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Date

Feb. 26, 2026 at 5 p.m. ET

Call participants

  • Chief Executive Officer — Dan Dischner
  • Chief Financial Officer and Executive Vice President of Finance — William Peters
  • Executive Vice President, Corporate and Business Development — Tony Marrs

Takeaways

  • Net revenues -- $719.9 million for the full fiscal year ended Dec. 31, 2025, reflecting a 2% decline due to headwinds in legacy products.
  • Baqsimi full-year revenue -- $185.4 million, up 12% year over year, driven by higher U.S. unit volume and the shift to direct global distribution.
  • Primatene Mist full-year sales -- $108.7 million, a 7% increase attributed to consumer demand and marketing investment.
  • Iron sucrose revenue -- $4.4 million contributed since its August 2025 launch as part of product expansion.
  • Full-year operating cash flow -- $156.1 million, supporting strategic investments and operational flexibility.
  • Fourth-quarter sales -- $183.1 million, down 2% compared to $186.5 million in the prior-year quarter.
  • Baqsimi Q4 revenue -- $46.7 million, up 12% from $41.8 million in the comparable prior quarter.
  • Primatene Mist Q4 revenue -- $27.9 million, a 3% decline compared to $28.9 million year over year.
  • Glucagon Q4 revenue -- $14.1 million, a 45% decrease caused by heightened competition and market preference for ready-to-use products like Baqsimi.
  • Epinephrine Q4 revenue -- $17.1 million, reflecting a 9% decrease tied to competition in the multi-dose vial, partially offset by higher prefilled syringe demand from supplier shortages.
  • Other pharmaceutical Q4 revenue -- $62.4 million, an 8% increase mainly from albuterol and iron sucrose (launched August 2024 and August 2025, respectively).
  • Gross margin -- 47% of revenues and unchanged from the prior year, as gains in Baqsimi and iron sucrose were offset by weaker pricing in glucagon and epinephrine multi-dose vials.
  • Selling, distribution, and marketing expenses -- $10.3 million in Q4, essentially flat compared to $10.4 million in the previous year's period.
  • General and administrative expenses -- $16.5 million in Q4, up 27% year over year due to higher legal and ERP system implementation costs.
  • Research and development expenses -- $23.3 million in Q4, a 29% increase mainly for insulin and proprietary pipeline development.
  • Nonoperating expenses -- $3.7 million for the quarter, primarily from foreign currency effects and mark-to-market on an interest rate swap.
  • GAAP net income -- $24.4 million in Q4, or $0.51 per share, compared to $38.0 million, or $0.74 per share, in the prior year.
  • Adjusted net income -- $34.2 million in Q4, or $0.73 per share, versus $47.2 million, or $0.92 per share, year over year; adjustments exclude amortization, equity compensation, and one-time events.
  • Fourth-quarter operating cash flow -- $32.9 million, supporting liquidity and investment capacity.
  • FDA approvals -- Iron sucrose, teriparatide, and ipratropium bromide HFA received FDA approval, with ipratropium bromide HFA awarded 180 days' generic exclusivity under Paragraph IV certification.
  • Product pipeline expansion -- New proprietary programs were added: three novel peptides in oncology and ophthalmology, and a fully synthetic corticotropin in immunology, collectively targeting over $60 billion in addressable market.
  • Manufacturing expansion -- Rancho Cucamonga facility investment aims to quadruple production capacity, boosting scalability and supply reliability for future commercial launches.
  • 2026 outlook — revenue -- Management expects consolidated revenue growth in the mid- to high-single-digit range, with the largest driver being the launch of ipratropium bromide HFA (AMP-007) in the second quarter.
  • 2026 outlook — gross margin -- Expected to decline, driven by continuing pricing pressure on high-margin legacy drugs (glucagon, epinephrine, and phytonadione), elevated input costs, and higher API sales at below-corporate-average margin.
  • 2026 outlook — opex -- Selling and marketing expense to rise slightly as a percentage of sales; G&A spending to remain flat-to-up due to one-time ERP expenses; R&D to increase for clinical trials and supply purchases; capital expenditure to ramp for facility expansion.
  • Cash and short-term investments -- Over $300 million available as of the call date, planned to fund buybacks and the major capacity expansion.
  • AMP-007 market opportunity -- William Peters said, "the IQVIA data last year was $112 million. We think that there is a meaningful market share for being the first and having 180 days of exclusivity with the product—it is a meaningful opportunity for us."
  • Baqsimi international market exit -- Management will discontinue distribution in several international markets in July as a three-year commitment ends, impacting total franchise growth in the year's second half.

