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DATE
Thursday, August 7, 2025 at 9:00 p.m. ET
CALL PARTICIPANTS
Chief Executive Officer — Dan Dischner
Chief Financial Officer & Executive Vice President of Finance — Bill Peters
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RISKS
Glucagon injection salesdeclined 25% to $20.6 million in Q2 2025, driven by increased competition and a market shift toward ready-to-use products.
Epinephrine salesdecreased 42% to $16.2 million in Q2 2025, reflecting heightened competition in multidose vials and the reentry of a rival supplier for prefilled syringes.
Gross margindropped to 49.6% from 52.2% in Q2 2025, due to competition-related pricing declines for glucagon and epinephrine, and the conclusion of a transition service agreement that had provided 100% gross margin on Lilly-sourced Baqsimi sales.
Management guidanceindicates further margin compression is expected absent new product launches, with continued price pressure particularly on glucagon.
TAKEAWAYS
Net Revenue(GAAP) -- $174.4 million for Q2 2025, down 4% from $182.4 million, reflecting legacy product declines offset by Baqsimi growth.
GAAP Net Income-- $31 million, or 64¢ per diluted share, for Q2 2025, representing a decrease from $37.9 million, or 73¢ per share, in Q2 2024.
Adjusted Net Income-- $40.9 million, or 85¢ per diluted share, versus $48.7 million, or 94¢ per share, in the second quarter of last year.
Baqsimi Sales-- $46.5 million, up from $30.9 million in the prior year period; revenue grew 21% as global commercialization integration accelerated under Amphastar.
Primatene Mist Sales-- $22.9 million for Q2 2025, with year-to-date growth of 10%, indicating steady consumer demand.
Glucagon Injection Sales-- $20.6 million, down 25% year over year in Q2 2025, primarily due to competition and a market shift to ready-to-use products such as Baqsimi.
Lidocaine Sales-- $15 million in Q2 2025, up 17% due to increased demand resulting from competitor supply shortages.
Other Pharmaceutical Sales-- $53.1 million in Q2 2025, down from $57.6 million in Q2 2024, reflecting declines in enoxaparin, dextrose, and sodium bicarbonate, partially offset by the August 2024 launch of albuterol.
Cost of Revenues-- $87.9 million, up from $87.2 million in the previous year's period, as the completion of the Baqsimi transition now results in all product costs being directly reflected in this line item.
Gross Margin-- 49.6%, down from 52.2% in the previous year's period, pressured by competitive pricing declines and the conclusion of Lilly's transition service agreement.
Selling, Distribution & Marketing Expense-- $10.2 million, up 14% for Q2 2025, driven largely by Baqsimi and Primatene Mist promotional activities, including a co-promotion agreement with MannKind.
General & Administrative Expense-- $14 million, up 5% for Q2 2025, due to higher personnel-related costs.
Research & Development Expense-- $20.1 million, up 14% for Q2 2025, primarily associated with inhalation pipeline and proprietary product projects.
Nonoperating Expense-- $2.8 million, down from $5 million for Q2 2025, due to decreased interest expense and favorable currency fluctuations.
Cash Flow from Operations-- $35.6 million for Q2 2025, supporting internal funding strength amid market shifts.
Share Repurchase-- $39.2 million in buybacks completed in Q2 2025, exhausting the existing authorization; the board approved a new $50 million program.
Manufacturing Investment-- Announced California headquarters expansion to quadruple domestic manufacturing capacity, with a focus on pipeline and proprietary products.
Pipeline Regulatory Progress-- Two risk-adjusted product launches (AMP-002 and AMP-015) are included in the flat full-year revenue outlook for 2025; AMP-007 has an expected GDUFA date in 2026; the GLP-1 ANDA (AMP-018) response to the complete response letter remains on track for the second half of 2025.
AMP-004 (Insulin Aspart BLA)-- Management views FDA approval for the first interchangeable insulin aspart as a “meaningful milestone” supporting future biosimilar competition and validating Amphastar Pharmaceuticals’ regulatory pathway.
Guidance-- Management maintains full-year sales guidance as “flat” for 2025 and reaffirms Baqsimi guidance of high single-digit unit growth and a 3% U.S. price increase.
GLP-1 Generic Opportunity (AMP-018)-- CFO Bill Peters said, “we think it's going to be a very crowded generic market, so we expect it to be a small contributor to our sales.”
SUMMARY
Amphastar Pharmaceuticals (AMPH 0.49%) reported declines in net revenue and profitability for Q2 2025, driven by increased competition and margin pressure on legacy injectable products. Management emphasized the continued outperformance of Baqsimi, reflecting successful integration and commercial execution, and signaled that the product remains key to offsetting broader product headwinds. Regulatory updates highlighted a risk-adjusted expectation of two product launches contributing to the full-year outlook, while emphasizing the importance of proprietary product development and manufacturing capacity expansion in the United States. Newly approved domestic manufacturing investments are aimed at strengthening the R&D pipeline and securing supply chain resilience.
