Amphastar Pharmaceuticals Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 7, 2025

Key Takeaways

  • Mixed Q1 results with net revenues down 1% to $170.5 M as glucagon, dextrose, and epinephrine faced increased competition.
  • Gross margins declined to 50% from 52.4% and net income fell to $25.3 M (51¢ per share) from $43.2 M (81¢), driven by distribution shifts for Baqsimi and pricing declines on higher-margin products.
  • Vaxemia sales remained stable at $38.3 M with Amphastar assuming full global distribution and a new co-promotion partnership with MannKind, with most benefits expected in H2 2025.
  • Primatene Mist sales jumped 20% to $29 M thanks to higher unit volumes and an expanded physician sampling program, positioning it and Baqsimi as key growth drivers in 2025.
  • Pipeline momentum includes positive FDA feedback on AMP-002, an accepted BLA for interchangeable insulin aspart (AMP-004) with a SUFA goal date in Q1 2026, and planned ANDA CRL responses for AMP-007 (Q2), AMP-015 (Q4), and AMP-018 (H2 2025).
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Earnings Conference Call
Amphastar Pharmaceuticals Q1 2025
00:00 / 00:00

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals First Quarter Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note that certain statements made during this call regarding matters that are not historical facts, including, but not limited to management's outlook or predictions for future periods are forward looking statements. These statements are based solely on information that is now available to us.

Operator

We encourage you to review the section entitled Forward Looking Statements in the press release issued today and the presentation on the company's website. Also, please refer to our SEC filings, which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance. We will also discuss certain non GAAP measures. Important information on our use of these measures and reconciliations to U. S.

Operator

GAAP may be found in our earnings release. Please note this conference call is being recorded. Our speakers today are Mr. Bill Peters, CFO Mr. Dan Dishner, Senior Vice President of Corporate Communications and Mr. Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations. I'll now turn the conference over to your host, Mr. Dan Dishner, Senior Vice President of Corporate Communications. Dan, you may begin.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

Thank you, Paul, and good afternoon, everyone. Before we begin our Q1 earnings call, I'd like to take a moment to acknowledge the incredible dedication demonstrated by our teams here at Amphastar. Recently, in the first quarter of this year, we were honored to receive the Drug Shortage Assistance Award from the U. S. FDA.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

This prestigious award recognizes our significant efforts in preventing and alleviating critical drug shortages, ensuring that patients have access to essential medications. We take great pride in how our employees understand the importance of consistent access to medicine and continue to work diligently to prevent shortages. The dedication of our teams is what strengthens our company, our company culture, and fuels our drive for success. We appreciate your continued support of Amphastar and are excited to share our progress with you today. So let's get started.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

As anticipated, Amphastar's performance in the first quarter exhibited a mix of results. With our critical care products such as dextrose and epinephrine experiencing softened demand due to increased competition, similarly, the competitive landscape for glucagon has intensified. As a result, we reported net revenues of $170,500,000 for the first quarter, reflecting a modest 1% decline compared to the same period last year. Despite this relatively flat performance, it underscores the enduring strength and resilience of our diversified portfolio in a dynamic market environment. We recognize the cyclical nature of drug shortages and anticipate that the trends observed in the first quarter will continue throughout the year.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

As we mark the beginning of 2025, Vaxemia achieved sales of $38,300,000 in the first quarter. This figure is closely aligned with the combined Vaxemia sales by Lilly and Amphastar of 38,700,000.0 recorded in the first quarter of the previous year. The first quarter of twenty twenty five also represents the first in which Amphastar has taken full control of all vaccine operations, including distribution in all countries following the successful conclusion of our transition from Lilly. In January, we proudly launched our strategic partnership with MannKind whose experienced sales force has enhanced our promotional reach for Vaxmi. While this expansion positions us favorably for sustainable long term growth, we remain focused on the fact that the majority of the benefits and returns from these initiatives are expected to materialize in the second half of twenty twenty five.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

Primatene Mist continues to be a cornerstone of our branded portfolio, demonstrating remarkable performance with sales reaching $29,000,000 this quarter, a 20 increase compared to $24,000,000 in the same period last year. This growth can be attributed to significant increase in unit volumes and sustained demand across our distribution channels. In tandem with this success, we have expanded our physician sampling program, which was enhanced earlier this year by launching a pilot initiative aimed at improving outreach to primary care physicians. We are confident that these strategic efforts will further bolster the growth of market position for Primatene Mist. Together with Baqsimi, we anticipate that both products will serve as key drivers of revenue growth throughout 2025, further solidifying our commitment to expanding our branded product portfolio.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

