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• ANI Pharmaceuticals is like a smaller, growing Teva Pharmaceuticals.
• ANI Pharmaceuticals is like a smaller Viatris, focusing on both generic and mature branded prescription drugs.

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• Generic Prescription Products: A diverse portfolio of generic pharmaceuticals, including oral solids, liquids, topicals, and controlled substances, across various therapeutic areas.
• Cortrophin® Gel: A branded prescription drug used to treat certain autoimmune and inflammatory conditions.
• Branded Pharmaceutical Portfolio: A collection of acquired branded prescription medications such as Inderal® LA, Arimidex®, Atacand®, Atacand HCT®, and Casodex®.

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Major Customers of ANI Pharmaceuticals (ANIP)

ANI Pharmaceuticals (ANIP) sells primarily to other companies, specifically major pharmaceutical wholesalers and group purchasing organizations (GPOs). These entities then distribute ANIP's products to hospitals, institutions, and pharmacies.

As disclosed in their latest public filings, the company's major customers include:

• AmerisourceBergen Drug Corporation (Symbol: ABC)
• Cardinal Health, Inc. (Symbol: CAH)
• McKesson Corporation (Symbol: MCK)

These three pharmaceutical wholesalers accounted for approximately 75.7% of ANI Pharmaceuticals' net revenues in 2023.

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Nikhil Lalwani, President and Chief Executive Officer

Mr. Lalwani joined ANI Pharmaceuticals in September 2020. Before joining ANI, he held various positions of increasing responsibility at Cipla Ltd from May 2012 to August 2020, including CEO of Cipla USA, CEO of InvaGen, Head of US Strategy, M&A & Integration, and Head of Cipla's Global Respiratory business. In these roles, he developed and executed multi-year strategic growth plans for key products and facilitated successful acquisitions as Cipla entered the specialty pharmaceutical space. Prior to Cipla, Mr. Lalwani was an Associate Partner with McKinsey & Company and an engineer with Medtronic.

Stephen P. Carey, Senior Vice President, Finance and Chief Financial Officer

Mr. Carey has served as ANI's Senior Vice President, Finance and Chief Financial Officer since May 2016, bringing over 30 years of experience as a financial executive, with more than 25 years in the pharmaceutical industry. Before ANI, he held various executive financial positions at Par Pharmaceutical Companies, Inc. from June 2007 to October 2015, including Senior Vice President, Controller and Principal Accounting Officer. During his tenure at Par, he supported the company through its $1.9 billion leveraged buyout with TPG Capital in 2012 and its subsequent $8 billion sale to Endo International plc in 2015. His career also includes financial and accounting roles at Schering-Plough Corporation and beginning his career at PricewaterhouseCoopers.

Muthusamy Shanmugam, Head of Research & Development and Chief Operating Officer of New Jersey Operations

Mr. Shanmugam joined ANI's Board in November 2021, coinciding with ANI's acquisition of Novitium Pharma, where he was the President and Founder from 2016 to November 2021. He has over three decades of experience in the pharmaceutical industry. He is also a director and founder of Scitus Pharma Services Pvt Ltd, a clinical research organization, and Nuray Chemicals Private Limited and Sthree Chemicals Private Limited, which are involved in manufacturing active pharmaceutical ingredients. Mr. Shanmugam started his career as a formulation scientist at Kali Laboratories, Inc.

Chad Gassert, Senior Vice President, Corporate Development and Strategy

Mr. Gassert joined ANI in November 2021 as part of the acquisition of Novitium Pharma, where he was a Co-Founder and CEO. At Novitium, he was responsible for building out a fully integrated generic pharmaceutical company. Prior to co-founding Novitium, Mr. Gassert worked at Par Pharmaceuticals from 2005 to 2016, where he progressed through various roles, including Senior Vice President of Business Development.

Christopher Mutz, Chief Commercial Officer & Head of Rare Diseases

Mr. Mutz joined ANI in February 2021 and leads the Company's Rare Disease business. Before joining ANI, he provided consulting services to pharmaceutical and biotech companies, focusing on pre-launch commercial strategy and life cycle management for rare diseases. Mr. Mutz has over 25 years of experience in the pharmaceutical industry, including eight years at Alexion Pharmaceuticals and 10 years at Merck and Co.

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The key risks to ANI Pharmaceuticals (ANIP) are primarily related to its reliance on specific products and suppliers, the highly regulated nature of the pharmaceutical industry, and intense market competition.

1. Reliance on Key Products and Single/Limited Suppliers: ANI Pharmaceuticals' financial health is significantly dependent on the performance of its key products, such as Cortrophin Gel, ILUVIEN, and YUTIQ. Any disruption in the production or supply chain of these products could materially impact the company. A significant risk stems from the limited number of suppliers for active pharmaceutical ingredients (API) and other raw materials, which could lead to production delays, inability to meet market demand, and potential revenue loss. The company also relies on single-source third-party contract manufacturing for certain key products, further increasing this risk.
2. Regulatory Challenges and Litigation Risks: Operating in the heavily regulated pharmaceutical industry in the U.S. and Canada, ANI Pharmaceuticals is subject to rigorous scrutiny by regulatory authorities like the FDA. Non-compliance or adverse regulatory actions, including those related to products sold without approved New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs), could result in substantial financial penalties, product recalls, or market withdrawals. Such events could severely damage the company's reputation and financial performance.
3. Competitive Pressures and Pricing Erosion: ANI Pharmaceuticals faces intense competition from both generic and branded pharmaceutical companies. The ongoing trend of consolidation among customer groups and the potential for new market entrants can lead to significant price pressures and a reduction in market share. Payer pushback and weaker pricing for generic products could quickly undermine the company's profitability. This is particularly pertinent given the company's reliance on a few specialty products and a relatively thin pipeline, leaving earnings vulnerable to competitive and pricing pressures.

