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ANIP 10-K & 10-Q changes, risk factors and insider trading

Ani Pharmaceuticals Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1023024 · All filings on SEC.gov

Everything below is quoted or computed from Ani Pharmaceuticals Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

61 / 58risk-factor paragraphs added / removed in latest 10-K
7new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
21Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-02-27 (period ending 2025-12-31) with 10-K filed 2025-02-28 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

61new paragraphs
58removed paragraphs
128reworded paragraphs
27,880 → 29,092words in section

New heading “Our manufacturing facilities or those of our third-party manufacturers or suppliers may fail to meet regulatory requirements. Failure to meet cGMP requirements could increase production costs or impact supply of our products.”

New heading “If we fail to comply with broad and complex U.S. healthcare and other laws, as well as comparable laws and regulations in foreign jurisdictions, we could face substantial penalties and our business, operations and financial condition could be adversely affected.”

New heading “Any significant adverse events or undesirable side effects caused by our products may impact regulatory approval or market acceptance, or result in significant negative consequences.”

New heading “Our current and potential future use of artificial intelligence and machine learning may not be successful and introduces emerging risks and challenges to our business.”

New heading “Inadequate funding for the FDA, DEA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”

New heading “The successful commercialization of our products depends on adequate coverage and reimbursement from third party payors.”

New heading “Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.”

Removed heading “We are subject to United States federal and state laws related to healthcare fraud and abuse and health information privacy and security, and the failure to comply with such laws may adversely affect our business.”

Removed heading “The NEW DAY clinical trial may fail to demonstrate the efficacy of ILUVIEN as baseline therapy in patients with early DME, fail to generate data demonstrating the benefits of ILUVIEN when compared to the current leading therapy for DME, take longer or be more costly to complete than we currently anticipate or fail to change physician prescribing practices.”

Removed heading “We may fail to realize the benefits expected from our acquisition of Alimera and the combined company may not perform as we or the market expects, which could have an adverse effect on the price of our common stock.”

Removed heading “The obligations and liabilities of Alimera, some of which may be unanticipated or unknown, may be greater than we have anticipated, which may diminish the value of Alimera us.”

Removed heading “We have incurred, and will continue to incur, direct and indirect costs as a result of the Merger.”

Removed heading “In connection with the Merger, we recorded goodwill and intangible assets and if either goodwill or intangible assets become impaired, our earnings could be significantly impacted.”

Removed heading “The Merger may become the target of derivative lawsuits that could result in substantial costs in connection with the Merger.”

Removed heading “If third-party payers deny coverage, substitute another company’s product for our product, or offer inadequate levels of reimbursement, we may not be able to market our products effectively or we may be required to offer our products at prices lower than anticipated.”

Removed heading “Our operations in an international market subject us to additional regulatory oversight both in the international market and in the U.S., as well as, social, and political uncertainties, which could cause a material adverse effect on our business, financial position, and operating results.”

Removed heading “Our principal stockholders, directors, and executive officers own a significant percentage of our stock and will be able to exercise meaningful influence over our business.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: investigation, lawsuit, fine, penalt
“Any adverse outcome in these types of actions, or the imposition of penalties or sanctions for failing to comply with fraud and abuse laws, could adversely affect us and may have a material adverse effect on our business, results of operations, financial condition and cash flows. Some of the statutes and regulations that govern our activities, such as federal and state anti-kickback and false claims laws, are broad in scope, and while exemptions and safe harbors protecting certain common activities exist, they are often narrowly drawn and construed by the courts. …”
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Removed text topics: investigation, litigation, penalt, sanction
“The domestic and foreign laws that may affect our ability to operate include, but are not limited to: (i) the U.S. …”
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Reworded topics: investigation, litigation, breach, liquidity

Paragraph as it now reads, with added and removed wording marked:

We rely significantly on our information technology and manufacturing infrastructure to effectively manage and maintain inventory and financial reports, manufacture and ship products, and invoice customers in a timely manner. While we have invested in the protection of data and information technology, any failure, accidents, inadequacy, or interruption of that infrastructure or security lapse of that technology, including cybersecurity incidents, could harm our ability to operate our business effectively. Our ability to manage and maintain inventory and financial reports, manufacture and ship products, and invoice customers timely depends significantly on our general ledger, our contracted electronic data interface system, and other information systems. Cybersecurity attacks in particular are evolving and include, but are not limited to, malicious software, attempts to gain unauthorized access to data and other electronic security breaches that could lead to disruptions in systems, misappropriation of confidential or otherwise protected information and corruption of data. Cybersecurity incidents resulting in the failure of our information systems to operate effectively or to integrate with other systems, or a breach in security or other unauthorized access of these systems, may affect our ability to manage and maintain inventory and financial reports, and result in delays in product fulfillment and reduced efficiency of operations. Unauthorized parties or rogue insiders may also attempt to gain access to our systems or facilities through fraud or other forms of deception targeted at our customers, associates, suppliers and service providers. Any such incidents could compromise our networks and the information stored there could be accessed, misused, publicly disclosed, lost, stolen or rendered, permanently or temporarily, inaccessible. A breach in security, unauthorized access resulting in misappropriation, theft, or sabotage with respect to proprietary and confidential information, including research or clinical data, could require significant capital investments to remediate any such failure, problem or breach, all of which could adversely affect our business, financial position, and operating results. Further, any security breach incident could expose us to risks of regulatory and law enforcement investigations, enforcement actions, litigation (including class claims) and liability and could result in negative publicity, any of which could significantly harm our reputation and relationships with our customers and adversely affect our business, financial condition, operating results, liquidity and stock price. Insurance policies that may provide coverage with regard to such incidents may not cover any or all of the resulting financial losses. See “Cybersecurity – Risk management and strategy,Strategy,” Item 1C of this Annual Report on Form 10-K for additional information.
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Removed text topics: fine, sanction, recall, regulation
“All U.S. facilities where prescription drugs are manufactured, tested, packaged, stored, or distributed must comply with FDA current good manufacturing practices (“cGMPs”). All of our products are manufactured, tested, packaged, stored, and distributed according to cGMP regulations. The FDA performs periodic audits to ensure that our facilities remain in compliance with all applicable regulations. …”
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New text topics: fine, penalt, restructuring, regulation
“Efforts to ensure that our activities comply with applicable healthcare laws and regulations will involve substantial costs. Given the breadth of the laws and regulations, limited guidance for certain laws and regulations, and evolving government interpretations of the laws and regulations, governmental authorities may possibly conclude that our business practices may not comply with such laws. …”
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New text topics: fine, sanction, recall, regulation
“The FDA performs periodic audits to ensure that our facilities remain in compliance with all applicable regulations. If it finds violations of cGMP, the FDA could make its concerns public and could impose sanctions including, among others, fines, product recalls, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, injunctions, and civil or criminal prosecution. If imposed, enforcement actions could have a material adverse effect on our business, financial position, and operating results. …”
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Full comparison: every changed paragraph (247)

Green = added, red = removed. Unchanged paragraphs, 1 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Added

Investing in our common stock involves a high degree of risk. Below is a summary of the principal risks that could adversely affect our business, financial position and operating results:

Removed

Investing in our common stock involves a high degree of risk. You should carefully consider all information in this Annual Report on Form 10-K prior to investing in our common stock. These risks are discussed more fully in the section titled “Risk Factors.” These risks and uncertainties include, but are not limited to, the following:

Reworded

•Our approved products, including Cortrophin Gel, ILUVIENGel and YUTIQ,ILUVIEN, may not achieve commercialization at levels of market acceptance that will continue to allow us to achievemaintain profitability;

Reworded

•Cortrophin Gel is our first rare disease pharmaceutical product. To the extent our ongoing and continuing efforts to commercialize Cortrophin Gel, ILUVIEN, and our other products for which we have received marketing approval are not able to continue to achieve commercial success with this product, including expanding the market and gaining market share,unsuccessful, our business, financial condition, and results of operations will be negatively impacted;

Removed

•We may fail to realize the benefits expected from our acquisition of Alimera and the combined company may not perform as we or the market expects;

Reworded

•Several of the products we have acquired cannot be manufactured in our facilities and we must secure and maintain qualified and compliant contract manufacturers. Noncompliance by these contract manufacturers or our inability to find qualified contract manufacturers could result in us being unable to commercialize these products; Several of our products are manufactured and/or packaged by single-sourced third parties, which we cannot control and could result in us being unable to market and distribute products;

Added

•Several of our products are manufactured and/or packaged by single source third parties, which we cannot control and could result in us being unable to market and distribute products;

Added

•If we fail to comply with broad and complex U.S. healthcare and other laws, as well as comparable laws and regulations in foreign jurisdictions, we could face substantial penalties and our business, operations, and financial condition could be adversely affected;

Removed

•We are subject to United States federal and state laws related to healthcare fraud and abuse and health information privacy and security, and the failure to comply with such laws may adversely affect our business;

Reworded

•FailureIf we fail to comply with data protection laws and regulationsregulations, we could be subject us to government enforcement actions,actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and business;