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Risks

  • Management explicitly guided to lower gross margins in 2026, attributing the pressure to "continued pricing pressure on glucagon, epinephrine, and phytonadione, which are high-margin products," and also citing higher input costs and increased lower-margin API sales.
  • Significant year-over-year Q4 declines in glucagon (45% drop to $14.1 million) and epinephrine (9% drop to $17.1 million), attributed to "increased competition" and market shift to ready-to-use products, with expectation of continued declines.
  • General and administrative expenses increased 27% in Q4, "primarily due to increased legal expenses and expenses related to the implementation of a new ERP system," with management stating G&A spending could remain flat-to-up in 2026.
  • Management disclosed the exit from a "handful of unprofitable" Baqsimi international markets in the second half of the year will partially offset U.S. growth for the franchise.

Summary

Amphastar Pharmaceuticals (AMPH +0.71%) reported multiple new FDA approvals that strengthen its complex generics and proprietary portfolios, including the launch-ready ipratropium bromide HFA with 180 days of market exclusivity. The company detailed a forthcoming acceleration in manufacturing expansion at its main U.S. site, which is expected to support new product launches and address supply reliability across growing markets. For 2026, management plans mid- to high-single-digit revenue growth, driven by key launches but tempered by lower gross margin expectations and increased operational investments.

  • Management confirmed AMP-004 (insulin aFPAR) and AMP-018 (GLP-1) regulatory progress is on track with commercial launches projected for 2027.
  • Peters clarified the company performed approximately $75 million in buybacks last year, with $15 million remaining under the current authorization, and future repurchases will depend on business development opportunities.
  • Marrs stated no FDA engagement has yet occurred for the proprietary AMP-110 corticotropin program, but internal planning is underway for regulatory submission strategy.
  • Dischner noted a new Primatene Mist formulation is under development, with one patent secured and further life cycle management actions ongoing to retain market position post-expiry.
  • The company cited anticipated increases in R&D and capital expenditures for 2026, as it advances both clinical programs and facilities expansion, funded mostly with existing cash flow.

Industry glossary

  • ANDA (Abbreviated New Drug Application): Application submitted to the FDA for approval to market a generic drug product.
  • Paragraph IV certification: Legal certification made in an ANDA seeking to challenge patents held by the branded drug for earlier generic entry, often conferring market exclusivity if granted.
  • aFPAR (Analog of Fully Processed Active Recombinant): Descriptor for synthetic or recombinant versions of biologic active pharmaceutical ingredients.

Full Conference Call Transcript

Dan Dischner: Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar Pharmaceuticals, Inc.'s fourth quarter 2025 earnings call. 2025 was a pivotal year for the company, demonstrating the strength and balance of our business model with our continued focus on both commercial execution and scientific innovation. Baqsimi maintained its strong double-digit growth trajectory, reinforcing the durability of our franchise and continued execution, while FDA approvals for iron sucrose and teriparatide highlighted our technical depth in complex generics. And just this week, we achieved another major regulatory milestone with the FDA approval of our ipratropium bromide HFA inhalation aerosol, previously referenced as AMP-007.

