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Amphastar Pharmaceuticals reported strong financial results for the second quarter of 2025, surpassing analysts’ expectations with an earnings per share (EPS) of 85 cents against a forecast of 74 cents, marking a 14.86% surprise. The company also reported revenues of $174.4 million, slightly above the forecast of $173.95 million. Following the earnings announcement, Amphastar’s stock rose by 3.84% in after-hours trading, closing at $21.62. According to InvestingPro analysis, the stock appears undervalued, with a P/E ratio of 7.31 and strong financial health metrics. The company maintains a robust free cash flow yield of 15%, suggesting significant value potential.
Key Takeaways
- Amphastar’s Q2 2025 EPS of 85 cents exceeded forecasts by 14.86%.
- Revenue reached $174.4 million, a slight increase over expectations.
- Stock price increased by 3.84% in after-hours trading.
- Baqsimi sales grew by 21% year-over-year.
- The company announced a new $50 million stock buyback program.
Company Performance
Amphastar Pharmaceuticals demonstrated resilience in Q2 2025 despite a 4% year-over-year decline in net revenues. The company maintained strong performance in its Baqsimi product line, which saw a 21% sales increase. However, other products like Glucagon injection and Epinephrine experienced declines, reflecting shifting market dynamics and increased competition.
Financial Highlights
- Revenue: $174.4 million, down 4% year-over-year
- Earnings per share: 85 cents, up from 64 cents GAAP per diluted share
- Baqsimi sales: 21% year-over-year growth
- Primatene Mist sales: $22.9 million, steady performance
- Glucagon injection sales: Decreased 25% to $20.6 million
Earnings vs. Forecast
Amphastar’s Q2 2025 EPS of 85 cents beat the forecast of 74 cents, resulting in a 14.86% surprise. Revenue slightly exceeded expectations at $174.4 million compared to the forecast of $173.95 million. This positive earnings surprise is consistent with the company’s historical performance of surpassing market predictions.
Market Reaction
Following the earnings announcement, Amphastar’s stock price rose by 3.84% in after-hours trading, closing at $21.62. This movement reflects investor confidence in the company’s ability to exceed earnings expectations and execute its strategic initiatives. Currently trading near its 52-week low of $20.39, the stock presents potential opportunity, with analysts setting price targets between $25 and $38. Management’s aggressive share buyback program further signals confidence in the company’s value proposition. For detailed valuation analysis and comprehensive research reports, visit InvestingPro.
Outlook & Guidance
Amphastar maintains its guidance for flat sales year-over-year, with expectations of high single-digit unit growth for Baqsimi. The company anticipates a 3% price increase in the U.S. market. Potential approvals for AMP-002 and AMP-015 in 2025 could further bolster future performance.
Executive Commentary
Dan Dishner, SVP of Corporate Communications, emphasized the company’s strategic positioning, stating, "We are exceptionally well positioned to benefit from this shift." He also highlighted the company’s commitment to advancing regulatory programs, noting, "We continue to advance several additional key regulatory programs."
Risks and Challenges
- Increased competition in legacy product lines could impact market share.
- The glucagon market is expected to decline, affecting sales.
- Macroeconomic pressures may influence consumer spending on pharmaceuticals.
- Regulatory hurdles in product approvals could delay market entry.
- Supply chain disruptions may impact manufacturing and distribution.
Q&A
During the earnings call, analysts inquired about the company’s flat sales guidance and its implications. Executives expressed optimism regarding the FDA approval of AMP-002 and addressed concerns about the crowded GLP-1 market, which is expected to contribute modestly to future growth.
Full transcript - Amphastar P (AMPH) Q2 2025:
Paul, Conference Operator: Please note that certain statements made during this call regarding matters that are not historical facts, including, but not limited to management’s outlook or predictions for future periods, are forward looking statements. These statements are based solely on information that is now available to us.
We encourage you to review the session entitled Forward Looking Statements in the press release issued today and the presentation on the company’s website. Also, please refer to our SEC filings, which can be found on our website and the SEC’s website for a discussion of numerous factors that may impact our future performance. We will also discuss certain non GAAP measures. Important information on our use of these measures and reconciliations to U. S.
