Q4 2022 Esperion Therapeutics Inc Earnings Call
Speaker 3: 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.
Speaker 3: I would now like to hand the conference over to Tiffany Aldridge, Associate Director, Corporate Communications at Asparion. Please go ahead Tiffany.
Speaker 4: Thank you. Good morning and welcome to experience fourth quarter and full year 2022 financial results and company update conference call. I'm Tiffany Aldrich and I'm part of corporate communications here at this period. I want to remind callers that the information discussed on the call today is covered under the state's harbor.
Speaker 4: risks and uncertainties associated with the business.
Speaker 4: These forward-looking statements are qualified in their entirety by the cautionary statement 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, February 21, 2023.
Speaker 4: 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.
Speaker 4: A copy can be found at www.esperium.com within the investors and media section.
Speaker 4: We will begin with prepared comments and then open the call for your questions.
Speaker 4: Following today's call, the team will be available for follow-up questions. Please email corporate team at isvaryon.com to schedule time to speak with the team.
Speaker 4: With us today are Sheldon Caining, President and CEO , Dr. Joanne Foudy, Chief Medical Officer, Ben Halliday, Chief Financial Officer, Eric Warren, Chief Commercial Officer, and BJ Sports, Chief Strategy Officer. I'll now turn the call over to Sheldon for some prepared remarks.
Speaker 5: Thank you, Tiffany, and good morning, everyone. Thank you for joining us today to review our recent progress as we wrap up a successful year for Aspirion. I'm incredibly proud of our team's ability to deliver on the commitments we made in 2022. As you know, we are now only 11 days from providing detailed results from our Positive Clear Outcomes trial at ACC on March the 4th.
Speaker 5: And as such, we will keep today's remarks brief. We'll be able to provide more visibility on our plans in full year 2023 financial guidance after the important presentation for the company. Thank you.
Speaker 5: We generated $15 million in USNet sales in the fourth quarter 2022, a 23% increase versus fourth quarter 2021. USNet product revenue grew approximately 40% year-over-year to $55.9 million in full year 2022, while selling, general, and administrative expenses came in 41% lower year-over-year.
Speaker 5: use criteria.
Speaker 5: Recent formulary additions at Tufts, Summa Healthcare, and Kinetic Care have expanded our access and reimbursement to help more patients reach their LDLC goal. We established a Scientific Advisory Board comprised of world-renowned experts to support our pipeline and lifecycle management, and we welcome Ben Halliday as our CFO .
Speaker 5: Internationally, our partner, Daiichi Sanquio, has demonstrated robust, persistent growth for the Nexotol and NexoZit franchise, and regulatory submissions have been made in Vietnam and Taiwan. Lastly, we have continued to build brand awareness amongst patients by partnering with RFK Racing. Now let me walk you through some key highlights. Every component of our long-term plan is geared towards creating shareholder value.
Speaker 5: This includes appropriately building awareness of our clear outcomes results among doctors and patients and advancing our global regulatory filing to enable the company to collect milestone payments from our partners.
Speaker 5: Lastly, we are positioning the company for long-term growth by advancing our innovative pipeline assets and also maximizing the blockbuster opportunity for Bemidoic Acid. As I mentioned earlier, in 11 days we are very excited to be presenting detailed results from our landmark Clear Outcomes Trial.
Speaker 5: which will demonstrate the cardiovascular risk reduction benefits of lymphodonic acid. These practice-changing results will be discussed as the first late-breaking clinical trial by Dr. Niffin at ACC and published simultaneously in a top-tier medical journal.
Speaker 5: The positive results from the Clear Outcomes Study will lay the foundation to reach our blockbuster sales potential.
Speaker 5: Plans are underway for the scaling of our commercial organization and the transition from our focus promotional approach to our future selling model, including positioning, targeting, messaging, and creative campaign.