Added

•Any failure to comply with the complex reporting and payment obligations under the Medicaid Drug Rebate Program and other government pricing and price reporting programs may result in penalties and sanctions, which may have a material adverse effect on our business, financial position, and operating results;

Reworded

•Our Medicaid rebate accruals have increased and continue to increase due to our acquisitions and subsequent sales of branded products and authorized generics of branded productsproducts, and the estimates on which our accruals are based are subject to change. Any such change could have a material adverse effect on our business, financial position, and operating results;

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•Our accruals for the Medicare Coverage GapManufacturer Discount Program have increased due to growth and acquisitionsacquisitions. Any such change could have a material adverse effect on our business, financial position and operating results;

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•We expect to spend a significant amount of resources on research and development efforts, and such efforts may not result in marketable products;

Reworded

•We may be adversely affected by the expiration of patents that protect key aspects of ourILUVIEN productsand YUTIQ in the near- to medium-term;

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•We rely significantly on information technology and any failure, inadequacy, interruption, or security lapse of that technologytechnology, including any cybersecurity incidents, could harm our ability to operate the business effectively;

Reworded

•We are involved in and may become involved in legal proceedings from time to time, which may result in substantial losses, government enforcement actions, damage to our business and reputation, and place a strain on our internal resources;

Removed

•The obligations and liabilities of Alimera, some of which may be unanticipated or unknown, may be greater than we have anticipated, which may diminish the value of Alimera to us;

Removed

•Our operations, including those resulting from our acquisition of Alimera, and its international operations, will subject us to political and economic risks, increase our exposure to potential liability under anti-corruption, trade protection, tax, and other laws and regulations;

Added

•Public health outbreaks, epidemics, or pandemics have adversely affected and may in the future adversely affect our business;

Added

•Four of our products are marketed without approved NDAs or ANDAs and we cannot be certain that the FDA will not require us to either seek approval for these products or withdraw them from the market. In either case, our business, financial position, and operating results could be materially adversely affected;

Added

•The FDA does not provide guidance on safety labeling for products that are marketed without approved NDAs or ANDAs, which could increase our potential liability with respect to failure-to-warn claims for these products;

Added

•If the DEA does not approve supply of the API we need to manufacture our controlled substances, we may be unable to manufacture controlled substances, which would eliminate our revenue on these products;

Reworded

•Pharmaceutical product quality standards are steadily increasing on all products,products as set forth by the FDA and other governmental agencies, and if we cannot meet these standards, we may be required to discontinue marketing and/or recall products from the market;

Added

•The successful commercialization of our products depends on adequate coverage and reimbursement from third party payors;

Removed

•Third-party payer actions may prevent us from effectively marketing our products or cause us to decrease pricing;

Reworded

•HealthcareU.S. healthcare reform legislationinitiatives couldmay havematerially aand materialadversely adverse effect onaffect our business, financial position, and operating results;

Added

•The international nature of our operations, including those resulting from our acquisition of Alimera and its international operations, will subject us to political and economic risks and increase our exposure to potential liability under anti-corruption, trade protection, tax, and other laws and regulations;

Removed

•Public health outbreaks, epidemics, or pandemics (such as COVID-19) have adversely affected and may in the future adversely affect our business;

Removed

•The Food and Drug Administration (“FDA”) does not provide guidance on safety labeling for products that are marketed without approved New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”), which could increase our potential liability with respect to failure-to-warn claims for these products;

Removed

•Four of our products are marketed without approved NDAs or ANDAs and we can offer no assurances that the FDA will not require us to either seek approval for these products or withdraw them from the market. In either case, our business, financial position, and operating results could be materially adversely affected;

Removed

•If the Drug Enforcement Administration (“DEA”) does not approve supply of the API we need to manufacture our controlled substances, we may be unable to manufacture controlled substances, which would eliminate our revenue on these products;

Reworded

•Our policies regarding returns, allowances and chargebacks, andas well as marketing programs adopted by wholesalerswholesalers, may reduce revenues in future fiscal periods;

Reworded

•Our indebtedness and liabilities could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and operating results of operation;

Removed

•To service our indebtedness, we will be required to generate a significant amount of cash;

Reworded

•Our New2024 Credit Agreement containcontains restrictive and financial covenants and if we are not in compliance with these covenants, our outstanding indebtedness under this facility could be accelerated and the lenders could terminate their commitments under the facility;

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•CertainWe incurred certain risks relating to our 2.25% Convertible Seniorthe Notes due 2029 and related capped call transactions; and

Reworded

•Raising additional funds by issuing additional equity securities may cause dilution to our current stockholders.stockholders; Raisingraising additional funds by entering into additional credit or other borrowing facilities or issuing debt may subject us to covenants and other requirements that may restrict our operations.

Reworded

Our approved products, including Cortrophin Gel, ILUVIENGel and YUTIQ,ILUVIEN, may not achieve commercialization at levels of market acceptance that will continue to allow us to achievemaintain profitability and we may face substantial competition from competitors that discover, develop or commercialize competing products before or more successfully than we do, which could have a material adverse effect on our business, financial position, and operating results.

Reworded

The development and commercialization of new drugs is highly competitive, and the commercial success of our products or any of our future products or product candidates will depend on several factors, including our ability to differentiate any such products or product candidates from our competitors’ current or future products, including the creation of generic competitive products. We seek to develop, license, or acquire products that we can commercialize at levels of market acceptance that would allow us to recoup our costs, grow market share, and achievemaintain profitability. However, we face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to our current products and to any future products or product candidates that we may develop or commercialize in the future.

Reworded

Even if we are able to obtain regulatory approvals for our pharmaceutical products, if we fail to predict accuratelythe demand for such products,products accurately, or if our competitors more effectively develop competitive products, that have few or less severe adverse side effects and have higher rates of acceptance by physicians, our business, financial position, and operating results could be adversely affected. Levels of market acceptance for our products could be impacted by several factors, including but not limited to:

Added

•relative convenience and ease of administration of our products;

Added

•publicity and health authority communications concerning our products or competing products and treatments;

Reworded

Cortrophin Gel is our first rare disease pharmaceutical product. To the extent our ongoing and continuing efforts to commercialize thisCortrophin productGel, ILUVIEN, and our other products for which we have received marketing approval are unsuccessful, our business, financial condition and results of operations will be negatively impacted.

Added

We have received approval from the FDA for our Cortrophin Gel product for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to other indications. In 2025, a significant portion of our net product revenues were derived from the sale of Cotrophin Gel, and we expect that sales of Cortrophin Gel will continue to account for a significant portion of our net product revenues in future years. As a result, our business is dependent on our ability to sustain and grow revenues from sales of Cortrophin Gel, and we are accordingly subject to risks relating to the commercial success of Cotrophin Gel, including the risk that physicians, payors or patients will perceive the cost of Cortrophin Gel to outweigh the benefits of treatment; that we may be unable to maintain and increase sales of Cotrophin Gel or continue to gain market share from competing products; and that we may be unable to obtain and sustain favorable access and reimbursement rates.

Reworded

OnIn October 29, 2021,addition, we have received approval from the FDA for our Cortrophin Gel productILUVIEN for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”),NIU-PS in addition to excessDME, urinaryfor proteinwhich dueILUVIEN was already approved. To the extent we receive FDA approval to nephroticcommercialize syndrome.other Weproducts havein devotedthe future, we expect to devote significant time and money to the development of this product since we acquired the rights to the product in 2016. We have invested and continue to invest significantly in thetowards commercialization of this producteffects in the U.S, including building out aour sales force and developing a patient support program,program. In addition, we are expanding our commercialization efforts with arespect full-scaleto launchCortrophin inGel Januaryto 2022. In October 2023, we announced FDA approval and commercial availability ofinclude a 1-mLvial1 ofmL Cortrophin Gel,vial, appropriate for adjunctive treatment of certain patients with acute gouty arthritis flares. Additionally, on February 28, 2025, the FDA approved a prefilled syringe format for Cortrophin Gel. This new presentation became available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network during the second quarter of 2025. The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials. The ability for us to generate significant net product revenues from ILUVIEN, our Cortrophin Gel products or any other products for which we receive marketing approval will depend upon our ability to successfully sell the product and numerous other factors, including:

Reworded

•successfully establishing and maintaining effective sales, marketing, and distribution systems in jurisdictions in which Cortrophinour Gelapproved isproducts are approved for sale;

Reworded

•successfully establishing and maintaining manufacturing capabilities with our third-party suppliers and CMOscontract manufacturers and manufacturing adequate commercial quantities of Cortrophinour Gelapproved products at acceptable cost and quality levels, including maintaining current good manufacturing practice (“cGMP”) and quality systems regulation standards required by various regulatory agencies;

Reworded

•broad acceptance of Cortrophinthe Gelproducts for which we have received marketing approval by physicians,physicians and patients, andas gainingwell as our ability to gain market access share in the healthcare community;

Reworded

•the acceptance of pricing and placement of Cortrophinthe Gelproducts for which we have received marketing approval on payers’ formularies and the associated tiers;

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•effectively competing with the only other competitorproducts that has anare approved adrenocorticotropicand hormoneavailable (“ACTH”)to therapypatients product onfor the market,same conditions, as well as other products that are in development or may be developed in the future as a treatment optionoptions;

Reworded

•continued demonstration of safety and efficacy of Cortrophinthe Gelproducts for which we have received marketing approval in comparison to competing products or treatment options;

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•our ability to comply with ongoing regulatory obligations and continued regulatory review of the products for which we have received marketing approval, which may result in significant additional expense and may require labeling changes based on new safety information, post-market studies or clinical trials to evaluate safety risks related to the use of Cortrophin Gel; and

Reworded

If we do not achieve one or more of these factors, we could experience an inability to successfully commercialize or continue to successfully commercialize ILUVIEN, Cortrophin Gel,Gel or any other products for which we receive marketing approval, which would negatively impact our business, financial condition and results of operations. In addition, sales of Cortrophinour Gelproducts that have received marketing approval could be negatively affected by discovery of previously unknown problems with the product, such as adverse events of unanticipated severity or frequency, problems with the facilities where the product is manufactured, or imposition of restrictions on Cortrophinsuch Gel,products, including requiring withdrawal of the product from the market,market by a regulatory agency if it disagrees with the promotion, marketing, or labeling of the product.

