NASDAQ:ESPR Esperion Therapeutics Q3 2024 Earnings Report $1.09 +0.11 (+10.77%) Closing price 04:00 PM EasternExtended Trading$1.08 -0.01 (-0.46%) As of 07:59 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Esperion Therapeutics EPS ResultsActual EPS-$0.15Consensus EPS -$0.14Beat/MissMissed by -$0.01One Year Ago EPS-$0.37Esperion Therapeutics Revenue ResultsActual Revenue$51.63 millionExpected Revenue$55.44 millionBeat/MissMissed by -$3.81 millionYoY Revenue GrowthN/AEsperion Therapeutics Announcement DetailsQuarterQ3 2024Date11/7/2024TimeBefore Market OpensConference Call DateThursday, November 7, 2024Conference Call Time8:00AM ETUpcoming EarningsEsperion Therapeutics' Q1 2025 earnings is scheduled for Tuesday, May 6, 2025, with a conference call scheduled at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Esperion Therapeutics Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 7, 2024 ShareLink copied to clipboard.There are 13 speakers on the call. Operator00:00:00Ladies 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 hand the conference over to Alina Vincia, Director of Investor Relations for Experion Therapeutics. Operator00:00:19Please go ahead. Speaker 100:00:25Thank you, operator. Good morning, and welcome to Experion's Q3 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 and A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. Speaker 100:00:48A 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. Speaker 100:01:30The 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. Speaker 200:02:04Thank 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 nexlitol, nexlazet labels to include broad new indications for primary and secondary cardiovascular risk reduction, scoured 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. Speaker 200:02:47In addition, we've supported international growth and further expansion of Nalendo and NUSTENDI, which continue 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 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 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. Speaker 200:03:42Now 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 nexlazet and Nexlazetal in Q3 2024 of 10% sequential and 53% year over year growth. Speaker 200:04:01These increases were driven by the meaningful progress we continue to make during the 1st 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 in 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 NexoPal and NexoZet to the 70,000,000 patients eligible under the expanded labels. Speaker 200:04:50Starting Speaker 300:04:50with Speaker 200:04:51the payers, where we initially focused on making sure the utilization management criteria or for the expanded labels were in place. As of mid July, more than 80% of 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 114,000,000 lives. Since then, we have grown that number to more than 165,000,000 patient lives across all payers who have updated their criteria. This is a foundational building block to securing reimbursement and removing significant restrictions and barriers to access, so physicians can now prescribe Nexlutol and Nexlazette with increased confidence. Speaker 200:05:38Another milestone achievement on this front was the expansion of our commercial and Medicare formulary coverage for Nexlutetl and Nexlutet. 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 criteria. Again, we expect this expanded payer coverage to drive further increases in physician confidence to prescribe Nexlutol and Nexlazet, 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 Nexol and Nexolazette 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. Speaker 200:06:46As a result of these combined initiatives by our managed care, sales force and marketing teams in these 1st 6 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 to the Q2. This is just the type of momentum we want to see in the 1st 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 1st 4 weeks of the 3rd 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 NexoVet and our ability to realize that potential remain unchanged. Speaker 200:07:571, we have compelling data from the CLEAR outcome study that support and validate the safety and efficacy of NexoTol and NexoVet to reduce cardiovascular risk. 2, there is a massive underserved patient population of 70,000,000 people at risk who need additional treatment options and 3, 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 DSC continues to post strong prescription and revenue growth as evidenced by approximately 19% sequential increase in our royalty revenue, which was $8,900,000 in the Q3 of 2024. DSC received its approved expanded labels for Nalendo and Nuxtendi 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. Speaker 200:09:02With 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 DSC. Beyond Europe, our partner Daiichi Sankyo Company Limited gained approval for Nalendo in Taiwan on October 7, 2024. The totality of expected country launches enhances the global awareness of the cardiovascular benefits of our pempetoic 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 therapies. Speaker 200:09:58This 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 submission and or partnerships in Australia and Israel in the first half of twenty twenty five. Collectively, these advances expand the global commercial opportunity for our bempedoic 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. Speaker 