All right. Well, thanks everyone for joining this session. I'm pleased to have Amphastar here with us. We have Bill Peters, CFO, and Dan Dischner, Head of IR. Thanks so much for being here.
Thank you.
Thank you.
All right. So I'll let you guys give an intro for those who are not yet familiar with the company, and then we'll go into questions.
Okay. Amphastar Pharmaceuticals, we're headquartered in Rancho Cucamonga, California. We're a pretty vertically integrated company where we develop products from preclinical stage all the way through to finished product stage. We do the manufacturing. We do distribution, so we cover the gauntlet. We have about 1,500 employees, and we've been public for about 10 years now.
11.
11 years. That's right, so that's a high level of Amphastar.
Sounds good. And I'll start with a key product. A theme over the past year has been the transition from Baqsimi being under Lilly Distribution to you guys. So now that it's fully under Amphastar, can you talk about how year-to-date growth has tracked relative to expectations? You also have that MannKind collaboration. So can you talk about any expectations for acceleration in the second half and just what the growth dynamics could look like?
Yeah. So we've been really happy with the way Baqsimi's been performing this year. Now that we have complete control over it around the world, we're very happy with it. Our scripts have grown double-digit rates so far this year. Now, remember, part of that has to do with some hiccups that we had in the second quarter last year as we transitioned from the Eli Lilly label to the Amphastar label as a couple of insurance plans had some bad data on that, and there was a few state Medicare and Medicaid programs that weren't covering it just because of the timing of it, and it took them longer to put it on their formulary, so the second quarter was a little weak last year, so some of our growth this year is because of that weakness last year.
But even now, into the third quarter, we've seen script growing in the month of July, I think, about 16%. So we're really happy with that. That's performing at or above expectations. The MannKind collaboration has gone very well so far. We're really happy with the way that's been going. We have seen a lot of strong growth in a lot of areas that we hadn't been at before. But even with all that same growth, we're still guiding to high single-digit unit growth this year. So we haven't changed that at this point yet. But we're very happy with the way things have moved so far.
Got it. And just to remind us, for the high single-digit growth this year, how does that compare to last year?
Yeah. So last year, it was low single-digit growth. But part of that, as I mentioned, was because of some of the hiccups that we had. And the high single-digit growth is just the unit growth. We also took a small price increase in the United States this year. So we'll have some pricing increase as well this year.
Okay. And looking beyond 2025, what would you say are the drivers for growth? Maybe a general getting more insulin users onto glucagon, any annual price increase strategy. And then from where you stand now, what is your confidence into that $250 million-$270 million peak sales guidance?
Yeah. So first of all, when we take a look at who should be getting a glucagon script, and really everyone who is on insulin should be getting one. When we acquired Baqsimi, only 10% of people who are getting an insulin script were actually getting a glucagon script as well at any point during that one-year time period. So up to now, we've grown that from 10% - 12%. So we have some what we call market penetration from that standpoint. So that's what we're really focusing on, is getting the compliance of people who are on insulin to get a glucagon script. So that's our main focus and really the main lever that we see as helping us grow the product going forward.
With that, we think that the sales force, both our internal or we have an external sales force, plus we have the MannKind agreement. So we have sales force from their group. Both groups have been doing very well this year. So we've been very happy with the growth that we've had out of that. But the question of the long-term forecast that we have of peak sales of $250 million-$275 million, we think that's very attainable. So we'll probably give some further updates maybe on timing of that later this year or early next year.
Okay. And since there are other ready-to-use products like the Gvoke and Zegalogue, can you talk about the competitive dynamics between those?
Yeah. Right now, Gvoke is our biggest competitor. But we think we have a better product. Ours is an intranasal product. It's very easy to use. One of the issues that people have with products with needles is hesitancy to use them. And now people say, "Oh, well, diabetics use needles all the time." Yes, that's true. But it's not the diabetic that would be actually using this product because it's an emergency use product. It's usually a family member or a caregiver or a teacher or a friend. So when you take a look at it from that standpoint, it's someone who's not used to dealing with needles frequently.
So because of that, we think that the product that doesn't have a needle that you just use as a nasal spray is a much more usable product and more beneficial for the patient because of the hesitancy people have to use needle products and hesitancy or weariness to use it. So they might not use it when they should. So with this product, it gives the user so much time to do that, and it's very easy, so.
Okay. That sounds good. Moving on to another key product in the proprietary brand's portfolio, Primatene Mist. So this grew at a pretty solid pace, 10% year-over-year in the first half of 2025. Can you talk about how durable you think this growth is and how some of the recent efforts around DTC and physician sampling can accelerate the growth from here?
