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Amphastar Pharmaceuticals (AMPH) investor relations material

Amphastar Pharmaceuticals Wells Fargo 20th Annual Healthcare Conference 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Wells Fargo 20th Annual Healthcare Conference 2025 summary3 Sep, 2025

Company Overview, Strategy, and Business Model

  • Vertically integrated operations span R&D, manufacturing, and distribution, with 1,500 employees and over a decade as a public entity.

  • Dual growth strategies include organic pipeline expansion and inorganic growth via strategic acquisitions.

  • Focus on expanding proprietary pipeline to 50% and biosimilars to 35% by 2026, with ongoing business development.

  • Emphasis on quality, efficiency, and technology has led to rising net income margins and strong revenue growth from 2018 to 2024.

  • Revenue reached $732 million in 2024, with adjusted net income margin at 27.4%.

Pipeline Evolution, R&D, and Regulatory Updates

  • Substantial R&D investment of $351 million over five years supports a diverse and scalable product portfolio.

  • Six generic pipeline candidates in advanced stages, with several FDA approvals expected between late 2025 and 2026.

  • In-licensed three new peptide assets targeting oncology and ophthalmology, expanding into high-growth markets.

  • Iron sucrose launched with capacity constraints limiting market share to 25%, but competitive generic therapy status provides six-month exclusivity.

  • Teriparatide ANDA on track for Q4 GDUFA date, with AMP007 and other ANDA/BLA filings anticipated through 2026.

Key Products and Commercial Performance

  • BAQSIMI® acquisition expands the diabetes portfolio and international presence to 26 countries, with projected peak sales of $250–$275 million.

  • Baqsimi transitioned to full control, achieving double-digit script growth and high single-digit unit growth guidance for the year.

  • Primatene MISTⓇ, the only FDA-approved OTC asthma inhaler, surpassed $100 million in sales in 2024 and is forecasted for continued growth.

  • Primatene Mist posted 10% year-over-year growth, supported by DTC and physician sampling, with durability expected despite upcoming patent expiry.

  • Existing products provide a strong revenue base, with new launches supporting diversification.

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Frequently asked questions

Amphastar Pharmaceuticals Inc. is a specialty pharmaceutical company engaged in the development, manufacture, and marketing of generic and proprietary injectable, inhalation, and intranasal products. The company focuses on producing pharmaceuticals for hospital, emergency, and clinical use, including treatments for respiratory conditions, diabetes, and pain management. Amphastar operates manufacturing and research facilities to support its product portfolio and pipeline development. Amphastar Pharmaceuticals Inc. is headquartered in Rancho Cucamonga, California, and its shares are listed on the NASDAQ.

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