200:10:47To 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 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 NexoZet 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 3 poster presentations at Statin intolerance due to muscle symptoms affects management of patients insights from the CLEAR OUTCOMES trial. Speaker 200:11:46Liver 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, 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. Speaker 200:12:22Consequently, we expect the efforts DSC made at ESC will also benefit our efforts to enhance the awareness and visibility for our products among U. S. Healthcare practitioners. Beyond ESC, DSC reported final 2 year real world results from the Milos 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 bempedoic acid. Speaker 200:12:57The 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 the 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 Q3. Ben? Speaker 300:13:27Thank 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 6 months, we focused on strengthening our balance sheet by monetizing the European royalties on our bemphidouac 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 Q4. Speaker 300:14:04I 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 Q3 ended September 30, 2024. Total revenue for the Q3 2024 was $51,600,000 compared to $34,000,000 for the comparable period in 2023. U. S. Speaker 300:14:32Net product revenue was $31,100,000 compared to $20,300,000 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 165,000,000 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. Speaker 300:15:14While 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 1st 4 weeks of Q4 compared to the 1st 4 weeks of Q3. Speaker 300:15:57Collaboration revenue was $20,500,000 compared to $13,700,000 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 in the LEMDO and Nuestendi 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 and L. For the Q3 of 2024, research and development expenses were $10,400,000 compared to $14,900,000 for the comparable period in 2023, a decrease of 30%, primarily attributable to our CLEAR outcome study that was completed in 2023. Speaker 300:16:48Selling, general and administrative expenses were $40,000,000 compared to $33,200,000 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 $29,500,000 compared to a net loss of $41,300,000 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. Speaker 300:17:28Turning to our balance sheet. As of September 30, 2024, we had $144,700,000 in cash and cash equivalents. We are reiterating our full year 2024 operating expense guidance, which is expected to be approximately $225,000,000 to 245,000,000 including $20,000,000 in non cash expenses related to stock compensation. Now, let me turn the call back to Sheldon for closing remarks. Sheldon? Speaker 200:17:55Thank 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 ECLY biology to explore new therapeutic opportunities and develop next generation inhibitors optimized to address multiple life threatening diseases. Speaker 200:18:40We look forward to providing a detailed update on our plans and timeline 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 and A. Operator00:19:09Thank you. At this time, we will conduct the question and answer session. First question comes from the line of Dennis Ng of Jefferies. Your line is now open. Speaker 400:19:34Hi, good morning. Thanks for taking our questions. I had a question on lebodilatosis. So it seems like prescriptions are starting to pick up in the Q4 and that's very encouraging. What's been driving that strength? Speaker 400:19:47And 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 pricing headwinds towards the end of the year? Thank you. Speaker 500:20:07Good morning, Dennis. It's Eric. Yes, absolutely. So Q3, again, double digit growth on all metrics. The start of Q4, really strong. Speaker 500:20:17You 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. Speaker 500:20:38But 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. Speaker 200:21:00And Dennis, I would just 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. Speaker 500:21:15Great. Thank you. Operator00:21:17Thank you. One moment for next question. Our next question comes from the line of Serge Belanger of Needham. Your line is now open. Speaker 600:21:31Good 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 an important uptick in prescription. Just curious how different is the product being used now? Speaker 600:21:50Is it just 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. Speaker 500:22:21Good 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 We're seeing an increased use in the primary prevention patient or the patient that hasn't had a prior event. Speaker 500:22:57We'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 1 point decrease in new to brand prescriptions or new to brand share for PCSK9 since we've had our label change. Speaker 200:23:21I 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 bepanoic acid products that these are recognized they are a recognized place in therapy. And it's the awareness just continues and continues to grow. Vijay, Medicare? Speaker 700:23:43And with that said, Sheldon, I think, Serge, when we started at launch, we were 28% Medicare coverage. Where we are now is 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. Speaker 700:24:12But we also know that right now we're well poised between the 3 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. Speaker 600:24:28Great. 