GAAP may be found in our earnings release. Please note this conference is being recorded. Our speakers today are Mr. Bill Peters, CFO Mr. Dan Dishner, Senior Vice President of Corporate Communications and Mr.
Tony Morris, Executive Vice President of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dishen, Senior Vice President of Corporate Communications. Dan, you may begin.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: Thank you, Paul. Good afternoon, and thank you for joining our second quarter twenty twenty five earnings call. I’m pleased to share that Amphastar delivered a solid performance in the 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 174,400,000.0 and a GAAP net income of 31,000,000 or 64¢ per diluted share. On a non GAAP basis, adjusted net income was 40,900,000.0 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. Total revenue for Vaximi 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 from 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 US manufacturing footprint is essential to mitigate risks associated with international supply chain. This investment not only strengthens our operational resilience, but also supports the advancement of our r and d pipeline. Our vertical integrated infrastructure backed by US 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, a m p zero zero two, 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 seven inhalation filing, we have received additional feedback from the FDA and now expect a GDUFA date in the 2026. We’re pleased to report that our teriparatide product, AMP-fifteen, 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-one ANDA or AMP zero one eight, we are on track to respond to the the complete response letter in the second half of this year. Additionally, we’re incredibly excited about the long term potential of our insulin part BLA, a m p zero zero four, 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 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 in this evolving market. We believe the long term implications of this program could be transformative, both for Amphastar 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’s 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 and 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 and D as a critical engine of long term value creation that enhances the 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’s 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 US 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’s 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. Thank you, Dan.
Revenues for the second quarter decreased 4% to $174,400,000 from January 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 Vaximi, which recorded its highest quarterly sales since the product’s acquisition. Vaximi sales grew to $4,046,700,000.0 dollars compared to the prior year period of $30,900,000 as Amphastar assumed full commercialization responsibilities globally at the 2025. Keep in mind that during the same period last year, Lilly had Baqsimi sales of $7,600,000. Therefore, total Baqsimi sales for the period grew by 21%.
Primatene Mist sales held steady at $22,900,000 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 $20,600,000 from $27,400,000, primarily due to increased competition and a move to ready to use glucagon products such as vaccine. Epinephrine sales decreased 42% to $16,200,000 from $27,900,000 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 $15,000,000 from $12,800,000, 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 $53,100,000 from $57,600,000, 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 $87,900,000 from $87,200,000, with gross margins declining to 49.6% from 52.2% in the previous year’s period. That 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 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 multi dose vial product negatively impacts margins.
Because of these trends, management focused on cost control efforts across the business, which mitigated the impact of these pricing declines. Selling, distribution and marketing expenses increased 14% to $10,200,000 from $9,000,000 in the previous year’s period due to the sales and marketing efforts related to Vaxmi, including the co promotion agreement with MannKind, as well as sales efforts related to Primatene Mist. General and administrative spending increased 5% to $14,000,000 from $13,300,000, primarily due to increased personnel related expenses. Research and development expenditures increased 14% to $20,100,000 from $17,700,000 due to an increase in material and supply expenses for our inhalation pipeline products and expenses related to our proprietary projects. Nonoperating expenses decreased to $2,800,000 from $5,000,000 due to a decrease in interest expense and currency fluctuations.
Net income decreased to $31,000,000 or 64¢ per share in the second quarter from $37,900,000 or 73¢ per share in the 2024. Adjusted net income decreased to $40,900,000 or 85¢ per share compared to an adjusted net income of $48,700,000 or 94¢ per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long lived assets, and certain onetime events. In the second quarter, we had cash flow from operations of approximately 35,600,000 We used a portion of our cash on hand to buy back $39,200,000 worth of shares. These purchases finished our previous authorization, so our board of directors approved an additional $50,000,000 stock buyback program.
I’ll now turn the call back over to Dan. Thank you, Bill, for the updates. We’ll now turn the call over to questions. Operator?
