Thank you, Kathleen, and thanks for having us here today. We really appreciate that and always enjoy this conference. I'm Bill Peters. I'm the Chief Financial Officer of Amphastar Pharmaceuticals. I'm going to be jointly presenting today with Jack Zhang, our CEO, and one of our co-founders. Just always start off with the forward-looking statements. You know, some of these things that we're going to say are forward-looking, so please read this in your press release or in your presentation or on our website. Amphastar is a fully integrated business. We have really one-stop shopping for everything here. We do our extensive in-house product development capabilities, analytical techniques that are very advanced. We have in-house animal studies. We can do fully integrated manufacturing. We manufacture several of our own APIs and key materials.
We also manufacture devices and components for many of our products, and all of our finished product is made in the United States at one of three of our plants. We have a complete front-end integration with marketing and distribution as well. So we have a dual growth strategy. Primary is development internally. Examples of this include our Primatene Mist, our glucagon injection, which was a product that was developed and the only generic on the market for about four years, which really highlighted some of our advanced capabilities in this area, and we're also developing insulin analogs for BLAs and some other biologics.
Additionally, we have a secondary prong, which is strategic acquisitions, which includes things like our Armstrong facility, which we acquired many years back, our French facility, which manufactures recombinant human insulin, and also the acquisition in 2023 of Baqsimi, which was an NDA we acquired from Eli Lilly, and we'll talk a little bit more about that later. Additionally, we licensed several early-stage NCEs in August of 2025, and also we announced one earlier this week, so we'll talk about those as well later on. The company likes to focus on what we consider our Three H's, which are high quality for products, high efficiency in operations, and high technology for our pipeline.
So focusing on the harder-to-do products allows us to have strong growth and also earn a higher margin than many of our competitors in the business, and you can see the adjusted net income margin growth we've had over the years as we've been able to focus on these areas. One of the things we get a lot of questions about right now is our pipeline evolution. Five years ago, we were 63% of our products were generic in the pipeline, and 21% were proprietary, 16% were biosimilar. And at that time, we saw increased competition on the complex generics where we were working, and we decided that our time would be better suited focusing more on proprietary products.
So we set up a goal at that point to be 50% proprietary by this year, 2026, and we're well on our way to doing that, and I think we'll achieve that in short order. So our goal this year is 50% proprietary, 35% biosimilar, and 15% generic. Our technical platforms include particle engineering and novel formulations, as evidenced by Primatene Mist, characterization and immunogenicity, which is multiple peptide and protein products, including AMP-028 rD NA, insulin analogs, BLAs, and biosimilar interchangeables, highly purified peptides and proteins, including glucagon, which I mentioned earlier, and then novel devices, including the dry powder inhalation for Baqsimi. And all of these slides are on our website, so feel free to take a look at the website when you get a chance.
So along with this shift that I mentioned earlier from the generics to the proprietary, that includes many steps along the way, starting with the complex generics, focusing then on expanding our commercial opportunities, our commercial capabilities. So we expanded our footprint into 26 countries with the acquisition of Baqsimi, and we also have now a sales force which markets that product, which sets us up for future proprietary products as well. Expected and actual launches, including teriparatide, which we were able to get launched by the end of the year last year, AMP-007, which we plan to launch in mid-year this year, and AMP-018, which we plan to launch in 2027. Additionally, the biosimilar portfolio, which includes AMP-028 and two biosimilar insulins, is the next step towards the proprietary pipeline.
And then finally, the proprietary pipeline itself, which is the ultimate goal in this transition, includes products like the intranasal epinephrine. We've been working on three early-stage products that we've developed internally that we'll talk a little bit about later, and then Primatene Mist, which we're reformulating with a new green propellant, and three early-stage in-licensed NCEs that we in-licensed last year, and then also the new synthetic corticotropin product that we licensed in this week. So I'll turn the presentation over to Jack Zhang now.
Thank you, Bill. Good afternoon. I will continue to report research and development and our proprietary products. So our company focuses on the R&D investment. From these two plots, you can see that every year Amphastar will spend $60 million-$75 million on research and development. And here I introduce some of our promising new peptide pipeline. These are NDA new chemical entities. First one is the code is AMP-105. So this is an oncology product and a potentially novel mechanism of action, targeting cell growth and metastasis inhibition. Early study showed broader anti-tumor activity. Second one is the AMP-107. This is a first non-injectable anti-VEGFR eye drop. And this is exciting, the new product configuration. This is double-targeted VEGFR and integrin alpha-v beta-3. So aims to reduce treatment burden and improve compliance.
