Amphastar Pharmaceuticals, Inc. (AMPH) Earnings Call Transcript & Summary

Greetingsn and welcome to the Amphastar Pharmaceuticals, Inc. Second Quarter Earnings Call. [Operator Instructions] 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. Please refer to our SEC filings, which can be found on the company's 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 Second Quarter 2026 Earnings Call. Earlier today, we reported the financial results for the second quarter ended June 30, 2026, which are available on the Investors page of our website. The second quarter was marked by strong execution across each of our strategic growth pillars. We observed continued demand across our commercial portfolio. We expanded our manufacturing capabilities and advanced both our development pipeline and regulatory programs. As a result, we generated improved financial performance during the second quarter. Revenue increased to approximately $184 million, reflecting both sequential and year-over-year growth. Profitability also improved significantly from the first quarter, driven by increased revenue, margin expansion, and enhanced operating performance. Despite a dynamic operating environment, our strategic priorities have remained consistent. We continue to focus on building a diversified pharmaceutical company supported by 3 complementary growth pillars. First, expanding and optimizing our branded and differentiated commercial portfolio. Second, advancing our pipeline of complex generic and biosimilar products. Third, progressing our proprietary development programs that have the potential to create significant long-term value. We believe this diversified business model provides multiple avenues for growth, enhances resilience, and reduces our dependence on any single product, market, or revenue stream. Turning to the first pillar of our growth strategy, expanding and optimizing our branded and differentiated commercial portfolio. We continued to make meaningful progress during the second quarter. Products such as BAQSIMI and Primatene MIST remain central to our long-term strategy and continue to demonstrate strong consumer demand. BAQSIMI remained an important contributor to our business. Total prescriptions increased approximately 17% compared with the second quarter of last year, demonstrating continued growth in patient demand. BAQSIMI's net sales were approximately $45.5 million, a decrease of approximately 3% compared to the prior year quarter. The difference primarily reflects pricing, rebates, and commercial dynamics. Importantly, strong prescription growth continues to reinforce our confidence in the long-term strength of the franchise. In June, we also completed the third contract year following our acquisition of BAQSIMI from Eli Lilly. During the contract year, BAQSIMI generated $178.3 million in net sales, exceeding the $175 million threshold and triggering our first milestone payment to Lilly. Achieving this milestone reflects the continued strength of the franchise and the successful execution of our commercial strategy since acquiring the product. Our focus remains on expanding patient access, supporting continued prescription growth, and managing the business with disciplined commercial execution to maximize long-term value. Primatene MIST continued to demonstrate strong consumer demand during the quarter. Each in-store sales increased compared with both the prior year quarter and the first quarter of 2026, reflecting continued brand strength and market penetration. While reported net sales declined, the decrease was largely attributable to consumer ordering patterns and the timing of shipments associated with pricing discussions with certain retailers. We believe these were temporary channel-related effects rather than a change in consumer demand. Retail performance remained healthy throughout the quarter, reinforcing our confidence in the Primatene MIST franchise and the effectiveness of our marketing investments and commercial execution. At the same time, performance across our broader portfolio reflected the competitive dynamics that are characteristic of the generic pharmaceutical market. glucagon sales declined compared with the prior year as a result of increased competition. We believe this underscores the importance of continuing to diversify our commercial portfolio and advance new products, which can create multiple sources of growth and enhance the resilience of our business over the long term. Furthermore, during the quarter, our manufacturing facility, Armstrong, benefited from the successful launch of our ipratropium bromide product in April. The launch further demonstrates our ability to advance technically complex generic products from development through regulatory approval and into commercial production, reinforcing a core capability that differentiates our platform. Based on early demand and the current competitive landscape, we believe ipratropium bromide represents an attractive long-term opportunity for Amphastar. We continue to invest strategically across our U.S. manufacturing network to strengthen quality and efficiency, expand automation and capacity, and prepare for upcoming pipeline products. As policymakers and consumers place greater emphasis on domestic pharmaceutical manufacturing and supply chain resilience, we believe our U.S.-based manufacturing footprint, combined with our vertically integrated development and commercialization capabilities, represents a meaningful competitive advantage. These investments not only support our current commercial portfolio, but also provide a strong foundation for future product launches and sustainable long-term growth. IMS, one of our subsidiaries, recently received an FDA warning letter related to the FDA inspection conducted in December 2025. Since the inspection, IMS has continued implementing corrective actions. We have responded to the FDA in a timely manner regarding our remediation plan and continue to work closely with the agency to address the items identified in the warning letter. The warning letter does not require IMS to stop manufacturing or distributing its products. While the remediation effort will require additional resources, at this time, we do not currently anticipate a material adverse effect on Amphastar's overall business operations, commercial portfolio, development pipeline, or sales. We remain committed to addressing the FDA's observations thoroughly and sustainably. Quality remains a fundamental responsibility throughout Amphastar, and we will continue strengthening the overall effectiveness of our quality systems. Turning to our third pillar of growth strategy, advancing our development pipeline, we continue to achieve important regulatory and clinical milestones during the second quarter. For our insulin aspart biosimilar and interchangeable program, we continue preparing for potential commercialization in 2027, subject to regulatory approval. We have also made meaningful progress with our proprietary pipeline. During the second quarter, we initiated the phase I clinical program for AMP-101, our epinephrine nasal product. For AMP-109, our targeted oncology program, non-clinical studies are underway. During the quarter, we received constructive feedback from the FDA and are continuing preparation for regulatory interactions in the near future and an anticipated IND submission. Development activities are ongoing for AMP-110, our synthetic human corticotropin program, and AMP-107, our eye drop program for wet age-related macular degeneration and diabetic macular edema, as we look to advance both towards a future IND submission. While these programs remain in early stages of development, we believe they represent meaningful long-term opportunities. Leveraging our scientific, regulatory, and manufacturing capabilities, these programs have the potential to expand our presence into larger proprietary markets and create additional drivers of future growth and value creation. 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 second quarter.

Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the second quarter results and then update some of our assumptions for 2026. Revenues for the second quarter increased 5% to $183.9 million from $174.4 million in the previous year's period. Ipratropium Bromide Inhalation, which we launched in April, led to growth with strong sales of $8.4 million. Vaccinia revenues decreased 3% to $45.5 million, compared to $46.7 million in the prior year. An increase in units sold, contributing $6.9 million in sales, was driven by our continued marketing efforts. Lower average selling prices negatively impacted sales by approximately $8.1 million, primarily as a result of higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated. In May, in response to these pricing dynamics we had seen over the past few quarters, we engaged a third party to support data-driven identification, validation, and resolution of potential 340B duplicate discounts, which led to a smaller impact than we saw in the first quarter. Primatene sales were $21 million in the second quarter, down 8% from $22.9 million in the second quarter of last year due to the timing of customer purchases. Epinephrine sales were relatively flat, as weakness in the vial product was offset by increased demand for our pre-filled syringe product. Glucagon sales declined 42% to $11.9 million from $20.6 million due to increased competition. Sales of other products increased 25% to $66.2 million from $53.1 million, primarily due to recently launched products, including iron sucrose, with sales of $3.5 million, and teriparatide, with sales of $4.5 million, which we launched in August 2025 and December 2025, respectively. An increase in albuterol sales of $2.4 million, which we launched in 2024, also contributed to the increase. Additionally, an increase in phytonadione and sodium bicarbonate sales, driven by higher demand resulting from supplier shortages, and an increase in sales of API from our AMP subsidiary, had a positive impact on sales. Cost of revenues increased 3% to $90.4 million from $87.9 million. However, gross margins increased to 51% of revenues in the second quarter of 2026 compared to 50% in the previous year period. The primary drivers of the change were sales of recently launched products with higher margins such as ipratropium bromide, teriparatide, and iron sucrose. This trend was partially offset by a lower average selling price for BAQSIMI, glucagon, and epinephrine multidose vials. Additionally, we had increased manufacturing costs at our Amphastar facility. Selling, distribution, and marketing expenses increased 30% to $13.3 million from $10.2 million, primarily due to an increase in marketing efforts for BAQSIMI and higher freight expenses. General and administrative spending increased 30% to $18.2 million from $14 million, driven by higher legal expenses, salary and personnel-related expenses, as well as expenses related to the implementation of a new ERP system. Research and development expenditures increased 10% to $22.2 million from $20.1 million, primarily due to an increase in clinical trial expense, largely for our insulin pipeline. Our non-operating expense of $1.2 million during the period compares to a non-operating expense of $2.8 million in the prior year period, primarily due to foreign currency fluctuations and mark-to-market adjustments related to our interest rate swap contract during the quarter. Net income decreased slightly to $30.3 million, but increased on a per-share basis to $0.67 in the second quarter from $31 million, or $0.64 per share in the second quarter of 2025. Adjusted net income was relatively flat at $40.8 million, but increased on a per-share basis to $0.91 in the second quarter compared to an adjusted net income of $40.9 million or $0.85 per share in the second quarter of last year. Adjusted earnings excludes amortization, equity compensation, and one-time events. In the second quarter, we had cash flow from operations of approximately $51.3 million. During the quarter, we accelerated our share repurchase program and bought back approximately $45 million worth of shares. Separately, in June, we achieved the first annual BAQSIMI net sales milestone under our asset purchase agreement with Eli Lilly, which triggers a $100 million payment due in the third quarter of 2026. Before I turn the call back over to Dan, I would like to update some of our guidance for 2026. Due to remediation efforts at our IMS facility, we expect expenses there will increase by $2 million to $3 million per quarter for the next several quarters. Capital expenditures will also increase at this facility, but there will be no change to our previously communicated capital expenditure profile as we redirect spending from our Amphastar facility to our IMS facility. We also expect a slight slowing of sales from IMS as we concentrate on addressing corrective actions, thus improving the quality and manufacturing systems. Importantly, even with this revised outlook, we maintain our overall corporate sales guidance of mid-single digit to high single-digit sales growth, reflecting the strength of our broader portfolio. I will now turn the call back over to Dan.

