Esperion Therapeutics Q1 2025 Earnings Call Transcript

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Operator

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call will be recorded. I would now like to hand the conference over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. Please go ahead.

Alina Venezia
Alina Venezia
Head of Investor Relations at Esperion Therapeutics

Thank you, operator. Good morning, and welcome to Esperion's first quarter twenty twenty five earnings conference call. With us on today's call are Sheldon Koenig, president and CEO, and Ben Halliday, CFO. Other members of the executive team will be available for Q and A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call.

Alina Venezia
Alina Venezia
Head of Investor Relations at Esperion Therapeutics

A copy can be found on the investor page of our website together with a copy of the presentation that we will also be referencing. I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward looking statements. Actual results could differ materially from those stated or implied by our forward looking statements due to the risks and uncertainties associated with the business. These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings.

Alina Venezia
Alina Venezia
Head of Investor Relations at Esperion Therapeutics

The content of the conference call contains time sensitive information that is accurate only as of the date of this live broadcast, 05/06/2025. We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. I now turn the call over to Sheldon.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thank you, Alina. Good morning, everyone and thank you for joining us. Throughout the first quarter, we continued to make progress across our three pillars for growth, revenue growth, portfolio expansion and pipeline advancement. We posted year over year net U. S.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Product sales growth, enhanced reimbursement and access efforts, introduced new marketing initiatives targeting both physicians and patients and advanced our ACLY pipeline with our declaration of our lead indication in primary sclerosing cholangitis known as PSC. Turning to our progress and plans moving forward with our first pillar, increasing revenue and operating profitability, let me start with the sales and marketing of our bempedoic acid products in The U. S. And global markets. We are pleased with our performance this past quarter, which despite an overall flat lipid market in The US saw green shoots of progress with significant strides in expanding our reach both domestically and internationally.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Total revenue for the first quarter twenty twenty five grew 63% year over year to $65,000,000 after adjusting for a one time milestone received in the first quarter twenty twenty four. US net product revenue grew 41% year over year to $34,900,000 driven by the expanded label and commercial initiatives started in 2024. First quarter '20 '20 '5 script growth increased 2% sequentially compared to fourth quarter twenty twenty four. This was somewhat muted by the impact of a flat lipid lowering market in the first quarter twenty twenty five that experienced seasonal headwinds due to changes in Medicare Part D and higher out of pocket costs as patients need to meet their annual insurance deductibles. In The US, we expanded our field reimbursement support team threefold and now have 15 seasoned payer access specialists strategically aligned with the 15 sales regions to support our growing prescriber base and educate on the favorable reimbursement landscape for our products.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Our market access team achieved a number of victories this quarter. We had more than 30 plans, including several of the nation's largest insurance, removed prior authorizations, implemented electronic step edits and included new formulary additions. These milestones highlight the strong clinical profile and competitive pricing of Nexletol and Nexlazet, instilling greater confidence in healthcare providers to prescribe these treatments. These achievements not only broaden access for patients, but also reinforce our commitment to improving cardiovascular health on a large scale. In further support of our sales and marketing efforts, we are particularly pleased to report that NEXLETOL and NEXLASET were recently added to the new twenty twenty five ACCAHA multi society guidelines for the management of patients with acute coronary syndrome or ACS.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Phemedoic acid earned level 1A recommendations, the highest level of guidance indicating strong recommendation where benefit greatly outweighs risk for patients with ACS already on maximally tolerated statin therapy and in patients with ACS who are statin intolerant. Phenphidic acid also earned a level 2A recommendation, meaning that moderate evidence exists and a recommendation is reasonable for patients with ACS who are already on maximally tolerated statin therapy. Here again, a non statin lipid lowering therapy is recommended to reduce the risk of MACE. Inclusion in these guidelines allows us to more effectively market our bempedoic acid products to healthcare practitioners. Combined with expanded payer coverage, reductions in prior authorization requirements and the available reimbursement support resources, we believe we have significantly improved the access environment for patients and physicians alike.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