As you know, there are two to three million patients with wet AMD or DME. The market size is $9.4 billion in 2024. Next, the peptide is AMP-109. This has shown strong efficacy for various cancers. This is the peptide drug conjugate or PDC, and with the docetaxel. This conjugate improves the safety profile, reduces toxicity, and also improves the efficacy. We'll explain more later. The number four is AMP-110. This is a novel synthetic human corticotropin or ACTH. This is highly purified and can improve the impurity and also improve the safety profile. Currently, phase one clinical development has been done. This peptide product is based on our company's proven track record in peptide development and manufacturing. We have multiple products on the market or pending FDA, and these target high growth therapy area, including oncology ophthalmic product.
This accelerates shift toward the novel proprietary and innovative products. This is supported also by our GMP manufacturing and clinical development expertise. This is an example for our recent results obtained for AMP-107. This is the nude mouse model, xenograft model, and we measure the inhibition rate. Our product AMP-109 is the green one. We have three green ones here, and 150% is low dose. In the middle, 87% is the mid dose. And on the right side, the blue one is the high dose. You may notice that inhibition rate as high as 99.6%. And on the right side is the positive control. It is the marketed product with indication of treatment of pancreatic cancer, only 56.8%. This plot shows the more detailed results. We have seven different groups of mice treated by the product for 21 days first.
After finished treatment, continue for 21 days, so a total of 42 days. So these results, first line is negative control, that means without any treatment, so that cancer size is pretty big. Next, the two lines are for the taxane product at a low dose and a mid dose. Then next, the three lines are treated by AMP-109 with low dose, mid dose, and high dose. The last one, high dose, you can see many green circles. So these green circle results make me feel excited because usually the efficacy showed that cancer size will become smaller. But for the high dose AMP-109, so this cancer, most of mice, actually nine of 10, the pancreatic cancer disappeared, could not be observed. So only one mice could find a smaller cancer. The last one is the currently marketed product indicated for the treatment of pancreatic cancer.
The six mice showed that very still very large cancer, and the other two died before 42 days. This slide showed our AMP-110, a novel corticotropin study. This showed the efficacy study. The left side showed the number of the flexion spasms in 60 minutes, and first the red color showed it's a model, there's no any treatment. When we use a small amount, small dose of AMP-110, you can see this reduces a lot. And then when we increase the dose, and these spasms reduce to only 0.1 events, then become only zero at a dose of 12 units per kilogram. The last one is a marketed product. On the right side, this is the mice tail flicks in number per 60 minutes. You can see without any treatment that the model makes the mice shake the tails 158 times.
When you use a very minor dose, that is 0.75 units per kilo, this reduced then further use a larger dose, for example, three units per kilo, it only becomes 40 then further increase to 12 units per kilo, this becomes zero and besides the peptide, Amphastar also has multiple pipeline candidates in development by inhalation delivery technology so we have the novel technology for both powder and spray and solution formulation and this formulation uses strong absorption enhancement and dedicated device platform so as you see, with this powder and solution, we have dedicated device inclusion complex technology. Also, we have controlled PK sustainability. For this category of pipeline, Amphastar has proven cases, including Baqsimi and Forteo. Amphastar also has the multiple pipeline candidates in development using MDI metered dose inhaler delivery technology.
We also have the novel formulation technology for solution and suspension, high delivery efficiency, advanced particle engineering, and we use green propellant technology. We own state-of-the-art manufacturing facility. We also have the proven case Primatene Mist. Now I'll pass to our CFO, Bill Peters. Thank you.
Thank you, Jack. Anybody that's followed us for a while, I've seen this chart before. It's our biosimilar and generic pipeline. At the top, we have the injectables; in the middle, inhalation; at the bottom, biosimilar. The injectables, we just launched teriparatide. We got that approved at the end of December, and that launch is underway. AMP-018, it's a GLP-1 that's planned to launch in 2027. AMP-007, we talked about a little bit earlier. We do expect that to launch in mid-2026. That's an exciting product for us. It's a metered dose inhaler where there's no generics on the market yet, so we think we have an opportunity to be the first and only generic in that market. Additionally, we're developing two other inhalation products, AMP-017 and AMP-023. On the biosimilar side, we have AMP-004, insulin aspart, which is filed, and we expect a commercial launch in 2027.
