Amphastar Pharmaceuticals - Earnings Call - Q2 2025

Transcript

Speaker 0

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, Chief Financial Officer; 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.

Speaker 3

Thank you, Paul. Good afternoon, and thank you for joining our second quarter 2025 earnings call. I'm pleased to share that Amphastar Pharmaceuticals delivered a solid performance in the second quarter of 2025, highlighting the continued strength of our commercial execution, the resilience of our diversified portfolio, and our strategic focus on long-term growth. For the second quarter, we reported net revenues of $174.4 million and a GAAP net income of $31 million, or $0.64 per diluted share. On a non-GAAP basis, adjusted net income was $40.9 million, or $0.85 per diluted share. The performance was primarily driven by the strong momentum of Vaximi, which has quickly established itself as a reliable top performer for Amphastar Pharmaceuticals. Total revenue for Vaximi increased by 21% year over year.

The growth reflects our successful integration of global commercialization at the start of 2025, as well as an increase in unit volume and higher average selling prices. Additionally, we observed stable performance for Primatene Mist, indicating consistent consumer demand. Turning to our capital investment strategy, we recently announced a significant expansion at our California headquarters aimed at quadrupling domestic manufacturing capacity at that facility. In today's geopolitical environment, expanding our US manufacturing footprint is essential to mitigate risks associated with international supply chains. This investment not only strengthens our operational resilience but also supports the advancement of our R&D pipeline. Our vertically integrated infrastructure, backed by US-based production, has long been a cornerstone of our operational excellence, as we focus on maintaining control of quality and upholding high standards. Shifting our discussion to our regulatory initiatives, our product candidate, AMP-002, has been under FDA review for an extended period.

We have engaged in productive and ongoing dialogue with the agency and value the collaborative nature of these interactions. Based on the progress of our discussions and the feedback received to date, we remain optimistic for a near-term approval and look forward to the opportunity to deliver this important product to patients as soon as possible. We continue to advance several additional key regulatory programs. For our AMP-007 inhalation filing, we have received additional feedback from the FDA and now expect a good due date in the first half of 2026. We're pleased to report that our teriparatide product, AMP-015, remains on track and is expected to meet our previously communicated guidance, with a good due action date in the fourth quarter of this year. As for our GLP-1 ANDA, or AMP-018, we are on track to respond to the complete response letter in the second half of this year.

Additionally, we're incredibly excited about the long-term potential of our insulin aspart BLA, AMP-004, as we continue to advance this program with interchangeability as our ultimate goal. While the recent approval of the first interchangeable insulin aspart product triggers a marketing exclusivity period, we view this as a meaningful milestone for the entire category. The FDA's decision to grant interchangeability not only validates the regulatory pathway but sets a strong precedent that supports the potential for future competing interchangeable biosimilars in the U.S. insulin market. This development underscores the growing importance of accessible and affordable insulin options, a trend we expect will accelerate beyond 2026. Amphastar Pharmaceuticals is exceptionally well positioned to benefit from this shift. With all U.S.-based finished product manufacturing and a deep expertise in developing and manufacturing complex injectables, we are confident in our ability to be a major contributor in this evolving market.

We believe the long-term implications of this program could be transformative, both for Amphastar Pharmaceuticals and for the millions of patients who depend on high-quality insulin therapies. As we look beyond our core pipeline and diabetes portfolio, we are actively driving Amphastar Pharmaceuticals' evolution into a more diversified, innovation-led company with a growing emphasis on branded and proprietary products. Operationally, we continue to balance fiscal discipline with strategic investment, ensuring our resources are allocated to high-impact opportunities. Our R&D expense grows 14% year over year, driven primarily by increased material and clinical trial costs, reflecting our deliberate investment in future growth. We view R&D as a critical engine of long-term value creation that enhances and extends our commercial capabilities.

Looking ahead, our strategy remains firmly anchored in sustainable growth, with a strong focus on advancing our pipeline, both through internal innovation and carefully selected external opportunities that align with our vision and expertise. In summary, Amphastar Pharmaceuticals' unique blend of scientific innovation in developing high-quality complex products, operational excellence, and deep commercial expertise positions us as a standout leader in the pharmaceutical industry. We believe that our strategic shift towards proprietary product development, supported by an all US-based finished product manufacturing that bolsters supply chain resilience, and our strong commercial franchise focus on sustainable shareholder value, collectively form the foundation of Amphastar Pharmaceuticals' growth. Driven by these unique strengths and disciplined execution, we are well positioned to confidently accelerate into the next phase of long-term transformative growth. Thank you again for joining us today.

