Esperion Therapeutics Q4 2024 Earnings Call Transcript

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Provided by Quartr
March 4, 2025

Key Takeaways

  • U.S. bempedoic acid products achieved 12% sequential Q4 TRPE growth, with over 173 million lives covered and 25,000 prescribers, supporting continued revenue momentum.
  • Triple combination therapy (bempedoic acid, ezetimibe, and a statin) in development offers LDL-C reductions in excess of 60% and lifecycle management potential without requiring new CVOTs.
  • Global partnerships drove international expansion: Japan NDA submitted for H2 2025 approval, European royalties rose 9% sequentially and 116% year-over-year, and new licensing deals secured in Australia/New Zealand, Israel, and Canada.
  • Financial transactions strengthened the balance sheet—$304.7 million royalty purchase, $150 million term loan, $100 million convertible note—ending 2024 with $144.8 million cash and full-year 2025 OpEx guidance of $215 million.
  • Upcoming data presentations (post hoc CLEAR Outcome analyses) and an R&D Day on April 24, 2025 will highlight clinical advancements and unveil a next-generation ACLY inhibitor pipeline.
AI Generated. May Contain Errors.
Earnings Conference Call
Esperion Therapeutics Q4 2024
00:00 / 00:00

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Operator

Ladies 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 may be recorded. I would now like to turn the call over to Alina Venezia, Director of Investor Relations for Asperian Therapeutics. You may begin.

Alina Venezia
Alina Venezia
Head of Investor Relations at Esperion Therapeutics

Thank you, operator. Good morning, and welcome to Experian's Fourth Quarter and Full Year twenty twenty four 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 Venezia
Alina Venezia
Head of Investor Relations at Esperion Therapeutics

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 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.

Alina Venezia
Alina Venezia
Head of Investor Relations at Esperion Therapeutics

The contents of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, 03/04/2025. 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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 Asburyon 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 three strategic pillars for building a blockbuster company: continued revenue growth, operating profitability and portfolio expansion and pipeline advancement.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Focusing on our first pillar, increasing revenue and operating profitability, let us turn now for a 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

FDA approval for the expanded labels for Nexotol and Nexlazet, making them the only FDA approved non statins to lower LDL cholesterol and reduce the risk of myocardial infarction and coronary revascularization in both primary and secondary prevention patients. Since that time, we have consistently posted double digit sequential quarterly growth in total retail prescription equivalents or TRPEs. During the fourth quarter of twenty twenty four, we achieved 12% sequential quarterly growth in TRPEs compared to the third quarter of twenty twenty four. Substantially expanded payer access and now have more than 173,000,000 lives covered in The U. S.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

We are also proud that Nexlutol and Nexlutet have been recently added as preferred agents to the U. S. Department of Defense Uniform Formulary, now accessible to the 9,000,000 active duty dependents and retirees covered under this program. In tandem, we increased our prescriber base by 10% from last quarter and now have more than 25,000 healthcare providers writing scripts. The large and growing prescriber base is an important indicator of potential future growth as we have the opportunity to grow their base as they prescribe our products to more and more of their eligible patients.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

We expect to continue to build on this momentum throughout 2025 and believe that the established cardiovascular clinical benefits of our products combined with an expanding awareness among healthcare providers and ever improving and growing patient access will support increasing TRPEs and revenues. To drive both physician and patient awareness of the prevalence of statin intolerance, we are introducing a series of leave behind resources that highlight the fact that up to thirty percent of patients are statin intolerant and showcase the evidence that demonstrate how NexoTol and NexoVet can effectively manage these patients at high risk of cardiovascular disease. Our goal is to continue to underscore the persistent unmet need while promoting our safe and effective solution. Consequently, to further aid healthcare professionals in the management of partial statin intolerance, we are developing triple combination products in The U. S.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

