Ani Pharmaceuticals, Inc. · NASDAQ:ANIP

Ani Pharmaceuticals — Jefferies Healthcare Conference 2025

29 slides from Ani Pharmaceuticals's conference presentation, Jun 4, 2025

  1. Slide 1: Corporate Presentation June 2025

    © 2025 ANI Pharmaceuticals, Inc. 1 Corporate Presentation June 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. Any statements about our expectations, beliefs, plans, obj

  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 three growing and durable commercial assets: Purified Cortrophin Gel, ILUVIEN

  5. Slide 5: Well-positioned to continue driving strong growth in 2025

    © 2025 ANI Pharmaceuticals, Inc. 5 Well-positioned to continue driving strong growth in 2025 Adjusted Non-GAAP EBITDA ($ millions)(1),(3) 1. Based upon 2025 guidance issued on May 9, 2025. 2. CAGR calculated using 2022-2025E utilizing mid-point of full year 2025 guidance. 3. Adjusted Non-GAAP EBITDA

  6. Slide 6: Delivered record results in Q1 2025

    © 2025 ANI Pharmaceuticals, Inc. 6 Q1 Adj. Non- GAAP EBITDA(1) $51M 35% YoY Delivered record results in Q1 2025 setting strong foundation for full year Q1 Total Revenues $197M 43% YoY Q1 Cortrophin Gel Revenues $53M 43% YoY Q1 Rare Disease & Brand Revenues $94.1M 50% YoY 1. Adjusted non-GAAP EBITDA

  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: Revised full year guidance – second guidance raise in 2025

    © 2025 ANI Pharmaceuticals, Inc. 8 Revised full year guidance – second guidance raise in 2025 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.

  9. 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 Rare Disease Net Revenues ($ millions) $198 $32 1. Based upon 2025 guidance issued on May 9, 2025. 2. 2022-25 CAGR is based on the midpoint of 2025 guidance issued on May 9, 2025. $265-$274 +106%(2) ILUV

  10. 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

  11. Slide 11: ANI Rare Disease markets three therapeutics with growth and durability

    © 2025 ANI Pharmaceuticals, Inc. 11 ANI Rare Disease markets three therapeutics with growth and durability U.S. Indications FDA-approved ACTH treatment option with 22 indications for patients suffering with specific chronic autoimmune and inflammatory conditions, including multiple sclerosis, rheuma

  12. 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

  13. Slide 13: ACTH market returned to growth following the 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 >16% in 2025 • Number of patients on ACTH therapy today is substantially l

  14. Slide 14: Cortrophin Gel: Successful launch and strong underlying demand

    © 2025 ANI Pharmaceuticals, Inc. 14 Growth in specialties targeted at launch(1) Cortrophin Gel: Successful launch and strong underlying demand; further strengthening the franchise to support a strong multi-year growth journey Gaining traction in newer therapeutic areas Continuing to strengthen the f

  15. Slide 15: Acute gouty arthritis indication opportunity

    © 2025 ANI Pharmaceuticals, Inc. 15 • Gout affects >9M patients in the U.S.(1) with ~3.6M receiving treatment for it annually(2) • Patients experience an average of ~1.5 - 2 flares/year that are reported to their physician(3) • Commonly treated with NSAIDs, steroids or colchicine as equivalent first

  16. Slide 16: ILUVIEN and YUTIQ: Novel, long-acting implants for serious eye diseases

    © 2025 ANI Pharmaceuticals, Inc. 16 Chronic Non-Infectious Uveitis ● Disease state: Chronic non-infectious uveitis affecting the posterior segment (NIU-PS) is inflammation of the eye that can lead to pain, visual impairment, and vision loss ● Over 500,000 patients in U.S., many of working age, with

  17. Slide 17: ILUVIEN label expansion enhances supply security and operational efficiency

    © 2025 ANI Pharmaceuticals, Inc. 17 ILUVIEN label expansion enhances supply security and operational efficiency

  18. Slide 18: Underserved DME patient group exceeds 50,000 patients in the U.S.

    © 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

  19. Slide 19: Overview of Uveitis and opportunity

    © 2025 ANI Pharmaceuticals, Inc. 19 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

  20. Slide 20: Larger ophthalmology sales team expected to accelerate growth

    © 2025 ANI Pharmaceuticals, Inc. 20 Larger ophthalmology sales team expected to accelerate growth of Cortrophin Gel, ILUVIEN, and YUTIQ(1) Combined efforts expected to expand the ability to drive appropriate utilization of all three products for patients in need ANI deployed a targeted ophthalmology

  21. Slide 21: Alimera acquisition provided an international commercial footprint

    © 2025 ANI Pharmaceuticals, Inc. 21 Acquisition of Alimera provided ANI’s Rare Disease business an international commercial footprint

  22. Slide 22: Long-term clinical studies and ongoing trials for ILUVIEN and YUTIQ

    © 2025 ANI Pharmaceuticals, Inc. 22 Long-term clinical studies, real-world use, and ongoing trials provide a strong foundation for ILUVIEN and YUTIQ(1) SYNCHRONICITY • NEW DAY investigates the earlier utilization of ILUVIEN in patients with DME in combination with anti-VEGF treatment • Multicenter,

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

    © 2025 ANI Pharmaceuticals, Inc. 23 $72 $70 $74 $78 $99 Strong R&D capabilities and operational excellence driving growth in Generics Robust pipeline and new product launch execution • Launched seventeen new products in 2024, including two Competitive Generic Therapy (CGT) products with 180-day excl

  24. Slide 24: U.S.-based manufacturing footprint with strong GMP track record

    © 2025 ANI Pharmaceuticals, Inc. 24 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

  25. Slide 25: Investment summary

    © 2025 ANI Pharmaceuticals, Inc. 25 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 forecast to reach $270M(1) revenue in 2025 and is on a strong multi-y

  26. Slide 26: Appendix

    © 2025 ANI Pharmaceuticals, Inc. 26 Appendix

  27. Slide 27: Adjusted non-GAAP EBITDA calculation and reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 27 Adjusted non-GAAP EBITDA calculation and US GAAP to non-GAAP reconciliation Three months ended March 31, Twelve months ended December 31, Twelve months ended December 31, ($ in thousands, except per share amounts) 2025 2024 2023 Net Income (Loss) $15,681 $(18,522)

  28. Slide 28: Adjusted non-GAAP diluted EPS calculation and reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 28 Adjusted non-GAAP diluted earnings per share calculation and US GAAP to non- GAAP reconciliation Three months ended March 31, Twelve months ended December 31, Twelve months ended December 31, ($ in thousands, except per share amounts) 2025 2024 2023 Net Income (Lo

  29. Slide 29: June 2025

    © 2025 ANI Pharmaceuticals, Inc. 29 June 2025

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