Paul, Conference Operator: We’ll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. Our first question is from Serge Belanger with Needham and Company.
Serge Belanger, Analyst, Needham and Company: Hi. Good afternoon. Thanks for taking my questions. I guess the first one for for Bill. I think in the past, you’ve indicated you expected to be the top line to be flat year over year.
Just curious if those expectations have changed now that we’re we’re halfway through the year. And secondly, maybe if you can highlight what we should expect from vaccine over the second half of the year, and are you starting to see some of the the MannKind collaboration impacts on on those sales? Thanks.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: Sure. Yeah. We we still are guiding to flat sales year over year, and we still anticipate that two products could be approved and contribute to that to that level. So we’re still comfortable with that that flat sales. And secondly, Baqsimi, you know, we’re still consistently saying that we 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 the second quarter.
Serge Belanger, Analyst, Needham and Company: Then I guess, terms of potential approvals, a and p o o two, I hate to ask again, but has your level of confidence increased or or or changed at all from the last quarterly update?
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: 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.
Serge Belanger, Analyst, Needham and Company: Okay. Thank you.
Paul, Conference Operator: Our next question is from Serena Chen with Wells Fargo.
Serena Chen, Analyst, Wells Fargo: I wanted to ask about AMP 18, the GLP-one. I saw that the IQVIA trailing twelve month sales, that used to be 1,100,000,000.0 at the start of the year, and now that’s moved down to 400,000,000. So I was wondering how you’re thinking about this opportunity, especially with the recent CRL delaying approval time lines. Thank you.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: Yeah. This is one where we think it’s gonna be a very crowded generic market, so we expect it to be a relatively small contributor to our sales.
Bhavan Patel, Analyst, Bank of America: Okay. Helpful.
Paul, Conference Operator: Our next question is from Jason Gerberry with Bank of America.
Bhavan Patel, Analyst, Bank of America: Hey, guys. This is Bhavan 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, you know, the the competitive environment. Has pricing eroded significantly, or is this primarily a market share issue? Just the latest there. Thank you.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: Sure. So the expected margin trajectory, we do expect that the new products that we have will either be at or or above the 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 the new approval launches. And as far as Epi prefilled syringes goes, that that competition is really baked into the current quarter numbers that we have there.
So, you know, the pricing and the unit drop have have both happened for that, we believe. And it’s been both. It’s been both pricing and unit drops that have contributed to this overall sales decline. Thank you.
Paul, Conference Operator: Our next question is from Ikedarina Nayakova with JPMorgan.
Ikedarina Nayakova, Analyst, JPMorgan: 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 the manufacturing capacity.
Could you talk about, you know, what motivated the decision? I’m assuming, you know, some of that was probably tariffs. And just thoughts on, you know, how you could leverage this capacity over time. Thank you.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: Yeah. I’ll take I’ll take the first one. And and, no, glucagon is not at a a run rate yet. So while we did have the 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 this.
So we expect to see glucagon drop on a go forward basis. And 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 vaccine. 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 is right for us to do that at this time. But it is is designed more to support our pipeline.
All the 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.
Ikedarina Nayakova, Analyst, JPMorgan: Thank you.
Paul, Conference Operator: Our next question is from David Amsellem with Piper Sandler.
David Amsellem, Analyst, Piper Sandler: Thanks. Wanted to circle back on the informal revenue guide. Does that contemplate contribution from AMP two? And as a follow-up to to the question on on revenues for for the year, how many launches or even if you can say this, how which launches are you 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 a and p zero zero seven, 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.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: Yeah. So for the revenue side, it does include you know, we we 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 risk on a risk adjusted basis. So and those include zero zero two and zero one five. 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 the vaccine e growth if that exceeds our expectations as well. So that answers that question. And on o o seven, as far as the contribution, we don’t know of any other filer or 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 significant market opportunity, potentially the biggest in the near term.
David Amsellem, Analyst, Piper Sandler: Okay. Thank you.
Paul, Conference 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.
Dan Dishner, Senior Vice President of Corporate Communications, Amphastar Pharmaceuticals: 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.
Paul, Conference Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.
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