Ani Pharmaceuticals, Inc. · NASDAQ:ANIP

Ani Pharmaceuticals — Guggenheim SMID Cap Biotech Conference 2025

28 slides from Ani Pharmaceuticals's conference presentation, Feb 5, 2025

  1. Slide 1: Guggenheim SMID Cap Biotech Conference February 5, 2025

    © 2025 ANI Pharmaceuticals, Inc. 1 Guggenheim SMID Cap Biotech Conference February 5, 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 on 2024 financial guidance as issued on November 8, 2024. 2. CAGR calculated using 2022-2025E utilizing mid-point of full

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

    © 2025 ANI Pharmaceuticals, Inc. 6 4Q Adj. Non- GAAP EBITDA(1,3) $43-47M 49% YoY Momentum continued in 2024 with ANI delivering record results in Q4 4Q Total Revenues(1) $170-178M 32% YoY 4Q Cortrophin Gel Revenues(2) $59-60M 42% YoY 4Q Rare Disease Revenues (2) $86-87M 107% YoY 1. Based on 2024 fin

  7. Slide 7: Preliminary 2025 Outlook

    © 2025 ANI Pharmaceuticals, Inc. 7 Preliminary 2025 Outlook 1. Based upon 2024 financial guidance as issued on November 8, 2024. 2. Adjusted Non-GAAP EBITDA is a Non-GAAP financial measure. Metric ($ millions) Full Year 2025 Guidance Mid-Point 2024 Guidance(1) 2025 Growth vs 2024 Guidance Midpoint N

  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)(1) 1. 2022-24 CAGR is based on the midpoint of full-year 2024 preliminary, unaudited results 2. Based on full-year 2024 preliminary, unaudited results 42 112 2022

  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 U.S. Indications FDA-approved ACTH treatment option with 22 indications for patients suffering with specific chronic autoimmune and inflammatory conditions, including multiple sclerosis, rheumat

  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 • 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 expected to grow >20% in 2024 on a dollar basis • Number of patients on ACTH therapy today is substan

  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 Sciences acquisition on track to deliver financial targets in 2025

    © 2025 ANI Pharmaceuticals, Inc. 15 Transaction closed September 2024 Highly synergistic acquisition of Alimera Sciences on track to deliver financial targets in 2025 Two differentiated commercial assets with high barriers to genericization and significant growth potential, which we expect to furthe

  16. Slide 16: Alimera acquisition aligned with M&A strategy

    © 2025 ANI Pharmaceuticals, Inc. 16 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(

  17. Slide 17: ILUVIEN and YUTIQ: Novel, long-acting implants for serious eye diseases

    © 2025 ANI Pharmaceuticals, Inc. 17 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

  18. Slide 18: The most underserved patient group within DME represents more than 50,000 US patients

    © 2025 ANI Pharmaceuticals, Inc. 18 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

  19. Slide 19: Larger ophthalmology sales team expected to accelerate growth

    © 2025 ANI Pharmaceuticals, Inc. 19 Larger ophthalmology sales team expected to accelerate growth of Cortrophin Gel, ILUVIEN, and YUTIQ Combined efforts expected to expand the ability to drive appropriate utilization of all three products for patients in need ANI deployed a targeted ophthalmology- f

  20. Slide 20: Long-term clinical studies provide a foundation for ILUVIEN and YUTIQ

    © 2025 ANI Pharmaceuticals, Inc. 20 Long-term clinical studies, real-world use, and ongoing trials provide a strong foundation for ILUVIEN and YUTIQ 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-infectious u

  21. Slide 21: Strong R&D capabilities and operational excellence driving growth in Generics

    © 2025 ANI Pharmaceuticals, Inc. 21 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 exclusivity • Number two

  22. Slide 22: U.S.-based manufacturing footprint with strong GMP track record

    © 2025 ANI Pharmaceuticals, Inc. 22 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

  23. Slide 23: Investment summary

    © 2025 ANI Pharmaceuticals, Inc. 23 Investment summary Strategic focus on strong and growing Rare Disease business • Expected to represent ~50% of 2025 revenues and be largest driver of future growth • Cortrophin Gel reached ~$198M (2) revenue in 2024 and is on a strong multi-year growth trajectory

  24. Slide 24: Appendix

    © 2025 ANI Pharmaceuticals, Inc. 24 Appendix

  25. Slide 25: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation

    © 2025 ANI Pharmaceuticals, Inc. 25 Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation Three months ended September 30, Nine months ended September 30, Twelve months ended December 31, ($ in thousands, except per share amounts) 2024 2024 2023 2022 2021 Net (Loss) Income (24,

  26. Slide 26: Non-GAAP reconciliation footnotes

    © 2025 ANI Pharmaceuticals, Inc. 26 (a) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring act

  27. Slide 27: Strong balance sheet to support Rare Disease business development

    © 2025 ANI Pharmaceuticals, Inc. 27 Strong balance sheet to support Rare Disease business development 2022 2023 Q3 2024(2) Cash & Cash Equivalents $48M $221M $145M Net Debt/EBITDA 4.4x 0.5x 3.0x Gross Debt $297M $294M $641M Net Debt $249M $73M $496M Adjusted Non-GAAP EBITDA (1) $56M $134M $168M 1. A

  28. Slide 28: February 5, 2025

    © 2025 ANI Pharmaceuticals, Inc. 28 February 5, 2025

ANI Pharmaceuticals — Guggenheim SMID Cap Biotech Conference 2025 on 6ix