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? Speaker 800:24:42Yes. 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 it actually gets included in the U. Speaker 800:24:58S. 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. Speaker 600:25:16Got it. Thanks. Operator00:25:18Thank you. One moment for next question. Our next question comes from the line of Jason Ziminski of Bank of America. Your line is now open. Speaker 900:25:30Good morning. Congratulations on the progress and thank you 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'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? Speaker 900:25:58Thank you. Speaker 200:26:01Yes. 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 at the fact that patients had to go through maximum tolerated dose of a statin. That actually changed back in December. Speaker 200:26:21But 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 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 2 very large accounts, we don't even have prior authorization. Speaker 200:27:05So SilverScript's 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 the representatives say, and we're seeing it in our prescription performance. Getting Nexlazette and Nexlazette just got easier. As far as concessions, we did not have to give any concessions at all for any of these changes. Speaker 200:27:29And I applaud all of the payers because what it demonstrated to us is that they really recognize the clinical benefits of the clear outcome study and our products. Speaker 900:27:42Got it. Thank you so much for the color. Operator00:27:45Thank you. One moment for next question. Our next question comes from the line of Jessica Fye of JPMorgan. Your line is now open. Speaker 1000:27:58Hey, good morning, everyone. This is Tanmay on for Jessica Fye and thanks for taking my 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. Speaker 1000:28:20S. Channel in 3Q? Thanks. Speaker 800:28:24Yes, I'll jump in on both of those. Inventory changes, I will say non existent. We are 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. Speaker 800:28:44However, 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. Speaker 1000:29:13Thank you. Operator00:29:15Thank you. One moment for next question. Our next question comes from the line of Joe Pantginis of H. C. Wainwright. Operator00:29:25Your line is now open. Speaker 1100:29:29Hi, 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? Speaker 1100:29:44Anything different compared to the U. S. For example, that we should consider? Thank you. Speaker 200:29:51Yes, 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. Speaker 200:30:11But what I would like to remind you of is Japan is one of the largest lipid markets in the entire world. And 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 prepared remarks, that really benefits us as well. That's a significant royalty stream to the organization. Speaker 1100:30:40Perfect. Thank you. Congrats on the update. Operator00:30:46Thank you. One moment for next question. And our next question comes from the line of Tom Schroeder of BTIG. Your line is now open. Speaker 1200:30:58Good morning. Congratulations on the uptick in taking 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 or a commercial patient? Speaker 700:31:22Yes. How are you, Tom? We basically for Medicare, it's all about the 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 contracts, there are probably an average out of pay now with the preferred co pays $45 as opposed to going anywhere from $1.50 up to $200 before they even reach their deductible. Speaker 700:31:46So that's been a great 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 co pay card that ranges, we really have our co pay card. So that's probably more of a $25 range for patients in commercial. Speaker 200:32:09And 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 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. Speaker 1200:32:40And 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 co pay for a significant duration? Speaker 200:32:57Well, 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 co pay 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, etcetera. So that's also important. Speaker 1200:33:33Okay, great. Thanks for all the detail. Operator00:33:37Thank you. We are out of time. This concludes the question and answer session. I would now like turn it back to Sheldon Koenig for closing remarks. Speaker 200:33:46Thank 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 19 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. Operator00:34:16Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallEsperion Therapeutics Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Esperion Therapeutics Earnings HeadlinesZacks Research Has Strong Forecast for ESPR FY2027 EarningsMay 1 at 3:01 AM | americanbankingnews.comZacks Research Issues Optimistic Forecast for ESPR EarningsMay 1 at 2:15 AM | americanbankingnews.comBuffett’s favorite chart just hit 209% – here’s what that means for goldA Historic Gold Announcement Is About to Rock Wall Street For months, sharp-eyed analysts have watched the quiet buildup behind the scenes. Now, in just days, the floodgates are set to open. The greatest investor of all time is about to validate what Garrett