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Item 9A. Controls and Procedures

2025-02-28 compared with 2024-02-29 · 79 added, 58 removed, 200 unchanged (41% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures are controls and other procedures that are designed to ensure information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our principal executive officer and principal financial officers, as appropriate, to allow timely decisions regarding required disclosures.

In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

Our management has carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 154-15(e) under the Exchange Act), as of December 31, 2023.

Based on this evaluation, our principal executive officer and principal financial officers concluded that our disclosure controls and procedures were effective as of December 31, 2023.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

Our management has carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of December 31, 2024 .

Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective at the reasonable assurance level.

In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how well d esigned and operated, can provide only reasonable assurance of achieving the desired control objectives.

Management’s Annual Report on Internal Control over Financial Reporting

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Based on this assessment, management has concluded that, as of December 31, 2024, 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.

As disclosed in Item 9A.

Controls and Procedures in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, we identified material weaknesses related to an ineffective control environment at our Novitium subsidiary, and information technology general controls (“ITGCs”) in the areas of user access over certain information technology systems that support our financial reporting processes.

As of December 31, 2022, we determined that the designed internal controls were not operating effectively in Novitium related processes including (i) purchase to pay (purchasing, accounts payable, and cash disbursements);

(ii) manufacturing and inventory;

(iii) human resources/payroll;

(iv) financial statement close;

and (v) information technology related controls, as well as overall ITGC related to user access which were not operating effectively to adequately restrict user access to our network and financial applications and data, and therefore did not reduce the risk of a material error occurring and going undetected in our financial statements to an acceptable level giving rise to the material weaknesses.

During the fiscal year ended December 31, 2023, we implemented our material weakness remediation plan that included:

(i) refining and completing our plan to incorporate procure to pay cycle into the overall company controls;

(ii) review and revise control documentation for controls at our Novitium subsidiary;

(iii) ensure Novitium processes and controls have adequate resources to properly perform identified controls including hiring of additional resources with the requisite skills to consistently perform control procedures without material exception;

(iv) implement one ERP system for the entire company to support the internal control structure;

and (v) ensure all personnel are properly trained as to the importance of and specifics over the internal controls for which they are responsible, including consistent, repeatable performance of such controls.

We completed our testing of the operating effectiveness of the implemented controls and found them to be effective.

As a result, we have concluded the material weaknesses have been remediated as of December 31, 2023.

Our independent registered public accounting firm, EisnerAmper LLP, has issued an attestation report on the effectiveness of our internal control over financial reporting, which is included in Item 8.

Financial Statements and Supplementary Data of this Annual Report on Form 10-K.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, our 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.

Other Information

Oakville Sale

On November 6, 2023, ANI Pharmaceuticals Canada Inc., a wholly owned subsidiary of the Company, entered into an agreement (the “Agreement”) with Mastercom Inc.

for the purchase and sale of the Company's Oakville, Ontario former manufacturing facility at a total purchase price of approximately 17.9 million Canadian dollars, or approximately $13.0 million US Dollars based on the current exchange rate, subject to certain market adjustments.

On December 22, 2023, the Agreement was terminated by mutual agreement.

In February 2024, the Company entered into an agreement for the purchase and sale of the Oakville site, for a purchase price of 19.2 million Canadian Dollars, or approximately $14.2 million US Dollars, based on the current exchange rate.

The sale is expected to close in March 2024.

Trading Arrangements

Our directors and officers (as defined in Exchange Act Rule 16a-1(f)) may from time to time enter into plans or other arrangements for the purchase or sale of our shares that are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or may represent a non-Rule 10b5-1 trading arrangement under the Exchange Act.

On November 27, 2023 , Mr.

Muthusamy Shanmugam , Head of R&D and COO of NJ Operations, adopted a trading arrangement for the sale of securities of the Company’s common stock (a “Rule 10b5-1 Trading Plan”) that is intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c).

Shanmugam's Rule 10b5-1 Trading Plan, which has a term from March 4, 2024 through November 29, 2024, provides for the sale of up to 400,000 shares of common stock pursuant to the terms of the plan.

On December 12, 2023 , Mr.

Chad Gassert , Sr.

Vice President, Corporate Development and Strategy , adopted a trading arrangement for the sale of securities of the Company’s common stock (a “Rule 10b5-1 Trading Plan”) that is intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c).

Gassert's Rule 10b5-1 Trading Plan, which will terminate September 30, 2024, provides for the sale of up to 100,000 shares of common stock pursuant to the terms of the plan.

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.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

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Principal Accountant Fees and Services

Our independent registered public accounting firm is EisnerAmper LLP , Philadelphia, Pennsylvania , Auditor Firm ID:

Our independent registered public accounting firm is EisnerAmper LLP , West Palm Beach, Florida , 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 2025 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.

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(a) Financial Statements:

The consolidated balance sheets of the Registrant as of December 31, 2023 and 2022, 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, 2023, 2022, and 2021, 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, 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.

(b) Financial Statement Schedules:

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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.

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.

3.1 Certificate of Amendment of the Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc., dated as of July 17, 2013, Certificate of Amendment of the Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc., dated as of June 1, 2012, and Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc.

8 unchanged sentences

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.

Employment Agreement, entered into by the Company and James G.

Incorporated by reference to Exhibit 10.4 to ANI’s Current Report on Form 8-K filed January 22, 2020 (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

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)

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.

2 unchanged sentences

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed August 3, 2020 (File No.

Exhibit Method of Filing

Employment Agreement between Muthusamy Shanmugam and the Company, dated as of March 8, 2021 and effective as of November 19, 2021.

12 unchanged sentences

10.9 Amendment No.

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

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

and ANI Pharmaceuticals, Inc.

10 unchanged sentences

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.

Exhibit Method of Filing

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

9 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, 2022 (File No.

A NI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc.

2016 Employee Stock Purchase Plan

3 unchanged sentences

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.

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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 June 23, 2023 (File No.

Exhibit Method of Filing

Amendment No.

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Amended and Restated 2022 Stock Incentive Plan

Filed herewith

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

Incorporated by reference to Exhibit 10.5 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

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Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 (File No.

Exhibit Method of Filing

ANI Pharmaceuticals, Inc.

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

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

and Cold Genesys, Inc., dated as of November 15, 2010

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.

10.37 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

Incorporated by reference to Exhibit 10.2 to ANI’s Current Report on Form 8-K filed on August 13, 2024 (File No.

10.39 Contingent Value Rights Agreement dated September 16, 2024, by and between ANI Pharmaceuticals, Inc.

and Continental Stock Transfer & Trust Company

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.

Filed herewith

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.

Filed herewith

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.

Filed herewith

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.

10.44 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.

Insider Trading Policy

Filed herewith

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Furnished herewith

97.1 A NI Pharmaceuticals, Inc.

Amended and Restated Clawback Pol icy

Filed herewith

97.1 ANI Pharmaceuticals, Inc.

Amended and Restated Clawback Policy

Incorporated by reference to Exhibit 97.1 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (File No.

Exhibit Method of Filing

101 The following financial information from this annual report on Form 10-K for the fiscal year ended December 31, 2024, formatted in Inline XBRL:

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* Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Annual Report on Form 10-K pursuant to Item 15(a).

† Certain schedules and certain exhibits to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K.

A copy of any omitted schedule or exhibit will be furnished supplementally to the SEC upon request;

provided, however, that the parties may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any document so furnished.

Form 10-K Summary

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Haughey Director February 28, 2025

Nash, M.D., M.B.A.

Director February 29, 2024

Nash, M.D., M.B.A.

/s/ Matthew J.

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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