ESPR - NASDAQ

Ladies and gentlemen, thank you for standing by and welcome. [Operator Instructions] Please be advised that today's conference call may be recorded. I would now like to turn the call over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. You may begin.

Thank you, operator. Good morning, and welcome to Esperion's Fourth Quarter and Full Year 2024 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 information discussed on the call today is covered under the safe harbor provision 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, March 4, 2025. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. I'll now turn the call over to Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. As I've noted in prior calls, 2024 was a transformational year for Esperion as we received the expanded labels for our bempedoic acid products in the U.S., supported global expansion with our partners in key markets and significantly strengthened our financial structure to enhance our balance sheet and provide us with financial and operational flexibility to support our future growth. Importantly, the advances and improvements we made during 2024 formed a strong foundation from which we can focus on our bold vision for the future that is centered around 3 strategic pillars for building a blockbuster company: continued revenue growth, operating profitability and portfolio expansion and pipeline advancement. Focusing on our first pillar, increasing revenue and operating profitability, let us turn now or look at our progress and plans moving forward with the sales and marketing of our bempedoic acid products in the U.S. and global markets. In March 2024, we received U.S. FDA approval for the expanded labels for NEXLETOL and NEXLI

Thank you, Sheldon. Good morning, everyone, and thank you for joining us today. During 2024, we executed 2 transformational financial transactions that fundamentally reshaped our capital structure, providing us with enhanced operational and financial flexibility. These improvements, coupled with our fortified balance sheet, empower us to focus on investing in our 3 pillars for growth to build a leading global biopharmaceutical powerhouse. In June 2024, we closed on a royalty purchase agreement with OMERS Life Sciences, receiving approximately $304.7 million in cash in exchange for 100% of our royalty interest from DSE royalty sales. OMERS will receive the DSE royalty stream net bempedoic acid product sales in Europe until it has received an aggregate amount equal to 1.7x its investment. Thereafter, all future payments on DSE royalties will revert back to Esperion. Proceeds from the royalty purchase agreement facilitated early payout and termination of the Oberland secured facility, removing all liens and covenants associated with that agreement. In December 2024, we executed a series of financing transactions that supported the repayment of the majority of our $265 million convertible debt facility. The transactions included a $150 million secured term loan facility led by funds managed by Athyrium Capital and joined by funds managed by HealthCare Royalty and a new $100 million convertible note with accredited investors. We used the proceeds from the loan and approximately $60 million of the proceeds from the note to repay $210 million of the existing convertible debt with the remaining approximately $27 million of the net proceeds for general operating purposes. Our fourth quarter 2024 financial results can be found in the press release we issued this morning and more detail will be included in our upcoming 10-K. Fourth quarter 2024 total revenue was $69.1 million, an increase of 114% compared to $32.3 million in the fourth quarter of 2023. U.S. net product revenue of $31.6 million compared to $20.8 million for the comparable period in 2023, an increase of approximately 52%. We have continued to demonstrate double-digit RPE growth with a 12% increase from last quarter and 8% growth in new-to-brand prescriptions. We have previously discussed the impact of the Medicare coverage gap, and in Q4 2024, we experienced an exceptional impact due to the number of new Medicare contracts we initiated in 2024. With the anticipated Medicare reform this year and the removal of the coverage gap, we are confident that quarterly revenue growth will more closely align with RPE growth going forward. Collaboration revenue was $37.6 million compared to $11.5 million for the comparable period in 2023, an increase of approximately 227%. This revenue growth reflects the strong momentum we are seeing from our partner, DSE, as well as a onetime milestone from Otsuka upon the JNDA submission. Turning to the rest of the P&L. For the fourth quarter 2024, research and development expenses were $11 million compared to $17.7 million for the comparable period in 2023, a decrease of 38% primarily attributable to our CLEAR Outcomes study that was completed in 2023. Selling, general and administrative expenses were $36.9 million compared to $45.4 million for the comparable period in 2023, a decrease of 19%. The decrease was primarily related to increased legal litigation expenses, reflecting onetime legal expenses from the legal resolution of the fourth quarter 2023, partially offset by increased compensation costs related to the ramp-up of our sales force associated with our commercial launch and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to current levels in 2025. We entered 2025 in a very strong financial position with cash and cash equivalents of $144.8 million as of December 31, 2024. With the expected milestones from our global partners, we believe we will finish 2025 with an even stronger cash position. We are reiterating our full year 2025 operating expense guidance, which is expected to be approximately $215 million to $235 million, including $15 million of noncash expenses related to stock compensation. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