As we assess the glucagon and epinephrine markets, we recognize the ongoing competitive pressures influencing our performance. This remains we remain committed to navigating these challenges while focusing on delivering quality and value to our customers and stakeholders. In the first quarter, our pipeline is strategically focused on capturing several promising near term opportunities. We are encouraged by the FDA's recent communication concerning our AMP-two filing. While we typically refrain from providing details on FDA communication and do not intend to set a precedent in doing so, we feel it is important to share this exception due to the extended time since our filing has exceeded its original GDUFA date.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

We responded to a simple FDA request promptly within one day and maintain a positive outlook on the progress of a m p zero zero two's submission. As we look ahead to our upcoming ANDA filings, we'd like to provide an update on the progress. For AMP-seven, our inhalation product, we are on track to submit our response to the recent recently received complete response letter or CRL in the second quarter. Additionally, for AMP-fifteen, our teriparatide product, we are pleased to report that the GDUFA gold date is still on schedule for the fourth quarter of this year. Furthermore, concerning AMP-eighteen, our GLP one ANDA, we anticipate submitting our response to the recently received CRL in the second half of this year.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

We are pleased to announce that the FDA has accepted our Biologics License Application or BLA for insulin aspart, identified as a m p zero zero four, with a Biosimilar User Fee Act or the SUFA goal date set in the first quarter of twenty twenty six. This acceptance represents a significant milestone in our efforts to expand our portfolio of interchangeable biosimilar insulin offerings, demonstrating our commitment to enhancing patient access to vital treatments. In light of the current tariff discussions, we, as a domestic manufacturer, are closely monitoring the evolving situation. We hope policymakers will take into account the distinctive aspects of the pharmaceutical sector and the vital role we play in the health care system as they attempt to level the playing field and shape trade policies. While we manufacture all of our finished product in The United States, we do import some components and API.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

As the tariffs currently stand, it will not materially impact our costs. We understand that transitioning from a generic driven business model to a more diversified portfolio that includes proprietary and interchangeable biosimilar products is a process that requires time and strategic effort. Our expertise in critical care areas like immunogenicity and product characterization demonstrated through the successful development of complex products such as glucagon and enoxaparin underscores the robust capabilities of our R and D team. As we move forward, we remain optimistic about the potential to strengthen our commercial position and enhance our portfolio of products awaiting approval. We are particularly excited about the future of our pipeline within high value therapeutic areas, which we believe will drive significant value for our stakeholders.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

Our commitment to operational excellence will be the cornerstone of our strategy as we navigate the path ahead. Thank you for your continued support, and we look forward to sharing our progress in the coming quarters. Now I will turn our call over to our CFO and Executive Vice President of Finance, Bill Peters.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Thank you, Dan. Revenues for the first quarter decreased 1% to $170,500,000 from $171,800,000 in the previous year's period. Paxini revenues for products shipped by Amphastar grew 177% to $38,400,000 compared to $13,800,000 in the prior year period. As we have now fully assumed responsibility for distribution in all company all countries around the world, we no longer have a net economic benefit booked to other revenues, which in the prior year period accounted for sales of $14,200,000. Private team missed sales grew to $29,100,000 in the quarter, which represents sales growth of 20% from $24,200,000 in the first quarter of last year.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Glucagon injection sales declined 27% to $20,800,000 from $28,500,000 due to increased competition. Epinephrine sales decreased 29% to 18,600,000 from $26,100,000 due to increased competition for our multidose vial product. Other finished pharmaceutical product sales decreased $2,200,000 to $50,000,000 from $52,200,000 due to competition for enoxaparin, naloxone, and dextrose. This trend was partially offset by sales of albuterol, which we launched in August, and increased unit sales of fisanodion. Cost of revenues increased to $85,300,000 from $81,700,000 Gross margins declined to 50% of revenues in the first quarter of twenty twenty five from 52.4% in the previous year.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

The primary driver of the change was the shift in distribution of Baqsimi from Lilly to Amphastar. As Baqsimi sales from Lilly were booked net of expenses, giving them a gross margin of 100. Additionally, pricing declines for our epinephrine multi dose vial product, which is one of our higher margin products, contributed to this change. These changes were partially offset by an increase in sales of Primatene Mist and Pythonidine, both of which are higher margin products. Selling, distribution and marketing expenses increased 27% to $11,900,000 from $9,400,000 in the previous year's period due to the expansion of our sales and marketing efforts related to Baqsimi, particularly the co promotion agreement with MannKind, as well as increased marketing efforts for Primatene Mist.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