Reworded

From time to time, we may enter into new lines of business that offer new products and/or services. For example, in September 2024 we acquired Alimera, a global pharmaceutical company that specializes in the commercialization and development of ophthalmic retinal pharmaceuticals, which for us iswas a new line of business. Our lack of experience with or knowledge of such business or other new lines of business we may choose to enter, as well as external factors, such as competitive alternatives, potential conflicts of interest, either real or perceived, and shifting market preferences, may impact our implementation and operation of such new lines of business. Other risks of implementing new lines of business include:

Reworded

We depend on a limited number of suppliers for API. Generally, only a single source of API is qualified for use in each product due to the costs and time required to validate a second source of supply. We may experience lengthy delays if we need to change an API supplier, which could have a material adverse impact on our business and results of operations.

Reworded

Our ability to manufacture and distribute products is dependent, in part, upon ingredients and components supplied by others, including entities based outside the U.S. During the year ended December 31, 2024,2025, approximately 12%,17%, of our raw materialmaterials inventoryand API purchases were from one domestic supplier. During the year ended December 31, 2024, approximately 12% of our API purchases were from one domestic supplier. During the year ended December 31, 2023, no single vendor represented more than 10% of our raw material inventoryAPI purchases. During the year ended December 31, 2022 approximately 19%, of our raw material inventory purchases were from one domestic supplier. Any disruption in the supply of these ingredients or components or any problems in their quality could materially affect our ability to manufacture and distribute our products and could result in legal liabilities that could materially affect our ability to realize profits or otherwise harm our business, financial,financial condition, and operating results. We source the raw materials and API for our products from both domestic and international suppliers. Generally, we qualify only a single source of API for use in each product due to the cost and time required to validate and qualify a second source of supply. Any change in one of our API suppliers mustgenerally usuallyis required to be approved by the FDA through a Prior Approval Supplement (“PAS”) by the FDA.PAS. The process of obtaining an approval of such a PAS can requiretake between foursix and 18nine months.months, and could take an additional eight to ten months if additional information is required to be submitted by the FDA. While we also generally qualify a single source for non-API raw materials, the process required to qualify an alternative source of a non-API raw material is typically much less rigorous. If we were to change the supplier of a raw material for a product, the cost for the material could be greater than the amount we paid with the previous supplier. Changes in suppliers are rare but could occur as a result of a supplier’s business failing, an issue arising from an FDA inspection, or failure to maintain our required standards of quality. As a result, we carefully select suppliers,suppliers based on various factors including quality, reliability of supply, and long-term financial stability. Certain of the API for our drug products, including those that are marketed without approved NDAs or ANDAs, are sourced from international suppliers. From time to time, we have experienced temporary disruptions in the supply of certain of such imported API due to FDA inspections.inspections, and we may experience future disruptions in the supply of certain imported API due to trade tensions or embargoes, geopolitical tensions and macroeconomic conditions. Any disruptions in our API supply, and particularly with respect to the API used to manufacture Cortrophin Gel and ILUVIEN, could have a material adverse effect on our business, financial condition and operating results.

Added

Our manufacturing facilities or those of our third-party manufacturers or suppliers may fail to meet regulatory requirements. Failure to meet cGMP requirements could increase production costs or impact supply of our products.

Added

All facilities where prescription drugs are manufactured, tested, packaged, stored, or distributed must comply with FDA cGMPs. All of our products are manufactured, tested, packaged, stored and distributed according to cGMP regulations, which govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control and assure the quality of drug products. Poor control of cGMP production processes can lead to product quality failures that can impact our ability to supply product, resulting in cost overruns, which could be extensive. Such production process issues include: failure to meet target production costs and yields, facility and equipment failures, raw material failures, failure to meet product release specifications, including stability of the product, quality assurance system failures, operator error, equipment malfunction, and shortages of qualified personnel, as well as noncompliance with strictly enforced federal, state and foreign regulations.

Added

The FDA performs periodic audits to ensure that our facilities remain in compliance with all applicable regulations. If it finds violations of cGMP, the FDA could make its concerns public and could impose sanctions including, among others, fines, product recalls, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, injunctions, and civil or criminal prosecution. If imposed, enforcement actions could have a material adverse effect on our business, financial position, and operating results. Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals. Although we have internal compliance programs in place that we believe are adequate, the FDA may conclude that these programs do not meet regulatory standards. If compliance is deemed deficient in any significant way, it could have a material adverse effect on our business, financial condition and operating results.

Showing the first 60 of 247 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

15new paragraphs
45removed paragraphs
82reworded paragraphs
13,226 → 11,408words in section

New heading “Purchase of SWK Royalty”

New heading “"N/M" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ on September 16, 2024.”

New heading “The 2024 Credit Facility”

Removed heading “Building a successful Rare Disease and Brands Segment”

Removed heading “Purified Cortrophin® Gel”

Removed heading “ILUVIEN and YUTIQ”

Removed heading “Strengthening our Generics and Other segment through continued investment in our generic research and development capability and increased focus on niche opportunities”

Removed heading “Generic Product Development Considerations”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: goodwill, labor
“Pursuant to a Royalty Purchase Agreement dated as of December 17, 2020, EyePoint sold its right to receive royalty payments on future sales of ILUVIEN to SWK Funding LLC (“SWK”) under the existing collaboration agreement entered into in July 2017 between EyePoint and the Company (the “RPA Transaction”). In connection with the RPA Transaction, the Company agreed to pay such royalty payments directly to SWK (see Note 11 “Goodwill and Intangible Assets” to the notes to the consolidated financial statements).”
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Removed text topics: china, middle east
“ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg, was developed in the U.S. and internationally for the treatment of diabetic macular edema (“DME”), a leading cause of severe vision loss and blindness, and certain international markets for chronic non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). We acquired exclusive commercialization rights to YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, in May 2023 from EyePoint Pharmaceuticals, Inc. …”
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Removed text
“Strengthening our Generics and Other segment through continued investment in our generic research and development capability and increased focus on niche opportunities”
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New text
“"N/M" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ on September 16, 2024.”
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Removed text
“Building a successful Rare Disease and Brands Segment”
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Removed text
“Generic Product Development Considerations”
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Full comparison: every changed paragraph (142)

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Reworded

Please read the following discussion in conjunction with Item 1A. (“Risk Factors”) and our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K. Some of the statements in the following discussion are forward-looking statements. See the discussion about forward-looking statements on page 1 of this Annual Report on Form 10-K.10-K, as actual results may differ materially from those contained in any forward-looking statements.

Reworded

This section of this Form 10-K generally discusses 20242025 and 20232024 items and year-to-year comparisons between 2025 and 2024. Discussions of 2024 items and year-to-year comparisons between 2024 and 2023. Discussions of 2022 items and year-to-year comparisons between 2023 and 2022 that are not included in this Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023,2024, filed with the SEC on February 29,28, 2024.2025.

Reworded

ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”)Pharmaceuticals is a diversified bio-pharmaceutical companycompany. committedThe to itsCompany's mission ofis “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovativetherapeutics through its Rare Disease, Generics, and highBrands quality therapeutics.businesses.

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On September 16, 2024, the Company completedacquired its previously announced acquisition of Alimera Sciences, Inc., a Delaware corporation, pursuant to the terms of the Agreement and Plan of Merger, dated as of June 21, 2024 (the “Merger Agreement”), by and among the Company, Alimera and ANIP Merger Sub INC., a Delaware corporation and wholly-owned subsidiary of the Company (“Merger Sub”). Pursuant to the Merger Agreement, Merger Sub merged with and into Alimera, with Alimera surviving the merger as a wholly-owned subsidiary of the Company (the “Merger”).Alimera. In connection with the Merger, the Company added a growing and durable franchise, ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in the United States (“U.S.”) and 24 countries for the treatment of diabetic macular edema (“DME”) and YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the U.S. for the treatment of non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). InSubsequent connection withto the acquisition of Alimera, we expanded the Companylabel hasfor assessedILUVIEN to include an indication for chronic NIU-PS in addition to its strategicthen-current goalsindication andin aligned its operational initiatives into two reportable segments, and the discussion of the historical results of operations below has been revised, as applicable, to be consistent with the presentation of the revised reportable segments (see Note 19 "Segment ReportingDME in the notes to the consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K).U.S.

