Amphastar at BofA Conference: Strategic Transition Year

On Wednesday, 14 May 2025, Amphastar Pharmaceuticals (NASDAQ:AMPH) presented at the BofA Securities 2025 Healthcare Conference, outlining a strategic transition year. The company faces increased competition and regulatory slowdowns but remains optimistic about new product launches and strategic partnerships. The conference highlighted both challenges and opportunities, with a focus on long-term growth despite near-term headwinds.

Key Takeaways

• Amphastar anticipates flat sales in 2025, with a decline in existing products offset by new launches.
• Positive FDA interactions bolster confidence in the pipeline, particularly for AMP-002.
• The company is expanding into proprietary products, especially in endocrinology.
• A partnership with MannKind aims to enhance Baqsimi’s market reach.
• Manufacturing capacity is a focus to support future growth.

Financial Results

• Revenue: The company expects relatively flat sales this year, with declines in legacy products balanced by new product introductions.
• Gross Margin: Last year’s high margins are not expected to repeat. Future launches will exceed average margins but fall short of last year’s peak.
• Capital Allocation: Amphastar is prioritizing business development to acquire proprietary products, especially in endocrinology.

Operational Updates

• FDA Interactions: Recent engagements with the FDA have been positive, with quick resolutions to information requests, particularly for AMP-002.
• Manufacturing: Limited capacity for AMP-002 affects potential market share despite exclusivity.
• Pipeline: An action date for AMP-007 is anticipated in Q3.
• Partnerships: Co-promotion with MannKind for Baqsimi is underway.
• Epinephrine: Sales of pre-filled syringes now surpass those of multi-dose vials.
• Insulin: The company is pursuing an interchangeable pathway for its insulin products.

Future Outlook

• New Products: Amphastar plans 2 to 3 product launches later this year.
• Primatene Mist: The company expects minimal impact from potential generic competition.
• Baqsimi: Sales are projected to grow steadily over the coming years.
• Margins: Profit margins are expected to decrease in the short term.
• Strategy: The company is open to mergers and acquisitions to drive growth.
• Manufacturing: Expanding manufacturing capacity is a priority to meet demand.

Q&A Highlights

• FDA Cutbacks: Contrary to expectations, FDA efficiency has improved, with smooth inspections and action dates.
• Section 232 Investigation: The impact of potential tariffs depends on whether they target finished products or components/API.
• AMP-002: Increased confidence due to a swift response to an FDA information request; a single-digit market share is possible.
• AMP-007: A response is expected in Q3.
• Primatene Mist: Market dynamics and patent protection make generic competition unlikely.
• Baqsimi: The product is expected to have a long lifecycle due to formulation and device patents, with the MannKind partnership proving beneficial.
• Capital Allocation: The company is keen to expand in the endocrinology space with proprietary products.
• Insulin: Significant investments have already been made in insulin production.

For more detailed insights, please refer to the full transcript below.

Full transcript - BofA Securities 2025 Healthcare Conference:

Jason, Analyst: 2025, kind of a transition year for you guys. Right? You you you absorbed some competition to sort of your legacy generic based business, and and you’ve got sort of the growth opportunity in front of you, which is gonna be driven by your more your pipeline, which is a mix of proprietary brand and generic and then Baqsimi. So, you know, with that said, I I don’t know if you would add anything to, you know, investors on how to think about Amphastar as a company, as an investment opportunity and where you kind of want the company to be in the next three to five years.

Bill, Amphastar: You’re exactly right about it being a transition year for us with as we said on our first conference call of year in February, we expect this year to have declining sales on several products, and that’s unusual for us because most of our products historically have been more immune to competition. But this year, we are expecting to see or have seen competition on the epinephrine vial product, which, you know, had a couple new competitors coming last year. Glucagon had a new competitor launch in the first quarter of this year. Fotonodion, another one where we see another competitor on. And at the same time, we’ve seen a little bit of a slowdown at the FDA.