The FDA also confirmed that this product is eligible for 180 days of generic drug exclusivity, as we were the first ANDA applicant with Paragraph IV certification. This approval reinforces the strength of our integrated R&D and manufacturing model and represents a meaningful addition to our respiratory portfolio. We expect to launch this product commercially early in 2026, positioning it as a significant near-term growth driver. Across the pipeline, we advanced and expanded our proprietary portfolio with the addition of three novel peptides in oncology and ophthalmology, and a fully synthetic corticotropin program in immunology. These additions support our transition towards a portfolio increasingly anchored in high-value proprietary and biosimilar assets.

On the commercial side, we remain attentive to the competitive pressures in certain legacy products and continue to prioritize resources towards our strongest growth opportunities. Our performance this year was driven by three core pillars: resilient commercial momentum, strategic pipeline progress, and disciplined operational execution supported throughout by our U.S.-based manufacturing advantage. For the full year, net revenues were $719.9 million. Baqsimi remained a key contributor, generating $185.4 million in revenue, up 12% year over year, driven by higher U.S. unit volume and the successful transition to direct global distribution. Primatene Mist also performed well, with sales rising 7% to $108.7 million, supported by strong consumer demand and continued marketing investment.

We saw additional contributions from newer and expanding products, including $4.4 million from iron sucrose following its August launch, and strong growth in albuterol driven by market demand. These gains helped offset competitive pressures in epinephrine and glucagon. Full-year revenue declined modestly by 2%, reflecting greater-than-expected headwinds in legacy products. Even so, we maintained strong operational discipline, tightening expenses, prioritizing long-term investments, and mitigating margin pressures in areas facing pricing challenges. Operating cash flow totaled $156.1 million, demonstrating the resilience of our model and our ability to continue investing in strategic priorities. On the pipeline side, we achieved several major regulatory milestones with approvals for iron sucrose, teriparatide, and most recently, ipratropium bromide HFA.

These achievements broadened our capabilities across complex injectables and inhalation products. We also expanded our proprietary pipeline with high-value assets, including AMP-105, AMP-109, AMP-110, and AMP-107—programs that collectively open more than $60 billion in addressable market opportunity and strengthen the long-term foundation of our portfolio. We also continue to advance several high-impact programs that remain on track for near-term launches. Our insulin aFPAR BLA for AMP-004 and our GLP-1 ANDA for AMP-018 are moving steadily through regulatory proceedings, with anticipated commercialization for each expected in 2027. Together, these programs represent meaningful near- and mid-term value drivers as we expand our presence across complex formulations and high-demand therapeutics.

To support this expanding pipeline, our U.S. manufacturing investment in Rancho Cucamonga remains a critical pillar of our long-term strategy. The expansion will quadruple production capacity at the site, significantly enhancing scalability and improving supply reliability. The upgraded footprint positions us to meet future demand as our proprietary programs and complex generics advance towards commercialization, ensuring we can execute with the speed and consistency required in these high-growth markets. I will now turn the call over to William Peters, our CFO and Executive Vice President of Finance, for a more detailed financial review of the fourth quarter and full year.

William Peters: Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the fourth quarter results and then our assumptions for 2026. Sales for 2025 decreased 2% to $183.1 million, from $186.5 million in the previous year's period. Baqsimi sales grew 12% to $46.7 million from $41.8 million in the prior year period, as we continue our sales and marketing efforts in the United States. Primatene Mist declined 3% to $27.9 million from $28.9 million in the prior year period. Glucagon sales declined 45% to $14.1 million from $25.6 million in the prior year period due to increased competition as well as a market move towards ready-to-use products such as Baqsimi.

Epinephrine sales declined 9% to $17.1 million from $18.7 million in the previous year's period due to increased competition for our epinephrine multi-dose vial product. This decrease was partially offset by an increase in unit volumes for our epinephrine prefilled syringe, driven by increased demand caused by shortages from other suppliers during the quarter. Other pharmaceutical product revenue grew 8% to $62.4 million from $57.5 million in the previous year's period, primarily due to increased sales of albuterol and iron sucrose, which we launched in August 2024 and August 2025, respectively. Gross margins remained flat at 47% of revenues as we saw increased sales of Baqsimi and iron sucrose.

