Esperion Therapeutics, Inc. (ESPR) Q3 2024 Earnings Report, Transcript and Summary

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 hand the conference over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. Please go ahead.

Thank you, operator. Good morning, and welcome to Esperion’s third quarter 2024 earnings conference call. With us today 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 7, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. I now turn the call over to Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. As I look back over the past year, I continue to be so proud of all our team has accomplished. It has truly been a watershed year for Esperion, in which we successfully expanded our NEXLETOL, NEXLIZET labels to include broad new indications for primary and secondary cardiovascular risk reduction, scaled up our commercial team and launched these new indications and broaden payer access and implemented marketing programs that have enhanced awareness of our new indications among health care providers to drive prescription growth. As a result of our team’s collective efforts, we have posted double-digit prescription growth in both quarters since the launch. In addition, we’ve supported international growth and further expansion of NILEMDO and NUSTENDI which continued to be impressive and support our continued confidence in the global market opportunity for our bempedoic acid products. And importantly, we substantially strengthened our balance sheet by monetizing the European royalties on our bempedoic acid product sales and allocated the proceeds for their early discounted payoff and termination of our previous revenue interest facility. We also continue to focus on additional ways to fortify our capital structure. Any one of these accomplishments would be meaningful on its own. Collectively, they have transformed Esperion and laid a strong foundation from which to build and grow global revenues for our bempedoic acid products and to expand and advance our very promising clinical development program of ACLY inhibitors. Now let me turn to our progress with our U.S. commercialization efforts, which are gaining additional momentum as demonstrated by U.S. net product revenue growth of NEXLIZET and NEXLETOL in Q3 2024 of 10% sequential and 53% year-over-year growth. These increases were driven by the meaningful progress we continue to make during the first 6 months of the launch for our label expansions. As a reminder, our expanded labels have 3 significant differences. They now include CV risk reduction benefits, expand the patient population by including primary prevention and enable use patients that are unable to tolerate or maximize statin therapy. We have done an exceptional job building a strong foundation with the 3 key pillars for success: payers, physicians and patients. We understand the necessity to remain committed to addressing the needs of each of these constituencies in order to successfully bring the benefits of NEXLETOL and NEXLIZET to the 70 million patients eligible under the expanded labels. Starting with the payers, where we initially focused on making sure the utilization management criteria or UM, for the expanded labels were in place. As of mid-July, more than 8% of UM criteria were updated to reflect the new label updates and more importantly, a significantly less burdensome prior authorization process was put in place. The updates totaled more than 114 million lives. Since then, we have grown that number to more than 165 million patient lives across all payers who have updated their UM criteria. This is a foundational building block to secure reimbursement and removing significant restrictions and barriers to access, so physicians can now prescribe NEXLETOL and NEXLIZET with increased confidence. Another milestone achievement on this front was the expansion of our commercial and Medicare formulary coverage for NEXLETOL and NEXLIZET. In early September, we made new additions to Medicare formularies at Optum, United AARP and CVS SilverScript coupled with our earlier coverage with Humana, we currently have access to more than 65% of Medicare insured lives and more than 92% of commercially insured lives under the new labels and UM criteria. Again, we expect this expanded payer coverage to drive further increases in physician confidence to prescribe NEXLETOL and NEXLIZET, ultimately leading to higher product sales in the upcoming quarters and beyond. In tandem, we further advanced our sales and marketing campaigns aimed at educating health care providers about the clinical benefits of NEXLETOL and NEXLIZET and empowering patients to talk with their clinicians about their cardiovascular risk. We continue to optimize our commercial tactics and remain efficient in allocating resources to initiatives that are yielding the most favorable ROIs. As a result of these combined initiatives by our managed care, sales force and marketing teams, in these first 6 months of launch, we now have nearly 24,000 health care practitioners writing scripts with total retail prescription equivalents