But we have four products there right now that we think we can get two to three launches later this year. So that’s why, you know, you’re right about the transition year, but and why we’ve also said we expect to see sales relatively flat this year. Because at the beginning of the year, we’re gonna see these declines, but then at the end of the year, we we expect to see increases because of these pickups of these new products.

Jason, Analyst: Okay. A couple of high level questions on the DC front. First, with a lot of dislocation in FDA and headcount reduction, you know, usually when there’s a lot of facility supply facility supplier inspections that tends to be what drives a lot of shortages. Shortages have been things that you guys historically have been nimble in being able to respond to and drive value in certain products. And so what’s your sense lay of the land in terms of FDA and that dynamic for you?

I mean, you feel FDA on two fronts, I imagine, right? You’re and a portfolio, your pipeline turning approvals around. And if you feel like you’re getting the level of engagement that you’ve gotten historically, and then separately, you feel like the on the inspections and things like that, that that’s happening with the same sort of frequency?

Dr. Zeng, CEO, Amphastar: Yeah. It’s interesting because intuitively with the cutbacks at FDA, you would expect, to see maybe a slowdown in their timelines on inspections or, action dates and such. But, actually, we’ve seen sort of the opposite. We’ve had an inspection. They were there full five days.

Everything went well. We’ve had two action dates that were met. One of them was actually a week early. So our experience has been that the agency is actually, in some ways, maybe a little more efficient now. I I have the same feelings that that with cutbacks, there’s gonna be some things that get that get lost in the shuffle and cause delays.

But right now,

Bill, Amphastar: we haven’t seen it. Okay.

Jason, Analyst: In terms of the administration’s two thirty two investigation, it seems much broader than when I think about your business. It seems like it’s more about oral solid dosage, anti infectives, what are called critical medicines that where there’s a heavy reliance on China. You guys play, I think, of you as more of a niche company, inhalation products, injectables, things like that. So when you when you see that and and you try to conceptualize, what is, like, really the solution that the administration is after? And can Amphastar play a role in any way to, address that?

Are are are you at the table discuss discussing with the the government as this two thirty two investigation is ongoing?

Dr. Zeng, CEO, Amphastar: Yeah. I think it’s a it it puts us in a unique position, right, because we manufacture all our finished product in The United States. So obviously, that looks like it’s a good opportunity for us. However, depending on the details of this, what happens if you have components and API, and we do rely on some components and API outside The United States. And if they they tariff the components in the API, then that puts us into kind of more of a disadvantage in some cases.

Because if other of our competitors are manufacturing their finished product and getting their API and components outside The United States and then they they don’t tariff finished product and they come in, then they have an advantage over us because we still need to get certain API and components outside The United States. However, if they if the tariffs target finished product, well, that’s great for us because we manufacture our finished product in The United States. So I think the uncertainty we’ll have to see how these things, play out, and we are at the table. We do discuss these things, with our trade groups and such, and we we the best we can do is just watch and see how they they, roll these things out.

Jason, Analyst: Yep. Okay. So, yeah, pipeline’s key for you guys. You had a few updates on the one q call. Maybe I think it feels like you guys offered more detail than you’ve historically offered on on two programs in particular, which are the two product products we kinda see as, like, your most near term interesting value opportunities, would be AMP two and AMP seven.

So maybe just the high points on each of these and where you think you’re at. And I know that you’ve mentioned that sort of, I think, to revenue guide sort of soft guide, if you look, because I know you have an official guide, but like your outlook for revenue for the full year assumes, I guess, one of three potential pipeline approvals.

Dr. Zeng, CEO, Amphastar: Yeah. So on AMP two, we had a GDUFA date a little more than two years ago where the FDA missed that action date. And throughout this the last two years, we’ve been having routine normal communication with the FDA about what are their concerns, what are their issues. And honestly, it was a little frustrating on our end because we really never got an answer of what exactly was holding the application up. Recently and after we the award that Bill was referencing, this award for our, for, the drug shortage award that we got from the FDA, it gave, Bill and and our CEO, Doctor.