To better leverage this broader patient access, we recently introduced a series of payer and provider tactics that highlight the fact that up to thirty percent of patients are statin intolerant and showcase the evidence to demonstrate how Nexletol and Nexlezet are the only approved therapies proven to reduce cardiovascular events in statin intolerant patients. Our goal is to underscore the persistent unmet need while promoting our safe and effective therapies. As a result of our efforts, we began seeing a shift in prescribing behavior starting in March. Early Q2 trends are encouraging with prescription volume currently tracking approximately 8% higher than Q1. We expect this growth to continue as momentum builds and patient access improves further, particularly as copay levels continue to decline.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

To further support healthcare practitioners in the management of their LDL cholesterol levels, we are excited by the opportunity for the triple combination product we are developing in The US as it will provide physicians with the flexibility of a suite of options that include monotherapy Nexletol, dual therapy Nexlezette and triple combination therapy bempedoic acid, ezetimibe and either atorvastatin or rosuvastatin. We view this as a compelling opportunity to expand our role in the cardiovascular prevention market as the published literature suggests that the triple combo products can lower LDL cholesterol in excess of 60%. This level of efficacy has the potential to rival existing injectable and emerging oral therapies offering a valuable oral option for both patients and physicians. We expanded our partnerships with regulatory experts and others in the field to advance this important work with a goal to complete the clinical requirements and commercialize this triple combination in 2027. Moving on to international markets where we and our partners are making great strides.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

We continue to see compelling growth from our partner Daiichi Sankyo Europe, where they are making meaningful progress expanding the use of Nolemdo and Ustendi to benefit patients at risk of cardiovascular disease who cannot manage their LDL cholesterol levels. In addition, we are looking ahead to an exciting year of continued growth in Europe and new product approvals and launches across a number of key geographies. Our royalty revenue from DSE increased 8% from the fourth quarter of twenty twenty four to $10,500,000 in the first quarter of twenty twenty five. As of the February, approximately four hundred and seventy two thousand five hundred patients have been treated with our therapies in Europe. The ongoing growth in these European markets give us confidence that with our label expansion, we can build a sizable market in The US.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

In addition, the tech transfer for both Nolemdo and Yustendia are also progressing nicely. Our Japanese partner, Otsuka Pharmaceuticals submitted for approval of our bempedoic acid product in Japan for LDL cholesterol lowering and remain on track for approval and national health insurance pricing in the second half of twenty twenty five. The Japanese market is the world's third largest cardiovascular prevention market and we believe the royalties on Japanese product sales will be a meaningful revenue contributor over time. Looking to the progress we made during the first quarter twenty twenty five, we expanded the breadth of our global reach by entering commercial partnerships with CSL Sequirus in Australia and New Zealand. As an update, NeoPharm Israel filed for regulatory approval during the first quarter and expects to receive approval in early twenty twenty six.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

In addition, Esperion filed submissions for approval in Canada for Nexlotol and Nexlazet and we anticipate market approval in the fourth quarter of twenty twenty five. Our international partnerships continue to deliver increasing royalty revenue, further demonstrating the global potential of our bempedoic acid products and supporting our strategic focus to drive revenue growth and operating profitability. Turning to advancing the pipeline pillar, we recently hosted our R and D day in New York, where we introduced our novel program targeting PSC. PSC is a rare progressive liver disease with no approved therapies and represents a major unmet need with an estimated $1,000,000,000 annual market opportunity. This program reflects our strategy to expand into high need, high value indications and highlights the broader potential of ACLY biology.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

The R and D Day event was very engaging and featured KOL discussions, a patient advocacy representative for the PCS community, a patient video and an engaging Q and A session. I encourage those of you who may have missed it to listen to the archive of the event that is available on the Investor Relations section of our website. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the first quarter. Ben?

