Amphastar at Needham Conference: Strategic Growth Amidst Challenges

On Wednesday, 09 April 2025, Amphastar Pharmaceuticals (NASDAQ: AMPH) presented at the 24th Annual Needham Virtual Healthcare Conference. The company outlined a strategic plan focusing on growth through complex generic injectables and proprietary branded products. While Amphastar is optimistic about future growth, challenges such as increased competition and market dynamics persist.

Key Takeaways

• Amphastar is transitioning towards proprietary branded products to drive growth.
• The company expects double-digit growth next year through internal product development.
• Amphastar received an FDA award for preventing drug shortages.
• The company is investing over $125 million in a new manufacturing facility.
• Limited impact from tariffs due to domestic manufacturing focus.

Financial Results

• Revenue: Anticipates flat sales for the current year; previous glucagon sales were $108 million, and Primatene Mist sales surpassed $100 million.
• Growth Expectations: High single-digit growth expected for Baqsimi and Primatene Mist. Double-digit growth anticipated next year.
• Capital Expenditures: Over $125 million invested in a new state-of-the-art manufacturing facility.
• Leverage: Currently less than two times leverage, with potential to increase for strategic opportunities.

Operational Updates

• Baqsimi Transition: Completed transition from Lilly, managing supply chain and distribution independently.
• MannKind Collaboration: Co-promotion agreement to expand sales force for Baqsimi.
• Manufacturing: Expansion of manufacturing capabilities, particularly in epinephrine prefilled syringe production.
• FDA Relations: Positive relationship with FDA, evidenced by early action dates and a drug shortage award.

Future Outlook

• Revenue Growth: Expects to return to double-digit growth through internal products and potential acquisitions.
• Pipeline: Actively pursuing ANDA submissions, including AMP002, AMP015, AMP007, and AMP018.
• Business Development: Focus on branded products and global assets, leveraging existing global footprint for future acquisitions.
• Strategic Focus: Emphasizing R&D and long-term investment in manufacturing capabilities, with a commitment to domestic manufacturing.

Q&A Highlights

• Tariffs: Limited impact expected due to domestic manufacturing and API sourcing strategy.
• Baqsimi: High single-digit unit growth anticipated, with peak sales target of $250 to $275 million.
• Glucagon: Decline expected due to market dynamics and increased competition.
• Epinephrine: Anticipates return of competitor in prefilled syringe market.
• Pipeline: AMP015 has a high probability of approval this year, actively pursuing inhaled epinephrine program.

In conclusion, Amphastar Pharmaceuticals is strategically positioned for growth amidst market challenges. Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Serge Belanger, Healthcare Analyst, Needham: Hi. Good afternoon. I'm Serge Belanger, one of the health care analysts at Needham. Wanna welcome everybody to, day three of, Needham's twenty fourth annual health care conference. And for next, fireside chat session, we have Amphastar Pharmaceuticals with us.

So from the company, the CFO, Bill Peters, and the, senior VP, communications, Dan Dishner, are joining us from California to, give us an update on the company. Before we move to q and a, maybe I'll hand it over to to Bill and Dan just maybe to give us an overview of Amphastar for those who aren't familiar with the company. And then we'll move to, you know, to some questions. I guess I should highlight that we are, able to take questions. Those listening in on the listening to the presentation on the portal can submit questions on that platform.

We'll take those as they come in. So with that said, Bill, Dan, thanks for, Bill and Dan, thanks for joining us, and I'll let you, give us an overview quick overview of the company.

Bill Peters, CFO, Amphastar Pharmaceuticals: Thanks for having us, Serge.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Appreciate it. Yep. Pleasure being here. Amphastar is a specialty biopharmaceutical company, focused focused on developing, manufacturing, marketing, technically challenging injectable inhalation and intranasal products. We're able to do this because we have, a strong foundation in developing complex generic injectables with a robust, vertically integrated capabilities that include product development, things like state of the art analytical technologies, animal studies, an in house, clinical research team.

