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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

TAKEAWAYS

  • Net Revenue -- $171.2 million, rising slightly from $170.5 million in the prior-year period and supported by new product launches and stable base business performance.
  • Vaxini Revenue -- $32.4 million, a 15% decline despite an 8% increase in units sold, primarily reflecting lower average selling prices resulting from rebate and 340B pharmacy discounts.
  • Primatene Mist Sales -- $29.8 million, climbing 2% with continued consumer demand and a 6.5% increase in store-level sales volumes.
  • Epinephrine Sales -- $19.2 million, up 3%, driven by growth in prefilled syringe demand but partially offset by heightened competition in multidose vial products.
  • Glucagon Injection Sales -- $9.2 million, contracting 56% due to increased competition and a shift toward ready-to-use formats.
  • Other Finished Pharmaceutical Products -- $67.1 million, up 34%, led by contributions from recent launches such as albuterol, iron sucrose, and teriparatide, plus increased dextrose sales due to supply shortages elsewhere; this was partially offset by declining cyclinodion revenue.
  • Gross Margin -- 71%, up from 50% in the previous year, despite cost increases of $100.8 million versus $85.3 million previously; the improvement was mainly driven by a higher revenue base, with margin pressure from lower prices and product mix shifts.
  • R&D Expenditure -- $26.7 million, advancing 33% due to a $2 million upfront payment for a new corticotropin program and increased investment in insulin inhalation and proprietary pipeline projects.
  • Net Income -- $6.4 million, or $0.14 per share, dropping from $25.3 million, or $0.51 per share, as margin and operating cost factors offset underlying revenue gains.
  • Adjusted Net Income -- $19.5 million, or $0.42 per share, declining from $36.9 million, or $0.74 per share, with adjustments for noncash and one-time items.
  • Operating Cash Flow -- $47.8 million, providing liquidity to support internal R&D funding without need for external capital.
  • Share Repurchase -- $29.5 million worth of repurchases completed this quarter, reducing shares outstanding by approximately 3%.
  • Guidance: Vaxini Revenue -- Now expected to be flat to low single-digit percentage growth, revised downward due to ongoing pricing pressures; a 3% list price increase was implemented May 1.
  • Unit Sales Growth Guidance -- Maintained at mid-single-digit to high-single-digit percentage growth, reflecting optimism for the newly launched ipratropium bromide product, which does not currently face generic competition.
  • Ipratropium Bromide Inhalation (AMP007) -- Approved by FDA and launched in April; currently the sole generic ipratropium inhaled product with management citing expectations as a major 2026 growth driver.
  • Pipeline Timing -- Insulin aspart biosimilar (“004”) and GLP-1 ANDA remain on track for commercial launch in 2027, with no change to regulatory milestones.
  • International Market Withdrawal (Vaxini) -- Gradual exit from select smaller international markets will begin in July, with U.S. sales mix projected to rise from 80% to approximately 85%.

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RISKS

  • Revenue from Vaxini was pressured by lower average selling prices linked to higher rebates and 340B discounts; these pricing headwinds are expected to persist in the near term according to management commentary.
  • Glucagon injection sales are expected to decline further beyond the quarter, though the "rate of decline is slowing significantly."
  • General and administrative expenses advanced 13% due to increased legal, personnel, and ERP implementation costs.

SUMMARY

Amphastar Pharmaceuticals (AMPH +0.54%) delivered quarterly revenue growth from new launches and stable core products while facing substantial pricing and competitive pressure on several legacy brands. Margin contraction occurred despite rising costs, with sharply reduced net income due to higher rebate deductions, increased general and administrative spending, and a further slide in glucagon injection sales. Capital deployment included a $29.5 million share repurchase and incremental investments in both marketed and pipeline assets. New product launches—especially ipratropium bromide inhalation—are anticipated to offset headwinds in more mature areas, while core pipeline programs for biosimilars and proprietary drugs remain on schedule for 2027 launch without delay.

  • CFO William J. Peters indicated that, for Vaxini, duplicated rebates related to 340B pharmacies are under third-party review, and a 3% price increase took effect as of May.
  • CEO Dan Dischner stated, Primatene Mist has 60 years of brand recognition. The product is over the counter. It would be difficult from a regulatory perspective for generics to enter, citing unique over-the-counter market dynamics.
  • Discussions confirmed no regulatory agency alignment yet for accelerated approval of the synthetic corticotropin (“110”) pipeline candidate, with Phase 1 entry targeted for 2027.
  • The launch of AMP007 is expected to drive unit and revenue growth guidance even in the absence of generic competition; segment-level forecasts remain undisclosed, but management described it as the biggest growth driver this year.

INDUSTRY GLOSSARY

  • 340B Discount: Federally mandated drug pricing program in the United States requiring manufacturers to offer deep discounts to eligible health providers, often creating pricing complexities across channels.
  • ANDA (Abbreviated New Drug Application): Regulatory pathway for U.S. approval of generic pharmaceuticals, demonstrating bioequivalence to a reference product.

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.

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.