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OurThe Company owns and operates three pharmaceutical manufacturing facilities, of whichincluding two are locatedfacilities in Baudette, Minnesota, and one is located in East Windsor, New Jersey, which collectively are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. WeThe Company ceased operations at ouranother subsidiarymanufacturing facility in Oakville, Ontario, CanadaOntario as of March 31, 2023. This action was part of ongoing initiatives to capture operational synergies following our acquisition of Novitium Pharma LLC (“Novitium”) in November 2021. We have fully completed the transition of the products manufactured or packaged in Oakville to one of our three U.S. based manufacturing sites. In February 2024, our Canadian subsidiary 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, based on the currentthen-current exchange rate. The sale closed on March 28, 20242024. (seeSee Note 4 "Restructuring Canada Operations" in the notes to the consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K).10-K.

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On August 13, 2024, the Company entered into a credit agreement with JPMorgan Chase Bank, N.A., as administrative agent, and the financial institutions party thereto as lenders,lenders (the "New2024 Credit Agreement"), which provides for aggregate principal commitments consisting of (i) a senior secured delayed-draw term loan facility in an aggregate principal amount of $325.0 million, and (ii) a senior secured revolving credit facility in an aggregate commitment amount of $75.0 million,million ($74.9 million of which remains undrawn), which may be used for revolving credit loans, swingline loans and letters of credit.

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On September 16, 2024, ANI drew the full $325.0 million of New Credit Agreement principal, with proceeds used to finance the acquisition of Alimera, including fees, costs and expenses incurred in connection with the acquisition. As of December 31, 2024, the revolving credit facility remains undrawn, and $75.0 million is available for borrowing, subject to the satisfaction of certain conditions. The New Credit Agreement and the revolving credit facility mature on September 16, 2029.

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On August 13, 2024, the Company completed an offering of $316.25 million aggregate principal amount of the Company's Convertible Senior Notes due 2029 (the “Notes”). The Notes are due September 1, 2029, unless earlier repurchased, redeemed, or converted. After deducting the initial purchasers’ discounts and commissions of approximately $9.5 million, but before deducting the Company’s offering expenses, the net proceeds to the Company from the offering of the Notes waswere approximately $306.8 million. In connection with the offering of Notes, on August 7, 2024 and August 8, 2024, the Company entered into capped call transactions with certain financial institutions (“Capped Calls”). After payment of the cost of entering into the Capped Calls transactions, of approximately $40.6 million, the Company used the remainder of the net proceeds from the Notes offering, together with cash on hand, to repay the Company’s existing senior secured credit agreement with Truist Bank, dated as of November 19, 2021.

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On September 16, 2024, ANI drew the full $325.0 million of principal under the 2024 Credit Agreement, with proceeds used to finance the acquisition of Alimera, including fees, costs and expenses incurred in connection with the acquisition. As of December 31, 2025, the revolving credit facility remains undrawn, and $74.9 million is available for borrowing, subject to the satisfaction of certain conditions. The 2024 Credit Agreement and the revolving credit facility mature on September 16, 2029.

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In May 2023, through a public offering, the Company completed the issuance and sale of 2,183,545 shares of ANI common stock, resulting in net proceeds after issuance costs of $80.6 million.

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Strategy

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Our objective is to build a sustainable and growing biopharmaceutical company serving patients in need and creating long-term value for our investors. Our overall strategy is enabled by an empowered, collaborative, and purposeful team with high performance-orientation that seeks to deliver on our purpose of “Serving Patients, Improving Lives.”

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Our strategy is driven by the following key growth drivers:

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Building a successful Rare Disease and Brands Segment

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We have spent significant time, effort and resources in establishing and expanding our Rare Disease and Brands segment which consists of our Rare Disease and Brands portfolio of products. We plan to continue to expand our Rare Disease business, through a combination of organic growth and acquisition. While we execute against our strategic initiatives that we believe will result in the long-term, sustainable growth and value to our stockholders, we continue to evaluate potential acquisitions and other strategic transactions of businesses that we believe complement our existing portfolio, infrastructure and capabilities or provide us with the opportunity to expand our existing capabilities. The Brands portion of the segment is comprised of various branded products.

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The acquisition of Alimera is anticipated to strengthen our Rare Disease business and expand our footprint beyond the U.S. with the addition of Alimera’s direct marketing operations located in Germany, the United Kingdom, Portugal, and Ireland, as well as its partnerships in Europe, Asia, and the Middle East. ILUVIEN and YUTIQ are a durable franchise with high barriers to genericization which the Company believes have a clear role for patients in need of alternative therapeutic options. ANI sees the potential to unlock significant additional growth for the ILUVIEN and YUTIQ franchise through commercial synergies and execution.

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Purified Cortrophin® Gel

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We acquired the NDAs for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (“Cortrophin Gel”) and Cortrophin-ZincTM in January 2016 and executed long-term supply agreements with a supplier of our primary raw material for corticotrophin API, a supplier of corticotrophin API with whom we have advanced the manufacture of commercial scale batches of API, and a Cortrophin Gel fill/finish contract manufacturer. On October 29, 2021, the FDA approved the Company’s Supplemental New Drug Application ("sNDA") for Cortrophin Gel for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (“ACTH”), also known as purified corticotropin. On January 24, 2022, we announced the commercial launch of Cortrophin Gel in the U.S. as our foundational Rare Disease asset.

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Throughout 2023 and 2024, we continued to build and invest in our infrastructure to support growth in new areas of opportunity, such as pulmonology, ophthalmology, and gout in the ACTH market. On October 2, 2023, we announced FDA approval and commercial availability of a 1-mLvial of Cortrophin Gel, appropriate for adjunctive treatment of certain patients with acute gouty arthritis flares.

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During the first quarter of 2024, ANI launched a targeted ophthalmology-focused sales force for Cortrophin Gel. The team has continued to gain momentum in ophthalmology, driving significant growth in the number of new patient starts during 2024. Importantly, the addition of Alimera expands the reach of the ophthalmology sales team and we believe there will be significant overlap between high potential prescribers of Cortrophin Gel, ILUVIEN, and YUTIQ.

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ILUVIEN and YUTIQ

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ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg, was developed in the U.S. and internationally for the treatment of diabetic macular edema (“DME”), a leading cause of severe vision loss and blindness, and certain international markets for chronic non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). We acquired exclusive commercialization rights to YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, in May 2023 from EyePoint Pharmaceuticals, Inc. (“EyePoint”) for the treatment and prevention of NIU-PS worldwide except for Europe, the Middle East, Africa, (known as ILUVIEN in Europe, the Middle East and Africa) and certain Asian countries including China. ILUVIEN and YUTIQ are state-of-the-art sustained release intravitreal implants that respectively help patients maintain vision longer and reduce disease recurrence. ILUVIEN is being evaluated as baseline therapy in naïve or near naïve patients with early DME in combination with the current standard of care, anti-vascular endothelial growth factor (“VEGF”) therapy in the NEW DAY clinical trial. YUTIQ is being further studied in the SYNCHRONICITY Clinical Trial, a prospective, open-label clinical trial evaluating the safety and efficacy of YUTIQ for the treatment and prevention of chronic NIU-PS and related intraocular inflammation.

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Both ILUVIEN and YUTIQ treat patients by delivering a continuous microdose of the corticosteroid fluocinolone acetonide (“FAc”) in the eye, for up to 36 months. ILUVIEN was developed internally and initially to treat DME, a disease of the retina that affects individuals with Type 1 or Type 2 diabetes and can lead to severe vision loss and blindness. ILUVIEN is sold to treat DME only in the U.S. YUTIQ is sold to treat NIU-PS only in the U.S. In certain European and Middle Eastern countries, ILUVIEN is approved and commercialized to treat DME and to prevent relapse in recurrent NIU-PS, an inflammatory disease of the uveal tract, which is comprised of the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. We also have rights to commercialize ILUVIEN for NIU-PS in Africa.

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ILUVIEN and YUTIQ are both intravitreal implants that are inserted into the back of the patient’s eye in non-surgical procedures employing devices with 25-gauge needles, which allow for a self-sealing wounds. “Intravitreal” refers to the space inside the eye behind the lens that contains the jelly-like substance called vitreous. The implants, which are non-bioerodible, provide consistent delivery as a result of their constant surface area, permitting elution of FAc to the vitreous. We call this CONTINUOUS MICRODOSING™. This delivery mechanism provides lower daily and aggregate exposure to corticosteroids than any other intraocular dosage forms currently available, which we believe mitigates the typical risks associated with corticosteroid therapy. CONTINUOUS MICRODOSING delivery makes ILUVIEN and YUTIQ the only approved drug therapies for DME and NIU-PS that are designed to deliver consistent daily therapeutic levels of corticosteroid and reduce the recurrence of DME and uveitis for up to three years. Other therapies that physicians currently use to treat DME, such as anti-VEGF treatments and other corticosteroids, are acute (short-acting) therapies that provide a higher initial daily dose but then rapidly decline, requiring frequent reinjection by the physician to maintain an effective dose or reestablish the therapeutic effect after the disease has recurred.

