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Item 9A. Controls and Procedures

2026-02-27 compared with 2025-02-28 · 42 added, 112 removed, 167 unchanged (48% of the section changed)

19 unchanged sentences

Based on this assessment, management has concluded that, as of December 31, 2025, our internal control over financial reporting is effective.

The scope of management's assessment of the effectiveness of internal control over financial reporting includes all of the Company's consolidated operations except for the operations of Alimera, which the Company acquired on September 16, 2024.

Alimera's operations represent approximately 5% of the Company's consolidated revenues for the year ended December 31, 2024, and assets associated with Alimera's operations represent approximately 1% of the Company's consolidated assets, as of December 31, 2024.

Management has concluded that the Consolidated Financial Statements included in this Annual Report on Form 10-K present fairly, in all material respects, the Company’s financial position, results of operations and cash flows for the periods disclosed in conformity with U.S.

The effectiveness of the Company’s internal control over financial reporting as of December 31, 2025 has been audited by EisnerAmper LLP, an independent registered public accounting firm, as stated in their attestation report, included herein.

Changes in Internal Control over Financial Reporting

On September 16, 2024, we completed the acquisition of Alimera.

Other than the addition of Alimera’s operations to our internal control over financial reporting and any related changes in control to integrate Alimera into ANI Pharmaceuticals, Inc., there has not been any change in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

See Note 3 “ Business Combination" of the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K for additional information on this acquisition.

There were no other changes in our internal control over financial reporting during the quarter end ed December 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were no changes in our internal control over financial reporting during the quarter end ed December 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information

Trading Arrangements

During the fiscal quarter ended December 31, 2024, none of our directors or officers informed us of the adoption or termination of a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as those terms are defined in Regulation S-K, Item 408(a).

Non-Renewal of YUTIQ Supply Agreement

On February 27, 2025, the Company received written notice of non-renewal from EyePoint, effective May 31, 2025, of the YUTIQ Supply Agreement, dated May 17, 2023, by and among Alimera and EyePoint.

under which EyePoint manufactures YUTIQ for ANI.

Under the YUTIQ Supply Agreement, EyePoint is responsible for manufacturing and exclusively supplying to the Company agreed-upon quantities of YUTIQ necessary for the Company to commercialize YUTIQ in the U.S.

at certain cost plus amounts, subject to adjustments as set forth in the YUTIQ Supply Agreement.

The YUTIQ Supply Agreement contains customary representations and warranties.

A copy of the YUTIQ Supply Agreement was filed as Exhibit 10.1 to the Alimera’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 18, 2023.

The above description of the YUTIQ Supply Agreement is qualified in its entirety by reference to such exhibit.

During the fiscal quarter ended December 31, 2025, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) entered into, adopted, modified (as to the amount, price or timing of trades), or terminated (i) contracts, instructions or written plans for the purchase or sale of our securities that are intended to satisfy the conditions specified in a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as those terms are defined in Regulation S-K, Item 408(a).

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

14 unchanged sentences

Principal Accountant Fees and Services

Our independent registered public accounting firm is EisnerAmper LLP , West Palm Beach, Florida , Auditor Firm ID:

Our independent registered public accounting firm is EisnerAmper LLP , Iselin, New Jersey , Auditor Firm ID:

Information required by this item with respect to principal accounting fees and services will be set forth under the caption “Ratification of Selection of Independent Registered Public Accountants” in our definitive proxy statement for our 2026 annual meeting, to be filed with the SEC pursuant to Regulation 14A no later than 120 days after the close of our fiscal year, and is incorporated herein by reference.

2 unchanged sentences

(a) Financial Statements:

The consolidated balance sheets of the Registrant as of December 31, 2024 and 2023, the related consolidated statements of operations, statements of other comprehensive (loss) income , changes in stockholders’ equity, and cash flows for each of the years ended December 31, 2024, 2023, and 2022, the footnotes thereto, and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.