Yeah. So we're really encouraged by the 10% year-over-year growth that you referenced. We do think that the DTC, the direct-to-consumer, and the physician sampling program has been performing as we expected. And we continue to see these things along with our collaboration with our retail partners at the point of sale. We think that's a really important element to this growth. And we continue to kind of we think these things will lead us to that single high-digit growth rate that we're used to seeing here with Primatene Mist.
Okay. And then it looks like patent expiry is coming up in 2026. But you guys have talked about having confidence into growth beyond this. So can you talk about the underlying expectations for that?
Yeah. So Primatene Mist, being a retail product, and we think that it's been on the market for a long time, and it has a lot of brand recognition. We think that at $100 million, the sales rate around there, it would be really hard for someone to—it'd be maybe not hard, but maybe not great for them to come into that market because by the time they get there, we cut that price in half. You cut again in half because we launch an AG. And then what's the real opportunity for them as they get there? And then especially with the brand recognition that Primatene has, we think that it already has a strong presence in the market. So the opportunity might not be as great for somebody to compete with us.
And the other thing is that we're also working on a follow-on formulation, Primatene Mist now. So we're working on a new propellant that's a very even lower global warming propellant than we have with the existing one. Now, the existing one, remember, is a replacement of the old CFC formulation. So the HFA is a replacement of that. There's another one that's going to be even less impacting on the global warming. So because of that, we think that that's the focus of future inhalation products. So we've already started formulating that, working on patents for that, and then potentially working on an IND in the not-too-distant future for that as well.
Okay. Yeah. That sounds interesting. So right now, what stage of development is this in?
It's still, we've already developed the formulation, and we're working on the patents and filing some patents.
Okay. Cool. More to come.
Yes.
All right, so I wanted to talk about recent approval, iron sucrose. Can you talk about the opportunity here, especially given news about competition from Viatris and Sandoz, and then also, you've previously mentioned capacity constraints, so then is this a product that can help with margins?
Yeah. So right now, we've always had a capacity constraint. We've been mentioning this to investors for some time. The maximum market share we could hope to achieve is 25% based on that capacity constraint. So that's one thing. So whether it was us and one other player or us and four players, I don't think that that changes too much our ability to get that, let's say, 20%-25% of the market. What will change because of the three players is the pricing, unfortunately. So we've been ready to launch this product for years now. And it's unfortunate to have two other competitors launch at the same time. But that's the way things happen in the generic business sometimes. But we and one of those two players were ready to launch right away. And so we've launched, and one of the other parties has launched.
The third has not, as far as I know, as of the most recent data I have. And because our product and the Viatris product were both considered competitive generic therapies, the FDA cannot approve another product for at least six months. So it's unfortunate that they also approved Sandoz on the same day. If they had not, then they wouldn't have been able to approve them on the same day either or until six months. But so there's at least a halt in approvals for a six-month period of time. So that helps us get our market share.
Okay. And I think you've mentioned you have competitive generic label for certain doses.
Yeah. So we have it on all three. Viatris has it on two of the things. There are three different sizes of this product. There is a 2.5 ml, a 5 ml, and a 10 ml. But between Viatris, we have all three. Viatris has two. But that really doesn't make a big difference because we have all three. No one else can get approved for six months because we have launched.
Okay. Gotcha. And then it sounds like contracting discussions are ongoing. Is that something that we may be able to find out more color, say, like the next earnings call?
Yeah. We'll give some more information about that. We've already begun selling the product. So that started shipping in August. So we're very happy with the way that's moving so far. We expect to get a reasonable share of this market. So I think that it's something that we'll be able to get to relatively quickly. It's a little different type of market because it's used a lot in dialysis centers. So it's a slightly different customer target. We'll be contracting with our normal customers like the GPOs. However, in addition, we'll also be contracting directly with those dialysis centers as well as the major players in that business.
All right. Sounds good. And then looking at what could get approved next, AMP-015 teriparatide. I was wondering what gives you confidence into this being the second approval this year? And then how do you view the market for teriparatide versus other osteoporosis treatments like Prolia, Tymlos, and Evenity?
We're optimistic about our teriparatide application. Kind of where the stage of it is in the review process and the quality of our submission, we feel pretty confident. And we're on track for that GDUFA in the fourth quarter of this year. Yeah. The osteoporosis market is diverse. We know that there's a lot of different. But teriparatide has kind of stayed pretty constant even with the two generics that are already on the market. So we think that there's still an opportunity for us. And we always will go into a market to take, targeting a reasonable share. It's not the market we thought it once would be, but it's still an opportunity for us.
