Amphastar (AMPH) Q1 2026 Earnings TranscriptMay 8, 2026
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DATE
Thursday, May 7, 2026 at 5 p.m. ET
CALL PARTICIPANTS
Chief Executive Officer — Dan Dischner Chief Financial Officer & Executive Vice President, Finance — William J. Peters Senior Vice President, Regulatory & Clinical Affairs — Tony Marrs
Full Conference Call Transcript
Dan Dischner: Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar Pharmaceuticals, Inc.'s first quarter 2026 earnings call. Before we begin, I would like to recognize the continued dedication of our employees across Amphastar Pharmaceuticals, Inc. Their commitment to ensuring reliable access to essential medicines remains central to who we are and how we operate. Our first quarter performance demonstrated the continued strength and balance of our underlying business amid a rapidly evolving market landscape, with solid commercial execution across our branded and differentiated portfolio, alongside meaningful progress in our pipeline.
We are actively managing near-term pricing and competitive pressures across certain legacy products with discipline and focus, and we remain confident that the strategic investments we are making today in our branded portfolio, biosimilars, complex generic pipeline, and manufacturing infrastructure are building the foundation for durable long-term growth. We reported net revenues of approximately 1.712 billion dollars for the first quarter, reflecting a return to growth, driven primarily by contributions from recent product launches, while overall performance across the base business remained stable. We saw continued strength in key areas, partially offset by pricing pressure, product mix shift, and increased competition—trends that are broadly consistent with the current market environment.
We continue to deploy capital towards initiatives that we believe will drive long-term growth, and while the full benefits of these investments are not yet visible in our financials, we remain confident in the value they will create. From a strategic perspective, our focus remains centered on three key priorities: one, strengthening the resilience of our business; two, expanding and optimizing our branded and differentiated portfolio; and three, advancing our pipeline of complex and proprietary products. First, strengthening the resilience of our core business. We continue to see variability in pricing and competitive intensity across certain legacy products. We remain disciplined in managing costs and focusing on operational efficiency, ensuring supply reliability, and maintaining our position in essential product categories.
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This stability provides the foundation that supports both our near-term performance and our ability to invest in future growth. Second, expanding and optimizing our branded and differentiated portfolio. Products such as Vaximi and Primatene Mist remain central to our long-term growth strategy and continue to demonstrate underlying demand in the first quarter. Vaximi generated approximately 32 million dollars in revenue this quarter. While reported revenue was impacted by higher rebates, channel mix, and increased utilization of government programs, these dynamics did not reflect the underlying demand. It is also important to note that rebate pressure across these channels is an industry-wide dynamic and not unique to our portfolio.
Demand trends remain positive, with U.S. sales unit volumes increasing approximately 8% year over year. We are actively addressing these factors through investments in rebate management, contracting strategy, and program optimization. We expect these pressures to moderate over time and remain confident in Vaximi’s long-term growth trajectories. Primatene Mist generated approximately 30 million dollars in revenue in the quarter, with performance driven by sustained consumer demand, continued commercial investment, and brand strength. The brand maintained strong momentum, with store-level sales increasing approximately 6.5% year over year, reflecting incremental consumer adoption and an ongoing impact of our marketing program. In addition, we recently received FDA approval for AMP007, our ipratropium bromide inhalation product, and successfully launched the product in April.
The launch is progressing as planned and reinforces our ability across development, regulatory approval, manufacturing, and commercialization in technically complex product categories. Importantly, our product is currently the first and only generic ipratropium inhaled product on the market, which we believe positions us for a meaningful near-term commercial opportunity. Third, advancing our pipeline of complex and proprietary products. We are continuing to expand our efforts towards higher-value opportunities, including proprietary and biosimilar programs, which now represent a significant and growing portion of our pipeline. Our strategy is built on a foundation that we have developed over many years, combining regulatory expertise, vertically integrated manufacturing, and commercial capabilities to efficiently advance complex products from development through commercialization.