The consolidated balance sheets of the Registrant as of December 31, 2025 and 2024, the related consolidated statements of operations, statements of other comprehensive income (loss) , changes in stockholders’ equity, and cash flows for each of the years ended December 31, 2025, 2024, and 2023, the footnotes thereto, and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.

(b) Financial Statement Schedules:

6 unchanged sentences

Exhibit Method of Filing

2.1 Amended and Restated Agreement and Plan of Merger, dated as of April 12, 2013, by and among BioSante Pharmaceuticals, Inc., ANI Merger Sub, Inc.

and ANIP Acquisition Company (1)

Incorporated by reference to Exhibit 2.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on April 12, 2013 (File No.

2.2 Agreement and Plan of Merger dated March 8, 2021 by and among ANI Pharmaceuticals, Inc., Nile Merger Sub LLC, Novitium Pharma LLC, Esjay LLC, Chali Properties, LLC, Chad Gassert, Muthusamy Shanmugam and Thorappadi Vijayaraj and Shareholder Representative Services LLC as the representative of the Company Members

Incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 9, 2021 (File No.

2.3 A greement an d Plan of Merger dated June 21, 2024, by and among ANI Pharmaceuticals, Inc., ANIP Merger Sup INC .

and A limera Sciences, Inc.

2.3 Agreement and Plan of Merger dated June 21, 2024, by and among ANI Pharmaceuticals, Inc., ANIP Merger Sup INC.

and Alimera Sciences, Inc.

Incorporated by reference to Exhibit 2.1 to ANI's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 (File No.

1 unchanged sentence

Incorporated by reference to Exhibit 3.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013 (File No.

3.2 C ertificate of Amendment to the Restated Certificate of Incorporation of ANI Pharmaceuticals, Inc., dated May 22, 2025

Incorporated by reference to Exhibit 3.1 to ANI's Current Report on Form 8-K filed on May 22, 2025 (File No.

3.3 Second Amended and Restated Bylaws of ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 3.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on March 6, 2023 (File No.

3.3 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company, effective as of November 19, 2021.

Incorporated by reference to Exhibit 3.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

4.1 Description of Securities

Incorporated by reference to Exhibit 4.1 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (File No.

4.2 Registration Rights Schedule to the Merger Agreement, effective as of November 19, 2021

Incorporated by reference to Exhibit 4.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

4.3 I ndenture, dated as of A ugust 13, 2024, between ANI Pharmaceuticals, Inc.

Bank Trust Company, National Association, as tru stee

Filed herewith

4.3 Indenture, dated as of August 13, 2024, between ANI Pharmaceuticals, Inc.

Bank Trust Company, National Association, as trustee

Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K filed on August 13, 2024 (File No.

4.4 F orm of Certificate representing the 2.25% Convertible Senior Note s due 2029 (included as Exhibit A to Exhibit 4.3)

4.4 Form of Certificate representing the 2.25% Convertible Senior Notes due 2029 (included as Exhibit A to Exhibit 4.3)

Incorporated by reference to Exhibit 4.2 to ANI's Current Report on Form 8-K filed on August 13, 2024 (File No.

Exhibit Method of Filing

Employment Agreement, entered into by the Company and Stephen P.

4 unchanged sentences

Incorporated by reference to Exhibit 10.3 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

Exhibit Method of Filing

Employment Agreement between and Christopher Mutz and the Company, dated February 10, 2021.

2 unchanged sentences

Incorporated by reference to Exhibit 10.27 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Employment Agreement between Chad Gassert and the Company, dated March 8, 2021.

Incorporated by reference to Exhibit 10.28 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Employment Agreement between Meredith Cook and the Company, dated June 21, 2022.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 (File No.

Employment Agreement between Krista Davis and ANI Pharmaceuticals, Inc.

dated July 14, 2022.

Amendment No.

1 to Employment Agreement between Stephen P.

Carey and ANI Pharmaceuticals, Inc., dated October 27, 2025

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 (File No.

Amendment No.

2 to Asset Purchase Agreement, dated as of July 10, 2015, Teva Pharmaceuticals, Inc.

and ANI Pharmaceuticals, Inc.