Speaker 5: We made significant progress in 2022 and look forward to significant achievements to come in 2023. We are on track to submit the appropriate regulatory filings with the FDA and EMA in the first half of 2023 and expect an updated label in the first half of 2024.
Speaker 5: We also continue to engage with payers to garner broader patient access and improve prior authorization criteria. And now I'll turn it over to Ben to review our fourth quarter and full year 2022 financial results.
Speaker 5: Earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2022, which is available on our investor website. I am proud of the strong capital management that we demonstrated throughout 2022, reducing our net cash used in operating activities by $89 million compared to 2021, while still executing and accelerating our corporate priorities.
Speaker 5: US net product revenue for the fourth quarter ended December 31, 2022, was $15 million, up 23% year over year, and $55.9 million for the 12 months ended December 31, 2022, up approximately 40% year over year. Retail prescription equivalents for the fourth quarter were generally flat and in line with our expectations.
Speaker 5: Our partner, Dachy Sanco, continues to report strong, Nilemdo and Nustendi growth in their European territories with over 82,000 patients in the month of November 2022. As of December 31st, 2022, cash equivalents restricted cash and investment securities available for sale totaled $166.9 million compared with 309 million dollars compared to 309 million dollars.
Speaker 5: Combined royalty and partner revenue was $3.9 million for the fourth quarter ended December 31, 2022, an increase of approximately 22% year-over-year, and $19.6 million for the 12 months ended December 31, 2022, a decrease of 49% year-over-year.
Speaker 5: The decrease for the 12 months ended December 31, 2022, was due to a one-time milestone payment from our collaboration partners in the second quarter of 2021, partially offset by increases in royalty revenue and product sales to our collaboration partners under our supply agreement. Finally, total revenue for the fourth quarter ended December 31, 2022, was $18.8 million, an increase of $22 million. The increased revenue for the 12 months ended December 31, 2022, was $29.8 million. The increase in royalty revenue was $29.8 million, an increase of $22.6 million. The increase in royalty revenue was $30.9 million, an increase of $3.8 million.
Speaker 5: ended December 31, 2022 were $33 million, an increase of 20% year-over-year, and $118.9 million for the 12 months ended December 31, 2022, an increase of 12% year-over-year. The increase is primarily related to accelerated CVOT costs.
Speaker 5: SG&A expenses were $24.1 million for the fourth quarter ended December 31, 2022, a decrease of 37 percent year-over-year, and $109.1 million for the 12 months ended December 31, 2022, a decrease of 41 percent year-over-year. These decreases reflect savings from the transformation for Long-Term Success Plan implemented in Q4 of 2021. We will provide 2023 operational expense guidance after disclosing our detailed data results at ACC.
Speaker 5: Thank you, Ben. I'm proud that we have delivered on the commitments we made in 2022. From prudent expense management to consistent quarter-over-quarter growth to timely completion of the Transformational Clear Outcomes Study, we did what we said we would do. Throughout 2023, we will continue to ensure that data from clear outcomes serves as the catalyst for greater access to improved clinical management for the millions of patients with or at risk for cardiovascular disease. Thank you all for joining today and we look forward to seeing many of you at ACC.
Speaker 3: Operator, we are now ready for Q&A. To ask a question, please press star 1 1 on your telephone and please wait for your name to be announced.
Speaker 3: To withdraw your question, please press store 11 again. Please stand by while we compile the Q&A roster.
Speaker 3: Our first question comes from Serge.
Speaker 3: Balajay with Netham, your line is now open.
Speaker 6: Hi, good morning. Hi, there. I guess the first one for Sheldon, I think you've been pretty consistent since December that this dataset is statistically significant and clinically meaningful.
Speaker 6: So, with 10 days before the unveiling of the full data here, what do you think is the divergence of the meaning of clinically meaningful between the investment community and the medical community and the impact of the pandemic?
Speaker 6: for the unveiling of the full data here. What do you think is the divergence of the meaning of clinically meaningful between the investment community and the medical community? And how do you think that changes?