Our advances in 2024 formed the foundation for us to successfully execute 3 strategic pillars for growth that will drive our mission forward. These pillars are supported by innovation, collaboration and expansion. These are not just words. They represent our commitment to advancing cardiovascular prevention and improving patient outcomes. Innovation is at the heart of what we do. We continue to implement cutting-edge sales and marketing programs to reach more health care providers and patients. Our strengthened financial position supports our goal to acquire or in-license synergistic products and we are investing in novel research and development to bring new life-saving technologies to market. Collaboration is essential in our field. At Esperion, we continue to forge strong partnerships with leading health care providers, industry experts and global partners. Together, we are executing a robust strategy that supports our vision and amplifies our impact. Expansion is our promise to reach more patients and communities. We are growing our U.S. revenue, entering new markets by enhancing our global footprint and have plans to add to our portfolio. Our goal is to make cardiometabolic prevention accessible to everyone, everywhere. As we look to the future, I am confident these pillars will guide us to new heights. Our commitment to excellence, our passion for innovation and our dedication to our mission will continue to drive our success. Before we open the call to your questions, I want to take a moment to thank our shareholders, partners and team members for your unwavering support. Together, we are making a difference in the lives of millions and I look forward to sharing our continued progress with you throughout the coming year. Operator, we are ready to open the call to questions.

[Operator Instructions] And the first question will come from Dennis Ding with Jefferies.

Congrats on all the progress. I have one question on the triple combo in the U.S. Have you agreed with the FDA on the regulatory path forward here and we need to have to run a CVOT? And then does the triple combo impact to 2031 LOE, which I think is based off of composition matter plans?

Yes. Thanks, Dennis. So right now, we're not going to provide any additional details related to our discussions with the FDA. We'll be sharing more of that probably in the fall time frame. What I can tell you is it does not necessitate a CVOT and does not necessitate any heavy lift as it relates to doing any type of clinical studies. So stay tuned. We're very excited about it. I'll ask Ben Halladay to comment as it relates to impact on LOE. Ben?

Yes. Similar to what Sheldon just said. We're going to release more information over the course of the year. However, I will say this is a very important step to the life cycle management of bempedoic acid and further substantiates and solidifies our position in potentially extending our patent.

Okay. Got it. Very helpful. And if I can have one follow-up. For U.S. bempedoic acid revenue in 2025, is it reasonable to assume that quarterly revenue growth can accelerate this year since volumes should pick up from improved access and the typical gross to net pressure that you traditionally see going through the year has now smoothed out with the Part D redesign?

Ben?

Yes. I think you'll continue to see the same study and, I would call it, significant growth that we've seen in the past. On the gross to net fact, I mentioned it in the prepared remarks. You'll see that smooth out of the gross to net and so you should see more of a 1:1 translation of RPE growth to revenue growth, which when you look at the second half of the year, that was our biggest headwind going through there. So compared to 2024, I think that second half growth will be much more consistent and much more steady, which is a net positive for us.

And the next question will come from Joe Pantginis with H.C. Wainwright.

A couple of questions if you don't mind. So first, with regard to U.S. sales. How should we view your efforts to build efficiencies into COGS?