Zeng, an opportunity to meet with the director of CEDAR. And in that meeting, they had a great conversation about AO two. And she was very much aware of it and very much engaged with and and and understood the our frustration with it. And then within two within two weeks, we actually got an IR, an information request, which was great from our perspective because at least now we’re getting some sort of feedback from the agency. What are you looking for?

And the great thing is is that we were able to respond to that IR within one day, so it wasn’t major. So now our level of confidence with this product becomes much higher than it was maybe prior, just because we feel like now we understand what they were thinking about, and we were able to address it in a very in a very short time.

Jason, Analyst: Hey. Can can I stop you there for second? Yeah. When you get an IR, do they tend to be isolated? Like, they wanna lay out all the issues in one IR, or are there multiple IRs and ones they follow?

Like, how do we interpret what an IR really

Dr. Zeng, CEO, Amphastar: Yeah. I mean, that’s a great question, and it can mean all of the above. So it can be all inclusive or it can

Bill, Amphastar: be Just put in a word. We usually don’t talk about IRs because we can’t always read into them.

Dr. Zeng, CEO, Amphastar: Right.

Bill, Amphastar: But we did this time because we felt it was such an important one because we hadn’t heard anything really in three years. Because we had responded to a CRL, then they missed the action date, and it had been two years since they missed the action date. So because of this, we thought that we should communicate that we did have some official written communication as opposed to the oral communication that we’ve been having for the last year. Yeah.

Dr. Zeng, CEO, Amphastar: Absolutely. You can No. No. Absolutely. I mean, Bill’s a % right.

You know, sometimes the hardest thing is is is is trying to explain to people what the issue is and without, you know, really getting into the details. And I think in this particular case, because we’ve been talking about having interactions with the FDA, I think we had 16 of them prior to that meeting. And what did that really mean? You know? We have so many meetings.

But now that we actually got an action item, it made us feel so like, okay. Now we’re we’re making some headway. So

Bill, Amphastar: And going back to your question, IRs are all over the place. It could be anything that they want to tie up in the time frame between your submission or your last response and the action date. So it could be that they ask you five things, and some of those are complicated things like, you know, do another you know, show, show some data on this, you know, this study. And other ones can be, you know, change this the word on this label to a boldface. You know, they they’re they run the gamut, but there’s things that come in individually and are not a complete response.

So the complete response letter is supposed to be everything that’s open at that point in time. This is, hey, this is an open item now. Please address it. So Does it

Jason, Analyst: make sense to you that you’d be sitting for two years with, like, a very negligible IR on the other side of that?

Bill, Amphastar: I’ll say it’s a difficult situation. That’s unusual for us, and it’s really hard

Dr. Zeng, CEO, Amphastar: to put that. We’ve never seen a situation where the FDA has missed an action day. And for two years, we never. Yeah. So it’s something to do.

Bill, Amphastar: It’s certainly unusual, and I’m sure the FDA has their reasons for

Jason, Analyst: doing what they’re doing and the

Bill, Amphastar: timeline that they’re doing it and, you know, just they’re just maybe not all be apparent to us.

Jason, Analyst: Yeah. And now this is injectable product, IQVIA sales, greater than 500,000,000. Not saying much more than that. There are no generics in the market? That’s correct.

That’s good. If you are approved, in theory, you could have some

Dr. Zeng, CEO, Amphastar: We do have CGT designation on this. So it’s possible. Again, we don’t know. We’d have to be the first and only approved in order to get that exclusivity and get that Competitive generic therapy.

Bill, Amphastar: So it’s something where the FDA has put, on it that this is an important product to them. It’s a big enough product that it should make a difference to the market out there and that they wanna encourage people to, to work on it. So it’s something that, you know, we’ve been given that so we could it’s it’s it’s similar in a lot of ways to the hundred and eighty day exclusivity for the first, you know, paragraph four filer, but this is for things that don’t have that paragraph four

Jason, Analyst: Mhmm.

