AMPH - NASDAQ

Greetings, and welcome to the Amphastar Pharmaceuticals, Inc. Third 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 the 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 the U.S. GAAP may be found in our earnings release. Please note that 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. Please go ahead, sir.

Thank you, operator. Good afternoon, and thank you for joining Amphastar's Third Quarter 2025 Earnings Call. I'm pleased to share that the company delivered another strong quarter, underscoring the continued success of our vertically integrated strategy and steadfast commitment to science-driven innovation. Our performance this quarter was anchored by 3 core pillars: strong commercial execution, the strategic expansion of our pipeline and focused regulatory progress, all reinforcing our long-term growth trajectory. For the third quarter, Amphastar achieved net revenues of $191.8 million with GAAP net income of $17.3 million (sic) [ $17.4 million ] or $0.37 per diluted share. On a non-GAAP basis, adjusted net income was $44.6 million (sic) [ $44.7 million ] or $0.93 per diluted share. This performance was primarily driven by sustained momentum in our core products, BAQSIMI and Primatene MIST. BAQSIMI delivered $53.6 million in total sales, up 14% year-over-year. This growth was driven by seasonal demand and expanded sales execution through our partnership with MannKind sales force. Additionally, total revenue from Primatene MIST increased by 11% year-over-year, validating persistent consumer engagement in the OTC respiratory space as the product consistently sees a positive growth trend. Turning to our proprietary pipeline. I'm excited to highlight a significant expansion this quarter, fueled by exclusive in-licensing agreement with Nanjing Anji Biotechnology, securing U.S. and Canadian rights to 3 early-stage novel peptide candidates targeting high-growth markets across oncology and ophthalmology. The first candidate, AMP-105, is a first-in-class oncology peptide targeting tumor proliferation and metastasis, representing a novel mechanism of action with broad clinical potential. Early studies have shown anti-tumor activity across multiple cancer types. The second candidate, AMP-109, is a peptide-coupled docetaxel with improved selectivity and bioavailability, targeting lung, colorectal, gastric and pancreatic cancers. It is designed to reduce docetaxel-induced toxicity and has the potential to improve the efficacy and safety of current Taxane therapies. Lastly, the third candidate is AMP-107, which is a noninvasive eye-drop therapy for wet age-related macular degeneration and diabetic macular edema. Offering a patient-friendly alternative to injectable treatments and the potential to improve treatment adherence and quality of life. AMP-107 has the potential to be the first non-injectable [indiscernible] endothelial growth factor receptor or anti-VEGFR eye drop in a $9.4 billion market. These newly added assets broaden our pipeline beyond diabetes and complex generics, unlocking a combined market opportunity of over $60 billion. To capitalize on this growth, our U.S. manufacturing expansion will quadruple production capacity at our Rancho Cucamonga headquarters, strengthening operational agility and positioning us to capture greater value across our portfolio. Our investment in domestic capacity reflects a strategic commitment to resilience and scalability as we navigate an increasingly dynamic landscape. We are delighted to share that we are well positioned to reach our target of proprietary products comprising 50% of our pipeline by 2026. Shifting our discussion to our regulatory initiatives. We made meaningful progress this quarter, highlighted by FDA approval of iron sucrose injection or AMP-002, which is now commercially available as one of the generic options in the United States. This milestone expands patient access to affordable therapies while contributing to our revenue growth. During this quarter, iron sucrose injection generated total sales of $2.4 million. Beyond these launches, we continue to advance several high-impact regulatory programs across our portfolio. For our AMP-007 inhalation filing, we are on track for a launch in mid-2026, with the potential to be the first-to-market generic in a $1.5 billion addressable market. We're also pleased to report that our generic teriparatide product, AMP-015, is also on track for a launch in the first half of 2026. Additionally, our GLP-1 ANDA, AMP-018 is on schedule for a 2027 launch. The obesity and diabetes markets continue to attract significant competition. And as a result, we expect the commercial opportunity to be limited, and we will focus on maintaining cost and quality leadership in this space. And finally, our insulin aspart BLA or AMP-004, is moving steadily towards a launch in 2027. The recent approval of biosimilars in this space helps derisk the opportunity by establishing a proven pathway for market acceptance and adoption. Collectively, these programs position us to expand patient access and deliver sustainable growth across multiple high-demand therapeutic areas in the coming years. 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 third quarter.