General and administrative spending increased 2% to $16,000,000 from $15,700,000 Research and development expenditures increased 18% to $20,100,000 from $17,000,000 due to the timing of clinical trials and FDA filing fees. Our nonoperating expense of $6,400,000 compared to a nonoperating expense last year of $100,000, primarily due to foreign currency fluctuations. Net income decreased to $25,300,000 or 51¢ per share in the first quarter from $43,200,000 or 81¢ per share in the first quarter of twenty twenty four. Adjusted net income decreased to $36,900,000 or 74¢ per share to an adjusted net income of $55,300,000 or $1.04 per share in the first quarter of last year. Adjusted earnings excludes amortization, equity compensation, impairments of long lived assets and onetime events.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

In the first quarter, we had cash flow from operations of approximately $35,100,000 and we used a portion of our cash to buy back $11,000,000 worth of shares. Before I turn the call back over to Dan, I wanted to address the first question on investors' minds this year, which is the potential impact of tariffs. While we don't know where our tariffs will end up, we believe we are in a good position because we manufacture all of our finished products in The United States. Our current exposure is on certain active ingredients and components which we import from various countries. At this time, we estimate that the impact to Amphastar under the current tariff situation is an increase in cost of about $500,000 per quarter.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

The impact in the first quarter was less than half of that amount. I will now turn the call back over to Dan.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

Okay, Paul. We'll take questions now.

Operator

Thank you. We'll now be conducting a question and answer session. You. Our first question is from David Amsellem with Piper Sandler.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

So just wanted to talk more about the expectations for the rest of the year as it relates to new launches. I think you had titled at least the potential for a couple of launches before the end of this year. And with CRLs and just the multicycle nature of these filings, can you just talk about how you're thinking about impact from new launches this year and the extent to which that could cushion the impact of competition? So that's number one. And then number two, on Baqsimi, I'm just trying to better understand your commercial support initiatives here.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

And I I guess I I understand, you know, the focus or at least in part on on primary care, but I I guess is the the uptick in volumes that you're expecting also a function of you assuming full responsibility over the asset? In other words, was there some disruption that muted volume growth and now assuming full responsibility gets you to a better place in terms of volume growth? I'm just trying to understand, you know, how you're getting there just beyond these commercial initiatives. Thanks.

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

Hey, David. I'll take the first part of your question relating to approvals. We have our first cycle, CRL for our a and p zero zero seven. That's the one that that we really feel very positive about. We plan to respond to that CRL in the second quarter of this year.

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

So I think from that perspective is is giving us a a lot of optimism. The second is the meetings that Dan referred to for our a and p zero zero two. I think that the meeting that we held, the the IR that that they engaged us with, that we responded the next day, I think that's pretty telling about the optimism about that product. We still have the action date for a and p zero one five for the fourth quarter of this year. And and that one, as far as the revenue driver, I I think given that this would be the third generic in that space, although it's a a decent sized product, and the timing of that, I think the revenue optimism wouldn't be too high for this year.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Yeah. And just to to follow-up on that. So so going back to that again, so we we think that o seven, o two, and o 15 are all things that have a possibility to be approved in time to get revenues this year. And our assumption to get to flat revenue for the year was based on sales from two of those products later on in the year. So at this time, I will say, even though you didn't ask it, but we're still comfortable with our flat revenue for the year guidance that we gave at the last conference call.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

And then for your your second question, the vaccine support, so, you know, we took over all of the the selling responsibilities for it or the promotional responsibilities for it at the end of twenty twenty three. So we've been doing that for more than one year now. What's changed over the course of last year, we did increase the sales force size. And then this year, we also added the co promote agreement with MannKind. So we've we've, over time, have been increasing the outreach that we have.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

And most of that is focused on endocrinologists, not really on primary care. So just to clarify that as well. And then additionally with the the script growth, we did see, if you remember last year, as we transitioned from Lilly to Amphastar at the end of the first quarter, we did have a couple hiccups that we mentioned in in the second quarter call last year where there was a couple pharmacies that showed the product is being discontinued. A couple of states, Medicare took a little longer to get stuff online. So all of those things are are are past us now.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So, you we're still comfortable with the guidance that we gave on that product as well, which was the high single digit unit growth for this year.

Operator

Our next question is from Serena Chen with Wells Fargo.

