Hello, ladies and gentlemen, and thank you for standing by, and welcome to Esperion's Second Quarter 2025 financial results. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Alina Venezia, Head of Investor Relations for Esperion Therapeutics. Please go ahead. Alina Ve

Thank you, operator. Good morning, and welcome to Esperion's Second 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 today's call 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 this conference call contains time-sensitive information that is only accurate as of the date of this live broadcast, August 5, 2025. We undertake no obligation to revise or update any forward-looking statements in the 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 you, Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. We're thrilled to report a standout second quarter that delivered double-digit sequential growth, more than 42% year-over-year gains in U.S. net product sales and our first quarter of operating income from ongoing business. These results reflect accelerating clinical adoption of NEXLETOL and NEXLIZET fueled by our sharpened commercial execution, strong payer alignment and our ongoing targeted promotional strategy that's resonating with the statin-intolerant community. Total revenue for the second quarter 2025 grew 12% year-over-year to $82.4 million. Looking at our strong U.S. performance, where we saw a return to sequential double-digit quarterly prescription and revenue growth, U.S. net product revenue grew 42% year-over-year to $40.3 million and grew 15% sequentially from the first quarter of 2025. Given our strong performance, we achieved operating income from ongoing business of approximately $15 million, giving us confidence that with continued global growth, we expect to transition to sustainable profitability beginning in the first quarter of 2026. As we shared on our last call, the endorsement of NEXLETOL and NEXLIZET from leading cardiovascular professional societies was a powerful validation of our science, and it's already translated into action. Later this month, we look forward to the European Society of Cardiology, updating their lipid management guidelines at the Society's Annual Meeting, where we expect to be included in these updates. Turning to the progress we made on a number of our core marketing initiatives, including our campaign to reach patients who are statin intolerant, our tagline, Can't take a statin? Make NEXLIZET happen was well received, and this catchy phrase supported increased brand awareness among our target audience. In fact, during the second quarter alone, we had more than 650,000 visits to our new consumer statin intolerance website and more than 600,000 click-throughs to our physician site underscoring the impact of this successful campaign. We are implementing the right balance of in-person and digital outreach and are pleased to report that 23% or nearly 1/4 of our prescriptions were written by physicians with only digital touch points. In addition of prescriptions coming from new writers, 38% were driven by digital-only touch points. This highlights the importance of our digital omnichannel programs and underscores the impact they can continue to have. We remain committed to building on these successful programs and are confident in their continued contribution to our growth. Our expanded U.S. field reimbursement manager support team made great strides in supporting our growing prescriber base by educating over 1,100 target prescribers on NEXLETOL and NEXLIZET favorable reimbursement landscape. This was evident by an increase in all targeted prescriber approval rates to over 80%. Combined with further expanded payer coverage, reductions in prior authorization requirements, increased reimbursement support resources and our appropriate balance of direct and digital marketing efforts, we believe we have significantly improved the access environment for patients and physicians alike, which resulted in a 10% increase in total retail prescription equivalents from this first quarter of 2025 and increase our total prescriber base to more than 28,000 health care practitioners. This momentum validates the growing confidence among clinicians and the expanding role of our therapies in addressing the unmet needs of statin-intolerant patients. Our consumer marketing program featuring the lipid lurkers tackles a challenge of high cholesterol, a silent but serious threat by transforming it into mischievous characters that demand attention, which may be quietly lurking without their knowledge. Rather than relying on fear tactics, the lurkers personify LDL-cholesterol's hidden dangers making the risk tangible and manageable without intimidation. This fresh compelling approach reshapes how patients perceive and address their cardiovascular risk. By blending engagement with patient empowerment, the campaign stood out in a crowded market, driving awareness and action for proactive cholesterol management with NEXLETOL and NEXLIZET, the next step after statins. This campaign has won the prestigious Med Ad News Best Consumer Digital campaign and is nominated for several more awards this year. Moving forward, we plan to launch a consumer television ad later in the year that will stream on connected TV, such as Hulu and NBC Sports. These branded ads are expected to broaden awareness of statin intolerance and will feature our award-winning lipid lurkers. The combined strength of the statin intolerance and lipid lurkers campaign, coupled with improving payer dynamics support our continued growth now and into the future. Speaking of future growth, we remain committed to Esperion's continued growth in cardiovascular risk reduction with our plans to develop a triple combination product. This therapy has the potential to be the most effective oral LDL-cholesterol lowering option and to rival both existing injectables and emerging oral therapies. Development remains on track. In addition, our business development efforts are progressing nicely as we evaluate a number of potential opportunities to in-license or acquire synergistic products to leverage our existing commercial infrastructure. We look forward to updating you on progress here as it unfolds. Additionally, we reached important settlement agreements with 3 NEXLETOL -- 3 generic manufacturers have agreed not to market a generic version of NEXLETOL in the United States prior to 2040. We continue to identify opportunities to strengthen our intellectual property position and look forward to updating you on our progress. Turning to our pipeline, where our strategy is to expand into high-need, high-value indications that highlight the broader potential of our novel ACLY biology, we continue to make progress advancing IND-enabling studies to support our recently introduced program targeting primary sclerosing cholangitis, known as 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. We look forward to completing these studies and to filing an IND and potentially initiating first-in-human studies in the second half of 2026. Throughout the second quarter, we and our international partners continue to make tremendous progress across a number of key geographies. Our European partner, Daiichi Sankyo Europe, continues to expand their reach of NILEMDO and NUSTENDI to benefit patients at the risk of cardiovascular disease who cannot manage their LDL cholesterol levels. Our royalty revenue from DSE increased 30% from the first quarter of 2025 to $13.6 million in the second quarter of 2025. We are also thrilled to report that DSE has surpassed the 500,000 patient mark for patients who have been treated with our therapies in Europe. 0.5 million patients, this is a meaningful milestone that reinforces confidence in our ability to build a similarly sized market in the U.S. Throughout the first half of the year, we continue to advance multiple processes for the technology transfer for manufacturing of NILEMDO and NUSTENDI to DSE with the various working capital benefits expected in 2025. Our Japanese partner, Otsuka Pharmaceuticals, submitted for approval of our bempedoic acid products in Japan for LDL-cholesterol lowering and remain on track for approval and national health insurance pricing in the second half of 2025. Upon this achievement, we expect to receive milestone payments of up to $120 million. The Japanese market is the world's third largest cardiovascular prevention market, and we believe the royalties on Japanese product sales will be a major revenue contributor over time. Building on our global progress, we expanded our international reach through our commercial partnership with HLS Therapeutics, giving them the exclusive rights to commercialize NEXLETOL and NEXLIZET in Canada. Our previously filed new drug submissions to Health Canada are on track for review, and we continue to expect market approval in the fourth quarter of 2025. Our partner in Israel, Neopharm Israel remains on track for market approval of NEXLETOL and NEXLIZET in the first half of 2026. And CSL Seqirus, our partner in Australia and New Zealand filed a marketing application in Australia for NEXLETOL and NEXLIZET in July 2025 and expects market approval in Q4 2026. The progress with these international partnerships is expected to deliver a consistent cadence of approvals and product launches over the coming months and year that will also provide a growing royalty stream and milestone payment, all of which support our strategic focus to drive revenue growth and profitability. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the second quarter. Ben?