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ANI Pharmaceuticals (ANIP) operates across several key business segments, primarily focusing on Rare Disease products, Generic Pharmaceuticals, and Established Brands. The addressable market sizes for its main products are as follows:

• Purified Cortrophin Gel: The annual market for Cortrophin Gel was approximately $950 million in the U.S. as of 2020. The broader ACTH (Adrenocorticotropic Hormone) therapy market, which includes Purified Cortrophin Gel, grew to approximately $684 million in 2024.
• ILUVIEN: For Diabetic Macular Edema (DME), the U.S. addressable market for ILUVIEN is approximately $477 million, with potential to grow to $675 million. The U.S. addressable market for Non-Infectious Uveitis affecting the Posterior Segment (NIU-PS) treated by ILUVIEN is between $700 million and $1 billion.
• YUTIQ: While YUTIQ is part of ANI Pharmaceuticals' rare disease ophthalmology portfolio, a specific addressable market size for YUTIQ alone was not identified in the search results, beyond its combined revenue contributions with ILUVIEN.
• Generic Pharmaceuticals: For a pipeline of seven development-stage generic products acquired by ANI Pharmaceuticals in 2019, the combined annual U.S. market value was estimated at $1.02 billion. A comprehensive addressable market size for ANI's entire current generic pharmaceutical portfolio was not identified.
• Established Brands: An addressable market size for ANI Pharmaceuticals' overall Established Brands segment or individual established brand products was not identified.

Therefore, based on the available information, the addressable markets for:

• Purified Cortrophin Gel (U.S.)
• ILUVIEN for DME (U.S.)
• ILUVIEN for NIU-PS (U.S.)

have been identified. For YUTIQ, the broader Generic Pharmaceuticals portfolio, and Established Brands, a specific addressable market size beyond individual product revenues or a subset of pipeline products was not found.

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• Continued Growth of Cortrophin Gel: Cortrophin Gel remains a primary growth engine, with expected continued adoption in established therapeutic areas such as rheumatology, neurology, and nephrology, and expansion into newer areas like ophthalmology and pulmonology. The company is actively investing in the franchise to drive greater adoption, including pursuing new indications like acute gouty arthritis. Cortrophin Gel revenues are projected to see significant year-over-year growth, with guidance for 2025 at $265 million to $274 million, reflecting a 34% to 38% increase.
• Integration and Growth of Acquired Ophthalmology Products (ILUVIEN and YUTIQ): The September 2024 acquisition of Alimera Sciences expanded ANI's rare disease portfolio with ILUVIEN and YUTIQ, two ophthalmology products. These products are expected to contribute to top-line growth, with significant room for expansion given their novel, long-acting nature and the size of their addressable markets. Completing the integration of Alimera and increasing the supply security for ILUVIEN and YUTIQ are near-term priorities to realize their full potential.
• New Generic Product Launches: ANI Pharmaceuticals' Generics business is a consistent contributor to revenue growth, driven by a robust R&D pipeline, operational excellence, and its U.S.-based manufacturing capabilities. The company has a track record of consistent new product launches, including 17 new products in 2024 and the launch of Prucalopride with 180-day exclusivity, which are expected to continue fueling growth in the generics segment.
• Strategic Expansion of the Rare Disease Business: ANI Pharmaceuticals is focused on strategically expanding the scope and scale of its rare disease business. This involves both organic growth initiatives and targeted business development, including identifying and acquiring products that offer synergistic "call points" with existing rare disease assets. The rare disease segment is anticipated to be the largest revenue growth driver in 2025 and beyond.
• Potential New Drug Approvals: Analyst commentary indicates that potential new drug approvals could serve as future revenue drivers. For example, Libigel, a potential first-ever FDA-approved female testosterone drug, is anticipated as a possible 2026 event. The marketing and potential approval of other new drugs like Inzirqo and Tezruly have also been highlighted as contributors to future revenue.

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Share Issuance

• In May 2023, ANI Pharmaceuticals priced an underwritten public offering of 1,898,735 shares of common stock at $39.50 per share, expecting gross proceeds of $75 million. The offering closed with the full exercise of the underwriters' option to purchase additional shares.
• In November 2021, the company completed an underwritten public offering of 1,500,000 shares of common stock at $50.00 per share, generating gross proceeds of $75 million.
• As part of the Novitium Pharma LLC acquisition in November 2021, ANI Pharmaceuticals issued 25,000 shares of Series A Convertible Preferred Stock for $25 million to Ampersand 2020 Limited Partnership. These preferred shares were later converted into 602,900 common shares by September 2025.

Inbound Investments

• In November 2021, Ampersand Capital Partners made a $25 million PIPE (Private Investment in Public Equity) investment in ANI Pharmaceuticals through convertible preferred equity.

Outbound Investments

• In September 2024, ANI Pharmaceuticals completed the acquisition of Alimera Sciences, Inc., adding commercial assets ILUVIEN® and YUTIQ® to its Rare Disease portfolio. This acquisition included a new capital structure and potential contingent value rights (CVR) payments to Alimera shareholders based on future net revenue milestones for ILUVIEN and YUTIQ.
• In November 2021, ANI Pharmaceuticals acquired Novitium Pharma LLC.
• Net cash used in investing activities for the year ended December 31, 2023, included $9.6 million for asset acquisitions of ANDAs and other product rights.

Capital Expenditures

• Capital expenditures were approximately $2.5 million for the first quarter of 2025 and approximately $4.6 million for the first quarter of 2024.
• For the full year ended December 31, 2024, capital expenditures were approximately $16.2 million.
• Capital expenditures were approximately $8.9 million for the year ended December 31, 2023. The company generally invests in generic R&D and to support future growth of Rare Disease and Generics.