ANI Pharmaceuticals (NasdaqGM:ANIP) Q4 2025 Earnings call February 27, 2026 08:00 AM ET Company ParticipantsBrandon Folkes - Managing DirectorChristopher Mutz - SVP and Head of Rare DiseaseCourtney Mogerley - Managing DirectorGlen Santangelo - Managing DirectorLeszek Sulewski - VP of Spec Pharma and Biotech Equity ResearchNikhil Lalwani - President and CEOStephen Carey - SVP and CFOVamil Divan - Managing DirectorConference Call ParticipantsDavid Amsellem - Managing Director and Senior Research AnalystThomas ...

ANI Pharmaceuticals (NasdaqGM:ANIP) Q4 2025 Earnings call February 27, 2026 08:00 AM ET Speaker8Thank you for your continued patience. Your meeting will begin shortly. If you need assistance at any time, please press star zero and a member of our team will be happy to help you. Thank you for your continued patience. Your meeting will begin shortly. If you need assistance at any time, please press star zero and a member of our team will be happy to help you. Thank you for your continued patience. Your meetin ...

ANI Pharmaceuticals Conference Call Summary Company Overview - ANI Pharmaceuticals is a growing, profitable biopharmaceutical company with three business segments: rare disease, generics, and brands [2][3] - The rare disease segment includes Purified Cortrophin Gel and ILUVIEN, accounting for approximately half of the estimated 2025 revenues [2][4] Financial Guidance - Revenue guidance for 2025 is between $854 million and $873 million, representing a growth of 39% to 42% [3][4] - Adjusted non-GAAP EBITDA guidance is between $221 million and $228 million, indicating a growth of 42% to 46% over the prior year [4] Strategic Priorities - The primary focus is to expand the scope and scale of the rare disease business while maintaining a virtuous cycle of growth through reinvestment in R&D [4][6] - There is significant organic growth potential in existing assets, particularly with Cortrophin Gel and ILUVIEN, which have a large addressable patient population [6][11] M&A Strategy - ANI is open to acquisitions that would enhance the rare disease business but is under no pressure to pursue deals due to strong organic growth potential [5][6] - The company is looking for commercial assets that limit regulatory risk and can significantly contribute to the rare disease segment [7][8] Cortrophin Gel Insights - The ACTH market is projected to reach approximately $993 million in 2025, with significant growth potential due to a large addressable patient population [10][11] - Approximately 50% of prescribers of Cortrophin Gel were previously unfamiliar with ACTH, indicating a strong opportunity for market penetration [12][14] - The company is investing in clinical evidence generation for Cortrophin Gel, including a phase 4 study for acute gouty arthritis flares [17] Product Development and Sales Strategy - The launch of a prefilled syringe for Cortrophin Gel has seen over 70% of new cases initiated with this format, enhancing patient convenience [19][20] - The sales force consists of approximately 60 reps focused on rheumatology, nephrology, and neurology, with additional teams for pulmonology and ophthalmology [22] Payer Access and Market Dynamics - ANI has collaborated with payers and PBMs to improve access for patients, achieving parity access with competitors [23] - The company is cautious about pricing strategies, balancing competitive sensitivity with the need for greater access [24] ILUVIEN Product Strategy - 2025 is viewed as a reset year for ILUVIEN, with plans to strengthen the commercial organization and enhance physician education [28][29] - The company is focusing on leveraging Medicare Part D for better patient access to ILUVIEN [30] Generics Business Outlook - The generics segment is driven by a strong R&D capability, with 10 to 15 product launches expected annually [31] - ANI operates three U.S.-based manufacturing plants, ensuring strong operational execution and compliance with FDA standards [31] Conclusion - ANI Pharmaceuticals is positioned for significant growth across its business segments, particularly in rare diseases and generics, with a strong focus on expanding market access and enhancing product offerings [4][31]