Speaker 5: Hi, Serge, let me start and then I'll turn it over to Joanne Foody as well for her comment. She's a physician. I think we've all been in this industry for some time. I've been in for thirty four years and we've all seen many studies report out saying that they are clinically meaningful. We came out and we said that our study was positive. It was statistically significant at the primary endpoint, even across several.
Speaker 5: of the secondary endpoint. Clinically meaningful means that we believe, and we'll have market research that will demonstrate as well, that this is something physicians will find meaningful to treat their patients. It's meaningful to patients in improvement of health, and it's the way that they prescribe these types of lipid lowering.
Speaker 5: such as Nexplatol and Nexplazet. So we've also have used the term practice changing because we do believe in the paradigm of treating LDL or bad cholesterol that, you know, we have a drug that's very differentiated. Not only do we lower LDL, but we also know that we lower HSCRP. We know that we...
Speaker 5: And that this is something that's going to be very meaningful in the practice of medicine. Thank you, Joanne.
Speaker 4: Thank you, Sheldon, and thank you, Serge, for the question. I think, you know, we are absolutely thrilled to present our data in just 11 days. It's the culmination of years of work effort and thousands putting into this. I think what's important to recognize is that when the medical community looks at numbers to see how this law is playing out upon
Speaker 4: and I would hope the investment community would do the same when I look at results. It's not a single number. It's the totality of the results.
Speaker 4: It's the importance of the unmet need, and it's the importance of the question. So let me frame maybe the importance and meaningfulness as I think about it.
Speaker 4: As Sheldon mentioned, this will lead off the American College of Cardiology World Congress of Cardiology late-breaking session with a simultaneous publication in a top-tier journal. That speaks to the meaningfulness and clinical relevance of the study.
Speaker 4: Another point, bimpedoic acid, the compound in both Nexlitol and Nexlazet,
Speaker 4: will be the first LDL lowering therapy since statins to decrease hard ischemic events in both primary and secondary prevention patients. That's the population studied and clear outcomes. Remember the PCFK-9 inhibitors?
Speaker 4: did not study this large population and were limited to ASCVD patients. So here's a brief Kind letter point
Speaker 4: This will be the first and only oral to be studied in a cardiovascular outcome study in those unable to maximize or tolerate a statin.
Speaker 4: In addition, this is the first and only LDL-lowering therapy to be studied in a representative population with equal numbers of men and women. Finally, at a recipient's point, we provide a
Speaker 4: you will see in 11 days that CLEAR Outcomes results, along with the totality of the CLEAR program, will position both NexLitol and NexLizat.
Speaker 4: as clear choices as the next LDL lowering therapy after statin. This is how I think about the clinical meaningfulness and the potential of these results.
Speaker 5: Anne, I'd like to have Eric make a few comments about the research that we've conducted. Eric, thank you, Joanne. Yeah. Thanks, Sheldon and Joanne. And good morning, Serge. Thanks for your question. So in the first quarter, early part of the first quarter of this year, I conducted a clinician quantitative market research project.
Speaker 5: looking at both current prescribers as well as non-prescribers of Nexotol and Nexozet.
Speaker 5: And the goal was to really assess the impact of potential CVOT data on willingness to prescribe as well as market share. Confirming everything that Joanne said, the primary, key secondary, end points, Mace 4 and Mace 3, as well as
Speaker 5: all of the additional secondary endpoints evaluated or deemed clinically meaningful. I think it's important to say that 95 percent of clinicians, after being exposed to these data, said that they would prescribe Nexotol, and Nexozet, interestingly, non-prescribers to date, said they would now prescribe for both primary and secondary.
Speaker 5: and secondary prevention patients, and current prescribers would significantly increase their utilization for both primary and secondary prevention. So, I'll turn it back to Sheldon.
Speaker 3: Thanks, Eric. Our next question. Please stand by for our next question. Our next question comes from Joseph Tom with Cohen. Your line is now open.
