Ani Pharmaceuticals, Inc. · NASDAQ:ANIP

Ani Pharmaceuticals — Investor Presentation (September 2025)

29 slides from Ani Pharmaceuticals's investor presentation, Sep 8, 2025

  1. Slide 1: Corporate Presentation September 2025

    © 2025 ANI Pharmaceuticals, Inc. 1 Corporate Presentation September 2025

  2. 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

  3. Slide 3: Presentation of financial information: Non-GAAP Financial Measures

    © 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

  4. Slide 4: Rare Disease and Generics drive robust, profitable growth

    © 2025 ANI Pharmaceuticals, Inc. 4 ANI Pharmaceuticals: Rare Disease and Generics drive robust, profitable growth as we fulfill our purpose of Serving Patients, Improving Lives Key Growth Drivers Rare Disease business with two growing and durable commercial assets: Purified Cortrophin Gel and ILUVIE

  5. Slide 5: Well-positioned to continue driving strong growth

    © 2025 ANI Pharmaceuticals, Inc. 5 Well-positioned to continue driving strong growth in 2025 Adjusted Non-GAAP EBITDA ($ millions)(1),(3) 1. Based on 2025 financial guidance issued by the Company on August 8, 2025. 2. CAGR calculated using 2022-2025E utilizing mid-point of full year 2025 guidance. 3

  6. Slide 6: Delivered record results in Q2 2025

    © 2025 ANI Pharmaceuticals, Inc. 6 Q2 Adj. Non- GAAP EBITDA(1) $54M 63% YoY Delivered record results in Q2 2025 setting strong foundation for full year Q2 Total Revenues $211M 53% YoY Q2 Cortrophin Gel Revenues $82M 66% YoY Q2 Rare Disease & Brand Revenues $117M 98% YoY 1. Adjusted non-GAAP EBITDA a

  7. Slide 7: Over 90% of revenues from finished goods manufactured in the U.S.

    © 2025 ANI Pharmaceuticals, Inc. 7 Over 90% of ANI’s revenues come from finished goods manufactured in the U.S.; only ~5% revenues have a direct reliance on China United States 93% Europe 2% India 2% Others 3% Growth vs Prev. Year - 25%United States 48% Europe 26% India 18% China 5% Others 3% ~95% o

  8. Slide 8: U.S.-based manufacturing footprint with strong GMP track record

    © 2025 ANI Pharmaceuticals, Inc. 8 U.S.-based manufacturing footprint with strong GMP track record • Manufacturing, packaging, warehouse • Schedule CII vault & CIII cage space • Lab space - R&D/analytical testing • Solutions, suspensions, topicals, tablets, capsules, and powder for suspension • DEA-

  9. Slide 9: Full year 2025 guidance

    © 2025 ANI Pharmaceuticals, Inc. 9 Full year 2025 guidance 1. Adjusted Non-GAAP EBITDA and Adjusted Non-GAAP Diluted EPS are Non-GAAP financial measures. 2. Not meaningful percentage due to comparison of only a partial year of ILUVIEN and YUTIQ Net Revenue in 2024. 3. Based on 2025 financial guidanc

  10. Slide 10: Rare Disease expected to continue as primary driver of growth

    © 2025 ANI Pharmaceuticals, Inc. 10 Rare Disease expected to continue as primary driver of growth and to account for ~57% of 2025 H2 revenues Rare Disease Net Revenues ($ millions) $198 $32 1. Based on 2025 financial guidance issued by the Company on August 8, 2025. 2. 2022-25 CAGR is based on the m

  11. Slide 11: Rare Disease portfolio focuses on patients underserved by other therapies

    © 2025 ANI Pharmaceuticals, Inc. 11 Rare Disease portfolio focuses on patients underserved by other therapies RARE DISEASE(1) UNDERSERVED PATIENTS: HIGH PREVALENCE DISEASE Idiopathic Nephrotic Syndrome Sarcoidosis Systemic Dermatomyositis (Polymyositis) Rheumatoid Arthritis Multiple Sclerosis Acute

  12. Slide 12: ANI Rare Disease markets two high-growth, durable therapeutics

    © 2025 ANI Pharmaceuticals, Inc. 12 ANI Rare Disease markets two high-growth, durable therapeutics with multiple indications U.S. Indications FDA-approved ACTH treatment option with 22 indications for patients suffering from specific chronic autoimmune and inflammatory conditions, including multiple

  13. Slide 13: Cortrophin Gel: Primary growth engine for ANI Rare Disease

    © 2025 ANI Pharmaceuticals, Inc. 13 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