Thank you, Dan. Revenues for the third quarter increased slightly to $191.8 million from $191.2 million in the previous year period. BAQSIMI recorded its highest quarterly sales ever, growing $53.6 million compared to the prior year period of $40.4 million, and Amphastar assumed full commercialization responsibility globally at the beginning of 2025. Keep in mind that during the same period last year, Eli Lilly had BAQSIMI sales of $6.4 million. Therefore, total BAQSIMI sales for the period grew by 14%. Primatene MIST sales grew 11% to $28.8 million in the third quarter compared to $26.1 million in the prior-year period, primarily due to our increased marketing efforts. Glucagon injection sales declined 49% to $13.6 million from $26.8 million, primarily due to a decrease in unit volumes and increased competition and a shift to ready-to-use glucagon products such as BAQSIMI. Epinephrine sales decreased 12% to $18.8 million from $21.3 million in the prior-year period due to increased competition on our multi-dose vial product. This decrease was partially offset by an increase in unit volume for our epinephrine prefilled syringe as a result of increased demand caused by shortages from other suppliers during the quarter. Sales of lidocaine decreased 19% to $12.9 million from $15.9 million in the prior-year period, primarily due to a decrease in unit volumes as a result of other suppliers returning to historical distribution levels. Other pharmaceutical product sales increased to $64.1 million from $58.3 million, primarily due to a $4.7 million increase in sales of Albuterol during the period as well as $2.4 million in sales of iron sucrose injection, which we launched in August 2025. This increase was partially offset by a decrease in unit volumes of enoxaparin and dextrose, primarily due to increased competition. Cost of revenues decreased -- or increased to $93.2 million from $89.3 million, with gross margins declining to 51.4% from 53.3% in the previous year's period. BAQSIMI sales made by Lilly in the prior year were recorded under the transition service agreement with Lilly and were booked at 100% gross margin. With the completion of the transition to Amphastar, cost of revenue for all products shipped are included in this line, which negatively impacts margin rate. Additionally, pricing declines as well as a decrease in unit volumes due to competition for both our glucagon kit and epinephrine multi-dose vial products negatively impacted margins. Because of these trends, management implemented cost control measures across the business, mitigating the impact of pricing pressures. Selling, distribution and marketing expenses increased 28% to $11.5 million from $9 million in the previous year's period due to the sales and marketing efforts related to BAQSIMI, including the co-promotion agreement with MannKind as well as sales and marketing efforts related to Primatene MIST. General and administrative spending increased to $39.5 million from $14.8 million, primarily driven by a litigation provision related to a recent jury verdict in a civil case against the company. While we plan to appeal the decision, accounting standards require us to book provision for the full amount, net of applicable insurance coverage. Research and development expenditures increased 6% to $22.4 million from $21.1 million in the prior year period due to the $5.25 million upfront payment we made to Nanjing Anji Biotechnology to license 3 peptide products for our proprietary product portfolio. This increase was partially offset by a decrease in material and supply expenses. Nonoperating expenses decreased to $3.8 million from $9.4 million, primarily due to currency fluctuations. Net income decreased to $17.4 million or $0.37 per share in the third quarter from $40.4 million or $0.78 per share in the third quarter of 2024. Adjusted net income decreased to $44.7 million or $0.93 per share compared to an adjusted net income of $49.6 million or $0.96 per share in the third quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and certain onetime events, including the aforementioned litigation provision that was recorded this quarter. In the third quarter, we had cash flow from operations of approximately $52.6 million. We used a portion of our cash on hand to buy back $4.9 million worth of shares. I will now turn the call back over to Dan.

Thank you, Bill, for the update. In summary, Amphastar's performance this quarter reflects the power of our integrated strategy and our commitment to long-term transformative growth. We demonstrated enduring commercial momentum with strong performance from our leading proprietary products, BAQSIMI and Primatene MIST. We advanced our regulatory pipeline with the approval and launch of iron sucrose injection, alongside steady progress on our interchangeable insulin aspart BLA. Furthermore, we strategically enriched our proprietary portfolio with novel peptide candidates in high-growth indications across oncology and ophthalmology. These achievements underscore our unique combination of scientific innovation, U.S.-based manufacturing capabilities and deep commercial expertise. With a disciplined focus on proprietary product development and a robust R&D engine powered by our advanced technology, we believe we are positioned to accelerate into the next phase of sustainable growth and value creation. Thank you for your continued support and for joining us today. With that, we will now take your questions. Operator?

[Operator Instructions] First question we have comes from Serge Belanger of Needham & Co.