Thank you, Bill. Looking ahead, our priorities remain clear. We are focused on supporting continued growth across our commercial portfolio, expanding our U.S. manufacturing capabilities, completing the IMS remediation activities, advancing our near-term regulatory programs, and continuing disciplined investment in our proprietary pipeline. We believe the second quarter highlighted the strength and resilience of Amphastar's diversified business model. Faced with a dynamic operating environment, we delivered improved financial performance, generated continued demand across our key commercial brands, and achieved important regulatory and development milestones. These results reflect the benefits of our diversified growth strategy and the balanced foundation we have built across our commercial portfolio, development pipeline, and manufacturing platform. We also believe Amphastar is well-positioned for the evolving pharmaceutical landscape. Our diversified product portfolio, our U.S.-based finished product manufacturing footprint, vertically integrated capabilities, and growing development pipeline provide multiple avenues of growth and support long-term value creation. With that, we will now take your questions. Paul?

[Operator Instructions] Our first question is from Ekaterina Knyazkova with JPMorgan.

First question is just on operating costs. Can you just elaborate a bit on how we should think about spend from here and what both R&D and SG&A could look like over the next several quarters? A related question just on adjusted gross margins. Seems like there's been quite a bit of volatility in that number over the past few quarters. Just what's been driving that, and what's a good baseline to use for gross margins in the second half of the year?

