Esperion Therapeutics, Inc. (ESPR) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome. [Operator Instructions] 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.

Thank you, operator. Good morning, and welcome to Esperion's First Quarter 2025 Earnings Conference Call. With us on today's call are Sheldon Koenig, President and CEO; and Ben Halladay, CFO. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. 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. The content of the conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 6, 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'll now turn the call over to Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. Throughout the first quarter, we continued to make progress across our 3 pillars for growth: revenue growth, portfolio expansion and pipeline advancement. We posted year-over-year net U.S. 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 U.S., saw green shoots of progress with significant strides in expanding our reach, both domestically and internationally. Total revenue for the first quarter 2025 grew 63% year-over-year to $65 million after adjusting for a onetime milestone received in the first quarter 2024. U.S. net product revenue grew 41% year-over-year to $34.9 million, driven by the expanded label and commercial initiatives started in 2024. First quarter 2025 script growth increased 2% sequentially compared to fourth quarter 2024. This was somewhat muted by the impact of a flat lipid-lowering market in the first quarter of 2025 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 U.S., 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. 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 NEXLIZET, 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 NEXLIZET were recently added to the new 2025 ACC/AHA multi-society guidelines for the management of patients with acute coronary syndrome or ACS. Bempedoic 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. Bempedoic acid also earned a Level 2a recommendation, meaning that moderate evidence exists and the 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, reduction on prior authorization requirements and the available reimbursement support resources, we believe we have significantly improved the access environment for patients and physicians alike. To better leverage this broader patient access, we recently introduced a series of payer and provider tactics that highlight the fact that up to 30% of patients are statin intolerant and showcasing evidence to demonstrate how NEXLETOL and NEXLIZET 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 co-pay levels continue to decline. 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 U.S., as it will provide physicians with the flexibility of a suite of options that include monotherapy NEXLETOL, dual therapy NEXLIZET 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. We continue to see compelling growth from our partner, Daiichi Sankyo Europe, where they are making meaningful progress expanding the use of NILEMDO and NUSTENDI 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 2024 to $10.5 million in the first quarter of 2025. As of the end of February, approximately 472,500 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 U.S. In addition, the tech transfer for both NILEMDO and NUSTENDI 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 2025. The Japanese market is the world's third largest cardiovascular prevention market and we believe the royalties on Japanese project sales will be a meaningful revenue contributor over time. Looking to the progress we made during the first quarter 2025, we expanded the breadth of our global reach by entering commercial partnerships with CSL Squires 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 2026. In addition, Esperion filed submissions for approval in Canada, for NEXLETOL and NEXLIZET, and we anticipate market approval in the fourth quarter of 2025. 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&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 billion annual market opportunity. This program reflects our strategy to expand into high-need, high-value indications and highlights the broader potential of ACLY biology. The R&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&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?

Thank you, Sheldon. Good morning, everyone, and thank you for joining us today. Our first quarter 2025 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 2025 total revenue was $65 million, a decrease of 53%. This decrease was driven by a onetime settlement agreement milestone with DSE, which we received in the first quarter of 2024. Excluding the settlement agreement milestone, total revenue grew 63%. U.S. net product revenue was $34.9 million compared to $24.8 million for the comparable period in 2024, an increase of approximately 41%. Q1 product revenue growth in the U.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. 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 $30.1 million compared to $113 million 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 to our 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&L. For the first quarter 2025, research and development expenses were $12.6 million compared to $13.4 million for the comparable period in 2024, a decrease of 6%. Selling, general and administrative expenses were $43 million compared to $42 million 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 $114.6 million as of March 31, 2025. We are reiterating our full year 2025 operating expense guidance, which is expected to be approximately $215 million to $235 million, including $15 million in noncash expenses related to stock compensation. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

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. 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 Instructions] Our first question will come from the line of Dennis Ding from Jefferies.

Congrats on the progress. And I have 2 questions. One is on BD. I guess, when should we expect the 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 obicetrapib gets approved in 2027 because from an efficacy perspective, like as your triple gets 60%-plus LDL reduction in 1 pill, but obicetrapib can get there or higher with 2. So is that how you see the value proposition here for the triple 1 versus 2 pills?