increasing approximately 12% and new-to-brand prescriptions approximately 18% compared to the second quarter. This is just the type of momentum we want to see in the first 6 months of launch to drive accelerated growth in the coming quarters and into the new year. In fact, our October 2024 results further validate this trajectory, with total retail prescription equivalents up 17% and new-to-brand prescriptions rising 20% compared to the first 4 weeks of the third quarter. This positive trend speaks to the effectiveness of our strategy, and we remain focused on sustaining this momentum to drive continued growth and long-term success. Notably, the three reasons that give us continued confidence in the blockbuster opportunity for NEXLETOL and NEXLIZET and our ability to realize that potential remain unchanged. One, we have compelling data from the CLEAR Outcomes study that support and validate the safety and efficacy of NEXLETOL and NEXLIZET to reduce cardiovascular risk. Two, there is a massive underserved patient population of 70 million people at risk who need additional treatment options. And three, we have the right plan and the right people to drive adoption in this market and successfully execute our strategy. Let me now shift to the tremendous international progress we and our partners are making. In Europe, our partner, DSE, continues to post strong prescription and revenue growth as evidenced by approximately 19% sequential increase in our royalty revenue, which was $8.9 million in the third quarter of 2024. DSE received its approved expanded labels for NILEMDO and NUSTENDI from the European Commission in May and consequently kicked off their country launches with the new indications for cardiovascular risk reduction and expanded LDL-cholesterol lowering in primary and secondary prevention patients. With up to 80% of patients in Europe unable to reach guideline recommended levels for LDL-cholesterol despite taking statins, there is a meaningful market opportunity for DSE. Beyond Europe, our partner, Daiichi Sankyo Company, Limited, gained approval for NILEMDO in Taiwan on October 7, 2024. The totality of expected country launches enhances the global awareness of the cardiovascular benefits of our bempedoic acid products and is expected to incrementally contribute to royalty revenue over time. Our Japanese partner, Otsuka Pharmaceutical remains on track to file a new drug application in Japan by year-end 2024, with expected approval and national health insurance pricing anticipated in 2025. We are enthusiastic about the continued momentum in Japan as it is one of the largest markets for lipid-lowering therapy. This is a substantial market for Otsuka as well as a valuable royalty contributor for Esperion growth in the future. Turning to our own efforts internationally. We expect to file a new drug application for approval in Canada this month and are optimistic about finalizing a partnership soon. Additionally, we expect potential submissions and our partnerships in Australia and Israel in the first half of 2025. Collectively, these advances expand the global commercial opportunity for our bempedoic acid products, incrementally add to growing global revenue and position Esperion as an attractive potential partner with a compelling value position. Finally, we continue to build a growing body of scientific and clinical knowledge that supports the cardiovascular risk reduction benefits of our products. To that end, we are delighted to be presenting key data at the American Heart Association Scientific Sessions, which will be taking place next week in Chicago. The AHA Scientific Sessions draw approximately 18,000 health care providers, including primary care physicians for more than 100 countries. This offers Esperion an exceptional opportunity to showcase the clinical benefits of NEXLETOL and NEXLIZET before an audience of key physicians we aim to influence to prescribe our therapeutics. We were honored to have been selected for an oral featured presentation in the Late Breaker/Featured Science Track where our products will be highlighted in a presentation titled Bempedoic Acid and Limb Outcomes in Statin-Intolerant Patients with Peripheral Artery Disease: New insights from the CLEAR Outcomes trial. We also have three poster presentations at AHA, statin intolerance due to muscle symptoms affects management of patient insights from the CLEAR Outcomes trial, liver steatosis and liver fibrosis predict major adverse cardiovascular events in the CLEAR Outcomes trial and effectiveness of lipid-lowering therapy with bempedoic acid plus ezetimibe in a real-world cohort. In addition to these U.S. presentations, DSE has a strong medical and commercial showing at the European Society of Cardiology Congress or ESC, in late August. ESC is the largest cardiovascular medical meeting of the year and is well attended by key opinion leaders from around the globe, including the United States. Consequently, we expect the efforts DSE made at ESC will also benefit our efforts to enhance the awareness and visibility for our product among U.S. health care practitioners. Beyond ESC, DSE reported final 2-year real-world results from the MILOS German cohort at DGK Herztage 2024 in Hamburg, Germany in late September. The data demonstrate a strong increase in the achievement of LDL-cholesterol goals with the addition of bempedoic acid. The ongoing publication and presentation of data in support of the cardiovascular benefits of our products strongly validates our clinical value proposition and enhances awareness of their benefits among a growing physician base who are responsible for prescribing our products to their patients. We will look forward to updating you on our further progress over the coming months. 