Amphastar Pharmaceuticals (AMPH) Jefferies 2024 Global Healthcare Conference summary

Financial performance and product trends

• Strong Q1 driven by glucagon, critical care products, and Baqsimi, with Baqsimi benefiting from wholesaler stocking in the US.

• Margins were higher due to 100% gross margin revenue from Lilly and lower R&D spend from delayed clinical trials.

• Baqsimi sales exceeded projections, with peak sales estimates of $250M–$275M expected in over five years.

• Margin normalization for Baqsimi expected by Q4, with most countries transitioning to direct distribution.

• Glucagon expected to have a flat year in 2024 due to volume-based competitive pressures, not price erosion.

Product-specific outlooks

• Primatene is on track for $100M in 2024, driven by volume growth and seasonal demand.

• Epinephrine growth is sustained by competitor shortages, expected to normalize in 2025.

• Lidocaine sales are expected to remain flat, with market stability after previous supply fluctuations.

• Other finished products saw a decline due to API supply issues for MPA, with efforts underway to resolve supply via a new facility in China.

• The product portfolio is diversified, with new launches supporting revenue base expansion and proprietary products like Primatene MIST® and BAQSIMI® leading growth.

Pipeline and approvals

• Teriparatide (AMP-015) is expected to respond to a minor CRL in Q2, targeting Q3/Q4 approval despite not being first to market.

• AMP-02 has no generic competitors yet, with ongoing FDA discussions but no approval timeline.

• Albuterol sulfate (AMP-008) approved as a generic to ProAir, entering a market with significant opportunity and expected to improve margins, with Q3 2024 launch planned.

• Multiple potential approvals and regulatory filings in 2024, including intranasal Naloxone Rx-to-OTC switch and ANDAs for GLP-1 and other pipeline products.

• Rextovy launched in Q2 2024, with additional ANDA/BLA filings for insulin and GLP-1 products.