With that, I'll turn the call over to Bill Peters, our Chief Financial Officer and Executive Vice President of Finance, to walk through the financials in more detail.

Speaker 0

Thank you, Dan. Revenues for the second quarter decreased 4% to $174.4 million from $182.4 million in the previous year's period. We're proud to share that while revenue was impacted by increased competition in our legacy products, this was largely offset by Vaximi, which recorded its highest quarterly sales since the product's acquisition. Vaximi sales grew to $46.7 million compared to the prior year period of $30.9 million, as Amphastar assumed full commercialization responsibilities globally at the beginning of 2025. Keep in mind that during the same period last year, Lilly had Vaximi sales of $7.6 million. Therefore, total Vaximi sales for the period grew by 21%. Primatene Mist sales held steady at $22.9 million in the second quarter, and we are pleased to report that our year-to-date sales have grown by 10%.

Glucagon injection sales declined 25% to $20.6 million from $27.4 million, primarily due to increased competition and a move to ready-to-use glucagon products such as Vaximi. Epinephrine sales decreased 42% to $16.2 million from $27.9 million due to increased competition on the multi-dose vial and as sales of the prefilled syringe dropped due to another supplier returning to the market. Sales of lidocaine increased 17% to $15 million from $12.8 million, primarily due to an increase in unit volumes as a result of an increase in demand caused by shortages from other suppliers during the quarter. Other pharmaceutical product sales decreased to $53.1 million from $57.6 million, primarily due to a decrease in sales of enoxaparin, dextrose, and sodium bicarbonate as a result of increased competition. This trend was partially offset by sales of albuterol, which we launched in August 2024.

Cost of revenues increased to $87.9 million from $87.2 million, with gross margins declining to 49.6% from 52.2% in the previous year's period. Vaximi sales in the prior year period were recorded under a transition service agreement with Lilly and were booked at 100% gross margins. Now that the transition to Amphastar has been completed, cost of revenues for all products shipped are included in this line, which negatively impacts margin rates. Additionally, pricing declines due to competition for glucagon and our epinephrine multi-dose vial product negatively impact margins. Because of these trends, management focused on cost control efforts across the business, which mitigated the impact of these pricing declines.

Selling, distribution, and marketing expenses increased 14% to $10.2 million from $9 million in the previous year's period due to the sales and marketing efforts related to Vaximi, including the co-promotion agreement with MannKind, as well as sales efforts related to Primatene Mist. General and administrative spending increased 5% to $14 million from $13.3 million, primarily due to increased personnel-related expenses. Research and development expenditures increased 14% to $20.1 million from $17.7 million due to an increase in material and supply expenses for our inhalation pipeline products and expenses related to our proprietary projects. Non-operating expenses decreased to $2.8 million from $5 million due to a decrease in interest expense and currency fluctuations. Net income decreased to $31 million, or $0.64 per share in the second quarter, from $37.9 million, or $0.73 per share in the second quarter of 2023.

Adjusted net income decreased to $40.9 million, or $0.85 per share compared to an adjusted net income of $48.7 million, or $0.94 per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and certain one-time events. In the second quarter, we had cash flow from operations of approximately $35.6 million. We used a portion of our cash on hand to buy back $39.2 million worth of shares. These purchases finished our previous authorization, so our board of directors approved an additional $50 million stock buyback program. I will now turn the call back over to Dan.

Speaker 3

Thank you, Bill, for the updates. We'll now turn the call over to questions. Operator?

Speaker 0

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 your handset before pressing the star keys. One moment, please, while we pull for questions. Thank you. Our first question is from Serge Belanger with Needham & Company.

Speaker 5

Hi, good afternoon. Thanks for taking our questions. I guess the first one's for Bill. I think in the past you've indicated you expected the top line to be flat year over year. Just curious if those expectations have changed now that we're halfway through the year. Secondly, maybe if you can highlight what we should expect from Vaximi over the second half of the year, and are you starting to see some of the MannKind collaboration impacts on those sales? Thanks.

Speaker 0

Sure. We still are guiding to flat sales year over year, and we still anticipate that two products could be approved and contribute to that level. We're still comfortable with that flat sales. Secondly, Vaximi, you know, we're still consistently saying that the guidance that we gave at the beginning of the year, which was high single-digit unit growth and a 3% price increase in the U.S., we're right on track for that, and we're really pleased with the strong growth we had in the second quarter.

Speaker 5

Yeah. In terms of potential approvals, AMP-002, I hate to ask again, but has your level of confidence increased or changed at all from the last quarterly update?