Bill, Amphastar: Challenge. So it’s something that we’re working on, and we have that. But and we could get an exclusive period. However, they could also approve five people and say, but not that

Dr. Zeng, CEO, Amphastar: we That also has CGT designation. Yeah. And then it really becomes a race to who launches first.

Bill, Amphastar: So it’s not specific to one company like a paragraph four. They could have multiple people doing it, so you’re not necessarily alone.

Jason, Analyst: But Logically, if if if a whole bunch of different filings were held up for, this amount of time and and and it wasn’t some complicated major thing that was overcome, like, if there were some complicated major hurdle in the regulatory science, that that would suggest to me that, like, maybe the floodgates could open for multiple players. But if it’s sounds like if it’s a trivial IR that was the swing factor, and they’re finally maybe just getting around to it because administratively, they’ve got deeper That’s

Bill, Amphastar: what it is. I don’t think that’s what it is at all, but it’s it’s really hard to say what it is at this point in time. So it’s not an admin you know, a trivial administrative thing. I think it’s more of a something where they have a difficulty in either making a decision for one reason or another. And so it’s it’s like, how do you make a decision?

And, you know, it I really can’t say too much more about Yeah.

Jason, Analyst: I I I guess, like, we’ve just given everybody a tutorial as to why you don’t tell the street about these things because there’s a lot of questions that ensue, and and you probably just wanna avoid that entirely.

Dr. Zeng, CEO, Amphastar: There’s a lot of nuances to that. Sorry.

Jason, Analyst: But in theory, this could, I mean, maybe be as large as some of your disclosed generic products if you have single source exclusivity.

Bill, Amphastar: So here’s the thing, though. We have also stated that we do have a limited manufacturing capacity for this product because the manufacturing process is very difficult. And it’s more complicated than some of the other manufacturing processes. And, therefore, what we have said is that even if we are the only generic, we can’t get to a level of market share that you would normally expect in a first and only generic to get to. And we haven’t really quantified that much more other than to say that some of the at some point, some of the high ends of the ranges of potential sales were were too high.

Jason, Analyst: So is that something that over time, if you got through the regulatory hurdle, you may look to solve for with cash and investment or in the manufacturing side? Or do you think that

Bill, Amphastar: This product is so specific that I don’t see us potentially putting in the money that we would need to do for this product because it’s not something that we could then replicate and use for a different product.

Jason, Analyst: So best case is pricing remains healthy, but share is niche.

Bill, Amphastar: Yes. Yeah.

Jason, Analyst: How how how niche just in percentage terms are we talking in terms of market share?

Bill, Amphastar: You know, we haven’t said, but I’ll say it’s it’s probably less than 25%

Dr. Zeng, CEO, Amphastar: market share.

Jason, Analyst: Okay. It’s still pretty meaningful if that’s your threshold. Okay. And then, o o seven?

Dr. Zeng, CEO, Amphastar: Yeah. So o o seven, we received a, a CRL in this earlier this year. We’ll be responding to it within the next couple weeks. We

Jason, Analyst: classify it as a sort of

Dr. Zeng, CEO, Amphastar: a minor CRL. We do expect an action date to be in the third quarter of this year. This is a product that there is no other generic that we there was a paragraph for with, but we were not we did we did not, we did not get sued on on on that finally. So, there’s a possibility as well for a hundred and eighty day exclusivity once we get that approved.

Jason, Analyst: And I think you said on the call if it’s, ends up being a a minor issue, it could be, like, a ninety day turnaround on the regulatory review time.

Dr. Zeng, CEO, Amphastar: Typically, that’s the way it works. Yeah.

Jason, Analyst: So in theory, it could be a twenty twenty five contributor. And how should we think about, like, the supply dynamics with something like that? Like, would you be you’re clearly ready ready to spring to action in one of these products or maybe multiple.

Bill, Amphastar: Yeah. So going back to your original question about the, you know, the guidance for the year of getting to flat and what that contribution was. We’d originally said that we would get contributions from two products. Our expectation was contribution from two products later in the year. And at the time, we had different probabilities.

