Amphastar Pharmaceuticals, Inc. Q4 FY2025 Earnings Call

Greetings, and welcome to the Amphastar Pharmaceuticals Fourth Quarter Earnings call. 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 section 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.

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. 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 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 3 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 3 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 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 Bill Peters, our CFO and Executive Vice President of Finance, for a more detailed financial review of the fourth quarter and full year.

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 continued 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 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 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 contracts. 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 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 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 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 in 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 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 to 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. 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 our hands, and 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 that fit Amphastar's strategy.

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?

Our first question is from Dennis Ding with Jefferies. Our next question is from Ekaterina Knyazkova with JPMorgan.

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's anything you can share on that, that would be helpful. And then the 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?

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

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

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

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, 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 has now stabilized after a significant step down in 2025 from 2024?

Yes. 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 3-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're likely to discontinue from a handful of countries. There are several countries where either the regulatory requirements are very hard and expensive or the sales are just very minimal. So those are the 2 things that we're looking at. So 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, 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's a meaningful market share for being the first and having 180 days of exclusivity with the product, which is a significant 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 more of a pricing decline last year and not so much in a demand-driven decline. So we think it's fairly stable at this point.

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. So we think that this will lead to stabilization in terms of units for the product.

Got it. So 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?

I'll say it's potentially one of the differences between mid- and high-single digits.

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

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're able to help me size what proportion of that is going to be used potentially for buybacks versus BD? And 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.

BAQSIMI will certainly contribute to our gross margin growth next year due to two main factors. First, we anticipate increased sales in the United States, and second, in the latter half of the year, we will cease operations in countries where we currently have negative gross margins, which means we are losing money there. This change will positively influence our margins. However, we do face significant reductions in glucagon, and we expect to see declines in sales for products like the epi vial and phytonadione, which are typically high-margin items. Additionally, we are experiencing rising costs from our suppliers, which is impacting our margins as well. Another point to mention is our higher API sales from our China business expected next year, but these will also have a gross margin lower than our corporate average, affecting the overall margins. Regarding buybacks, we completed about $75 million in buybacks last year, which appears to be at the upper limit of our range. Currently, we have about $15 million remaining on our existing buyback authorization. We also repurchased some stock in January and February. We may initiate another buyback authorization later this year, but this will be influenced by any business development opportunities that arise and our cash needs, which could slow down the buybacks if necessary.

Our next question is from David Amsellem with Piper Sandler.

This is David. I have a couple of questions. First, regarding Primatene MIST, what are your thoughts on competition for the product with the patent expiring this year? Also, could you update us on the life cycle management activities for this product? Secondly, how should we approach the timing of filings this year compared to previous years? Is your main focus on inhalation products?

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

Yes. I think with the OTC market, it's a different dynamic when it comes to generics. Primatene MIST has 60 years of brand equity in it. And so 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. And 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 franchise. The second question was about...

The cadence of the filing. So we expect late this year, early next year to have 2 filings and then next year, total 2 to 3 filings. And we think that should be the case moving forward.

Our next question is from Ben Burnett with Wells Fargo.

This is a question regarding the in-licensed assets from Nanjing Anji. Could you provide any updates on those assets? How confident are you about them, and what does the clinical development path look like for their specific indications?

Yes. 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, 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, so 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, but we've not yet engaged the FDA with conversations of that. But we're just kind of in the preclinical evaluation of that and looking at the prioritization of that. But overall, I think we're very, very excited and encouraged by these products.

There are no further questions at this time. I would like to hand the floor back over to management for any closing remarks.

Thank you, Paul, and 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.

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