Hello, ladies and gentlemen, and thank you for standing by. Welcome to Esperion's Third Quarter 2025 Financial Results. 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.

Thank you, operator. Good morning, and welcome to Esperion's Third Quarter 2025 Earnings Conference Call. With us on today's call are Sheldon Koenig, President and CEO; and Ben Halladay, CFO. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. A copy can be found on the Investor page of our website, together with a copy of the presentation that we will also be referencing. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to the risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 6, 2025. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open up the line for your questions. I'll now turn the call over to Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. Once again, we are very pleased to be reporting another strong quarter. Total revenue for the third quarter 2025 grew 69% year-over-year to $87.3 million. Looking at our strong U.S. performance, we saw nearly double-digit sequential quarterly prescription growth with U.S. net product revenue growing 31% year-over-year to $40.7 million. During the third quarter, we continued to lay the groundwork for the future by investing in enhanced patient access programs that are intended to drive prescription growth and revenue in the months and years ahead. While this impacted sequential growth this quarter, these were important one-time costs that we are confident will provide significant return on investment. That said, this was also our strongest third quarter on record, a particularly meaningful achievement given that this period has historically delivered more modest growth due to summer months and both patient and physician vacations. This outstanding performance reflects the strength of our execution and the growing recognition of bempedoic acid as a differentiated treatment for patients, especially those who cannot tolerate statins. Our commercial strategy is resonating. Prescriber engagement is up. Patient access is expanding and our creative campaigns are winning industry recognition. In addition to our commercial momentum, we made important strategic progress this quarter. We finalized agreements with four generic manufacturers, including Dr. Reddy's, not to market generic versions of NEXLETOL and NEXLIZET prior to April 2040, which supports the long-term value for our blockbuster franchise. We also saw our bempedoic acid products included in the ESC/EAS guidelines, a significant validation of their clinical benefit and a strong signal for expanded use. We expect similar inclusion in U.S. guidelines in early 2026, further reinforcing our leadership in cardiovascular risk reduction in both primary and secondary prevention for patients who need alternatives to statins. Turning to our progress in the U.S. market. During the third quarter, we outpaced the broader adjunct lipid-lowering market, delivering growth that exceeded all other non-statin products in the category, including branded products. This momentum reflects both the clinical relevance of our bempedoic acid products and the effectiveness of our winning commercial strategy. I want to take a moment to recognize the outstanding work of our commercial team. From sales and marketing to reimbursement and market access, their execution has been nothing short of exceptional, a textbook example of what commercial excellence looks like in our industry. Our continued growth is a direct result of making smart strategic choices, striking the right balance between in-person and digital engagement, investing in top-tier talent and high-impact programs and delivering bold, award-winning marketing campaigns that resonate with our audience. Their dedication and agility have been instrumental in driving performance and positioning us for sustained growth. In further support of these achievements, we are excited to welcome John Harlow to our team as Chief Commercial Officer effective November 17. John joins us with more than two decades of experience building and scaling commercial organizations across both large and emerging pharmaceutical companies. Most recently, he was Chief Commercial Officer at Melinta Therapeutics, where he led a team of 80 professionals across all commercial functions, nearly doubling revenue and delivering approximately 85% growth in 2024 from 2020. His proven ability to drive performance and inspire teams will be invaluable as we expand our reach, scale our operations and unlock the full potential of our portfolio. Turning now to our commercial progress. Last quarter, we launched several strategic marketing initiatives, including a targeted campaign aimed at patients who are statin intolerant, a population that represents a significant unmet need. Our research indicates that nearly 50% of individuals who begin statin therapy either discontinue treatment or have over a six-month gap in therapy within two years. This gap leaves many patients vulnerable to cardiovascular events and presents a substantial market opportunity for NEXLETOL and NEXLIZET. To address this, we introduced our 'Can’t take a statin? Make NEXLIZET happen!' campaign. This initiative has already begun to elevate brand awareness among our key demographics with healthcare professionals reporting a significant increase in their perception ratings of NEXLETOL and NEXLIZET for statin-intolerant patients based on quantitative data. These findings further support the transition from awareness to use and the impact of our powerful marketing. On September 22, we launched pilot promotional ads on connected TV platforms such as Hulu and Disney+. Building on that momentum, we began airing branded commercials during Grey's Anatomy on Disney+ and Hulu starting October 10. These ads feature our award-winning lipid lurkers and are designed to spotlight the issue of statin intolerance while positioning NEXLETOL and NEXLIZET as compelling alternatives. We anticipate these commercials will generate approximately 18 million impressions, specifically targeting adults over the age of 50 who have a history of statin use but have not been on therapy for at least a year. As of mid-October, we have already had greater than 6 million views of the full length of the commercial. We remain deeply committed to expanding the reach of these successful programs and are confident in their continued contribution to our growth trajectory. In addition to driving demand for our bempedoic acid products, we have made meaningful progress improving the access environment