Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Amphastar Pharmaceuticals Inc (AMPH, Financial) reported a 25% year-over-year increase in total revenues, reaching $182.4 million.
- BAQSIMI achieved impressive worldwide sales of $38.5 million for the quarter, representing a 10% increase compared to the same period last year.
- Primatene MIST sales grew 38% to $22.9 million, and Epinephrine sales increased 67% to $27.9 million, driven by other supplier shortages.
- The company has focused on enhancing efficiencies in the production of Epinephrine and other products, leading to increased capacity without additional square footage.
- Amphastar Pharmaceuticals Inc (AMPH) is well-positioned for a promising second half of 2024 with the potential for three significant product approvals: teriparatide, AMP-015, and AMP-002.
Negative Points
- Phytonadione sales decreased to $10.3 million from $17.9 million due to increased competition.
- Enoxaparin and Naloxone sales also saw a decline due to increased competition.
- The company anticipates a decline in glucagon injection sales from peak levels due to increased availability of competitor products in the diagnostic market.
- Selling, distribution, and marketing expenses increased 34% to $9 million, and general and administrative spending increased 8% to $13.3 million, primarily due to expenses related to BAQSIMI.
- Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of BAQSIMI.
Q & A Highlights
Q: Can you discuss expectations for the epinephrine franchise over time, considering competitor supply shortages and potential new market entrants?
A: We have two presentations for epinephrine: a multi-dose vial and a prefilled syringe. The prefilled syringe has been on the drug shortage list for about a year due to a competitor's supply issues. We've increased our production capacity and expect competitor supply to return by the fourth quarter. For the multi-dose vial, a new competitor has entered the market, which may reduce our sales.
Q: How are you thinking about the size and launch timeline for generic ProAir?
A: We have launched generic ProAir and it has been well received. We are working on securing business and increasing packaging capacity over the next few quarters to meet demand.
Q: Any updates on AMP-002 and the FDA interactions?
A: We continue to have routine conversations with the FDA and believe they are close to resolving their issues. We expect action on the application in the near future.
Q: Can you provide details on the GLP-1 product AMP-018 and its market competition?
A: AMP-018 is a paragraph four filing, and we expect competition when we launch. We have not been sued yet but it is still possible.
Q: How do you expect BAQSIMI's growth to impact overall company gross margins in the second half of the year?
A: BAQSIMI sales are expected to ramp up in the third quarter. As we transition from Lilly's distribution to our own, we will incur more cost of goods, which will affect gross margins. This trend will continue into the next quarter.
Q: How are you approaching business development to achieve your goal of 50% proprietary programs by next year?
A: We are actively looking at both development-stage assets and market-ready assets like BAQSIMI. We remain disciplined in our approach to ensure we pay the right price for these assets.
Q: Can you comment on the performance and expectations for REXTOVY?
A: REXTOVY is in a crowded field, and our focus is on government and first responders. It is too early to say how it will perform, but we do not anticipate it being a major product due to the competitive environment.
Q: How do you expect selling and marketing costs to evolve in the second half of the year?
A: We plan to add to our sales force in the third quarter, particularly in the US. Sales and marketing expenses should grow in line with the 10% increase in BAQSIMI sales.
Q: What drove the 10% year-over-year growth in BAQSIMI sales this quarter?
A: The growth was primarily driven by unit volume. In the US, we saw a net pricing decrease due to higher wholesaler fees, while ex-US pricing remained stable.
Q: Can you provide more details on the country-by-country transition for BAQSIMI distribution?
A: We aim to transition most countries to our distribution by the end of the third quarter, with only three countries remaining under Lilly's distribution by the fourth quarter. These final transitions may occur by January 1.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
