[Management View] Amphastar Pharmaceuticals reported a solid performance in Q2 2025, driven by the strong momentum of Baqsimi and steady consumer demand for Primatene Mist. The company emphasized its strategic focus on long-term growth, regulatory progress, and expansion of U.S.-based manufacturing capacity.
[Outlook] Management maintains a flat full-year sales guidance for 2025, with expectations of high single-digit unit growth and a 3% price increase for Baqsimi in the U.S. The company is optimistic about near-term product approvals and continues to advance its regulatory initiatives.
[Financial Performance] Net revenue for Q2 2025 was $174.4 million, down 4% from $182.4 million in Q2 2024. GAAP net income decreased to $31 million, or 64¢ per diluted share, from $37.9 million, or 73¢ per share, in Q2 2024. Adjusted net income was $40.9 million, or 85¢ per diluted share, versus $48.7 million, or 94¢ per share, in the prior year period. Baqsimi sales increased 21% year over year to $46.5 million.
[Q&A Highlights] Question 1: I think in the past, you've indicated you expected the top line to be flat year over year. Just curious if those expectations have changed now that we're halfway through the year. And secondly, maybe if you can highlight what we should expect from Baqsimi over the second half of the year. And are you starting to see some of the MannKind collaboration impacts on those sales? Thanks. Answer: We still are guiding to flat sales year over year. We still anticipate that two products could be approved and contribute to that level. Baqsimi guidance remains high single-digit unit growth and a 3% price increase in the U.S., and we are pleased with the strong growth in the second quarter.
Question 2: Has your level of confidence increased or changed at all from the last quarterly update regarding AMP-002? Answer: We remain optimistic about the approval of AMP-002. We continue to engage with high-level officials at the FDA, which keeps us optimistic about an approval.
Question 3: I wanted to ask about AMP-018, the GLP-1. I saw that the IQVIA trailing twelve-month sales, that used to be $1.1 billion at the start of the year, now that's moved down to $400 million. So I was wondering how you're thinking about this opportunity, especially with the recent CRL delaying approval timelines? Thank you. Answer: We think it's going to be a very crowded generic market, so we expect it to be a small contributor to our sales.
Question 4: Maybe first, if you could walk us through the expected margin trajectory for the second half of the year. And then second, on epinephrine PFS competition. Maybe if you could speak to the competitive environment. Has pricing eroded significantly? Or is this primarily a market share issue? Just the latest there. Thank you. Answer: We expect new products to be at or above the corporate average margin. However, we anticipate increased price competition on glucagon, leading to margin contraction absent new approval launches. For epinephrine PFS, both pricing and unit drop have contributed to the overall sales decline.
Question 5: Just as you think about the revenues for glucagon from here, is Q2 kind of a good runway to think about going forward? Or would you expect to see some sequential erosion as we think about Q3 and Q4? And second question is just on your plans to expand manufacturing capacity. Could you talk about what motivated the decision? Thank you. Answer: Glucagon is not at a run rate yet. We expect further declines due to new competitor entries and market contraction. The expansion in manufacturing capacity is driven by pipeline support and geopolitical risk mitigation.
Question 6: Does the informal revenue guide contemplate contribution from AMP-002? And how many launches are you actually contemplating before the end of the year? And secondly, more color on AMP-007, the extent to which that's going to be a crowded market and how should we think about the size of that opportunity? Thanks. Answer: The revenue guide includes two risk-adjusted product launches, AMP-002 and AMP-015. AMP-007 could be a significant market opportunity if we are the first approval, as we haven't seen any other filings.
[Sentiment Analysis] Analysts and management maintained a cautiously optimistic tone, with confidence in Baqsimi's performance and regulatory progress. Concerns were raised about competitive pressures and margin contraction.
[Quarterly Comparison] | Metric | Q2 2025 | Q2 2024 | |-------------------------------|---------------|---------------| | Net Revenue | $174.4 million| $182.4 million| | GAAP Net Income | $31 million | $37.9 million | | Adjusted Net Income | $40.9 million | $48.7 million | | Baqsimi Sales | $46.5 million | $30.9 million | | Primatene Mist Sales | $22.9 million | N/A | | Glucagon Injection Sales | $20.6 million | $27.4 million | | Epinephrine Sales | $16.2 million | $27.9 million | | Lidocaine Sales | $15 million | $12.8 million | | Other Pharmaceutical Sales | $53.1 million | $57.6 million | | Cost of Revenues | $87.9 million | $87.2 million | | Gross Margin | 49.6% | 52.2% | | Selling, Distribution & Marketing Expense | $10.2 million | $9 million | | General & Administrative Expense | $14 million | $13.3 million | | Research & Development Expense | $20.1 million | $17.7 million | | Nonoperating Expense | $2.8 million | $5 million | | Cash Flow from Operations | $35.6 million | N/A | | Share Repurchase | $39.2 million | N/A |
[Risks and Concerns] - Declines in glucagon and epinephrine sales due to increased competition and market shifts. - Margin compression expected to continue absent new product launches. - Potential geopolitical risks impacting supply chains.
[Final Takeaway] Amphastar Pharmaceuticals faced competitive pressures in Q2 2025, leading to declines in net revenue and profitability. However, the strong performance of Baqsimi and strategic investments in U.S.-based manufacturing capacity and regulatory progress provide a foundation for future growth. Management remains optimistic about near-term product approvals and continues to focus on long-term growth through innovation and diversification.
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