Okay. All right. And then touching on other products on the commercial portfolio. So what is your outlook on products like glucagon and epinephrine that have started to face increased competition this year? Do you think there could be a return to growth, or would there be steady erosion from here on?
Specifically those products, I don't see a return to growth. But let's take them one at a time. Glucagon is our older glucagon, the kit, the emergency kit. With that product, remember, there's two segments to the market. There is the diagnostic segment, and then there's the anti-hypoglycemic market. With the anti-hypoglycemic market, we see that market continuing to shrink just in general, whereas the diagnostic market should expand, let's say, at the rate of the growth rate in the population. With the two new competitors coming in, they have Viatris last year and this year the glucagon, we see our share of the market shrink as the overall market shrinks, but shrinks at a slower pace. It's shrinking in two ways for us. One, the overall market, and two, is the competition.
The good thing about this product, though, is it's still a high-margin product for us even with the new competition. And it's one where even though we have a couple of new players, it is a very difficult product to do. So hopefully, that'll keep more other players out of the market. On the epinephrine side, remember that that's split into two markets as well. We have the multidose vial product, which began 2024 with us and one other player. There were two new entrants in the market last year. So they did take a bit of the market share and had to cut price a reasonable amount to get their market share. So we've seen both price and unit drops on that product. However, by the second quarter, we see things have kind of stabilized at this point. Additionally, the other epinephrine product is the prefilled syringe product.
Now that we had one competitor on. And last year, that competitor was not supplying the product due to operational issues. So we were the only player actually shipping the product last year. Now, this year, that competitor has come back to the market. So we are sharing the market with that player. But one of the things that we have had seen over time is that for this and other emergency syringes, we've been a very good supplier to our customer base. We haven't had recalls. We haven't had the shortages that our competitor has. So we've been a much better supplier. And because of that, we've actually been able to increase our price over time. So we charge a premium price to the competition because of our reliability. And also, we know that the customer base favors us because of our reliability.
That's not just on the epinephrine. It goes to other products such as dextrose, sodium bicarbonate, atropine, several other products where we're the major supplier in that market and have been a reliable supplier for a long time. So we've done a very good job at, first of all, expanding our manufacturing capability by doubling our prefilled syringe line at our IMS facility in South El Monte, and then increasing production over time as well. And so that's why earlier this year, we actually got an award from the FDA as a top supplier for shortage products for the epinephrine pens. So they gave us an award. And it's nice to get that recognition from the FDA as well so that they know you're a good supplier. Really helps our relationship overall with the FDA as well. So I think it's been a real positive for us.
I wanted to ask quickly on glucagon. I don't know if it's possible, but are you seeing some of the glucagon use go to Baqsimi, generally a conversion to the ready-to-use product?
I don't have the data on specific people, but we do see that market share shift. So as I mentioned earlier, it's gone from 10% of the people getting a glucagon script who are on insulin to 12%. So we've seen that growth. But we've also seen faster growth of Baqsimi. So we believe it has to do with that shift away from the regular glucagon product. And right now, Baqsimi has the largest market share in the glucagon market. So we're really happy about that because I think the patients realize it's the best alternative. So we're really happy with that.
Awesome. Wanted to turn to the rest of the pipeline, AMP-007, an inhalation product. Can you talk about the nature of the recent feedback from the FDA, how you're thinking about the market opportunity for this, if this is still potentially the only generic on the market if approved, and then also any possibility of patent challenge from the innovator?
Yeah. So AMP-007 is our second inhalation ANDA. And we have a GDUFA date in the first half of next year. As far as the conversations that we have with the FDA, and we don't usually go into detail about our submission and those kinds of conversations, but we do feel we're on track. Things are progressing as we expect. We want to make sure that we meet all of the regulatory requirements for this product because it is an opportunity where, as you mentioned, we could be the first generic, which would give us a significant advantage as a first-to-market generic. As far as patent challenges, we did notify the innovative product company about our application. They did not, our Paragraph IV. They did not issue a lawsuit at that time. So we don't anticipate that happening, but it could. And we're prepared. And if that happens. But it's unlikely at this time.
Okay. And then two questions. Can you remind us what cycle of review AMP-007 is?
This is the second cycle review for this product.
Okay. Gotcha. And then in terms of patent challenge, is there a window in which the originator can challenge?
Yeah. Technically, they have, I think it's up to 60 days. 45 or 60 days to sue you. They didn't do that. We're well past that. Theoretically, could they still sue us? Yes. But they don't have the Hatch-Waxman protection, which offers the 30-month stay and that sort of thing. So we would be able to launch the product.