for patients and physicians alike. In the third quarter, we achieved an 87% average approval rate for Medicare coverage with out-of-pocket costs of $29 for a 30-day supply compared to $64 for a 30-day supply in the first quarter of 2025. In the third quarter, we averaged an 86% approval rate for commercial coverage with an out-of-pocket cost of $36 for a 30-day supply compared to $55 for the first quarter of 2025. In addition, the benefits of these co-pay programs have improved patient fulfillment of their prescriptions by 17%. These are meaningful cost reductions that underscore the growing payer confidence in our therapies and the fact that patient access for NEXLETOL and NEXLIZET has never been easier. Importantly, we added enhanced coverage with two major Medicare providers beginning October 1. While this coverage required near-term investment, we believe it will drive volume into the future that will more than compensate for these one-time costs. We now have greater than 90% of commercial lives and more than 80% of Medicare beneficiaries covered, with all national commercial and Medicare payers covering all indications. This combined progress, including expanded payer coverage, reduced prior authorization barriers, enhanced reimbursement support resources and our balanced approach to direct and digital marketing resulted in a 9% increase in total retail prescription equivalents from Q2 2025 and a 7% increase in the number of healthcare professionals prescribing NEXLETOL and NEXLIZET, bringing our total prescriber base to more than 30,000 healthcare practitioners. This growth validates the rising confidence among clinicians and the expanding role our therapies are playing in addressing the unmet needs of statin-intolerant patients. The combined strength of our statin intolerance campaign, improving payer dynamics and the continued success of our Lipid Lurkers campaigns position us well for sustained momentum in the quarters ahead. A very important advancement during the third quarter was the inclusion of bempedoic acid as a Class 1 Level A recommendation in the 2025 ESC/EAS guidelines. This endorsement by Europe's leading cardiovascular societies validates the clinical impact of our therapy for patients unable to tolerate statins and reinforces our commitment to expanding access to innovative lipid-lowering solutions. As I noted earlier, we believe this recognition will be reflected similarly in the forthcoming U.S. guidelines expected in Q1 2026. In preparation, we are laying the foundation to leverage this growth opportunity by increasing patient support programs, market access contract activation, engagement with integrated delivery networks and direct-to-consumer initiatives such as our connected TV campaign. Turning now to the progress we are making through our international partners around the world, where we continue to see significant growth in both geographic expansion and in-licensing product sales. Let's start with Europe, where our partner, Daiichi Sankyo Europe, continues to deliver robust revenue growth and expand market share for both NILEMDO and NUSTENDI. We expect the recent inclusion of ESC/EAS guidelines to support its expanded utilization across the 30 countries of the European Union, where Daiichi Sankyo Europe already has in excess of 600,000 patients who have been treated with our therapies in Europe. DSE also expanded their geographic reach with the launch of NILEMDO in Denmark, Sweden, and Finland. Third quarter royalty revenue from DSE increased 21% sequentially to $16.4 million compared with the second quarter of 2025. In August 2025, DSE announced the development of oral triple combination liquid-lowering tablets with the Santorini study simulation showing improved LDL-C goal attainment aligned with the 2025 ESC/EAS guidelines. We continue to make progress advancing multiple processes for the technology transfer for the manufacturing of NILEMDO and NUSTENDI to DSE, with expectations for DSE to ramp up beginning in early 2026, and with certain working capital benefits expected in 2025. In September, we are delighted to report that our Japanese partner, Otsuka Pharmaceutical, received marketing approval from the Japanese Ministry of Health, Labour and Welfare for NEXLETOL as a treatment for hypercholesterolemia and familial hypercholesterolemia. Most recently, Otsuka received favorable preliminary pricing approval from the National Health Insurance in Japan, which will trigger significant milestone payments from Otsuka upon final pricing approval. This favorable pricing is particularly encouraging as the Japanese market is the world's third largest cardiovascular prevention market, and the royalties on Japanese product sales will be a meaningful revenue contributor over time. We are also expanding our international reach in a variety of other regional markets where cumulatively, we are building meaningful revenue streams through commercial partnerships. Our Canadian partner, HLS Therapeutics, has already filed new drug submissions to Health Canada for NEXLETOL and NEXLIZET and is on track for market approval by year-end 2025. Our partner in Israel, Neopharm Israel, also expects market approval of NEXLETOL and NEXLIZET by year-end 2025. CSL Seqirus, our partner in Australia and New Zealand, filed a marketing submission for NEXLETOL and NEXLIZET in July and expects to receive market approval in the fourth quarter of 2026. The progress with these international partnerships is expected to deliver a steady cadence of approvals and product launches over the coming months and year, which will provide a growing royalty stream and a few potential milestone payments, all of which support our strategic focus to drive revenue growth and profitability. 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 beyond cardiovascular disease. Here, we are excited to nominate ESP-2001, our highly specific ACLY inhibitor as our first preclinical development candidate for the treatment of primary sclerosing cholangitis, or PSC. With this candidate selection, we will begin IND-enabling studies with a goal to file an IND with the FDA to initiate first-in-human clinical studies in 2026. PSC is a devastating condition with no approved treatment, and our preclinical data suggests ESP-2001 has the potential to meaningfully impact disease progression. We're proud to advance a candidate that reflects the capabilities of our next-generation ACLY inhibitor program and our commitment to addressing areas of high unmet need. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the third quarter. Ben?