We have a full back end manufacturing, including API and starting material manufacturing, and we have a US based finished product manufacturing. We also have a complete front end integration that includes in house marketing and distribution. So we cover the gauntlet when it comes to, the vertical integration. We believe this gives us a a better cost control and supply chain security as well as it allows us to to maintain a high level of quality assurance. We've invested in research to bring differentiated products to market across key therapeutic areas such as critical care, respiratory, and endocrinology.

We have a strategic growth plan for developing branded and interchangeable bios biopharmaceutical products and leveraging our proven established scientific technologies. So that's kind of a lot of our focus at this time. And we have we've also shown a consistent revenue growth with a solid balance sheet for for future expansion. So, we feel like we're in a good place to do some things if we need to. But, basically, that's a a brief overview of Amphastar and who we are and what we're working on.

Serge Belanger, Healthcare Analyst, Needham: Great. Thanks for the overview. I guess, first question, one of the topical topics of of current, of the Azure the last few weeks has been tariffs. So far pharmaceutical products have been exempt, but I think there's, expectations that it's only temporary. I know the Amphastar has subsidiaries in China as well as in France.

So maybe just give us an overview of kind of the manufacturing and what kind of exposure you could potentially have if tariffs were enacted on pharmaceutical products.

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. So, you know, right now, we're, you know, we're we, like a lot of other people, aren't sure exactly what's gonna happen, and we've been looking at different scenarios. But, you know, we do have, API and starting material manufacturing in China where we make five APIs or starting materials for our products plus, a couple APIs for our pipelines. We do import those as well. I'll say of those, you know, we import them, but we make the APIs for two of those in The United States.

We make the APIs for a couple other APIs, for our other products in The United States as well. So compared to most companies manufacturing multiple APIs in The United States and making all of our finished product in The US, I think the tariffs will probably have a less less of an impact on us than they will on others, but it all depends on how it plays out. For example, like, on on the China tariffs, if it's on if there's a tariff on API but not finished products, that's bad for us because our competitors are making, for an OXperant, for example, are making their finished product in China, whereas we're just making the starting material there. But if there's a tariff on finished products from China, then that will really benefit us because the, our competition there is primarily on an OXperant lease is primarily making finished product there, and they have a distinct cost advantage right now. So that would give us a cost advantage, and we might be able to pick up some of the market share that we had to give up due to pricing decreases recently.

As far as other countries go, we we source products from around the world. So we may buy APIs from a multitude of different other countries. We source certain, components from, Europe, Canada, and Mexico. So all of those things have the potential to be hit by tariffs. Right now, when we took a look at the first cut at it, we didn't think the, tariff, exposure that we had was going to have a material impact on our financials or a significant change to the guidance that we gave in February, which was, pre tariff.

But, you know, we have to keep monitoring this, and and, you know, we'll we'll take a look at what happens, you know, because, like I said, it could benefit us in some ways or it could hurt us in others. So it just depends on how the tariffs in the end are are actually, laid out.

Serge Belanger, Healthcare Analyst, Needham: Okay. I think the the other, area where, new administration has had some, some impacts has been with the FDA. I know Amphastar has a close relationship with the FDA, you know, for the, the the product shortages as well as, you have a number of ANDAs under review. So just curious if any of those recent changes that FDA have may have impacted some of your, relationships that you had either on the product shortage side or or with the generics in the ANDA reviews.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah. So as we've said or we're saying is, you know, we really haven't seen yet any real changes at the FDA. As we we posted today in our presentation that the FDA actually met two action dates already, and, actually, one of them was a week early. So, we saw that. And last week, we had an inspection at one of our facilities.

That was something that was, I guess, you know, projected to not happen or to cut back from the FDA on inspections, but that didn't happen. We actually had an inspection last week. So what we've seen is, pretty much business as usual with the FDA, maybe even, you know, like I said, a week early on an action date. But I think it we're anticipating there to be some slowdown at the agency. I mean, when you lose that many people, it's there's a good chance that it will impact us as we move forward.

So it's still really early in the process. I I I don't you know, I know our regulatory team is there today at at at the FDA for a conference. Maybe we'll get some more feedback about what's happening, and what he sees. But, right now, it's kinda just business as usual for us.

Serge Belanger, Healthcare Analyst, Needham: Got it. Okay. Alright. So let's talk about, growth drivers for 2025. I think you highlighted some of them in your last earnings conference call.