  14. Slide 14: ACTH market returned to growth following the launch of Cortrophin Gel

    © 2025 ANI Pharmaceuticals, Inc. 14 • 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 >39% in 2025 • Strong multi-year growth potential with number of patients

  15. Slide 15: Cortrophin Gel: Successful launch and robust underlying demand

    © 2025 ANI Pharmaceuticals, Inc. 15 Growth in specialties targeted at launch Cortrophin Gel: Successful launch and robust underlying demand; further strengthening the franchise to support a strong multi-year growth journey Gaining traction in newer therapeutic areas Continuing to strengthen the fran

  16. Slide 16: Cortrophin Gel addressable patient populations significantly under-penetrated

    © 2025 ANI Pharmaceuticals, Inc. 16 Cortrophin Gel has strong multi-year growth potential with addressable patient populations across indications significantly under-penetrated ~300,000 addressable annual exacerbations (~187,500 patients) Addressable Patient Populations* * All references provided in

  17. Slide 17: ILUVIEN and YUTIQ are durable (~36 months) ocular therapies

    © 2025 ANI Pharmaceuticals, Inc. 17 ILUVIEN and YUTIQ are durable (~36 months) ocular therapies • Provide 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 thre

  18. Slide 18: ILUVIEN label expansion enhances supply security and operational efficiency

    © 2025 ANI Pharmaceuticals, Inc. 18 ILUVIEN label expansion enhances supply security and operational efficiency ANI began marketing ILUVIEN in the U.S. under the combined label in June, 2025 ILUVIEN is now approved for the treatment of chronic NIU-PS in addition to diabetic macular edema (DME) Opera

  19. Slide 19: Underserved DME patient group exceeds 50,000 patients in the U.S.

    © 2025 ANI Pharmaceuticals, Inc. 19 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

  20. Slide 20: Overview of Uveitis and opportunity

    © 2025 ANI Pharmaceuticals, Inc. 20 Overview of Uveitis and opportunity 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

  21. Slide 21: International accounts for ~30%+ of ILUVIEN revenues

    © 2025 ANI Pharmaceuticals, Inc. 21 International accounts for ~30%+ of ILUVIEN revenues Direct commercial operations in: High-quality partnerships cover an additional 18 territories in Europe, the Middle East, and Asia Germany United Kingdom Portugal Ireland

  22. Slide 22: NEW DAY study results shared across conferences

    © 2025 ANI Pharmaceuticals, Inc. 22 NEW DAY study results shared across national and international conferences Announced New Day Study Results Jul 2025 1. Results of Synchronicity clinical trial will be applicable to ILUVIEN. Jan 2026Oct 2025Sep 2025Jul 2025 American Society of Retina Specialists (A

  23. Slide 23: Strong R&D capabilities and operational excellence driving growth in Generics

    © 2025 ANI Pharmaceuticals, Inc. 23 $74 $78 $99 $90 Strong R&D capabilities and operational excellence driving growth in Generics Robust pipeline and new product launch execution • Launched seven new products so far in 2025(1), on track to deliver on several new launches through the rest of the year

  24. Slide 24: Investment summary

    © 2025 ANI Pharmaceuticals, Inc. 24 Investment summary Strategic focus on strong and growing Rare Disease business • Expected to represent approximately half of 2025 revenues and be largest driver of future growth • Cortrophin Gel 2025 revenue forecast at $326M(1) and is on a strong multi-year growt

  25. Slide 25: Appendix

    © 2025 ANI Pharmaceuticals, Inc. 25 Appendix

  26. Slide 26: Adjusted non-GAAP EBITDA calculation and reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 26 Adjusted non-GAAP EBITDA calculation and US GAAP to non-GAAP reconciliation Three months ended June 30, Three months ended March 31, Twelve months ended December 31, ($ in thousands, except per share amounts) 2025 2025 2024 Net Income (Loss) $8,549 $15,681 $(18,52

  27. Slide 27: Adjusted non-GAAP diluted EPS calculation and reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 27 Adjusted non-GAAP diluted earnings per share calculation and US GAAP to non- GAAP reconciliation Three months ended June 30, Three months ended March 31, Twelve months ended December 31, ($ in thousands, except per share amounts) 2025 2025 2024 Net Income (Loss) A

  28. Slide 28: References for Cortrophin Gel Addressable Patient Population

    © 2025 ANI Pharmaceuticals, Inc. 28 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

  29. Slide 29: September 2025

    © 2025 ANI Pharmaceuticals, Inc. 29 September 2025

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