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. As Sheldon mentioned earlier, we continue to build and solidify the foundation of our business, and this year has been a banner year for taking the right steps that will allow us to grow and succeed in long-term. Most notably, over the past 6 months, we focus on strengthening our balance sheet by monetizing the European royalties on our bempedoic acid product sales and allocating the proceeds for the early discounted payoff and termination of a previous revenue interest facility. This company will always be focused on solidifying our financial position, and that work continues into the fourth quarter. I will now provide a brief overview of the results, noting that additional information can be found in our press release issued earlier this morning and 10-Q that will be filed shortly. Please note that unless otherwise specified, my comments reflect results for the third quarter ended September 30, 2024. Total revenue for the third quarter 2024 was $51.6 million compared to $34 million for the comparable period in 2023. U.S. net product revenue was $31.1 million compared to $20.3 million for the comparable period in 2023, an increase of approximately 53%. Sequential quarterly net revenue growth was 10%. Our steady revenue growth, combined with the rise in total retail prescription equivalents and an 18% increase in new-to-brand prescriptions speaks to the success of our launch and the potential of these drugs. To date, we have expanded our coverage to include more than 165 million patient lives. We activated these managed care contracts with the understanding that we would face an immediate impact to our previously undiscounted business with the expectation that we will outpace this initial cost with significant future growth. While we’re feeling the gross to net headwinds of these changes now, the decisions we made are essential to building a pipeline of patients necessary for future growth. We are expecting the pull-through to come from this effort in the coming quarters with additional contracts serving as another key tactic to advance our brand strategy. While it will take time, this approach sets us up for long-term success. We are already beginning to see acceleration in prescribing as a result of these recent Medicare contracts and our comprehensive marketing and sales strategy. This approach is delivering results with recent data showing a 17% increase in total retail prescription equivalents and a 20% rise in new-to-brand prescriptions for the first 4 weeks of the fourth quarter compared to the first 4 weeks of the third quarter. Collaboration revenue was $20.5 million compared to $13.7 million for the comparable period in 2023, an increase of approximately 50% primarily due to increased royalty sales growth within our partner territories and increased product sales to our collaboration partners from our supply agreements. We’re making solid progress with DSE on the tech transfer to enable them to independently manufacture NILEMDO and NUSTENDI for European distribution. This will lead to a significant reduction in our future COGS for the products and reduce working capital costs once finalized. Turning to the rest of the P&L. For the third quarter of 2024, research and development expenses were $10.4 million compared to $14.9 million for the comparable period in 2023, a decrease of 30%, primarily attributable to our CLEAR Outcomes study that was completed in 2023. Selling, general and administrative expenses were $40 million compared to $33.2 million for the comparable period in 2023, an increase of 20%. The increase is primarily related to increased commercial head count in addition to bonus payments and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to current levels. Total net loss for the quarter was $29.5 million compared to a net loss of $41.3 million for the comparable period in 2023. Basic and diluted net loss per share was $0.15 compared to basic and diluted net loss per share of $0.37 for the comparable period in 2023. Turning to our balance sheet. As of September 30, 2024, we had $144.7 million in cash and cash equivalents. We are reiterating our full year 2024 operating expense guidance, which is expected to be approximately $225 million to $245 million, including $20 million in non-cash expenses related to stock compensation. Now let me turn the call back to Sheldon for closing remarks. Sheldon?