Thank you, Sheldon. Good morning, everyone, and thank you for joining us today. Our third 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. Third quarter 2025 total revenue was $87.3 million, an increase of 69%. U.S. net product revenue was $40.7 million compared to $31.1 million for the comparable period in 2024, an increase of 31%. Collaboration revenue was $46.7 million compared to $20.5 million for the comparable period in 2024, an increase of approximately 128%, driven by increases in royalty sales within our partner territories and product sales to our collaboration partners from our supply agreement. Turning to the rest of the P&L. For the third quarter of 2025, research and development expenses were $14.1 million compared to $10.4 million for the comparable period in 2024, an increase of 36%. Selling, general and administrative expenses were $41.8 million compared to $40 million for the comparable period in 2024, an increase of 5%. The increase quarter-over-quarter was primarily related to the increased legal costs associated with the ANDA litigation and increased media costs. We are extremely pleased with our third quarter developments and are planning the business differently with a focus on laying the groundwork to significantly increase our sales and marketing efforts to accelerate our revenue growth as we prepare to introduce our Vision 2040. During the quarter, we made meaningful progress to extend our IP runway and now anticipate inclusion in the U.S. guideline recommendations in the first quarter of 2026, which provides substantial opportunity to solidify our position as a premier therapy and build on our blockbuster franchise. In October, we closed on a $75 million follow-on equity offering, which provided net proceeds of approximately $72.6 million. This equity offering was not a result of any changes in our liquidity outlook, but rather a strategic decision to ensure the company is well capitalized in order to make the most of these developments. We are reiterating our full-year 2025 operating expense guidance, which is expected to be approximately $215 million to $235 million, including $15 million in noncash expenses related to stock compensation. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

In closing, thank you, Ben. This was a quarter defined by strong execution, strategic progress, and growing momentum across every facet of our business. From commercial performance and market access to international expansion and pipeline advancement, we are laying the groundwork for our future growth and delivering on our mission to transform cardiovascular preventative care for patients. We remain focused, energized, and confident in our ability to drive sustained growth and long-term shareholder value. We look forward to a strong fourth quarter and to introducing our Vision 2040 in the new year. Thank you for your continued support and belief in our vision. We look forward to updating you on our progress in the quarters ahead. Operator, we are now ready to open the call for questions.

And our first question comes from Jessica Fye of JPMorgan.

This is on behalf of Jess. Just one question from us. What were the drivers behind the gross margins for this quarter? And how can we expect this to progress moving forward?

Yes. Thanks for the question. So the gross margin drivers were the same dynamic we've seen in previous quarters, right? We have low-margin tablet sales to our partners. And the margin that you see really reiterates the importance of the tech transfer and moving that manufacturing off of our books, which we still expect to complete by the end of the year and early into next year. So going forward, I would expect the gross margins to get better over the course of 2026 and be much more in line with where you would expect a pharmaceutical company of this type to be.

And our next question comes from Dennis Ding of Jefferies.

This is Georgia Bank on for Dennis Ding. Can you comment a bit more on achieving sustainable profitability in Q1 of 2026? And should this include any incoming milestones?

I'll start with the second half. We do not count milestones when we talk about profitability. Last quarter, we discussed sustainable ongoing profitability, which remains our focus. As we evaluate our progress against the earlier statements, we are currently aligned with the forecast we used to make those statements. Therefore, we remain confident in our path to profitability. It's important to note that some of the expenses in Q3 were one-time or nonrecurring, which negatively impacted our net income. We do not anticipate these expenses recurring next year, which may have influenced Q3 results but does not change our outlook for the company.