Management notes that further price and volume declines for glucagon are anticipated going forward, due to another competitor’s market entry and broader antihypoglycemic category contraction.
The announced expansion in U.S.-based capacity is driven by pipeline support and risk mitigation for supply chains in a volatile geopolitical environment.
Margin compression is expected to continue if new products are not approved and launched within the expected timelines.
Potential for incremental top-line upside is tied to Baqsimi exceeding expectations or favorable competitive dynamics in the remainder of the year.
INDUSTRY GLOSSARY
Baqsimi: A ready-to-use, intranasal glucagon product for severe hypoglycemia, acquired by Amphastar Pharmaceuticals and a current revenue driver.
ANDA: Abbreviated New Drug Application, the regulatory pathway for generic drug approval in the U.S.
GDUFA Date: Generic Drug User Fee Amendments action date, the FDA’s scheduled response timeline for generic drug applications.
BLA: Biologics License Application, the regulatory submission for approval of biologic products in the U.S.
Prefilled Syringe (PFS): Injectable drug delivery device pre-loaded with medication, referenced in context of epinephrine product competition.
CRL: Complete Response Letter, an official FDA communication outlining deficiencies preventing approval of a drug application as submitted.
Full Conference Call Transcript
Dan Dischner: Thank you, Paul. Good afternoon, and thank you for joining our second quarter 2025 earnings call. I'm pleased to share that Amphastar Pharmaceuticals delivered a solid performance in 2025, highlighting the continued strength of our commercial execution, the resilience of our diversified portfolio, and our strategic focus on long-term growth. For the second quarter, we reported net revenues of $174.4 million and a GAAP net income of $31 million, or 64¢ per diluted share. On a non-GAAP basis, adjusted net income was $40.9 million, or 85¢ per diluted share. The performance was primarily driven by the strong momentum of Baqsimi, which has quickly established itself as a reliable top performer for Amphastar Pharmaceuticals.
Total revenue for Baqsimi increased by 21% year over year. The growth reflects our successful integration of global commercialization at the start of 2025, as well as the increase in unit volume and higher average selling prices. Additionally, we observed stable performance for Primatene Mist, indicating consistent consumer demand.
Turning to our capital investment strategy, we recently announced a significant expansion at our California headquarters aimed at quadrupling domestic manufacturing capacity at that facility. In today's geopolitical environment, expanding our U.S. manufacturing footprint is essential to mitigate risk associated with international supply chains. This investment not only strengthens our operational resilience but also supports the advancement of our R&D pipeline. Our vertically integrated infrastructure, backed by U.S.-based production, has long been a cornerstone of our operational excellence as we focus on maintaining control of quality and upholding high standards.
Shifting our discussion to our regulatory initiatives, our product candidate, AMP-002, has been under FDA review for an extended period. We have engaged in productive and ongoing dialogue with the agency and value the collaborative nature of these interactions. Based on the progress of our discussions and the feedback received to date, we remain optimistic for a near-term approval and look forward to the opportunity to deliver this important product to patients as soon as possible. We continue to advance several additional key regulatory programs. For our AMP-007 inhalation filing, we have received additional feedback from the FDA and now expect a GDUFA date in 2026.
We're pleased to report that our teriparatide product, AMP-015, remains on track and is expected to meet our previously communicated guidance with a GDUFA action date in the fourth quarter of this year. As for our GLP-1 ANDA, or AMP-018, we are on track to respond to the complete response letter in the second half of this year.
Additionally, we're incredibly excited about the long-term potential of our insulin aspart BLA, AMP-004. As we continue to advance this program with interchangeability as our ultimate goal, while the recent approval of the first interchangeable insulin aspart product triggers a marketing exclusivity period, we view this as a meaningful milestone for the entire category. The FDA's decision to grant interchangeability not only validates the regulatory pathway but sets a strong precedent that supports the potential for future competing interchangeable biosimilars in the United States insulin market. This development underscores the growing importance of accessible and affordable insulin options, a trend we expect will accelerate beyond 2026. Amphastar Pharmaceuticals is exceptionally well-positioned to benefit from this shift.
With all U.S.-based finished product manufacturing and a deep expertise in developing and manufacturing complex injectables, we are confident in our ability to be a major contributor to this evolving market. We believe the long-term implications of this program could be transformative both for Amphastar Pharmaceuticals and for the millions of patients who depend on high-quality insulin therapies.
