Amphastar at Barclays Conference: Strategic Focus on Growth and Innovation

On Wednesday, 12 March 2025, Amphastar Pharmaceuticals (NASDAQ: AMPH) presented at the Barclays 27th Annual Global Healthcare Conference. The company showcased its strategic initiatives, highlighting strong sales performances and future growth plans while acknowledging challenges in competitive markets. Amphastar’s management emphasized their focus on expanding their product pipeline and leveraging partnerships to boost growth.

Key Takeaways

• Amphastar’s products Baximy and Primatene Mist achieved $102 million in sales.
• Increased competition is affecting epinephrine vial and glucagon markets.
• The company anticipates high single-digit growth for Baximy in 2025.
• Amphastar is expanding its pipeline with biosimilars and proprietary products.
• The company is exploring acquisitions in the endocrinology space.

Financial Results

• Primatene Mist sales exceeded expectations, reaching $102 million.
• Baximy continues to perform well, with a 3% price increase in the U.S.
• Epinephrine vial sales faced erosion due to new market entrants.
• High single-digit unit growth is expected for Baximy in 2025.

Operational Updates

• Amphastar signed a co-promotion agreement with MannKind to enhance Baximy’s market penetration.
• The company targets 15-18% market penetration for Baximy, aiming for $250 million to $275 million in peak sales.
• Primatene Mist’s growth is supported by direct-to-consumer marketing and physician sampling.

Future Outlook

• Amphastar is focusing on biosimilars and proprietary products, including AMP-018 and biosimilar insulin products.
• The company is awaiting regulatory actions on key pipeline products, including a generic inhalation product.
• Amphastar is actively seeking strategic acquisitions in the endocrinology sector to complement existing products.

Q&A Highlights

• The MannKind collaboration is expected to accelerate Baximy’s growth from Q1 to Q3/Q4.
• The glucagon market faces challenges with new entrants, impacting sales dynamics.
• Amphastar is awaiting FDA feedback on Interparatide, with tempered expectations due to competition.

For a deeper dive into Amphastar’s strategic plans and financial performance, please refer to the full transcript below.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Unidentified speaker, Interviewer: Early in the morning there. Good morning, everyone.

Thanks for joining us at the Barclays Healthcare Care Conference and continuing our sessions for the day. We have the management team from Amphastar with us, Bill Peters, the CFO and Tony Mars, the EVP, Regulatory Affairs. Bill and Tony, thanks for joining us today. Thank you. And I wish you have a great lineup of meetings and productive conference.

Before we go into the Q and A, I would love to invite you to provide some opening remarks around the company, and we can then parse through some of the questions.

Bill Peters, CFO, Amphastar: Yes. So Amphastar is a company that was founded back in the late 1990s by Jack Tsang and Doctor. Mary Lo. And we’ve always been focused on working on the more complex side of the generic business, so the complex injectables and we’re kind of famous for being one of the first to get enoxaparin approved. We’ve used those learnings to then develop more complex generics such as glucagon.

We were the first and only one for four years on the glucagon generic injection kit. Now we’re taking those learnings and moving into biosimilars and proprietary products as well. Right now working on three different insulin biosimilars as being one of the key initiatives that we’re working on

Unidentified speaker, Interviewer: today. Got it. And you recently reported your Q4 earnings. Can you walk us through some of the key points there and then maybe use that as

Bill Peters, CFO, Amphastar: a segue to also discuss the outlook for 2025? Sure. So, right now, we had a really strong quarter for Baximy and for Primatene BIST. Both those products are showing growth. Primatene BIST was particularly strong in the quarter.

And also we had a long term goal of getting to $100,000,000 in sales for that product and we surpassed it this year hitting $102,000,000 So we’re really happy with the progress and the trajectory for that product. Also, Baximu is performing well. And while we have some setbacks in the quarter, we have more competition on our epinephrine vial product. So remember we sell epinephrine in both pre filled syringes and vials. So the competition is on the vial side

Tony Mars, EVP, Regulatory Affairs, Amphastar: of that. I’ve had two new competitors launch over the last several months. So we did see some price and unit volume erosion in the fourth quarter.

Unidentified speaker, Interviewer: Got it. And as it relates to your outlook for 2025, I would love to dig into some of the key priorities that you have there.