That would provide physicians with the flexibility of a suite of options that include monotherapy, nexlitol, dual therapy, nexlazette and triple combination therapy, bempedoic acid, ezetimibe and either atorvastatin or rosuvastatin. This represents an exciting opportunity to expand our role in the cardiovascular prevention market. As the published literature suggests, triple combination products can lower LDL cholesterol in excess of 60%. This level of efficacy has the potential to rival both existing and emerging injectable and oral therapies, offering a valuable oral option for both patients and physicians. Now turning to the meaningful progress we're making internationally through our partnerships.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

We are looking ahead to an exciting year of continued growth in Europe and new product approvals and launches in key geographies. First, we are particularly pleased that our Japanese partner, Otsuka Pharmaceutical, has submitted a new drug application for the manufacture and sale of our bempetoic acid product in Japan for LDL cholesterol lowering. They expect 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 world peace on Japanese product sales will be a meaningful revenue contributor over time. Turning now to the European market.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Our European partner, DSE, continues to successfully market Nalendo and NUSENDI and has demonstrated strong revenue growth. Our royalty revenue from DSE increased 9% sequentially to $9,700,000 in the fourth quarter of twenty twenty four. For the full year of 2024, royalty revenue increased 116% year over year to $32,600,000 As of the December, approximately four hundred and fifty three thousand patients have been treated with our therapies in Europe, representing 19% sequential growth over the past three months since September. This continued expansion gives us confidence that with our label expansion, we can build a sizable market in The U. S.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

The tech transfer for both NOLENDO and YUSTENDI are also progressing nicely. Yesterday, we are pleased to announce that we partnered with CSL Sequeras to commercialize Nexlitol and Nexlova in Australia and New Zealand. Under the terms of the agreement, we received an upfront payment and are eligible for near term milestones along with a profitable transfer price on product sales. This is an important market for our products as cardiovascular disease affects one point two million people and is a leading cause of death in Australia. In New Zealand, an estimated one hundred and seventy five thousand adults are living with cardiovascular disease and one in three deaths are caused by cardiovascular disease.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Furthering our international expansion, we entered into a licensing agreement with NeoPharm Israel for the exclusive rights to commercialize Nexlitol and Nexlodet in Israel and expect to file an NDA for marketing approval in Israel in the first half of twenty twenty five. In addition, we filed new drug submissions to Health Canada for Nexlutol and Nexlazette and anticipate market approval in the fourth quarter of twenty twenty five. Collectively, our international partnerships are delivering increasing royalty revenue, further demonstrating the global potential of our bempetoic acid products and supporting our strategic focus on driving revenue growth and operating profitability. Finally, we continue to reinforce the cardiovascular risk reduction benefits of our products with the ongoing presentation and publication of compelling clinical data. In the coming weeks, we look forward to presenting two post hoc analysis from our CLEAR outcome study and poster presentation at the upcoming American College of Cardiology's annual scientific session being held in Chicago.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Importantly, we will be presenting these data to an audience of key physicians who play a critical role in treatment decisions. In addition, we will have an interactive exhibit booth allowing healthcare professionals to engage with our clinical and commercial teams to gain deeper insights into the cardiovascular benefits of our bemphidemic acid products. For those attending this year's ACC, we welcome you to visit us at our booth. Turning our attention to our other pillars for growth, portfolio expansion and pipeline advancement, our commitment to R and D strengthens all three strategic pillars: continued revenue growth, operating profitability and portfolio expansion and pipeline advancement. With a strengthened balance sheet, we are well positioned to in license or acquire synergistic cardiometabolic assets, while continuing to advance our clinical pipeline.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Leveraging our leadership in ACLY biology, we are actively exploring new therapeutic opportunities and developing next generation inhibitors designed to address serious diseases, including rare and orphan chronic liver and kidney diseases. We look forward to sharing more details on our clinical development plans at our R and D Day on 04/24/2025, where we will announce a lead indication and introduce our first candidate for development. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the fourth quarter. Ben?