Speaker 5: Hi there, good morning and thank you for taking my question. Maybe just in terms of some of the other data measures that you mentioned on C-reactive protein and glucose control, I guess how familiar are the prescribing physicians with these sort of benefits? Obviously we're going to see the overall risk reduction, but will it take some education on your part to kind of point out these additional benefits? And in terms of looking at...
Speaker 5: pair coverage and then treatment guideline. Will these also take into account to reactive protein and glucose control on the overall package or is it largely driven by Mace4 risk reduction? Joanne, do you want to start with HSCRP and education? I'll address just as you're like to HSCRP and pair.
Speaker 4: Excellent. Excellent. Thank you, Joe. Thank you for the question. So, we again believe that Bempedoic acid is the first ATP citrate-lyase inhibitor, has very unique properties. And, like statins, reduces HSCRP and inflammation and markers of inflammation, but not like statins, actually does not.
Speaker 4: increase glucose or promote new onset diabetes. We believe this is differentiating. I think to your point about the clinical community, remember for those of you who followed statins, that really the idea of pleiotropic effects of statins were really critical.
Speaker 4: to thinking about the potential benefits of statins, whether it be with respect to outcomes data. In fact, one could argue that PCSK9 inhibitors have underperformed because they don't reduce inflammation. And for those of you paying attention to some of the science or attending ACC, I would point you all to an important presentation on Monday of the meeting.
Speaker 4: that looks to explore the relationship of LDL cholesterol, inflammatory marker reduction, and outcomes. As far as labor opportunities, though, in general, the labels are based on the primary pre-specified endpoints, but may have information with respect to some of these, including glucose relative to safety.
Speaker 4: So, stay tuned. The regulators are quite interested and have expressed interest in hearing our data, and we will look forward to a broadly expanded label based on clear outcomes. Sheldon, you want to cover the payer aspect.
Speaker 5: Thanks, Dwayne. Joe, as it relates to payers, we already have a meeting set up post the presentation of the CLEAR study. BJ Schwartz, who leads our market access and HOR group and her team will be there. Also, the folks that go with her for the presentation.
Speaker 5: We'd be really kind of reset up, if you will, our medical affairs groups. So the overall presentation will be a package of not only study results, but also this aspect of HSCRP, how it's differentiating, and how it potentially could make a difference.
Speaker 5: So, it'll just be part of that presentation to payers. As we mentioned in our prepared remarks, BJ and her team already have seen some formulary wins in anticipation of the Clear Outcomes Study, where the Azetimide step edit, which used to be a headwind for us, this is agnostic of HSCRP lowering, they've been actually removed.
Speaker 5: from the prior authorization process. So it's already, we're getting some clear wins even before the actual presentation of the data.
Speaker 5: And one last thing there, one question we get how many meetings do we have we've had over so far we've had scheduled thirty appointments to discuss both clinical and formulary positioning post clear outcome study.
Speaker 5: One question we get is how many meetings do we have? We've had over, so far, we've had scheduled 30 appointments to discuss both clinical and formulary positioning post-clear outcome study. Thank you.
Speaker 3: Please stand by for our next question. Our next question comes from Michael Yee with Jefferies. Your line is now open.
Speaker 5: Hey, good morning guys. Thanks for the question. We had maybe 2 questions. 1 was in the definition of practice changing. How do you think about the scenarios? In other words. The primary end point important to the primary end point.
Speaker 5: versus all of the other important secondary endpoints and how do you weigh those two. And related to that is I know that you commented previously that you believe you're eligible for the important milestones from the European partner. Can you just remind us what the criteria is for that milestone and do you have to wait for the label change and how do we think about the importance of that? Thank you so much.