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Thank you, Sheldon. Good morning everyone and thank you for joining us today. Our first quarter twenty twenty five financial results can be found in the press release we issued this morning and more detail will be included in our upcoming 10 Q. First quarter twenty twenty five total revenue was $65,000,000 a decrease of 53%. This decrease was driven by one time settlement agreement milestone with DSE, which we received in the first quarter of twenty twenty four.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Excluding the settlement agreement milestone, total revenue grew 63%. U. S. Net product revenue was $34,900,000 compared to $24,800,000 for the comparable period in 2024, an increase of approximately 41%. Q1 product revenue growth in The U.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

S. Was impacted by several factors, including changes to Medicare Part D and patient deductible requirements. Every year during the first quarter, we experienced lower product revenue as patients fulfill their insurance deductibles impacting branded prescription fills. This year with changes to the IRA and confusion around Medicare made this season trend particularly burdensome. Despite these seasonal headwinds, we remain committed to navigating these complexities and ensuring patient access to our innovative cardiovascular health solutions.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Beginning in March, we have seen a clear shift in prescribing behavior that signals a return to our typical growth trajectory. Early Q2 data shows prescription volume tracking approximately 8% above Q1 levels and we expect this upward trend to continue. Collaboration revenue was $30,100,000 compared to $113,000,000 for the comparable period in 2024, a decrease of approximately 73% driven by the settlement agreement milestone with DSE offset partially by increases to our royalty sales within our partner territories and product sales for collaboration partners from our supply agreements. Excluding the settlement agreement milestone, collaboration revenue grew 97% from the comparable period. Turning to the rest of the P and L, for the first quarter twenty twenty five, research and development expenses were $12,600,000 compared to $13,400,000 for the comparable period in 2024, a decrease of 6%.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Selling, general and administrative expenses were $43,000,000 compared to $42,000,000 for the comparable period in 2024, an increase of 2%. The increase quarter over quarter was primarily related to increased marketing and consulting costs. We entered 2025 in a very strong financial position with cash and cash equivalents of $114,600,000 as of 03/31/2025. We are reiterating our full year 2025 operating expense guidance, which is expected to be approximately $215,000,000 to $235,000,000 including $15,000,000 in non cash expenses related to stock compensation. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

As we conclude today's earnings call, I want to take a moment to reflect on the meaningful progress we've made and the exciting journey ahead. Our commitment to revolutionizing cardiovascular risk reduction through our innovative bempedoic acid products is unwavering. In addition, we are excited by the opportunities to leverage our leadership in ACLY biology and look forward to advancing our newly introduced pipeline that has groundbreaking potential. Our focus on innovation, collaboration and expansion will continue to guide us as we strive to make cardiometabolic prevention accessible to everyone, everywhere. We are confident that our strategic initiatives will propel us towards a future where millions of lives are positively impacted by our efforts.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thank you to our shareholders, partners and team members for your steadfast support. Your commitment to our mission inspires us every day and we are excited to share our continued progress with you in the coming year. Together, we are making a difference and I look forward to the incredible advancements we will achieve. Operator, we are now ready to open the call to questions.

Operator

Thank you. Our first question will come from the line of Dennis Ding from Jefferies. Your line is open.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Hi. Good morning. Congrats on the progress. And I have two questions. One is on BD.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

I guess when should we expect a new BD deal? And perhaps remind us of your cash outlook for the remainder of this year if you'll have to wait for the Otsuka milestones before executing a deal? And then my second question is on the triple. Is that your way of playing defense by specifically leveraging convenience for when ovaciptuib gets approved in 2027? Because from an efficacy perspective, I guess your triple gets 60% plus LDL reduction in one pill, but olicitropiv can get there or higher with two.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

So is that how you see the value proposition here for the triple one versus two pills? Thank you.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Hey, Dennis. Thanks for joining. Appreciate the question. On the BD side, so to answer your question, we're, you know, I think making very good progress there. I've said before, we're not gonna set a timeline just because we don't wanna feel like we have to execute a deal to get a deal done.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

