NASDAQ:ESPR Esperion Therapeutics Q1 2025 Earnings Report $1.17 -0.03 (-2.50%) Closing price 06/13/2025 04:00 PM EasternExtended Trading$1.19 +0.02 (+1.62%) As of 06/13/2025 07:56 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Esperion Therapeutics EPS ResultsActual EPS-$0.21Consensus EPS -$0.18Beat/MissMissed by -$0.03One Year Ago EPSN/AEsperion Therapeutics Revenue ResultsActual Revenue$65.00 millionExpected Revenue$54.97 millionBeat/MissBeat by +$10.03 millionYoY Revenue GrowthN/AEsperion Therapeutics Announcement DetailsQuarterQ1 2025Date5/6/2025TimeBefore Market OpensConference Call DateTuesday, May 6, 2025Conference Call Time8:00AM ETUpcoming EarningsEsperion Therapeutics' Q2 2025 earnings is scheduled for Monday, August 11, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Esperion Therapeutics Q1 2025 Earnings Call TranscriptProvided by QuartrMay 6, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00Ladies 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 VeneziaHead of Investor Relations at Esperion Therapeutics00:00:22Thank 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 VeneziaHead of Investor Relations at Esperion Therapeutics00:00:48A 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 VeneziaHead of Investor Relations at Esperion Therapeutics00:01:27The 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 KoenigPresident & CEO at Esperion Therapeutics00:01:58Thank 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 KoenigPresident & CEO at Esperion Therapeutics00:02:13Product 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 KoenigPresident & CEO at Esperion Therapeutics00:03:00Total 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 KoenigPresident & CEO at Esperion Therapeutics00:04:07Our 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 KoenigPresident & CEO at Esperion Therapeutics00:04:59Phemedoic 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 KoenigPresident & CEO at Esperion Therapeutics00:05:57To 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 KoenigPresident & CEO at Esperion Therapeutics00:06:48To 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 KoenigPresident & CEO at Esperion Therapeutics00:07:54We 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 KoenigPresident & CEO at Esperion Therapeutics00:08:41In 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 KoenigPresident & CEO at Esperion Therapeutics00:09:33In 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 KoenigPresident & CEO at Esperion Therapeutics00:10:28The 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 HalladayCFO at Esperion Therapeutics00:10:56Thank 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 HalladayCFO at Esperion Therapeutics00:11:21Excluding 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 HalladayCFO at Esperion Therapeutics00:11:39S. 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 HalladayCFO at Esperion Therapeutics00:12:08Beginning 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 HalladayCFO at Esperion Therapeutics00:13:04Selling, 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 KoenigPresident & CEO at Esperion Therapeutics00:13:45As 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 KoenigPresident & CEO at Esperion Therapeutics00:14:28Thank 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. Operator00:14:48Thank you. Our first question will come from the line of Dennis Ding from Jefferies. Your line is open. Dennis DingVice President - Equity Research Analyst at Jefferies Financial Group00:15:15Hi. Good morning. Congrats on the progress. And I have two questions. One is on BD. Dennis DingVice President - Equity Research Analyst at Jefferies Financial Group00:15:21I 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 DingVice President - Equity Research Analyst at Jefferies Financial Group00:15:53So is that how you see the value proposition here for the triple one versus two pills? Thank you. Ben HalladayCFO at Esperion Therapeutics00:15:59Hey, 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 HalladayCFO at Esperion Therapeutics00:16:13We 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 KoenigPresident & CEO at Esperion Therapeutics00:16:36Thanks 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 KoenigPresident & CEO at Esperion Therapeutics00:17:07So 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 DingVice President - Equity Research Analyst at Jefferies Financial Group00:17:30Got it. Thank you. Operator00:17:32One 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 PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.00:17:42Hey 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 PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.00:18:11So, 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 KoenigPresident & CEO at Esperion Therapeutics00:18:29Sure, 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 KoenigPresident & CEO at Esperion Therapeutics00:18:53You 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 KoenigPresident & CEO at Esperion Therapeutics00:19:30So 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 KoenigPresident & CEO at Esperion Therapeutics00:19:52So 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 KoenigPresident & CEO at Esperion Therapeutics00:20:36There'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 PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.00:20:48Fantastic. Thanks a lot, Sheldon. Sheldon KoenigPresident & CEO at Esperion Therapeutics00:20:50Sure. Thank you. Operator00:20:52One moment for our next question. Next question comes from line of Jason Zamanski from Bank of America. Your line is open. Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:21:03Good 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 ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:21:36So, you know, in terms of looking at the landscape down the road, you know, where does the triple fall into place here? Sheldon KoenigPresident & CEO at Esperion Therapeutics00:21:43Yeah, 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 KoenigPresident & CEO at Esperion Therapeutics00:22:09There'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 KoenigPresident & CEO at Esperion Therapeutics00:22:27But 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 ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:23:08But again, for patients who aren't interested in taking a statin, I mean, is this the option for them? Sheldon KoenigPresident & CEO at Esperion Therapeutics00:23:13Well, 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 ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:23:55Got it. Thanks for the color. Sheldon KoenigPresident & CEO at Esperion Therapeutics00:23:57Sure thing. Operator00:23:58Thank 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 KluskaEquity Research Analyst at Cantor Fitzgerald00:24:10Hi, 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 KoenigPresident & CEO at Esperion Therapeutics00:24:32Yes, 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 KluskaEquity Research Analyst at Cantor Fitzgerald00:25:25Thank you. Operator00:25:27One moment for our next question. Our next question will come from the line of Serge Belanger from Needham. Your line is open. Serge BelangerSenior Analyst at Needham & Company00:25:37Hi, 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 BelangerSenior Analyst at Needham & Company00:25:53You 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 KoenigPresident & CEO at Esperion Therapeutics00:26:11Yeah, 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 SwartzChief Business Officer at Esperion Therapeutics00:26:25Yeah, 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 SwartzChief Business Officer at Esperion Therapeutics00:27:03So, 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 KoenigPresident & CEO at Esperion Therapeutics00:27:14And 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 BelangerSenior Analyst at Needham & Company00:27:52Great. 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 KoenigPresident & CEO at Esperion Therapeutics00:28:09Sure, 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. Operator00:28:36Thank 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 FyeManaging Director & Equity Research Analyst - Biotechnology at JP Morgan00:28:47Hey 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 HalladayCFO at Esperion Therapeutics00:29:07Yes. 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 HalladayCFO at Esperion Therapeutics00:29:37It'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 FyeManaging Director & Equity Research Analyst - Biotechnology at JP Morgan00:30:08Thank you. Operator00:30:10Thank 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 KoenigPresident & CEO at Esperion Therapeutics00:30:22Thank 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. Operator00:30:47Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day.Read moreParticipantsExecutivesAlina VeneziaHead of Investor RelationsSheldon KoenigPresident & CEOBen HalladayCFOBetty SwartzChief Business OfficerAnalystsDennis DingVice President - Equity Research Analyst at Jefferies Financial GroupJoseph PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill LynchKristen KluskaEquity Research Analyst at Cantor FitzgeraldSerge BelangerSenior Analyst at Needham & CompanyJessica FyeManaging Director & Equity Research Analyst - Biotechnology at JP MorganPowered by 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.Conference Call Audio Live Call not available Earnings Conference CallEsperion Therapeutics Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Esperion Therapeutics Earnings HeadlinesCan The Promise Of Profitability And Pipelines Sustain A Recovery For Esperion Therapeutics?June 14 at 8:00 AM | seekingalpha.comEsperion Therapeutics, Inc. (NASDAQ:ESPR) Receives $6.25 Consensus Price Target from AnalystsJune 14 at 1:11 AM | americanbankingnews.comWhen This Happens, You Don’t Wait. You Act.This same signal has appeared twice before in the past 8 years — both times, it kicked off major moves in crypto. Now it’s back, and the smart money is already positioning. A free training reveals the step-by-step strategy and altcoin picks designed to help you capitalize on the next wave.June 15, 2025 | Crypto Swap Profits (Ad)Research Analysts Set Expectations for ESPR FY2026 EarningsJune 13 