This was offset by a decrease in pricing of glucagon and our epinephrine multi-dose vial product. Selling, distribution, and marketing expenses were essentially unchanged at $10.3 million in the fourth quarter of 2025 compared to $10.4 million in the previous year's period. General and administrative expenses increased 27% to $16.5 million compared to $12.9 million in the prior year, primarily due to increased legal expenses and expenses related to the implementation of a new ERP system. Research and development expenditures increased 29% in the quarter to $23.3 million from $18.1 million in the comparable quarter of 2024, primarily due to increased spending on our insulin and proprietary pipeline.

Nonoperating expenses in 2025 were $3.7 million compared to $1.2 million in the prior year period, primarily as a result of foreign currency fluctuations and mark-to-market adjustments related to our interest rate swap contract. We reported net income of $24.4 million, or $0.51 per share, compared to the previous year's fourth quarter net income of $38.0 million, or $0.74 per share. Adjusted net income was $34.2 million, or $0.73 per share, compared to an adjusted net income of $47.2 million, or $0.92 per share, in the fourth quarter of the previous year. Adjusted earnings exclude amortization, equity compensation, and one-time events.

In the fourth quarter, we had cash flows provided by operations of approximately $32.9 million, and for the full year, cash flow from operations was $156.1 million. As we look ahead to 2026, we are basing our outlook on several key financial assumptions. For Baqsimi, we expect mid-single-digit unit growth in the U.S., partially offset by a planned reduction in international volume as we exit a handful of unprofitable markets later in the year. We do not expect to take any price increases in 2026, as our primary focus is on unit growth.

For Primatene Mist, we expect unit growth in the mid- to high-single digits this year, and we plan to take a 5% increase in price in the second quarter. We expect the largest driver of growth will be the launch of ipratropium bromide, with a planned launch in early the second quarter. Our third metered-dose inhalation product is poised to be a meaningful contributor as sales ramp up. We also expect increased contributions from third-party API sales from our AMP subsidiary. Offsetting these growth trends will be sales declines due to increased competition for glucagon and, to a lesser extent, epinephrine and phytonadione.

Overall, we expect these dynamics to drive consolidated revenue growth in the mid- to high-single-digit range for 2026. We expect gross margins to be lower, primarily driven by continued pricing pressure on glucagon, epinephrine, and phytonadione, which are high-margin products. In addition, we are seeing higher input costs, including labor and supplier-related increases, which will further impact margins. Our selling and marketing expense will increase slightly as a percentage of sales, due to increased sales and marketing efforts for both Baqsimi and Primatene Mist. General and administrative spending will be flat to up as a percentage of sales due to one-time spending associated with the implementation of our new ERP system.

Turning to research and development, we plan to ramp up spending on clinical trials and purchases of materials and supplies for inhalation and proprietary pipeline products. We also anticipate a significant increase in capital spending from the expansion project at our Rancho Cucamonga facility we announced last year. Spending on this major project was slower than we anticipated in 2025 but will ramp up more significantly in 2026. We plan to finance this expansion with cash flow from operations. As of today, we have over $300 million in cash and short-term investments on hand, and we plan to utilize a portion of our strong cash position to continue our stock buyback program.

Additionally, we will continue to look for business development opportunities which fit Amphastar Pharmaceuticals, Inc.'s strategy. I will now turn the call back over to Dan.

Dan Dischner: Thank you, Bill. In summary, 2025 was a year of meaningful progress and disciplined execution. We strengthened our commercial foundation with resilient performance from Baqsimi and Primatene Mist, advanced our regulatory pipeline with FDA approvals of iron sucrose, teriparatide, and most recently, ipratropium bromide HFA inhalation aerosol, and made significant progress across our AMP-004 and AMP-018 near-term commercial product candidates. We also expanded our proprietary pipeline portfolio into high-growth therapeutic areas through the addition of novel product candidates in oncology, ophthalmology, and immunology. These achievements reinforce the depth of our scientific capabilities, the strategic value of our U.S. manufacturing footprint, and our commitment to delivering high-quality therapies that improve patient access and outcomes.

The momentum we have built positions Amphastar Pharmaceuticals, Inc. for significant long-term value creation through focused execution, innovation, and a robust pipeline designed to support sustainable growth. With that, we will take your questions.

Operator: Thank you. We will now be conducting a question and answer session. Please press the star key followed by the number one to ask a question. One moment while we poll for questions. Our first question is from Dennis Ding with Jefferies. Dennis, is your line on mute? Our next question is from Ekaterina V. Knyazkova with JPMorgan.

Ekaterina V. Knyazkova: So first question is just on AMP-110, the corticotropin asset. Just have you had any conversations with the FDA on just what the development path could look like? And if there is anything you can share on that, that would be helpful. And then second question is just on business development. Just latest thoughts on appetite and priorities, just what kind of assets are you most interested in? And how big of a priority is BD for you guys in 2026?

Tony Marrs: Thank you. I will take the first question for AMP-110. We have not engaged the FDA with conversation on that. We are internally still having the discussion and putting our program paper together. We will be doing that in the relatively near future.

Dan Dischner: And the second one for business development. Our focus will be on areas where we either have a presence or a planned presence. And that would include endocrinology because of our Baqsimi products and also the oncology, ophthalmology, and immunology spaces in terms of the areas where we have early-stage proprietary pipeline products.

Operator: Our next question is from Serge D. Belanger with Needham & Company.

Serge D. Belanger: First question around Baqsimi expectations for 2026. Bill, I think you mentioned you expect mid-single-digit growth on units, but to be offset by some discontinuation of international sales. Just curious what the level of those international sales are and what that means—if you expect growth from the franchise at all for the year. And then the second question around AMP-007. You know, just how big of an opportunity is this? I guess, have you gotten any news whether there is an authorized generic coming on the market? And whether you think the Atrovent market is now stabilized after a significant step down in 2025 from 2024? Thanks.

William Peters: Yeah. So Baqsimi, we do expect to see that mid-single-digit increase in units in the United States, and the international decline will come in the second half of the year. We had a three-year commitment to keep marketing the product in all countries where Lilly was selling the product, and that commitment is up in July. So at that time, we are likely to discontinue from a handful of countries. There are several countries where either the regulatory requirements are very hard and expensive, or their sales are just very minimal. So those are the two things that we are looking at.

So that will offset some of the growth in the U.S., but we do still see this as growing this year, especially in the first half of the year, as the international sales will keep going on until the third quarter. And for your AMP-007 question, the IQVIA data last year was $112 million. We think that there is a meaningful market share for being the first and having 180 days of exclusivity with the product—it is a meaningful opportunity for us. We do not currently have any visibility into whether other authorized generics could or will be launched.

As far as the decline, I think we saw that mostly as more of a pricing decline last year, and not so much a demand-driven decline. So we think it is fairly stable at this point. Usually, when you see a market go generic, you will see that tend to stabilize because of the price considerations and because of the payers wanting to have people on a generic product. So we think that this will lead to stabilization in terms of units for the product.

Serge D. Belanger: Got it. So I guess just a follow-up. If there is no AG, would that be an upside to this mid- to high-single-digit growth expectation for this year?

William Peters: I will say it is, you know, potentially one of the differences between mid and high single digit.

Operator: Our next question is from Pavan R. Patel with Bank of America.

Pavan R. Patel: Hey, guys. Thanks for taking my questions. My first is on gross margins. I know you commented that you expect it to be lower in 2026, but maybe if you can help me understand to what degree pricing pressure on glucagon, epinephrine, and these legacy products can be offset by Baqsimi growth. Maybe if you could just frame the sizing between those pushes and pulls there. And then my second question is with regards to buybacks. I know you said that you plan to use a portion of your cash, and you have about $300 million of cash.

So maybe if you are able to help me size what proportion of that is going to be used potentially for buybacks versus BD. And if you cannot speak in terms of absolute value numbers, totally fine. If you could just frame which is a higher priority, that would also be helpful. Thank you.

William Peters: Yeah. Sure. So Baqsimi, that, you know, that will definitely help us grow our gross margins next year, because two things. One, the growth in the United States of the sales there. And two, in the second half of the year, the countries where we will discontinue it have negative gross margin, so we are actually losing money in those countries. That will help our margins. However, the glucagon reduction is felt fairly large, and those products—the epinephrine multi-dose vial and the others—are high-margin products, and we are expecting to see sales declines in those products as well, as well as we are seeing just cost increases from our vendors or our suppliers at this time.

So that is also eating into the margins. Also, another thing I did not mention is the higher API sales from our China business next year. That is going to be at a generally lower-than-corporate-average gross margin as well, which will impact the overall margins. And then as far as buybacks go, we had about, last year, we did about $75 million in buybacks. I think that would be the high end of the range for what we are contemplating. We have about $15 million left on the current buyback as of today. So we did buy back some stock in January and February as well.

We are likely to have another authorization later this year, but a lot of it will depend on whether we have business development opportunities and how close we are to potentially executing on those—we are likely to slow the buyback down if we have a need for cash utilization.

Operator: Our next question is from David A. Amsellem with Piper Sandler.

Nalkia (for David A. Amsellem): Hi. Thank you. This is Nalkia on for David. Just a couple from us. First, regarding Primatene Mist, how are you thinking about competition for the product, considering that the patent expires this year? And can you also remind us about life cycle management activities for the product? So that is one. Number two, how should we think about the cadence of filings this year compared to prior years? And is your primary focus on inhalation products? Thank you.

Dan Dischner: So Primatene Mist, the patent has already expired. So we do not see any competition now. We think it is unlikely to see much given the economics for this. We think it is a strong product. I think with the OTC market, it is a different dynamic when it comes to generics. You know, Primatene Mist has 60 years of brand equity in it, and so we feel like we are in a good position—even if there was competition, we are in a good position of maintaining a large market share with that product. And at the same time, we are in the process of developing a new formulation of Primatene Mist.

We have secured one patent, and we are currently working on another. So that is kind of our strategy as we move through that franchise. The second question was about the cadence of filings. So we expect late this year, early next year to have two filings, and then next year, a total of two to three filings. And we think that should be the case moving forward.

Operator: Our next question is from Benjamin Burnett with Wells Fargo. This is Tianqi calling in for Ben. Thanks for taking our question. So I wanted to ask you about the Nanjing in-licensed assets. Just see if you have any updates on that. What kind of level of confidence do you have in these assets? And what does the clinical development path look like in their respective indications? Thank you very much.

Tony Marrs: Yeah. We are very excited about those products. We are currently in the preclinical stage. We are getting our packages together to have early conversations with the Agency on them. We think these products are very, very exciting. Internally, there is a lot of positive excitement around them. We are building teams and coming up with priorities for these projects. These will be new drugs, so they will be going through the standard NDA process. Whether we have expedited pathways or not remains to be seen. We are optimistic that we should have some for those.

We have some oncology products that we think likely will have some of that, but we have not yet engaged the FDA with conversations on that. We are in the preclinical evaluation and looking at the prioritization. But overall, I think we are very, very excited and encouraged by these products.

Operator: 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, and thank you all once again for joining us today. We appreciate your continued engagement and support. We look forward to keeping you updated on our progress throughout 2026. Have a wonderful evening.

Operator: This concludes today's conference call. You may disconnect your lines at this time. Thank you again for your participation.