And our next question comes from Jason Zemansky of Bank of America.

On the progress. Just a question in terms of reimbursement per script. It looks like you said scripts were up 9% quarter-over-quarter, but U.S. revenues were fairly flat. Was there a one-time hit here? Sorry if I missed it? And I guess, what does it mean moving forward in terms of reimbursement there?

Thank you, Jason. I want to emphasize that our reimbursement rate is increasing, primarily due to strong coverage in both commercial and Medicare sectors. There were some one-time impacts, which we mentioned earlier, but we aim to establish a foundation for future growth. We've been planning for 2040, leading to our Vision 2040 initiative, which we will discuss further in the coming months. The one-time impacts included investments with two major Medicare plans for preferred access, starting October 1, and we will account for these adjustments from the third quarter onward. This decision was made for the benefit of our future growth. Additionally, we introduced a new e-voucher for our 90-count prescriptions. This program has reduced patient abandonment and balanced the co-pay amounts between 30-day and 90-day fills, which is crucial for us. These commitments were one-time only. Interestingly, when comparing the fourth quarter to the same period last quarter, we've already observed around a 30% increase in our gross sales. These initiatives are proving beneficial, and we're pleased with our decisions for the future. Thank you.

And our next question comes from Kristen Kluska of Cantor Fitzgerald.

I know it's early days, so this isn't going to be reflected in the revenues. But now that the ESC guidelines have been changed for a little bit over two months, I'm curious if your partner has given any feedback about the level of incoming requests that they've gotten or how their reps' dialogue has changed and the reception since that's occurred. And just trying to also understand again how this is going to really help give you a preview of what could come in the U.S. early next year.

Yes. Thank you, Kristen. So actually, I just spoke to the CEO of Daiichi Sankyo in Europe. I was saying this on the call yesterday. I don't know if this is the most professional thing to say, but it's not often that he's very German and he said, we are over the moon. This is a very U.S. expression. We are over the moon by the excitement that we've seen with physicians, key opinion leaders, et cetera, related to the guidelines, and they see it as already being very, very meaningful. He actually showed me some of the early trends. And to your point, it is early in some of their leading countries where they continue to show these positive inflections, and it's only going to get better because of the guidelines. The guidelines really came across as representing bempedoic acid as a foundational therapy. As we've mentioned before, the way the guidelines were presented at ESC, they specifically said they added bempedoic acid based on two items: practice-changing and compelling data, which is a result of the CLEAR Outcomes study. We think that's a great indicator for what we're going to see here in the U.S. for our guidelines. Our U.S. representatives have an approved piece where they're educating physicians on the EU guidelines because many U.S. physicians, especially cardiologists, look at EU guidelines since they have a goal of 55 milligrams per deciliter for high-risk patients. So it's a great lead-in for us for the U.S. guidelines, which we think will be released in early first quarter, and they'll use the meeting at ACC as a training ground. Again, some of these one-time investments we've made, that's why we made them to set us up for a longer sustained pathway of growth.

Okay. And then just regarding Otsuka and the opportunity in Japan, now that there's preliminary pricing, what's really the next step for them with the authorities there? And what is your expectation on the timing of when this could occur?

Yes. So with Otsuka, to your point, we received preliminary pricing, and I will note we are very, very happy with it. It's fantastic. It's a great outcome for us. The next steps for them are waiting for final pricing, and shortly after the final pricing is when they will launch. I would say just a few days after the final approved pricing, we would expect all of that to happen probably in the next two to three weeks, pending some administrative paperwork on their end. From there, it's off to the races for them. As Sheldon mentioned, this is the third largest lipid market in the world, and it's really just this regulatory hurdle that is the last step for them to start getting out there and selling this product.

I would just add, we're excited personally because Ben and I will be heading out to Tokyo later this year to celebrate with them and help them and observe the launch. So it's really exciting.

And our next question comes from Paul Choi of Goldman Sachs.

I want to maybe just ask on what you're seeing with regard to 340B utilization of NEXLETOL and NEXLIZET and how you're thinking about that dynamic potentially evolving in 2026? And my second question is just with regard to the pipeline and PSC. I know you guys are still working on IND filing, but just how do you think about the number of centers and if you had to put some bookends around what enrollment timing might look like? Any clarity there would be helpful.

Thanks, Paul. Good to hear from you. So on the 340B side, honestly, it's a minuscule unnoticeable portion of the business. So as far as the dynamics going forward, it would have no impact on our outlook or on our revenues. It's not a factor in how we operate.