So I can take that one. From the U.S. side, our COGS have been very consistent. To put some numbers behind it, our price per tablet hasn't really changed since beginning of 2024. When you look at COGS, really the biggest driver is some of that gross to net deterioration in the second half as well as the, I would say, proportion of DSE tablet sales. We are constantly evaluating how we can drive our per tablet cost down. That's a longer-term discussion as we start validating some of these cheaper and lower cost suppliers. However, that, again, is a longer-term discussion. And I think once we've completed the tech transfer, that's when you really will see that gross margin benefit as we remove most of these low-margin sales off our books.

No, that's very helpful. And then I guess, maybe some feedback from the field if you don't mind. I guess as you're really detailing in marketing here with the launch really in play now, I guess I would phrase it this way. What are the key yeses that you're getting right now from new prescribers, number one? And what are the key nos, if you will, presumably education is still the main reason for not prescribing yet or any other factors you'd like to share with us?

Joe, it's Eric. I'll take this one. So the yeses, as you state, are based upon the efficacy of the clinical profile of the products that we have. NEXLETOL and NEXLI

I just wanted to add. We actually just had, also Joe, gotten some feedback directly from the field. There's one physician in New Jersey that was -- after he had seen some of the new data and the piece that Eric showed, a very large practice, so just to give you a real live example said, wow, I should really not be starting these patients going from a statin to ezetimibe, I should be going right to NEXLI

No, that's actually very helpful feedback. I appreciate it. And then just a quick question here, probably can't provide too much visibility is, I guess, can you describe the level of maturity at least with regard to your discussions for potential in-licensing?

Yes. So we've been actually looking at this since last year. And as you know, Joe, we mentioned this at JPMorgan. I think it was a small bullet and lost upon folks. But where we are right now is we are doing a landscape analysis. We've been looking at products that are either late-stage Phase III soon to be approved or already approved. And I would say we're far along, but we want to make sure that it's the right product. And as you know, I think the one thing that really differentiates us as a company is that we are a company. We have medical affairs. We have a sales force. We have a compliance department. We have manufacturing. A lot of these companies, they don't have the infrastructure, and that's where we think we can really add value. So we're still looking at these different companies. We want to make sure we pick the right one, and we'll continue to update you. But we're really excited about the fact that we can leverage what we have in order to do this.

That's great. I appreciate all the color.

And the next question will come from Tom Shrader with BTIG.

I wanted to make sure what I think I just heard that you think it's attractive to help sell somebody else's product. Is that a big opportunity given there is such a dearth of cardiovascular sales forces right now? And then I have a second question for Sheldon that I think you were close to. When Merck added a statin to

Tom, it's Eric. I'll take the first part of that. So the answer is yes, whether that's us commercializing someone's compound or whether we're actually acquiring an asset. The key is we've built a really compelling commercial infrastructure, as Sheldon mentioned, in addition to other elements of the company. We've got a team that's proven their ability to generate 50% year-over-year growth, a team that covers about 20,000 HCPs, including cardiologists and primary care and has a digital footprint that goes to not only clinicians, but patients. So when you think about these companies that have assets in late-stage development or under regulatory review, maybe just starting to be commercialized, that's a pretty compelling value proposition for those organizations and for us to be able to infuse additional assets that complement the existing portfolio enables us to be really efficient with that. So hopefully, that answers your question.

And let's be honest, brings in more money to our company as well if we strike the right deal, which we would. Regarding combination therapy. So I think what you're referring to, Tom, is after VYTORIN, Merck actually looked at doing a combination of ezetimibe with Lipitor, which was called LIPTRU

And the next question will come from Jessica Fye with JPMorgan.

This is [indiscernible] on for Jess. I have a bunch of questions on these triples. So first of all, why are you starting to pursue these triples just now? And you mentioned in the PR that triple combination products may offer LDL lowering in excess of 60%. So what I'm trying to get at is are there any other ways to differentiate these triples from other products other than the LDL metric?