We you know, we had four products that had potential to be launched this year. Since then, 18 has gotten a CRL that’s that’s put us out of that that launch. But, with o two, our probability of launching that this year, we think, has gone up just because given the ease that we were able to respond to the, single IR, it makes us more comfortable that the next step is more likely to be an approval. We thought previously the most likely next step was a CRL. And now it still could be a CRL, but, you know, it could be an approval as well.

And then what we’ve done with this this guidance to get the flat is we’ve probability weighted the different products. And so if we have, like, a 70% chance of one product and a 60% chance of another and a 50% chance of another Mhmm. You know, all none of those things could happen or all of them could happen, but we need to get contributions from two of those products to make our flat number. Okay.

Jason, Analyst: And maybe to you know, getting to your your back to your base business, right, you you have two, what I’d characterize as as as more higher visibility, stable growth drivers in Primatene and and Baqsimi. What are the barriers to entry for any competition directly to Primatene Mist? Like, does anyone try to develop a generic? What is the patent situation like there? Or is it just maybe not big enough given sort of the cost of a development program to go after?

Bill, Amphastar: So with Primatene Mist, because it’s an OTC product, it has a different market dynamic than it would from a normal prescription product. So while it’s a hundred million dollar product, the way we see it is that it’s unlikely that someone would wanna try to genericize it. And we know there’s been no paragraph four filings of the date because we have, patent protection out until next year. But, the way we see it is, alright. So if half of the market is likely to stay with the brand anyway, so let’s say it’s a $50,000,000, you know, total addressable market for the generic, and of that, they’d probably have to offer a 50% price reduction to get the market share.

Jason, Analyst: So you’re saying

Bill, Amphastar: around 25,000,000, and we could we would then launch our own authorized generic for that. So you’re talking maybe a 12 and a half million dollar sales market, and now your mark margins are getting lower. And it just doesn’t seem like the amount of money that you have to spend on a generic inhalation product to get to that market. It just doesn’t seem like it would be worth it to us. Yeah.

Jason, Analyst: That would be like a generic store brand.

Bill, Amphastar: Right? Exactly. Exactly. So we just don’t see that as being it’s a possible scenario, but we don’t see it as being a likely scenario. Yep.

Jason, Analyst: Okay. And Vaxmi, pretty straightforward situation with the IP that you have.

Bill, Amphastar: Yeah. So we’ve gotten multiple patents there. And And beyond the patents, though, because we’ve got a formulation patent, we’ve a device patent, the combination of the formulation with the device patent. So we’ve got three different patents that go out there more than ten years. So but more importantly, when we took a look at Baqsimi, we thought that this would be an extremely difficult product to genericize.

And that’s coming from the company that was the first company to genericize the glucagon kit. And not only that, but, you know, that was off patent for twenty years before we could get it. And then it took four years for another company to get a generic of that approved. So we think this is so harder to do than that would be that there would be a limited number of people that could do it, and it would probably take them a very long time. And to, we also have signed an exclusivity agreement with the device manufacturer where we are the only company that can put glucagon into that device for a long period of time.

So then a company who’s going to try to genericize this would have to come up with a device that was similar but didn’t, you know, violate their patents. And that that would be extremely difficult as well. Okay. So we think that this is something that, has a very long life to it. That’s one of the things that we really liked about it because we think this is not only a good cash flow right now, but we see this as something that’s gonna have a very long life to it.

Okay.

Jason, Analyst: And now maybe the MannKind partnership, how did that come about? Did you did you feel like you were sort of maybe didn’t have enough sales push, you know, on your own end internally after you had the product, you know, within your portfolio?

Bill, Amphastar: So we have a a really good relationship with MannKind because we sell them the insulin for their Afrezza products. So we’ve we’ve been dealing with them for a very long time. And, you know, we’ve talked to them. Since we got bought back, Stamie, we’ve had conversations about with them about how we could, work together on it. And in the end, we decided for ourselves that what made the most sense was just a co promote arrangement where we’re paying them to promote Vaxemia in the second position.