First one for Bill. Now that we're 3 quarters in for this year, any updated thoughts on your informal guide for a flat year-over-year top line and maybe more importantly, a double-digit growth for -- a return to double-digit growth for next year? And then secondly, on iron sucrose, you've now been in the market for a couple of months. So maybe just highlight or give us an idea of how big the opportunity can be for you, given the competition and your manufacturing capacity for the product.

Yes. So we still believe that we can get to flat this year based on some outperformance by BAQSIMI and Primatene MIST and some other factors. And then next year, what we're looking at is probably either high single-digit to low double-digit growth rates. So we'll talk a little bit more about that in the next call. And on iron sucrose, I think the best way to look at that is that we had $2.4 million this quarter, which is about half a quarter. And that's probably a good run rate for the time being on a go-forward basis.

The next question we have comes from Dennis Ding of Jefferies.

This is [indiscernible] for Dennis. We would like to ask if there's any updates on 007. And what about the communication with FDA? Has the shutdown impacted that process at all? And also, would you like to comment on the FDA bandwidth to handle these applications, especially given the shutdown situation?

Sure. This is Tony. For our AMP-007, we continue to have engagement with the agency on it. Given the nature of the combination and complex products like this, this is kind of the due course for these type of products. And as a result, we've aligned our guidance more precisely around the anticipated launch date, as you'll see there. And we've done this because we believe it offers a more meaningful and actionable reference point for the analysts. As far as the bandwidth from the agency, we have seen just slight delays in interaction, not necessarily directly related to any delays in products, just maybe taking a little bit longer to respond to questions. But this hasn't resulted directly to anything that we've seen as far as [indiscernible].

The next question we have comes from Jason Gerberry of Bank of America.

This is Pavan Patel on for Jason Gerberry. The first on generic Venofer, maybe can you just speak to the competitive dynamics? Just wondering, why it seems like the competitor generic Venofer that's launched seems to have garnered a little bit more market share since the start of the launch? And what are the key pushes and pulls in working with these dialysis centers? I'm just trying to think through if there are any levers such as contracting or anything else that you can pull in order to increase the run rate headed into 2026. And then maybe as you look towards 2026, it sounds like high single-digit to double-digit growth is the new sort of commentary there. And I'm just wondering, is that baking in all of the pipeline assets that you've talked about in terms of AMP-007, generic Forteo, generic GLP-1 and insulin -- maybe not the insulin as [ pricing 2027 ], but is that all on a nominal basis? Or is there any risk adjusting that's going on there?

Yes. So for the iron sucrose question, so our goal is to launch it with a profitable price portfolio and hit points where we can have a nice margin on this. So we may not have gone as aggressively in some areas where there's some lower margin. Also, I think we were -- while we had some supply initially, I think that we were not we didn't have enough supply at the beginning of the quarter, but we were by the end of the quarter. But I still think the initial guidance I gave a little while ago, which was we were in for half a quarter, that's probably the run rate to look at on a going-forward basis. I think that's the best way to look at that. As far as the guidance for next year, we do risk adjust our guidance. But I will say that the insulin product and also the GLP-1, we've assumed that those do not launch until 2027. So they're not in the guidance for next year.

The next question we have comes from Ekaterina Knyazkova of JPMorgan.

So just on the licensing you did with Nanjing Anji, just elaborate a bit more on what brought you to that portfolio of assets initially and just your level of excitement, both about the science and the potential commercial opportunity. And kind of a related question, but just on business development more broadly, just level of appetite of doing more deals kind of going forward and maybe your preference between doing something more with more clinical risk like you just did or something kind of closer to BAQSIMI that's more commercial stage.

Yes. When we looked at this opportunity in working with Anji and these products, this is something that's been a long -- part of our long-term plan, and that is to get more into branded products. As we've gone along over the years, we've had that toolbox that's been very effective for us, immunogenicity, preclinical animal studies, doing a lot of work in these early development has helped us considerably. And so when we looked at this opportunity, it seemed like a very good fit. All of the pieces were in place for us to be able to actually do the development of these type of products.

And as far as business development on a going-forward basis, I would say that we're -- now that we have some early-stage assets and with some commercial assets, I think what we would be looking for primarily is either assets that are already commercialized or very late-stage R&D assets.

Now one other thing too, a level of excitement about these products. We're very, very excited about them. We've seen some early data for us on some of these animal models that it looks very encouraging for, as Dan had mentioned, some broad -- potentially broad applications for some of these cancer treatments. It seems very exciting for us to have.

The next question we have comes from David Amsellem of Piper Sandler.

