Amphastar Pharmaceuticals, Inc. Q3 FY2024 earnings call

Key Points

• Net revenues grew 6% to $191.2M. Primatene Mist had highest quarterly sales since launch, aiming for $100M annual sales by end 2024; expanding physician sampling program in 2025.
• BAQSIMI transition smooth except European supply disruption; plan to strengthen US sales force. Glucagon sales down 9% due to competition from ready-to-use products like BAQSIMI.
• Launched Albuterol MDI in Q3 2024, expanding respiratory portfolio. Regulatory updates: AMP-002 discussions ongoing with FDA; Teriparatide NDA received CRL, to respond by end 2024; BA for AMP-004 refiled in Q4 2024; AMP-018 granted competitive designation and priority review; AMP-007 GDUFA goal date extended to Q2 2025; announced AMP-028, new biosimilar in pipeline.

In Q3 2024, Amphastar reported net revenues of $191.2 million, a 6% year-over-year increase. BAQSIMI sales totaled $40.4 million. Glucagon sales decreased 9% to $26.8 million. Primatene Mist sales grew to $26.1 million, a new record, with 5% growth year-over-year. Epinephrine sales increased 6% to $21.3 million. Phytonadione sales jumped 57% to $11.7 million. Enoxaparin and Naloxone sales declined. Other finished pharmaceutical product sales decreased to $35.5 million. The launch of Albuterol MDI in Q3 expanded the respiratory portfolio. BAQSIMI sales in prior year were higher due to Lilly's distribution, while this year Amphastar's direct sales impacted gross margins. Hurricane Helene led to $2M-$4M in unrecognized Q3 sales.

Forward-Looking

• Primatene Mist aims for $100M annual sales by end 2024. Plan to expand BAQSIMI sales force starting Jan 2025. Anticipate announcing additional candidates in proprietary and biosimilar pipelines in 2025. AMP-002 expected near approval; AMP-018 on track for Q2 2025 GDUFA goal date; AMP-007 GDUFA goal date extended to Q2 2025.

Risks

• Hurricane Helane caused $2M-$4M in unrecognized Q3 sales due to logistics delays. Temporary supply disruption in 14 European countries for BAQSIMI limited sales by $2M-$3M. Increased competition in glucagon market led to 9% sales decline.

Q: On BAQSIMI uptake, competitive dynamics, peak sales potential A: BAQSIMI transition smooth except European supply issue; on track for $250M-$275M peak sales Q: GLP-1 category role A: AMP-018 coming in 2025, updates to follow Q: Epinephrine revenue decline, BAQSIMI competitive headwinds, sales force investment A: Epinephrine affected by competitor multi-dose vial launch; BAQSIMI sales decline due to European supply issue; sales force expansion starting Jan 2025 with outsourced sales force Q: Albuterol generic sales footprint, AMP-002, AMP-007 A: Albuterol MDI to be meaningful in 2025; AMP-002 discussions ongoing with FDA; AMP-007 GDUFA extended, no alarm on agency conversations