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FAc is a non-proprietary corticosteroid and the active compound in ILUVIEN (0.19mg) and YUTIQ (0.18mg). We believe that corticosteroids provide the best option in the treatment of DME and NIU-PS because they reduce the inflammatory aspects of both diseases. ILUVIEN and YUTIQ deliver continuous daily sub-microgram levels of FAc in in vivo release kinetic studies for up to 36 months. ILUVIEN and YUTIQ are the only single injection therapies available to treat retinal diseases consistently every day for up to three years, which may allow patients to see better, longer, with fewer injections.

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Brands

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We have grown our brands portfolio of products through acquisition. We have acquired the NDAs for and market Atacand, Atacand HCT, Arimidex, Casodex, Lithobid, Vancocin, Inderal LA, Inderal XL, InnoPran XL, Oxistat, and Veregen. We are innovating in our go-to-market strategy through creative partnerships and a sales force for these products.

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Strengthening our Generics and Other segment through continued investment in our generic research and development capability and increased focus on niche opportunities

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We have grown our generics business through a combination of market share gains on existing products and new product launches. We have also successfully acquired numerous ANDAs through business and asset acquisitions. Our most recent business acquisition in the Generics and Other segment was the acquisition of Novitium in 2021, which included its portfolio of commercial and pipeline generic products, manufacturing and development facilities and expert workforce. The Novitium acquisition significantly increased our generic pharmaceutical research and development and manufacturing capabilities. We have begun to increase our focus on niche lower competition opportunities such as injectables, Paragraph IV, and competitive generic therapy (“CGT”) designation filings.

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Additionally, we will continue to seek opportunities to enhance our capabilities through strategic partnerships and acquisitions of assets and businesses. During 2023, we acquired two ANDAs and one pipeline product from the Chapter 7 Trustee for the estates of Akorn Holding Company and certain of its affiliates, acquired an ANDA and registered patents and pending patent applications from Slayback Pharma Limited Liability Company, and acquired additional ANDAs and product rights for two products in the second half of 2023. During 2022, we completed an asset acquisition of four ANDAs from Oakrum Pharma, including two that were commercial at the time of acquisition.

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Generic Product Development Considerations

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We consider a variety of criteria in determining which products to develop. These criteria include:

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•Formulation Complexity. Our development and manufacturing capabilities enable us to manufacture pharmaceuticals that are differentiated and include high potency, modified release, combination, and hormonal products. This ability to manufacture a variety of differentiated products is a competitive strength that we intend to leverage in selecting products to develop and commercialize.

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•Market Size and Patient Need. When determining whether to develop or acquire an individual product, we review the current and expected market size for that product and competitive environment. We endeavor to pursue products with sufficient market size to enable us to enter the market with a strong likelihood of serving patients in need and thus being able to price our products both competitively and at a profit.

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•Profit Potential. In determining the potential profit of a product, we forecast our anticipated market share, pricing, competitive environment and the estimated cost to manufacture the products.

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•Manufacturing. We generally seek to develop and manufacture products at our own manufacturing plants to ensure quality control of our products, supply chain reliability and to more closely control the economic inputs and outputs of our products.

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•Competition. When determining whether to develop or acquire a product, we research existing and expected competition. We seek to develop products for which we can obtain sufficient market share and may decline to develop a product if we anticipate significant competition. Our manufacturing facilities provide a means of entering niche markets, such as hormone therapies, in which fewer generic companies typically compete.

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Fiscal 2024Recent Developments

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Purchase of SWK Royalty

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Pursuant to a Royalty Purchase Agreement dated as of December 17, 2020, EyePoint sold its right to receive royalty payments on future sales of ILUVIEN to SWK Funding LLC (“SWK”) under the existing collaboration agreement entered into in July 2017 between EyePoint and the Company (the “RPA Transaction”). In connection with the RPA Transaction, the Company agreed to pay such royalty payments directly to SWK (see Note 11 “Goodwill and Intangible Assets” to the notes to the consolidated financial statements).

Added

On June 19, 2024, Alimera entered into a letter agreement with SWK, pursuant to which the parties agreed to a lower fixed royalty payment of 3.125% (the “Alternative Royalty”) on combined sales of ILUVIEN and YUTIQ. The letter agreement included a buy-out of the Alternative Royalty at Alimera’s option at any time during the period within six (6) months after a change of control of Alimera, after which SWK would have no further right to receive any payments under the letter agreement or the RPA (the “Buy-Out Option”). On March 17, 2025, the Company exercised the Buy-Out Option and paid SWK $17.3 million with cash on hand, and as such, no further royalty is due to SWK on net revenues after January 1, 2025.

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On September 16, 2024, the Company completed our previously announced merger with Alimera (the “Closing”). At the effective time of the Merger (the “Effective Time”), each share of common stock, par value $0.01 per share, of Alimera (the “Alimera Common Stock”) outstanding immediately prior to the Effective Time including each Alimera RSA, Alimera PSU, Alimera RSU, and Alimera Warrant (each as defined below), but excluding any treasury shares or shares owned by the Company, Mergermerger Subssubsidiaries or any other subsidiary of the Company or Alimera), was canceled and ceased to exist and was converted into the right to receive (i) $5.50 in cash (“Closing Cash Consideration”), and (ii) one contingent value right (a “CVR”), which represents the right to receive the milestone payments (as defined below) subject to the terms and conditions set forth in the CVR Agreement entered into on September 16, 2024 (clauses (i) and (ii) collectively, the “Merger Consideration”). The Company also repaid $72.5 million of Alimera debt.

Reworded

Each CVR entitles the holder to receive milestone payments for 2026 and 2027. The milestone payments for each CVR equals the product (rounded to the nearest 1/100 of $0.01) of $0.25 multiplied by a fraction (which is no case will exceed one), and (i) for 2026, equals the amount, if any, by which the 2026 Net Revenue (as defined therein) exceeds $140.0 million, divided by $10.0 million (subject to adjustment for the exercise price of eligible options), and (ii) for 2027, equals the amount, if any, by which the 2027 Net Revenue exceeds $160.0 million, divided by $15.0 million (subject to adjustment for the exercise price of applicable Alimera Options).

Reworded

In addition to the amounts payable to the holders thereof in connection with the Closing,Merger, all of the outstanding awards of restricted stock with respect to shares of Alimera Common Stock (each, an “Alimera RSA”), each Alimera Performance Stock Unit (“Alimera PSU”), each Alimera Restricted Stock Unit (“Alimera RSU”) and each Alimera warrant ("Alimera Warrant") that were outstanding immediately prior to the Effective Time were automatically canceled and converted into the right to receive one (1) CVR per share of Alimera Common Stock then underlying the applicable instrument.

Reworded

Each stock option previously granted by Alimera to purchase Alimera Common Stock (each, an “Alimera Option”) that was outstanding and unexercised as of the Effective Time and which had a per share exercise price that was less than the Closing Cash Consideration was, in addition to the amounts payable to the holders thereof in connection with the Closing, automatically canceled and converted into the right to receive one (1) CVR per share of Alimera Common Stock then underlying such Alimera Option. No other Alimera Options were cancelled and converted into the right to receive a CVR, provided that each Alimera Option with a per share exercise price greater than or equal to the Closing Cash Consideration but less than the Total Consideration (as defined in the Merger Agreement) may receive a payment in connection with the payout of the CVRs (if any). See Note 3 “Business Combination” to the notes to the consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K for further information on the acquisition.

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During the year ended December 31, 2024, the Company incurred approximately $12.4 million in transaction costs related to the Merger Agreement, all of which were expensed. See Note 3 “Business Combination” to the notes to the consolidated financial statements for further information on the acquisition.

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New Capital Structure

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On March 8, 2021, concurrently with the acquisition of Novitium, and as financing for a portion of the acquisition, the Company entered into an Equity Commitment and Investment Agreement with Ampersand 2020 Limited Partnership (the “PIPE Investor”), pursuant to which the PIPE Investor purchased 25,000 shares of Series A Convertible Preferred Stock (the “PIPE Shares”), for a purchase price of $1,000 per share and an aggregate purchase price of $25.0 million on November 19, 2021. The PIPE Shares were classified as mezzanine equity because the shares were mandatorily redeemable for cash upon a change in control, an event that was not solely within the Company’s control.

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The PIPE Shares accrued dividends at 6.50% per year on a cumulative basis, payable in cash or in-kind, and participated, on a pro-rata basis, in any dividends that would be declared with respect to the Company's common stock. The PIPE Shares were convertible into common shares at the conversion price of $41.4662 (i) beginning two years after their issuance date, at the election of ANI, if the volume-weighted average price of the common stock for any 20 trading days out of 30 consecutive trading days exceeds 170% of the conversion price, or (ii) at any time after issuance, at the election of the PIPE Investor.

