ANI PHARMACEUTICALS INC
For the period ended Dec 31, 2024. Filed Apr 10, 2025.
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Dec 31, 2024 · Filed Apr 10, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
Filed by the Registrantx
Filed by a Party other than the Registranto
Check the appropriate box:
| o | Preliminary Proxy Statement |
|---|---|
| o | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
| x | Definitive Proxy Statement |
| o | Definitive Additional Materials |
| o | Soliciting Material Pursuant to §240.14a-12 |
ANI PHARMACEUTICALS, INC.
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
| x | No fee required. |
|---|---|
| o | Fee paid previously with preliminary materials. |
| o | Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. |
April 10, 2025
Dear Fellow Stockholders:
ANI delivered exceptional results in 2024, reflecting the strength of our strategy and our focus on operational excellence. Our team delivered $614.4 million in total revenue for the year, an increase of 26% over 2023. Adjusted non-GAAP EBITDA 1 was a record $156.0 million, up 17% year-over-year, and adjusted non-GAAP earnings per share 1 was $5.20, an increase of 10% from 2023. We also significantly expanded the scope and scale of our Rare Disease business with the acquisition of Alimera Sciences in September, in keeping with our longer-term strategy to broaden our presence in the Rare Disease space.
These accomplishments would not have been possible without the dedication and hard work of our employees, for which I am very grateful. Our company remains well positioned for continued long-term success.
Rare Disease – Driving Current and Future Growth
Our lead Rare Disease asset, Purified Cortrophin® Gel (“Cortrophin Gel”), generated net sales of $198.1 million in 2024, representing year-over-year growth of 77% and a compound annual growth rate (CAGR) of 117%since launch in 2022. Our Rare Disease team drove accelerating demand across our core therapeutic areas of rheumatology, neurology, and nephrology, and our newer therapeutic areas of ophthalmology and pulmonology. Prescribing for acute gouty arthritis flares, for which Cortrophin Gel is the only approved adrenocorticotropic hormone (ACTH) therapy, continued to ramp and now represents approximately 15% of Cortrophin Gel use.
Our Rare Disease team continued to build awareness and drive expansion of the overall ACTH market, which grew by 27% to $684 million in 2024. Importantly, Cortrophin Gel remains on a strong multi-year growth trajectory. We believe the number of patients on ACTH therapy now is approximately half the level of patients on therapy when the category previously peaked in 2017, and we estimate that the addressable patient population for ACTH therapy could be many times larger than the previous high. We expanded our commercial team in early 2025 to help drive continued prescribing momentum, and our larger sales team has already contributed to growing the number of Cortrophin Gel prescribers.
As part of our commitment to investing in initiatives to improve patient and physician convenience, we developed a Cortrophin Gel prefilled syringe, which was approved by the U.S. Food and Drug Administration in February 2025 and we expect to launch in the second quarter. We’re also exploring other ideas to enhance convenience for patients starting on Cortrophin Gel and the health care providers who treat them, and look forward to sharing more details on these initiatives in the future.
With the acquisition of Alimera, we expanded our Rare Disease portfolio with two growing and durable ophthalmology products, ILUVIEN and YUTIQ, and expanded our sales force in ophthalmology, a key growth area for Cortrophin Gel. We believe there is significant room for growth for both ILUVIEN and YUTIQ given the novel, long-acting nature of the products and size of the addressable markets.
R&D and Operational Excellence Driving Growth in Generics; Brands an Important Contributor
Our Generics business performed exceptionally well in 2024, generating net sales of $301.0 million, an increase of 12% over 2023, driven by operational excellence and new product launches. 2024 was our third straight year with double-digit growth in Generics. We delivered 17 new product launches, including two with competitive generic therapy (CGT)
1 Adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). See Appendix D to this Proxy Statement for the definition of these non-GAAP measures and reconciliation to the most comparable GAAP financial measure.
designation, and leveraged our U.S.-based manufacturing footprint to deliver over 1 billion doses to patients in the U.S. We are proud that we retained the number two ranking in CGT approvals in 2024.
Our Brands business (previously Established Brands) continued to address patient needs in 2024 with reliability of supply and a unique set of commercial capabilities. Our overall portfolio is strengthened by this high-gross margin business, which features low working capital requirements and strong cash flow generation.
Looking Ahead
The strong momentum in our business has continued in 2025. We expect Rare Disease to be our largest revenue growth driver in 2025 and beyond, driven by Cortrophin Gel. We anticipate continued adoption of Cortrophin Gel in the therapeutic areas of rheumatology, neurology, and nephrology, helped in part by our expanded commercial team, and strong growth in ophthalmology and for acute gouty arthritis flares. We also expect continued growth for the overall ACTH market. Our 2025 Cortrophin Gel sales guidance of $265 million - $274 million reflects year-over-year growth of 34% - 38%.
