Amphastar Pharmaceuticals Q1 2025: Unpacking Key Contradictions in BAQSIMI Sales, FDA Timelines, and Market Dynamics

BAQSIMI's sales and growth prospects, FDA review timelines and regulatory changes, BAQSIMI's market dynamics and sales expectations, Epinephrine sales and competition, BAQSIMI's impact on gross margins are the key contradictions discussed in Amphastar Pharmaceuticals' latest 2025Q1 earnings call.



Revenue and Market Performance:
- Amphastar Pharmaceuticals reported net revenues of $170.5 million for Q1 2025, reflecting a modest 1% decline compared to the same period last year.
- The decline was due to increased competition in critical care products such as Dextrose, Epinephrine, and Glucagon, impacting demand.

BAQSIMI and Primatene MIST Growth:
- BAQSIMI achieved sales of $38.3 million in Q1 2025, closely aligned with the combined BAQSIMI sales by Lilly and Amphastar of $38.7 million in the previous year.
- Primatene MIST sales grew to $29 million, a 20% increase from the previous year, driven by increased unit volumes and sustained demand.

Pipeline and Regulatory Developments:
- The FDA accepted Amphastar's Biologics License Application (BLA) for insulin aspart identified as AMP-004, with a biosimilar user fee act (BsUFA) goal date set in the first quarter of 2026.
- This acceptance represents a significant milestone, reinforcing the company's commitment to expanding its portfolio of interchangeable biosimilar insulin offerings.

Impact of Tariffs and Cost Management:
- Amphastar is closely monitoring the evolving tariff situation and anticipates a potential impact on costs, with an estimated increase of about $500,000 per quarter under the current tariff situation.
- The company is taking proactive measures to manage costs and ensure operational efficiency to mitigate potential impacts.