This integrated platform allows us to move efficiently while maintaining control over quality, timeline, and cost. We continue to make steady progress across key programs, including our insulin aspart biosimilar and GLP-1 ANDA program, both of which remain on track for planned commercial launches in 2027. At the same time, we continue to develop our next-generation proprietary assets, including programs in oncology and immunology. While these programs remain in early stages, we are encouraged by the progress to date and are focused on advancing them through IND submissions into clinical development. Together, these efforts reflect our broader objectives of expanding into higher-value therapeutic areas over time. Our continued investment in these programs is underpinned by a strong financial position.
The cash flow generated by our commercial portfolio supports ongoing internal R&D while allowing flexibility in how we allocate capital. This enables us to advance our proprietary programs in a disciplined manner without relying on external financing or partnership. We also continue to actively evaluate targeted acquisitions and licensing opportunities that align with our existing capabilities, and our balance sheet provides the capacity to pursue these in a disciplined and selective manner. Looking ahead, we expect the operating environment to remain dynamic, particularly regarding pricing and competitive pressures. Against this backdrop, we are focused on disciplined execution while continuing to invest in the capabilities that underpin our long-term strategy.
We believe this balanced approach, grounded in diversification, operational rigor, and sustained investment in our proprietary pipeline, positions us to navigate near-term variability and support durable long-term growth. Over the next 12 to 18 months, we expect continued contribution from our commercial portfolio, supported by Vaxmi, Primatene Mist, and the recent launch of our ipratropium bromide. In parallel, we are focused on executing the next phase of our pipeline strategy, with several important regulatory and development milestones ahead. This includes progress across our biosimilar program, as well as our continued advancement of our emerging proprietary assets, which we believe are central to the long-term growth profile.
We have updated the corporate presentation on our website with timelines for our proprietary candidates. I will now turn the call over to William J. Peters, our CFO and Executive Vice President of Finance, for a more detailed financial review of the first quarter. Thank you, and good afternoon, everyone.
William J. Peters: In my comments today, I will discuss the first quarter results and then update some of our assumptions for 2026. Revenues for the first quarter increased to 171.2 million dollars from 170.5 million dollars in the previous year’s period. Vaccine revenue decreased 15% to 32.4 million dollars compared to 38 million dollars in the prior-year period as a result of lower average selling prices, which were partially offset by an 8% increase in units sold. The lower average selling price of Vaxini was driven by higher rebate and higher 340B pharmacy discounts, some of which may have been duplicated.
Primatene Mist sales grew to 29.8 million dollars in the first quarter, up 2% from 29.1 million dollars in the first quarter of last year. Epinephrine sales increased 3% to 19.2 million dollars from 18.6 million dollars, as increased demand for our prefilled syringe product was partially offset by increased competition for our multidose vial product. Glucagon injection sales declined 56% to 9.2 million dollars from 20.8 million dollars due to increased competition and a shift to ready-to-use products.
Other finished pharmaceutical product sales increased 34% to 67.1 million dollars from 50 million dollars, primarily due to recently launched products, including an increase in albuterol sales of 2.8 million dollars, iron sucrose sales of 1.4 million dollars, and teriparatide sales of 2.2 million dollars, which we launched in August 2024, August 2025, and December 2025, respectively. Dextrose sales also increased due to shortages from other suppliers, while cyclinodion sales declined due to increased competition. Cost of revenues increased to 100.8 million dollars from 85.3 million dollars. Gross margins declined to 71% of revenues in 2026 from 50% in the previous year.
The primary drivers of the change were a lower average selling price for Baqsimi, as well as lower sales of glucagon, pythonodion, and epinephrine multidose vials, which are higher-margin products. Additionally, increased costs at our Amphastar Pharmaceuticals, Inc. facility negatively impacted margins. Selling, distribution, and marketing expenses were relatively unchanged at 11.9 million dollars. General and administrative spending increased 13% to 18 million dollars from 16 million dollars, driven by higher legal expenses, salary and personnel-related expenses, and expenses related to the implementation of our new ERP system.