Completing the integration of Alimera and increasing supply security for ILUVIEN and YUTIQ is a near-term priority. We recently secured FDA approval to expand the ILUVIEN label to include YUTIQ’s indication of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) and extended our partnership with our ILUVIEN contract manufacturer Siegfried for five years until 2029. We plan to begin marketing ILUVIEN for chronic NIU-PS later this year.
We expect another year of low double-digit growth for our Generics business in 2025, supported by our high-performing R&D engine, operational acumen, and U.S.-based manufacturing footprint. Our Brands business will continue addressing patient needs through reliability of supply and a unique set of commercial capabilities, strengthening the overall company portfolio with its high margins and strong free cash flow generation.
As we progress through 2025, I’m confident that ANI is well positioned to deliver another year of strong revenue growth and profitability while maintaining a steadfast commitment to our core values: Patient First, Teamwork, Innovation, Integrity & Compliance, Accountability & Transparency, and Commitment to Excellence. I have never been more excited about the future of our company. As I have expressed in this letter over the past several years, I am incredibly proud of the work ANI and its employees have done towards delivering on our company’s purpose of “Serving Patients, Improving Lives.”
Sincerely,
Nikhil Lalwani
Chief Executive Officer
The Board of Directors unanimously recommends that our stockholders vote “FOR” all of the proposals presented in the Proxy Statement.
Your vote is very important. Even if you plan to attend the Annual Meeting, if you are a stockholder of record of Common Stock, Series A Preferred Stock or Class C Special Stock, please submit your proxy by Internet, mail or telephone as soon as possible to make sure that your shares are represented at the Annual Meeting, or you may submit your proxy at the Annual Meeting. If you hold your shares of Common Stock, Series A Preferred Stock or Class C Special Stock in “street name” through a bank, broker or other nominee, you must vote in accordance with the voting instructions provided to you by such bank, broker or other nominee, which include instructions for voting by Internet or telephone.
Forward-Looking Statements
In this communication we have made certain forward-looking statements within the meaning of the federal securities laws. These statements are based on management’s estimates and assumptions and are subject to risks and uncertainties. Such statements include, but are not limited to, statements about the Company’s corporate strategy, growth strategy, future plans, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations. These risks and uncertainties include, but are not limited to, the risks detailed in our filings with the Securities and Exchange Commission, including the Risk Factors section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and the Company assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. The Company gives no assurance that it will achieve its expectations.
NOTICE OF 2025 ANNUAL MEETING OF STOCKHOLDERS
To Be Held Thursday, May 22, 2025, 9:00 A.M. (Eastern Time)
Virtual Meeting Only — No Physical Meeting Location
| TIME AND DATE | 9:00 A.M. Eastern Time on Thursday, May 22, 2025, virtually at |
|---|---|
| PLACE | www.virtualshareholdermeeting.com/ANIP2025 |
| AGENDA | •Elect the eight director nominees named in the Proxy Statement •Ratify the appointment of EisnerAmper LLP as our independent registered public accounting firm for the year ending December 31, 2025 •Advisory vote to approve the compensation of the Company’s named executive officers •Approve an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 33,333,334 shares to 66,000,000 shares•Approve the Company's Amended and Restated 2022 Stock Incentive Plan •Approve the Company's Amended and Restated 2016 Employee Stock Purchase Plan (the “2016 ESPP”)•Transact such other business as may properly come before the annual meeting (including adjournments and postponements) |
| RECORD DATE | March 24, 2025 |
The Company’s 2025 Annual Meeting of Stockholders (the “Annual Meeting”) will be held as a virtual-only meeting on Thursday, May 22, 2025 at 9:00 A.M. Eastern Time. We have adopted a virtual format for the Annual Meeting to provide a safe, consistent and convenient experience to all shareholders regardless of location. You will be able to attend the meeting, submit your questions and comments during the meeting, and vote your shares at the meeting by visitingwww.virtualshareholdermeeting.com/ANIP2025.
The platform for the virtual Annual Meeting includes functionality that affords validated stockholders the same meeting participation rights and opportunities they would have at an in-person meeting. Instructions to access and log into the virtual Annual Meeting are provided in the accompanying Proxy Statement.
Only holders of the Company’s Series A Convertible Preferred Stock, Common Stock and Class C Special Stock of record as of March 24, 2025 are entitled to notice of and to vote at the Annual Meeting.
