Esperion Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference over to Tiffany Aldridge, Senior Manager in Corporate Communications at Asperion. Please go ahead.

Thank you. Good morning and welcome to Experian's first quarter 2022 financial results and company update conference call. I'm Tiffany Aldrich and I'm part of the corporate communications team here at Experian. 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 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 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, May 3, 2022. 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 issued a press release this morning detailing the content of today's call. A copy can be found at www.esperion.com within the Investors and Media section. We will begin with prepared comments and then open the call for your questions. Following today's call, the team will be available for follow-up questions. Please email corporateteam at esperion.com to schedule a time to speak with the team. With us today are Sheldon Koenig, President and CEO, Dr. Joanne Foody, Chief Medical Officer, Eric Warren, Chief Commercial Officer, and BJ Swartz, Chief Strategy Officer. I'll now turn the call over to Sheldon for some prepared remarks. Sheldon?

Thank you, Tiffany, and good morning, everyone. We are excited to be here with you today to recap the first quarter of what will be a transformational year for Aspirion and reaffirm our goals for 2022. Over the past few quarters, Aspirion has outlined a strategic vision to position our company for long-term growth and success. and we continue to execute both commercially and in the clinic to attain our goal of becoming an innovative cardiometabolic leader. As part of that strategy, in 2021, we streamlined our operational structure to focus our resources on driving the consistent growth of our commercial products, Nexlatal and Nexlavet, and the advancement of our ongoing unprecedented clear outcomes trial leading up to the planned top-line readout in the first quarter of 2023. Now, during the remainder of 2022, we remain steadfast and are focused on delivering these objectives. I'd like to begin with a brief overview of the commercial progress of Nexlatal and NexlaZec. To recap the last quarter, year-over-year demand for our medicines grew 56.7% in the first quarter, with U.S. net product revenue of $13.4 million, up approximately 109%, from the same period of 2021. These robust results were the culmination of the enhanced product positioning and refined patient support programs we initiated in 2021 and continue to improve. We have enhanced our targeting efforts even further to identify and optimize new physician targets using the contract sales organization we began deploying this year, concentrating on physicians who will help drive more frequent utilization. Our partners, Daiichi Sankyo Europe, continue to actively grow Nolendo and Nustendi in their European territory and have cumulatively treated at least 52,000 patients through the first quarter of 2022. Our products have demonstrated significant traction in the European market with a stronger launch trajectory than PCSK9 inhibitors, and we continue to believe that the accessibility and convenience of an oral medication will provide a significant improvement to the quality of patient care. I am also pleased to report that this quarter we have achieved year-over-year cost savings of 32% in our operational expenses compared to the first quarter of 2021. This represents effective execution of our transformative plan announced in the fall. We are approaching 95% MACE accumulation in our unprecedented clear outcomes trial and expect to reach 100% of MACE by the end of the year, with top-line data in the first quarter of 2023. As you all know, this is a critical priority for Aspirion, and our entire team is focused on the task of assuring a high-quality trial close and proper data collection. With an estimated 41 million patients impacted by hypercholesterolemia globally and 18 million patients in the U.S. alone, it is more crucial than ever to identify and treat patients who are unable to achieve their LDL cholesterol goals with existing treatment options. Presently, an estimated 70% of patients are not at guideline recommended LDL levels despite the numerous treatment options in the cholesterol management landscape. Other cardiovascular drug manufacturers also see the significant value waiting to be realized in cholesterol management. By 2026, annual worldwide revenue in the lipid market is projected to exceed $11 billion. Aspirion remains committed to its mission of providing oral, accessible therapies to address cardiovascular risk. We recently announced support for a collaborative study with a large integrated and learning healthcare delivery system in Northern California to study the effects of Nexoset in reducing LDL cholesterol following a heart attack. These data will add to the extensive body of evidence supporting the clinical value of NexLizet. Now, I'd like to turn the call over to Joanne for an overview of our ongoing clinical activities and data presentations.