And I think it’s a real win win because we get we more than double our sales force, and we do so in a very economic basis. And then Mankind wins because they’ve got another product to talk about, and they’re getting paid to do that.

Jason, Analyst: Yeah.

Bill, Amphastar: So it’s it’s a real win win. We we’ve seen the results starting to pay off already with some of the the anecdotal data we’re getting and some of the the script data we’re getting in in the areas that they’re covering where we didn’t have that footprint. So we’re we’re very happy with the way that this has has started off.

Jason, Analyst: And so where specifically are

Bill, Amphastar: you seeing that benefit from from mankind? So we’re seeing it in the script data in in areas where we didn’t have people because we have a limited number of reps. So they have more reps than they have reps in places where we didn’t. And we also have anecdotally seen some targets of some high writing high glucagon writing doctors that they’ve been able to move to our product that they’ve had a good relationship with.

Jason, Analyst: This is doctor types you weren’t reaching or geographies that you weren’t reaching?

Bill, Amphastar: They’re both, really, because they’re covering their coverage is in certain, has certain geographic coverage where we didn’t have. And then also they were able to get into certain doctors’ offices in geographies where we were, and we hadn’t been able to get into those offices. And they were able to do that.

Jason, Analyst: Is this really key in your mind to unlocking the type two diabetic patient and higher treatment rates there?

Bill, Amphastar: I don’t know if I’d call it key, but I think it’s like I said before, it’s a real win win for us because we expand our sales force, and we’re doing so, I think, in a way that’s you know, we’re spending money on it, but we’re not breaking the bank either to get this done. So I think it’s a very economical way to significantly increase our footprint. Yep. And

Jason, Analyst: you’ve got peak product sales guidance out there, but have you specified when you think

Bill, Amphastar: you might get to that level? The only thing we’ve said about the timing of that was that it would be after the five year period where we owe Lilly payments for this because we have, four potential milestones that we would pay to Lilly. So we just wanted to be clear, when people took a look at that sales guidance of 02/1950, ’2 hundred ’70 ’5 that they didn’t think that it was happening during the first five years that we own the product. Mhmm.

Jason, Analyst: So after the first five years, then those Lilly payments sunset and then some point in time after that.

Bill, Amphastar: And so yeah. We haven’t said how much longer after that.

Jason, Analyst: Yeah. Okay. And then overall, like, just thinking about, you know, the puts and takes in your margin profile, as you said, you know, this is a bit of a reset year for for for company then. Our our product opportunities like two seven. Is that enough coupled with maybe the incremental growth you get in Baqsimi to drive back to kind of some of the historical peak operating margins?

Bill, Amphastar: So going back to those, last year was we had some onetime events really because of the structure of the deal that we had with Lilly. So when we booked revenues that when Lilly was selling back CME, all of the revenues that we booked were net of all of Lilly’s expenses. So we had a % gross margin on those sales. So we won’t get back to a product that has a % margins again. And so to do that, we’d need multiple products that are above the corporate average.

And now while we think that the next four launches will be above the corporate average, I don’t think that gets us to where we were last year, but it gets us above where we were in the first quarter of this year. Okay.

Jason, Analyst: So let’s see. Going down the list, a couple of products that you’ve seen a little bit of competitive headwinds to would be epinephrine and the glucagon kit. So with glucagon kit, is that primarily Beatrice is, like, a single new competitive entrant that’s weighing on that business for you specifically?

Bill, Amphastar: Yeah. So they’re you know, they launched in the first quarter. And what we’ve said about that is that because their launch wasn’t at the beginning of the first quarter that their impact is not fully baked in the first quarter in terms of units or in terms of pricing decline. So we have further erosion in both of those as we move forward into the second quarter.