Sure. First, let me start with your first question. We view the triple combination as complementary to our existing portfolio and it definitely supports our path to achieving blockbuster status with the products that we are already commercializing. As it relates to what further differentiates versus just lowering LDL. First of all, I would say, it's all about lowering LDL. If you look at the guidelines, it's about essentially getting patients in Europe. As you know, the guidelines show who are at high risk to at least 55 milligrams per deciliter. Now in the U.S., there really isn't a goal and guidelines aren't coming out we have heard until 2026. But most cardiologists and primary care physicians you speak to, they want to get patients down to that 55 milligram per deciliter, especially if they're at high risk. But I think the other differentiating factor with our product that drugs like PCSK9 and future competition do not have is we also lower hsCRP. And there's a lot of information out there regarding lowering hsCRP, which, as you know, is a key marker of inflammation. Also as you know, we have, at least with bempedoic acid, no effect on glucose. So I think that's also important, and we think that will also play a role as we move forward in the development of this asset. You might have seen also that we submitted a paper recently regarding our effect on those patients who are obese and our efficacy there. So there's a lot of effects that bempedoic acid, in combination with other products, in this case a statin, that we think will be very favorable. And I can tell you that this is something payers are looking for as well. It helps them with their NCQA and HEDIS quality measures. So there's a lot of aspects of what this product would bring and why we're developing it now.

All right. And maybe one more. Can you also briefly comment on the overall development timelines for these triple products? And how long do you think you'll have exclusivity for them?

Yes. So we're going to speak more around the development timeline in the fall. As we mentioned earlier, as it relates to patent life, it's too early to say, but we'll have more clarity as development progresses on what this means as it relates to extending our patent life.

And the next question comes from Jason

Congratulations on the progress. I wanted to ask a follow-up on some of your earlier comments, Sheldon, appreciating the momentary from the KOL back in January who mentioned that awareness may be an issue. And I was curious what you're hearing from your sales force from prescribers. How familiar are they with bempedoic acid? Do you expect this to inflect anytime soon if it hasn't? And basically, what you're hearing from boots on the ground there?

Yes, I'll take this one, Jason. It's Eric. Yes, so every quarter or two, we do something called an ATU where we look at the awareness, we look at the trial, we look at utilization. We do it with hundreds of HCPs to keep score and how we're doing from a progress perspective. And we look at awareness on 2 levels. We look at unaided awareness and then we look at aided awareness. And I think the bottom line is we've progressively seen improvements in our unaided awareness. This is, if you just ask an HCP, what they're aware of without giving them any prompt. We're roughly where one would expect, and we asked the

Maybe during a recent health care conference, Sheldon mentioned that sales force was appropriately sized. But is this something that would benefit from an increased sales force?

Yes. I would say right now, we're appropriately sized. We continue to evaluate and whether that's changing the size, potentially changing some of the composition of the components of the team. As Sheldon mentioned, our ability to go to systems, for example, and turn on broader utilization. So right now, our focus is on being efficient, achieving profitability with profitability, which is on the near horizon, we'll be able to potentially pull other levers.

And one other lever I would mention, Jason, is that we've seen that consumers are being activated. And I would say Eric's team has a lot of initiatives that are geared towards consumers. We're actually expanding that. What we're finding is when consumers ask for the drug, they get the drug. So it's not just going through the traditional physician pathway, but also using our digital assets to activate consumers. And that's going very well.

And the next question will come from Serge Belanger with Needham.

I guess first question for Ben. Regarding the Medicare contract impact in the fourth quarter, do you expect that to linger into 2025? And then secondly, regarding recent prescription trends, I guess, midway through 1Q here, we're seeing low single-digit growth, a step down from 4Q. Just curious what is behind that trend? Is it the typical slowdown of the first quarter? And should that portend a tick down in sales sequentially from 4Q?

Yes. I'll answer the Medicare contract real quick. So the short answer is no. With the changes coming in 2025, the Medicare coverage gap will go away in that sort of, see, like I said, that seasonality will go away and we'll have a much more steady and I would say, normalized gross to net rate over the course of the year. So I think we've seen the worst of it now. We do have some additional contracts that came on in January that we've talked about. However, I think we'll see a much more consistent, steady and normalized gross to net rate.