AMP-005, which is in development of our recombinant human insulin. The insulin degludec is something we're probably going to put on hold given the market conditions there. But AMP-028 is another product; it's a biosimilar where we believe we have a competitive advantage because of the API involved in this allows us to make that better and easier than most companies. The diabetes portfolio is very important to us, which includes those insulins that we were working on, as well as the glucagon, both the kit that we have and the Baqsimi nasal powder, and the GLP-1 that we have in our pipeline as well. Our insulin pipeline covers $1.7 billion in sales, as measured by IQVIA. So it's a nice, very large target market that we're going after with those products.
On the sales and marketing side, we've had very strong revenue growth over the past several years, very strong EPS growth. One of the great things about Amphastar, going back to the time of our IPO, over half of our product sales were in one product, enoxaparin. You can see that that product has shrunk, but the company is almost more than tripled in size. So right now, it's a very small share, and we've really diversified our portfolio over the last decade. One of the transformative deals for Amphastar was acquiring Baqsimi from Eli Lilly. It expanded us into proprietary commercial Rx products. It allowed us to establish a proprietary branded sales team. It strengthened our presence in an underutilized market and expanded our international footprint to 26 countries, and also enhanced our intranasal delivery portfolio with a product that has strong intellectual property protection.
We're still reiterating our peak sales guidance for this product at $250-$275 million. We expect mid-single digit growth this year, and that's going to be driven by two things. One, in the United States, we expect low double digit growth, but we're not planning to take a price increase this year like we did last year. And internationally, we expect a small decline because we're going to withdraw from a handful of countries later on in the year because they're money-losing countries where we believe we'll have a better margin profile once we get out of them. Selling expenses projected at about 15% of Baqsimi sales. And at peak, we expect this product to add $2-$2.50 of incremental EPS. Primatene Mist, another one of our great branded products. It's the only FDA-approved OTC asthma inhaler that's available.
We're growing that market with an increased physician sampling program, and we're also shooting our fourth commercial on that product right now. And we're developing a new version with a patented green formula for the propellant. So with that one, we'll even have lower global warming potential with that propellant. And we're forecasting high single digit growth this year for this product. Some of the highlights and catalysts, the key growth drivers this year are going to include Baqsimi, Primatene Mist, AMP-002, and AMP-015. And the upcoming milestones include the launch of AMP-007, which will really be one of the key growth drivers as well for this year. And then upcoming milestones include probably launches in 2027 for AMP-004 and AMP-018. And with that, I'll turn it over to Ekaterina for some Q&A.
All right. So first question is, just looking back at 2025, what were the key highlights for the company? What went better than expected, worse than expected, and what are you most focused on heading into 2026?
2025 was a solid execution year for us. Baqsimi and Primatene Mist performed well. We had two new product launches, which progressed also well. And we continue to strengthen our manufacturing and pipeline development with more than proprietary product. However, we saw the pricing pressure to our generic portfolio and some timing-related delays. Heading into 2026, our focus is growing Baqsimi, Primatene, and newer products while focusing on the proprietary pipeline development and staying in control on cost.
I think you previously mentioned targeting double-digit revenue growth in 2026. Is that something that you're still expecting, and main drivers as we think about outlook?
Yeah, we're modifying that slightly to be mid-single digit to low double digits. That's the range that we're forecasting now, and the drivers of that will include the launch of AMP-007. So that's going to be the biggest driver of growth this year based on our forecast, and so we do expect to launch that mid-year this year. Additionally, we're still seeing the vaccine growth that I mentioned, the Primatene Mist growth. The other factors include products such as teriparatide, which we barely had a chance to sell any of it at the end of last year. We'll have a full year of sales of that, and then iron sucrose, which we launched in August, we'll have a full year of sales for that product as well, so those are going to be the big drivers.
Additionally, one thing that we'd like to highlight now is that we're also going to be selling some APIs in China from that business, so we've developed a couple different GLP-1 APIs, and we're going to have third-party sales of those materials, which is a change from our strategy historically, was that that business was built to supply APIs to ourselves.
And then on Baqsimi, just going back to 2025, growth has accelerated nicely. Just main drivers of this, and I think you've touched upon this, but just how you think about the U.S. side of the business and trajectory for Baqsimi?