Cerena Chen
Cerena Chen
VP - Biotech and Pharma Equity Research at Wells Fargo

Hi. Thanks for taking my question, and congrats on the filing acceptance for AMP four. Can you talk more about the insulin aspart opportunity specifically of the insulin pipeline and what are some of the competitive dynamics to keep in mind? And, also, just wanted to ask what you think might be the challenges but also benefits of pursuing interchangeability. Thank you.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Yeah. So it we first of all, it's a a large a large sales product. So when we take a look at the opportunities out there, it's one of the one of the bigger products out there with sales of over you know, the the IQVIA level sales of over $1,400,000,000, and and it's also yeah. I think it's over, you know, three, forty million units. So it's a big unit draw as well.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So what we're seeing is, you know, a really big market opportunity. Right now, there's the brand and there is one generic. However, you know, the generic out there is is not a bio is not an interchangeable biosimilar. So our goal is to become the first product that's interchangeable. And that's been our our goal all along, and and and maybe Tony can elaborate on on on the interchangeability aspect. But

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

Yeah. We see the value of interchangeability is being able to get an immediate replacement whenever the patient needs one. They don't have to write a script to a specific type of insulin. It would be just an equivalent of a generic. So from a Salesforce perspective, we wouldn't have to have any kind of branded name like the biosimilars that you see are.

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

So it'd be just a simple switch whenever a physician wrote the prescription for insulin aspart, they would immediately just convert it over to ours. So we see that as a a very big value to the interchangeability. We've we've working with the FDA, our our perspective is that we want to have the interchangeability only, and our our targeted first approval for this would be for interchangeability rather than what we often see, which is companies get approved as a biosimilar and then later meet the threshold for the interchangeable.

Cerena Chen
Cerena Chen
VP - Biotech and Pharma Equity Research at Wells Fargo

Alright. Thank you.

Operator

Our next question is from Jason Gerberry with Bank of America.

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

Just wanted to come back to the outlook for sales to be flat in 2025. So on the pipeline comment, just wanted to make make sure I heard this right. So that that assumes that there's some second half contribution from one or both of o o two, o o seven. And from time of, like, submitting a response

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

15.

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

What's the what's the turnaround time for for getting a GDUFA? And then with Baqsimi, I think you've you've mentioned, I think, high single digit volume growth for the product and a little bit of of the price benefit carrying over in '25. But if I'm looking at the $38,000,000 this quarter, isn't the comparable year on year number roughly 38,500,000.0 so kind of flat growth on a year on year basis in 1Q? So I'm just kind of and so we just need to kind of buy into the second half kind of uptick from the MannKind driven promotion?

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Yeah. So so just to clarify, first thing is that we said we we have the possibility of sales from a and p zero zero two, a and p zero one five six fifteen, and a and p zero zero seven. So those are the three that we believe that we have the possibility in in our forecast. And what we said is that we would need sales from from two products. And Tony can tell you a little bit more about this for the for the GDUFA, which right now would be really for o o seven. What should we plan to respond to shortly?

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

Yeah. The the turnaround, depending on what categorization the agency would would put these into, would would either be a minor or a major. If it's a a major response, it would be eight to ten months. If it's minor, it would be nine ninety days.

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

Got it. And and then maybe just on the margin pressure that we see in 1Q on gross and net income, just are these good run rates in the absence of pipeline surprises or or or a major inflection in Baqsimi when we look to the next couple quarters?

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So so first, let me ask your your previous Vaxmi question first. So you're right. We were relatively flat year over year with the sales dollars. And what you know, in the first quarter of last year, what we saw was that there was a little bit of a channel load as both Lilly was selling products in The United States and we launched. So there was a little bit of extra inventory in the channel by the end of the first quarter.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So that was part of the reason for that. And then we saw a little bit of weakness in the second quarter because of some of the the software issues with certain pharmacies and some of the state Medicaid issues. So what we've seen in in the first quarter is from the IQVIA data is relatively low single digit growth year over year. But so far in the second quarter, every week has shown a low double digit growth rate so far this quarter. So I think we're we're getting back to that number.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So I think you'll see, you know, some of those trends reverse and that we're still confident that we will get to this high single digit digit growth. Now back to the margin question, there's a couple things that are going against each other there. And one is we have not seen all of the price pressure on glucagon in the first quarter. That was something where the launch didn't happen at beginning of the quarter. So the lower price for that product was only in there for maybe one month out of the quarter, not not three.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So we will see margin pressure on that product and pricing pressure on that product as we go forward. But we're also, you know, as as we mentioned, we're still growing Primacy Myths and Vaximi, which are higher margin products. And we're taking some actions internally to to to make sure that we're cost competitive. So we're focusing on on a lot of things that could help us operate the business a little bit more efficiency efficiently with a little bit less cost. So those are things that we're management is actively working on over the last several months and that we've already taken action on this time.

Operator

Thank you. Our next question is from Ekaterina Nayakova with JPMorgan.