We wanna wait for the right deal that makes sense for this company. I will say they are not predicated on having the Otsuka milestones in hand. Everything we've been looking at would be sort of separate from that. And when we see the right asset that makes sense in the commercial bag that we can put it in, then we're going to execute it and not necessarily wait around for some other timeline here.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thanks Ben. Thanks Dennis. As it relates to the triple combination, keep in mind Dennis, and we've talked about this before that and there's publications that support this, the triple combination, we've seen LDL lowering in excess of 60%, actually in some cases up to 70%. It's definitely something as it relates to a play of convenience, it's one pill. And it also has really the potential of being the most efficacious LDL lowering drug on the market.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

So that's how we look at it, is it's just one pill that a patient has to take. And as you know, many patients are taking sometimes six to seven medications. In this case, they would only have to take one. I'm not going to make comments compared to ogacetrafib, that's a product in development and we'll just have to wait to see if that product actually comes to the market. Thank you.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Got it. Thank you.

Operator

One moment for our next question. Our next question will come from the line of Joe Pantginis from H. C. Wainwright. Your line is open.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Hey everybody, good morning. Thanks for taking the questions. So first on the sales front, you're up to about 15 right now as you said. Wanted to get a sense of do you feel it's right sized, you're continuing to wait to see on the potential expansion of sales to consider expanding your sales force, number one. And then number two, I think more importantly, as you continue to talk about education around I'll provide one example and maybe you have others as well.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

So, with regard to the education, what are you seeing with regard to any potential variability with regard to physicians defining statin intolerance and are there any other key factors that still need to be tackled with regard to education? Thanks.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Sure, thanks Joe and good morning. So let me start with the sales force. So right now we have approximately 155 sales representatives and we do think that is the right amount. We've commented before that we have found the right balance between personal promotion and digital promotion and we do return on investment analysis on all those. So we're constantly monitoring those investments.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

You started off with 15 and I think what you were talking about were the 15 field reimbursement managers and that is new. They were effective on April. We have 15 sales regions across the nation and we did have six field reimbursement managers but we've expanded that to 15 where we have one in each sales region. And we think that is going to be, and we've already seen, something that's very successful because it really helps physicians think about how they have to fill out the prior authorization. And so it's just another way of supporting limiting barriers to prescribing.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

So we're excited about that. Regarding education, so it's very interesting. We've been very focused on statin intolerance. We have a new piece out there that our representatives are using. The National Lipid Association earlier in the year came out and actually defined that statin intolerance is about thirty percent of the population, three zero.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

So a significant amount of folks just do not want to take a statin or can't tolerate a statin. And so what we're finding is that physicians are really responding to the fact that the NLA is put out there, it's actually in our Detail Aid and we go to physicians' offices just to give you a real life story to your point and tell them, you know, doctor, the patients are sitting in your waiting room, you know, I'm sure that many of them can't take a statin or they're just tolerating taking the statin, but they really can't take it. And here, now this is an opportunity where you prescribe Nexletol and Nexlezet. And I can tell you that message is gaining a lot of traction. So the education and we're just starting, by the way.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

There's some other things that we have planned that we'll continue to update you through the year. But, you know, we're not only focusing on physicians, but we're also looking at ways to activate the consumer.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Fantastic. Thanks a lot, Sheldon.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Sure. Thank you.

Operator

One moment for our next question. Next question comes from line of Jason Zamanski from Bank of America. Your line is open.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

Good morning. Congrats on the quarter and thank you so much for taking our question. I wanted to ask, is the triple combination the right approach here? And I ask this because on one hand, as you've just mentioned, there are patients who aren't necessarily interested in taking the statin. And on the other hand, does seem to be a growing buzz or interest in lipoprotein A and reducing that, which is again something that both the PCSK9s and the CETPs have had success lowering.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

So, you know, in terms of looking at the landscape down the road, you know, where does the triple fall into place here?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Yeah, so thanks Jason. So yeah, we actually do think it's the right approach for the products that we have. Keep in mind that we also lower HSCRP, which is a marker of inflammation. We actually showed a 22 reduction in HSCRP in our endpoint, in our clear outcome study. And not only are we excited about this, but our partners at Daiichi Sankyo are excited about this.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