Speaker 4: Mike Joanne, will not pick that first question. Thanks, Mike. Thanks for the question. As we think about the various scenarios in the primary versus the key secondary end points, I think what's important to recognize is our primary H4 as your well-informed case for includes
Speaker 4: coronary revascularization, which some folks might think is a more biased endpoint as a component of that composite of MACE-4. MACE-3 has typically been the hard ischemic endpoints, and in fact, MACE-3 is the endpoint utilized predominantly by the EMA for that purpose. And so, again, I think those are the ways folks think about those. The other aspect, Mike, that's important is…
Speaker 4: Also, to think not only about the hazard ratio, but also the absolute risk reduction in a given population, right? So, not just the MACE-3 or MACE-4, but then within that, the absolute risk reduction. With all cardiovascular outcome studies, there's a hierarchy of...
Speaker 4: results and the interpretation of all the numbers.
Speaker 6: Ben, do you want to speak to the milestones? Yeah, thanks, Mike. So turning to the milestones, as a reminder, the criteria for those is that the milestones are due upon inclusion of cardiovascular endpoints in the European label. It reminded the scale from...
Speaker 6: with a digesting of a scale from 200 to 300 million. And that's just dependent on the magnitude of the reduction percentage. So those will be, do we think of it as an early first half 2024 event, and we will disclose the exact amount that we think we will receive in our ACC press release.
Speaker 3: Got it. Super helpful. Thanks guys. Please stand by for our next question.
Speaker 3: Got it. Super helpful. Thanks guys. Please stand by for our next question.
Speaker 3: Our next question comes from Jason Butler with JMP Securities. Your line is now open. Hi. Thanks for taking the question. I guess this is somewhat of a follow-up to Eric's comments on the market research. Have you guys seen to date, you know, since the top line outlooks?
Speaker 3: So that's new to brand prescriptions. And yes, since the release of data, so far this first quarter, we've seen a pretty significant increase in NBRX.
Speaker 5: Great. Thanks for taking the question. Looking forward to seeing the data. Jason, just one fun note from anyone watching. We had the Daytona 500 this past weekend.
Speaker 5: and we sponsored the number six car, the next was that car, which led almost the entire race. Our pickup on that as it relates to website activity, etc. was, you know, like 100 times that we've ever seen before people wondering asking what next was that is, etc. But just a fun fact and a lot of exposure for the product this weekend with 9 million people, you know, watching that race.
Speaker 3: Please stand by for our next question. Our next question comes from Jeff Hung with Morgan Stanley . Your line is now open.
Speaker 6: Thanks for taking my question. Last year you cut back on SGA and expenses. I guess with the positive clear outcomes data at hand, how are you thinking about spending on sales? Do you need to ramp that back up to meet expected demand from physicians and patients or to increase that for additional educational efforts?
Speaker 5: Yeah, maybe I can share it and I'll turn it over to Ben. We have, first of all, we've said, you know, a couple of times now that obviously with the clear study, you know, ending that this would be a pivotal point for us would be an inflection point for the organization and these products. Right now today we only have 60 representatives out there, six zero, somewhere between 60 of them.
Speaker 6: Yeah, so we'll put full guidance out again as part of our ACC presentation and press release. You know, I think a lot of the SG&A activities that we're looking at, including will come kind of later on in the year. And I'd also like to remind everyone that we have a 14,000 patient outcomes trial coming off the books. So I think when you look at total company spend, we're at a very healthy rate, and I don't see that changing. So right now, to, to end talking, what we're looking at most is what could become of last year. And, you know, changing that ethic of come 99 or something, ways that I think it might
Speaker 6: significantly next year. You know, we have been very meaningfully managing our cash last year, and we plan on continuing doing that into this next year. So, I don't really see that changing too significantly, even with an increase in the SG&A. Great. Thank you. Please stand by for our next question.
Speaker 3: Our next question comes from Tom Schrader with BTIG. Your line is now open.
Speaker 5: Good morning thank you for taking the call. You mentioned the scaling of sales. I guess my question is do you know what you're going to do now or are you waiting for a reaction?
