Amphastar Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Core pillars: strong commercial execution, strategic pipeline expansion, and regulatory progress. - Proprietary pipeline: Secured U.S. and Canadian rights to 3 early-stage novel peptide candidates from Nanjing Anji Biotechnology for oncology and ophthalmology. - Regulatory initiatives: FDA approval of iron sucrose injection, progress on AMP-007 (on track for mid-2026 launch), AMP-015 (on track for first half of 2026 launch), AMP-018 (scheduled for 2027 launch), and AMP-004 (moving towards 2027 launch). - Manufacturing: U.S. manufacturing expansion to quadruple production capacity at Rancho Cucamonga headquarters.

For the third quarter, Amphastar achieved net revenues of $191.8 million. Key product segments: BAQSIMI delivered $53.6 million in total sales, up 14% year-over-year. Primatene MIST sales grew 11% to $28.8 million. Glucagon injection sales declined 49% to $13.6 million. Epinephrine sales decreased 12% to $18.8 million. Lidocaine sales decreased 19% to $12.9 million. Other pharmaceutical product sales increased to $64.1 million, including $2.4 million from iron sucrose injection launched in August 2025.

• Still believe to get flat top line in 2025 due to outperformance by BAQSIMI and Primatene MIST. - Next year, expecting high single-digit to low double-digit growth rates. - Iron sucrose injection had $2.4 million this quarter, which is a good run rate going forward.

• Competition in obesity and diabetes markets, expecting limited commercial opportunity. - General and administrative spending increased due to a litigation provision related to a recent jury verdict. - Primatene MIST's Orange Book patent expires in 2026, potential for competition though not expecting immediate significant impact.

Q: Any updated thoughts on top line for 2025 and growth for next year?

A: Still believe can get to flat this year based on some outperformance by BAQSIMI and Primatene MIST, and next year likely high single-digit to low double-digit growth rates.

Q: How big is the opportunity for iron sucrose?

A: Had $2.4 million this quarter, which is about half a quarter, and that's a good run rate going forward.

Q: Updates on AMP-007 and FDA communication?

A: Continue to have engagement with the agency, slight delays in interaction but not directly impacting product launches.

Q: Competitive landscape for insulin aspart launch in 2027?

A: Likely 3 or more competitors in the market, but it's a large market with volume, and making API and finished product in-house helps cost structure.

Q: Primatene MIST's patent expiration in 2026?

A: Don't know of immediate competition, but if generic enters, assume brand gets half the market, and we'd launch our own generic to capture half the generic market, so competitors limited to 1/4 of the market.