Thank you, Ben. We continue to be especially pleased with our progress advancing the launch of these expand indications in cardiovascular risk reduction, confident that the foundation we are building today will serve to support significant future growth and expansion globally. In the near-term, we are laser focused on ensuring the continued successful launch of our expanded labels in the U.S., while in tandem, expanding our global reach through partnerships and collaborations. Longer term, we plan to advance our promising pipeline where we have the potential to leverage our established leadership in ACLY biology to explore new therapeutic opportunities and develop next-generation inhibitors optimized to address multiple life-threatening diseases. We look forward to providing a detailed update on our plans and timelines for the development of our innovative pipeline as we move into 2025. Looking ahead, we are confident in our strategy and our ability to deliver long-term value to both the patients we serve and to our shareholders. As always, we appreciate your continued support as we execute on these initiatives. Operator, we are now ready for Q&A.

[Operator Instructions] First question comes from the line of Dennis Ding of Jefferies. Your line is now open.

Hi, good morning. Thanks for taking our questions. I had a question on bempedoic acid. So it seems like prescriptions are starting to pick up in the fourth quarter, and that’s very encouraging. What’s been driving that strength? And do you think you can work through some of the headwinds in Q4, like from the holidays and even Hurricane Milton at the beginning of Q4? And what’s your level of confidence that Q4 revenue will be higher than Q3 given some of the price headwinds towards the end of the year? Thank you.

Good morning, Dennis, it’s Eric. Yes. Yes, absolutely. So Q3, again, double-digit growth on all metrics. The start of Q4 really strong. You saw the metrics that we posted. What’s driving that? The pull-through of the access. So as we’ve mentioned before, we’ve improved the quality and quantity of access. It’s taken a little bit for physicians to believe it based upon the prior years of more difficult access. But now we’re starting to see that increase momentum. I’ve been out in the field multiple times over the course of the last quarter as have other members of the ELT and we’re seeing the excitement of physicians and the ease in getting the product. So very confident in what we’re seeing and very confident that Q4 will be even better than Q3.

And Dennis, I would like to add that one thing that we’ve said for, I think, the past 2 years is that we will demonstrate growth, continued growth, and we’ve done that, and we will continue to do that.

Great. Thank you.

Thank you. Our next question comes from the line of Serge Belanger of Needham. Your line is now open.

Good morning. Congrats on the progress. A couple of questions from us. I guess now that utilization management criteria has been updated, and we’ve seen, I think, an important uptick in prescription. Just curious how different is the product being used now? Is it just in a broader set of patients and has it moved up the treatment paradigm relative to the PCSK9 inhibitors? And secondly, regarding the Medicare coverage. I think you mentioned you’re now at 65%, is that at this current time or that’s when we flip the calendar to 2025? And I guess, do you expect to expand beyond that 65% over the next few months? Thanks.

Good morning, Serge, Eric again. So yes, thanks for noting the increased momentum that we’ve been seeing. Indeed, it’s a function of physicians increased confidence, the fact that prescribing has become easier. In terms of patients that are being utilized, so yes, so we’ve seen that shift from ASCVD patients, which were the patients that our clinicians were bound to with the prior label in UM. We’re seeing an increased use in the primary prevention patient or the patient that hasn’t had a prior event. We’re also starting to see increase in the statin intolerant utilization. In terms of where we’re seeing that utilization come from, we’re seeing ezetimibe start to leak some share on its own. We’ve also seen about a one point decrease in new-to-brand prescriptions or new-to-brand share for PCSK9 since we’ve had our label change.