Ekaterina Knyazkova
Ekaterina Knyazkova
Analyst at JP Morgan

Thank you so much. So first is just on the regulatory landscape, there's obviously been a lot of changes at the FDA with the new administration. Do see that kind of impacting review time lines or the approval process more broadly or for kind of complex generics specifically? And then the second question is just around tariffs. Depending on what they end up looking like, is there an opportunity for you guys to leverage your US footprint to potentially pick up more share in certain markets?

Ekaterina Knyazkova
Ekaterina Knyazkova
Analyst at JP Morgan

How much spare capacity do you potentially have that you could leverage for this? Thanks.

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

Yeah. As far as the the switches and the changes that we've seen at the FDA, we we've seen some changes to some persons, and some of those are are public, and we've seen it. And some are at the project management level. And we really haven't seen an impact to our any of our timings for our applications. The only the only different the only change we've seen are just minor.

Tony Marrs
Tony Marrs
Executive VP of Regulatory Affairs & Clinical Operations at Amphastar Pharmaceuticals

Sometimes it would take a few days for a project manager to get back to us with a question, and now it may be a week. But I would I would categorize that as really minor. It it really has an effect that we've had a few action dates that the agency has met in responding to, so we haven't seen any impact with that.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Second thing on on tariffs is yeah. Yeah. Because we are a US manufacturing company, I think we're in a much better place than a lot of companies are. So it really depends on how the tariffs are implemented. At the moment, with certain with tariffs on certain components and APIs, like, right now, we are paying a a tariff on the API that we bring in from our China facility.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

And so that's what's leading mostly to that that cost increase that that I mentioned. However, if if we take a look at if those go away and they focus on the finished product, we're in a much better position. So, you know, we're definitely, you know, hoping that the government focuses more on where the finished product is made. So but on the the components and and raw materials, the good thing is that, you know, we source from a variety of countries around the world. We make several of our APIs in The United States as well.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So, you know, there's we're not really overexposed to any single country.

Ekaterina Knyazkova
Ekaterina Knyazkova
Analyst at JP Morgan

Thank you.

Operator

Our next question is from Serge Belanger with Needham.

Analyst

Hi. Good afternoon. This is John on for Serge today. Just wanna touch on glucagon and epinephrine first. Currently, they're down about 29% year over year in this quarter.

Analyst

Is this something we should expect, you know, based on more competitive pressures on these products? And is this more or less, you know, a full time impact of the competition? And, you know, then with the remainder of the portfolio as well, you kinda touched on some external factors that are that are hitting those as well. If you can just give a little clarity on some of the dynamics going on there as well, that'd be great. Thanks.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Yeah. So for epinephrine, you know, we saw two new launches in that on our multidose vial presentation last year. So with that, you know, that the pricing impact is fully baked in there and our margin our our share loss is fully baked into the epinephrine. However, we we also sell the prefilled syringe as well for epinephrine. So right now, we're still the only company making that in The United States.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

So there's there's always the possibility that someone returns to that. So that's that's certainly the risk to that. On glucagon, as I mentioned earlier, the competitor on that product didn't launch at the beginning of the quarter. So we only have about a third of the quarter baked into that to that extra competition going from really a two player to a three player market. So I would expect the, you know, that product to decline even faster.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

And also keeping in mind that, as we've said, people are moving from for the people that are using the glucagon injection kit as an antihypoglycemic product, which is about 30% of our market now, those people are generally moving over to ready to use products like Vaximi. So that was a a declining market anyway. So, you know, we we do expect that one to continue to decline. As far as the rest of the portfolio goes, you know, we do see the growth in Vaximi and private team missed. Most of our other you know, we have some have some pressure on dextrose as a company returned to competition there.

Bill Peters
Bill Peters
EVP, CFO & Director at Amphastar Pharmaceuticals

Keep seeing competition on enoxaparin and naloxone, and we're expecting competition on the phytonadione in the coming year as well. But so there's, you know, about a handful of products with increased competition, a couple products with, you know, where we think we're gonna have growth, and then the rest of the products should remain relatively flat.

Operator

Thank you. There are no further questions at this time. I'd like to hand the floor back over to management for any closing comments.

Dan Dischner
Dan Dischner
Senior Vice President of Human Resources & Corporate Communication at Amphastar Pharmaceuticals

Thank you all for joining us today. We appreciate your support, and we look forward to sharing more updates in our next call. Have a great day.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Executives
    • Dan Dischner
      Dan Dischner
      Senior Vice President of Human Resources & Corporate Communication
    • Bill Peters
      Bill Peters
      EVP, CFO & Director
    • Tony Marrs
      Tony Marrs
      Executive VP of Regulatory Affairs & Clinical Operations
Analysts
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