Your vote is very important. Regardless of whether you plan to attend the virtual Annual Meeting, please promptly vote your shares. You may vote your shares over the Internet or via a toll-free telephone number. You may submit your proxy for the Annual Meeting by completing, signing, dating and returning your proxy in the pre-addressed envelope provided. For specific instructions on how to vote your shares, please refer to the section titled “Voting Methods” on page 5 of the Proxy Statement.
It remains very important that your shares are represented and voted at the Annual Meeting. We therefore strongly encourage you to vote in advance of the Annual Meeting.
IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE 2025 ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON MAY 22, 2025.
THE NOTICE OF THE 2025 ANNUAL MEETING, THE 2025 PROXY STATEMENT AND THE 2024 ANNUAL REPORT TO STOCKHOLDERS ARE AVAILABLE AT WWW.PROXYVOTE.COM.
By Order of the Board of Directors,
Meredith W. Cook
Senior Vice President, General Counsel and Corporate Secretary
Princeton, New Jersey
April 10, 2025
TABLE OF CONTENTS
| Page | |
|---|---|
| PROPOSAL 1: ELECTION OF DIRECTORS | 6 |
| CORPORATE GOVERNANCE | 11 |
| PROPOSAL 2: RATIFICATION OF APPOINTMENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM FOR THE YEAR ENDING DECEMBER 31, 2025 | 18 |
| AUDIT AND FINANCE COMMITTEE REPORT | 20 |
| EXECUTIVE OFFICERS | 21 |
| EXECUTIVE COMPENSATION | 23 |
| PROPOSAL 3: ADVISORY (NON-BINDING) VOTE TO APPROVE EXECUTIVE COMPENSATION | 47 |
| PROPOSAL 4: APPROVAL OF AMENDMENT TO THE COMPANY’S RESTATED CERTIFICATE OFINCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF COMMONSTOCK | 48 |
| PROPOSAL 5: APPROVAL OF THE AMENDED AND RESTATED 2022 STOCK INCENTIVE PLAN | 50 |
| PROPOSAL 6: APPROVAL OF THE AMENDED AND RESTATED 2016 EMPLOYEE STOCK PURCHASE PLAN | 62 |
| PRINCIPAL STOCKHOLDERS | 67 |
| CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS | 69 |
| OTHER MATTERS | 70 |
| ADDITIONAL INFORMATION | 70 |
i
FOR 2025 ANNUAL MEETING OF STOCKHOLDERS
To Be Held at 9:00 A.M. Eastern Time
on Thursday, May 22, 2025
Our Board of Directors (the “Board”) solicits your proxy for the 2025 Annual Meeting of Stockholders (the “Annual Meeting”) and any postponement or adjournment of the Annual Meeting for the matters set forth in “Notice of 2025 Annual Meeting of Stockholders.” The Annual Meeting will be held virtually on Thursday, May 22, 2025 at 9:00 A.M. Eastern Time atwww.virtualshareholdermeeting.com/ANIP2025. This Proxy Statement is being made available to holders of the Company’s Series A Convertible Preferred Stock, $0.0001 par value per share (the “Series A Preferred Stock”), the Company’s Common Stock, $0.0001 par value per share (the “Common Stock”) and the Company’s Class C Special Stock, $0.0001 par value per share (the “Class C Special Stock” and the holders of the Series A Preferred Stock, the Common Stock and the Class C Special Stock together, the “Stockholders”) beginning on or around April 10, 2025.