Joanne? Thank you, Sheldon. I'd like to begin by emphasizing the severe impact of cardiovascular disease on life expectancy in the U.S., particularly in recent years during the COVID-19 pandemic. Despite the staggering losses from COVID, heart disease remains the leading cause of death in the United States. In fact, heart disease and stroke mortality rates have risen sharply since the onset of the COVID-19 pandemic. Age-adjusted death rates from heart disease increased 4.1% from 2019 to 2020, contributing to a loss in life expectancy of almost two years during this period. It is important to highlight that 85% of all cardiovascular disease deaths are attributed to atherosclerotic cardiovascular disease, driven in large part by high LDL cholesterol. These sobering statistics reaffirm the importance of Aspirion's mission to bring transformational oral therapies to patients. They reaffirm added urgency to our ongoing clinical, medical, and commercial efforts tackling chronic diseases and supporting our benpidoic acid franchise. We are also leveraging our scientific data, patent state, and other unique mechanisms of action to advance a pipeline of novel compounds, which we expect to be extremely competitive in the multibillion-dollar lipid market projected for 2026. We will have more to share with you on our oral PCSK9 and next-generation ATP citrate lye inhibitors platform by the end of the year. Our unprecedented Clear Outcomes trial continues to progress as we expected and represents the most modern outcomes data set collected in today's evolving medical care environment. As a reminder, Clear Outcomes is a 14,000-patient randomized outcome trial. one of the largest outcome trials of non-statin therapies yet. This study will assess femtodoic acid's ability to reduce incidence of adverse cardiovascular events in a unique patient population that is unable to adequately address their LDL cholesterol risk with the current standard of care. The study was developed in partnership with experts and regulators and is headed by world-renowned trialist, Dr. Steven Nissen, and a team of international experts. The trial is approaching 95% of its required major adverse cardiac events. Our deeply committed and experienced team expects 100% accumulation of our MACE IV events in the second half of this year. And a top line readout, first quarter of 2023, which is now less than one year away. A positive cardiovascular outcome trial in 2023 not only has the potential to expand our current labeled indication, but also to be practice-changing for physicians and paradigm-shifting for millions of patients around the world, advancing Aspirion's mission of making cardiovascular risk reduction more accessible and convenient for all. A positive outcome study in the ensuing label has the potential to make benfodoic acid the only oral LDL-lowering therapy since statins to be indicated for CV risk reduction. We also continue to actively present our data at scientific meetings. We recently announced multiple presentations on Nexortol at the American College of Cardiology's 71st Annual Scientific Session. Additionally, we announced multiple publications of data in peer-reviewed journals, all supporting the safety and efficacy of benpidoic acid in diverse patient populations and highlighting patients most likely to benefit from our therapies. As you can see, Aspirion has made a commitment to the science of lipids, to advancing our understanding of benpidoic acid as a key oral therapy to address LDL cholesterol, and executing clear outcomes while progressing our pipeline of oral compounds to address cardiovascular and cardiometabolic disease. I'll now pass it back to Sheldon for additional commentary on our quarterly results. Sheldon?