Thank you, Sheldon. Good morning, everyone, and thank you for joining us. I'm extremely excited and proud to share our financial results today. Our second 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. As you've heard Sheldon discuss, we had an exceptional second quarter, highlighted by our first of operating income from ongoing business in the company's history, which sets us up nicely and supports our plans to transition to sustainable profitability starting in the first quarter of 2026. We are proud of the progress we've made and it underscores our long-held assertion that incremental growth when compounded and expanded will drop to the bottom line. Over time, this gives us considerable leverage as we move forward with confidence. Turning now to the financial results. Second quarter 2025 total revenue was $82.4 million, up 12% from the comparable period in 2024. Note, this impressive growth was achieved even when compared to second quarter 2024, during which we received a $25 million onetime milestone payment, further highlighting the strength of our underlying business. U.S. net product revenue was $40.3 million compared to $28.3 million for the comparable period in 2024, an increase of approximately 42%. Sequential quarterly net revenue growth was 15%. Collaboration revenue was $42.1 million compared to $45.5 million for the comparable period in 2024, a decrease of approximately 7%, driven by the settlement agreement milestone with DSE received in the 3 months ended June 30, 2024, offset partially by increases in royalty sales with our partner territories and product sales to our collaboration partners from our supply agreements. Excluding the settlement agreement milestone, collaboration revenue grew 105% from the comparable period. Turning to the rest of the P&L. For the second quarter 2025, research and development expenses were $7.2 million compared to $11.5 million for the comparable period of 2024, a decrease of 37%. Selling, general and administrative expenses were $39.5 million compared to $44.2 million for the comparable period in 2024, a decrease of 11%. The decrease quarter-over-quarter was primarily related to decreased media and marketing costs. 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. We are on our way to transitioning to sustainable profitability starting in first quarter of 2026, and our operating income from ongoing business in the second quarter validates those expectations. We ended the quarter with cash and cash equivalents of $86.1 million, which combined with our excellent operational results and continued global growth well positions us to create value and achieve our goals. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