Speaker 3

We still remain optimistic about the approval of it. We continue to engage with high-level officials at the FDA, and it keeps us optimistic about an approval.

Speaker 5

All right. Thank you.

Speaker 0

Our next question is from Serena Chen with Wells Fargo Securities.

Speaker 2

Hi. Thanks for taking my question. I wanted to ask about AMP-018, the GLP-1. I saw that the IQVIA trailing 12-month sales that used to be $1.1 billion at the start of the year, now that's moved down to $400 million. I was wondering how you're thinking about this opportunity, especially with the recent CRL delaying approval timelines. Thank you.

Speaker 0

Yeah, this is one where we think there's going to be a very crowded, generic market. We expect it to be a relatively small contributor to our sales.

Speaker 2

Okay. Helpful.

Speaker 0

Our next question is from Jason Gerbere with BofA Securities.

Speaker 4

Hey, guys. This is Pavan Patel on for Jason Gerbere. Just two questions from us. Maybe first, if you could walk us through the expected margin trajectory for the second half of the year, and then second, on epinephrine PFS competition, maybe if you could speak to, you know, the competitive environment, has pricing eroded significantly, or is this primarily a market share issue? Just the latest there. Thank you.

Speaker 0

Sure. The expected margin trajectory, we do expect that the new products that we have will either be at or above the corporate average margin that we have right now. What we are expecting to see is increased price competition on glucagon on a go-forward basis. Therefore, we expect margins to contract, absent the new approval launches. As far as epi prefilled syringe goes, that competition is really baked into the current quarter numbers that we have there. The pricing and the unit drop have both happened for that, we believe. It's been both pricing and unit drop that have contributed to this overall sales decline.

Speaker 4

Thank you.

Speaker 0

Our next question is from Ekaterina Knyazkova with JPMorgan Chase & Co.

Speaker 1

Thank you so much. First question is just on glucagon. As you think about the revenues for the product from here, is Q2 kind of a good runway to think about going forward, or would you expect to see some sequential erosion as we think about Q3 and Q4? The second question is just on your plans to expand your manufacturing capacity. Could you talk about what motivated the decision? I'm assuming some of that was probably tariffs. Just thoughts on how you could leverage this capacity over time. Thank you.

Speaker 0

I'll take the first one. No, glucagon is not at a run rate yet. While we did have the competition come in from one competitor, another competitor was recently approved. Our expectation is that they'll launch in the near future, therefore bringing down both our units and our pricing on that. We expect to see glucagon drop on a go-forward basis. Not to mention the fact that the overall market on the anti-hypoglycemic side of that is shrinking as people move towards ready-to-use products like our Vaximi.

Speaker 3

As for the expansion, it's been in our plans for quite a while to expand here at our headquarters. Certainly, the geopolitical environment is ripe for us to do that at this time. It is designed more to support our pipeline. All the products that are currently on file at the FDA are already supported with manufacturing here at our facilities that already exist. For our pipeline, and specifically our pipeline as we move more into proprietary products and stuff, that's where we're looking at expanding the manufacturing, supporting that. That's the reason behind it.

Speaker 1

Thank you.

Speaker 0

Our next question is from David Amsellem with Piper Sandler.

Thanks. Wanted to circle back on the informal revenue guide. Does that contemplate contribution from AMP-002? As a follow-up to the question on revenues for the year, how many launches, or even if you can say this, which launches are you actually contemplating before the end of the year? That's number one. Number two, I wanted to get some more color on AMP-007, the extent to which that's going to be a crowded market, and how should we think about the size of that opportunity to the extent that you ultimately get approval next year. Thanks.

Yeah. For the revenue guide, it does include, you know, we, I'll say we weight the expectations of these products as we take a look at them, and we risk-adjust them. It includes two launches on a risk-adjusted basis, and those include AMP-002 and AMP-015. Right now, those are the only two that we believe could be approved this year. Could we get to that flat in other ways? We could, depending on competition on other products and also just the Vaximi growth if that exceeds our expectations as well. That answers that question. On AMP-007, as far as the contribution, we don't know of any other filer or anybody else working on it or close to it. We haven't seen anything about it. As far as we know, we could be the first approval on that.

If we're the first approval, we think that this has the potential to be a significant market opportunity, potentially the biggest in the near term.

Okay. Thank you.

Thank you. There are no further questions at this time. I'd like to hand the floor back over to management for any closing comments.

Speaker 3

Thank you, Paul, and thank you, everyone, for joining us today. We look forward to sharing more updates in the near future. Have a great day.

Speaker 0

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