Thank you, Joanne. Earlier today, we issued a press release containing our financial results for the first quarter, which is available on our investor website. U.S. product revenue for the first quarter ended March 31, 2022, was $13.4 million, up approximately 109% year-over-year. Royalty revenue for the first quarter ended March 31, 2022, was $1.1 million, up 83% year-over-year. Combined royalty and partner revenue of $5.5 million for the first quarter ended March 31, 2022, 2022 grew approximately 244% year-over-year, driven by launches in Belgium, Switzerland, and the Netherlands, and continued growth in previously launched territories. We expect our partners to continue rolling out Nalemdo and Yustendi to new geographies. Finally, total revenue for the first quarter ended March 31, 2022, with $18.8 million, compared to $8 million for the first quarter of 2021, an increase of approximately 135% year over year. Turning to expenses, gross margin decreased as a percent of revenue, largely driven by an increase in the purchase of inventory from our international partners, which has a lower margin than our U.S. sales. We expect this to improve over the year as shipments reach steady state compared to the first half of 2022. R&D expense for the first quarter was $24.3 million, a decrease of 13% year-over-year, primarily related to a reduction in alternative supply manufacturing and compensation costs. SG&A expense was $30.4 million for the first quarter, a decrease of 50% year-over-year, or 36% year-over-year when adjusting for one-time legal expenses of $13.3 million in Q1 2021. These decreases reflect savings from the transformation for long-term success plan implemented in Q4 of 2021. As of March 31, 2022, cash equivalents, restricted cash, and investment securities available for sale totaled $268.5 million, compared with $309.3 million on December 31, 2021. We are well capitalized and anticipate that our cash runway extends through the anticipated completion and readout of the clear outcomes trial and continues to fund continuing operations for the foreseeable future following those results. Our operating expense guidance for the full year 2022 remains unchanged. We continue to anticipate full year 2022 R&D expenses to be between $100 to $110 million, and SG&A expenses to be between $120 to $130 million. These estimates are inclusive of approximately $25 million of non-cash stock-based compensation expense expected to be incurred during this year. We recently filed a $400 million shelf registration statement after our previous registration statement expired in February upon the filing of our annual report. This new filing preserves our financial flexibility for the future, but does not change our belief that we are financed through the readout of a clear outcomes trial and for the foreseeable future beyond that. That said, we view our stock prices extremely depressed at current levels and continue to work diligently to maximize shareholder value. In closing, I am proud of what our team has accomplished in positioning our organization for the future in alignment with our ever-important mission of of reducing cardiovascular risk today and in the future. Cardiovascular disease continues to be the number one killer across the world, and it is critical for patients to be able to manage their cholesterol levels effectively. We believe Nexlipol and Nexlovet have significant potential to help patients reduce their risk of heart attack and stroke, and we look forward to the top-line results from our CLEAR Outcomes Trial to provide further insight into the benefits our medicines can provide and key underrepresented patient groups within today's medical care environment. We have a solid strategy in place to execute on our planned activities, and we look forward to providing additional updates on what will be an exciting and productive year for us. Thank you all for joining today and for your continued support and interest in this period. Operator, we are now ready for Q&A.

Thank you. To ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, that's star 1 on your touch-tone telephone to ask a question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Michael Yee of Jefferies. Your question, please.

Hi, good morning. This is Jarjian Wei on the line for Mike Yee. Thanks for taking my question, and congrats on a strong quarter. Maybe two for me. First of all, could you comment on the U.S. sales trajectory, appreciating there's a recent increase in price? And can you comment on the volume as well? Do you see the volume accelerating into the second quarter as well and maybe beyond? Or do you see any impact from the pandemic? I guess the second one is, could you clarify how good your CBOT data needs to be to get the milestone payment from the IEG? Specifically, is there a bar for efficacy? And if you could talk about what are the scenarios for the data to drive what kind of payments, and how confident are you in each of the scenarios, that would be very helpful. Thank you.

Great. Well, first of all, good morning. Let me start with your second question, and I'll turn it over to Eric Warren for your first question. as it relates to sales, et cetera. So, again, thank you for your message. As a rate to milestone payments for Daiichi Sankyo, we have the ability to receive up to $300 million from Daiichi Sankyo upon the conclusion of the clear outcome study, and then that data being included into the European label. I just want to reiterate, again, the timing of the top line. This is, again, the top line will be – in the first quarter of 2023, then the data will be reported at a major meeting. But, of course, we'll also be filing the data with regulatory committees. But that is the milestone, and that's how it works with Daiichi. Thank you. Eric?

Yeah, absolutely. Good morning, and thanks for the question. With regards to growth from a volume perspective, we saw about a 6.5% volume increase, so that's consistent with the mantra that we've provided of delivering consistent growth throughout the year. So that will be the mission for the team. We're on track to do so. And then, of course, with clear outcomes, we unlock the exponential growth.

Great. Thank you. Thank you.

Thank you. Our next question comes from Serge Bellinger of Needham. Your line is open.