1 to Employment Agreement between Meredith Cook and ANI Pharmaceuticals, Inc., dated October 27, 2025

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 (File No.

Amendment No.

1 to Employment Agreement between Ori Gutwerg and ANI Pharmaceuticals, Inc., dated October 27, 2025

Incorporated by reference to Exhibit 10.5 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 (File No.

Amendment No.

1 to Employment Agreement between Nikhil Lalwani and ANI Pharmaceuticals, Inc., dated October 27, 2025

Incorporated by reference to Exhibit 10.6 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 (File No.

Amendment No.

1 to Employment Agreement between Christopher Mutz and ANI Pharmaceuticals, Inc., dated October 27, 2025

Incorporated by reference to Exhibit 10.7 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 (File No.

Amendment No.

1 to Employment Agreement between Muthusamy Shanmugam and ANI Pharmaceuticals, Inc., dated October 27, 2025

Incorporated by reference to Exhibit 10.8 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 (File No.

10.13 Asset Purchase Agreement, dated as of September 18, 2015, between Merck Sharp & Dohme B.V.

3 unchanged sentences

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2016 (File No.

10.12 Asset Purchase Agreement between AstraZeneca AB, AstraZeneca UK Limited, and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.25 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (File No.

10.13 Asset Purchase Agreement between Amerigen Pharmaceuticals LTD.

and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.24 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (File No.

Exhibit Method of Filing

10.14 Credit Agreement, dated as of November 19, 2021 by and among the Company, certain of the Company’s subsidiaries, as guarantors, Truist Bank, as Administrative Agent and other parties party thereto.

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

10.15 Equity Commitment and Investment Agreement, dated as of March 8, 2021, by and between the Company and Ampersand 2020 Limited Partnership

Incorporated by reference to Exhibit 10.2 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on March 9, 2021 (File No.

10.16 Sublicense Agreement, dated as of October 30, 2009, by and between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., and Jazz Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.24 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

10.17 Master Product Development and Collaboration Agreement, dated as of July 11, 2011, by and among ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc.

and RiconPharma LLC (2)

Incorporated by reference to Exhibit 10.25 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

10.18 Asset Purchase Agreement between Cranford Pharmaceuticals, LLC and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2022 (File No.

10.19 Asset Purchase Agreement between Holmdel Pharmaceuticals, LP and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2022 (File No.

ANI Pharmaceuticals, Inc.

Ame nded and Re stated ANI Pharmaceuticals, Inc.

2016 Employee Stock Purchase Plan

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement on Schedule 14A filed with the Commission on April 14, 2016

ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.1 to ANI's Form S-8 filed on July 11, 2025 (File No.

Amended and Restated 2022 Stock Incentive Plan

Incorporated by reference Appendix A to ANI Pharmaceuticals, Inc.’s definitive proxy statement dated March 25, 2022 filed with the Securities and Exchange Commission on March 25, 2022 (File No.

A mended and Restated 2022 Stock Incentive Plan

Incorporated by reference to Appendix A to ANI's Definitive Proxy Statement on Schedule 14A filed with the Commission on April 5, 2024

A mended 2022 Stock Plan, Form of Restric ted Stock Grant Agreement (Directors)

Incorporated by reference to Exhibit 10.2 to ANI's Current Report on Form 8-K filed on May 23, 2024 (File No.

A mended 2022 Stock Plan, Form of Restri cted Stock Grant Agreement (Employee s)

Incorporated by reference to Exhibit 10.3 to ANI's Current Report on Form 8-K filed May 23, 2024 (File No.

Amendment No.

2023-1 to ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan (including form of Performance Stock Unit Award Agreement)

Incorporated by reference to Exhibit 10.1 to ANI's Form S-8 filed on June 23, 2023 (File No.

Incorporated by reference to Exhibit 10.1 to ANI's Form S-8 filed on July 11, 2025 (File No.

Exhibit Method of Filing

Amendment No.

2024-2 to ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan

Incorporated by reference to Exhibit 10.24 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (File No.