INFORMATION ABOUT THE ANNUAL MEETING AND VOTING
| Record Date | March 24, 2025 |
|---|---|
| Quorum Requirement | Holders of at least one-third of the outstanding shares of the Company’s capital stock issued and outstanding and entitled to vote on the record date must be present at the Annual Meeting or represented by proxy. Abstentions and broker non-votes are counted as present and entitled to vote for purposes of determining a quorum. |
| Voting Shares Outstanding on the Record Date | 25,000 shares of Series A Preferred Stock, 21,574,175 shares of Common Stock and 10,864 shares of Class C Special Stock outstanding as of March 24, 2025. The 25,000 shares of Series A Preferred Stock outstanding as of March 24, 2025 are entitled to cast an aggregate of 611,937 votes. The 21,574,175 shares of Common Stock and 10,864 shares of Class C Special Stock outstanding as of March 24, 2025 are entitled to cast an aggregate of 21,585,039 votes, which is one vote per share. |
| Voting by Proxy Voting at the Meeting | Internet, telephone, or mail: We encourage Stockholders to vote in advance of the Annual Meeting, even if they plan to access the Annual Meeting virtually. In order to vote in advance, proxies submitted by Internet or telephone must be received by 11:59 P.M. Eastern Time on May 21, 2025. Stockholders can vote during the Annual Meeting, using the Internet. Beneficial holders who wish to vote during the Annual Meeting must obtain a valid legal proxy and control number from their broker, bank, or other nominee prior to the date of the Annual Meeting giving them the right to vote the shares. Voting by a Stockholder during the Annual Meeting will replace any previous votes. |
| Changing Your Vote | If you have given your proxy and later wish to revoke it, you may do so at any time before it is voted at the Annual Meeting by (a) delivering a proxy revocation or another duly executed proxy bearing a later date to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717 or (b) casting a later vote via the Internet or Telephone, or (c) attending the Annual Meeting and voting online. Attendance online at the Annual Meeting will not revoke a proxy unless the Stockholder actually votes online during the virtual meeting. Your latest Internet or telephone proxy is the one that will be counted. If you hold shares through a broker, bank, or other nominee, you may revoke any prior voting instructions by contacting that firm. |
Votes Required to Adopt Proposals
| Proposal | Vote Required | Voting Choices | Broker Discretionary Voting Allowed |
|---|---|---|---|
| Election of the director nominees named in the Proxy Statement ("Proposal 1") | The number of votes cast by Stockholders present at the Annual Meeting in person (virtually) or by proxy and voting “FOR” a nominee must exceed the number of votes cast “AGAINST” the nominee. | “FOR”, “AGAINST”, or “ABSTAIN” | No |
| Ratification of appointment of EisnerAmper LLP as our independent registered public accounting firm for the year ending December 31, 2025 ("Proposal 2") | The vote of the holders of a majority of the stock represented and entitled to vote on such proposal. | “FOR”, “AGAINST”, or “ABSTAIN” | Yes |
| Advisory vote to approve the compensation of the Company’s named executive officers ("Proposal 3") | The vote of the holders of a majority of the stock represented and entitled to vote on such proposal. | “FOR”, “AGAINST”, or “ABSTAIN” | No |
| Approval of amendment to theCompany’s RestatedCertificate of Incorporationto Increase the Number ofAuthorized Shares ofCommon Stock (“Proposal4”) | The vote of the holders of amajority of the issued andoutstanding shares of theCompany. | “FOR”, “AGAINST”, or “ABSTAIN” | Yes |
| Approval of the Company's Amended and Restated 2022 Stock Incentive Plan ("Proposal 5") | The vote of the holders of a majority of the stock represented and entitled to vote on such proposal. | “FOR”, “AGAINST”, or “ABSTAIN” | No |
| Approval of the Company's Amended and Restated 2016 Employee Stock Purchase Plan ("Proposal 6") | The vote of the holders of a majority of the stock represented and entitled to vote on such proposal. | “FOR”, “AGAINST”, or “ABSTAIN” | No |
Each holder of Common Stock and Class C Special Stock represented at the Annual Meeting will be entitled to cast one vote for each share of Common Stock and Class C Special Stock, as applicable, entitled to vote and held by such holder as of the Record Date. Each holder of Series A Preferred Stock will be entitled to a number of votes equal to the largest number of whole shares of common stock into which all shares of Series A Preferred Stock held of record by such holder could then be converted as of the Record Date. Stockholders do not have cumulative voting rights. The Series A Preferred Stock, the Common Stock and the Class C Special Stock vote together as a single class.