Okay. Sounds good. For AMP-018, the GLP-1 injectable, was wondering because there's been a lot of concerns from investors for the current GLP-1s in the market about a potential price war, do you guys have any concerns about pricing or margins for this product? And also, would you have interest in pursuing other GLP-1 or GLP-1 drip assets?
Yeah. We've said all along we didn't see this as a major opportunity because we knew there could be multiple competitors. We do know that it is a significant market that's very large, very sizable. So there's still an opportunity for us to get in, but it's a smaller opportunity, as we've mentioned. As far as future reformulations into another GLP-1, we haven't disclosed that. We're working on that yet. It is a peptide, an important peptide. And that is in our wheelhouse, if you will. It's something that we do very well. So it's something we'll take a look at.
Okay. Continuing along the diabetes portfolio, so AMP-004, insulin aspart. I was wondering how the recent approvals of Sanofi's and Biocon's biosimilars set your expectations for what the approval pathway and uptake could look like?
Yeah. So we're always disappointed when somebody gets to the market before we do. But we're still very happy with our application. And now, as a reminder, this is our first biologic application that we have. We have one historic product or a couple of historic products that were converted to biosimilars, but were originally approved as NCEs. But this is our first biologic application as an application. So it goes through a different process. There's a different review team. There's a different set of things that we have to do. And it's much more complex than the NCEs or clearly than the ANDAs. So because of that, it's also been a learning process for us. But we're working very hard on this. We have a very active dialogue with the FDA. So it's pretty clear to us that the FDA also thinks that this is an important product.
We can see that from the amount of time they're spending on it as well, so it's something where we think it will be an important product for us. It should be the first of three different insulin products that we'll bring to market, and it's something that will help our cost structure as well in two ways. First of all, it will potentially be one of the larger products that we make the API for in our facility in China, and secondly, we have a pen filling line in the Amphastar facility for the finished product that isn't being used at all right now, so we've already made the investments in the plant and equipment and all the R&D to do these products, so bringing them to market will just be some very minor incremental costs. The overall benefit of the product will help us really alleviate a lot of the costs that we already have.
Okay. And then how confident are you into approval for this next year since this would be first cycle review, also your first biosimilar? And I think with Biocon, we saw them, I want to say, get at least two CRLs before it got approved. So it does seem like a complicated product.
It is a very complicated product, and like I said, it's our first biologic, so for complicated products, for complex products, I don't think a CRL is something that's surprising, so while we think we have a product and a package at the FDA right now that is approvable, I think it would be a huge upside for us and a huge win for us if we did get it approved, but I will say that when we take a look at our guidance and we've guided towards double-digit revenue growth next year, we give sales of this product a very low weighting, so it's really not important for us. We could get to double-digit growth next year without this approval.
Okay. Excellent. It was recently announced that you guys had licensed some products from Anji. Can you talk about the preclinical assets here? And it sounds like you're going into a new direction with oncology and ophthalmology. So if you can talk about your interest there.
Yeah. I think that's really what it does. It represents kind of our strategic focus on our future where we're looking for long-term potential assets. These are NCEs. They're in the oncology and ophthalmology fields, which we think are really good, strong fields to be in. But to talk specifically about these three candidates right now, it's probably too early because they're really in the preclinical stage. And so as we continue to develop them, we'll give more updates as we hit certain milestones, but right now, it's just more of a signal showing our strategic direction as we move forward.
Diversifying the portfolio.
One thing I did want to mention about this is something that probably we haven't communicated enough, which is that for this quarter, that $5.25 million payment to Anji will be expensed in R&D, IPR&D. So that's a one-time expense that we have. We had a previous payment of $750,000 that allowed us to do the detailed due diligence that we needed to do for this. We expensed that in the second quarter. But $750,000 really wasn't enough to talk about it, to break out in our 10-Q or our earnings release, especially since we hadn't signed the licensing agreement at that time. But now that we have signed that agreement and we have made this payment to An, that $5.25 million payment will be expensed in this quarter.
All right. Notes. And then broadly talking about the pipeline, so how is the company tracking towards its goal of for 50% of the pipeline to be proprietary products by 2026? And then is this the main driver for the company's view on BD opportunities?
Yeah. So we have stated that our goal, and it's our pipeline, not our product offering, but our pipeline is 50% in the proprietary range. So we are on track to get there next year in 2026. We're on track to have our pipeline be at least 50% in a proprietary-type product category for us. And then as far as BD, BD has always been an important lever for us in development. Obviously, our main focus is always organic growth, but BD is something that we've set up. We're very conservative with our balance sheet. We have that flexibility. If a product or an opportunity comes available to us, we have that flexibility to do that, but it would have to be the right product. We don't need it to grow our pipeline, but it's a nice lever to be able to pull if we need to.