Bill Peters, CFO, Amphastar: So, the key priority is really growing backsemi further. And to that end, we actually have signed a co promote agreement with MannKind. So, they’re going to be using their sales force to promote our product as well. It’s a fee for service arrangement and I think it works well for both of us. We’re really happy with it.

And as you probably know, we’ve had a long term partnership with MannKind. We supply them the insulin API for their Afrezza product. So, we have a good relationship with them going back. So, really, I think it’s a win win scenario for us. So, we really want to make sure that we get this vaccine moving on a faster growth path than it had last year.

So, that’s why for this year we’ve also given guidance that we expect high single digit unit growth, which is a little higher than it was last year. And we’ve also taken a price increase in The United States of about 3%. So we’ve had some price upside and some unit upside this year. So, we’re really excited about the opportunity for that product to continue the growth pattern and accelerate the growth pattern this year. Additionally, Primatene Mist, we see this as a high single digit growth rate type of product again as we’ve surpassed that $100,000,000 point.

I know some people saw that $100,000,000 point as like a peak sales kind of target, but we’ve never set it as a peak sales target. We’ve just set it as a growth target out there for last year to give analysts something to see how far we thought it could grow. And it grew so nicely that we expect it to continue growing this year. We’re increasing our physician sampling program, still continuing to do our DTC marketing on that one. So, we definitely see that one as being a good grower.

But then on the negative side for the coming year, we have more competition on glucagon. We’ve had a new competitor into that. So, on the glucagon injection kit, so we see both price and units declining there. And then on epi, we have as I mentioned as we saw in the fourth quarter, there’s some new competition there too. So we do see some price and unit erosion

Tony Mars, EVP, Regulatory Affairs, Amphastar: there.

Unidentified speaker, Interviewer: Got it. And as we maybe digging through Baxmi again, starting with just you had this asset for more than a year now. And

Bill Peters, CFO, Amphastar: help us understand how does this product perform related to your own expectations? Yes. So far, it’s actually outperformed our expectations. So when we bought this product, it was going to be one of our we saw this as being a really key product for us. It fit very well into the strategic initiatives that we were working on.

So first of all, we were the only ones at the time selling the Glucagon generic. And so this was a brand in Glucagon. So we really like that market. We’re working on other products in the endocrinology space, the insulin products that I mentioned earlier and also GLP-1s. So it fit well into that.

Also we took a look at the formulation and thought it was really novel, very unique, very difficult to replicate. So one of the things that we really liked about Baximy was the fact that has we think a very long life ahead of it. And we also saw a very underserved market. So, we saw that only ten percent of people who were getting insulin were getting a glucagon script filled. And the Diabetes Association recommends that everyone who’s on insulin gets a glucagon script filled.

So we saw that as a significantly underserved market there. And actually over the year and a half, almost two years that we’ve owned it, that increase that rate has now increased from ten percent to twelve percent. So we’ve definitely seen an upward trend there. So that’s led led to the some of the growth in Baximy. So it’s performed it’s actually exceeded what we thought we would do when we bought the product two years ago or signed an agreement two years ago.

So we’re happy with that, but we have to keep on the gas pedal there. And that’s why we’ve signed that agreement with MannKind for the Kokomo to accelerate the growth this year.

Unidentified speaker, Interviewer: Understood. And you commented about your collaboration with MannKind. So can you give us a little more color on what this means in terms of sales force? And also maybe towards the profitability dynamics of this collaboration?

Bill Peters, CFO, Amphastar: Yes. So right now, this is it’s a fee for service arrangement. We haven’t disclosed how much it is. We haven’t disclosed their sales force size. But what we have said is that their sales force is larger than our existing sales force.

So this more than doubles the number of representatives out there who are going calling on doctors, endocrinologists to promote the product. And we think that that will really help with the growth trajectory this year.

Unidentified speaker, Interviewer: Got it. Thinking longer term, how should we think about the peak sales potential for this asset?

Bill Peters, CFO, Amphastar: Yes. So, we’ve been looking at $250,000,000 to $275,000,000 long term peak sales for the product. And if you take a look at what gets us there, it’s really only that I had mentioned that we’ve gotten to about 12% penetration on the number of people with glucan. It really only takes us getting above that 15% threshold to like 17%, eighteen % kind of range to get to that target. So, we think that that’s a very achievable goal.

And we haven’t said when we’re going to get to that, but we think it will take several years to get there, but we do think that it’s an achievable goal. And as I mentioned earlier, we think this is a really long life product. So we think that this is something that’s going to keep generating and keep cash flow for the company going for many years.

