Esperion Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in 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'd like to hand the conference over to Alina Bencia, Director of Investor Relations for Experian Therapeutics. Please go ahead.

Thank you, operator. Good morning, and welcome to Experian's third quarter 2024 earnings conference call. With us today are Sheldon Koenig, president and CEO, and Ben Halliday, 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 Aspirion in which we, successfully expanded our Nexlatal Nexlazet labels to include broad new indications for primary and secondary cardiovascular risk reduction, scaled up our commercial team and launched these new indications, and broadened payer access and implemented marketing programs that have enhanced awareness of our new indications among healthcare 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 Nalemdo and Newstendi, which continue to be impressive and support our continued confidence in the global market opportunity for our Bempadoic acid products. And importantly, we substantially strengthened our balance sheet by monetizing the European royalties on our Bempadoic acid product sales and allocated the proceeds for the 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 Aspirion and laid a strong foundation from which to build and grow global revenues for our benpidoic 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 Nexazet and Nexazol in Q3 2024 of 10% sequential and 53% year-over-year growth. These increases were driven by the meaningful progress we continued to make during the first six months of the launch for our label expansions. As a reminder, our expanded labels have three significant differences. They now include CV risk reduction benefits, expand the patient population by including primary prevention, and enable use in patients that are unable to tolerate or maximize statin therapy. We have done an exceptional job building a strong foundation with the three 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 Nexlital and Nexlivet 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 80% of UM criteria were updated to reflect the new label update, and more importantly, a significantly less burdensome prior authorization process was put in place. These 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 securing reimbursement and removing significant restrictions and barriers to access so physicians can now prescribe Nexlatol and Nexlazet with increased confidence. Another milestone achievement on this front was the expansion of our commercial and Medicare formulary coverage for Nexlatol and Nexlazet. 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 Nexlital 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 healthcare providers about the clinical benefits of Nexlital and Nexlavet 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 six months of launch, We now have nearly 24,000 healthcare practitioners writing scripts with total retail prescription equivalents, increasing approximately 12% and new to brand prescriptions, approximately 18% compared with the second quarter. This is just the type of momentum we want to see in the first six 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 four 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 Nexotol and Nexlovet 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 Nexotol and Nexlovet 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 Nalemdo and Newstendi 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 Nalemdo in Taiwan on October 7, 2024. The totality of expected country launches enhances the global awareness of the cardiovascular benefits of our benpatoic acid product 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 therapies. This is a substantial market for Otsuka as well as a valuable royalty contributor for Aspirion 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 or partnerships in Australia and Israel in the first half of 2025. Collectively, these advances expand the global commercial opportunity for our Bempatoic acid products, incrementally add to growing global revenue and position Aspirion 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 Session, which will be taking place next week in Chicago. The AHA Scientific Sessions draw approximately 18,000 healthcare providers, including primary care physicians from more than 100 countries. This offers Aspirion an exceptional opportunity to showcase the clinical benefits of Nexotol and Nexoset before an audience of key physicians we aim to influence to prescribe our therapeutics. We are 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, Bempatoic 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 patients, 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 benpidoic acid plus azetamide in a real-world cohort. In addition to these U.S. presentations, DSC had 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 DSC made at ESC will also benefit our efforts to enhance the awareness and visibility for our product among U.S. healthcare practitioners. Beyond ESE, DSE reported final two-year real-world results from the Mylos German cohort at DGK Herzog 2024 in Hamburg, Germany, in late September. The data demonstrated a strong increase in the achievement of LDL cholesterol goals with the addition of benpidoic acids. The ongoing publication and presentation of data in support of the cardiovascular benefits of our product 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 the long term. Most notably, over the past six months, we focused on strengthening our balance sheet by monetizing the European royalties on our Bempadoc acid product sales and allocating the proceeds for the early discounted payoff and termination of the previous revenue interest facilities. 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 10Q that will be filed shortly. Please note that unless otherwise specified, my comments reflect results for the third quarter ended September 30th, 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're 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 four weeks of the fourth quarter compared to the first four 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 DSC on the tech transfer to enable them to independently manufacture in the LEMDO and USPENDI for European distribution. This will lead to a significant reduction in our future COGS for the product 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 headcount 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 15 cents compared to basic and diluted net loss per share of 37 cents for the comparable period in 2023. Turning to our balance sheet, as of September 30th, 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 expanded 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.

Thank you. At this time, we'll conduct the question and answer session. To ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. First question comes from the line of Dennis Ng of Jefferies. Your line is now open.

