Amphastar Pharmaceuticals (AMPH) 6 Nov 24 2024 Q3 Earnings call transcript

In the third quarter of 2024, Amphastar Pharmaceuticals reported net revenues of $191.2 million, marking a 6% increase from the previous year. This growth underscores the company's robust core business and strategic initiatives, despite facing challenges like Hurricane Helene's impact on logistics.

A Growing Portfolio and Strategic Initiatives

Amphastar's strategic focus on regulatory filings and commercial portfolio execution is on track, with key revenue drivers like BAQSIMI, Primatene MIST, and core hospital and clinical use products in the critical care arena showing promising growth. Primatene MIST, in particular, achieved its highest quarterly sales since its launch, reaching $26 million, a significant step towards the company's goal of $100 million in annual sales. The company also announced the launch of its albuterol MDI product, marking a significant expansion of its respiratory portfolio.

Navigating Competition and Regulatory Challenges

Competition in the glucagon injection kit market intensified, leading to a 9% decline in sales from the previous year. However, Amphastar views this as a reflection of the growing awareness of effective hypoglycemia management options and the attractiveness of the market. The company also announced the launch of its first biosimilar addition to its pipeline, AMP-028, which could mark its first BLA target outside of insulin. This strategic shift towards more advanced therapeutic areas is expected to maximize value and impact while reducing competitive pressures.

Financial Performance and Future Outlook

Amphastar's financial performance in Q3 was marked by a 6% increase in revenues to $191.2 million, with key products like BAQSIMI and Primatene MIST driving sales growth. However, the company faced challenges in the form of Hurricane Helene's impact on logistics, which delayed shipments and impacted sales. The company's net income decreased by 18% to $40.4 million or $0.78 per share, with adjusted net income also decreasing to $49.6 million or $0.96 per share. Despite these challenges, Amphastar remains optimistic about its future, with plans to announce additional candidates in its proprietary and biosimilar pipelines in the coming year.

Q&A Highlights

During the Q&A session, Ekaterina Knyazkova from JPMorgan asked about BAQSIMI's competitive dynamics and peak sales potential. William Peters, Amphastar's CFO, confirmed that BAQSIMI's sales are trending close to the base case of $250 million to $275 million in peak sales, with no major surprises. On the GLP-1 category, Amphastar expressed optimism about its role, with AMP-018, a GLP-1 ANDA, granted competitive generic therapeutic designation and priority review.

Pavan Patel from Bank of America questioned the main driver of lower revenue in the quarter for epinephrine and where to look for offsetting revenue. William Peters attributed the decline to increased competition from multi-dose vials and the launch of Pfizer's supply shortages. He also discussed plans to expand the sales force for BAQSIMI and the impact of outsourcing the sales force for flexibility and control.

David Amsellem from Piper Sandler asked about the albuterol generic and the footprint sales for 2025. William Peters confirmed that the sales footprint for albuterol will be meaningful in 2025, but not in the fourth quarter. He also provided updates on AMP-002 and AMP-007, expressing optimism about their progress despite regulatory challenges.

In conclusion, Amphastar Pharmaceuticals' Q3 earnings call highlighted the company's resilience and strategic initiatives, including the launch of Primatene MIST and the introduction of AMP-028. Despite challenges like Hurricane Helene and increased competition, Amphastar remains confident in its future growth prospects, with a clear strategy and expanding pipeline.