Research and development expenditures increased 33% to 26.7 million dollars from 20.1 million dollars due to the 2 million dollar upfront payment made to in-license a new corticotropin product and spending on our insulin inhalation and proprietary product pipeline. Our nonoperating expense of 3.6 million dollars compares to a nonoperating expense last year of 6.4 million dollars, primarily due to foreign currency fluctuations as well as mark-to-market adjustments related to our interest rate swap contracts in the quarter. Net income decreased to 6.4 million dollars, or 0.14 dollars per share, in the first quarter, from 25.3 million dollars, or 0.51 dollars per share, in 2025.
Adjusted net income decreased to 19.5 million dollars, or 0.42 dollars per share, compared to an adjusted net income of 36.9 million dollars, or 0.74 dollars per share, in the first quarter of last year. Adjusted earnings exclude amortization, equity compensation, and one-time events. In the first quarter, we had cash flow from operations of approximately 47.8 million dollars. During the quarter, we accelerated our share repurchase program and bought back 29.5 million dollars worth of shares, which represents about 3% of our share count. Before I turn the call back over to Dan, I would like to update some of our guidance for 2026.
We now believe that Vaxena revenue growth will be flat to up low single-digit percentages compared to last year due to the previously mentioned pricing pressures. In response to these pricing dynamics, we have taken additional steps to strengthen the durability of this business, including engaging a third party to support data-driven identification, validation, and resolution of potential 340B duplicate discount. Additionally, we have implemented a 3% list price increase on Vaxini as of May 1. Importantly, even with this revised outlook for Vaxini, we are maintaining our overall corporate sales guidance of mid-single-digit to high-single-digit unit growth.
This reflects the strength of our growth portfolio, including ipratropium bromide inhalation, which we launched in April and currently does not face any generic competitors. I will now turn the call back over to Dan.
Dan Dischner: Thanks, Bill. In summary, our first quarter performance reflects our resilience and ability to execute in a dynamic market environment. Growth was supported by new product launches and stable performance across our base portfolio, while actively managing pricing and competitive pressures. Daxchemia and Primatene Mist continue to demonstrate solid underlying demand, and we are taking targeted actions to improve net pricing and optimize performance over time. The recent approval and launch of our ipratropium bromide inhalation product adds an important near-term growth driver. We remain on track with late-stage programs, including our insulin apt apart biosimilar and our GLP-1 ANDA, both expected in 2027, while continuing to advance our early-stage pipeline.
With a strong financial position, we are focused on executing against our strategy, navigating near-term variability, and positioning the business for sustained long-term growth. With that, we will now take your questions. Operator?
Operator: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press 1 on your telephone keypad. Please hold for a moment while we poll for questions. Our first question is from Serge Belanger with Needham and Company.
Serge D. Belanger: Couple of questions on Baqsimi. Obviously, there were some headwinds in the first quarter. How much of it was seasonality peculiar to the first quarter, and how much of it will continue to linger into the coming quarters? Specifically on price, can you talk about the price decrease and where you think you can get it to with the activities you will be undertaking? And last one on Baqsimi: in the past, you had talked about discontinuing commercialization in some international markets. Has that started to occur, and what impact would that have on sales levels? Thank you.
William J. Peters: The pricing issue that we have been encountering appears to be driven by multiple things. One, there are some increased rebates, but we also potentially believe there are some duplicate rebates, which seems to be a 340B pharmacy issue. We have engaged an outside firm to validate these claims before they are paid. We believe that, in doing that, we will stop that practice. We just engaged that firm, and that process began at the beginning of May. That trend continues into April, but we hope that changes in May. Additionally, the 3% price increase that we took is effective May 1.
We believe that we could get at least partway back to the pricing where we were last year, or most of the way back by later this year, but part of the way back this quarter. Seasonality did not have anything to do with that. As far as the discontinuation from certain international markets, we have talked about withdrawing from a handful of markets. We have given notice in some countries that require a lengthy notice period, and we also have some inventory in other countries that we plan to discontinue.
The discontinuation would begin in July, but it is not going to be all at once because some countries will have inventory that might extend into August or September, and others with a notice-period requirement will keep selling probably through the end of this year and into the first quarter of next year. It is not going to be a falloff. Remember, we have characterized this as 80% of our sales were in the United States last year and only 20% were foreign. We are only going to drop out of a handful of countries out of the 20-something foreign countries. We are going to remain in most of the foreign countries, including all of the top-selling markets.