Yeah, we're really encouraged by the momentum we've seen on that product, and it's been great. We've captured a majority of the prescription market for the ready-to-use glucagon. So we're very proud of that. The primary growth driver is really just going to be expanding that commercial footprint. We have our own internal SIT. We have our sales force that we have the contract for. And then additionally, we have the co-promotion with MannKind, which is going very well. But one of the main drivers of this year and long-term growth is really going to be just the penetration of people that are on insulin. So when we bought Baqsimi, you remember that only 10% of people who were getting an insulin script were getting a glucagon script filled. We've grown that to 12% now.
But you can see going from 10 to 12 is great growth, but there's still a large market opportunity out there, which gets to the growth this year, but also the long-term potential for this product.
And then your outlook ex U.S. for the product, I think you mentioned that you're going to be scaling back some geographies. Just talk a little bit about that as well as what you can do to maximize the ex U.S. opportunity in the regions you're staying.
Yeah, so right now, in most countries outside the United States, the pricing environment is not as strong. But in many cases, it's to the point where we're actually losing money, and we can't sustain that. So we did have a provision in our contract when we bought the product from Eli Lilly to continue selling the product for at least three years as part of their commitment and really our commitment to patients that were on this product. We wanted to give them an opportunity for this. However, given the economics in certain countries, we just can't maintain that on a long-term basis. So that commitment ends at the end of June this year. So our plan is to withdraw from a handful of countries, and those countries are ones where we're losing money. So it's actually going to increase our profitability to withdraw from those areas.
Last question on Baqsimi, $250-$275 million, is that still kind of the good peak sales number for you?
Yeah, we're very comfortable with that.
Okay, perfect. And then switching gears a little bit, but just quick thoughts on some of the recently approved products, ProAir, which was, of course, a little bit later, but then Venofer and Forteo, just how are they performing versus your expectations, and how significant will these be for growth in 2026?
Yeah, so they're really performing right as we ended up kind of some of our adjusted forecasts. So ProAir took a little bit of a slow start, but had nice growth last year. And we'll see that growth carry into this year with the iron sucrose. Prior to the approval, we were hoping to be the only or one of two generics. Unfortunately, there were three approved at the same time. So that one's a little bit lighter than we had originally thought. But since we knew that, we're right on track for the comments we've said since that. And Forteo, it's really just a new product, just getting that out there. But right now, it's performing as we would expect.
And then pipeline updates you're expecting this year, particularly AMP-007, just your confidence in that application?
AMP-007 remains on the track for mid-2026 launch. We feel confident in the approval path based on the strength of our data and our experience with complex submissions.
Perfect. And then switching gears again, Primatene Mist, just any thoughts with the patent expiring? Just have you heard of anybody kind of working on a generic? And actually, the next part of the question is, what does generic competition typically look like in an OTC market?
Yeah, so right now, we're not aware of anybody working on this, but that's not to say that there isn't. But the way we've framed the math around this problem is that it's probably not a top priority for anyone given the economics of it. So when we take a look at it, let's just use round numbers, it's a $100 million market. If a generic was to come in, because it's an OTC product, there's not automatic substitution. So the brand is likely to retain half the market. So that leaves half for a generic part of the market. And then if there was a generic that came in, we could launch our own generic as well. So our expectation was that we'd get half of that generic market. So then that leaves only 25% of the market for someone to come in on.
To get any kind of market share, they'd have to cut the price in at least half. So now you're talking something that's about a $12 million market or so. And instead of what is a $100 million market at a high margin, you're talking about a $12 million market at a moderately low margin. So it's really, we don't think the economics are there for someone to do that. And not to say that they won't, but it just doesn't seem to make sense to us. But then, as we mentioned earlier, the other thing that we have going on here is that we are working on a new formulation. And we've already had a patent that's been issued for that formulation. And the formulation is going to be for a new propellant. And the new propellant will be a global warming propellant.
So that's one that's going to be more environmentally friendly. So we're really excited about working on that right now.
Perfect. Then just on glucagon and epinephrine, just how much further erosion are you expecting in 2026 and maybe looking beyond 2026? What does the tail end of these opportunities look like?