As we look beyond our core pipeline and diabetes portfolio, we are actively driving Amphastar Pharmaceuticals' evolution into a more diversified, innovation-led company with a growing emphasis on branded and proprietary products. Operationally, we continue to balance fiscal discipline with strategic investment, ensuring our resources are allocated to high-impact opportunities. Our R&D expense rose 14% year over year, driven primarily by increased material and clinical trial costs reflecting our deliberate investment in future growth. We view R&D as a critical engine of long-term value creation that enhances and extends our commercial capabilities.
Looking ahead, our strategy remains firmly anchored in sustainable growth, with a strong focus on advancing our pipeline both through internal innovation and carefully selected external opportunities that align with our vision and expertise. In summary, Amphastar Pharmaceuticals' unique blend of scientific innovation in developing high-quality complex products, operational excellence, and deep commercial expertise positions us as a standout leader in the pharmaceutical industry. We believe that our strategic shift towards proprietary product development, supported by an all U.S.-based finished product manufacturing that bolsters supply chain resilience and our strong commercial franchise focused on sustainable shareholder value, collectively form the foundation of Amphastar Pharmaceuticals' growth.
Driven by these unique strengths and disciplined execution, we are well-positioned to confidently accelerate into the next phase of long-term transformative growth. Thank you again for joining us today. With that, I'll turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, to walk through the financials in more detail.
Bill Peters: Thank you, Dan. Revenues for the second quarter decreased 4% to $174.4 million from $182.4 million in the previous year's period. We're proud to share that while revenue was impacted by increased competition in our legacy products, this was largely offset by Baqsimi, which recorded its highest quarterly sales since the product acquisition. Baqsimi sales grew to $46.467 million compared to the prior year period of $30.9 million. As Amphastar Pharmaceuticals assumed full commercialization responsibilities globally in 2025. Keep in mind that during the same period last year, Lilly had Baqsimi sales of $7.6 million. Therefore, total Baqsimi sales for the period grew by 21%.
Primatene Mist sales held steady at $22.9 million in the second quarter, and we are pleased to report that our year-to-date sales have grown by 10%. Glucagon injection sales declined 25% to $20.6 million from $27.4 million, primarily due to increased competition and a move to ready-to-use glucagon products such as Baqsimi. Epinephrine sales decreased 42% to $16.2 million from $27.9 million due to increased competition on the multidose vial and as sales of the prefilled syringe dropped due to another supplier returning to the market.
Sales of lidocaine increased 17% to $15 million from $12.8 million, primarily due to an increase in unit volumes as a result of an increase in demand caused by shortages from other suppliers during the quarter. Other pharmaceutical product sales decreased to $53.1 million from $57.6 million, primarily due to a decrease in sales of enoxaparin, dextrose, and sodium bicarbonate as a result of increased competition. This trend was partially offset by sales of albuterol, which we launched in August 2024.
Cost of revenues increased to $87.9 million from $87.2 million, with gross margins declining to 49.6% from 52.2% in the previous year's period. Sales in the prior year period were recorded under a transition service agreement with Lilly and were booked at 100% gross margin. So now that the transition to Amphastar Pharmaceuticals has been completed, cost of revenues for all products shipped are included in this line, which negatively impacts margin rate. Additionally, pricing declines due to competition for glucagon and our epinephrine multidose vial product negatively impacts margins. Because of these trends, management focused on cost control across the business, which mitigated the impact of these pricing declines.
Selling, distribution, and marketing expenses increased 14% to $10.2 million from $9 million in the previous year's period due to the sales and marketing efforts related to Baqsimi, including the co-promotion agreement with MannKind, as well as sales efforts related to Primatene Mist. General and administrative spending increased 5% to $14 million from $13.3 million, primarily due to increased personnel-related expenses. Research and development expenditures increased 14% to $20.1 million from $17.7 million due to an increase in material and supply expenses for inhalation pipeline products and expenses related to our proprietary projects. Nonoperating expenses decreased to $2.8 million from $5 million due to a decrease in interest expense and currency fluctuations.
Net income decreased to $31 million or $0.64 per share in the second quarter from $37.9 million or 73¢ per share in 2024. Adjusted net income decreased to $40.9 million or 85¢ per share compared to an adjusted net income of $48.7 million or 94¢ per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and certain one-time events. In the second quarter, we had cash flow from operations of approximately $35.6 million. We used a portion of our cash on hand to buy back $39.2 million worth of shares. These purchases finished our previous authorization, so our board of directors approved an additional $50 million stock buyback program.
I'll now turn the call back over to Dan.
Dan Dischner: Thank you, Bill, for the updates. We'll now turn the call over to questions. Operator?