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Thank you, Sheldon. Good morning, everyone, and thank you for joining us today. During 2024, we executed two 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 three pillars for growth to build a leading global biopharmaceutical powerhouse.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

In June 2024, we closed on a royalty purchase agreement with Omers Life Sciences receiving approximately $304,700,000 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 1.7 times its investment. Thereafter, all future payments on DSE royalties will revert back to Espira. Proceeds from the royalty purchase agreement facilitated early payout and termination of the Oberlin 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 $265,000,000 convertible debt facility.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

The transactions included a $150,000,000 secured term loan facility led by funds managed by Ethereum Capital and joined by funds managed by Healthcare Royalty and a new $100,000,000 convertible note with accredited investors. We used the proceeds from the loan and approximately $60,000,000 of the proceeds from the note to repay $210,000,000 of the existing convertible debt with remaining approximately $27,000,000 of the net proceeds for general operating purposes. Our fourth quarter twenty twenty four financial results can be found in the press release we issued this morning and more detail will be included in our upcoming 10 ks. Fourth quarter twenty twenty four total revenue was $69,100,000 an increase of 114% compared to $32,300,000 in the fourth quarter of twenty twenty three. U.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

S. Net product revenue of $31,600,000 compared to $20,800,000 in 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 twenty twenty four, 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.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Collaboration revenue was $37,600,000 compared to $11,500,000 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 one time milestone for Otsuka upon their JNDA submission. Turning to the rest of the P and L, for the fourth quarter twenty twenty four, research and development expenses were $11,000,000 compared to $17,700,000 for the comparable period in 2023, a decrease of 38% primarily attributable to our CLEAR outcome study that was completed in 2023. Selling, general and administrative expenses were $36,900,000 compared to $45,400,000 for the comparable period in 2023, a decrease of 19%. The decrease was primarily related to increased legal litigation expenses reflecting one time legal expenses from the legal resolution of the fourth quarter twenty twenty three, partially offset by increased compensation costs related to the ramp up of our sales force associated with our commercial launch and promotional costs.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

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 $144,800,000 as of 12/31/2024. 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 $215,000,000 to February including $15,000,000 of non cash expenses related to stock compensation. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Our advances in 2024 form the foundation for us to successfully execute three 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

We continue to implement cutting edge sales and marketing programs to reach more healthcare providers and patients. Our strengthened financial position supports our goal to acquire or in license CynergisTek 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 healthcare providers, industry experts and global partners. Together, we are executing a robust strategy that supports our vision and amplifies our impact.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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

Thank you. And the first question will come from Dennis Ding with Jefferies. Your line is open.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Hi, good morning and congrats on all the progress. I have one question on the triple hey, good morning. 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 CBOT?

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

And then does the triple combo impact your 2,031 LoE, which I think is based off of composition matter plans? Thank you.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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 timeframe. What I can tell you is that it does not necessitate a CVOT and does not necessitate any heavy lift as it relates to doing any type of clinical studies.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

So stay tuned. We're very excited about it. I'll ask Ben Howdy to comment as it relates to impact on LOE. Ben?

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

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 lifecycle management of pempedoic acid and further substantiates and solidifies our position and potentially extending our patent.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Okay, got it. Very helpful. And if I can have one follow-up. For U. S.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

BEMDOC asset revenue in 2025, is it reasonable to assume that quarterly revenue growth and accelerate this year since volumes should pick up from improved access and the typical gross net pressure that you traditionally see going through the year is now smoothed out with the Part D redesign? Thank you.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Ben?

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Yes. I think you'll continue to see the same steady 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 one to one 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.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Perfect. Thank you.

Operator

And the next question will come from Joe Pantginis with H. C. Wainwright. Your line is open.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Hi, good morning, everyone. Thanks for taking the question. A couple of questions, if you don't mind. So first, with regard to U. S.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Sales, how should we view your efforts to build efficiencies into COGS?

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

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 twenty twenty four.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

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 DSC 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 complete 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.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

No, that's very helpful. Thank you. 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?

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

And what are the key noes, 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?