Unidentified speaker, Interviewer: Got it. For your stakeholders, as we look at this collaboration, what could be the data points or key milestones that we could look at to see that this collaboration is progressing as it should and that it’s delivering the results?

Bill Peters, CFO, Amphastar: Yes. So one of the things that we’re going to be taking a look at is the IQVIA sales level, the unit level in The United States and watching that growth trend. So we’re going to be monitoring that throughout the year and working with them to make sure that this we’re getting the right targets and the right doctors. So, we think as I said, we think that this has high single digit growth rate this year. So, what we’re going to be looking for is that growth rate to grow and accelerate over the course of the year.

So they just started promoting that in the first quarter. So we haven’t had a lot of time to get out there to all the different endocrinologists that they’d want to yet, but we think that so the way we look at it is that we’re expecting a certain level of growth in the first quarter and by the third or fourth quarter, we expect that to significantly increase.

Unidentified speaker, Interviewer: Understood. Maybe you could use that as a sec to discuss the broader dynamics within the glucagon market itself. While Noah Lilly exited this late ’twenty three and then we had

Bill Peters, CFO, Amphastar: to launch in 1Q ’twenty five, How is the market overall evolving? And what’s the market dynamics here overall? Yes. So right now, you have to remember that it’s not really one market. It’s two markets for the glucagon injection kit.

So, right now, there’s the core market or the historic market, which is the bigger side, which is the anti hypoglycemic market, which is the individual patient population, the person who’s on insulin getting this. And we’ve seen that shrink over time as people are moving towards the ready to use products, which we think are much better for the patients such as Baximy. So, we see that trend continuing. And right now, it’s our sales are only about 30% for that product to the anti hypoglycemic market. The other 70% is the diagnostic side.

And we see that to be a relatively flat market and that’s probably where some of the competition will be. So there’s already us and one other player in that market and then now a new entrant coming in to the market. So there’ll be three players. But we have a strong market share in that and we see that continuing to be a good market for us, but a flat market. The market size will be flat.

Understood.

Unidentified speaker, Interviewer: Primitive, Mr. Again, commented around outlook for around high single digit growth. So what is driving this? And as we think about the various efforts that you’re involving in with DTC or sampling, so how should we

Bill Peters, CFO, Amphastar: think about the near term dynamics for the market? Yes. So we’ve increased the physician sampling program some more. We’re continuing to advertise. We’ve been seeing strong growth across all the different chains that we’ve been selling this through.

So we’ve really been happy with it. The chains have been happy with this. So this is a good product for us. And it’s one where we’ve only taken one price increase in the seven years that we’ve had the product on the market or almost it’ll be seven years this fall. So I also think there’s room for price increases in the future, but that’s not baked into this year’s sales forecast, which is the high single unit high digit single unit growth rate.

So, we think that there’s it’s just a really good product. It has a very low market share still when you take a look at all the different products that are out there for asthma. We have a relatively low market share even though about sixty percent of the people who have asthma have mild asthma and this is a product that’s aimed at that market. So, we have a lot of room to grow there.

Unidentified speaker, Interviewer: Sure. Can we spend a few minutes on the pipeline side of things? Talk to us a bit more about your pipeline evolution and what will your focus be like through 2025 as it as you shift towards more of proprietary and biosimilar drugs?

Tony Mars, EVP, Regulatory Affairs, Amphastar: Yes. It seems to be a natural evolution for us to go towards branded products and biosimilar products. And this is where our focus is shifting towards. And the evolution, I guess, started indirectly with us with a product that one of the early products that we developed was hyaluronidase, which at the time was categorized by the FDA as a drug, but it’s an animal derived product. And so as part of that, we needed to properly characterize it.

We needed to work out all the issues with it being animal derived. And so early on, this is one of the areas that we focused on. The FDA later categorized it in 2020 as a biologic. And so doing all the work for getting the approval of that product took a lot of innovation on our part. We also developed a generic version of enoxaparin, which is another complex molecule.

Most of the rest of the world considers it a biologic. It’s a large molecule. And for this one, we had to characterize the product and spent quite a long amount of years characterizing it. Towards the end Additionally, on the branded side, one of the products we developed was Primatene Mist. And for this, we had to do clinical trials, Phase I to Phase III.

So we had to do large scale trial, hundreds of patients, daily dosing multiple times for quite a long period of time. We also had to do human factors label studies. So it was part of the branding there we needed to learn from the molecule, we had to learn from the clinical trial and the label studies what it took to do that. Most recently with the acquisition of Baximi, we’ve also got the sales force portion of the branded product. So selling a product, a commercially branded product is something that now is in our capabilities.

Also with Baximia, we have the international footprint from a logistical perspective, not only from the sales and contracts, but the distribution, the releases of these batches for international uses is quite an endeavor. So when you combine all of these, it seems kind of a natural evolution. I mean, you could see as we look at our history of the products that we’ve developed, we’ve always taken a position of going after more complex products, complex injectable products, combination products. And it seems just very well to fit. Other companies now are starting to be more adaptive being able to develop some of those that we’ve been developing for many, many years or decades.

And so it makes sense for us to evolve into something getting more complex.

Unidentified speaker, Interviewer: Thanks, Tony. That was very helpful. Maybe just drilling through some of the select assets that you have in the pipeline, Could we maybe start with speaking about AMP-eighteen and talk to us more about the Xanda

Tony Mars, EVP, Regulatory Affairs, Amphastar: and the upcoming JADUFA? What should we expect from this area at all? Yes, sure. So GLP-one product, we’ve mentioned before, this is the first cycle approval. But GLP-one is we’re excited.

It’s very much aligned with our portfolio for some of our other insulin and glucagon products. So this endocrine space, it’s very much aligned with it. From a chemical molecule perspective, it’s a peptide. So again, very much in our wheelhouse. So as a first cycle, we’re excited about it.

We’ve been working with responding to any information requests with the agency and now we’re just waiting for the action date. And you do not expect to hear any more with any more requests for information? Well, they’re past that stage. So now we’re just kind of sitting and waiting for them to make an action for it. Again, it’s a first cycle in this area of these complex products, combination product, as well as the peptide.

We’d be very optimistically happy to get a first cycle approval. But I think historically, companies that are in this area would be extremely surprised to have that.

Unidentified speaker, Interviewer: Got it. And maybe can you also just speak about your ability or preparation to be able to launch these products as when

Tony Mars, EVP, Regulatory Affairs, Amphastar: they get approved? Yes. Anytime we have a looming or a pending action day, we’re always prepared for launch. So we have components in inventory for those largely. And so depending on the type of product, we’ll have the chemical raw material for the formulation and then the components necessary.

We’ll maintain a supply of that. Now granted, a first cycle versus a multi cycle as we’ve seen will depend how much risk we’ll take on that. But generally, the last stage of that is the labeling. The agency generally reviews the label last and any label changes obviously would affect that. And so generally, the label is the part that takes us the longest lead time.

But we’re always ready for launching after we have an approval of any of our products.

Bill Peters, CFO, Amphastar: However, we rarely will make product at risk the finished final product at risk. So we’ll have all the components as Tony mentioned. But it would take if we’re extremely confident, we might start making batches before the GDUFA date, but that would be more of a rare instance just because of the uncertainty given the potential.

Unidentified speaker, Interviewer: Got it. Thanks for the context. Shifting to the second asset, let’s see, seven on the inhalation side, again, another good offer coming up into 2Q. So help us understand this opportunity a bit more. Yes.

Tony Mars, EVP, Regulatory Affairs, Amphastar: This is as we said, this is a first cycle again, a first cycle. This action date coming up would be our first action date for the product. It’s an inhalation product, as you mentioned, so a combination product. And there are currently no generic products for this product. So we would be the first generic if we were to get approval there.

So we obviously like that position. The other thing about it is it’s manufactured at our U. S. Facility in Boston. And so we have two other products that are manufactured there, our Primatene Mist and our generic albuterol.

So this would be the third product there and from an operation cost, being able to share some of those expenses would be great for us.

Bill Peters, CFO, Amphastar: So we’re very excited about that product.

Unidentified speaker, Interviewer: Got it. The interparatide, I mean, you received the you received a CRL there. And they also submitted a response to the FDA. So what are the next steps that we need to look forward here? And has the FDA given you any particular timelines in terms of their response and clearance of this?

Tony Mars, EVP, Regulatory Affairs, Amphastar: They have and they’ve given a fourth quarter of this year as an action day. And so we’ve responded to their CRL in a relatively short amount of time. What we believe is address their concerns.

Unidentified speaker, Interviewer: Got it. And how much does the CRL or this delay to market impact your view on the opportunity that you saw with respect?

Tony Mars, EVP, Regulatory Affairs, Amphastar: As we’ve disclosed, there are two other generic products that have been approved. And so it’s not necessarily the timing of our CRL or the CRL itself, but just the other entrance into the generic market for that that would cause us to have less positivity on that product revenue.

Unidentified speaker, Interviewer: Shifting from there, maybe just let’s touch upon the biosimilar side of the pipeline with AMP four, your biosimilar insulin aspart. Help us understand again how big of an opportunity could this be and the potential timing around this, when could we expect a launch?

Bill Peters, CFO, Amphastar: Yes. So from the size of the market, we’re working on the three different biosimilar insulin products and they totaled with $6,000,000,000 in IQVIA sales. Now, we know that IQVIA tends to overstate because it doesn’t get all the discounts on the rebates, but still it’s a very large opportunity for us. And it’s also a very large opportunity for us which would significantly help increase the productivity of our current factory where we make some other products. So it’s a really interesting and large opportunity for us.

So the four is the biggest of the three. So it’s one that we’re the most excited about.

Unidentified speaker, Interviewer: And within this, could you break down the market opportunity further between these assets?

Bill Peters, CFO, Amphastar: So right now, like I said, the total one is $6,000,000,000 I think this one is closer to $3,000,000,000 So it’s the biggest of them. And so there is one other company that has a biosimilar, but it’s not interchangeable yet. And so our goal is to get that interchangeability. So we think that we can get our goal is to get that as soon as possible.

Unidentified speaker, Interviewer: Understood. I want to focus on your second pillar of your strategy on the inorganic side. So help us understand where the balance sheet is currently, your comfort level with leverage and your appetite and desire to do BD now to further further the company?

Bill Peters, CFO, Amphastar: Yes. So right now, we have $345,000,000 converted, dollars $215,000,000 term loan is the debt on the balance sheet and we have $250,000,000 of cash and short term investments. So, we’re not highly levered from a net basis. On a net basis, we’re just over one time EBITDA leverage. So, for us, we see significant opportunities for us to be able to leverage that strong balance sheet to buy new things.

So we’re actively looking at things, particularly things in the endocrinology space that would fit well with Vaximy, other proprietary products, looking at a wide variety of things. So far nothing has hasn’t met the criteria that we like the product enough and at a price that we’re willing to pay for it. So, we’ve seen some things we really like, but the price is very high more than we wanted to pay or there’s been other things where in the end we’ve decided they just we just didn’t like them enough. They didn’t fit well. So, when you go back to our Baximi acquisition, it really checked all the boxes for us again.

So, it was in the glucagon space and in the endocrinology space. It was a proprietary product. It was an intranasal product. We really liked the intranasal delivery form. It was a unique formulation that we thought would be extremely difficult to genericize.

So we thought it would have a very long life for it. So it really was something that met all of the things that we were looking for. So those assets don’t come around every day. But I think we have the opportunity and the balance sheet to take advantage of those opportunities if one was to come along again.

Unidentified speaker, Interviewer: Got it. Last minute remaining, maybe just provide us your thoughts around the generics industry and where you see Amphastar generics and bison blowers industry and where you see Amphastar within this and probably a longer term outlook?

Bill Peters, CFO, Amphastar: Yes. So, we’re definitely, I’ll say, a niche player in that industry because we’re really only looking at the complex side of it. So we’re not really interested in being everything to everyone. We want to be someone that can develop the most difficult products, the ones that are hardest to develop, hardest to manufacture and focus on those opportunities that will hopefully have fewer other entrants. And I think our skill set allows us to do that really well.

Anything to add, Tony?

Tony Mars, EVP, Regulatory Affairs, Amphastar: Fair enough. Thanks.

Unidentified speaker, Interviewer: Bill and Tony, thank you so much for your time and your thoughts. I also wish you a very productive day at the conference. Great.

Bill Peters, CFO, Amphastar: Thank you.

Unidentified speaker, Interviewer: Thanks for joining us.

Tony Mars, EVP, Regulatory Affairs, Amphastar: Thanks for

Bill Peters, CFO, Amphastar: having us.

Unidentified speaker, Interviewer: Great. Thank you.

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