Goggin has been saying for months: Gold is entering a once-in-a-generation mania. Front-running Buffett has never been more urgent — and four tiny miners could be your ticket to 100X gains.May 2, 2025 | Golden Portfolio (Ad)Needham & Company LLC Reaffirms Buy Rating for Esperion Therapeutics (NASDAQ:ESPR)April 27, 2025 | americanbankingnews.comBrokerages Set Esperion Therapeutics, Inc. (NASDAQ:ESPR) Target Price at $6.42April 27, 2025 | americanbankingnews.comEsperion to Participate in The Citizens Life Sciences ConferenceApril 25, 2025 | globenewswire.comSee More Esperion Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Esperion Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Esperion Therapeutics and other key companies, straight to your email. Email Address About Esperion TherapeuticsEsperion Therapeutics (NASDAQ:ESPR), a pharmaceutical company, develops and commercializes medicines for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C). Its marketed products include NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) tablets that are oral, once-daily, non-statin medicines for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The company's products also include NILEMDO, an ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating the LDL receptors; and NUSTENDI, a bempedoic acid and ezetimibe tablet to treat elevated LDL-C. The company has license and collaboration agreements with Daiichi Sankyo Co. Ltd to; Otsuka Pharmaceutical Co., Ltd; and Daiichi Sankyo Europe GmbH. 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There are 13 speakers on the call. Operator00:00:00Ladies 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 hand the conference over to Alina Vincia, Director of Investor Relations for Experion Therapeutics. Operator00:00:19Please go ahead. Speaker 100:00:25Thank you, operator. Good morning, and welcome to Experion's Q3 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 and A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. Speaker 100:00:48A 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. Speaker 100:01:30The 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. Speaker 200:02:04Thank 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 nexlitol, nexlazet labels to include broad new indications for primary and secondary cardiovascular risk reduction, scoured 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. Speaker 200:02:47In addition, we've supported international growth and further expansion of Nalendo and NUSTENDI, which continue 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 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 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. Speaker 200:03:42Now 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 nexlazet and Nexlazetal in Q3 2024 of 10% sequential and 53% year over year growth. Speaker 200:04:01These increases were driven by the meaningful progress we continue to make during the 1st 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 in 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 NexoPal and NexoZet to the 70,000,000 patients eligible under the expanded labels. Speaker 200:04:50Starting Speaker 300:04:50with Speaker 200:04:51the payers, where we initially focused on making sure the utilization management criteria or for the expanded labels were in place. As of mid July, more than 80% of 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 114,000,000 lives. Since then, we have grown that number to more than 165,000,000 patient lives across all payers who have updated their criteria. This is a foundational building block to securing reimbursement and removing significant restrictions and barriers to access, so physicians can now prescribe Nexlutol and Nexlazette with increased confidence. Speaker 200:05:38Another milestone achievement on this front was the expansion of our commercial and Medicare formulary coverage for Nexlutetl and Nexlutet. 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 criteria. Again, we expect this expanded payer coverage to drive further increases in physician confidence to prescribe Nexlutol and Nexlazet, 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 Nexol and Nexolazette 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. Speaker 200:06:46As a result of these combined initiatives by our managed care, sales force and marketing teams in these 1st 6 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 to the Q2. This is just the type of momentum we want to see in the 1st 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 1st 4 weeks of the 3rd 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 NexoVet and our ability to realize that potential remain unchanged. Speaker 200:07:571, we have compelling data from the CLEAR outcome study that support and validate the safety and efficacy of NexoTol and NexoVet to reduce cardiovascular risk. 2, there is a massive underserved patient population of 70,000,000 people at risk who need additional treatment options and 3, 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 DSC continues to post strong prescription and revenue growth as evidenced by approximately 19% sequential increase in our royalty revenue, which was $8,900,000 in the Q3 of 2024. DSC received its approved expanded labels for Nalendo and Nuxtendi 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. Speaker 200:09:02With 