Financial Data and Key Metrics Changes - Company revenues grew by 54% year over year, reaching $227.8 million in Q3 2025, with adjusted EBITDA growth of 70% year over year [4][20] - Adjusted non-GAAP diluted earnings per share increased to $2.04 from $1.34 in the prior year period [24] - The company raised its 2025 financial guidance, expecting net revenues of $854 million to $873 million, up from previous guidance of $818 million to $843 million [26][28] Business Line Data and Key Metrics Changes - Rare disease revenues were $118.5 million, up 109.9% from the prior year, with Cortrophin Gel revenues at $101.9 million, up 93.8% [20][21] - Revenues from the generics segment increased by 19.3% to $98.7 million, driven by a successful partner generic product launch [22][24] - Iluvien net revenues were $16.6 million, with expectations for modestly lower demand in the fourth quarter due to normalization trends [21][27] Market Data and Key Metrics Changes - The ACTH market is expected to grow approximately 40% to $957 million in 2025, with Cortrophin projected to grow by 75%-78% [8] - The addressable patient population for acute gouty arthritis is estimated at 285,000 patients, indicating significant growth potential for Cortrophin Gel [8][35] Company Strategy and Development Direction - The company aims to grow its rare disease business, with Cortrophin Gel as a top strategic priority, focusing on clinical evidence generation and enhancing patient convenience [5][11] - The company is exploring inorganic opportunities to expand its rare disease business while continuing to support its genetics and brands business [11][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong multi-year growth trajectory of Cortrophin Gel, driven by increased demand and a growing prescriber base [7][35] - The company anticipates continued strong momentum in Cortrophin and positive impacts from initiatives to grow Iluvien in 2026 [11][72] Other Important Information - The company ended Q3 2025 with $262.6 million in unrestricted cash, up from $217.8 million at the end of Q2 [25] - Non-GAAP gross margin was 59.2%, a slight decrease from the prior year, primarily due to product mix [24] Q&A Session Summary Question: Impact of Medicare Part D redesign on Cortrophin growth - Management noted a modest tailwind from the redesign, improving affordability and access for patients, but tempered by mandatory Medicare manufacturer payments [34] Question: Details on the new partner generic product - The company did not specify the name of the partner generic but indicated it was launched successfully, with expectations of competition entering the market [38] Question: Growth trajectory in pulmonology for Cortrophin - Management acknowledged pulmonology as an important area with significant growth potential, although it currently represents a smaller portion of the overall mix [44] Question: Durability of Cortrophin Gel against potential generic competition - Management expressed confidence in the long-term durability of Cortrophin Gel, citing the complexity of developing a generic version [62] Question: Challenges of label expansion in the ACTH category - Management indicated that any label expansion would require a phase three clinical trial, and they are focused on generating evidence to support treatment guidelines [66]

Financial Data and Key Metrics Changes - The company provided guidance for 2025 revenues between $768 million and $793 million, representing a year-over-year growth of approximately 25% to 29% [4][5] - Adjusted non-GAAP EBITDA guidance for 2025 is between $195 million and $205 million [4] - Q1 2025 revenues reached a record $197 million with adjusted non-GAAP EBITDA of $51 million [6] Business Line Data and Key Metrics Changes - The rare disease segment is the primary growth driver, with Cortrophin Gel expected to generate $265 million to $274 million in 2025, reflecting a year-over-year growth of 384% to 38% [8][9] - Generic revenues reached a record high of $98.7 million in Q1 2025, driven by successful new product launches [8] - The generics business is expected to sustain high single-digit to low double-digit growth, with a mid double-digit growth forecast for 2025 [37] Market Data and Key Metrics Changes - The ACTH market, which includes Cortrophin Gel, is projected to grow to $792 million in 2025, with a 16% growth rate [16] - The addressable market for Cortrophin Gel is significantly larger than the current patient population, indicating substantial growth potential [19][20] Company Strategy and Development Direction - The company aims to reinvest cash flows from generics and established brands into the rare disease business, which is expected to account for approximately half of 2025 revenues [4][36] - The acquisition of Alimera is intended to expand the rare disease business and align with the company's M&A strategy [24][32] - The company is focusing on expanding the adoption of Cortrophin Gel in targeted specialties and addressing sales factors impacting ILUVIEN and YUTIQ [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning, with over 90% of revenues coming from U.S.-manufactured products and minimal reliance on China [5] - The management highlighted the strong growth momentum in the rare disease segment, particularly for Cortrophin Gel, and the ongoing investment in R&D to support this growth [20][23] Other Important Information - The company has a healthy balance sheet with $150 million in cash and a net leverage of 2.7 turns [4][38] - The generics business launched 17 products in 2024, including two competitive generic therapy products with exclusivity [33] Q&A Session Summary Question: What is the growth outlook for Cortrophin Gel? - Management indicated that Cortrophin Gel is on a strong multiyear growth trajectory, with significant headroom for expansion in its addressable market [19][20] Question: How is the company addressing the sales impact on ILUVIEN and YUTIQ? - The company is focusing on capturing larger opportunities in diabetic macular edema and chronic noninfectious uveitis, while also expanding the sales team to drive growth [38] Question: What are the priorities for 2025? - The company outlined four key priorities: expanding Cortrophin Gel adoption, addressing sales factors for ILUVIEN and YUTIQ, sustaining generics momentum, and expanding the rare disease business through M&A [38]