So it is not going to be a significant decrease in the third quarter. Also, the other way to think about it is that last year U.S. sales were 80%. This year, they are probably going to be closer to 85%.
Operator: Thank you. Our next question is from Dennis Ding.
Analyst: Hi. This is Cynthia on for Dennis. Thanks for taking our questions. We just had two on the pipeline. First, on the synthetic corticotropin, I see in your slides that you are thinking to go into Phase 1 in 2027. Have you met with the FDA and had regulatory alignment there, and whether there could be an accelerated path? And second, any updates on 004, the insulin aspart? I think the prior BLA/STA was planned for Q4 2026. Any additional color there? Thank you.
William J. Peters: Okay. I will take the first one, the update on 004. It is still in progress, and nothing has changed. We are still planning on commercializing it in 2027. On your other question regarding—yeah, Tony, could you take that one?
Tony Marrs: Sure. For 110, we have not met with the agency. We think the possibility is there, among these pipeline products, for expedited approvals, but we have not met with the agency and we do not have alignment with them on that.
Operator: Okay. Thank you. Our next question is from Ekaterina Knyazkova with JPMorgan.
Ekaterina V. Knyazkova: Thank you so much. Another one on AMP004. Can you remind us how you are thinking about the size of that opportunity and how quickly it could ramp in 2027? And second, on glucagon, is the Q1 number a good tail end for the product, or would you expect sequential erosion from that Q1 number? Thank you.
William J. Peters: For the first one, this is a product that still has over 1 billion dollars in sales, so we think that it is going to be a relatively large product for us and a meaningful product for us when we launch it. We do think it will take a little time to get sales, and it will also depend on whether we have interchangeability or not, which we would like to get right away. There are going to be a couple of different drivers, and we should have a little more idea of that timing and pathway next year.
As far as glucagon, no, we have not reached the bottom of that yet, but the rate of decline is slowing significantly. It will decline from here, but not at the same rate that it has been declining.
Operator: Our next question is from David Amsellem with Piper Sandler.
David A. Amsellem: Thanks for taking my question. This is Naki on for David. First, on Primatene Mist, how should we think about generic competition, and do you have any updates regarding life-cycle management? Second, how should we think about revenue contribution from 007 and the extent of the opportunity here? Thank you.
Dan Dischner: With Primatene Mist, we have not been notified of, nor have visibility into, whether there is a generic in place. We have always taken the position that we believe it would be very difficult to genericize this product. Primatene Mist has 60 years of brand recognition. The product is over the counter. It would be difficult from a regulatory perspective. Because it is retail and over the counter, it has different market dynamics than what you would see with a typical generic. We have no visibility outside of that. As far as our next generation, we have in our pipeline a green version that we are working on.
We have one patent already and another one pending, and we continue to advance that through development. On 007, we have not given a sales forecast. However, we have said that it would be our biggest growth driver this year, and we had a couple of different scenarios. We said that even when we thought that there might be a generic competitor on the market with us. As of today, there is not, and we launched this in mid-April. Right now, we are almost a month into it without a generic competitor.
That is one of the reasons why we are able to maintain our mid-single-digit to high-single-digit sales growth guidance for the year, as we believe that this product will outpace our original assumptions.
Operator: Great. Thank you. There are no further questions at this time. I would like to hand the floor back over to management for any closing remarks.
Dan Dischner: Thank you, Paul. Thank you all for your questions and your continued interest in Amphastar Pharmaceuticals, Inc. We remain focused on executing against our strategy and advancing the initiatives we discussed today. We appreciate your continued support and look forward to updating you on our progress next quarter. Have a great day.
Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.