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 DSC. Beyond Europe, our partner Daiichi Sankyo Company Limited gained approval for Nalendo in Taiwan on October 7, 2024. The totality of expected country launches enhances the global awareness of the cardiovascular benefits of our pempetoic 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 therapies. Speaker 200:09:58This 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 submission and or partnerships in Australia and Israel in the first half of twenty twenty five. Collectively, these advances expand the global commercial opportunity for our bempedoic 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. Speaker 200:10:47To 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 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 NexoZet 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 3 poster presentations at Statin intolerance due to muscle symptoms affects management of patients insights from the CLEAR OUTCOMES trial. Speaker 200:11:46Liver 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, 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. Speaker 200:12:22Consequently, we expect the efforts DSC made at ESC will also benefit our efforts to enhance the awareness and visibility for our products among U. S. Healthcare practitioners. Beyond ESC, DSC reported final 2 year real world results from the Milos 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 bempedoic acid. Speaker 200:12:57The 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 the 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 Q3. Ben? Speaker 300:13:27Thank 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 6 months, we focused on strengthening our balance sheet by monetizing the European royalties on our bemphidouac 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 Q4. Speaker 300:14:04I 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 Q3 ended September 30, 2024. Total revenue for the Q3 2024 was $51,600,000 compared to $34,000,000 for the comparable period in 2023. U. S. Speaker 300:14:32Net product revenue was $31,100,000 compared to $20,300,000 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 165,000,000 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. Speaker 300:15:14While 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 1st 4 weeks of Q4 compared to the 1st 4 weeks of Q3. Speaker 300:15:57Collaboration revenue was $20,500,000 compared to $13,700,000 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 in the LEMDO and Nuestendi 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 and L. For the Q3 of 2024, research and development expenses were $10,400,000 compared to $14,900,000 for the comparable period in 2023, a decrease of 30%, primarily attributable to our CLEAR outcome study that was completed in 2023. Speaker 300:16:48Selling, general and administrative expenses were $40,000,000 compared to $33,200,000 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 $29,500,000 compared to a net loss of $41,300,000 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. Speaker 300:17:28Turning to our balance sheet. As of September 30, 2024, we had $144,700,000 in cash and cash equivalents. We are reiterating our full year 2024 operating expense guidance, which is expected to be approximately $225,000,000 to 245,000,000 including $20,000,000 in non cash expenses related to stock compensation. Now, let me turn the call back to Sheldon for closing remarks. Sheldon? Speaker 200:17:55Thank 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 ECLY biology to explore new therapeutic opportunities and develop next generation inhibitors optimized to address multiple life threatening diseases. Speaker 200:18:40We look forward to providing a detailed update on our plans and timeline 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 and A. Operator00:19:09Thank you. At this time, we will conduct the question and answer session. First question comes from the line of Dennis Ng of Jefferies. Your line is now open. Speaker 400:19:34Hi, good morning. Thanks for taking our questions. I had a question on lebodilatosis. So it seems like prescriptions are starting to pick up in the Q4 and that's very encouraging. What's been driving that strength? Speaker 400:19:47And 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 pricing headwinds towards the end of the year? Thank you. Speaker 500:20:07Good morning, Dennis. It's Eric. Yes, absolutely. So Q3, again, double digit growth on all metrics. The start of Q4, really strong. Speaker 500:20:17You 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. Speaker 500:20:38But 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. Speaker 200:21:00And Dennis, I would just 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. Speaker 500:21:15Great. Thank you. Operator00:21:17Thank you. One moment for next question. Our next question comes from the line of Serge Belanger of Needham. Your line is now open. Speaker 600:21:31Good 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 an important uptick in prescription. Just curious how different is the product being used now? Speaker 600:21:50Is it just 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. Speaker 500:22:21Good 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 We're seeing an increased use in the primary prevention patient or the patient that hasn't had a prior event. Speaker 500:22:57We'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 1 point decrease in new to brand prescriptions or new to brand share for PCSK9 since we've had our label change. Speaker 200:23:21I 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 bepanoic acid products that these are recognized they are a recognized place in therapy. And it's the awareness just continues and continues to grow. Vijay, Medicare? Speaker 700:23:43And with that said, Sheldon, I think, Serge, when we started at launch, we were 28% Medicare coverage. Where we are now is 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. Speaker 700:24:12But we also know that right now we're well poised between the 3 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. Speaker 600:24:28Great. 