Operator: We will now open for questions. If you would like to ask a question, please press 1 on your telephone keypad. For participants using speaker equipment, it may be necessary to pick up your handset. Our first question is from Serge Belanger with Needham and Company.
Serge Belanger: Good afternoon. Thanks for taking my questions. I guess the first one's for Bill. 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.
Bill Peters: Sure. Yeah. We still are guiding to flat sales year over year. And we still anticipate that two products could be approved and contribute to that level. So we're still comfortable with that flat sales. And secondly, Baqsimi, you know, we're still consistently saying that the guidance that we gave at the beginning of the year, which was high single-digit unit growth and a 3% price increase in the United States, we're right on track for that, and we're really pleased with the strong growth we had in the second quarter.
Serge Belanger: And then, I guess, in terms of potential approvals, AMP-002, has your level of confidence increased or changed at all from the last quarterly update?
Bill Peters: We still remain optimistic about the approval of it. We continue to engage with high-level officials at the FDA, and it keeps us optimistic about an approval.
Operator: Thank you. Our next question is from Cerena Chen with Wells Fargo.
Cerena Chen: Hi, thanks for taking my question. 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.
Bill Peters: Yeah. This is one where we think it's going to be a very crowded generic market, so we expect it to be a small contributor to our sales.
Cerena Chen: Okay.
Operator: Our next question is from Jason Gerberry with Bank of America.
Pavan Patel: This is Pavan Patel on for Jason Gerberry. Just two questions from us. 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.
Bill Peters: Sure. So the expected margin trajectory, we do expect that the new products that we have will either be at or above the corporate average margin that we have right now. But what we are expecting to see is increased price competition on glucagon on a go-forward basis. Therefore, we expect margins to contract absent the new approval launches. And as far as epi prefilled syringe goes, that competition is really baked into the current quarter numbers that we have there. So, you know, the pricing and the unit drop has both happened for that, we believe. And it's been both. It's been both pricing and unit drop that have contributed to this overall sales decline.
Operator: Thank you. Our next question is from Ekaterina Knyazkova with JPMorgan.
Ekaterina Knyazkova: Thank you so much. So first question is just on glucagon. Just as you think about the revenues for the product 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 then second question is just on your plans to expand manufacturing capacity. Could you talk about what motivated the decision? I'm assuming some of that was probably tariffs. And just on how you could leverage your own capacity over time? Thank you.
Bill Peters: Yeah. I'll take the first one. And, no, glucagon is not at a run rate yet. So while we did have the competition come in from one competitor, a second or another competitor was recently approved. So our expectation is that they'll launch in the near future, therefore, bringing down both our units and our pricing on that. So we expect to see glucagon drop on a go-forward basis. And not to mention the fact that the overall market on the antihypoglycemic side of that is shrinking as people move towards ready-to-use products like our Baqsimi. As for the expansion, it's been in our plans for quite a while to expand here at our headquarters.
Certainly, the geopolitical environment is ripe for us to do that at this time. But it is designed more to support our pipeline. All the products that are currently on file with the FDA are already supported with manufacturing here at our facilities that we already exist. But for our pipeline and specifically, our pipeline as we move more into proprietary products and stuff, that's where we're looking at expanding the manufacturing. Supporting that. So that's the reason behind it.
Ekaterina Knyazkova: Thank you.
Operator: Our next question is from David Amsellem with Piper Sandler.
David Amsellem: Thanks. Wanted to circle back on the informal revenue guide. Does that contemplate contribution from AMP-002? And as a follow-up to the question on revenues for the year, how many launches or even if you can say this, which launches are you actually contemplating before the end of the year? So that's number one. And then number two, why don't we get some 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 to the extent that you ultimately get approval next year. Thanks.
Bill Peters: Yeah. So for the revenue side, it does include, I think we weight the expectations of these products as we take a look at them, and so we risk adjust them. And it includes two launches on a risk-adjusted basis. So those include AMP-002 and AMP-015. So right now, those are the only two that we believe could be approved this year. But could we get to that flat in other ways? We could, depending on competition on other products and also just the Baqsimi growth if that exceeds our expectations as well. So that answers that question.
And AMP-007, as far as the contribution, we don't know of any other file or anybody else working on it or close to it. We haven't seen anything about it. So as far as we know, we could be the first approval on that. And if we're the first approval, we think that this has the potential to be a significant market opportunity, the biggest in the near term.
David Amsellem: Okay. Thank you.
Operator: Thank you. There are no further questions at this time. I'd like to hand the floor back over to management for any closing comments.
Bill Peters: Okay. Well, thank you, Paul, and thank you, everyone, for joining us today. We look forward to sharing more updates in the near future. Have a great day.
Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.