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Amphastar (AMPH) Q1 2026 Earnings Transcript was originally published by The Motley Fool
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Amphastar Pharmaceuticals Q1 Earnings Call HighlightsMay 7, 2026
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Key Points
Interested in Amphastar Pharmaceuticals, Inc.? Here are five stocks we like better. Q1 revenue was roughly flat at about $171.2 million, but profitability fell sharply—net income dropped to $6.4 million (from $25.3 million) and adjusted net income fell to $19.5 million—while the company repurchased $29.5 million of shares. BAQSIMI revenue fell ~15% to $32.4 million due to lower average selling prices driven by higher rebates and 340B discounts despite an ~8% rise in units; Amphastar is auditing potential duplicate 340B rebates, raised BAQSIMI list prices 3% effective May 1, and will gradually exit a few international markets. New-product momentum is driving outlook: AMP-007 (ipratropium inhalation) launched in April as the first generic on the market and is expected to be the biggest growth driver this year, while insulin-aspart and GLP‑1 biosimilar programs remain on track for 2027 commercialization.
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Amphastar Pharmaceuticals (NASDAQ:AMPH) reported first-quarter 2026 net revenues of approximately $171.2 million, up slightly from $170.5 million in the prior-year period, as recently launched products helped offset pricing pressure and increased competition across parts of its legacy portfolio.
On the company’s earnings call, Senior Vice President of Corporate Communications Dan Dischner said the quarter reflected “continued strength and balance” in Amphastar’s underlying business despite a “rapidly evolving market landscape.” Dischner added that Amphastar is “actively managing near-term pricing and competitive pressures across certain legacy products” while continuing to invest in its branded portfolio, biosimilars, complex generics, and manufacturing infrastructure.
Branded products: BAQSIMI pricing pressure; Primatene MIST steady
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BAQSIMI generated about $32 million in quarterly revenue, which Dischner said was impacted by “higher rebates, channel mix, and increased utilization of government programs,” dynamics he characterized as industry-wide. He noted that underlying demand remained positive, with U.S. unit volumes increasing approximately 8% year-over-year.
CFO Bill Peters provided additional detail, stating BAQSIMI revenue decreased 15% to $32.4 million from $38.4 million a year ago due to lower average selling prices, partially offset by the 8% increase in units sold. Peters attributed the lower average selling price to “higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated.”
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During the Q&A, management said seasonality did not drive BAQSIMI’s pricing issues. Peters said the company believes “some duplicate rebates” may be tied to 340B pharmacy activity and that Amphastar engaged an outside firm to validate claims before they are paid, with the process beginning in early May. He also said the company implemented a 3% list price increase for BAQSIMI effective May 1.
“We believe that we could get at least partway back to the pricing where we were last year, or most of the way back by later this year,” Peters said.
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Management also discussed plans to discontinue BAQSIMI commercialization in a handful of international markets, noting the process will be gradual due to country-specific notice periods and existing inventory. Peters said the discontinuation would begin in July, but in some markets sales could continue “through the end of this year and into the first quarter of next year.” He emphasized that Amphastar expects to remain in most international markets, including top-selling ones, and does not anticipate a significant revenue drop from the change.
Primatene MIST posted revenue of approximately $30 million in the quarter. Dischner said performance was supported by sustained consumer demand and marketing, with store-level sales rising about 6.5% year-over-year. Peters reported Primatene MIST sales of $29.8 million, up 2% from $29.1 million in the prior-year quarter.
Asked about potential generic competition for Primatene MIST, management said it has not been notified of a generic entrant and has “no visibility” into whether one is in development. The company reiterated its view that it would be difficult to genericize the product, citing regulatory and over-the-counter retail dynamics. Management also referenced ongoing development of a “green version” and said Amphastar has one patent issued and another pending.
New product momentum and legacy product pressure
Dischner highlighted FDA approval and an April launch for AMP-007, Amphastar’s ipratropium bromide inhalation product. He said the product is currently “the first and only generic ipratropium inhalation product on the market,” which the company believes creates a meaningful near-term opportunity.
In response to an analyst question, management declined to provide a sales forecast for AMP-007 but said it expects the launch to be its “biggest growth driver this year.” Management noted that, as of the call, the product had been on the market for nearly a month without a generic competitor, and said this supported Amphastar’s ability to maintain its broader sales growth outlook for 2026.