Yes. There's a couple things driving the decrease in the first quarter. The primary thing was the BAQSIMI double dip counting that we saw there. That had a pretty negative impact. We had some better impacts in the second quarter as we began some procedures to mitigate that and hired an independent party that's going to help reduce that double discount. The second thing in the second quarter was that we had the launch of Ipratropium Bromide HFA, which is a higher margin product, that really helped out a lot. On a going forward basis, I would expect to see the coming quarter similar to this quarter, because remember, we'll have higher BAQSIMI sales next quarter, those higher sales should offset some of the costs that we're expecting at IMS. Additionally, on the G&A and selling expense, I think the second quarter is also a good comp for those. The R&D expense, we do expect that to tick up a little bit as a percentage of sales on a going forward basis.

Our next question is from Dennis Ding with Jefferies.

I have 2 questions. Number one, remind us what's going on with the IMS facility that got the warning letter. If I recall, you guys probably responded to it in late July. Remind us the revenue exposure here again from this facility, what are the next steps from the FDA and when, and then would remediation plans require shutting down some of the production lines? That's question number one. And then question number 2, on BAQSIMI's 340B dynamic, I think you said 80% of that pricing pressure can ultimately go away. Can you reiterate that number on the call today, and how much of that 80% was recovered in Q2, and how much is left to recover in Q3?

Okay. Let me start with the revenue. IMS makes, the sales are probably about a third of our overall corporate sales on a big picture. However, we are still shipping there. We don't expect to stop shipping there. We still are producing at the same rate that we've been. We have taken some quality steps which have slowed down some of the releases, some of the batches right now to make sure that they've gone through an extra quality review, so that's led to a small delay right now for that. I'll turn it over to Tony for some of the other next steps that we have going on there.

Yes. As you mentioned, we did respond to the warning letter in late July. Essentially the way these are is you have an interaction where you update the FDA on a routine basis, generally every month or two, just to go over your plan and the program. We've hired a third-party independent consultant that has great experience in helping to work with these kind of projects. We'll continue to just work with them and if there are any remediation efforts, we'll work with them and keep the FDA in the loop with that. If there are any shutdowns, as you mentioned, which is definitely a possibility, we'll do those as needed. We routinely do those now. Whether it's a little bit longer or not remains to be depending on what they find during the remediation and during the assessments. We do routinely have those, unlikely at this point. We don't have any expectation that there'll be any of those, again, it sort of remains to be seen based on the assessments.

And then going back to the last question on BAQSIMI on the 340B. Now we just implemented that consultant, or that firm that helps us with this in May. We only covered 2 months, and I'll say not all of their actions took place right away. When we talked about reducing 80% of the double-dipping on the last call, I'd say that we probably are halfway there at this point.

Our next question is from David Amsellem with Piper Sandler.

This is Naoki Martin on for David. First, with respect to BD, is your priority acquiring immediately accretive commercial products, or would you accept some development spending for a differentiated late-stage asset? That's number one. Number 2, also with respect to BD, are you willing to establish a new commercial organization in a new vertical or will any potential targets need to leverage existing commercial infrastructure? Thank you.

Yes. Good question. As far as the development goes, we have been looking at both development programs and things that would be immediately accretive or soon to be accretive, I'll say, things that are very late stage, essentially filed. Right now, because we in-licensed 3 products last year that are early stage, our real focus and what we prefer to look at are things that would be either immediately accretive or accretive to earnings within a year. That's the strong preference. However, we're looking at multiple things, and if we saw the right thing that was an early stage, we'd probably do that. I think the cost structure of those is very different. For example, when we took a look at the 4 products that we in-licensed last year, the upfront cost was $2 million each. Much, much lower than a BAQSIMI or something else that's already on the market. As far as new commercial verticals, we would consider new commercial verticals, but they would probably be in the areas where we have either some kind of planned product, such as the in-license assets that are in oncology, ophthalmology, and immunology. Those are the 3 areas that we would consider new verticals, in addition to the endocrinology where we have BAQSIMI. I don't see us moving outside of those verticals.

I do.