I just want to add one thing, Serge, before I turn it over to BJ regarding Medicare, and that is there is no doubt in our minds that the bempedoic acid products that these are recognized, they are a recognized place in therapy. And it’s the awareness, it just continues and continues to grow. BJ, Medicare?

That said, Sheldon, I think, Serge, when we started at launch, we were 28% Medicare coverage, where we are now with greater than equal to 65% Medicare coverage and we couldn’t be happier with that. Most of those plans accelerated their processes where they would have waited until 2026 to add us or 2025. We anticipate additional Medicare contracts to come through and really activate them. But we also know that right now, we are well poised between the three PBMs and having that coverage, both commercially and with Medicare. We are basically covering 90% of the U.S. national lives with that coverage, so stay tuned, more to come.

Great. I guess one more for Sheldon. Can you just remind us of the structure of the milestone payments as part of the Otsuka collaboration and what those payments are contingent on?

Yes. This is Ben. I am happy to walk through that. So, I don’t think we have assigned specific amounts to each of the steps, but the steps are filing of the JNDA, approval of the JNDA. There is a milestone based around – that actually gets included in the U.S. label, but payable once it’s approved as well as the pricing milestone. So, those will all come, I would say, by the end of 2025 is what we are expecting internally here. And we will have very shortly I think a lot more clarity on what that timing looks like.

Got it. Thanks.

Thank you. [Operator Instructions] Our next question comes from the line of Jason Zemansky of Bank of America. Your line is now open.

Good morning. Congratulations on the progress and thanks so much for taking our questions. I was hoping you could provide some color on ongoing payer dynamics. I appreciate you may not be able to provide any details. But if you could please speak to whether there has been an increase in concessions given the expansion of lives covered? And then do you have a sense of what percentage of lives are not required to go through or step through a generic alternative like a statin? Thank you.

Yes. So, I can take that. So, Jason, I think as we mentioned before, our biggest headwinds for that, let me start with your second part of your question first, if you don’t mind. The biggest headwind was that the fact that patients had to go through maximum tolerated dose of a statin, that actually changed back in December. But I think the biggest headwind, it goes back to a question that was asked earlier, is that the utilization management, there is a step criteria through ezetimibe as well. As part of our new label and as part of our negotiations with payers that was something that we demanded is that UM criteria would be easier and that we would no longer have to be step edited through ezetimibe, which again, is really the competition. 68% of the adjunct share is ezetimibe. That step edit has been removed in both the commercial and also the Medicare contracts that we have. As a matter of fact, this is quite interesting. In two very large accounts we don’t even have prior authorization. So, SilverScript’s Caremark, there is no prior authorization for a physician. Aetna, there is no prior authorization for a physician. It’s what we have in the field and what the representatives say, and we are seeing it in our prescription performance, getting NEXLIZET and NEXLETOL just got easier. As far as concessions, we did not have to give any concessions at all for any of these changes. And I applaud all of the payers because what it demonstrated to us is that they really recognize the clinical benefits of the CLEAR Outcomes study and our products.

Got it. Thank you so much for the color.

Thank you. [Operator Instructions] Our next question comes from the line of Jessica Fye of JPMorgan. Your line is now open.

Hey, good morning everyone. This is Tanmay on for Jessica Fye and thanks for taking our question. I guess the first thing I wanted to ask is, how do you see the net price outlook from here? And should we think of it as stable going forward? And can you also comment quickly on any inventory changes in the U.S. channel in 3Q? Thanks.

Yes. I will jump in on both of those. Inventory changes, I will say, non-existent. We were very stable for what was out in the channel at the end of the quarter compared to Q2 and Q1, so really no major changes there. As far as net price going forward, we will continue to see our standard Q4 cyclicality from the Medicare coverage gap this year. However, I think one thing that we are looking at next year as we go through the IRA and the benefits that for us expected to hit is that we will see a smoothing out of the gross to net over the course of the year. So, not a major change to the overall, but you may or may not see that sort of seasonality from Q1 to Q4 that we see now, which is great for us because that makes it a much more predictable, much more steady and streamlined revenue over the course of the year from a net price perspective.