Hi, good morning. Just a couple questions for me. The first one on the contract Salesforce effort, I think you mentioned you've been able to target some new physicians, so maybe just describe the effort and whether it can be scaled up as you see success with it. And then secondly, regarding the collaborative study with the healthcare delivery system in Northern California, could that end up in a label extension, or it's more of a move for a guideline positioning down the road? Thank you.

Eric? Good morning, Serge. Yeah, so the CSO team, as you know, is in pilot form. We're leveraging the CSO to do three things for us, cover the white space, cover vacancies as they may arise, and to create overlapping coverage for some some targeted HCPs where we feel like it's essential to have dual coverage. So far, so good. We're seeing the CSO able to get in, able to have meaningful discussions. We deployed the team late in January, so still early, but encouraging so far. And you're absolutely right, we've got the ability to scale depending upon the returns that we see, also depending upon the environment that we operate in. So, so far so good, but still in pilot and early phase.

George, this is Joanne. Thank you for your second question regarding the system in Northern California. We're, this is actually a pragmatic study that really is looking at the ability of NextLisette to improve LDL levels in patients post-heart attack. To your point, it would be unlikely that this would indicate a label expansion, but importantly, this is significant for practicing clinicians, and particularly for a system-level approach to allow the utilization of Nexlozet at time of discharge from an acute coronary syndrome or heart attack. So we believe that that will have important practice-changing implications, but not a label-changing one.

and continues to add to the wealth of information already out there as it relates to benpidoic acid. So excited about that. Thanks, Julian. Thank you, Serge.

Thank you. Thank you. Our next question comes from Jason Butler of J&P Securities. Your line is open.

Thanks. Thanks for taking the questions. Just a couple from me. Can you, I guess on the clear outcome study, can you just give us an update on the progress you're making with adjudicating events and just preparing for database lock in, you know, in the patients where you already have the events accumulated. And then a commercial question, can you speak to, you know, the dynamics of growth between, you know, adding new physicians versus new physicians writing more prescriptions in the quarter? Thanks.

So, Jason, thank you for your question on the CVOT. We are continuing to adjudicate events essentially in real time. really staying up to speed with our nearly 95% of events for our MACE 4, as well as well over now 100% of the MACE 3 events. We will continue to do that. Importantly, we are beginning to start end of study visits for the entire global study, which includes bringing in over 28,000 end-of-study visits, two per the 14,000 patients, and these are progressing, if anything, ahead of schedule. So we're continuing to look towards top-line results, Q1 of 2023, and, you know, stay tuned. We're less than a year away.

And then, Jason, with regards to your commercial question, it's Eric. So we're seeing both. So new HCPs are coming in. to the mix. This is driven by some of the digital activity. As you're aware, we've got a three-pronged approach. We're leveraging digital, we're leveraging our personal promotion, and we're leveraging peer-to-peer. We're also seeing increased depth. That depth comes as a result of the personal promotion and our representatives encouraging HCPs to prescribe deeper levels of the product. So, we've seen some meaningful gains in both of those dynamics.

Great. Thanks for taking the questions. Thank you.

Thank you. Our next question comes from Jessica Fye of J.P. Morgan. Please go ahead.

Hey, guys. Good morning. Thanks for taking my questions. Following up on one of the prior questions with the MACE accumulation in clear outcomes nearing 95%, is it reasonable to assume the trial could reach 100% accumulation by early in the third quarter? Second question is just hoping for a little more color on where you're seeing Nexlatal and Nexlazet used today. Is it more so in statin-intolerant patients or more so in those taking statins who need some additional LDL lowering. And then last question, gross net looks like they improved this quarter. Is this quarter's gross net a good run rate for the rest of the year, or could we think about continued improvement there?

So, Jeff, thank you so much for your question. With respect to the CVOT, you know, certainly we could consider having that 100% in earlier. in the second half of the year. However, you know, that'll depend on the event. The key, though, is that there still is a significant amount of time required to close out the study, but we are confident that the study will be closed out, including all those end of study visits by the end of the year with top line results Q1.

