• Net Revenue: $191.2 million, a 6% increase year over year.
• Primatene Mist Sales: $26 million, highest quarterly sales since launch.
• Glucagon Sales: $26.7 million, a 9% decline from the previous year.
• Vaccine Sales: $40.4 million through Amphastar, $6.4 million by Eli Lilly.
• Epinephrine Sales: $21.3 million, a 6% increase.
• Phytonadione Sales: $11.7 million, a 57% increase.
• Gross Margin: Declined to 53% from 60% in the prior year.
• Net Income: $40.4 million, an 18% decrease from the previous year.
• Adjusted Net Income: $49.6 million, compared to $61.9 million in the previous year.
• Cash Flow from Operations: Approximately $60 million.
• Share Repurchase: $35 million used to repurchase 797,000 shares.
• New Buyback Program: Authorized an additional $50 million.

• Warning! GuruFocus has detected 3 Warning Signs with AMPH.

Release Date: November 06, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) reported a 6% increase in net revenues year over year, reaching $191.2 million, demonstrating resilience and growth in their diversified product portfolio.
• Primatene Mist achieved its highest quarterly sales since launch, reaching $26 million, marking significant progress towards the company's goal of $100 million in annual sales by the end of 2024.
• The launch of the Albuterol MDI product in the third quarter of 2024 expanded Amphastar's respiratory portfolio, positioning the company to meet growing demand for affordable asthma management options.
• The company announced the introduction of AMP 028, a new biosimilar addition to their pipeline, which has potential sales of over $2 billion, marking a strategic shift towards high-value therapeutic areas.
• Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) continues to advance its diabetes portfolio, with plans to refile their BLA for insulin aspart in the fourth quarter and their GLP-1 NDA AMP 018 receiving priority review.

Negative Points

• Hurricane Helane impacted logistics, resulting in delayed shipments and negatively affecting sales by $2 to $4 million in the third quarter.
• Glucagon sales decreased by 9% to $26.8 million due to increased competition in the market, reflecting a decline in unit shipments.
• Gross margins declined to 53% from 60% in the prior year, primarily due to changes in the distribution of vaccine sales and increased labor and component costs.
• Selling, distribution, and marketing expenses increased by 40% due to the expansion of the vaccine sales force, impacting overall profitability.
• Net income decreased by 18% to $40.4 million, or 78 cents per share, compared to the previous year, with adjusted net income also showing a decline.

Q & A Highlights

Q: Can you provide any updates on the competitive dynamics and peak sales potential for your products, particularly in the GLP-1 category? A: William Peters, CFO, stated that the transition of vaccine distribution is going smoothly despite a temporary supply disruption in Europe. The company remains on target for peak sales of $250 to $275 million. Regarding the GLP-1 category, Dan Dischner, VP of Corporate Communications, mentioned that it's a crowded market, and while it's too early to discuss specifics, updates will be provided as they become available.

Q: What were the main drivers of lower revenue for Epinephrine, and how do you plan to offset this? A: William Peters explained that the decrease in Epinephrine revenue was due to competition in the multi-dose vial market, partially offset by increased sales of prefilled syringes in Canada. The company plans to expand its sales force to drive growth in other areas, such as vaccine, to offset fluctuations in the base business.

Q: Can you discuss the sales potential for the generic Albuterol HFA and any updates on AMP 002 and AMP 007? A: William Peters noted that Albuterol HFA is expected to be a meaningful product in 2025, with a gradual market share increase. Dan Dischner mentioned ongoing discussions with the FDA for AMP 002, with potential progress soon. For AMP 007, the FDA extended the action date, but there are no alarming issues, and the company remains optimistic.

Q: What are the competitive headwinds affecting vaccine sales, and what is the plan for sales force investment? A: William Peters attributed the year-over-year decline in vaccine sales to temporary supply disruptions in Europe and pricing adjustments in the U.S. The company plans a significant sales force expansion in January, with some related expenses in the fourth quarter, utilizing an outsourced model for flexibility.

Q: Can you clarify the nature of AMP 007 as a combination product and its competitive landscape? A: William Peters clarified that AMP 007 is a drug-device combination product, similar to other inhalation products. The company has not disclosed specific competition details for this product at this time.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.