I believe Backseemi, I think, is is a big one big one for the company. So maybe just talk about your expectations for for Baqsimi, in 2025, maybe by starting where the transition into Amphastar is currently?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. So, the transition is fully complete. You know, as of January 1, we were doing everything in all countries, you know, managing the supply chain, distribution, all of that was was up to us. And and that that was changed from the fourth quarter where there were still two countries out of 26 where, Lilly was managing that that relationship and, yeah, the the sales. So, but, you know, right now, we're we're doing everything.

It was a big, lift for us because of, you know, 24 of these countries where we we or 23 of these countries we hadn't been doing business in. So it's a, a nice change for us to have that additional work done in different, relationships in those other markets. So I think it really gives us an advantage as we look, to expand going forward.

Serge Belanger, Healthcare Analyst, Needham: And maybe for for those who aren't familiar, if you can just kind of outline the market opportunity for Baqsimi and, what it competes against, where the market shares are currently?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yes. So right now, just going back to one of your other questions, was the expectations for this year was we have said that we're going to have high single digit unit growth as our expectation and that we took a 3% price increase in The United States. So those those two things together help us get to to some nice growth. We've also mentioned that we've increased the marketing efforts, so some of that, increase will come at the end of the year as opposed to the beginning of the year. As market share, we have about, 60% of the ready to use market right now, and we're, you know, we're growing that.

But, you know, we're growing the ready to use market as through our marketing efforts, so we're really happy with with those efforts. And, you know, as far as the the product itself goes is just to take a step back. It's a ready to use glucagon product for, antihyperglycemia. So if some of person who is a diabetic takes too much insulin, and they get, an insulin level that's too high, you give them this to to offset that. So it's, you know, a really, important product out there in the endocrinology field.

Serge Belanger, Healthcare Analyst, Needham: Got it. And in in terms of government competition, I believe there's only one other major player that you compete against right now?

Bill Peters, CFO, Amphastar Pharmaceuticals: You know, Gvoke is the only other major player that's really making an impact in the ready to use space. So the the but we also sell our glucagon kit, which is kind of a legacy product. It's a generic product, a Lilly's glucagon kit. That's one where we sell, glucagon. Instead of the ready to use product like our Baqsimi, which is a nasal spray ready to use right away, this is a product that is, you know, you have to, take the, lyophilized powder in a vial, have diluent and and squirt the diluent in the vial, reconstitute it, and withdraw it into the refill into the syringe and then inject it into a person.

So it's a much longer and more difficult process. So the ready to use products like Baqsimi, really are are much better for the market and and for that.

Serge Belanger, Healthcare Analyst, Needham: Okay. So like you said, one is a nasal spray and Gvoke is an injectable. You know, what other differentiation or why would a patient or physician choose one over the other?

Bill Peters, CFO, Amphastar Pharmaceuticals: Well, you know, if you take a look at, you know, why would someone want to use the nasal spray? When you take a look at who's going to be administering the product, it's not the person, who, is diabetic. It's probably going to be someone else because they're gonna be in a condition that makes them, have some difficulty in doing it. They might be unconscious, or they might have be, not cognizant of what's going on. So you're gonna be relying on someone else to administer the drug.

And what we've found and what other studies have shown is that people who are bystanders that don't have training are hesitant to give an injection to someone and what even if it's an auto injector. And so that hesitation is a problem. So what we've found is that people are are more likely to want to give the, intranasal product. So it's it's a better solution for the people that are, that are out there that are gonna be actually administering. So it's a safer option for people to be to be getting.

Serge Belanger, Healthcare Analyst, Needham: Okay. So now that the transition of the the asset into Amphastar is complete, can you just maybe give us an idea of, like, the the size of the internal sales efforts at Amphastar? And I guess, also talk about the MannKind collaboration that you recently entered into?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yes. We haven't disclosed the size of our Salesforce or MannKind's Salesforce. But what we have said is that, we've recently entered into a a co promotion with Mankind where all of their reps are, detailing, Baqsimi, as their their second product after Afrezza. So this more than doubles the number of reps that are out there detailing the product, which is why we feel comfortable this year giving that guidance of the high single digit growth rate. It's also why we've we've said, in some other meetings that we expect the growth rate to accelerate this year.

So, it'll be higher in the second half of the year and a little bit lower in the first half of the year. So, it's it's a really good, collaboration between us. As you probably know, we also sell them the insulin for their Afrezza pen. So, you know, we already had a have a good relationship with them. We've worked with them well for years.

And so I think it's a real win win in that we're paying them. So they they have and they have a second product in the bag, so it's good for them. And, and more than doubles our sales force, so it's good for us. So, you know, we think it's a really, good collaboration.

Serge Belanger, Healthcare Analyst, Needham: And imagine they'll focus more on endocrinologists, which frees you up to focus on other folks?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. We're still gonna be focused on the endocrinologists, and what we've been focusing on in the past, was the endocrinologists. We've we're focusing on pediatric. They they're more focused on adult just because of the, the labeling age for their product versus our product. Now our product recently, got extended down to to one year and up.

So, you know, we take it all the way down there. There's there's as much higher than that. So they're more focused on adult endocrinologists. We're very focused on pediatric endocrinologists. And we do have some overlap because we also target some of the high writing adult endocrinologists as well.

So there's definitely some overlap in the trials that that sort of pediatric and adult populations. But, given the the number of, people out there, just just increases our our target coverage to new markets where we didn't have someone already marketing the product.

Serge Belanger, Healthcare Analyst, Needham: Got it. And in terms of peak sales, if I remember correctly, you've talked about 250 to 275,000,000.

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. That's correct. And we still think that's a good number. We haven't said when we're gonna get that. We have said it's after the five year mark Okay.

For owning the product. But, you know, we still see a very strong growth pattern here. And one of the things one of the reasons that we see this is that when you take a look at the people who should be getting a glucagon product, the diabetes association recommends that everyone who gets insulin should also be getting a glucagon script. When we purchased Baqsimi, only ten percent of people, who were on insulin were getting a glucagon script. Now it's up to twelve percent.

So we think that there's still a large unpenetrated market there that we have an opportunity to continue to grow this business. So we think there's a large, open space that we can keep, doing this. And and one of the things that we think with these ready to use products is that we expect compliance to continue longer into adulthood, where it sometimes drops off when you have a product that's easier to use, easier to carry. So we think that that 12% has a lot of upside opportunity there.

Serge Belanger, Healthcare Analyst, Needham: Okay. And for those who, get up early every Friday to look at IQVIA data, Is that data pretty reliable of the the trends that you're seeing internally?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. So, you know, we we actually do look at the IQVIA data, and and thanks for sending that report out so early. Every Friday, we take a look at your report because I think I get it faster from you than I get it internally. So but, so I appreciate that. But, yeah.

So I think in in general, it is. But, you know, there's always, the oddities in in the timing of sales. For example, you know, in the fourth quarter, '1 thing that we've noticed across pharmaceutical products is that wholesalers buy extra product going into the into the New Year. So we always see larger purchases of those products in December than we do in January. And so, the way I like like to look at it sometimes is that December sometimes is like a fourteen week sales month for our products, whereas, the first quarter is a twelve week sales, quarter.

So, you know, there's always those timing differences and and, retailers stocking up or or wholesalers stocking up. But in general, you know, we do we do see, we think it it it's a pretty good, long term indicator.

Serge Belanger, Healthcare Analyst, Needham: Yeah. And if I recall when you acquired, Baqsimi now almost two years ago, you talked about it as the, you know, the Baqsimi franchise being kind of a new beachhead for the company on which you could build on with additional BD opportunities in the future. Is that still, how you're thinking about Baqsimi as an opportunity?

Bill Peters, CFO, Amphastar Pharmaceuticals: Absolutely. So, you know, a lot of things that we've looked at over the last year are things that would fit well into the endocrinology space or, and just also potentially utilizing some of the, relationships that we've now established in other countries. So we're we're looking at that as a way to, you know, add add value and and where we can have, an easier entree, and it also allows us to look at more opportunities than we could have before. So that's a definite plus for us.

Serge Belanger, Healthcare Analyst, Needham: Got it. Okay. Primatene Mist, I believe it's been on the market now for for seven years. Is that correct?

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Well, overall, even longer than that. But, yeah, with us

Serge Belanger, Healthcare Analyst, Needham: I guess the return of Primatene Mist.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah. Yeah. Yep.

Serge Belanger, Healthcare Analyst, Needham: And last year, you surpassed your your guidance of a a hundred million annual sales. So how should we think about the the next leg of growth here for for Primatene Mist?

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah. Well, you know, like you said, we we have a solid presence in the over the counter asthma market with Primatene Mist, and, we still see, potential growth in in that market, mostly targeting, bringing more, you know, consumer awareness to the the opportunity that it that and looking at people that are you know, have mild or intermediate asthma focused on that, more targeted marketing opportunities through, the physician sampling program. And so I think we we're guiding towards a high single digit growth for that product this year. So And

Serge Belanger, Healthcare Analyst, Needham: and that's all volume?

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: That's that's volume. Yeah. Sales volume.

Serge Belanger, Healthcare Analyst, Needham: Okay. And is this still kind of a very promotionally sensitive product even seven years after its return?

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah. So, I mean, you know, we've been doing the physician sampling program for for a few years now, and, we see that it's really working. Bringing, you know, primary care physicians, you know, educating them so that they have informed discussions with their their patients about OTC options for treating their intermediate asthma or their asthma. You know, we see that as being and over the years with this physician assembly program, we've seen that being really successful. So this year, we actually expanded that those those that our effort there, by adding more people to go out and and educate these, primary care physicians so that they can have those discussions.

So, I think it's it's really helpful to continue to educate the the consumers about this product, and we it's been working for us.

Serge Belanger, Healthcare Analyst, Needham: K. Glucagon was a, I think, a pretty successful part of the story, a a couple years ago as it you saw some significant expansion, a little bit more pressure last year. So just curious, you know, entering 2025, whether we we'll still see that pressure. And then I believe there is also a new competitor from Beatrice. I think the last time we spoke, they hadn't launched yet.

So are they, now in the market?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. So, yeah, we they have launched. They are in the market, and we expect that, you know, you had alluded to, you know, there were declines last year due just due to the market dynamics, but also the shift of people moving from the the the ready to use, to the ready to use product from the kit. But but let's remember now that for glucagon, the the kit, there's two markets. So there's the antihypoglycemic market, and then there's also the diagnostic market.

So it you know, when we first launched, the glucagon, we were, you know, 60% antihypoglycemic, forty %, diagnostic. Now we're 70% diagnostic, 30% antihypoglycemic. So the market's really shifted a lot as people are moving towards the ready to use products for the for the movie on product. So what we have left is that that 30% is gonna continue to shrink as people move to the ready to use. So that that's something that that's gonna continue to happen.

But but that 70% that right now is on the diagnostic, that's gonna stay relatively flat, we believe, you know, just kinda grow as the population growth. But we do have a a third player now in that market, so we do expect pricing to come down, and we expect our volumes to come down this year. So we'd probably expect to see an acceleration of that decrease, which is really the the biggest reason why we've said that we're gonna be flat this year. It's because the the decline in in glucagon sales.

Serge Belanger, Healthcare Analyst, Needham: Okay. So the impact here, this was a about a hundred million dollars in sales product last year, roughly?

Bill Peters, CFO, Amphastar Pharmaceuticals: We had, I think what I have in front of me a second ago. But last year, we had a hundred and 8,000,000, in sales. The year before that was a hundred and, 14.

Serge Belanger, Healthcare Analyst, Needham: Okay. So a a 30% haircut would not be unreasonable?

Bill Peters, CFO, Amphastar Pharmaceuticals: It would not be unreasonable.

Serge Belanger, Healthcare Analyst, Needham: Okay. And then on epinephrine, I think another I think another product that's been, I think, a success story for for Amphastar. Also, two kind of segments here. Just give us an overview of where both segments currently are and where you think you'll be seeing more competition in 2025.

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. So, we sell the you know, first of all, you know, Primatene Mist has epinephrine based, but we're not gonna include that one because that's a different product completely. In the injectable side, we sell two epinephrine products. One of those is a multidose vial, and one of those is a prefilled syringe. The prefilled syringe is primarily used in critical care.

It's a hospital crash card item that's stocked on all hospital crash cards, and ambulances, emergency rooms, that that sort of thing. The multidose vial can be used in those situations, but it's also used in, allergy clinics and other places like that, so more of a health care use. So what we've seen on that is that we've seen two new competitors on the vial last year. So we've seen that market begin to change pretty significantly, and that was the higher margin product of of the two. So we've seen a unit erosion and a price erosion that started last year and has continued into this year.

As of right now, on the prefilled syringe side, though, we're still the only player in The United States that's shipping that product. So we had one competitor. That competitor had some, some problems and wasn't able to manufacture it. It's been almost two years now that we've been the only player in The United States, but the the good news is that we've been able to take up a % of the, the market for that product. And, actually, just a week or two ago, we got an award from the FDA for, drug shortage for being their supplier of the year, and they named they thanked us for the being able to take out the Epi from a shortage situation, so by by taking on a % of the manufacturing there.

And and what we've done there is, you know, similar to some of these other shortage products is that we've significantly increased our capacity at that facility. You know, we did it, you know, five years ago through putting on a second line, but we've done it since then by just taking every small bottleneck that we could out of the manufacturing process to just continually increase our production levels by double digit rates over the last three years even though we haven't had a big CapEx implant into that into that facility.

Serge Belanger, Healthcare Analyst, Needham: Okay. And the mix here between the multidose files and the prefilled syringe, is this kind of $50.50 in terms of revenues?

Bill Peters, CFO, Amphastar Pharmaceuticals: It was about fifty fifty last year.

Serge Belanger, Healthcare Analyst, Needham: Okay. So I guess it'll lean more towards prefilled syringe this year just because of the additional competition?

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. But we also you know, we expect you know, when we gave our forecast of flat sales for the year, we also anticipate that, the, the other player that's in the epinephrine prefilled syringe market returns the market at some point during the year. So Okay. We wouldn't we wouldn't be surprised by a decline in that in the second half of the year. And that that's baked into our, flat sales guides for the year.

Serge Belanger, Healthcare Analyst, Needham: Yeah. And then to follow-up on, your product shortages award from from the agency, just curious if there's any updates on on that front. I I know it kinds of coming comes and goes over time, but anything since, we we last spoke?

Bill Peters, CFO, Amphastar Pharmaceuticals: I don't think really, nothing's changed since the last time we spoke. So, you know, right now, we're still the only company not only selling the epi prefilled syringe, but also dextrose and sodium bicarbonate. So those three products were the only company in the country that makes those. And, you know, and we've been able to do that because of that increase in in capacity we've been able to get out of that that facility. So we're, you know, we're very proud of that.

In addition, we make other products that are frequently on shortage such as atropine, calcium chloride. Those are two other products that we also make that that our competitors have had problems with in the past. So, you know, we're, you know, I think very good at making all of those products and, you know, have a very stable supply of those.

Serge Belanger, Healthcare Analyst, Needham: Got it. I think you said you you updated your your slide deck earlier today. So maybe you can give us an update on the end of pipelines and and the GDUFA. Okay. So

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: we wanna start with a m p o two. Right? So nothing really has changed there. We are continuing to have our scheduled dialogue with the agency. This is a product that had a GDUFA date two years ago, and it came and went.

And we're still working with the agency on finding a pathway for them to approve it. We stay it still has it's still a product that's a plus $500,000,000 opportunity according to Equivia. There's no generics on it. As I said, we're continuing to have scheduled meetings with the agency. Some, you know, these are high level people at the agency, so we feel and it keeps going up higher and higher.

So we're feeling, you know, that that that we know that the agency has a desire to get it approved. We're currently we're definitely gonna continue to, you know, pursue this, opportunity, and, we're hopeful that we can get it across this year sometime. A m p zero one five, which is our teriparatide product. Yep. We have a GDUFA date in the fourth quarter of this year.

Bill Peters, CFO, Amphastar Pharmaceuticals: And, actually, just to go back to, o two, when the the director of Cedar actually gave us the award. We Jack and I met with her, at the time, and so we brought this up, this product up to Did

Serge Belanger, Healthcare Analyst, Needham: they come with a voucher for approval?

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: She was aware of the product.

Bill Peters, CFO, Amphastar Pharmaceuticals: So she said, I'm very aware of the product and the issues that are going on, and we're working, you know, working to get that approved. So so we know that, it's, known and and, at the highest levels of the FDA, the generic drug side. So we're we're pretty happy that, you know, that what we've been hearing from the lower level people rang true, and they were saying that it was getting the highest attention.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: K. Okay. So Okay. So back to a m p o five 01/05, we have GDUFA date in q four. That has not changed.

That's still that's still the same. As you know, there's there's some competition in that market now. So it's not the opportunity we originally thought it could be, but it's still a project that we see as a strategic opportunity, and it it aligns with our core strengths. So, we're gonna continue to pursue it and and and see what, we can do there. A m p zero zero seven, which had a GDUFA date, in the second quarter.

We just received the CRL from the FDA. We're currently reviewing it, and we plan to respond promptly. Our first glance at this is it appears to be easily addressable. So we'll update as soon as we get a new action date. But I like the caveat that the CRL situation with the agency and how they use it a little bit is that, you know, it could be something as simple as clarifying an issue to having to do studies, you know, even more long term situation.

From our first view review of this one, this is easily addressable. So we're hopeful that it will be, something we can get back to them really quickly and and get a GDUFA date, and then we can communicate that. Our a m p zero one eight, which is our GLP one, which had a GDUFA date, we also just received the the CRL for that. In fact, I think it was a week early, that the FDA responded to this action date, so that's somewhat so, again, we're assessing it. We're looking at it, reading through what is it gonna take to address the FDA's concerns and, the same.

We'll we'll we'll we'll update you as soon as we, do that. We have, our intranasal naloxone, Rx to OTC, submission. We're gonna we're always switching over to that or submitting that very soon here this year. And we have one other, a m p o one seven, which is another inhalation product that we plan on filing this year as well. So, we can get,

Bill Peters, CFO, Amphastar Pharmaceuticals: I don't know,

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: three two to three of these products approved this year, and then and and kinda keep that same cadence. But as you know, we're transitioning. We're I mean, our our strategic focus has been going more towards proprietary products. So a lot of our time and resources are kind of moving into that direction. So the number of submissions may go down a little bit, but, we really hope to update everybody on some new products that we're working on, this year.

That's our plan.

Serge Belanger, Healthcare Analyst, Needham: Okay. In terms of confidence, I guess, o one five is the most likely to to be approved in this year just because it it currently has a GDUFA, and it's been through a couple cycles. Is that the right way to think about it?

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah. I think o one five has a has a has a high probability of getting approved. We think a m p o two still has a prob probability of getting approved. And, I'm not gonna give up on the other two yet. I still it's it's still possible.

You know, we just need to assess. And like I said, at first glance, a m p o one a o m p zero zero seven looks like we might still be able to get that done this year as as and o eight, we're it's still too early to really look at it, so to comment on it. So I'm not sure. But, yeah, I would look at it from that perspective.

Serge Belanger, Healthcare Analyst, Needham: Got it. And as you mentioned, the strategy focusing more on branded products, proprietary branded products. Do you have any update on the inhaled epinephrine program and what's going on? Yeah. I mean, as

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: you know, there was an advisory committee meeting for the the the Nepi product that, is on the market now. And in that meeting, there was quite a we learned quite a few things there, and we've been able to rearrange our our filing and so forth to do it. We had we had some pretty big breakthroughs in that recently, but it's still a little too early to really give timelines about where we're at specifically with that product. So we'll just keep you updated as we could do, but we are really still focused on developing it.

Serge Belanger, Healthcare Analyst, Needham: Okay. Been following the company for for a long time. There hasn't been many years where, you know, expectations were for flat top line growth. So, you know, what do you view as the the keys to reinvigorating that growth? Is it through the pipeline or BD is kind of the an avenue that you're also leaning on?

Bill Peters, CFO, Amphastar Pharmaceuticals: Well, I'd say it's it's both. You know, we always, you know, are focused on the r and d, and that's the most important thing to us and the most important way that we get back to that growth. And right now, you know, we said we're gonna return to double digit growth next year, and that is only, through the products that we have internally. So we think we have a good stable of these products plus the insulin products coming, after those to keep that double digit growth going more than, just one year. So we see, multiple years of double digit growth, after this year.

So that that's the main thing. However, we still are looking at the business development opportunities. And now that we have, you know, the a branded product out there, you know, something on the branded side is something probably more likely we would be interested in. But we're also evaluating generic opportunities as well. So we'll we'll have to you know, we're considering both things.

And, as as you mentioned earlier, having, the global footprint now enables us to take on some products that we couldn't in the past, so it also helps us to, leverage Baqsimi in in other countries. So we think that we're gonna be more able to to look at global assets as opposed to just, US assets.

Serge Belanger, Healthcare Analyst, Needham: Okay. And and when you think of BD, I guess, what is kind of your dry powder potential here in terms of cash availability and

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah.

Bill Peters, CFO, Amphastar Pharmaceuticals: What you So, yeah, right

Serge Belanger, Healthcare Analyst, Needham: now to leverage.

Bill Peters, CFO, Amphastar Pharmaceuticals: Yeah. So right now, you know, we're we're less than two times leverage, so we certainly could lever up more than that. We will have a decline in EBITDA this year that we've we've talked about, so that that does bring that that ratio up a bit. But then, as we take a look at things that, you know, if we buy something else that is is a EBITDA contributor, that that's certainly gonna be easy for us to to to lever up. So we're we're happy to take on more leverage if in the right opportunity.

What we're really not happy to do is dilute the company. You know, the founders own 25% of the company, and they, like the long term aspects, and they don't wanna be diluted. So, unlikely that we would give, give up equity for anything.

Serge Belanger, Healthcare Analyst, Needham: Okay. I think the last quarterly update kinda outlined some some of the CapEx plans to expand the manufacturing capabilities. Just curious if those are have changed given the the tariff environment and

Bill Peters, CFO, Amphastar Pharmaceuticals: No. We're very long term focused, and, you know, I don't know whether, you know, whether these tariffs are gonna be here, you know, three years or not.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Next week. But

Bill Peters, CFO, Amphastar Pharmaceuticals: yeah. So, next week versus four years from now. But, you know, we're very long term focused. You know, building a new, injectable sterile facility is not something that you do overnight. You do it for the long term, and we're very long term focused.

So and we did some we're gonna spend over a hundred and $25,000,000 building a new facility that has a new state of the art, sterile manufacturing, state of the art packaging, new labs, new offices, and that that hundred 25,000,000 was gonna spend include money that we're gonna spend on the first two lines out of the five, and we're gonna three open bays that we hold on for future expansion as well. So we're really excited about a lot of the opportunities that we have in the pipeline and and looking forward to utilize that space for that.

Serge Belanger, Healthcare Analyst, Needham: Alright. Maybe just to to wrap up, if feel there's anything about the story right now that is still, misunderstood or underappreciated by investors.

Bill Peters, CFO, Amphastar Pharmaceuticals: Well, you know, and I'll I'll add the fact, you know, when we talk about tariffs, just go back to the fact that we make all the French product to The United States, and I think that that's you know, we're in the right environment for for that come that to happen here.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: Yeah. And I think as we continue to transition into more proprietary products, I think this is, you know, a logical transition for us. You know, we've worked on a lot of very complex products, and we've been established a lot of tools that, you know, and work with the FDA understanding the types of things they're looking for. So we're excited about the opportunities that we're working on and can't wait to be able to share them with, with the investing community, because it it is kind of a bright future for us.

Serge Belanger, Healthcare Analyst, Needham: Alright. I think we're we're up on time. So we'll end it here. I wanna thank you both for, spending time with us this afternoon and telling us more about, what's going on in Amphastar. So thanks for your time here.

Dan Dishner, Senior VP, Communications, Amphastar Pharmaceuticals: We appreciate your time. Alright. Thank you. Bye.

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