Ani Pharmaceuticals, Inc. · NASDAQ:ANIP

Ani Pharmaceuticals — Leerink Partners Global Healthcare Conference 2025

26 slides from Ani Pharmaceuticals's conference presentation, Mar 11, 2025

  1. Slide 1: Leerink Partners Global Healthcare Conference March 11, 2025

    © 2025 ANI Pharmaceuticals, Inc. 1 Leerink Partners Global Healthcare Conference March 11, 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: ANI Pharmaceuticals: 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: Delivered superior 2024 performance and well-positioned to continue driving strong growth

    © 2025 ANI Pharmaceuticals, Inc. 5 Delivered superior 2024 performance and well-positioned to continue driving strong growth Adjusted Non-GAAP EBITDA ($ millions)(1),(3) 1. Based upon 2025 guidance issued on February 28, 2025. 2. CAGR calculated using 2022-2025E utilizing mid-point of full year 2025

  6. Slide 6: Momentum continued in 2024 with record results in Q4

    © 2025 ANI Pharmaceuticals, Inc. 6 Q4 Adj. Non- GAAP EBITDA(1) $50M 66% YoY Momentum continued in 2024 with ANI delivering record results in Q4 Q4 Total Revenues $191M 45% YoY Q4 Cortrophin Gel Revenues $59M 42% YoY Q4 Rare Disease Revenues $87M 108% YoY 1. Adjusted non-GAAP EBITDA and Adjusted Dilu

  7. Slide 7: Full Year 2025 Guidance

    © 2025 ANI Pharmaceuticals, Inc. 7 Full Year 2025 Guidance 1. Adjusted Non-GAAP EBITDA and Adjusted Non-GAAP Diluted EPS are Non-GAAP financial measures. Metric ($ millions, except EPS) Full Year 2025 Guidance 2024 Actual Year-over-Year Growth Net Revenue (Total Company) $756 - $776 $614 23 - 26% Co

  8. Slide 8: Rare Disease well positioned to continue driving strong growth

    © 2025 ANI Pharmaceuticals, Inc. 8 Rare Disease well positioned to continue driving strong growth Rare Disease Net Revenues ($ millions) $198 $32 1. Based upon 2025 guidance issued on February 28, 2025. 2. 2022-25 CAGR is based on the midpoint of 2025 guidance issued on February 28, 2025. $265-$274

  9. Slide 9: ANI Rare Disease markets three therapeutics with growth and durability

    © 2025 ANI Pharmaceuticals, Inc. 9 ANI Rare Disease markets three therapeutics with growth and durability(1) U.S. Indications FDA-approved ACTH treatment option with 22 indications for patients suffering with specific chronic autoimmune and inflammatory conditions, including multiple sclerosis, rheu

  10. Slide 10: Rare Disease portfolio focuses on patients not well-served by other therapies

    © 2025 ANI Pharmaceuticals, Inc. 10 Rare Disease portfolio focuses on patients not well-served by other therapies • Idiopathic Nephrotic Syndrome • Lupus Nephritis • Systemic Dermatomyositis • Sarcoidosis • Keratitis • Chronic Non-Infectious Uveitis Posterior Segment • Rheumatoid Arthritis • Multipl

  11. Slide 11: Cortrophin Gel: Primary growth engine for ANI Rare Disease

    © 2025 ANI Pharmaceuticals, Inc. 11 Cortrophin Gel: Primary growth engine for ANI Rare Disease Cortrophin Gel is purified corticotropin (ACTH), a treatment option for patients struggling with certain chronic autoimmune disorders Limited competition (only one other ACTH product on the market); long-t

  12. Slide 12: ACTH market has returned to growth following the launch of Cortrophin Gel

    © 2025 ANI Pharmaceuticals, Inc. 12 $1,195 $1,110 • Following launch of Cortrophin Gel in 2022, the ACTH class stabilized after years of volume decline and returned to double-digit growth in 2024 • ACTH market is estimated to have grown >20% in 2024 on a dollar basis • Number of patients on ACTH the

  13. Slide 13: Cortrophin Gel: Successful launch and strong underlying demand

    © 2025 ANI Pharmaceuticals, Inc. 13 • Investing in high ROI commercial efforts such as expanding sales team to drive growth in core specialties targeted at launch and newer therapeutic areas • Focused smaller pulmonology sales team yielding positive results • Expanded Ophthalmology sales team to 46

  14. Slide 14: Acute gouty arthritis indication could be a significant opportunity

    © 2025 ANI Pharmaceuticals, Inc. 14 • Gout affects >9M patients in the US1 with ~3.6M receiving treatment for it annually2 • Patients experience an average of ~1.5 - 2 flares/year that are reported to their physician3 • Commonly treated with NSAIDs, steroids or colchicine as equivalent first-line op

  15. Slide 15: Alimera acquisition aligned with M&A strategy

    © 2025 ANI Pharmaceuticals, Inc. 15 Alimera acquisition aligned with M&A strategy Expanded Scope and Scale of Rare Disease Business Priority Therapeutic Area Assets with Growth & Durability ● Ophthalmology as a percentage of total ACTH prescribers has almost doubled to more than 10% over four years(

  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 n

  17. Slide 17: The most underserved patient group within DME represents more than 50,000 patients

    © 2025 ANI Pharmaceuticals, Inc. 17 The most underserved patient group within DME represents more than 50,000 patients in the US 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 Pati

  18. Slide 18: Larger ophthalmology sales team expected to accelerate growth

    © 2025 ANI Pharmaceuticals, Inc. 18 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 ophthalmolog

  19. Slide 19: Long-term clinical studies, real-world use, and ongoing trials support ILUVIEN and YUTIQ

    © 2025 ANI Pharmaceuticals, Inc. 19 Long-term clinical studies, real-world use, and ongoing trials provide a strong foundation for ILUVIEN and YUTIQ (1) SYNCHRONICITY >50,000 patients in the US are not well served by anti-VEGF therapy ~100,000 patients in U.S., many of working age, with non-infectio

  20. Slide 20: Strong R&D capabilities and operational excellence driving growth in Generics

    © 2025 ANI Pharmaceuticals, Inc. 20 $70 $74 $78 $79 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 exclusiv

  21. Slide 21: U.S.-based manufacturing footprint with strong GMP track record

    © 2025 ANI Pharmaceuticals, Inc. 21 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

  22. Slide 22: Investment summary

    © 2025 ANI Pharmaceuticals, Inc. 22 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 reached $198M revenue in 2024 and is on a strong multi-year growth tr

  23. Slide 23: Appendix

    © 2025 ANI Pharmaceuticals, Inc. 23 Appendix

  24. Slide 24: Adjusted non-GAAP EBITDA calculation and US GAAP to non-GAAP reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 24 Adjusted non-GAAP EBITDA calculation and US GAAP to non-GAAP reconciliation Twelve months ended December 31, ($ in thousands, except per share amounts) 2024 2023 2022 Net (Loss) Income (18,522) 18,779 (47,896) Add/(Subtract): Interest expense, net 17,602 26,940 28

  25. Slide 25: Adjusted non-GAAP diluted earnings per share reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 25 Adjusted non-GAAP diluted earnings per share calculation and US GAAP to non- GAAP reconciliation Twelve months ended December 31, Twelve months ended December 31, ($ in thousands, except per share amounts) 2024 2023 Net (Loss) Available to Common Shareholders (20,

  26. Slide 26: March 11, 2025

    © 2025 ANI Pharmaceuticals, Inc. 26 March 11, 2025

ANI Pharmaceuticals — Leerink Partners Global Healthcare Conference 2025 on 6ix