Corporate Presentation June 2025 © 2025 ANI Pharmaceuticals, Inc. 1 Disclaimers Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Act, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking. These statements are often, but are not always, made through the use of w ...

The Use of Purified Cortrophin® Gel in Murine Collagen-Induced Arthritis Mouse Model presented as a poster at the European Alliance of Associations for Rheumatology (EULAR) 2025 CongressPRINCETON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced new preclinical data on the use of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a mouse model of murine collagen-induced inflammatory arthritis. “In a precli ...

ANI Pharmaceuticals (ANIP) Conference Call Summary Company Overview - ANI Pharmaceuticals operates three business units: Rare Disease, Genetics, and Brands [2][3] - Rare Disease is the primary growth driver with key products including Cortrophin Gel, Iluvien, and YUTIQ [3] Financial Guidance and Performance - 2025 revenue guidance is set between $768 million to $793 million, representing a growth of 25% to 29% [4] - Adjusted non-GAAP EBITDA guidance is between $195 million to $205 million [4] - The company reported $197 million in total revenues for Q1 2025, with $94.1 million from Rare Disease [5] - Cortrophin Gel generated approximately $53 million in revenues during Q1 2025 [6] Rare Disease Business Insights - Cortrophin Gel is expected to generate $265 million to $274 million in revenue for 2025, reflecting a growth of 34% to 38% [10] - The Rare Disease segment is projected to reach $362 million to $377 million in revenue, showing a CAGR of nearly 106% over the last four years [11] - Cortrophin Gel is approved for 22 indications, focusing on six key areas including rheumatoid arthritis and acute gouty arthritis flares [12][13] - The ACTH market, where Cortrophin operates, is expected to grow from $684 million in 2024 to $792 million in 2025 [15] Generics Business Performance - The generics segment achieved record revenues of $98.7 million in Q1 2025, up 41% year-on-year [32] - ANI launched 17 new products in 2024, including two with competitive genetic therapy designation [32] Strategic Initiatives - The company is expanding its sales force, adding 20 new representatives focused on rheumatology, nephrology, and neurology [40][43] - A long-term contract with CMO Sigfried has been extended to enhance supply chain security for ILUVIEN and YUTIQ [24] - The Alimera acquisition has provided ANI with an international footprint, with 30% of ILUVIEN and YUTIQ revenues generated outside the U.S. [28][29] Market Dynamics and Challenges - Q1 revenues for ILUVIEN and YUTIQ were impacted by Medicare patient support funding issues and sales force turnover [7] - The company is addressing these challenges by tailoring its commercial approach and ensuring appropriate patient access to therapies [50][51] Conclusion - ANI Pharmaceuticals is well-positioned for growth in 2025, driven by its Rare Disease business and a robust generics segment [34] - The company maintains a strong balance sheet with $150 million in cash and a net leverage of 2.7 turns [4]

Financial Performance - Record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4%[4] - Rare Disease net revenues totaled $69.0 million, with Cortrophin Gel generating $52.9 million, an increase of 43.1% year-over-year[4][14] - Generics net revenues reached $98.7 million, reflecting a 40.5% year-over-year increase driven by new product launches[4][11] - Adjusted non-GAAP EBITDA for the first quarter was $50.7 million, an increase of 34.9% from the previous year[19] - Net revenues for Q1 2025 increased to $197,122,000, up from $137,430,000 in Q1 2024, representing a growth of approximately 43.5%[47] - Operating income for Q1 2025 was $26,194,000, compared to $20,312,000 in Q1 2024, indicating an increase of about 29.1%[47] - Adjusted non-GAAP EBITDA for the three months ended March 31, 2025, was $50,749 thousand, an increase of 34.8% from $37,633 thousand in the prior year[51] - Adjusted non-GAAP net income available to common shareholders for Q1 2025 was $34,144 thousand, up 45.5% from $23,466 thousand in Q1 2024[54] - Adjusted diluted earnings per share for the three months ended March 31, 2025, was $1.70, compared to $1.21 for the same period in 2024, reflecting an increase of 40.5%[54] Guidance and Future Projections - The company raised its 2025 guidance to expected net revenues of $768.0 million to $793.0 million, and adjusted non-GAAP diluted EPS of $6.27 to $6.62[4][21] - Cortrophin Gel is expected to generate net revenues of $265.0 million to $274.0 million in 2025, representing year-over-year growth of 33.8% to 38.3%[4][21] - Forward-looking guidance for 2025 adjusted diluted earnings per share is not provided due to insufficient information for accurate estimates[33] Expenses and Costs - The company experienced a 59.4% increase in selling, general, and administrative expenses to $76.5 million due to the acquisition of Alimera Sciences[17] - Total operating expenses for Q1 2025 were $170,928,000, compared to $117,118,000 in Q1 2024, an increase of approximately 46%[47] - Selling, general, and administrative expenses rose to $76,528,000 in Q1 2025 from $48,021,000 in Q1 2024, marking an increase of approximately 59.3%[47] - Research and development expenses for Q1 2025 were $10,564,000, slightly up from $10,511,000 in Q1 2024, showing a marginal increase of about 0.5%[47] - The company reported a significant increase in research and development expenses, totaling $76,528 thousand for Q1 2025, compared to $48,021 thousand in Q1 2024, reflecting a growth of 59.3%[51] Income and Earnings - The company reported diluted GAAP income per share of $0.69 and record adjusted non-GAAP diluted earnings per share of $1.70 for the first quarter[18] - Basic income per share for Q1 2025 was $0.70, down from $0.84 in Q1 2024, a decline of approximately 16.7%[47] - Diluted income per share for Q1 2025 was $0.69, compared to $0.82 in Q1 2024, reflecting a decrease of about 15.9%[47] - Net income for the three months ended March 31, 2025, was $15,681 thousand, a decrease of 13.4% compared to $18,207 thousand for the same period in 2024[51] - Adjusted non-GAAP net income for Q1 2025 was $15,681,000, compared to $18,207,000 in Q1 2024, reflecting a decrease of approximately 8.4%[47] Assets and Liabilities - Total current assets increased to $536,290 thousand as of March 31, 2025, up from $527,684 thousand on December 31, 2024, representing a growth of 1.15%[49] - Total liabilities decreased to $848,958 thousand as of March 31, 2025, down from $855,167 thousand on December 31, 2024, a reduction of 0.7%[49] - Cash and cash equivalents increased to $149,802 thousand as of March 31, 2025, compared to $144,861 thousand on December 31, 2024, marking a rise of 3.3%[49] - Current liabilities rose to $201,815 thousand as of March 31, 2025, up from $193,680 thousand at the end of 2024, indicating an increase of 4.9%[49] - The company’s total assets reached $1,292,428 thousand as of March 31, 2025, an increase from $1,283,697 thousand on December 31, 2024, representing a growth of 0.6%[49] Market and Product Insights - Approximately 40% of Cortrophin Gel prescribers were new to the ACTH category, indicating strong market penetration[6] - The company plans to market ILUVIEN under an expanded label that includes chronic non-infectious uveitis indications[9]