Peters detailed performance across other products:
Epinephrine sales rose 3% to $19.2 million, with increased demand for the prefilled syringe partially offset by increased competition in multidose vials. Glucagon injection sales fell 56% to $9.2 million due to increased competition and a shift toward ready-to-use products. Other finished pharmaceutical product sales increased 34% to $67.1 million, driven primarily by recently launched products.
Peters said the increase in “other finished pharmaceutical product sales” included higher albuterol sales of $2.8 million, iron sucrose sales of $1.4 million, and teriparatide sales of $2.2 million, with those products launched in August 2024, August 2025, and December 2025, respectively. He added that dextrose sales rose due to shortages from other suppliers, while phytonadione sales declined due to increased competition.
On glucagon, management said it does not believe the product has reached a bottom. Peters said the decline should continue but at a slower rate than in prior periods.
Margins, earnings, and capital allocation
Amphastar reported cost of revenues of $100.8 million, up from $85.3 million. Peters said gross margins declined to 71% of revenues in the first quarter of 2026 from 50% in the prior-year period, citing lower BAQSIMI net pricing, lower sales of certain higher-margin products (glucagon, phytonadione, and epinephrine multidose vials), and increased costs at the company’s Amphastar facility.
Selling, distribution, and marketing expense was $11.9 million, roughly unchanged year-over-year. General and administrative expenses increased 13% to $18.0 million, driven by higher legal costs, salary and personnel expenses, and costs associated with implementing a new ERP system.
Research and development expense increased 33% to $26.7 million. Peters said the increase included a $2 million upfront payment related to in-licensing a new corticotropin product, as well as spending on Amphastar’s insulin, inhalation, and proprietary pipeline programs.
Net income declined to $6.4 million, or $0.14 per share, compared to $25.3 million, or $0.51 per share, a year ago. Adjusted net income was $19.5 million, or $0.42 per share, down from adjusted net income of $36.9 million, or $0.74 per share, in the first quarter of 2025. Peters said adjusted results exclude amortization, equity compensation, and one-time events.
Amphastar generated approximately $47.8 million in operating cash flow during the quarter. Peters said the company accelerated its share repurchase program and bought back $29.5 million worth of shares, representing about 3% of its share count.
Guidance updates and pipeline timeline
Peters said the company updated its 2026 outlook for BAQSIMI, now expecting revenue growth to be “flat to up low single-digit percentages” versus last year due to pricing pressures. He said Amphastar is maintaining overall corporate sales guidance of “mid-single digit to high single-digit unit growth,” citing strength across the broader portfolio, including the newly launched ipratropium bromide inhalation product, which “currently does not face any generic competitors.”
On the pipeline, Dischner said Amphastar remains on track with its insulin aspart biosimilar and its GLP-1 ANDA program, both planned for commercial launches in 2027. Asked about AMP-004 (insulin aspart), management said the program remains in progress and “nothing’s changed,” reiterating the 2027 commercialization plan. Management also discussed a synthetic corticotropin program (referred to as AMP-110 in the Q&A), with Executive Vice President of Regulatory Affairs and Clinical Operations Tony Marrs stating the company has not yet met with the FDA for that program and does not have alignment on an expedited approval pathway, though it believes expedited approvals may be possible for certain pipeline products.
Looking ahead, Dischner said Amphastar expects continued contributions over the next 12 to 18 months from BAQSIMI, Primatene MIST, and the ipratropium bromide launch, while working toward upcoming regulatory and development milestones across its biosimilar and proprietary programs.
About Amphastar Pharmaceuticals (NASDAQ:AMPH)
Amphastar Pharmaceuticals, Inc is a specialty pharmaceutical company headquartered in Rancho Cucamonga, California. Founded in 2004, Amphastar focuses on the development, manufacturing and commercialization of injectable and inhalation products. The company's manufacturing facilities in California produce both generic and proprietary formulations designed to address urgent and chronic medical conditions.
Amphastar's portfolio includes a range of injectable generics such as epinephrine, naloxone and lidocaine, serving hospital, emergency medical and retail pharmacy channels.
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