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

Joe, it's Eric. I'll take this one. So the yeses, as you state, are based upon the efficacy, the clinical profile of the products that we have. Nexotol and NexoZet do something that other products don't do and they have that outcome benefit from a primary and secondary prevention perspective. And they've also been studied in a really unique population, these partial and complete statin intolerant patients.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

So those are the drivers of, yes, if you will, the distinct profile that we have, the unique population that we've been studied in. In terms of the opportunities, we continue to educate on the improved coverage that we have. So as you know, the coverage started to improve towards the midpoint of last year and still represents an opportunity for us to get the word out that coverage is better. But overall, tons of excitement in the field. I was just in Houston for a 1S meeting and our team has been doing a fantastic job and is motivated and the customers are responding well.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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, 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 Nexlazette. It's almost like this population health management. They're also actually going back now and looking at patients who've been on the statin for at least six months, who've tried and have failed and have not taken anything, almost complete statin failure, if you will, and they're writing NexoZette for these patients as well because to Eric's point, that's what's really unique.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

You can use this as a monotherapy, you can use this in combination. So that's real life feedback from the field that we're getting now.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

No, that's actually very helpful feedback. I appreciate it. And then my 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?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Yes. So we've been actually looking at this since last year. And as you know, Joe, we mentioned this to 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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's 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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.

Joseph Pantginis
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

No, it's great. I appreciate all the color.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

Thanks, Joe.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thanks.

Operator

And the next question will come from Tom Schroeder with BTIG. Your line is open.

Thomas Shrader
Equity Research Analyst at BTIG

Good morning. 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 are 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 ZEDIA, did that drive ZEDIA sales?

Thomas Shrader
Equity Research Analyst at BTIG

And can you give us a sense of how much so we can think about what the growth opportunity of your next combination is? Thank you.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

Hey, Thomas, 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.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

So when you think about these companies that have assets in late stage development or under regulatory view, 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Yes. 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 Vitorin, Merck actually looked at doing a combination of ezetimibe with Lipitor, which was called LipriZet. And it was never available in The U. S.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Because just couldn't find out couldn't figure out the right way to package it. But in Europe, it was, and it did very well. I think polypill strategy has come a long way since then. As a matter of fact, the World Health Organization and also the World Cardiology Association have both issued guidelines where similar to where you treat diabetes and hypertension with multiple products, they're recommending in their guidelines that patients start as soon as possible with multiple therapies to manage their LDL cholesterol. So now the fact, as we said in our prepared remarks, that we have honestly a monotherapy, we have NexoZet and soon we'll have a triple combination.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

It allows physicians and patients to have this flexibility to achieve their goals more rapidly. But the reason why Merck pursued it for the same reason we're pursuing it is because our market research shows that patients and physicians want this.

Thomas Shrader
Equity Research Analyst at BTIG

Got it. Okay. Thank you.

Operator

And the next question will come from Jessica Fye with JPMorgan. Your line is open.

Analyst

Hi guys, good morning. This is Tanvi 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%.

Analyst

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?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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 fifty five milligrams per deciliter.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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 fifty five 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 hs CRP. And there's a lot of information out there regarding lowering hs CRP, which as you know is a key marker of inflammation.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Also, as you know, we have at least with bemphidoric 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 bemprotoic acid in combination with other products, in this case, the statin that we think will be very favorable. And I can tell you that this is something payers are looking for as well.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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.

Analyst

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?

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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.

Analyst

All right. Thanks. Thanks so much.

Operator

And the next question comes from Jason Ziminski with Bank of America. Your line is open.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

Good morning. Thank you so much for taking our questions and congratulations on the progress. I wanted to ask a follow-up on one of some of your earlier comments Sheldon, appreciating the commentary 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 pempedoic acid?