And with regards, Jess and Eric, to the types of patients, So, maximally tolerated statin ASCVD still require additional LDL-C reduction. It's the primary population that aligns with the label, that aligns with the prior authorization criteria. And, of course, we remained very encouraged by clear outcomes and the potential to expand that population.

And then, Jess, regarding your question on GCaN, even going back to this time last year, the one thing that we've been consistent with, is the fact that we will look for ways to improve our gross to net. So that's something that is continuous. We're always continually to look for ways to improve our GCAN. I think I mentioned this before. We have weekly meetings that concentrate on this, and we'll continue to update you as we go through the quarters on our progress. But it's obviously a focus and a priority, and we have shown notable improvement since last year, and we'll continue to do so.

Great. Hey, Eric, can I just follow up on that question, recognizing that a statin-intolerant patient is on their maximum tolerated dose of statin, even if it might be no statin? I was hoping you could kind of, within the label, break out. Maybe we can phrase it as, you know, which patients are on moderate to high-intensity statins versus low or no statin as their max tolerated statin.

Yeah, I'll just say the bulk of the focus of our promotion has been on those patients that have tried statins. They're not able to get to goal, and they have that underlying ASCVD. There's some interest from an HCP level in those physicians that are able to push the statin dose to higher levels, but that's not the area that we're encouraging. That just creates challenges from a prior authorization perspective. Joanne?

And, Jess, if I could just provide some context, I think that, you know, in general in the U.S. population, even in ASCVD patients, that the majority of statin use is still in that lower intensity. You know, Lipitor 10 is still the most commonly prescribed. And we're seeing that. I think if we switch, you know, our label in the U.S. does not allow technically for statin intolerance, right? Although, to your point, you could say that maximally tolerated was zero. However, in Europe, and part of the reason for their success is that they don't have maximally tolerated in their label, and in their population, they do target, to your point, more consistently the statin intolerant group of patients. And then lastly, we see the CDOT as really being that opportunity to remove the maximally tolerated from our label and give us a much broader expansive opportunity irrespective of statin. All right. Thank you.

Thank you. Our next question comes from Jeff Hung. Morgan Stanley, please go ahead.

Thanks for taking my questions. You've talked about the goal of driving consistent growth up to the CBOT results. Can you talk about any additional levers that you may have to further drive growth ahead of the outcomes data? And then for the next-gen ACL inhibitor, given the broad therapeutic application, how do you think about prioritizing the different indications you'll pursue? Thanks.

Thanks, Jeff. Yeah, so with regards to consistent growth, obviously, The environment that we play in has a factor with the COVID environment. We're seeing greater access. That's a good sign for us and our ability to drive growth. There is an increased level of awareness that we're starting to see as the world opens up. We're starting to see, for example, live Congress engagement. We just recently completed our ACC Congress, where we think that there was somewhere in the neighborhood of 8,000 to 9,000 live attendees. Obviously, the team had a full suite of activities. So as the world continues to open up, that creates more momentum for us. Obviously, we're doing our three-prong approach from a digital perspective. We're spending more and more time. So I expect that to continue to bear fruit as well, also from a managed care perspectives. Maybe I'll have BJ comment on some momentum that we've got with regards to managed care.

Yes. From a payer perspective, we have favorable coverage from a commercial standpoint, and we've done a segmentation analysis down to each geography level showing the opportunity for pull-through. In addition to that, we are also working with very specific IDNs on demonstration projects from an HOR perspective, as well as really embarking into the long-term care market as well, which should provide incremental growth as well.

And I would just add, I think, you know, that speaks to partnership. We've talked about a partnership with the Northern California Institution as well. You've seen a number of publications that have also been rolling out over the past few weeks and months, and these are all ways to continue to gain more awareness as we continue to march towards the completion of CLEAR. And Joanne, do you want to speak too?