There's going be more news coming as it relates to this in the fall as we've mentioned before. As you know, with Lp, there's a lot of science around it. I think we're still waiting to see the data. We thought we'd see some data this year. We'll see it next year.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

But I think hsCRP, LP, are all important markers. As we've mentioned in the past, cardiovascular disease is the number one killer And we can do something about it today with Nexlazet and Nexlitol. And that's what we're focused on. We're focused on getting our drugs prescribed today and next year and the year after, Triple combination, the LDL efficacy, as you know, LDL efficacy is still a primary endpoint that the FDA considers for registering the drug. So yes, it's absolutely the right play and we look forward to bringing it to market.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

But again, for patients who aren't interested in taking a statin, I mean, is this the option for them?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Well, so the nice thing now is we have, and as we said in our prepared remarks, we have a suite of alternatives, which is something that the competition doesn't have. The beauty of the CLEAR Outcome study is it gave us a label where you can take our drug with a statin or you can take our drug without a statin. The other thing that you may recall out of the CLEAR Outcome study is that we are the only oral and only non statin that has both primary and secondary prevention. And so this allows a physician to have greater flexibility and we've done market research to support that.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

Got it. Thanks for the color.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Sure thing.

Operator

Thank you. One moment for our next question. Our next question will come from the line of Christian Kluska from Cantor Fitzgerald. Your line is open.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Hi, good morning everybody. As it relates to the ACCA multi society guidelines, can you talk about historically how adoption may have changed based on other therapies that have been added to these recommendations? Just essentially trying to figure out how instrumental it is to physician uptake and adoption.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Yes, thank you, Kristen. So I think right now it's a little bit too early to comment as it relates to other products, but I can tell you with us with initial feedback, this also something that we have included in our detailing of the product. So it's kind of a one two punch where we can talk about the NLA recommendation or the statement of statin intolerance, but we can also talk about this new guideline. And I can tell you that having that message as it relates to both of those is very impactful to not only cardiologists who really follow the guidelines more so than primary care, but we are seeing that primary care physicians are also very responsive to this as well. So for us it's been, I would say again very early, but feedback from the field is that it's been very meaningful.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Thank you.

Operator

One moment for our next question. Our next question will come from the line of Serge Belanger from Needham. Your line is open.

Serge Belanger
Senior Analyst at Needham & Company

Hi, good morning everyone. This is John on for Serge today. Thanks for taking our questions. So I just wanted to touch on first seasonal market dynamics for NEXLETON, NEXLIZET. Obviously, there's a little bit of a slowdown in 1Q.

Serge Belanger
Senior Analyst at Needham & Company

You mentioned the flat lipid market, changes in Med Part D, etcetera. Just curious qualitatively whether you think this was worse this year than in years prior and could this in any way kind of portend a bigger bounce back for 2Q?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Yeah, thanks John. No doubt this was definitely worse than years prior and part of it was just because of the IRA and a lot of it was new, but let me turn it over to BJ who can also give us more color on it.

Betty Swartz
Betty Swartz
Chief Business Officer at Esperion Therapeutics

Yeah, John. The prescription growth was impacted by a variety of seasonal factors, which included the annual insurance deductibles and resets. But there was also an added confusion also around the Inflation Reduction Act and those related adjustments. But from emerging positive trends, starting March, we have observed improving trends including reductions in patient co pays, which positively influences prescription uptake. And we're also seeing really great feedback and early signs from our targeted payer initiatives aimed at also increasing prescribing among previous non writers.

Betty Swartz
Betty Swartz
Chief Business Officer at Esperion Therapeutics

So, we're really, from an out of pocket perspective, we've seen this decrease in elevated levels and observed this in January and February. I'm really looking forward to that trend continuing.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

And to add just a little bit more color, BJ and team also did research, John, with Medicare providers to see what was causing this confusion and was there confusion and all the feedback, and these are from all the top Medicare providers in The United States, there is confusion amongst consumers of what do they have to pay, what was their true out of pocket expense. At one point, you may recall back in January, was rhetoric that Medicare was going to be shut down, which also created confusion. So there's a lot of different dynamics and that's what made it probably the worst that we've ever seen.