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

Do you expect this to inflect anytime soon if it hasn't? And basically what you're hearing from your boots on the ground there? Thank you.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

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.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

We do it with hundreds of HCPs to keep score on how we're doing from a progress perspective. And we look at awareness on two 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.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

We're roughly where one would expect and we ask the ZS associates for those benchmarks. When you look at the aided awareness, we're in the 95% range. So the bottom line is the word is getting out on our products. The team is doing a great job at reaching the universe that we have. Our HCP digital is allowing us to broaden that net.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

The efficacy is really what's resonating for us. And as I mentioned earlier in the Q and A, the opportunity for us not only is to communicate that efficacy, but also that expanded coverage that we have.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

But it may be during a recent healthcare conference, Sheldon mentioned that sales force was appropriately sized, but is this something that would benefit from an increased sales force? Thanks.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

Yes. I would say right now we're appropriately sized. We continue to evaluate and whether that's changing the size or potentially changing some of the composition or 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.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

With profitability, which is on the near horizon, we'll be able to potentially pull up their levers.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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 to 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.

Jason Zemansky
Jason Zemansky
Vice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch

Great. Thanks for the color.

Operator

And the next question will come from Serge Belanger with Needham. Your line is open.

Serge Belanger
Senior Analyst at Needham & Company

Hi, good morning. 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?

Serge Belanger
Senior Analyst at Needham & Company

Is it the typical slowdown of the first quarter? And should that portend a tick down in sales sequentially from 4Q? Thanks.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

Yes. I'll answer that Medicare contract real quick. So the short answer is no. With the changes coming in 2025, the Medicare coverage gap will go away and that sort of seems 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.

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

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.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

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's it impacts all branded products across the industry.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

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.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

They're motivated. Coming out of that meeting, we continue to hear great stories on 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.

Operator

And the next question will come from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Hi. Thank you. Good morning and thanks for taking the questions. 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 a Esperion proprietary triple?

Paul Choi
Paul Choi
Analyst at Goldman Sachs

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? Thank you very much.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thanks, Paul. I think it's safe to say, we've talked about this before and it's been our 10 K that Daichi 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 Aspirion. We have two other large companies that are also heavily invested in this product, to your point, Daichi 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, how well Daichi Sankyo continues to do as well as we do.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

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?

Ben Halladay
Ben Halladay
CFO at Esperion Therapeutics

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 non cash 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.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Got it. Thank you very much.

Operator

And the next question comes from Kristin Kluszka with Cantor Fitzgerald. Your line is open.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Hi, good morning, everybody. 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?

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

Hey, 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 Nexolazette to enhance that efficacy. And I think that sixty percent number that we put forth is conservative.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

So the numbers tend to typically be higher from what we hear. But it positions us incredibly well when we think about what clinicians want. They want efficacy. They want complementary mechanisms. And as Sheldon said, triple combination employs three mechanisms that work together, two of them that have proven cardiovascular outcomes in statins and bemphidouic acid.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

So it's a really compelling value proposition, which positions us not only well for patients and our customers, but positions us against the potential competition in the future.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

And if I just may add, Christa, is that we also have a cardiovascular advisory board, not too different from what I think our fellow friends in cardiovascular medicine, Amgen, Merck, etcetera, do as well. We have the top key opinion leaders on the 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.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

It really helps with adherence and compliance as well. So to the latter half of your question, they're very excited about it.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Okay, thanks. And just on that note then, how would you be thinking about the dosing regimens of the statins, just to your point to 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?

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

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 benbinoic acid and ezetimibe to get the best of both worlds. Outcomes, LDL C reduction, obviously safety and sparing those high doses of high intensity statins.

Kristen Kluska
Equity Research Analyst at Cantor Fitzgerald

Thanks very much.

Eric Warren
Eric Warren
Chief Commercial Officer at Esperion Therapeutics

Thank you.

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thank you.

Operator

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

Sheldon Koenig
Sheldon Koenig
President & CEO at Esperion Therapeutics

Thank you, operator, and thank you all again for your time and attention this morning. We are looking forward to our upcoming R and 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.

Operator

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

Executives
    • Alina Venezia
      Alina Venezia
      Head of Investor Relations
    • Sheldon Koenig
      Sheldon Koenig
      President & CEO
    • Ben Halladay
      Ben Halladay
      CFO
    • Eric Warren
      Eric Warren
      Chief Commercial Officer
Analysts
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