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On August 14, 2025, the PIPE Investor converted 5,000 PIPE Shares into 120,580 shares of common stock based on the conversion price of $41.4662 per share. On September 26, 2025, the Company elected mandatory conversion of the remaining 20,000 outstanding PIPE Shares into 482,320 shares of common stock based on the conversion price of $41.4662 per share, as the conditions for conversion had been satisfied. There were no shares of Series A Convertible Preferred Stock outstanding as of December 31, 2025.

Reworded

Refer to the Liquidity and Capital Resources below for further discussion of changes to our capital structure during 2025 and 2024.

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Restructuring

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On February 15, 2024, ANI Pharmaceuticals Canada, Inc., a wholly owned subsidiary of the Company, entered into an agreement (the “Agreement”) with 1540700 Ontario Limited (“Buyer”) for the sale of ANI’s Oakville, Ontario former manufacturing site (the “Property”) for a total purchase price of $19.2 million Canadian Dollars, or approximately $14.2 million, based on the exchange rate at closing. During February 2024, and in accordance with the Agreement, the Buyer deposited a total of approximately $1.9 million Canadian Dollars, or approximately $1.4 million in refundable deposits in escrow as part of the total purchase price.

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On March 28, 2024 the Company completed the sale of the Property. After payment of commissions, taxes, and other related costs of approximately $0.7 million, the Company received a net cash amount of approximately $13.5 million at closing. The gain on the sale of the Property was approximately $5.3 million, recorded in the consolidated statements of operations.

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"N/M" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ on September 16, 2024.

Reworded

We derive substantially all of our revenues from sales of rareour disease,Rare brandsDisease, portfolioBrands and Generics portfolios of pharmaceutical products, generics,as andwell as from other sources of revenue such as royalties on net sales of certain products, and other pharmaceutical services. Essentially all of our genericGenerics products face competition from other generic products, as do many of our brandsBrands products, and we expect them to continue to face competition from generic products in the future. The primary means of competition among generic manufacturers are pricing, contract terms, service levels, and reliability. Increased competition generally results in decreased average selling prices of generic and brands products over time. In addition, due to strategic partnerships between wholesalers and pharmacy chains, we have experienced, and expect to continue to experience, increases in net sales to the wholesalers, with corresponding decreases in net sales to the pharmacy chains.

Reworded

•Net revenues from Rare Disease and Brands, which includes our rare disease and brands portfolioportfolios of pharmaceutical productsproducts, was $294.3$484.0 million during the year ended December 31, 2024,2025, an increase of $96.8$189.6 million, compared to $197.5$294.3 million,million for the same period in 2023.2024.

Reworded

•Net revenues for rareRare diseaseDisease pharmaceutical products, include Cortrophin Gel and a full quarter contribution from ILUVIEN and YUTIQ,products were $229.6$422.6 million during the year ended December 31, 2024,2025, an increase of $117.5$193.0 million from $112.1$229.6 million for the same period in 2023.2024. This increase was driven by increased volume in this third year of launch of Cortrophin Gel (product was launched in late January 2022) from overall ACTH market growth and market share growth,gains, and a full quarteryear of sales from ILUVIEN and YUTIQ,YUTIQ. asILUVIEN aand resultYUTIQ ofwere theacquired acquisition offrom Alimera onin September 16, 2024.

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•Net revenues for brands portfolio of pharmaceutical products were $64.7 million during the year ended December 31, 2024, a decrease of $20.6 million compared to $85.4 million for the same period in 2023, driven by a net decrease in volume. During portions of the prior year and the first quarter and portions of the fourth quarter of 2024, we were successful in supplying incremental volume in markets that were experiencing supply chain disruptions for competing products. This incremental volume was not a significant factor in the second and third quarter of 2024. Incremental volume achieved toward the end of 2024 continued into the first half of the first quarter of 2025. The timing, magnitude and persistence of such market share gains are inherently difficult to predict and they may not persist in future reporting periods.

Reworded

•Net revenues for genericBrands andportfolio otherof pharmaceutical products were $320.0$61.3 million during the year ended December 31, 2024,2025, ana increasedecrease of 10.6%$3.4 million compared to $289.3$64.7 million for the same period in 2023,2024, primarilydriven by a resultnet ofdecrease thein following:demand for certain products.

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Comparing 10-Q filed 2026-08-07 (period ending 2026-06-30) with 10-Q filed 2026-05-08 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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The section in the latest 10-Q reads in full:

In addition to the other information set forth in this Quarterly Report on Form 10-Q, please carefully consider the factors described under the heading “Risk Factors” in our 2025 Form 10-K in Part I, Item 1A. The risks described are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that our management currently deems to be immaterial, also may adversely affect our business, financial condition, and/or operating results.

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Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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New heading “RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025”

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“RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025”
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“•Selling, general, and administrative expenses decreased from $76.5 million to $73.7 million, a decrease of approximately $2.9 million, and includes a litigation settlement received of $9.0 million and a decrease of approximately $1.5 million in transaction and integration costs related to the Alimera acquisition, offset by increased investment in Rare Disease sales and marketing infrastructure, including the initial marketing and recruitment expense related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in …”
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“•Selling, general, and administrative expenses increased from $158.3 million to $165.3 million, an increase of approximately $7.0 million, and includes increased investment in Rare Disease sales and marketing infrastructure, related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business, compared to the same period in 2025, offset by a litigation settlement received of $9.0 million, and a decrease of approximately $2.3 million in transaction and integration costs related …”
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Reworded

On September 16, 2024, the Company acquired Alimera.Alimera Sciences, Inc. (“Alimera”). In connection with the Merger, the Company added a growing and durable franchise, ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in the United States (“U.S.”) and 24 countries for the treatment of diabetic macular edema (“DME”) and YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the U.S. for the treatment of non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). Subsequent to the acquisition of Alimera, we expanded the label for ILUVIEN to include an indication for chronic NIU-PS in addition to its then-current indication in DME in the U.S.

Reworded

Impacts to our firstsecond quarter 2026 and 2025 results of operations, including to net revenues, operating expenses, interest and other expense, net, and income taxes are described below.

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RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCHJUNE 31,30, 2026 AND 2025

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____________________________________________ (1)There were no sales of YUTIQ induring Q1the quarters ended March 31, 2026 and June 30, 2026, as the Company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS during the second quarter of 2025.

Reworded

We derive substantially all of our revenues from sales of our Rare Disease, Brands and Generics portfolios of pharmaceutical products, as well as from other sources of revenue such as milestones, royalties on net sales of certain products, and other pharmaceutical services. Our Rare Disease products face competition from other brand products in many of the therapeutic categories in which they are sold. Essentially all of our Generics products face competition from other generic products, as do many of our Brands products, and we expect them to continue to face competition from generic products in the future. The primary means of competition among generic manufacturers are pricing, contract terms, service levels, and reliability. Increased competition generally results in decreased average selling prices of generic and brands products over time. In addition, due to strategic partnerships between wholesalers and pharmacy chains, we have experienced, and expect to continue to experience, increases in net sales to the wholesalers, with corresponding decreases in net sales to the pharmacy chains.

Reworded

Net revenues for the three months ended MarchJune 31,30, 2026 were $237.5$266.0 million compared to $197.1$211.4 million for the same period in 2025, an increase of 20.5%,25.9%, primarily as a result of the following:

Reworded

•Net revenues from Rare Disease and Brands, which includes our rareRare diseaseDisease and brandsBrands portfolios of pharmaceutical products, royalties, and other revenues were $128.2$165.4 million during the three months ended MarchJune 31,30, 2026, an increase of $34.2$48.2 million, compared to $94.1$117.2 million for the same period in 2025.

Reworded

•Net revenues for Rare Disease pharmaceutical products were $94.4$135.8 million during the three months ended MarchJune 31,30, 2026, an increase of $25.4$31.9 million from $69.0$104.0 million for the same period in 2025. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and market share gains. TheILUVIEN increasenet revenues were $18.7 million in salesthe forsecond ILUVIENquarter, wasdown driven16% byfrom the continuedprior executionyear of commercial and patient access initiatives established during 2025.period.

Reworded

•Net revenues for Brands portfolio of pharmaceutical products were $12.3$11.8 million during the three months ended MarchJune 31,30, 2026, a decrease of $12.8$1.4 million compared to $25.1$13.2 million for the same period in 2025, driven by a net decrease in demand for certain products during the firstsecond quarter.

Reworded

•Net revenues for Brand royalties and other revenues during the three months ended MarchJune 31,30, 2026, includes a $15.0 million upfront payment and associated royalties of approximately $6.5$9.7 million, and $8.0 million of revenue associated with development milestones satisfied over time, related to the Harmony Agreement.