Two for me. One on insulin aspart, what's the competitive landscape going to look like in your view, once you're in a position to launch in '27? And how are you thinking about just the size of that opportunity and how impactful that could be to your portfolio? That's number one. And then secondly, on Primatene MIST, I noticed that your one Orange Book patent expires in '26. Are you expecting competition there? How are you thinking about exclusivity for that product?

As far as the insulin aspart goes, we do -- we had originally hoped that we'd be there first or second, but it's likely to be 3 or more competitors in that market. So -- but it's a large market and a lot of volume. So there's a couple of things going for us there, which are we make the API ourselves and we also make finished product ourselves. And with a large volume market like that, it's going to really help our cost structure to get another high-volume product like that out here will affect our overall cost structure. So we still see that as being a good market that we can have strong sales and it would be something that will move the needle for our company. So it's not just another launch. On Primatene MIST, yes, the patent for the current product does expire next year. Two things on that. One, we don't know of any competition, but generic competition, but not that there won't be because there always could be. But we also have been saying all along that we think it's unlikely that we get competition early on because of this product being -- because it's an OTC product, a lot of the sales will stay with the brand. So if there's a generic come in, we assume that the brand gets half the market anyway. Of the other half of the market, if there was generic, we would also launch our own generic version of it and probably capture half the generic market. So any competitor would be limited to 1/4 of the market, and it has to cut the price at half or more to get any of that market share. So we're talking maybe it's a $10 million, $12 million sales market, and it's also now not a high-margin product. So it's a low-margin product. So spending $10-plus million to get to that low margin -- low sales, low-margin product, we don't think is a great idea for most players. So we don't see that as being a big opportunity for generics. We think it's not the most likely target for generics to go after. And then secondly, we've also discussed how we are working on a follow-on product that has an even lower global warming propellant. And so we're working with the FDA right now. We've already filed one patent on that and are working on some others as we plan to get that product moving forward. We'll probably give some more information about timing of that next year.

The final question we have comes from Ben Burnett of Wells Fargo.

I want to go back and ask a follow-up question around the in-licensed products that you just got. I wonder if you could maybe just kind of map out for us sort of the market or the regulatory and development path? And is there -- are one of these is -- could one maybe be developed before the other or have a shorter path to market? Like how do you see sort of the timing there?

Yes. What I could say about this, these will be new chemical products. So these would be going through the routine new product, new chemical entity pathway from the agency. We do -- from a prioritization, we have some that we think might be a little bit easier than others. And it's kind of early for us to give any kind of prioritization guidance on that. On others, then it's going to be some animal studies that we'll have to do and followed by some human studies, obviously, kind of the normal pathway that you would expect. How much prioritization the agency gives in that remains to be seen. We're very encouraged by some of the early data, and we think perhaps the agency will, too, which will help expedite the approval process of that. But we're still early in it, and we're still kind of evaluating some of the preclinical data that we're getting, although we're very encouraged by it.

And one thing I'd like to add to that is that this has been a plan of ours for a while. As we've illustrated in our presentation, our intent was always to get our pipeline to be 50% proprietary. So we've staffed up. We have the resources to work on all of these independently at the same time. And as we start hitting our stride with them, and we'll have a better outlook on how we'll report it and when we'll report it and what we'll report going forward.

Okay. Great. And if I could just maybe follow up with a BAQSIMI question, I guess what is your estimate for kind of the share of the ready-to-use market that you have? And I think -- I feel like in the past, you've talked about the glucagon market as potentially expanding. Curious if you're still seeing that? And if so, kind of what are sort of the drivers of that?

Yes. So right now, depending on the month, we usually have between 55% and 60% of the ready-to-use market, and that's how we're defining that segment of the market. And we have said that the glucagon market is expanding. And going back to the data on that, which was when we purchased BAQSIMI, only 10% of people who were on insulin were getting a glucagon script filled. And at that time, the Diabetes Association recommended that every person who is on insulin get a glucagon script filled. We've seen that increase pretty steadily, and we're now up to 12% of people getting a glucagon script filled. So it has increased pretty significantly, but we think that there's a lot of opportunity for that number to keep increasing. Therefore, we're very excited about the long-term cash flows from this product and long-term growth of that product. We're still have our forecast of peak sales of $250 million to $275 million. So -- and we think that, that's very achievable. So we're still excited about this, and BAQSIMI is our #1 growth product for next year.

There are no further questions at this time. I would now like to turn the floor back over to Dan Dischner for closing comments. Please go ahead, sir.

Thank you, operator. Thank you all for joining us today. We remain excited about closing 2025 on a positive trajectory and remain focused on delivering innovation and value as we enter 2026. I look forward to sharing updates next year. Have a great day.