And I can take the Q1 start, Serge. It's Eric. Yes. So the year typically starts off a bit slower. One of the key reasons is those deductibles, as you're aware, reset and a patient has to achieve those before they start getting lower prices for their branded products. And it impacts all branded products across the industry. The good news is they start to reach that point towards where we are now. And March typically is a strong month in the quarter. So we fully anticipate that, mentioned again, we were with the field last week. They're energized, they're motivated coming out of that meeting. We continue to hear great stories and the impact that they're having with our customers. So yes, continue to expect growth from us and January, February tend to typically be light.

And the next question will come from Paul Choi with Goldman Sachs.

I had a question regarding the triple development. And is this something that both you and your partner in Europe will be doing concurrently? Or is this a separate development program for Esperion proprietary triple? And then my second question is for Ben. Can you just give us maybe the net interest impact change based on all the recent financings and just sort of what that annualizes at?

Thanks, Paul. I think it's safe to say, we've talked about this before, and it's been in our 10-K that Daiichi Sankyo Europe is also developing a triple combination. Also in the past and also at JPMorgan more recently, I talked about the fact that I think when people think about bempedoic acid, they think about just Esperion. We have 2 other large companies that are also heavily invested in this product. To your point, Daiichi Sankyo and Otsuka. And we've always talked about that it's important for all of us to work together to make this product as big as possible and to achieve the blockbuster status. We talked about and you see in the corporate deck in how well Daiichi Sankyo continues to do as well as we do. So not to make it a long answer, but the answer is yes. They're doing it. We're doing it. We're doing it together. And you'll hear more about this as we go into the third quarter. Ben?

Yes. So to answer your question, Paul. So I don't have the exact percentage off hand, but I can follow up with you on that one. But overall, interest expense, we expect to remain roughly consistent with where we were in Q4 going forward. I will note that actually, the majority of that is kind of a noncash interest component related to how we account for the OMERS deal. So consistent and a large portion of it is really just accounting noise. So if you look at Q4, I would expect to carry that forward throughout the year.

And the next question comes from Kristen Kluska with Cantor Fitzgerald.

For the triple combination studies, I know you cite literature in terms of your expectations of effect. But I'm curious, now that there have been a lot of patients treated in the real world with these therapies, if you're hearing any anecdotes about this being utilized in combination and/or if any physicians have ever approached you about the potential to study such a combination?

Kristen, it's Eric. Yes, we do have a fair amount of utilization in combination with statins. And as you know, one of the key challenges with statins is either the inability to titrate any or tolerate any or to tolerate higher doses. So we're hearing clinicians that employ lower doses of these high-intensity statins, atorvastatin and rosuvastatin, and they add in NEXLI

And if I just may add, Kristen, is that we also have a cardiovascular advisory board, not too different from what I think our fellow friends in cardiovascular medicine, Amgen, Merck, et cetera, do as well. We have the top key opinion leaders on that advisory board. I can tell you they're very excited about this and what it offers to patients. Again, it really encompasses kind of where medicine is going in the future with this polypill delivery. It really helps with adherence and compliance as well. So to the latter half of your question, we're very excited about it.

Okay. And just on that note then, how would you be thinking about the dosing regimens of the statins? Just to your point, perhaps balance that you're still getting the added efficacy, but because it's in a combination setting, you may allow for lower dosing so that it becomes more tolerable?

Yes. I think. Without giving it all away, I think what you just said makes a lot of sense, Kristen. So lower doses of high-intensity statins in combination with bempedoic acid and ezetimibe to get the best of both worlds, Outcomes, LDL-C reduction and obviously, safety and sparing those high doses of high-intensity statins.

I show no further questions at this time. I would now like to turn the call back over to Sheldon for closing remarks.

Thank you, operator, and thank you all again for your time and attention this morning. We are looking forward to our upcoming R&D Day on April 24, 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. Have a great day, and thank you again.