Amphastar Pharmaceuticals, Inc. Q1 FY2025 earnings call

• Acknowledged receiving the USFDA Drug Shortage Assistance Award for efforts in preventing and alleviating drug shortages. - Performance mix in Q1: Critical care products like Dextrose and Epinephrine faced soft demand due to competition; Glucagon's competitive landscape intensified. - BAQSIMI achieved $38.3 million in sales, with full control of operations since transition from Lilly, and partnership with MannKind launched in January. - Primatene MIST had 20% sales growth to $29 million, with expanded physician sampling program. - Pipeline updates: AMP-002 filing noted, AMP-007 on track to respond to CRL in Q2, AMP-015 on schedule for Q4, AMP-018 to respond to CRL in H2, BLA for AMP-004 accepted with BsUFA goal Q1 2026. - Monitoring tariffs, with current cost impact on Amphastar estimated at ~$500k per quarter. - Focus on operational excellence and diversifying portfolio to include proprietary and biosimilar products.

In the first quarter, Amphastar's net revenues were $170.5 million, a 1% decline from the prior year. BAQSIMI revenues for products shipped by Amphastar grew 177% to $38.4 million compared to $13.8 million in the prior year period. Primatene MIST sales grew to $29.1 million, a 20% increase from $24.2 million in the first quarter of last year. Glucagon injection sales declined 27% to $20.8 million from $28.5 million due to increased competition. Epinephrine sales decreased 29% to $18.6 million from $26.1 million due to increased competition. Other finished pharmaceutical product sales decreased $2.2 million to $50 million from $52.2 million due to competition for Enoxaparin, Naloxone and Dextrose.

• Maintained flat revenue guidance for 2025. - BAQSIMI expected high single-digits unit growth. - Anticipated sales from pipeline approvals of AMP-002, AMP-007, AMP-015 to contribute later in the year.

• Competitive pressures on Glucagon, Epinephrine, and other products like Dextrose, Enoxaparin, Naloxone. - Tariff impact on imported components/APIs, with an estimated $500k per quarter increase. - Potential return of competition on products like Phytonadione.

Q: David Amsellem asked about expectations for rest of year regarding new launches and BAQSIMI commercial support.

A: William Peters mentioned plans to respond to CRL for AMP-007 in Q2, optimism about AMP-002, and AMP-015 on schedule; Dan Dischner clarified BAQSIMI has been under Amphastar's selling responsibility since end 2023, with increased sales force and co-promotion agreement with MannKind, and still confident in high single-digits unit growth for BAQSIMI.

Q: Cerena Chen asked about insulin aspart opportunities and interchangeability.

A: Dan Dischner noted insulin aspart is a large-sales product with big market opportunity, goal to be first interchangeable biosimilar; Tony Marrs elaborated on interchangeability's value of immediate replacement and working with FDA for interchangeability first.

Q: Jason Gerberry asked about margin pressures and BAQSIMI growth.

A: Dan Dischner said BAQSIMI saw low single-digit growth in Q1 but higher growth in Q2 so far, and margin pressures from Glucagon pricing, but offset by growth in Primatene MIST and internal cost actions; William Peters discussed tariff impact and sourcing from various countries.

Q: Ekaterina Knyazkova asked about FDA regulatory landscape and tariffs.

A: Dan Dischner said no significant impact on application timings from FDA changes; William Peters noted Amphastar's U.S. manufacturing position is beneficial for tariffs, with current impact on API from China facility.

Q: John (on behalf of Serge Belanger) asked about Glucagon, Epinephrine competition.

A: Dan Dischner said Epinephrine faced two new launches, Glucagon had lower pricing in one month of Q1, expecting continued pressure on these products and others like Dextrose, Enoxaparin, Naloxone with competition.