Thank you, Ben. As you've heard today, we have yet again delivered strong results and are executing with precision and building meaningful momentum across every dimension of our business from commercial performance and clinical adoption to global expansion and pipeline innovation. We are not just growing, we are transforming the landscape of cardiovascular disease prevention for underserved patients. With NEXLETOL and NEXLIZET, we are delivering real-world impact. And with every new prescriber, every new patient reach and every new market entered, we are advancing our mission to reduce cardiovascular risk on a global scale. Looking ahead, we are energized by the opportunities in front of us. Our international partnerships are poised to unlock new revenue streams, and our pipeline is expanding into high-value areas of unmet need with the potential to shape the future of care. When you combine all these factors with diligent expense management, we are on the path to sustainable profitability beginning in the first quarter of 2026 and remain deeply committed to creating long-term value for our shareholders, our partners and most importantly, for the patients we serve. Thank you for your continued support and belief in our vision. We look forward to updating you on our continued progress next quarter. At this time, we are ready for questions.

[Operator Instructions] That comes from Serge Belanger with Needham.

Congrats on the progress this quarter. A couple of quick questions on NEXLETOL and NEXLIZET. Can you remind us how many remaining prior auths are relative to the TAM for the product? And I think you mentioned you had over 80% approval rate for these prior auths. So is that a number you expect to continue improving on? And secondly, for Ben, I think you mentioned you expect some of the working capital benefits from the tech transfer to DSE to start occurring later this year. Just curious what that will look like on the balance sheet when it starts coming together?

Great. BJ?

Yes. Serge, as far as the approval rates, as Sheldon had mentioned, in less than 60 days with the new field reimbursement team, they've hit 1,100 targets in those 60 days, and we're showing rates well over 80%. We have certain pacesetter regions that are even higher than 80%. But as you know, with our approval rates, like CVS, where we had our prior authorizations removed, we've hit an all-time high there at -- hitting 93% approval rates there, Aetna 94%. And overall, we're well over 80%, but we have the certain key places where we've negotiated those prior authorizations really and improve that UM criteria. We're at 92 million live updated -- or 192 million, excuse me, aligned to our new label, and we continue to just see these approvals increasing day after day.

Thanks, Serge. This is Ben. Thanks for the question. On the working capital side, this is just in line with what we've been emphasizing on the importance from the tech transfer, right? We have a long time -- long production time line with our product. And so as DSE takes over, we will start to ramp down inventory production on our side, which we expect to happen towards the second half of this year. So I would -- inventory will come down as we start working through that backlog, and they will start ramping up in 2026.

Our next question is from Kristen Kluska with Cantor Fitzgerald.

Congrats on a strong quarter. So if I look at the graph on Slide 10, where you talk about the growth. Can you -- it looks like the jump from April to May was probably the largest numerical gain in the 2.5 years. So if you can -- I know you talked about several growth levers, but what in particular really like stood out during that transition time?

Thanks, Kristen. I think really for us, it's really been our strategy. We've talked a lot today about going after statin-intolerant patients and really establishing this beachhead, which has really continued to drive growth and create a significant amount of awareness. I think what you've heard today also is our plans as we move forward. You heard our tagline Can't take a statin? Make NEXLIZET happen. We've got representatives out there that are promoting that. We have a lot of material that shows that asking the question, can you take a statin? So to me, I think that's what's really continuing to continue to drive the growth. I also have Lisa Schafer, who is our Head of Marketing in the U.S., also provide some comments.

Yes, absolutely. And we see the strong growth both from Medicare, which was Medicare and commercial, which was really great and also with primary care physicians and cardiologists. So it really was just sustained growth quarter-over-quarter, but the out-of-pocket expense for Medicare patients has really improved in the second quarter as they reach that deductible. So that really will be tailwinds for the rest of the year as well.

Okay. So with the growth of the new prescribers that are coming on board, is the #1 selling point essentially that they have an option for these statin-intolerant patients? I guess, what would you rank maybe as the #2 and #3 selling points than primary prevention, secondary or anything else in particular that's really standing out as the other 2 selling points.