Absolutely. So Jeff, thank you so much for the question on our Next Generation ATP6-Drate Lyase Platform. As you're aware, we believe the mechanism is one that has opportunity across multiple disease states. beyond cardiovascular and moving into cardiometabolic and even oncology. As you've stated, we are continuing to refine potential opportunities and disease states with consideration of diseases such as NASH, kidney disease, as well as cardiometabolic and even oncology with diseases like hepatocellular carcinoma. We are doing this in a very refined way, leveraging data science, analytics, big data to really help us understand where the opportunities might lie, not only from a medical clinical perspective, but also from a commercial one. And we will be amassing a group of international experts to advise us in this so that we can really ensure that we're making the right decisions with respect to the platform, with respect to the disease, and with respect to the investment in those areas. But really very excited for that platform and the opportunity to expand to a much broader patient population with ATP citrate lye inhibitors. Stay tuned. We'll have more information for you the end of this year as we plan a research and development day.

Thank you.

Thank you. Our next question comes from Joseph Thome of Cohen. Your line is open.

Hi there. Good morning, and thank you for taking my questions. I guess as we look across 2023, we'll have the data, then you'll have the incorporation into treatment guidelines, and then also hopefully the updated label. I guess when you talk to your physicians, what do they watch and respond to the most? I guess which one of these events could potentially cause the largest increase in Scripps? And then second, I guess when you do talk to physicians, do they say we want to prescribe Bempatox acid, but we want to wait and see outcomes data? How does that conversation go? And any idea on reorder rates would be helpful. Thank you.

Joe, you're fading at the end. Oh, we got the part of what the folks want to see for outcomes. We got your second question, but the last part kind of faded out.

Yeah, just on reordering rates. Once patients come on, are they staying on therapy? Yeah, yeah, yeah.

So, Joe, thank you for the question. So, exactly as you've laid out, right, we anticipate that 2023 will have our top-line results. Ultimately, we would anticipate a presentation and publication of the results early within the year, and then label inclusion 2024. Over that time, what we would likely see and what we anticipate is that there will be those who have been awaiting outcomes and, if you will, voting with their feet and waiting for that. We anticipate that those individuals will start to prescribe well before we have data in the label. And importantly, we anticipate that guidelines would be updated mid-year based on our best understanding of the guideline process within the U.S. and what we anticipate for prevention guidelines. Understand that benpidoic acid is already in a very significant number of guidelines at present, but we do have that asterisk that says we don't have outcomes, but we anticipate those would be removed. Clearly, then, the label is one that starts to give us greatest value, of course, with payers. However, we'll be talking with payers well before and have a strategy to discuss the data with them before and would anticipate some wins well before the label. And Eric, did you want to speak to the prescriptions?

Yeah, yes, yes. So, thanks so much for the question. So, with regards to the growth, yeah, it comes from a few sources. So penetration, it's obviously a greater depth of penetration. It also comes from access, to Joanne's point, eliminating the maximally tolerated statin and eliminating the dependence upon the secondary prevention or the focus on ASCVD patients. We recently did some significant quantitative research, and we confirmed that both of those components or those levers are unlocked. with clear outcomes. So significant opportunity with clear outcomes on those two thresholds.

Great. And then just on the reorder rates, are patients staying on therapy once they come on?

Yeah. From an adherence perspective now, our adherence is very consistent with chronic oral therapies. So we're focused on driving new patients, but we're also focused on maintaining existing patients on therapy. The team's coming up with a program called Next Step, which will provide a suite of resources to further improve that rate of adherence, but very consistent with current chronic oral therapies.

Great. Thank you very much.

Thank you. Our next question comes from Tom Schrader of BTIG. Your line is open.

Hey, good morning. This is Song calling in for Tom. So just one question for me. So given the recent publications showing the long-term durability of vampyloic acid, I was just wondering if you guys have any plans to perform additional studies as a combination therapy with either drugs that are approved or in the development to see how much additional LDL lowering you guys can achieve? Thank you.

So good morning. Thank you for the question. This is Joanne. So as you mentioned, we've just recently published our open label extension studies demonstrating that consistent benefit. I think right now we are waiting for clear outcomes. And, you know, that will really then tell us the opportunity of whether or not we pursue additional studies with respect to combination therapies or the like. Importantly, in our discovery phase, As you know, we already have an oral PCSK9 inhibitor, as well as the next generation of benpidoic acid. And I think all of these programs will be informed based on clear outcomes, as well as the opportunity that presents for combination therapy. I think in the field, there's a growing importance of early combination oral therapies to address cardiovascular risk. And I think that we are well positioned with our existing therapies, Nexlatal and Nexlozet, and have the opportunity, as you say, to potentially combine with other oral therapies to bring those to patients.

