ANI Pharmaceuticals (NasdaqGM:ANIP) FY Conference December 02, 2025 02:00 PM ET Speaker1Until people catch on. All right, good afternoon, everyone, and let's kick things off. This is David Amselheim from the Piper Sandler Biopharma team, and welcome to our 37th Annual Healthcare Conference. So our next company, fireside chat, is ANI. Lots to talk about. We have Nikhil Lalwani, CEO. Thanks, Nikhil, for joining us. And I wanted to start off high level, just for those in the audience and listening in who might ...

Expert retina and uveitis specialists will help support the growth and innovation of ANI’s ophthalmology and retina franchise for a meaningful impact on patientsPRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that it has established The FutureVision Advisory Council to help guide the strategic advancement of its ophthalmology and retina franchise within the Company’s Rare Disease business. This steering committee includes s ...

Core Points - Patrick D. Walsh will retire as Chairman of ANI Pharmaceuticals, effective after the 2026 Annual Meeting of Stockholders, having served the company with distinction [1][2] - Thomas J. Haughey has been unanimously elected as the new Chairman of the Board, having been a member since May 2018 [1][2] - Haughey will step down from his role as Chair of the Audit and Finance Committee, with Jeanne Thoma taking over that position [2] Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [3] - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business, targeting areas such as ophthalmology, rheumatology, nephrology, neurology, and pulmonology [3]

Key Takeaways ANIP is seeing sharp rare-disease growth driven by Cortrophin Gel and steady generics performance.Cortrophin Gel sales are up 70% YTD and projected to rise 75-78% for 2025, offsetting softness elsewhere.AMRX benefits from diversified segments, though generics pricing pressure and mixed specialty trends persist.ANI Pharmaceuticals (ANIP) and Amneal Pharmaceuticals (AMRX) are both generic drugmakers, but their overall business models differ.ANIP’s operations are split between rare disease therap ...

PRINCETON, N.J., Nov. 25, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, at 2:00 p.m. ET. The live and archived fireside chat will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of the webcast will b ...

Core Insights - ANI Pharmaceuticals' rare disease franchise has become a significant growth driver in 2025, with segment revenues exceeding $291 million in the first nine months, more than doubling year over year [1][7] Revenue Growth - The growth is primarily driven by the ACTH-based injection Cortrophin Gel, which saw a 70% year-over-year sales increase to $236 million in the first nine months of 2025, supported by heightened demand across various specialties and an expanded sales force [2][7] - For the full year 2025, Cortrophin Gel sales are projected to reach between $347 million and $352 million, indicating a 75-78% increase from the previous year [2] Product Performance and Outlook - The performance of the rare disease franchise is helping to mitigate weaker contributions from newly acquired ophthalmology assets, Iluvien and Yutiq, with revised sales expectations for these products set at $73 million to $77 million due to reimbursement challenges [3] - Despite the current challenges, the company anticipates a return to growth for the ophthalmology franchise in 2026, driven by enhanced field efforts and a larger patient population [3] Competitive Landscape - ANI Pharmaceuticals faces competition in its rare disease portfolio, particularly for Iluvien and Yutiq, from major pharmaceutical companies like AbbVie and Regeneron, which market established products [4] - The primary competitor for Cortrophin Gel is Acthar Gel, marketed by Keenova Therapeutics, which has also raised its sales outlook for 2025 [5] Valuation and Market Performance - ANI Pharmaceuticals' shares have outperformed the industry year to date, and the company is currently trading at a discount compared to the industry, with a price/sales ratio of 2.00 versus the industry average of 2.41 [6][9] - EPS estimates for 2025 and 2026 have seen upward revisions over the past month [11]

ANI Pharmaceuticals (ANIP) has been beaten down lately with too much selling pressure. While the stock has lost 15% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator that measures the speed and change ...

ANI Pharmaceuticals Conference Call Summary Company Overview - ANI Pharmaceuticals is a growing, profitable biopharmaceutical company focused on rare diseases with three business units: rare disease, generics, and brands [2][3] Core Business Segments - **Rare Disease Business**: - Primary growth driver with two key assets: Purified Cortrophin Gel and ILUVIEN - Purified Cortrophin Gel is used for autoimmune diseases across multiple therapeutic areas [2][3] - ILUVIEN targets retinal diseases, specifically diabetic macular edema and non-infectious uveitis [2] - **Generics Business**: - Strong growth over the past four to five years, supported by R&D and U.S.-based manufacturing [3] Financial Guidance for 2025 - Total company revenues projected at $854 million to $873 million, reflecting a 39%-42% year-over-year growth [4] - Adjusted non-GAAP EBITDA expected to be $221 million to $228 million, indicating a 42%-46% year-over-year growth [4] - Adjusted non-GAAP EPS forecasted at $7.37 to $7.64, also showing a 42%-46% year-over-year growth [4] Growth Strategy - Transition to focus on rare diseases initiated by the current CEO, with significant growth in the rare disease segment [5] - Purified Cortrophin Gel revenue guidance for 2025 is $347 million to $354 million, representing a 75%-78% growth from the previous year [5][6] Market Potential and Demand - Addressable patient population for Purified Cortrophin Gel is substantial, with specific numbers cited for conditions like acute gouty arthritis [14][15] - The company has expanded its sales force to reach more prescribers, resulting in significant growth [17] Competitive Landscape - Both ANI and competitor Mallinckrodt have seen strong growth, validating the market for ACTH therapies [18][24] - The previous peak sales for the category were around $1.2 billion, and current projections suggest potential for surpassing this figure [24][25] Access and Reimbursement - The IRA Part D redesign provided a moderate tailwind for access, lowering out-of-pocket costs for patients [33] - Ongoing efforts to improve access through partnerships with payers and patient assistance programs [26][28] ILUVIEN Update - 2025 is viewed as a reset year for ILUVIEN, with expectations for growth driven by a larger addressable patient population and improved sales force engagement [36][37] - Anticipated revenue for ILUVIEN in 2025 is $73 million to $77 million, with growth expected in subsequent years [37][39] Conclusion - ANI Pharmaceuticals is positioned for significant growth in the rare disease market, with strong financial projections and a strategic focus on expanding its product offerings and market access initiatives [4][25][39]

Core Insights - ANI Pharmaceuticals (ANIP) shares have increased by 53% year-to-date, significantly outperforming the industry growth of 15% [1][4] - The company's strong financial performance has led to an upward revision of its full-year 2025 guidance, with expected sales between $854 million and $873 million and EPS in the range of $7.37-$7.64 [4][8] Financial Performance - ANIP reported third-quarter 2025 results that exceeded estimates for both revenue and earnings [4] - The company anticipates annual sales growth of 39-42% and earnings growth of 42-47% based on the revised outlook [4] Rare Disease Portfolio - Sales from the rare disease segment have surged over 100% year-over-year, reaching $291 million in the first nine months of 2025, primarily driven by demand for Cortrophin Gel [6][8] - Cortrophin Gel sales increased by 70% year-over-year to $236 million, supported by expanded sales efforts and broader prescriber adoption [7][9] Generics Business - Sales from the generics unit rose 27% year-over-year to over $283 million in the first nine months of 2025, aided by new product launches and temporary exclusivity [11] - Despite strong growth, the generics market faces increased competition, which may pressure pricing and margins [12] Market Position and Valuation - ANIP is currently trading at a price/sales (P/S) ratio of 2.16, lower than the industry average of 2.40, indicating a potential for further upside [13] - The company has maintained consistent EPS estimates for 2025 while slightly increasing those for 2026 [15] Future Outlook - The company is well-positioned for sustained profitability and growth, particularly in its rare disease segment and improving ophthalmology products [16][17] - ANIP's management has raised financial guidance for the fourth time this year, reflecting confidence in operational execution [17][18]

Core Viewpoint - ANI Pharmaceuticals, Inc. will participate in the Jefferies Global Healthcare Conference, highlighting its commitment to engaging with investors and stakeholders in the healthcare sector [1]. Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics aimed at improving patient lives [3]. - The company operates in three main segments: Rare Disease, Generics, and Brands, with a focus on sustainable growth through its diverse product offerings in various therapeutic areas including ophthalmology, rheumatology, nephrology, neurology, and pulmonology [3]. Event Details - The fireside chat featuring CEO Nikhil Lalwani is scheduled for November 18 at 3:00 p.m. GMT/10:00 a.m. ET, and will be accessible live and archived on the company's website for 90 days [1][2].