Yes, absolutely. So the fact that NEXLETOL and NEXLIZET are the only products indicated for reducing CV events in primary prevention is a very strong selling point. In addition, the only products that had the CV risk reduction, as you mentioned, in statin- intolerant patients, no other product now or in the future is studying that population for CV risk reduction. So those are really the strongest points that we have. Sheldon, anything to add to that?

[Operator Instructions] And it comes from Dennis Ding with Jefferies.

This is Georgia on for Dennis. Two questions from us. The first is, how do you view consensus U.S. revenue for the year, which is around $170 million and the underlying script growth required to get there? When will you consider giving revenue guidance? And then our second question is, can you remind us on the cadence of milestone payments from Otsuka? And are there very simple thresholds that need to be met and the contract language is very clear? And then can you reiterate that there won't be any confusion like we saw from Daiichi a few years ago?

Thanks for the question. I'll take those in 2 parts. So on the consensus side, yes, I think you can see that we're tracking nicely and in line. I think this was a good quarter in terms of beating consensus and we're tracking well ahead of where we would want to be for that. On the milestone side, I'll reiterate, we have milestones in the second half with the Japanese regulatory process, which is up to $120 million in milestone payments. We expect those to come like I said, in the second half of the year, we're confident we're going to achieve that full amount based on the contract language. There are tiers and thresholds associated with it, but looking and knowing what those are. I think we are in good shape to maximize the potential for those milestones.

Okay. And on the underlying script growth required to get there for the consensus, which is around $170 million?

We're not. I mean, we -- Georgia, we haven't really disclosed what we're doing. It falls in line with guidance. We haven't really given the financial guidance. We're not giving script guidance. But I think what's important is to show and something we've talked about before is that we will continue to demonstrate double-digit script growth, which we've done again this quarter with over 10% script growth, and we're confident that, that momentum will continue.

Our next question is from Jessica Fye with JPMorgan.

I have several questions this morning, mostly about the model and then kind of a bigger picture question. First, can you talk about the gross margin trend we should expect in the back half of the year and into '26? I guess I had thought it would kind of start to materialize, but maybe not. So just curious kind of how to think about the back half and then next year and frankly, ultimately, where you land. How should we think about gross to net over the rest of this year? And then it looks like R&D, particularly after this quarter is tracking below the 2025 R&D guidance. Should we expect a significant ramp-up in R&D in the back half to kind of get you into that range? So those are the model questions. And then the last one is just basically I want to ask you to kind of make the case here that NEXLETOL will remain competitive in the non-statin LDL space with additional oral mechanisms coming to market.

Thanks, Jess. I will handle the very exciting model questions first and then turn it over to Sheldon for the competitor side. So looking at the model, I think kind of going in order of what you asked about on the gross margin side, the true benefits from the tech transfer will kick in, I think, early next year. This quarter was a good gross margin. I think it was largely in part due to the revenue mix as well as some of the underlying movement of materials that we had. But I think it's indicative of what we can expect once the tech transfer kicks in place and the beneficial margins we would see there. On gross to net, I think we're in steady state at this point. We've seen 2 quarters of what post IRA gross to net would look like and the lack of the Medicare coverage gap. And frankly, it's been a huge tailwind for us over the course of this year. So we will not see that kind of compounding factor of gross to net worsening over the course of the year. And we will keep seeing the steady favorable gross to net, which you've seen so far in Q1 and Q2. On the R&D side, Q2 was light, but I think that's mostly just a timing thing. We have our pediatric trial, which is beginning to ramp up. And you'll see in the second half. I would not use the word significant ramp-up. R&D still remains pretty minimal in the grand scope of our spend, but you will see an increase compared to Q2 as that pediatric trial starts to ramp up in the second half of the year.

Great. Thanks, Ben. Jeff, let me address your question as it relates to NEXLETOL and NEXLIZET being competitive into the future, and I'll segment this in 2 ways. We do these live now and actually our computers were updating while I was actually reading the script. So I want to reiterate one part of it. And that is from an IP perspective, we've already mentioned that we've had three of the ANDA filers settle to 2040. And that's important because, as you know, our baseline projections were always June of 2031, and we started to actually plan beyond that. So we're very confident, as we stated before, about our patent. And so from a future perspective, that's going to allow us to continue to grow these products for a number of years. That's one aspect. But the second aspect is more about what do we have today. We're on the market today. We are the only product that study statin- intolerant patients. We are the only product that also has, as Lisa mentioned, an indication in primary prevention. No other future product is actually doing an outcome study, whether that be oral PCSK9 or CETP inhibition in primary prevention. Let's also not forget there have been 4 CETP inhibitors that have failed previously and it remains to be seen what happens with the CETP that's in development. So we're very confident based upon where we stand, really a summary of what we did today from a reimbursement perspective, how we've been able to drive growth, physicians becoming more aware of this product. So very bright future ahead. And I've always said when this product becomes generic, it's going to be the most utilized generic product ever in lipid lowering. Our mission is to make that goal now.