| Effect of Abstentions and Broker Non-Votes | A “broker non-vote” occurs when a stockholder holds shares of common stock in “street name” through a broker or similar organization, and the stockholder does not provide the broker or other organization with instructions within the required timeframe before the annual meeting as to how to vote the shares on “non-routine” matters. Under relevant Nasdaq rules, we believe that Proposal 2, to ratify the appointment of EisnerAmper LLP as our independent registered accounting firm for the year ending December 31, 2025, and Proposal 4, an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of Common Stock, are considered “routine” matters on which brokers are permitted to vote in their discretion even if the beneficial owners do not provide voting instructions. Accordingly, we do not expect there to be any broker non-votes for such proposals.Under relevant Nasdaq rules, we believe that Proposal 1, the election of directors, Proposal 3, the advisory vote to approve the compensation of the Company’s named executive officers, Proposal 5, the Company’s Amended and Restated 2022 Stock Incentive Plan, and Proposal 6, the approval to amend our 2016 Employee Stock Purchase Plan, are considered to be “non-routine” matters, and therefore, your broker cannot vote your shares on these non-routine matters unless your broker receives instructions from you as to how to vote. If you are a beneficial holder and do not provide specific voting instructions to your broker or custodian of your shares, your broker or custodian will not be authorized to vote on any of the matters other than Proposal 2 and Proposal 4. For Proposals 1, 3, 5, and 6, broker non-votes will have “NO EFFECT” on the outcome of such proposals. For Proposals 2, 3, 4, 5, and 6, abstentions will have the same effect as a vote “AGAINST” such proposals. For Proposal 1, abstentions will have “NO EFFECT” on the outcome of such proposal.We encourage you to vote promptly, even if you plan to attend the Annual Meeting. |
|---|---|
| Voting Instructions | If you complete and submit your proxy voting instructions, the persons named as proxies will follow your instructions. If you are a Stockholder of record and you submit proxy voting instructions but do not direct how to vote on each proposal, the persons named as proxies will vote as the Board recommends on each proposal. The persons named as proxies will vote on any other matters properly presented at the Annual Meeting in accordance with their judgment. Our Second Amended andRestated Bylaws (“bylaws”) set forth requirements for advance notice of nominations and agenda items for the Annual Meeting, and we have not received timely notice of any such matters that may be properly presented for voting at the Annual Meeting, other than the items from the Board described in this Proxy Statement. |
| Proxy Solicitation Costs | The expense of soliciting proxy cards, including the costs of preparing, assembling and mailing the Notice of 2025 Annual Meeting of Stockholders, proxy statement and proxy card, will be borne by the Company. Our directors and officers may also solicit proxies in person, by telephone or by other means of communication. These parties will not be paid any additional compensation for soliciting proxies. We may also reimburse brokerage firms, banks and other agents for the cost of forwarding proxy materials to beneficial owners. |
| Voting Results | We expect to announce preliminary results at the Annual Meeting. We will report final results from the Annual Meeting in a filing with the U.S. Securities and Exchange Commission (“SEC”) within four business days of the Annual Meeting in a Current Report on Form 8-K. |
Access and Log-in Instructions for Virtual Annual Meeting
The platform for the virtual Annual Meeting includes functionality that affords validated Stockholders the same meeting participation rights and opportunities they would have at an in-person meeting. Instructions to access and log into the virtual Annual Meeting are provided below, and once admitted, Stockholders may submit questions and vote their shares by following the instructions that will be available on the Annual Meeting website.
To be admitted to the Annual Meeting, go towww.virtualshareholdermeeting.com/ANIP2025 and enter the 16-digit control number included on your proxy card or on the instructions that accompanied your proxy materials. Online access to the Annual Meeting will open at 8:45 A.M. Eastern Time to allow time for you to log-in prior to the start of the live audio webcast of the Annual Meeting at 9:00 A.M. Eastern Time.
If you are unable to locate your proxy materials containing your 16-digit control number and cannot log-in as a validated Stockholder, you may opt to participate in the Annual Meeting as a “guest,” in which case you will be able to hear the audio webcast but will not be able to utilize the question, voting, or other functions noted above.
How Beneficial Owners May Participate in the Virtual Annual Meeting
If your shares are registered in the name of your bank, broker, or other nominee, you are the “beneficial owner” of those shares and those shares are considered as held in “street name.” If you are a beneficial owner, to vote or ask questions at the virtual Annual Meeting, you must first obtain a valid legal proxy from your bank, broker, or other nominee. Follow the instructions from your bank, broker, or other nominee included with the proxy materials that you are provided, or contact your bank, broker, or other nominee to request a legal proxy form.
Voting Methods
BEFORE the Annual Meeting:
Vote by Internet: Go to www.proxyvote.com until 11:59 P.M. Eastern Time on May 21, 2025.
Vote by Phone: Call toll-free 1-800-690-6903 until 11:59 P.M. Eastern Time on May 21, 2025.
Vote by Mail: Complete, sign, and date the proxy card/voting instruction card and return it in the postage-paid envelope that is enclosed with your proxy materials.
DURING the Annual Meeting:
Vote by Internet: Go to www.virtualshareholdermeeting.com/ANIP2025 and vote during the Annual Meeting by entering the 16-digit control number included in your proxy materials and following the instructions on the Annual Meeting website.
INTERNET AVAILABILITY OF PROXY MATERIALS
IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR
THE ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON MAY 22, 2025:
THE NOTICE OF THE 2025 ANNUAL MEETING, THE PROXY STATEMENT, AND THE 2024 ANNUAL
REPORT TO STOCKHOLDERS ARE AVAILABLE AT WWW.PROXYVOTE.COM.
QUESTIONS
| For questions regarding | Contact via mail or email: |
|---|---|
| Annual Meeting | ANI Pharmaceuticals, Inc. 210 Main Street West Baudette, Minnesota 56623 Attn: Investor Relations Email: IR@anipharmaceuticals.com |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.