Yeah, so let me start with the epinephrine, actually. So remember epinephrine, we've got two different products there. We've got the multidose vial and the prefilled syringe. So on the multidose vial, two years ago it was a two-player market. Unfortunately, it's devolved into a five-player market. So we have lost market share. The pricing has come down pretty significantly. But on the prefilled syringe, two years, it was a two-player market, but the other player in it was having some supply issues and wasn't in the market for 2024. That supplier came back in the market for 2025. But now they've indicated that they're going to exit the market. So it's going to go, I think, back to a one-player market again. But as far as that market goes, we saw most of the price and market share erosion for the total market last year.
So we don't really see that changing significantly from last year to this year. Glucagon, however, slightly different story. We had one competitor launch at the end of the first quarter last year and then two more get approved later on in the year. So year over year, the first and second quarter, we do expect to see some significant sales declines in that product. But it should level out. In the second half of the year, we see some declines, but relatively smaller declines.
And then just switching to your biosimilar portfolio, AMP-004, just your level of enthusiasm for that program and maybe some of the other programs you have in there, just any timelines as we think about some of the other assets?
We remain excited about the project AMP-004, and I believe our product will be recognized as the U.S. manufactured product on the market. In terms of the timelines, our insulin aspart BLA for AMP-004 is progressing. Meanwhile, we have multiple biosimilar pipelines in active development.
Just how do you think the company's biosimilar strategy evolves over the next five to 10 years? Will you remain largely focused on the insulin space, or are you considering other therapeutic areas?
We expect the biosimilar to become a meaningful, durable growth pipeline for our company. We plan to grow into related areas where we have strengths and there are opportunities regardless of the therapeutic area. So this is a portion of our pipeline strategy.
And then talk a little bit about the Nanjing-Anji deal that you did last year. Which of the three assets are you most excited about and when we might see initial data?
The Anji deal aligns with our strategy for selective partnership and enhancing our proprietary pipeline. All three projects are attractive, with one particularly standing out due to its progress. We have just shared some initial animal data for the first time, and we plan to continue to share data as it becomes available.
Then on the deal you announced earlier this week for AMP-110 with Hanxin, talk a little about what the development path for that one looks like. Obviously, a very big market, but just what kind of studies will you have to run for that?
Yeah, so that's a new one. We just announced that this week. But in some ways, it's an old one as well because this is a product that we were actually developing internally at our China business before we split off and divided that into two businesses and spun one of those off. At the time we spun it off, the market was declining, and it was, we thought, highly risky and expensive to get to market. So the subsidiary we spun off kept working on the product and really de-risked it and spent a lot of their own money on it and took it to a point now where we think it is de-risked and also on a nice path for approval. So as far as the timeline and the other R&D work that we have to do on it, that's a little bit up in the air still.
What we plan to do is put together all the data that we have on it and then go to the FDA and have a conversation with them about what's necessary. They already did human studies in China, so we're going to be able to take some of that development work and bring that along to the FDA and show them part of the pathway of what they've done there, so we're really excited about the work that was done and the future market opportunity for this product. Given it's growing so quickly right now, it's a product that when we split the companies apart, it was a declining asset and on the way down, and now it's a growing asset and a growing market, and so it's something that we are excited about.
Perfect, perfect. And then the last few minutes, just business development, just talk about your level of appetite, what kind of assets you would be most interested in, in early stage versus later stage, branded, non-branded, and anything transformational that you could potentially see yourself doing.
Yeah, so really transformational for us was just the Baqsimi deal. So I don't see us likely to do anything that's transformational. However, because we have in-licensed several early stage proprietary products, if we were going to do something, it would probably be something that's either later stage or something that's already commercialized. So right now, when we take a look at what we have, what we might want to do, I think deals that are probably smaller than Baqsimi, but up to that size would be the right way to think about size-wise. And areas, we look at it two ways. One is our capabilities. So we have strong injectable inhalation and intranasal capabilities. So building on those would be certainly something that we'd be interested in doing.
And then from therapeutic categories, because we have the Baqsimi and the endocrinology space, that's a natural fit for us and something that we'd be looking at. We've looked at several things in that area. And then also because we have the new Wet AMD licensed product, ophthalmology is an interesting area for us. So it's something that we would consider in that area. And then probably to a lesser extent, but also on our mind now that we have a couple of these oncology products, it's something in that area. But like I said, it's not as likely to be transformational like the Baqsimi deal was.
Perfect. Thank you so much, and I think we're right around time, so thank you so much.
All right, thank you.