Thanks, Ben. Paul, regarding PSC, first of all, again, we're super excited about announcing ESP-2001. Just a little color. We were at a patient support group symposium in Denver, where we were the highlighted company to speak about this potential drug for patients who just need something with such an unmet need. We've talked many times about how our drug is very differentiated, et cetera. As it relates to the amount of centers that we will need, we're still in the planning phase for that. I can tell you right now, we're planning to meet with the FDA just to discuss the necessary endpoints, etc. So we're in that preliminary aspect. We just had a Board meeting where we went over that plan yesterday. We'll continue to update you and others where we are, but we're trying to move this as quickly as possible because there is such an unmet need. Again, with ESP-2001, we have a drug that not only treats symptoms, etc., but repairs injury. I think that's what's most important. If we can prolong or even eliminate the need for a liver transplantation for a patient, that's transformational in this disease. So stay tuned, and we'll be giving more information as we continue to receive it ourselves.

And our next question comes from Serge Belanger of Needham.

First question regarding the prescriber base. I think you continue to expand it. It was up 7% this quarter. What's the split between specialists and primary care physicians? And as you keep adding, are those proportions changing towards one side or another? Then a couple of quick ones for Ben. Any updates on the DSE manufacturing process? And should we expect guidance for 2026?

Serge, thanks for the question. I'll answer your first, then turn it over to Ben for the second. It's pretty steady right now as it relates to the segmentation of prescribers. It's 60% primary care and about 40% cardiologists with a very small sliver of endocrinologists. That's exactly where we would have expected it. If you go back to the old days and look at Zetia, now ezetimibe as an analog, a program I managed for a number of years, it was 60% primary care physicians, 40% cardiologists. Again, that's where the real opportunity is with these primary care physicians. One other thing I'll just say before I turn it over to Ben is what really resonates with primary care physicians is our messaging related to primary prevention. They are very interested in it combined with our statin intolerance strategy, which has really been gaining traction as we mentioned in our prepared remarks.

Yes, so on the tech transfer, it's progressing nicely. We expect that manufacturing to ramp up early next year. I think I said earlier, I would expect gross margin to dramatically improve over the course of 2026 to be in line with where you'd expect a small molecule oral medication to be. It won't be an overnight flip, but I do think it will get better and better. We are starting to see some of the working capital benefits associated with it now and into next year. We're looking forward to the benefits of that tech transfer. On guidance, we haven't made a formal decision or announced anything as of yet. I think we're still batting that around internally. So we'll see is the answer there.

And our next question comes from Joe Pantginis of H.C. Wainwright.

This is Sara on for Joe. I just wanted to follow up a bit on the prescription momentum. You guys have been seeing consistently double-digit script growth. I wanted to get some granularity on what you're seeing in the field right now that gives you the confidence that the momentum will continue into the new year, especially with that January deductible reset that's historically been a headwind.

Yes. Great. Thank you. What we're hearing from the field and just to add some color, we actually conduct business reviews every Friday with all of our field managers. Feedback that we hear the most that really gives us confidence is that I've been doing this business for over 30 years, and it's the first time I'm never hearing that it's hard to get the drug. The reimbursement is just so pristine that it's not difficult to get the drug. The message is easy: talking to a physician with patients who can only take a low dose of a statin; you have an option now, an oral therapy with NEXLIZET or NEXLETOL. That's really what's given us confidence. We also have attribute trackers for market research that gives us qualitative feedback on why physicians will write more and continue to write more. Lisa, I don't know if you want to add anything else. We have Lisa Schafer, who heads up our marketing group here.

Yes. The other thing that I would add is just around the ESC guidelines. That is something that cardiologists are really receptive to with the Level 1A recommendation, and that will continue into next year because the U.S. guidelines will come out. We have a lot of great tailwinds coming into the fourth quarter and definitely expect it to continue next year in Q1.

I'm showing no further questions at this time. I'd like to turn it back to Sheldon Koenig for closing remarks.

We're all doing the slides today, folks. So, in closing, thank you. This was a quarter defined by strong execution, strategic progress, and growing momentum across every facet of our business. From commercial performance and market access to international expansion and pipeline advancement, we are laying the groundwork for our future growth and delivering on our mission to transform cardiovascular prevention for patients. I want to remind everyone that next week on November 11 at 2:00 p.m. Eastern Time, we'll be hosting a virtual key opinion leader event on the role of bempedoic acid for the treatment of statin-intolerant patients that will feature discussion with a number of lipidology experts. We hope you can join us for that, what we expect will be an interesting and very informative event. We're also looking forward to participating in a number of upcoming conferences, including Jefferies London and the Piper Sandler Healthcare Conferences, where we hope 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. Thank you so much.

This concludes today's conference call. Thank you for participating, and you may now disconnect.