Core Points - ANI Pharmaceuticals, Inc. will present at the 2025 Jefferies Global Healthcare Conference on June 4, 2025, at 2:35pm ET [1] - The live and archived webcast of the presentation will be available on the company's website for 60 days [2] - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing and commercializing innovative therapeutics, with a commitment to sustainable growth through its Rare Disease, Generics, and Brands businesses [3]

Core Viewpoint - ANI Pharmaceuticals, Inc. has initiated a Phase 4 clinical trial to evaluate the safety and efficacy of two dose levels of Purified Cortrophin Gel for treating acute gout flares, marking a significant step in the company's commitment to building scientific evidence for this therapy [1][3]. Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics, particularly in rare diseases, ophthalmology, rheumatology, nephrology, neurology, and pulmonology [11]. Clinical Trial Details - The Phase 4 trial will compare two dose levels (40 USP units and 80 USP units) of Cortrophin Gel in a randomized, double-blind study involving up to 160 patients, aiming to enroll 70 evaluable patients per dose group [4][5]. - The primary endpoint is the change in gout pain intensity from baseline at day 3 post-administration, measured by Visual Analog Scale (VAS) [5]. Expert Involvement - Dr. Hyon Choi, a leading physician investigator with extensive experience in gout research, will conduct the trial, emphasizing the need for effective treatments for patients who do not respond adequately to conventional therapies [2][3]. Product Background - Cortrophin Gel is the only ACTH therapy approved by the FDA for acute gout flares and is indicated for short-term administration as an adjunctive therapy during acute episodes [1][7]. - The product has seen steady growth since the launch of a 1-mL vial in October 2023, aimed at increasing access for in-office treatment [3].

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]

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 [3] Upcoming Event - ANI Pharmaceuticals will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 1:30 PM ET [1] - A live and archived webcast of the presentation will be available on the company's website for 90 days [2]

Group 1 - ANI Pharmaceuticals is currently outperforming its Medical peers with a year-to-date return of approximately 29.4%, while the average return for Medical companies is -5.7% [4] - The Zacks Rank for ANI Pharmaceuticals is 2 (Buy), indicating strong analyst sentiment and an improving earnings outlook, with a 23.2% increase in the consensus estimate for full-year earnings over the past three months [3] - ANI Pharmaceuticals is part of the Medical - Biomedical and Genetics industry, which has an average loss of 9% this year, further highlighting ANI's strong performance within this sector [5] Group 2 - The Medical group ranks 3 within the Zacks Sector Rank, which evaluates the strength of 16 individual sector groups based on the average Zacks Rank of the stocks [2] - Agenus is another Medical stock that has shown strong performance, returning 11% since the beginning of the year, and also holds a Zacks Rank of 2 (Buy) with an 18.5% increase in the consensus EPS estimate over the past three months [4][5] - Investors interested in Medical stocks should monitor both ANI Pharmaceuticals and Agenus for their continued solid performance [6]

Core Insights - ANI Pharmaceuticals reported $197.12 million in revenue for Q1 2025, a year-over-year increase of 43.4% and an EPS of $1.70 compared to $1.21 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $179.45 million by 9.85%, and the EPS surpassed the consensus estimate of $1.37 by 24.09% [1] Financial Performance - Net Revenues from Rare Disease and Brands - ILUVIEN and YUTIQ were $16.11 million, below the estimated $19.93 million [4] - Total Net Revenues from Rare Disease were $68.96 million, compared to the estimated $73.36 million [4] - Net Revenues from Rare Disease and Brands - Cortrophin Gel were $52.85 million, slightly below the estimated $53.43 million [4] - Net Revenues from Generic pharmaceutical products were $98.68 million, exceeding the estimated $84.28 million [4] - Total Net Revenues from Generics and Other were $103.04 million, below the estimated $105.45 million, representing a year-over-year change of 2.5% [4] - Net Revenues from Royalties and other pharmaceutical services were $4.36 million, significantly below the estimated $18.32 million [4] Market Performance - ANI's shares returned +9.8% over the past month, while the Zacks S&P 500 composite increased by +13.7% [3] - The stock currently holds a Zacks Rank 2 (Buy), indicating potential outperformance against the broader market in the near term [3]