Our next question comes from Jason Zemansky with Bank of America.

I guess, Sheldon, maybe for you, at a high level, we appreciate it's still early days in the launch, and we're certainly not overlooking the progress to date, but you've talked about the potential of bempedoic acid reaching blockbuster status and sort of comparing where we are, we're curious what gets you there? And when should we expect the inflection to occur, particularly given the potential of competitive oral non-statin agents entering and additional potential headwinds, including reductions in Medicare, Medicaid spend and so forth.

Yes. So first of all, it kind of goes back to Slide 10 of the presentation. We've seen an inflection. This is a big market. This is a TAM of 70 million patients. This isn't like an orphan rare, as you know, oncology product, where you see this hockey stick take off. It's something that -- a market that will continue to grow, and you'll continue to see the growth in our product. We're very happy in where we stand. The fact that we've been able to provide double-digit growth in basically every single metric that you look at. we think that, to your point, early in the launch, we've got a long way to go. We're just starting, and we're seeing tremendous gains. As we mentioned today, Europe is a great bellwether as well as we continue to maximize our label from the CLEAR Outcome study. As you know, Jason, we haven't given guidance of when we'll be at certain points. But I think you can see by our ongoing successful quarters we're going to get there. As it relates to future competition, as I mentioned previously, we really need to see what the outcomes data shows for these products, and they're a long way off. So I would actually ask you to ask them how they think that will look versus us in the future. Thank you.

[Operator Instructions] We have a question from Joe Pantginis with H.C. Wainwright.

I have 2, please. So first, on the back end, with regard to PSC and your plans, what would you consider any, if any, rate-limiting steps that might potentially impact your second half of 2016 guidance?

I mean we don't really anticipate any, to be honest. Everything associated with our PSC program is baked in and incorporated into our expense guidance. And we've always reiterated, this is a relatively cheap program to move forward through the IND process, which we expect to continue in the second half of the year.

So that's from an expense front, also, like, say, from the scientific or preclinical study part components?

No, no, no, nothing this year.

Okay. Got it. And my second question, I will admit is somewhat rhetorical, but I would love your thoughts. So when you look at just the U.S. you talked about currently having about 28,000 health care providers prescribing the drug. Looking at your various marketing campaigns, the new ones coming up, the digital campaigns and what have you, what would you say would be the key inflection areas that would take you more quickly from 28,000 HCPs to say, 50,000 versus, say, 28,000 to 29,000?

Yes. Well, look, I mean, I think to your point, Joe, we've been showing this growth every quarter as it relates to physicians increasing prescribing I think what it's allowed us to do is also analyze what are the tactics getting us there. We talked about this TV ad and connected television. This is not a big DTC campaign. But this is something as more folks look at their phone or their tablet or their iPad. These are consumers and they're watching, whether that be Hulu or NBC Sports, as we mentioned, there will be others, consumers being driven to the physician also is very helpful. A matter of fact, we've done market research that has shown that every time a consumer has asked for this drug, they've gotten it. So this tactic of Can't take a statin? Make NEXLIZET happen. That's one that's driving physician growth. The consumer activation will also drive growth. And what we're also seeing is that physicians who use this drug in patients who can't take a statin, whether they can't take a statin at all or they can only take a low dose of a statin, they say, well, if it works this well without even taking the statin, what would it be like if they were taking the statin. So we're seeing more adoption than that add-on therapy also. So -- and again, primary prevention is a big driver. So all of those levers are going to continue our growth. And again, I would remind folks that primary prevention is a lever, we own that airspace. Nobody now or in the future will have that type of indication.

No, perfect. I love the thoughts. I appreciate that. And again, it's just the growing strong blocking and tackling that you guys are doing.

And this concludes our Q&A session. I will turn it back to management for final comments.

Thank you, operator, and thank you all again for your time and attention this morning. We are looking forward to participating in a number of September conferences 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 a great week. Take care.

And this concludes our conference. Thank you all for participating, and you may all disconnect.