Great. Thank you.

Thank you. Our next question comes from Paul Choi of Goldman Sachs. Please go ahead.

Thank you. Good morning, team, and thanks for taking our questions. Congratulations on the progress. Sheldon, I was wondering if you could maybe just elaborate on your earlier comments regarding the commercial environment, and could you maybe just give us a little more color on as to how you're seeing and your sales force is seeing return to office in terms of patient visits, and how much in-person or in-face time your contract sales force is able to gain versus, let's say, the last couple quarters in terms of direct interaction, in-person interactions with prescribers?

Thanks, Paul. Yep, I'll take a start, and then I'll then also turn it over to Eric. So I think what we've been seeing, and I know even personally from having been to a doctor's office the past couple of weeks, I think patients are definitely coming back to the office. We're hearing I was just speaking to one of our business managers who Eric had a meeting with all of them last week in Philadelphia. They're even seeing large areas or large practices open up again and welcome patients in. So I still think there's a bit of a balance where people are doing telehealth, et cetera. But for the most part, you know, patients are starting to return back to the office. Our representatives are actually able to gain access where these physicians are open and And I know in the news there's more talk about variants, et cetera, but I think also everyone, I'm not an expert in this, is getting used to the ability to, okay, deal with this and get their health care addressed. So I don't see the environment being like what it was a year ago or even a year before that. So that would just be my overall comments, and Eric can talk about some specific examples.

Yeah, so Paul, good to hear your voice. So the CSO team is a virtual team. Again, a small team. Their focus is on engaging virtually, which is good. It gives us flexibility for times when the environment may not be as friendly. Our personal promotion, the Asperion team, Yeah, I would say it's about 95% in-person, 5% virtual engagement. And rather than being kind of an or, it's an and. I really want the team to leverage both virtual and in-person to extend their reach, to also improve their frequency. Let's see, from an environmental perspective, as I mentioned earlier in the call, Congresses are starting to open up. was encouraged by ACC. Obviously, it wasn't ACC of 2019 from an attendance perspective, but it was a step in the right direction. We're also seeing a lot more live in-person peer-to-peer via speaker programs such as larger programs or smaller peer discussion groups that we conduct. Yeah, I remain encouraged by the work that the team is doing, but I do think that we have the right model, and not being completely dependent upon any pillar, but having a balanced promotional pillar is going to be really important for us going forward to flex as the environment changes.

Okay, great. Thanks for that, Eric. And maybe just one for Joanne, which is just, you know, as you will debut a little bit more on your oral PCS canine program, Could you maybe sort of comment on how you think about potential development here relative to the Merck MK0616 program, which had some data last year at AHA, I believe. They're showing like 60% to 70% type LDL reduction in patients, and just how you think about development there and potential areas of focus for differentiation. Thank you.

Yeah, so, Paul, thank you so much. So we're excited, as you mentioned. We do have this oral PCSK9, and we're well aware of the Merck data, which was very impressive. Given that, however, we believe that the scaffold that we have and the approach, which is allosteric inhibition, allows us for a smaller molecule with better COGs. And I think as we think about development, really the key with an oral PCSK9 is obviously efficacy, which we believe will optimize with our development program. But if anything, and almost more importantly, is allowing an accessible, relatively less expensive option. And we believe that our COGS will be critical in that, and the approach we have is critical. So stay tuned. We're hoping to have more information for the investor community, the scientific community later in the year.

Thank you.

Thank you. Our next question comes from Emanuela Brancetti of HC Wainwright. Your line is open.

Good morning, everyone, and thank you for taking my questions. And so, um, a question regarding the launch of both tracks in Europe, perhaps you can, uh, could you provide more color on the status of, uh, their lunch in Europe, particularly in the regions that were recently added? Uh, also is there any specific update or strategy for their launch in additional geography?

