certificate of Incorporation of Anika Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K (File No. 001-14027) filed by the Registrant on June 6, 2018) |
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3.2 |
Bylaws of Anika Therapeutics, Inc., effective as of June 6, 2018 (incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K (File No. 001-14027) filed by the Registrant on June 6, 2018) |
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10.3 |
Fifth Amendment to Credit Agreement dated as of July 10, 2026, by and among Anika Therapeutics, Inc., the Subsidiary Guarantors party thereto, the Lenders party thereto, Bank of America, N.A., as administrative agent, L/C Issuer and Swingline Lender, and the other parties thereto (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on July 14, 2026. |
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*31.1 |
Certification of Stephen Griffin, pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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**32.1 |
Certification of Stephen Griffin, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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*101. INS |
Inline XBRL Instance Document |
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*101.SCH |
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents. |
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104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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* |
Filed herewith. |
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** |
Furnished herewith. |
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 thereunto duly authorized.
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ANIKA THERAPEUTICS, INC. |
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(Registrant) |
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Date: November 6, 2026 |
By: |
/s/ STEPHEN GRIFFIN |
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Stephen Griffin |
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President and Chief Executive Officer |
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(Authorized Officer and Principal Financial Officer) |
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