Serge Belanger
Senior Analyst at Needham & Company

Great. Yeah. Thanks for that color. And then just quickly to touch on the triple combo. You know, do you have any timelines at this point as to to when it could reach market and what any sort of regulatory framework would look like here to get it approved? Thanks.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Sure, yeah. So in our prepared remarks, the timing is we'd like to see this product hit in 2027. The regulatory aspects of this is that this is just really a bioequivalence and stability. There's no clinical study that's necessary in order to get the product onto the market. But I think the biggest question there is the timing, and that's 2027.

Operator

Thank you. One moment for our next question. Our next question will come from the line of Jessica Fye from JPMorgan. Your line is open.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Hey guys, good morning. Thanks for taking my question. I was hoping you could help us think about the gross margin trajectory over the remainder of this year and the next few years. And just kind of in addition to which direction the numbers are going, kind of explain to us what's behind the evolution in gross margin as well? Thank you.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Yes. Hi, Jess, this is Ben. So our gross margin is largely influenced by the proportion of what sales we see between The US and those tablet sales to our partners, mainly DSE, which I think we've mentioned before are at the flat to negative margin. So as the tech transfer progresses, we'll see those margins improve, and we'll also see improvement on the working capital side as we start transitioning some of that to DSE. I think that's kind of a a multiyear progression.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

It's not gonna be overnight. I I won't comment this quarter. We did have some cost adjustments in COGS, which inflated it, I would say more so than typical, and we do not expect those to recur again in q two. But, you know, I think we'll we'll we'll continue to see improving margins as the tech transfer goes on over the next year or so here. And, you know, ultimately, we'll come back to what I would say are a normal pharmaceutical margin for a biotech company in this space.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Thank you.

Operator

Thank you. I'm not showing any further questions in the queue. I'd like to turn the call back over to Sheldon for any closing remarks.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thank you, operator, and thank you all again for your time and attention this morning. We are looking forward to participating in the Citizens JMP Life Science Conference later this week and hope to have the opportunity to connect with many of you then. In the meantime, if you have any questions or would like to have a call with the team, just reach out to our Head of Investor Relations, Alina Venezia, and have a great day and thank you for your support.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day.

Executives
    • Alina Venezia
      Alina Venezia
      Head of Investor Relations
    • Sheldon Koenig
      Sheldon Koenig
      President & CEO
    • Ben Halladay
      Ben Halladay
      CFO
    • Betty Swartz
      Betty Swartz
      Chief Business Officer
Analysts

Key Takeaways

  • Revenue growth: Q1 total revenue reached $65 million, a 63% year-over-year increase (excluding a one-time milestone), with US net product sales up 41% to $34.9 million and early Q2 prescriptions tracking 8% above Q1.
  • Market access wins: Expanded the field reimbursement team to 15 specialists and secured removal of prior authorizations and electronic step edits across 30+ major plans, enhancing patient access and provider confidence.
  • Guideline inclusion: Nexletol and Nexlazet earned level 1A and 2A recommendations in the 2025 ACC/AHA acute coronary syndrome guidelines, reinforcing their use for patients on maximally tolerated statin therapy or statin-intolerant patients.
  • Pipeline expansion: Advanced an ACLY inhibitor into development for primary sclerosing cholangitis (PSC) with a $1 billion market opportunity and unveiled a triple-combination LDL-lowering therapy targeting a 2027 launch.
  • Global partnerships: Royalties from Daiichi Sankyo Europe rose 8% to $10.5 million, while collaborations in Japan (Otsuka), Australia/New Zealand (CSL), Canada and Israel position the company for broader international growth.
AI Generated. May Contain Errors.
Earnings Conference Call
Esperion Therapeutics Q1 2025
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