at 3:21 AM | americanbankingnews.comTraders Purchase High Volume of Esperion Therapeutics Call Options (NASDAQ:ESPR)June 10, 2025 | americanbankingnews.comWhat is Zacks Research's Forecast for ESPR Q2 Earnings?June 8, 2025 | americanbankingnews.comSee More Esperion Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Esperion Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Esperion Therapeutics and other key companies, straight to your email. Email Address About Esperion TherapeuticsEsperion Therapeutics (NASDAQ:ESPR), a pharmaceutical company, develops and commercializes medicines for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C). Its marketed products include NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) tablets that are oral, once-daily, non-statin medicines for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The company's products also include NILEMDO, an ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating the LDL receptors; and NUSTENDI, a bempedoic acid and ezetimibe tablet to treat elevated LDL-C. The company has license and collaboration agreements with Daiichi Sankyo Co. Ltd to; Otsuka Pharmaceutical Co., Ltd; and Daiichi Sankyo Europe GmbH. Esperion Therapeutics, Inc. was incorporated in 2008 and is headquartered in Ann Arbor, Michigan.View Esperion Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Broadcom Slides on Solid Earnings, AI Outlook Still StrongFive Below Pops on Strong Earnings, But Rally May StallRed Robin's Comeback: Q1 Earnings Spark Investor HopesOllie’s Q1 Earnings: The Good, the Bad, and What’s NextBroadcom Earnings Preview: AVGO Stock Near Record HighsUlta’s Beautiful Q1 Earnings Report Points to More Gains Aheade.l.f. 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PresentationSkip to Participants Operator00:00:00Ladies 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 VeneziaHead of Investor Relations at Esperion Therapeutics00:00:22Thank 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 VeneziaHead of Investor Relations at Esperion Therapeutics00:00:48A 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 VeneziaHead of Investor Relations at Esperion Therapeutics00:01:27The 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 KoenigPresident & CEO at Esperion Therapeutics00:01:58Thank 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 KoenigPresident & CEO at Esperion Therapeutics00:02:13Product 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 KoenigPresident & CEO at Esperion Therapeutics00:03:00Total 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 KoenigPresident & CEO at Esperion Therapeutics00:04:07Our 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 KoenigPresident & CEO at Esperion Therapeutics00:04:59Phemedoic 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 KoenigPresident & CEO at Esperion Therapeutics00:05:57To 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 KoenigPresident & CEO at Esperion Therapeutics00:06:48To 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 KoenigPresident & CEO at Esperion Therapeutics00:07:54We 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 KoenigPresident & CEO at Esperion Therapeutics00:08:41In 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 KoenigPresident & CEO at Esperion Therapeutics00:09:33In 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 KoenigPresident & CEO at Esperion Therapeutics00:10:28The 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 HalladayCFO at Esperion Therapeutics00:10:56Thank 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 HalladayCFO at Esperion Therapeutics00:11:21Excluding 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 HalladayCFO at Esperion Therapeutics00:11:39S. 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 HalladayCFO at Esperion Therapeutics00:12:08Beginning 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 HalladayCFO at Esperion Therapeutics00:13:04Selling, 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 KoenigPresident & CEO at Esperion Therapeutics00:13:45As 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 KoenigPresident & CEO at Esperion Therapeutics00:14:28Thank 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. Operator00:14:48Thank you. Our first question will come from the line of Dennis Ding from Jefferies. Your line is open. Dennis DingVice President - Equity Research Analyst at Jefferies Financial Group00:15:15Hi. Good morning. Congrats on the progress. And I have two questions. One is on BD. Dennis DingVice President - Equity Research Analyst at Jefferies Financial Group00:15:21I 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 DingVice President - Equity Research Analyst at Jefferies Financial Group00:15:53So is that how you see the value proposition here for the triple one versus two pills? Thank you. Ben HalladayCFO at Esperion Therapeutics00:15:59Hey, 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 HalladayCFO at Esperion Therapeutics00:16:13We 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 KoenigPresident & CEO at Esperion Therapeutics00:16:36Thanks 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 KoenigPresident & CEO at Esperion Therapeutics00:17:07So 