Ani Pharmaceuticals, Inc. · NASDAQ:ANIP

Ani Pharmaceuticals — Jefferies Healthcare Conference 2024

27 slides from Ani Pharmaceuticals's conference presentation, Nov 20, 2024

  1. Slide 1: Jefferies Healthcare Conference November 20, 2024

    © 2024 ANI Pharmaceuticals, Inc. 1 Jefferies Healthcare Conference​ November 20, 2024

  2. Slide 2: Disclaimers: Forward-Looking Statements

    © 2024 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

    © 2024 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

    © 2024 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, ILUVI

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

    © 2024 ANI Pharmaceuticals, Inc. 5 Well positioned to continue driving strong growth Adjusted Non-GAAP EBITDA ($ millions)(1),(2) 1. CAGR calculated using 2021-2024E utilizing full year 2024 guidance. 2. Adj Non-GAAP EBITDA is a Non-GAAP financial measure. See appendix for reconciliation to most dir

  6. Slide 6: Momentum has continued in 2024 with record results in Q3

    © 2024 ANI Pharmaceuticals, Inc. 6 Momentum has continued in 2024 with ANI delivering record results in Q3 3Q Total Revenues $148M 13% YoY 3Q Diluted Non- GAAP EPS(1) $1.34 6% YoY 3Q Rare Disease Revenues $56M 90% YoY 1. Adjusted non-GAAP EBITDA and Adjusted Diluted non-GAAP EPS are non-GAAP financi

  7. Slide 7: 2024 Guidance

    © 2024 ANI Pharmaceuticals, Inc. 7 2024 Guidance 1. Adjusted Non-GAAP EBITDA and Adjusted Non-GAAP Diluted EPS are Non-GAAP financial measures. See appendix for reconciliation to most directly comparable GAAP measure. Metric ($ millions except per share amounts) Full Year 2024 Guidance 2023 Actuals

  8. Slide 8: Rare Disease franchise expected to drive strong growth in 2024 and beyond

    © 2024 ANI Pharmaceuticals, Inc. 8 Rare Disease franchise expected to drive strong growth in 2024 and beyond Rare Disease Net Revenues ($ millions)(1) 1. CAGR calculated using 2022-2024E (2024E based on full year 2024 guidance). Cortrophin Gel was launched in 2022. 132-135% CAGR

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

    © 2024 ANI Pharmaceuticals, Inc. 9 ANI Rare Disease markets three therapeutics with growth and durability US Ophthalmology Indications Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa Diabetic macular edema (DME) Non-infectious uveitis affecting the post

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

    © 2024 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

    © 2024 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: Cortrophin Gel: Successful launch and strong demand

    © 2024 ANI Pharmaceuticals, Inc. 12 • Expansion of pulmonology sales team yielding positive results • Ophthalmology sales team pilot in early 2024 successful • Expanded Ophthalmology sales team to ~46 with Alimera acquisition • Launched 1-mL vial size of Cortrophin Gel during Q4 2023, the only appro

  13. Slide 13: Strong multi-year growth trajectory for Cortrophin Gel and the ACTH market

    © 2024 ANI Pharmaceuticals, Inc. 13 • 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

  14. Slide 14: Transaction closed September 2024

    © 2024 ANI Pharmaceuticals, Inc. 14 Transaction closed September 2024 Highly synergistic acquisition of Alimera Sciences closed in September with integration progressing well Two differentiated commercial assets with high barriers to genericization and significant growth potential, which can be furt

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

    © 2024 ANI Pharmaceuticals, Inc. 15 Alimera acquisition aligned with M&A strategy Expands 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(1

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

    © 2024 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: Larger ophthalmology sales team expected to accelerate growth

    © 2024 ANI Pharmaceuticals, Inc. 17 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

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

    © 2024 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: Long-term clinical studies and ongoing trials for ILUVIEN and YUTIQ

    © 2024 ANI Pharmaceuticals, Inc. 19 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

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

    © 2024 ANI Pharmaceuticals, Inc. 20 Strong R&D capabilities and operational excellence driving growth in Generics Robust pipeline and new product launch execution • Launched sixteen new products 2024 YTD(1), including a Competitive Generic Therapy (CGT) product with 180-day exclusivity • Number two

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

    © 2024 ANI Pharmaceuticals, Inc. 21 U.S.-based manufacturing footprint; strong GMP track record, including successful FDA audits at all three sites • Manufacturing, packaging, warehouse • Schedule CII vault & CIII cage space • Lab space - R&D/analytical testing • Solutions, suspensions, topicals, ta

  22. Slide 22: Investment summary

    © 2024 ANI Pharmaceuticals, Inc. 22 Investment summary Strategic focus on strong and growing Rare Disease business • Expected to represent ~50% of 2025 revenues and largest driver of future growth • Cortrophin Gel to reach ~$198M (2) revenue in 2024 with strong multi-year growth trajectory • 2024 ac

  23. Slide 23: Appendix

    © 2024 ANI Pharmaceuticals, Inc. 23 Appendix

  24. Slide 24: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation

    © 2024 ANI Pharmaceuticals, Inc. 24 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,

  25. Slide 25: Reconciliation footnotes: Canada operations and adjusted non-GAAP net income

    © 2024 ANI Pharmaceuticals, Inc. 25 (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

  26. Slide 26: Strong balance sheet to support Rare Disease business development

    © 2024 ANI Pharmaceuticals, Inc. 26 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

  27. Slide 27: November 20, 2024

    © 2024 ANI Pharmaceuticals, Inc. 27 November 20, 2024

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