Reworded

•Net revenues from Generics and Other, which includes our generic pharmaceutical products, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services, were $109.2$100.7 million during the three months ended MarchJune 31,30, 2026, an increase of 6.0%6.8% compared to $103.0$94.2 million for the same period in 2025, primarily as a result of the following:

Reworded

•Generic pharmaceutical products net revenues were $105.4$99.1 million during the three months ended MarchJune 31,30, 2026, an increase of $6.7$8.8 million over the prior year. This increase was driven by a partnered product launched in the third quarter of 2025, and increased volumes from the benefit of new product launches during 2026. From a product perspective, in addition to the partnered product cited above, the increase was principally driven by revenues from year over year increases in products such as Vancomycin and MAS ER, Vancomycin, among others.

Reworded

•Other generic net revenues were essentiallydown flatmodestly for the three months ended MarchJune 31,30, 20262026, compared to the same periodtime in 2025.the prior year due to fewer contract manufacturing shipments and lower royalties during the period.

Reworded

For the three months ended MarchJune 31,30, 2026, cost of sales increased to $93.6$100.2 million from $73.0$74.6 million for the same period in 2025, an increase of $20.5$25.5 million, or 28.1%.34.2%. The increase is primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel, and other products in our portfolio.

Reworded

Cost of sales, as a percentage of net revenues, increased to 39.4%37.6% from 37.1%35.3% for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025, primarily due to a shift in product mix year over year and an increase in sales of products that bear a royalty payable, and the non-recurrence of prior year sales from Prucalopride. These effects were somewhat tempered by the the initial revenue recognized under the Harmony Agreement.

Added

During the three months ended June 30, 2026 and 2025, no single vendor represented more than 10% of our raw inventory purchases.

Removed

During the three months ended March 31, 2026, approximately 33% of our raw material inventory purchases were from one domestic supplier. During the three months ended March 31, 2025, approximately 22% of our raw material inventory purchases were from one domestic supplier.

Reworded

For the three months ended MarchJune 31,30, 2026, total other operating expenses, net increased to $105.0$125.4 million from $97.9$122.9 million for the same period in 2025, an increase of $7.1$2.6 million, or 7.3%,2.1%, primarily as a result of the following factors:

Removed

•Research and development expenses were essentially flat for the three months ended March 31, 2026 compared to the same period in 2025.

Removed

•Selling, general, and administrative expenses decreased from $76.5 million to $73.7 million, a decrease of approximately $2.9 million, and includes a litigation settlement received of $9.0 million and a decrease of approximately $1.5 million in transaction and integration costs related to the Alimera acquisition, offset by increased investment in Rare Disease sales and marketing infrastructure, including the initial marketing and recruitment expense related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business, compared to the same period in 2025.

Reworded

•DepreciationResearch and amortizationdevelopment expenseexpenses was $20.9 million forduring the three months ended MarchJune 31,30, 2026,2026 compareddecreased from $16.5 million to $22.9$14.7 million for the same period in 2025,million, a decrease of approximately $2.0$1.8 million, primarily relateddue to certaintiming definiteof livedactivity intangiblesassociated thatwith haveongoing beenand fullynew amortizedprojects duringto 2025.support future growth of Rare Disease and Generics.

Added

•Selling, general, and administrative expenses increased from $81.8 million to $91.7 million, primarily resulting from increased investment in Rare Disease sales and marketing infrastructure, related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business, tempered by lower legal costs, compared to the same period in 2025.

Added

•Depreciation and amortization expense was $19.6 million for the three months ended June 30, 2026, compared to $23.3 million for the same period in 2025, a decrease of approximately $3.6 million, primarily related to certain definite-lived intangibles that have been fully amortized during 2025.

Reworded

•We recognized a net gain of approximately $0.2$0.6 million for the three months ended MarchJune 31,30, 2026 related to changes in our contingent consideration liabilities, which are measured at fair value. The net gain resulted from the adjustment of future forecasted cash flows and includes primarily: (1) a $0.4$0.5 million reduction related to the Alimera contingent value rights; and (2) a $0.2$0.1 million increasedecrease in contingent consideration related to the Novitium acquisition.

Reworded

Other Income (Expense),Expense, net

Reworded

For the three months ended MarchJune 31,30, 2026, we recognized total other income,expense, net of $1.3$3.4 million as compared to total other expense, net of $6.2$3.4 million for the same period in 2025.

Reworded

•We recorded an unrealized gain on investment in equity securities of approximately $5.8$0.7 million for the three months ended MarchJune 31,30, 2026, compared to an unrealized lossgain of approximately $0.9$0.3 million in the same period in 2025, which is based on the mark to market fair value of equity securities held in CG Oncology as of the balance sheet date.

Reworded

•Interest expense, net for the three months ended MarchJune 31,30, 2026 consists primarily of coupon interest expense on borrowings under our outstanding debt and amortization of deferred financingsfinancing costs on these debt instruments, interest income earned on our bank balances, and interest earned on our interest rate swap. Interest income earned on our bank balances increased approximately $1.3$1.2 million and interest expense related to our outstanding debt decreased approximately $0.6$0.8 million,million resulting in an increase of interest income of approximately $1.9$2.0 million. This impact was partially offset by a decrease of interest earned on our interest rate swap of approximately $0.2 million, compared to the same period in the prior year.

Reworded

•Other (expense) income, net, for the three months ended MarchJune 31,30, 2026 and 2025 consists primarily of unrealized foreign exchange gains and losses related to our Alimera UK subsidiary.

Reworded

For the three months ended MarchJune 31,30, 2026, our income tax expense was approximately $10.7$12.4 million. Our effective tax rate of 26.7%33.4% of pre-tax income for the current year was determined based on our pre-tax income, statutory tax rates and the tax impacts of certain discrete items for the three months ended MarchJune 31,30, 2026, which impact our income tax expense in the period in which they occur. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes and disallowed officersofficers' compensation partially offset by excess tax benefits recognized upon settlement of stock-based compensation.

Reworded

For the three months ended MarchJune 31,30, 2025, our income tax expense was approximately $4.3$2.0 million. Our effective tax rate was 21.5%18.8% of pre-tax income reported in the period, as well as the net effect of certain discrete items for the three months ended MarchJune 31,30, 2025 which impact our income tax expense in the period in which they occur. Discrete items areduring primarilythe relatedsecond quarter of 2025 relate predominately to excessfavorable return to provision adjustments attributable to certain foreign tax benefitsreturns recognizedfiled uponduring settlementthe of stock-based compensation awards.quarter.

Added

RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025

Added

Net Revenue

Added

________________________________________ (1)There were no sales of YUTIQ during the quarters ended March 31, 2026 and June 30, 2026, as the Company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which had a combined label of DME and NIU-PS during the second quarter of 2025.

Added

Net revenues for the six months ended June 30, 2026 were $503.5 million compared to $408.5 million for the same period in 2025, an increase of 23.3%, primarily as a result of the following:

Added

•Net revenues from Rare Disease and Brands, which includes our Rare Disease and Brands portfolios of pharmaceutical products, royalties, and other revenues were $293.6 million during the six months ended June 30, 2026, an increase of $82.4 million, compared to $211.2 million for the same period in 2025.

Added

•Net revenues for Rare Disease pharmaceutical products were $230.2 million during the six months ended June 30, 2026, an increase of $57.3 million from $172.9 million for the same period in 2025. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and market share gains. Net revenues for ILUVIEN were down modestly for the six months ended June 30, 2026, compared to the same time in the prior year.

Added

•Net revenues for Brands portfolio of pharmaceutical products were $24.1 million during the six months ended June 30, 2026, a decrease of $14.2 million compared to $38.3 million for the same period in 2025, driven by a net decrease in demand for certain products during the first half of 2026, compared to the same time in the prior year.

Added

•Net revenues for Brand royalties and other revenues during the six months ended June 30, 2026, includes a $15.0 million upfront payment, associated royalties of approximately $16.3 million, and $8.0 million of revenue associated with development milestones satisfied over time, related to the Harmony Agreement.

Added

•Net revenues from Generics and Other, which includes our generic pharmaceutical products, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services, were $209.9 million during the six months ended June 30, 2026, an increase of $12.6 million compared to $197.3 million for the same period in 2025, primarily as a result of the following:

Added

•Generic pharmaceutical products net revenues were $204.5 million during the six months ended June 30, 2026, an increase of $15.5 million over the prior year. This increase was driven by a partnered product launched in the third quarter of 2025, and increased volumes from the benefit of new product launches during 2026. From a product perspective, in addition to the partnered product cited above, the increase was principally driven by revenues from year over year increases in products such as Vancomycin and MAS ER, among others, tempered by decreased sales of Prucalopride.

Added

•Other generic net revenues was down modestly for the six months ended June 30, 2026, compared to the same time in the prior year due to fewer contract manufacturing shipments during the period.

Added

Cost of Sales (Excluding Depreciation and Amortization)

Added

For the six months ended June 30, 2026, cost of sales increased to $193.7 million from $147.7 million for the same period in 2025, an increase of $46.1 million, or 31.2%. The increase is primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel, and other products in our portfolio.