Jason, Analyst: And so 2Q, 3Q will be like a better kind of approximation of like the new reset runway. Right? And then what about with epinephrine? Right? I mean, because the impact was on a subsegment of that business, right, which is makes up call it directionally half of

Bill, Amphastar: So last year, half of our sales were in the multidose vial form of it, and our half of our epinephrine sales were in the multidose vial form, and that’s where we had a few new competitors last year. So we’ve seen both the units and the margin come down on that with pricing coming down. So we haven’t broken out the first quarter. We haven’t said what that breakout is, but it it is now to the point where the prefilled syringe is larger than the multidose vial. Okay.

Jason, Analyst: And you do get a fair amount of questions about when Pfizer had its issues at Rocky Mount and exited or temporarily exited some markets. But then I think you mentioned maybe they came back in dextrose over the quarter and kind of where is normalization, if you will, on competitive supply dynamics across the portfolio?

Bill, Amphastar: Yes. So with those shortage products, and we won the shortage award from the FDA for the epinephrine prefilled syringe because we were able to supply 100 of the market for that product over the last, more than a year. So, we have the ability to supply all those things. We have the capacity to supply all of them. If you know but many of these things are dual source products.

And so if there are two players in the market, the hospital chains will buy want to buy from both. They don’t want anything where there’s just a single source for this. So, you know, they will, you know, give sales to both companies when when they’re available.

Jason, Analyst: Yep. Okay. So in terms of capital allocation priorities for you guys, you guys have shown a willingness to go out, do meaningful size BD for for your company. Where do you stand with respect to that? And is there an appetite to maybe want to bring in an additional complementary product to Baqsimi?

As you think about kind of the, I guess, rollout of new product opportunities, you do have some biosimilars insulin and, you know, a stated strategy around GLP-one. So, you know, do you see kind of like the footprint migrating to endocrinology and diabetologists?

Bill, Amphastar: Yeah. So we we really do like the endocrinology space. So our first choice would probably do expand in that space, and we’ve looked at multiple assets in in that space over the last year. And we but the other thing is that we really, would like to move toward the proprietary product space. So that that’s where we’re looking the most right now.

And so if we find the right endocrinology product, then we’d be, you know, we’d be very happy about that. But we’re also interested in some of the spaces outside of endocrinology where we think we might either have a manufacturing expertise or have some other kind of expertise that would help us with the development of those products. So we are looking at multiple things on the proprietary side outside of that space.

Jason, Analyst: Yep. Okay. And then I ask this question a lot, but like so for insulin, right, we’ve seen a lot of companies try it and not have much success. How do you view success? And is there a certain amount of supply share you need to be producing at capacity?

I guess there’s a notion that like the investments, the CapEx investment to get in there and be able to make product at a competitive volume maybe isn’t worth it given how prices have deteriorated. And what will be the pushback onto onto those points?

Dr. Zeng, CEO, Amphastar: Yeah. So I think the most important part for us anyway is is the the pathway that we’re we’re going is an interchangeable pathway, meaning that at the pharmacy level, they could you know, they prescribe our product just a lot as they would they would it would be a generic form of insulin. Yeah. It wouldn’t have to be a separate script. So that convert to, the patient is is key, that, the interchangeable is is very key.

That’s why that’s the pathway we said. We believe our past kinda gives us the tools to get there. As far as capacity levels, I’m gonna let

Bill, Amphastar: Bill take that In the investment levels, we’ve already made significant investments into, insulin production. I mean, we bought the API facility from Merck in France that that started it, and then we built the API manufacturing for insulin in China as well. So we can do the recombinant human insulin in France, and we do the analogs in China. So we’ve built that API capacity. We’ve also built the high speed finished product lines in The United States as well now.

So we have that capacity, and that’s underutilized right now. So for us, we’ve made most of the investments. Everything right now is more r and d related and incremental investments. So there’s not a significant amount of CapEx that we would need to go to the next point. And, yeah, we started making these investments when the price was higher.

But even with the price where it is now, we believe we can sell insulin at a at a at a rate and at a margin that’s above our current 50% margin rate.

Jason, Analyst: Okay. Well, we’re out of time, gentlemen. So thanks so much for joining us in the discussion.

Bill, Amphastar: Alright. Thanks, Jason. Alright. Thanks, Jason.

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