Dennis, thanks for joining. Appreciate the question. On the BD side, so to answer your question, we're, I think, making very good progress there. I've said before, we're not going to set a time line just because we don't want to feel like we have to execute a deal to get a deal done. We want to 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 just for some other time line here.

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 1 pill. And it also has really the potential of being the most efficacious LDL-lowering drug on the market. So that's how we look at it is it's just 1 pill that a patient has to take. And as you know, many patients are taking sometimes 6 to 7 medications. In this case, they would only have to take one. I'm not going to make comments compared to obicetrapib. That's a product in development, and we'll just have to wait to see if that product actually comes to the market.

Our next question will come from the line of Joe Pantginis from H.C. Wainright.

So first, on the sales front, you're up to about 15 right now, as you said, I wanted to get a sense of do you feel it's rightsized 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 NEXLETOL, I'll provide one example and maybe you have others as well. 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?

Sure. Thanks, Joe, 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. You started off with 15. I think what you were talking about were the 15 field reimbursement managers, and that is new. They were effective on April 1. We have 15 sales regions across the nation. And we did have 6 field reimbursement managers, but we've expanded that to 15 where we have 1 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 prior authorization. And so it's just another way of supporting limiting barriers to prescribing. 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 to find that statin intolerance is about 30% of the population, 3-0. 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, 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 a statin, but they really can't take it. And here, now this is an opportunity where you can prescribe NEXLETOL and NEXLIZET. And I can tell you that message is gaining a lot of traction. So the education -- and we're just starting, by the way, there are some other things that we have planned that we'll continue to update you through the year. But we're not only focusing on physicians, but we're also looking at ways to activate the consumer.

One moment for our next question. Next question will come from the line of Jason Zemansky from Bank of America.

Congrats on the quarter. 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, there 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. So in terms of looking at the landscape down the road, where does the triple fall into place here?

Yes. So thanks, Jason. So yes, 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 and our CLEAR Outcomes study. And not only are we excited about this, but our partners at Daiichi Sankyo are excited about this. There's going to be more news coming as it relates to this in the fall, as we've mentioned before. As you know, with Lp(a), 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. But I think hsCRP, Lp(a), these are all important markers. As we've mentioned in the past, cardiovascular disease is the #1 killer, and we can do something about it today with NEXLIZET and NEXLETOL 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.

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

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.

Our next question will come from the line of Kristen Kluska from Cantor Fitzgerald.

As it relates to the ACC/AHA 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.

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 is 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.

Our next question will come from the line of Serge Belanger from Needham.

This is John on for Serge today. So I just wanted to touch on first seasonal market dynamics for NEXLETOL and NEXLIZET. Obviously, there's a little bit of a slowdown in 1Q. You mentioned the flat lipid market, changes in Med Part D, et cetera. Just curious qualitatively, whether you think this was worse this year than in years prior? And did this in any way kind of portend a bigger bounce back for 2Q.

Yes. 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 some more color on it.

Yes, John, the prescription growth was impacted by a variety of seasonal factors, which included the annual insurance deductibles and the reset. But there was also an added confusion also around the Inflation Reduction Act and those related adjustments. But from an emerging positive trends starting in 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 nonwriters. 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 and really looking forward to that trend continuing.

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 a 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 the true out-of-pocket expense. At one point, you may recall back in January, there is 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.

Great. Yes. And then just quickly to touch on the triple combo. Do you have any time lines at this point as to when it could reach market and what any sort of regulatory framework would look like here to get it approved?

Sure. Yes. 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.

Next question will come from the line of Jessica Fye from JPMorgan.

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?

Yes. Jess, this is Ben. So our gross margin is largely influenced by the proportion of what sales we see between the U.S. and those tablet sales to our partners, mainly DSE, which I think we 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 multiyear progression. It's not going to be overnight. 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 Q2. But I think we'll continue to see improving margins as the tech transfer goes on over the next year or so here. And ultimately, we'll come back to what I would say are a normal pharmaceutical margin for a biotech company in this space.

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.

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.

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