Added

Cost of sales, as a percentage of net revenues, increased to 38.5% from 36.1% for the six months ended June 30, 2026, compared to the same period in 2025, primarily due to a shift in product mix year over year, an increase in sales of products that bear a royalty payable, and the non-recurrence of prior year sales from Prucalopride. These effects were somewhat tempered by the revenue recognized under the Harmony Agreement.

Added

During the six months ended June 30, 2026, approximately 23% of our raw material inventory purchases were from one domestic supplier. During the six months ended June 30, 2025, approximately 23% of our raw material inventory purchases were from one domestic supplier.

Added

Other Operating Expenses, net

Added

For the six months ended June 30, 2026, total other operating expenses, net increased to $230.4 million from $220.8 million for the same period in 2025, an increase of $9.7 million, or 4.4%, primarily as a result of the following factors:

Added

•Research and development expenses during the six months ended June 30, 2026 decreased from $27.1 million to $25.3 million, a decrease of approximately $1.8 million, primarily due to timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics.

Added

•Selling, general, and administrative expenses increased from $158.3 million to $165.3 million, an increase of approximately $7.0 million, and includes increased investment in Rare Disease sales and marketing infrastructure, related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business, compared to the same period in 2025, offset by a litigation settlement received of $9.0 million, and a decrease of approximately $2.3 million in transaction and integration costs related to the Alimera acquisition.

Added

•Depreciation and amortization expense was $40.6 million for the six months ended June 30, 2026, compared to $46.2 million for the same period in 2025, a decrease of approximately $5.6 million, primarily related to certain definite-lived intangibles that have been fully amortized during 2025.

Added

•We recognized a net gain of approximately $0.8 million for the six months ended June 30, 2026 related to changes in our contingent consideration liabilities, which are measured at fair value. The net gain resulted from the adjustment of future forecasted cash flows and includes primarily: (1) a $0.9 million reduction related to the Alimera contingent value rights; and (2) a $0.2 million increase in contingent consideration related to the Novitium acquisition.

Added

Other (Expense), net

Added

For the six months ended June 30, 2026, we recognized total other expense, net of $2.0 million as compared to total other expense, net of $9.6 million for the same period in 2025.

Added

•We recorded an unrealized gain on investment in equity securities of approximately $6.5 million for the six months ended June 30, 2026, compared to an unrealized loss of approximately $0.6 million in the same period in 2025, which is based on the mark to market fair value of equity securities held in CG Oncology as of the balance sheet date.

Added

•Interest expense, net for the six months ended June 30, 2026 consists primarily of coupon interest expense on borrowings under our outstanding debt and amortization of deferred financing costs on these debt instruments, interest income earned on our bank balances, and interest earned on our interest rate swap. Interest income earned on our bank balances increased approximately $2.5 million and interest expense related to our outstanding debt decreased approximately $1.4 million, resulting in an increase of interest income of approximately $3.9 million. This impact was partially offset by a decrease of interest earned on our interest rate swap of approximately $0.5 million, compared to same period in the prior year.

Added

•Other (expense) income, net, for the six months ended June 30, 2026 and 2025 consists primarily of unrealized foreign exchange gains and losses related to our Alimera UK subsidiary.

Added

Income Tax Expense

Added

For the six months ended June 30, 2026, our income tax expense was approximately $23.1 million. Our effective tax rate of 29.9% of pre-tax income for the current year was determined based on our pre-tax income, statutory tax rates and the tax impacts of certain discrete items for the six months ended June 30, 2026, which impact our income tax expense in the period in which they occur. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes and disallowed officers’ compensation partially offset by excess tax benefits recognized upon settlement of stock-based compensation.

Added

For the six months ended June 30, 2025, our income tax expense was approximately $6.3 million. Our effective tax rate was 20.6% of pre-tax income reported in the period, as well as the net effect of certain discrete items for the six months ended June 30, 2025 which impact our income tax expense in the period in which they occur. Discrete items are primarily related to excess tax benefits recognized upon settlement of stock'based compensation awards.

Showing the first 60 of 68 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

ANIP insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 21 filings (8 insiders, 19 trade dates, 110,191 shares, about $8.6M; 16 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -110,191 (purchases minus sales); net value about -$8.6M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-09-29Carey Stephen P.
SVP & CFO
Open-market sale
10b5-1 plan
2,850$73.00 $208.1K168,993 SEC
2026-09-15Lalwani Nikhil
Director, PRESIDENT & CEO
Open-market sale
10b5-1 plan
5,400$71.00 $383.4K339,089 SEC
2026-09-14Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Open-market sale
10b5-1 plan
500$70.79 $35.4K73,924 SEC
2026-09-11Thoma Jeanne
Director
Open-market sale
10b5-1 plan
1,000$71.53 $71.5K26,762 SEC
2026-08-31Carey Stephen P.
SVP & CFO
Open-market sale
10b5-1 plan
2,850$72.80 $207.5K171,843 SEC
2026-08-25Lalwani Nikhil
Director, PRESIDENT & CEO
Open-market sale
10b5-1 plan
5,400$74.30 $401.2K344,489 SEC
2026-08-19Gosebruch Henry O
Director
Grant/award 6,662— —6,662 SEC
2026-08-13Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Open-market sale
10b5-1 plan
500$75.48 $37.7K74,424 SEC
2026-08-10Gutwerg Ori
SVP, GENERICS
Open-market sale 3,162$77.00 $243.5K75,534 SEC
2026-07-29Carey Stephen P.
SVP & CFO
Open-market sale
10b5-1 plan
2,850$81.36 $231.9K174,693 SEC
2026-07-18Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Shares withheld for tax 2,466$79.20 $195.3K74,924 SEC
2026-07-13Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Open-market sale
10b5-1 plan
500$81.84 $40.9K77,390 SEC
2026-07-02Carey Stephen P.
SVP & CFO
Option exercise
10b5-1 plan
3,313$49.51 $164.0K180,856 SEC
2026-07-02Carey Stephen P.
SVP & CFO
Open-market sale
10b5-1 plan
3,313$86.00 $284.9K177,543 SEC
2026-06-29Carey Stephen P.
SVP & CFO
Open-market sale
10b5-1 plan
2,850$84.12 $239.7K177,543 SEC
2026-06-12Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Open-market sale
10b5-1 plan
500$82.03 $41.0K77,890 SEC
2026-06-08Haughey Thomas
Director
Open-market sale
10b5-1 plan
2,000$80.88 $161.8K38,878 SEC
2026-06-05Carey Stephen P.
SVP & CFO
Open-market sale
10b5-1 plan
3,312$80.00 $265.0K180,393 SEC
2026-06-05Carey Stephen P.
SVP & CFO
Option exercise
10b5-1 plan
3,312$49.51 $164.0K183,705 SEC
2026-05-21Thoma Jeanne
Director
Grant/award 4,357— —27,762 SEC
2026-05-21Tannenbaum Renee P
Director
Grant/award 4,357— —29,514 SEC
2026-05-21Pera Antonio R
Director
Grant/award 4,357— —27,017 SEC
2026-05-21Leonard Matthew J
Director
Grant/award 4,357— —11,221 SEC
2026-05-21Haughey Thomas
Director
Grant/award
10b5-1 plan
4,357— —40,878 SEC
2026-05-13Walsh Patrick D
Director
Open-market sale 10,000$80.63 $806.3K38,432 SEC
2026-05-13Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Open-market sale
10b5-1 plan
500$78.16 $39.1K78,390 SEC
2026-05-12Rowland Thomas Andrew
SVP, HEAD - ESTABLISHED BRANDS
Open-market sale 459$79.21 $36.4K38,271 SEC
2026-05-12Gutwerg Ori
SVP, GENERICS
Open-market sale 2,772$79.50 $220.4K78,696 SEC
2026-05-11Walsh Patrick D
Director
Open-market sale 3,973$80.75 $320.8K48,432 SEC
2026-05-11Lalwani Nikhil
Director, PRESIDENT & CEO
Open-market sale 55,000$77.57 $4.3M349,889 SEC
2026-04-13Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
Open-market sale
10b5-1 plan
500$77.95 $39.0K78,890 SEC

Well-known investors holding ANIP (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Point72 Asset Management (Steve Cohen) NOTE 2.250% 9/02026-06-300$62.0M0.09%No change
Citadel Advisors (Ken Griffin) NOTE 2.250% 9/02026-06-300$45.4M0.03%No change
Millennium Management (Israel Englander) COM2026-06-30507,207$42.0M0.03%Reduced 14%
D. E. Shaw & Co. COM2026-06-30174,732$14.5M0.01%Reduced 18%
Citadel Advisors (Ken Griffin) COM2026-06-3096,082$8.0M0.0%Reduced 17%
Two Sigma Investments COM2026-06-3064,232$5.3M0.0%Reduced 34%
Renaissance Technologies COM2026-06-3063,700$5.3M0.01%Reduced 66%
AQR Capital Management (Cliff Asness) COM2026-06-3029,500$2.4M0.0%Added 57%
Gotham Asset Management (Joel Greenblatt) COM2026-06-306,027$498.9K0.0%Reduced 75%
Polen Capital Management COM2026-06-306,409$492.9K—Sold out

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when ANIP files, watchlists and downloadable comparisons.