Thank you.

Thank you. [Operator Instructions] Our next question comes from the line of Joe Pantginis of H.C. Wainwright. Your line is now open. Lander Egaña-Gorroño: Hi. Good morning everyone. This is Lander on for Joe. Thanks for taking our questions. So, just curious about the market dynamics in Japan, what are the expectations in terms of confidence from payers and physicians for distribution and pricing and sales ramp in Japan, anything different compared to the U.S., for example, that we should consider? Thank you.

Yes. Great. So, again, just as a reminder, in Japan, our partner is Otsuka. And as we mentioned, they finished their Phase 3 clinical trial, which showed statistical significance. And they are in the process right now of filing with the healthcare administration in Japan. Pricing and so forth will come later. But what I would like to remind you of is Japan is one of the largest lipid markets in the entire world. And the analog you can even look at is ezetimibe. So, more to come on Japan, but right now, we are on track of what we need to do, and there is high expectations by our partner, Otsuka. And as we mentioned in our prepared remarks, that really benefits us as well. That’s a significant royalty stream to the organization. Lander Egaña-Gorroño: Perfect. Thank you. Congrats on the update.

Thank you. [Operator Instructions] And our next question comes from the line of Tom Shrader of BTIG. Your line is now open.

Good morning. Congratulations on the uptick and thank you for the question. Back to Medicare, is part of the lag relative to commercial that you negotiate very hard to be in the best tier of Medicare? And can you – do you know your average co-pay for a Medicare patient versus a commercial payment for a commercial patient?

Yes. How are you Tom? We – basically for Medicare, it’s all about the out-of-pocket cost. And what was happening before, as you know, when we were non-preferred, those out-of-pocket costs were much higher. What we are able to do now is contract, there are probably an average out of pay now with the preferred co-pay is $45 as opposed to going anywhere from $150 up to $200 before they even reach their deductible. So, that’s been a great plug for us, and it’s great with the physicians, again, to Sheldon’s point previously, it’s giving those physicians the confidence and then getting the product to the patients in the shortest period of time. With commercial, with our co-pay card, that ranges, we really have our co-pay cards, so that’s probably more in the $25 range for patients in commercial.

And if I could just may add, what’s really interesting, Tom, is with these Medicare changes. Typically, when Medicare makes a decision, they make a decision today to be implemented a year from now. These decisions were made today and implemented a week from now, a month from now. And again, it goes back to what I said earlier, it really shows the applicability of the clinical profile as a result of our new label from the CLEAR Outcomes study. That was a huge win for us.

And just to follow-up, is the process in Medicare to get in and get an agreement at any price and then to provide data that it should be preferred or is the initial agreement very important for the price for a signification duration – for the co-pay for a significant duration?

Well, I think what it is, is that it’s really more of the status, and we are preferred in Medicare. So, I am not sure if I am following your question completely, but I am just looking at the end result and the end result is we have a co-pay that is acceptable for patients to pay and we are in a preferred physician [ph]. And I would say just thinking about our market access along commercial and Medicare, we are not disadvantaged to PCSK9. We are not disadvantaged to ezetimibe, etcetera. So, that’s also important.

Okay. Great. Thanks for all the detail.

Thank you. We are out of time. This concludes the question-and-answer session. I would now like to turn it back to Sheldon Koenig for closing remarks.

Thank you, operator, and thank you all again for your time and attention this morning. We will be participating at the upcoming Jefferies London Healthcare Conference on November 19th in London and at the Piper Sandler Healthcare Conference in New York on December 5th. So, we hope to have opportunity to connect with many of you at these events. And in the meantime, if you have any questions or would like to have a call with the team, just reach out to our Head of Investor Relations, Alina Venezia, and have a great day and thank you again.

Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect.