Amphastar Pharmaceuticals - Q4 2025

Transcript

Operator (participant)

Greetings, and welcome to the Amphastar Pharmaceuticals fourth quarter earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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 Dischner, Senior Vice President of Corporate Communications, and Mr. Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

Dan Dischner (SVP of Corporate Communications)

Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar'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. 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 the second quarter of 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 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 volumes 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 investments.

We saw additional contributions from newer and expanding products, including $4.4 million from iron sucrose following its August launch and a 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 aspart 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 midterm 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 Bill Peters, our CFO and Executive Vice President of Finance, for more detailed financial review of the fourth quarter and full year.

Bill Peters (CFO)

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 the fourth quarter of 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 sales dropped 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 toward 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 products.

This decrease was partially offset by an increase in unit volumes for our epinephrine pre-filled 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 is offset by a decrease in pricing of glucagon and our epinephrine multi-dose vial products. 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.

Non-operating expenses in the fourth quarter of 2025 were $3.7 million compared to $1.2 million in the prior year period, primarily as a result of foreign currency fluctuations, 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 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 from one-time events. In the fourth quarter, we had cash flows provided by operations of approximately $32.9 million.

For the full year, cash flow from operations were $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 on 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 inhaler product is poised to be a meaningful contributor as sales ramp up. We also expect increased contributions from third-party API sales from our ANP subsidiary. Offsetting these growth trends will be expected 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 up as a percentage of sales due to one-time spending associated with the implementations 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, which we announced last year. 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 our hands. We plan to utilize a portion of our strong cash position to continue our stock buyback program.

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

Dan Dischner (SVP of Corporate Communications)

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've built positions Amphastar for significant long-term value creation through focused execution, innovation, and a robust pipeline designed to support sustainable growth. With that, we'll take your questions. Paul?

Operator (participant)

Thank you. 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. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Dennis Ding with Jefferies. Dennis, is your line on mute? Our next question is from Ekaterina Knyazkova with J.P. Morgan.

Ekaterina Knyazkova (Equity Research Analyst)

Thank you so much. 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? If there's anything you can share on that would be helpful. 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? Thank you.

Dan Dischner (SVP of Corporate Communications)

Thank you. I'll take the first question for 110. We have not engaged the FDA with conversation on that. We're internally still having a discussion and putting our program on paper. We'll be doing that in the relative near future.

Bill Peters (CFO)

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 product and also the oncology, ophthalmology and immunology spaces in terms of the areas where we have early-stage proprietary pipeline products.

Ekaterina Knyazkova (Equity Research Analyst)

Thank you.

Operator (participant)

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

Serge Belanger (Managing Director of BioPharma Equity Research)

Hi, good afternoon. 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.

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's 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.

Bill Peters (CFO)

Yeah. BAQSIMI, we do expect to see the, 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. At that time, we're likely to discontinue from a handful of countries.

Dan Dischner (SVP of Corporate Communications)

there's several countries where either the regulatory requirements are very hard and expensive, or their sales are just very minimal. Those are the two things that we're looking at. That will offset some of the price, some of the growth in the U.S., but we do still see this as growing this year.

Bill Peters (CFO)

Especially in the first half of the year, as, you know, the international sales will keep going on until the third quarter.

Dan Dischner (SVP of Corporate Communications)

For your A07 question, the Atrovent data for last year was $112 million. We think that there's a meaningful market share for being the first and having 180 days of exclusivity with the product. There's a meaningful opportunity for us. We don't currently have any visibility into whether an authorized generic could or will be launched. But as far as the decline, I think we saw that mostly as a more of a pricing decline last year and not so much in a demand decline, demand driven. We think it's fairly stable at this point.

Bill Peters (CFO)

Yeah, usually when you see a market go generic, you'll see that tend to stabilize because of the price considerations and because of payers wanting to have people on a generic product. We think that this will lead to stabilization in terms of units for the product.