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? Speaker 800:24:42Yes. 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 it actually gets included in the U. Speaker 800:24:58S. 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. Speaker 600:25:16Got it. Thanks. Operator00:25:18Thank you. One moment for next question. Our next question comes from the line of Jason Ziminski of Bank of America. Your line is now open. Speaker 900:25:30Good morning. Congratulations on the progress and thank you 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'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? Speaker 900:25:58Thank you. Speaker 200:26:01Yes. 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 at the fact that patients had to go through maximum tolerated dose of a statin. That actually changed back in December. Speaker 200:26:21But 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 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 2 very large accounts, we don't even have prior authorization. Speaker 200:27:05So SilverScript's 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 the representatives say, and we're seeing it in our prescription performance. Getting Nexlazette and Nexlazette just got easier. As far as concessions, we did not have to give any concessions at all for any of these changes. Speaker 200:27:29And I applaud all of the payers because what it demonstrated to us is that they really recognize the clinical benefits of the clear outcome study and our products. Speaker 900:27:42Got it. Thank you so much for the color. Operator00:27:45Thank you. One moment for next question. Our next question comes from the line of Jessica Fye of JPMorgan. Your line is now open. Speaker 1000:27:58Hey, good morning, everyone. This is Tanmay on for Jessica Fye and thanks for taking my 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. Speaker 1000:28:20S. Channel in 3Q? Thanks. Speaker 800:28:24Yes, I'll jump in on both of those. Inventory changes, I will say non existent. We are 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. Speaker 800:28:44However, 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. Speaker 1000:29:13Thank you. Operator00:29:15Thank you. One moment for next question. Our next question comes from the line of Joe Pantginis of H. C. Wainwright. Operator00:29:25Your line is now open. Speaker 1100:29:29Hi, 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? Speaker 1100:29:44Anything different compared to the U. S. For example, that we should consider? Thank you. Speaker 200:29:51Yes, 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. Speaker 200:30:11But what I would like to remind you of is Japan is one of the largest lipid markets in the entire world. And 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 prepared remarks, that really benefits us as well. That's a significant royalty stream to the organization. Speaker 1100:30:40Perfect. Thank you. Congrats on the update. Operator00:30:46Thank you. One moment for next question. And our next question comes from the line of Tom Schroeder of BTIG. Your line is now open. Speaker 1200:30:58Good morning. Congratulations on the uptick in taking 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 or a commercial patient? Speaker 700:31:22Yes. How are you, Tom? We basically for Medicare, it's all about the 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 contracts, there are probably an average out of pay now with the preferred co pays $45 as opposed to going anywhere from $1.50 up to $200 before they even reach their deductible. Speaker 700:31:46So that's been a great 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 co pay card that ranges, we really have our co pay card. So that's probably more of a $25 range for patients in commercial. Speaker 200:32:09And 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 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. Speaker 1200:32:40And 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 co pay for a significant duration? Speaker 200:32:57Well, 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 co pay 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, etcetera. So that's also important. Speaker 1200:33:33Okay, great. Thanks for all the detail. Operator00:33:37Thank you. We are out of time. This concludes the question and answer session. I would now like turn it back to Sheldon Koenig for closing remarks. Speaker 200:33:46Thank 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 19 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. Operator00:34:16Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read morePowered by