Amphastar's Q2 2025: Unpacking Contradictions in BAQSIMI Growth, Manufacturing Capacity, and FDA Approvals

BAQSIMI growth and sales expectations, manufacturing capacity and expansion, FDA engagement and approval timeline, BAQSIMI sales growth expectations, expected approval timelines for AMP-002 are the key contradictions discussed in Amphastar Pharmaceuticals' latest 2025Q2 earnings call.



Strong Performance of BAQSIMI:
- Amphastar's BAQSIMI sales grew to $46.7 million in Q2 2025, up 64% year-over-year, marking its highest quarterly sales since acquisition.
- The growth was driven by successful global commercialization integration, increased unit volume, and higher average selling prices.

Challenges in Legacy Products:
- Sales of glucagon injection and epinephrine decreased by 25% and 42% respectively in Q2 2025.
- The decline was primarily due to increased competition and market share shifts towards ready-to-use products like BAQSIMI.

Capital Investment Strategy:
- Amphastar announced a significant expansion of its California headquarters to quadruple domestic manufacturing capacity.
- This investment aims to mitigate risks associated with international supply chains and support R&D pipeline advancements.

Regulatory Pipeline and Approval Optimism:
- The company remains optimistic about the near-term approval of AMP-002, benefiting from productive dialogues with the FDA.
- Progress in regulatory programs, such as AMP-007 and AMP-015, is expected to contribute to growth in the second half of 2025.

Insulin Market Potential with Interchangeable Biosimilars:
- Amphastar views the recent approval of the first interchangeable insulin aspart product as a significant milestone for the market.
- The company is well-positioned to benefit from this trend with U.S.-based finished product manufacturing and expertise in complex injectables.