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 DingVice President - Equity Research Analyst at Jefferies Financial Group00:17:30Got it. Thank you. Operator00:17:32One 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 PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.00:17:42Hey 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 PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.00:18:11So, 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 KoenigPresident & CEO at Esperion Therapeutics00:18:29Sure, 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 KoenigPresident & CEO at Esperion Therapeutics00:18:53You 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 KoenigPresident & CEO at Esperion Therapeutics00:19:30So 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 KoenigPresident & CEO at Esperion Therapeutics00:19:52So 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 KoenigPresident & CEO at Esperion Therapeutics00:20:36There'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 PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.00:20:48Fantastic. Thanks a lot, Sheldon. Sheldon KoenigPresident & CEO at Esperion Therapeutics00:20:50Sure. Thank you. Operator00:20:52One moment for our next question. Next question comes from line of Jason Zamanski from Bank of America. Your line is open. Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:21:03Good 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 ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:21:36So, you know, in terms of looking at the landscape down the road, you know, where does the triple fall into place here? Sheldon KoenigPresident & CEO at Esperion Therapeutics00:21:43Yeah, 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 KoenigPresident & CEO at Esperion Therapeutics00:22:09There'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 KoenigPresident & CEO at Esperion Therapeutics00:22:27But 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 ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:23:08But again, for patients who aren't interested in taking a statin, I mean, is this the option for them? Sheldon KoenigPresident & CEO at Esperion Therapeutics00:23:13Well, 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 ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:23:55Got it. Thanks for the color. Sheldon KoenigPresident & CEO at Esperion Therapeutics00:23:57Sure thing. Operator00:23:58Thank 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 KluskaEquity Research Analyst at Cantor Fitzgerald00:24:10Hi, 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 KoenigPresident & CEO at Esperion Therapeutics00:24:32Yes, 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 KluskaEquity Research Analyst at Cantor Fitzgerald00:25:25Thank you. Operator00:25:27One moment for our next question. Our next question will come from the line of Serge Belanger from Needham. Your line is open. Serge BelangerSenior Analyst at Needham & Company00:25:37Hi, 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 BelangerSenior Analyst at Needham & Company00:25:53You 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 KoenigPresident & CEO at Esperion Therapeutics00:26:11Yeah, 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 SwartzChief Business Officer at Esperion Therapeutics00:26:25Yeah, 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 SwartzChief Business Officer at Esperion Therapeutics00:27:03So, 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 KoenigPresident & CEO at Esperion Therapeutics00:27:14And 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 BelangerSenior Analyst at Needham & Company00:27:52Great. 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 KoenigPresident & CEO at Esperion Therapeutics00:28:09Sure, 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. Operator00:28:36Thank 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 FyeManaging Director & Equity Research Analyst - Biotechnology at JP Morgan00:28:47Hey 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 HalladayCFO at Esperion Therapeutics00:29:07Yes. 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 HalladayCFO at Esperion Therapeutics00:29:37It'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 FyeManaging Director & Equity Research Analyst - Biotechnology at JP Morgan00:30:08Thank you. Operator00:30:10Thank 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 KoenigPresident & CEO at Esperion Therapeutics00:30:22Thank 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. Operator00:30:47Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day.Read moreParticipantsExecutivesAlina VeneziaHead of Investor RelationsSheldon KoenigPresident & CEOBen HalladayCFOBetty SwartzChief Business OfficerAnalystsDennis DingVice President - Equity Research Analyst at Jefferies Financial GroupJoseph PantginisMD & Senior Healthcare Analyst at H.C. Wainwright & Co.Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill LynchKristen KluskaEquity Research Analyst at Cantor FitzgeraldSerge BelangerSenior Analyst at Needham & CompanyJessica FyeManaging Director & Equity Research Analyst - Biotechnology at JP MorganPowered by