Hi, good morning. Thanks for taking our questions. I had a question on levodopa gases. 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? What's your level of confidence that Q4 revenue will be higher than Q3, given some of the pricing headwinds towards the end of the year? Thank you.

Good morning, Dennis. It's Eric. Yes, yeah, 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 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 increased 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 just like to add that one thing that we've said for I think the past two 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. One moment for our next question. 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 questions from us. I guess now that utilization management criteria has been updated and we've seen an important uptick in prescription, just curious how different is the product being used now? in a broader set of patients and has it moved up the treatment paradigm relative to the PCSK9 inhibitors? And then 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, yeah, so we've seen that shift from ASCBD patients, which were the patients that our clinicians were bound to with the prior label in UM, We're seeing an increase 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 nudibrand prescriptions or nudibrand share for PCSK9s 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 benpidoic acid products, that these are a recognized, they are a recognized place in therapy, and it's, you know, the awareness, you know, just continues and continues to grow. BJ, Medicare?

With 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, 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're well poised between the three PBMs and having that coverage both commercially and with Medicare. We're 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 OTSUCA collaboration and what those payments are contingent on?

Yeah, this is Ben. I'm happy to walk through that. So I don't think we've 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 what actually gets included in the U.S. label, but payable once it's approved, as well as a pricing milestone. So those will all come, I would say, by the end of 2025 is what we're expecting internally here. And we will have very shortly, I think, a lot more clarity on what that timing looks like. Thanks.

Thank you. One moment for our next question. Our next question comes from the line of Jason Zeminski of Bank of America. Your line is now open.

Good morning. Congratulations on the progress, and thank you so much for taking our questions. I was hoping to provide some color on ongoing payer dynamics. I appreciate you may not be able to provide many details, but if you could please speak to whether there's 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.

Yeah, so I can take that. So, you know, Jason, I think as we mentioned before, our biggest headwinds were that, you know, let me start with your second part of your question first, if you don't mind. You know, the biggest headwind was that the fact that, you know, 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 Silver Scripps Caremark, there's no prior authorization for a physician. Aetna, there's no prior authorization for a physician. It's what we have in the field and what our representatives say, and we're seeing it in our prescription performance. Getting Nexlozet and Nexlatal 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. One moment for our next question. Our next question comes from the line of Jessica Tsai of JPMorgan. The line is now open.

Hey, good morning, everyone. This is Tanmay on for Jessica. Hi, 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.

Yeah, I'll 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're 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. One moment for next question. Our next question comes from the line of Joe Ptengis of HDWinrite. Your line is now open.

Hi, good morning, everyone. This is Lander on for Joe. Thanks for taking our question. So just curious about the market dynamics in Japan. What are the expectations in terms of confidence from payers and decisions for distribution and pricing and sales ramp in Japan? Anything different compared to the US, 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're on track of what we need to do, and there's high expectations by our partner of Otsuka. And as we mentioned in our prepare remarks, that really benefits us as well. That's a significant royalty stream to the organization.

Perfect. Thank you. Thank you. Congrats on the update.

Thank you. One moment for our next question. And our next question comes from the line of Tom Schrader at PTIG. Your line is now open.

Good morning. Congratulations on the uptick and taking the question back to Medicare is part of the lag relative to commercial that you negotiate very hard to be in the best year of Medicare. And can you, do you know your average copay for a Medicare patient versus a commercial payment or a commercial patient?

Yes, how are you, Tom? We basically, for Medicare, it's all about out-of-pocket costs. And what was happening before, as you know, when we were non-preferred, those out-of-pocket costs were much higher. What we're 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 opportunity. plug for us, and it's great with the physicians, again, to Sheldon's point previously, is giving those physicians the confidence and then getting the product to the patients in the shortest period of time. With commercial, with our copay card, that ranges. We really have our copay card, so that's probably more of a $25 range for patients in commercial.

And if I 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 of it really shows the applicability of the clinical profile as a result of our new label from the Clear Outcome 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 significant duration, for the copay for a significant duration?

Well, I think what it is is that it's really more of the status, and we're preferred in Medicare. So I'm not sure if I'm following your question completely, but I'm just looking at the end result, and the end result is we have a copay that is acceptable for patients to pay, and we're in a preferred position 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, et cetera. 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 Jeffries London Healthcare Conference on November 19th in London and at the Pippa Sandler Healthcare Conference in New York on December 5th. So we hope to have the 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.