Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (November 2025)
33 slides from Ani Pharmaceuticals's investor presentation, Nov 10, 2025
Slide 1: Corporate Presentation November 2025
© 2025 ANI Pharmaceuticals, Inc. 1 Corporate Presentation November 2025
Slide 2: Disclaimers: Forward-Looking Statements
© 2025 ANI Pharmaceuticals, Inc. 2 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. The guidance included herein is from or supplemental to th
Slide 3: Presentation of financial information
© 2025 ANI Pharmaceuticals, Inc. 3 Presentation of financial information Non-GAAP Financial Measures Adjusted non-GAAP EBITDA ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful meas
Slide 4: Rare Disease and Generics businesses drive robust, profitable growth
© 2025 ANI Pharmaceuticals, Inc. 4 Rare Disease and Generics businesses drive robust, profitable growth as we fulfill our purpose of Serving Patients, Improving Lives 1. ANI received FDA approval to add the NIU-PS indication to ILUVIEN in the U.S. and transitioned commercialization efforts for ILUVI
Slide 5: Multi-year growth trajectory
© 2025 ANI Pharmaceuticals, Inc. 5 Multi-year growth trajectory driven by: • Lead Rare Disease asset Cortrophin Gel expected to reach ~$350M(1) of sales in the fourth year of launch • Expanded Rare Disease franchise with the acquisition of Alimera in Q3 2024 • Organic generic revenue growth on stren
Slide 6: Delivered record results in Q3 2025
© 2025 ANI Pharmaceuticals, Inc. 6 Delivered record results in Q3 2025 1. Adjusted non-GAAP EBITDA and Adjusted Diluted non-GAAP EPS are non-GAAP financial measures. 2. Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the 2029 senior convertibl
Slide 7: Full year 2025 guidance
© 2025 ANI Pharmaceuticals, Inc. 7 Full year 2025 guidance Metric ($ millions, except EPS) Full Year 2025 Guidance(3) Previous 2025 Guidance 2024 Actual Year-over-Year Growth Net Revenue (Total Company) $854 - $873 $818 - $843 $614 39 - 42% Cortrophin Gel Net Revenue $347 - $352 $322 - $329 $198 75
Slide 8: Rare Disease Business
© 2025 ANI Pharmaceuticals, Inc. 8 Rare Disease Business
Slide 9: Rare Disease expected to continue as primary driver of growth
© 2025 ANI Pharmaceuticals, Inc. 9 Rare Disease expected to continue as primary driver of growth and to account for nearly half of 2025 revenues 1. Based on 2025 financial guidance issued by the Company on November 7, 2025. 2. 2022-25 CAGR is based on the midpoint of 2025 guidance issued on November
Slide 10: Rare Disease portfolio focuses on patients underserved by other therapies
© 2025 ANI Pharmaceuticals, Inc. 10 Rare Disease portfolio focuses on patients underserved by other therapies 1. Based on the US FDA considered definition of rare disease – disorders affecting <200,000 persons, translating to a prevalence of 58.5 per 100,000 at current time. 2. ANI continues to keep
Slide 11: Cortrophin Gel and ILUVIEN U.S. indications
© 2025 ANI Pharmaceuticals, Inc. 11 U.S. Indications FDA-approved ACTH treatment option with 22 indications for patients suffering from specific chronic autoimmune and inflammatory conditions, including multiple sclerosis, rheumatoid arthritis, excess urinary protein due to nephrotic syndrome, acute
Slide 12: Cortrophin Gel: Primary growth engine for ANI Rare Disease
© 2025 ANI Pharmaceuticals, Inc. 12 Cortrophin Gel: Primary growth engine for ANI Rare Disease 5 ml vial 1 ml vial Pre-Filled Syringe Cortrophin Gel is purified corticotropin (ACTH), a treatment option for patients struggling with certain chronic autoimmune disorders Approved for multiple indication
Slide 13: ACTH market returned to growth following launch of Cortrophin Gel
© 2025 ANI Pharmaceuticals, Inc. 13 • Following launch of Cortrophin Gel in 2022, the ACTH class stabilized and returned to double-digit growth in 2024 • ACTH market grew 27% in 2024 on a dollar basis and is projected to grow ~45% in 2025 • Strong multi-year growth potential with key indications sig
Slide 14: Cortrophin Gel: Robust underlying demand
© 2025 ANI Pharmaceuticals, Inc. 14 Cortrophin Gel Net Revenues ($ millions)(1) Cortrophin Gel: Robust underlying demand; further strengthening the franchise to support strong multi-year growth $42 $112 $198 2022 2023 2025E +103% CAGR $347-$352 2024 1. Based on 2025 financial guidance issued by the
Slide 15: Addressable Patient Populations
© 2025 ANI Pharmaceuticals, Inc. 15 Addressable Patient Populations* Diagnosed ~9,900,0001 ~500,000 addressable annual flares (~285,000 patients) Acute Gout Flares Cortrophin Gel has strong multi-year growth potential with addressable patient populations across indications significantly under-penetr
Slide 16: ILUVIEN is a durable (~36 month) ocular therapy
© 2025 ANI Pharmaceuticals, Inc. 16 ILUVIEN is a durable (~36 month) ocular therapy • Provides 36-months of continuous therapy via CONTINUOUS MICRODOSING of fluocinolone acetonide (FAc) in patients with retinal disease • Designed to deliver daily sub-microgram levels of FAc for up to three years fro
Slide 17: ILUVIEN single product transition benefits
© 2025 ANI Pharmaceuticals, Inc. 17 Operational Efficiency Simplifies the manufacturing process and reduces complexity by focusing on a single product, ILUVIEN, which already has a broader approval outside the U.S. Supply Chain Security Extended partnership with Siegfried and capacity expansion ensu
Slide 18: Underserved patient group within DME
© 2025 ANI Pharmaceuticals, Inc. 18 The most underserved patient group within DME represents more than 50,000 patients in the U.S. alone DME epidemiology model flow – inputs informed by ANI’s market research Diagnosed DME population (~3%): ~900,000 patients Treated DME population (~50%): ~450,000 pa
Slide 19: Uveitis epidemiology and opportunity
© 2025 ANI Pharmaceuticals, Inc. 19 Uveitis epidemiology model flow – inputs informed by ANI’s market research Total diagnosed NIU-PS population: ~206,000 patients Treated NIU-PS population: ~40-55% ~78,000 – 112,000 patients Significant room for ILUVIEN NIU-PS indication growth - <5,000 patient sta
Slide 20: ILUVIEN available in 22 territories outside the U.S.
© 2025 ANI Pharmaceuticals, Inc. 20 Direct commercial operations in: High-quality partnerships cover an additional 18 territories in Europe, the Middle East, and Asia Germany United Kingdom Portugal Ireland ILUVIEN available in 22 territories outside the U.S.
Slide 21: NEW DAY study results shared across conferences
© 2025 ANI Pharmaceuticals, Inc. 21 NEW DAY study results shared across national and international conferences Jan 2026Oct 2025Sep 2025Jul 2025 American Society of Retina Specialists (ASRS) Dr. Michael Singer, Presentation on Demand EURETINA Dr. Wykoff, Spotlight Oral Presentation American Academy o
Slide 22: Generics Business
© 2025 ANI Pharmaceuticals, Inc. 22 Generics Business
Slide 23: Robust pipeline and new product launch execution
© 2025 ANI Pharmaceuticals, Inc. 23 Robust pipeline and new product launch execution • Launched nine new products so far in 2025(1), on track to deliver on several new launches through the rest of the year • Q3 2025 Generics revenue, up 21% Y/Y, driven by opportunistic partnered generic launch Focus
Slide 24: U.S. Manufacturing Footprint
© 2025 ANI Pharmaceuticals, Inc. 24 U.S. Manufacturing Footprint
Slide 25: Revenues by country of origin
© 2025 ANI Pharmaceuticals, Inc. 25 United States 93% Europe 2% India 2% Others 3% United States 48% Europe 26% India 18% China 5% Others 3% Over 90% of ANI’s revenues come from finished goods manufactured in the U.S.; only ~5% revenues have a direct reliance on China API by Country of Origin Finish
Slide 26: U.S.-based manufacturing footprint with strong GMP track record
© 2025 ANI Pharmaceuticals, Inc. 26 U.S.-based manufacturing footprint with strong GMP track record Baudette, MN 130k sf Baudette, MN Containment Facility - 47k sf East Windsor, NJ 120k sf Facility Overview and Capabilities • Manufacturing, packaging, warehouse • Schedule CII vault & CIII cage space
Slide 27: Summary
© 2025 ANI Pharmaceuticals, Inc. 27 Summary
Slide 28: Investment summary
© 2025 ANI Pharmaceuticals, Inc. 28 Investment summary Strategic focus on strong and growing Rare Disease business • Expected to represent nearly 50% of 2025 revenues and be largest driver of future growth • Cortrophin Gel 2025 revenue forecast at ~$350M(1) and is on a strong multi-year growth traje
Slide 29: Appendix
© 2025 ANI Pharmaceuticals, Inc. 29 Appendix
Slide 30: Adjusted non-GAAP EBITDA calculation and reconciliation
© 2025 ANI Pharmaceuticals, Inc. 30 Adjusted non-GAAP EBITDA calculation and US GAAP to non-GAAP reconciliation 3 months ended 3 months ended 12 months ended September 30, 2025 September 30, 2024 December 31, 2024 Net Income (Loss) $26,617 $(24,166) $(18,522) Add/(Subtract): Interest expense, net 4,
Slide 31: Adjusted non-GAAP diluted EPS calculation and reconciliation
© 2025 ANI Pharmaceuticals, Inc. 31 Adjusted non-GAAP diluted earnings per share calculation and US GAAP to non-GAAP reconciliation 1. Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities. 2. Non-GAAP Adjusted Diluted Weighted-Aver
Slide 32: References for Cortrophin Gel Addressable Patient Population
© 2025 ANI Pharmaceuticals, Inc. 32 References for Cortrophin Gel Addressable Patient Population Gout 1. Singh G, Lingala B, Mithal A. Gout and hyperuricaemia in the USA: prevalence and trends. Rheumatology (Oxford). 2019 Dec 1;58(12):2177-2180. doi: 10.1093/rheumatology/kez196. PMID: 31168609 2. Th
Slide 33: November 2025
© 2025 ANI Pharmaceuticals, Inc. 33 November 2025
ANI Pharmaceuticals — Investor Presentation (November 2025) on 6ix