Gotcha. Would the Anji licensing suggest an interest in going into new therapeutic areas or perhaps maybe that was like a one-off and you want to stick with core competencies?
I'll say we were really excited by the technology and our ability to create peptides and manufacture peptides and both APIs and finished products and work with them on a finished product was one of the drivers of it. So it's more of the technology-based and the therapeutic-based that was driving us to those. However, we are excited about the oncology and ophthalmology spaces. So those are things that are more interesting to us than other areas. So of course, we already have the endocrinology focus with Baqsimi. So I think we have enough different therapeutic areas right now. So I don't think we would be looking to expand into other ones.
Okay. Gotcha. Wanted to talk about margins since AMP has pretty good margins compared to other peer companies. How should we think about the profile over time, especially as proprietary products can expand margins, but then you've also called out some pricing pressure on current products? And then how can the company implement further cost control initiatives to manage any price pressures?
Yeah. So right now, Iron sucrose will be a product that is above our corporate average. So even with the extra competitors that we have in there, we still see this as being something that benefits our margin profile. And the same thing, Teriparatide, even though there is competition on that already, that should be above our corporate average. So that will help contribute to that trend, as will 007. So 007 is probably the biggest opportunity for more profits and more profitability given the size and scope and the pricing expected on that product. So we see at least three levers over the next 12 months that will help us launch and increase that margin profitability. This year, we've really focused on the cost component of that because we've had some cutbacks in some of the areas that you mentioned before, the Epinephrine and the Glucagon.
So we've really focused on cost controls up to this point, specifically cutting back overtime, cutting back positions where we didn't need it, where we had some redundancies, and just taking a look at the entire cost structure for the manufacturing and for the operations. So I think we've done a good job and kind of pushed most of and pulled on most of those levers already. So I don't think that there's a lot of opportunity to keep going in that area just given the fact that we still plan to grow. So because of the growth aspect of it, there's really not going to be a lot. But what we will see, hopefully, are the operating leverage that we're going to be able to get from iron sucrose, teriparatide, 007, and then potentially 004. So with all those things, they help us operate more efficiently. And so that's something that we're really looking forward to as we move forward.
Okay. So is it possible to say for next year, the net effect of having some of these new approvals could expand margins?
Yeah. So I believe that maybe right now in the third quarter, we're kind of at that low point for the gross margins. So I think starting in the fourth quarter, there's opportunities for us to begin to increase that margin because of that. And I think when you take a look at the second quarter, I think the gross margin exceeded some people's expectations because of our cost cutting. But we've done that already. So now it's just a return to growth and a return to growing the assets that are the higher profitable products. The new products, Baqsimi, and Primatene Mist all have above our corporate average. And so those are the things that are going to grow.
Okay. And then lastly, wanted to touch on policy. How do the latest tariff discussions impact your expenses given that the company imports some components and API?
Yeah. Right now, this is something that's always changing. We got to keep watching this at all times. What we have seen so far, first of all, what we guided to earlier this year was an expense of about $500,000 per quarter. That was based on the tariffs at the time based on the planned imports that we were making at that time primarily from our facility in China. We make about a half a dozen APIs there that we're currently utilizing in the US, so importing those. We didn't have the expense in early on. I think it was $250,000. We didn't have any expense in the second quarter because we delayed some of those shipments. We're managing that right now.
Part of that is because we had already built up a supply in the United States of APIs primarily to take us through most of this year and into next year with one or two of those even to go out even further than that. We had prepared for that. It didn't have much of an impact. Looking forward, we will go back to that. It should be about an impact of about $500,000 per quarter as we see it right now based on the current rules. That could change at any time.
Okay. Sounds good. And wanted to leave the audience with perhaps some kind of takeaway statement. So as you look out one year from now, what would you say looking back would be one of your top few achievements?
We'll take a look at that. I think it took us a long time to get iron sucrose approved. It was disappointingly long, but we were really happy to finally get that over the hump. I think that's going to be the first of several products that are above our corporate average margin rate, that teriparatide 007. I think those are just going to be a string of products over the next year that we get approved that help us improve our profitability. We're really looking forward to that upswing from this point. Hopefully, we've hit the bottom and we're on our upswing and we'll keep going up.
That's what it looks like. So thanks so much for being here. Really appreciate you guys coming out from California.
All right. Thank you. Thank you, Graham. Appreciate you having us.