A NI Pharmaceuticals, Inc.

Am ended and Restated 2022 Stock Incentive Plan Sub-Plan for U.K.

Incorporated by reference to Exhibit 10.4 to ANI's Quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2024 (File No.

A NI Pharmaceuticals, Inc.

Am ended and Restated 2022 Stock Incentive Plan Notice of Restricted Stock Grant

ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan Sub-Plan for U.K.

Incorporated by reference to Exhibit 10.4 to ANI's Quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2024 (File No.

Form of Restricted Stock Grant Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2022 Virtual Annual Meeting filed on March 25, 2022 (File No.

Form of Stock Option Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2022 Virtual Annual Meeting filed on March 25, 2022 (File No.

Inducement Stock Option Award Agreement, effective as of September 8, 2020, between ANI Pharmaceuticals, Inc.

4 unchanged sentences

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed on February 28, 2022 (File No.

10.33 Amendment No.

1 to the Credit Agreement, dated as of July 3, 2023 by and among the Company, and Truist Bank, as Administrative Agent.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2023 (File No.

10.34 Underwriting Agreement, dated May 11, 2023, by and between ANI Pharmaceuticals, Inc.

and Guggenheim Securities, LLC

Incorporated by reference to Exhibit 1.1 to ANI’s Current Report on Form 8-K filed on May 12, 2023 (File No.

10.20 Assignment and Technology Transfer Agreement between BioSante Pharmaceuticals, Inc.

1 unchanged sentence

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024 (File No.

10.36 Voting Agreement, dated June 21, 2024, by and among ANI Pharmaceuticals, Inc., Alimera Sciences, Inc.

and Caligan Partners LP, Caligan Partners Master Fund LP and Caligan Partners CV VI LP

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed on June 24, 2024 (File No.

10.21 Form of Capped Call Transaction Confirmation

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed on August 13, 2024 (File No.

Exhibit Method of Filing

Credit Agreement, dated as of August 13, 2024, among ANI Pharmaceuticals, Inc., ANIP Acquisition Company, the guarantors party thereto., JPMorgan Chase Bank, N.A., as administrative agent, and other financial institutions as lenders

3 unchanged sentences

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed on September 20, 2024 (File No.

10.40 Agreement of Purchase and Sale between ANI Pharmaceuticals Canada, Inc.

and 1540700 Ontario Limited

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed on February 23, 2024 (File No.

10.41 Purchase and Sale Agreement between ANI Pharmaceuticals Canada Inc.

and Mastercom Inc.

Incorporated by reference to Exhibit 10.31 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (File No.

10.42 Amendment to Purchase and Sale Agreement between ANI Pharmaceuticals Canada Inc.

and Mastercom Inc.

Incorporated by reference to Exhibit 10.32 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (File No.

10.43 Notice of Termination of Purchase and Sale Agreement between ANI Pharmaceuticals Canada Inc.

and Mastercom Inc.

Incorporated by reference to Exhibit 10.33 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (File No.

10.24 Form of Indemnification Agreement

Incorporated by reference to Exhibit 10.34 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (File No.

19.1 A NI Pharmaceuticals, In c.

19.1 ANI Pharmaceuticals, Inc.

Insider Trading Policy

Filed herewith

Incorporated by reference to Exhibit 19.1 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (File No.

21 List of subsidiaries

54 unchanged sentences

Muthusamy Shanmugam

/s/ Patrick D.

Walsh Director and Chairman of the Board of

Directors February 28, 2025

/s/ Thomas J.

Haughey Director February 28, 2025

Haughey Director and Chairman of the Board of

Directors February 27, 2026

/s/ Matthew J.

Leonard Director February 27, 2026

/s/ Jeanne Thoma Director February 28, 2025

/s/ Antonio Pera Director February 27, 2026

1 unchanged sentence

Renee Tannenbaum

/s/ Jeanne Thoma Director February 27, 2026

/s/ Patrick D.

Walsh Director February 27, 2026

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures