Amphastar at Jefferies London Healthcare Conference: Strategic Shift and Future Prospects

On Wednesday, 19 November 2025, Amphastar Pharmaceuticals (NASDAQ:AMPH) presented at the Jefferies London Healthcare Conference 2025, outlining its strategic pivot towards proprietary and biosimilar products. While the company faced challenges in 2025, including flat sales and gross margin pressures, it remains optimistic about future growth driven by new product launches and strategic acquisitions.

Key Takeaways

• Amphastar is shifting focus from complex generics to proprietary and biosimilar products.
• Strong growth was reported for proprietary products Baqsimi and Primatene Mist.
• The potential launch of AMP-007 in 2026 could significantly drive revenue growth.
• The company is financially solid with plans for acquisitions and stock buybacks.
• New FDA guidelines are expected to expedite biosimilar development timelines.

Financial Results

• Amphastar reported flat sales in 2025 due to competitive pressures on older products.
• Gross margins faced challenges, but improvements are anticipated with new product launches.
• Operating margins are expected to contract in Q4 2025 due to seasonal factors.
• The company holds approximately $600 million in debt and $275 million in cash and short-term investments.

Operational Updates

• Amphastar has in-licensed three new chemical entities from Nanjing Anji Biotechnology.
• The company launched a complex generic, iron sucrose, in 2025.
• Baqsimi and Primatene Mist saw double-digit growth, bolstered by strategic marketing efforts.
• The company is developing a next-generation Primatene Mist with a low global warming potential propellant.

Future Outlook

• Amphastar anticipates high single-digit to low double-digit revenue growth in 2026.
• Key growth drivers include the potential approval and launch of AMP-007 and AMP-015.
• AMP-007, a generic HFA inhalation product, is expected to benefit from 180-day marketing exclusivity.
• The company is optimistic about its biosimilar pipeline, aided by favorable FDA updates.

Q&A Highlights

• Company representatives emphasized the strategic shift towards high-value proprietary products.
• They expressed excitement about AMP-007, noting its potential as a market-first generic entrant.
• Amphastar is actively exploring acquisition opportunities to enhance its portfolio.

For a complete understanding of Amphastar's strategic direction and detailed conference insights, refer to the full transcript.

Full transcript - Jefferies London Healthcare Conference 2025:

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Hi, good afternoon. Welcome to the Jefferies London Healthcare Conference. My name is Dennis Stain, biotech and specialty pharma analyst here. I have the great pleasure of having Amphastar here with us. Welcome.

Unidentified speaker: Thank you.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Thank you. Maybe to start things off, for people who are not super familiar with the company, just give us a little bit of background in terms of what the company is, what you're trying to achieve, as well as some of the progress you made in 2025.

Unidentified speaker: Sure. Historically, we've been a company that's focused on the hardest-to-do generic drug products. We were earlier innovators in enoxaparin, the first and only glucagon kit for a while. We've now been shifting our focus as well. Along those lines, last year was defined by a year of execution. We had strong performance from our two proprietary products, Baqsimi and Primatene Mist, which both had double-digit growth. Additionally, we were able to launch iron sucrose this year, which was another complex generic that took a while for us to work with the FDA to get to an approval. We consider that a great accomplishment. At the same time, we've navigated through some competitive dynamics on some of our historic products. We were able to come out with sales that were relatively flat this year, given the difficult competitive environment on some of those products.

On the pipeline front, as I mentioned, we were originally focused on complex generic products. About four years ago, we decided to shift our focus towards more proprietary and more biosimilar products. We have been executing upon that goal of having 50% of our pipeline be proprietary products by adding to that proprietary line, including the licensing of three products from a Chinese firm, Nanjing Anji Biotechnology. Three new chemical entities that we were able to in-license from them. We signed that deal in August. We look forward to continuing to move into that direction.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Got it. In terms of your mission, your medium to long-term mission in terms of growing more of the proprietary pipeline, you mentioned biosimilars. Can you give us your perspective on the recent FDA update on not requiring comparative efficacy studies for biosimilars? How does that change your view of the biosimilar opportunity?

Unidentified speaker: Yeah. We have always thought that this was a really good opportunity for us. We have four disclosed products in our pipeline, or three disclosed insulins plus one other product that we have in our pipeline. It is something that we have been working on for quite a while. We think this is going to be a tailwind for our strategy of focusing on these things. While it might make it easier, now that the agency is going to rely more on robust analytical pharmacokinetic and immunogenicity studies rather than those comparative efficacy studies, it is going to shorten the timelines. It is going to be able to allow us to be able to execute on these products in a faster timeline. It is a real tailwind for our strategy. It also will impact how we take a look at these products on a go-forward basis.

Overall, this new change doesn't change our strategy, but it does provide us a means to get some execution on these products in a shorter time frame than we otherwise would have.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: How do you pick which markets to go into with a biosimilar? How has that changed with the updated guidance?

Unidentified speaker: Originally, we moved into the insulin products because we had an interest in that whole endocrinology area. That is why we ended up buying an insulin API facility in France to start off with, and then developing a further insulin API facility in China. It is something where we wanted to get into that area. We see it as a good long-term area that will be around for a long time. Additionally, with the other one that is undisclosed, we believe we have a competitive advantage as far as manufacturing the API that other people would not have. We have not disclosed what that product is or what that advantage is, but we feel it is something that we could do more readily than most other companies.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Understood. Maybe going back into 2025, just talk about the progress that you made this year on revenue and the individual products that you feel like are growth drivers. Also, please remind us of Q3 and the earnings that you reported maybe about a week or two ago.

Unidentified speaker: For 2026, we expect continued growth for our proprietary products, Baqsimi and Primatene Mist. We expect contribution from iron sucrose throughout 2026. Baqsimi being the only intranasal glucagon, we see a lot of opportunity to continue increased growth of that brand. For Primatene Mist, as the only over-the-counter asthma inhaler, we see continued growth with our physician sampling program and continued national media coverage.

Unidentified speaker: Yeah. As far as the third quarter ago, we reported strong sales, really led by Baqsimi and Primatene growth. Our two proprietary products really had strong growth. Again, double-digit revenue growth is really they are both leading the way for our future.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Got it. Okay. Baqsimi has been growing quite well. I think for the year, maybe it'll be around low to mid-teens, year-over-year growth. What is really driving that, and how do we sustain that growth trajectory into 2026?

Unidentified speaker: Yeah, I think with our continued sales force detailing and also our collaboration with Mankind, adding our commercial voice for Baqsimi. In addition to the percentage of insulin patients that are prescribed glucagon or getting glucagon prescription, there are still a lot of opportunity to grow. I think as of 2024, it's only about 12% of insulin patients that actually have glucagon prescription. We think continue the same plan, continue maintaining a share of voice out there, building awareness of the importance of having glucagon for insulin patients.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Can you remind us of the competitive dynamics in the glucagon market with Gvoke and some of the product positioning of Baqsimi?

Unidentified speaker: Yeah, absolutely. Baqsimi roughly have about between 56%-60% market share in the ready-to-use glucagon. There are two other brands of ready-to-use. Both are injectable. One is Gvoke, and the other one is Zegalogue. Ours is the only one that is the non-injectable version of glucagon.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Got it. Do you plan on making additional investments to Baqsimi going to 2026 to maybe potentially even accelerate the revenue growth?

Unidentified speaker: Yeah, we continue evaluating that quarter to quarter if there's any opportunity for us to add into the marketing dollar to increase the basically growth trajectory. We evaluate that on a quarterly basis. At this time, at this moment, we see maintain the same investment, but that's always changed when opportunity basically presents itself, just like what we did collaboration with Mankind at the end of last year, which started in January this year.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Can you remind us about that collaboration with Mankind? How exactly does it expand your reach?

Unidentified speaker: Yeah. So basically, Mankind, they have their own endocrinology sales force that market their insulin products. So that same sales force are marketing Baqsimi as the second line products, basically the second product in the bags. So that has worked out really well, covering any white space that we may have in the past, and also roughly doubling our sales force to present commercial voice.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Have you been able to quantify the incremental impact from that collaboration in terms of Baqsimi growth this year?

Unidentified speaker: It's difficult to quantify it just because we have our own sales force as well. They basically are working together with the Mankind sales force, complementing each other. There's really no metrics that we could pull which one is more efficient.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Primatene Mist is the other growth driver of the business. Talk a little bit about that product and where you see that going in 2026.

Unidentified speaker: Yeah. So Primatene Mist, so prior to January 2025, our primary marketing tools is basically national media campaign, basically TV advertisement, and also work together with major retailers like Walgreens, Walmart to do point-of-sales marketing. In January 2025, we added a physician sampling program, basically a pilot sales program where we detail general physician or GP providing samples for GP to provide Primatene Mist samples to actual patients that can benefit from the products. That basically builds awareness. I think the biggest thing for Primatene is awareness of consumers that there's over-the-counter options available for asthma inhalers. We feel that's been received positively. We'll evaluate in 2026 if we're going to expand that pilot sales program because that can be easily expandable.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Remind me of the IP situation with Primatene Mist and how that could be navigated.

Unidentified speaker: Yeah. The current Primatene Mist, the Orange Book patent will expire in January 2026. Right now, we already start working on the next generation of Primatene Mist, which will be using a low global warming potential propellant that basically will be patented. We already have a patent granted for that new propellant. That's what we are working on.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Do you expect a generic to launch once the patents expire in 2026 or no?

Unidentified speaker: Yeah, we really don't because we don't think the economics support that from a generic on the OTC side. The way we look at it is most of the sales are likely to stay with the brand, given the brand equity that we've built up with Primatene Mist. Additionally, once the generic launched, we could launch our own authorized generic as well. We would have to split the generic opportunity with them, and there would be a significantly lower price. If you take a look at the potential economic gain from launching a store brand for something like this inhalation product, the return really isn't there on the investment that you would have to make to get this across the market. Given a $10-$20 million investment to bring this to market, the returns aren't there.

You'd be better off going after one of the prescription products because on the prescription side, they're likely to go 95% generic right away. It doesn't make as much sense to go after a generic on the store brand side, especially when there's the extensive cost you have to do and time they have to develop these.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Let's switch over to the pipeline. I think that's an area that could be particularly exciting next year. Remind us in terms of the various launch timings that you guys are thinking about in 2026 and 2027, and which one of those pipeline assets are you most excited about?

Unidentified speaker: Yeah. Basically, we have two potential launches in 2026. One is our AMP-015, which is a generic teriparatide. The second one we expect to launch in mid-2026, which is our AMP-007, which is a generic HFA inhalation product. We are most excited with the AMP-007 because that one has no generic products in the market. We are potentially the first generic entrant to the market. We believe our application is also eligible for 180 days marketing exclusivity because that product has a paragraph four challenge that we filed.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. It sounds like 007 could be a potential 2026 launch, no generic competitor. That can be relatively exciting. Can you just help frame the opportunity for 007 and what you think is a realistic amount of share that you guys can capture?

Unidentified speaker: Yeah. We have not disclosed the products due to competitive reasons, but we still believe with our experience with commercialization of first generic that we have in the past, we believe it's going to be a high conversion rate and with a high margin.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Remind us when is the GDUFA for 007?

Unidentified speaker: The GDUFA date, we originally had one for this year. It's been pushed off into the next year by the FDA because they needed more time. Right now, we're only disclosing that we expect to launch the product into the market around mid-year next year.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Relatively speaking, how big do you think that could be in 2026 in terms of the revenue contribution?

Unidentified speaker: I think it could be the most meaningful driver to our growth next year. We have said that we expect to have high single-digit to low double-digit growth of revenues next year off of a flat year this year. It is going to be a significant piece of that is our expectation.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. That growth guidance does assume that 007 gets approved.

Unidentified speaker: That is correct. When we take a look at our growth guidance, what we've done is we kind of probability weight the things that we expect to get approved next year. We're assuming a very high probability for 007 and 015, and a very low probability for 018 and for the insulin aspart.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. What would revenue growth look like if you exclude 007?

Unidentified speaker: You know, I'm really not in a position to say that right now because I don't want people to work into the math on the actual number, but it would be significantly lower than that range.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Remind me of the history of 007 because you did say the FDA did delay the decision. What was the reason behind that? How has the dialogue been with the FDA recently?

Unidentified speaker: Yeah. Basically, originally, as mentioned, the original GDUFA date was supposed to be Q4 this year. Without asking for more information, FDA basically needs more time, more reviews. That is why they pushed back the GDUFA date. We are very confident that we have provided the data that they require based on the question that they asked. I think with the regulatory interaction with FDA, we are fairly confident that we will get the approval and launch by mid 2026.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: What about from a manufacturing perspective? Maybe remind us where that is manufactured, if that facility has already had a prior product approved such that the inspection requirements may be a little bit lower. Just remind us of some of those dynamics.

Unidentified speaker: Yeah. The AMP-007 will be manufactured in our inhalation facility close to Boston, Massachusetts. That facility already manufactured Primatene Mist and also generic Albuterol HFA. This will be the third HFA product that we'll manufacture in that facility. We believe there'll be no issue for FDA to approve from the manufacturing perspective.

Unidentified speaker: Along those lines, with it being the third product approved, first of all, we think it will have a high margin given the fact where we think the competitive landscape will be and where we think the pricing will be. Additionally, because it's only the third product in that facility, it's a relatively large facility, the economies of scale will help us reduce the cost of Primatene Mist and Albuterol as well. It will lower our overall margins for those or raise our overall margins, lower our overall cost of goods for those products.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Speaking of margins, maybe remind us where you guys are in terms of your EBITDA margin, how that has kind of evolved over time, and how should we be thinking about that into 2026?

Unidentified speaker: Yeah. This year, we've had some gross margin pressures as we had competition on a couple of our larger higher margin products like glucagon and epinephrine in the vial form. We've also been ratcheting up some of the spending on the selling expense for Baqsimi and Primatene Mist as well as increasing our R&D efforts. We have had some contraction in the operating margin this year. We do think that the current margins are likely even to come down further in the fourth quarter of this year because the third quarter, remember, for Baqsimi is the peak quarter because of the back-to-school season. That's a high margin product that helps lift the margins in that third quarter.

They should come down a little bit in the fourth quarter and then not pick back up again until we have some of the launches next year of the 015 and the 007. Once they have that, the gross margins should pick up again. However, we do expect the R&D expense to continue to grow as a percentage of sales as we focus on more of the proprietary products. The impact will be that some of that gross margin expansion will be offset by that R&D.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Got it. I guess taking a step back and assuming 007 gets approved and launched in 2026, do you believe that 2025, in terms of an operating margin perspective, do you think that is the trough and it should only get better moving forward?

Unidentified speaker: I think part of the answer to that is the timing of when 007 is launched because until it is launched, I would not say that 2025 is a trough. Maybe the first half of 2026 will be a trough and the second half gets improved. Then we have some further approvals in 2027 that should also help contribute to margin expansion.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Perfect. Maybe remind us of some of the pipeline deals that you have done recently and some of the rationale behind those deals.

Unidentified speaker: Yeah. We did recently, we in-licensed products from Nanjing Anji Biotechnology. It's three products that were all peptide products. That's one of our areas of manufacturing expertise. We have a lot of experience working with the peptides, including glucagon, both the kit and the Baqsimi, and also teriparatide, as well as some of the other products that we're working on. It's an area where we feel very comfortable with. Additionally, when we took a look at these products, we were able to license them in at a very low upfront cost, only $2 million per NCE. While we're going to be taking on a lot of the cost of this, it's something that's the strategic area that we've wanted to move to. As I mentioned earlier, four years ago, we wanted to shift our focus from complex generics to proprietary products.

Our goal is to have 50% of our pipeline be proprietary products next year. This fits very well with that goal.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Where are they in terms of their development?

Unidentified speaker: We are currently working on animal models, GLP animal testings. The next milestone would be filing INDs. Because these are early-stage products, we'll update more once we get to file the INDs.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Do you think you can start phase one in 2027?

Unidentified speaker: We have not.

Unidentified speaker: We haven't commented on that yet. We're probably likely to make comments on the timing of some of these products in early next year.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. In terms of just the R&D spend over time, I guess it shouldn't materially pick up from these developments until once you guys enter phase one.

Unidentified speaker: That's true. Remember, we are doing preclinical studies right now on all three of those products. There is an uptick associated with that. That's part of the reason why I mentioned earlier we do expect an uptick in R&D as a percentage of sales next year.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Okay. Maybe last question in the last minute, just remind us of your balance sheet cash and cash equivalents and debt, etc.

Unidentified speaker: Yeah. We have about $600 million of debt, $275 million of cash, and short-term investments. We are very liquid. We are using a portion of that cash to buy back some of our stock right now and also taking a look at potential acquisition targets as well, which we would fund with the cash on hand and potentially debt.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Very good. Thank you guys very much for being here.

Unidentified speaker: All right.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Excited for 2026.

Unidentified speaker: All right. Thanks.

Dennis Stain, Biotech and Specialty Pharma Analyst, Jefferies: Bye.

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