Sure. Yeah. So happy to. So first of all, good morning, Emmanuel. So Europe is actually, as we mentioned in our prepared remarks is doing very well. The leading market there is Germany. That's their largest market. They've also launched in the UK. They've launched in Belgium. They've launched in Switzerland. And soon, I believe, they will also be in Spain. As we mentioned, the launch has been received very well. Now, again, they have a different label than what we have. They have a label that allows for patients to not have to be on the maximum tolerated dose of the statin. And they've done a very good job in being able to get out there, gain awareness, and use that message. The number of patients that are currently on, whether it be Nulemdo or Nustendi, actually exceeds the number of patients who are actually on PCSK9s. And keep in mind, PCSK9s have been out in Europe for about seven years. So we've been very happy with their performance. And we work very well together. We have weekly meetings with them, and it's a very good collaboration.

Great. Thank you for that. And perhaps a question regarding the CLEAR-ACS study. Could you give us a sense of what is the percentage of patients that currently achieve LDL-C goals post-ACS event only with the current standard of care? And I guess how important is the quick LDL-C lowering post-ACS event for the patient prognosis? I'm trying to understand what would be considered a positive outcome and how relevant is this study for physicians. Thanks.

Yeah. Manuela, thank you so much. We're really excited about clear ACS for many reasons. But, you know, one is that despite the existing therapies, We know that still, to this day, that post-ACS patients at a year, 70% are not at their goal. And we appreciate that in post-ACS patients, the LDL recommendation is less than 55. So you recognize that that's a very high bar to achieve with respect to LDL cholesterol. We believe that benpredilic acid, but particularly the combination with azetamide, Nexlazet, has a significant opportunity to achieve LDL goals in these patients. And that's exactly the study design of Clear ACS, right? Can we add our therapy to existing standard of care in this Northern California system? to improve the proportion of individuals post-ACS who achieve their LDL goals short-term, but even long-term. And it's a very pragmatic study, but I think will provide clinicians a tremendous amount of information in how to better achieve LDL goals in this very high-risk group of patients. So hopefully that helps.

It does. Thank you.

Thank you. Once again, to ask a question, please press star one on your touchtone telephone. Again, that's star one on your touchtone telephone. Our next question comes from Judah Former of Prentice Suisse. Your line is open.

Yeah. Hi. Thanks for taking the question. I would just hope you could remind us of the patient support process you have in place right now as you've moved away from the copay cards during the pandemic. What can patients expect with their first prescription? And And how has the prior authorization support process for physicians' offices changed, and what is feedback as of now?

Sure, Judith. So what we have found with our offices, about 50% of the offices do prior authorizations exquisitely well, and they have their own support process in place. But there's about 50% of our offices that really do need assistance with prior authorizations. We had put together the Next Step Navigator program to assist with this endeavor, and we have over 5,000 patients now enrolled in that program. We're seeing the refills from a Persistency standpoint, and we have a host of other materials and tactics used in offices to pull through and really get patients on product and staying on product. The prior authorizations continue, but what we found is with the right patient, the prior authorizations are to our label exact. And when physicians are writing for the right patient and they're documenting for the prior authorizations, then those prescriptions do go through. So it's been an education, but pleased to say it's going much better. And also the service we have, the Next Step Navigator, it is the conduit that almost concierge services with the offices, the patients, and then also we'll go back and forth with the payer on behalf of the physician's office.

Okay. Thank you.

Thank you. At this time, I'd like to turn the call back over to Sheldon Koenig for closing remarks. Sir?

Great. Thank you, Lateef. So I just wanted to, first of all, again, thank everybody and remind everyone that we are actively educating physicians about the benefits of benpatoic acid in different patient populations ahead of the clear outcome study and the conference presentations that will come in the future. With over $268 million on the balance sheet, Aspirion is well capitalized and positioned to execute on our strategy in these current market conditions and beyond. And again, I want to thank everyone for their interest in Aspirion. Have a great day.

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