Operator (participant)

Got it. I guess just a follow-up. If there's no AG, would that be an upside to this mid to high single digit growth expectation for this year?

Bill Peters (CFO)

I'll say it's, you know, potentially one of the differences between mid-single digit and high-single digit.

Operator (participant)

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

Pavan Patel (Associate of Biotech & Pharma Equity Research)

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.

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. Maybe if you're able to help me size what proportion of that is gonna be used potentially for buybacks versus BD. If you can't speak in terms of, like, absolute value numbers, totally fine.

If you could just frame, which is a higher priority, that would also be helpful. Thank you.

Bill Peters (CFO)

Yeah, sure. 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. Two, in the second half of the year, the countries where we'll discontinue it have negative gross margins. We're actually losing money in those countries. That will help our margins.

However, the glucagon reduction is fairly large. Those products, the Epi vial and the Cortrosyn, also are high margin products, and we're expecting to see the sales declines in those products as well. As well as we're seeing just cost increases from our vendors or our suppliers at this time. That's, that's also eating into the margins.

Also another thing, didn't mention is that we did mention the higher API sales from our China business next year. That's gonna be at a generally lower than corporate average gross margin as well, which will impact the overall margins. As far as buybacks go, last year, we did about $75 million in buybacks. I think that would be, like, the high end of the range for what we have. We have about $15 million left on the current buyback as of today. We did buy back some stock in January and February as well. We'll likely do have another authorization later this year.

A lot of it will depend on, you know, do we have business development opportunities and how close are we to potentially executing on those. Likely to slow the buyback down if we have a need for cash utilization.

Operator (participant)

Our next question is from David Amsellem with Piper Sandler.

David Amsellem (Managing Director and Senior Research Analyst)

Hi. Thank you. This is now 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? Can you also remind us about lifecycle management activities for the product? That's one. Number two, how should we think about the cadence of filings this year compared to prior years? Is your primary focus on inhalation products? Thank you.

Bill Peters (CFO)

Primatene, the patent has already expired. We don't see any competition now, and we think it's unlikely to, given the economics for this. We think, you know, you know, it's a strong product.

Dan Dischner (SVP of Corporate Communications)

I think with the OTC market, it's a different dynamic when it comes to generics. You know, Primatene MIST has 60 years of brand equity in it. We feel like we're in a good position. Even if there was competition, we're in a good position of maintaining a large market share with that product. At the same time, we're in the process of developing a new formulation of Primatene MIST. We've secured one patent, and we're currently working on another. That's kind of our strategy as we move through that brand.

Tony Marrs (EVP of Regulatory Affairs and Clinical Operations)

The second question was about the cadence of the filings. We expect late this year, early next year to have two filings, and then next year total two to three filings. We think that should be the cadence moving forward.

Operator (participant)

Our next question is from Ben Burnett with Wells Fargo.

Tianxi Cai (Analyst)

Hi. Hello. This is Tianxi calling in for Ben. Thanks for taking our question. Wanted to ask you about the Nanjing Anji in-licensed assets. Just see if you can have any updates on that. What kind of level of confidence do you have on these assets? What does the clinical development path look like in their respective indications? Thank you very much.

Tony Marrs (EVP of Regulatory Affairs and Clinical Operations)

Yeah, we're very excited about those products. We are currently in the preclinical stage of those. We're getting our packages together to have conversation, early conversation with the agency on it. We think these products are very exciting. Internally, we have a lot of positive excitement around them. We're building teams and coming up with priorities of these projects.

These will be new drugs, they'll be going through the standard NDA process. Whether we have expedited pathways or not remains to be seen. We're optimistic that we should have some for those. We have some oncology products that we think likely will have some of that. We've not yet engaged the FDA with conversations of that.

We're just kind of in the preclinical evaluation of that and looking at the prioritization of that. Overall, I think we're very excited, encouraged by these products.

Operator (participant)

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.

Tony Marrs (EVP of Regulatory Affairs and Clinical Operations)

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

Operator (participant)

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