Speaker 5: Other than NBRX, where do you look for a reaction, particularly in generalists? How do you know that these people have started to care about the drugs, the drugs? What are your early signs? Thank you. Eric, do you want to take that? Yeah, absolutely. Good morning, Tom. Thanks for your question. So right now we're in the midst of a segmentation process and that's really important for us. So what we're doing is we've been exposing HCPs to our current profile.
Speaker 5: and then to a potential post-CBOT profile. That gauges HCP's receptivity towards the changes that we'll be making in the TPP target product profile for our brands and ultimately their potential interest in prescribing. I will aggregate all that math that we do. We'll determine the right HCPs based upon that receptivity to the future profile and the right quantity where we reach that kind of tipping point, if you will. So that's what we're doing. That will ultimately yield a size and then we'll start putting the plans in place to realize that size. So in advance of the label change, we've got the folks in the field ready to go.
Speaker 5: Okay. Can you give us a sense of how predictive these conversations are? My experience is that physicians love everything beforehand, but it doesn't always translate. What gives you a sense that you will translate? I look at other models. I look at other measures that they utilize, and those shares are pretty consistent. So, I feel very hopeful, Tom, based upon the profiles we're putting forward. Okay. Great. Thank you.
Speaker 3: Please stand by for our next question. Our next question comes from Jessica Fye with JP Morgan. Your line is now open. Great. Good morning, guys. Thanks for taking the question. Two for me. First, can you share your latest thoughts on the cash runway and how you're thinking about funding the next leg of growth for Nexletol?
Speaker 5: And second, can you talk about how you're thinking about the competitive landscape as it relates to non-statin LDL-lowering therapies such as Merck's oral PCSK9? And can you remind us where you are with your own oral PCSK9 efforts? Thank you. Yep. This will be a trifecta of an answer. Ben, if you want to go first, and then I'll make some comments around competitive landscape, and then Joanna can also speak to it. Go ahead, Ben.
Speaker 6: Yeah, thanks, Jess. So as far as our cash runway, you know, I've said time and time again, I think we're very happy with how we've managed cash and gotten that burn rate into a manageable number. Yeah, I think as we approach ACC, you know, that presents a large catalyst opportunity for us and we're looking to do something to bring capital into the company. I will say what that looks like. We are very open and I would say optionality is what we're approaching it with. We have not locked in any plan at this point. You know, I think even if we did nothing, we would have enough cash to last us through 2023. You know, but we are looking to do something that would bridge us to those milestone payments that we mentioned.
Speaker 6: Yes. So as far as our cash runway, you know, I've said time and time again, I think we're very happy with how we've managed cash and gotten that burn rate into a manageable number. Yeah, I think as we approach ACC, you know, that presents a large catalyst opportunity for us and we're looking to do something to bring capital into the company. I will say what that looks like, we are very open and I would say optionality is what we're approaching it with. We have not locked in any plan at this point. You know, I think even if we did nothing, we would have enough cash to last us through 2023. You know, but we are looking to do something that would bridge us to those milestone payments that we mentioned earlier.
Speaker 5: Great. Thanks, Ben. Regarding the competitive landscape, Jess, something we're always looking at, obviously there's a couple products out there. There's Obacetrapib, which is a CETP inhibitor from New Amsterdam. There's the Merck oral PCSK9. In a nutshell, these drugs are essentially five to seven years away. Our product is available now. We have an outcome study that's going to be available in 11 days. We'll see what happens with drugs like Obacetrapib. If you look at, I remember even the first CETP inhibitor, Toracetrapib, at the time I was at Merck. We had a non-flushing niacin that we were looking at. My goodness, we're going to have to compete against this Toracetrapib. The effects are amazing, et cetera. Then the 11th hour, they had an off-target aldosterone effect. The drug never came to fruition. As it is, the non-flushing niacin at Merck also never came to fruition. We're operating in here and now. I will say there's a reason why companies want to go from an injectable PCSK9 to an oral PCSK9 because patients don't want to use an injectable. They're just not desirable.
Speaker 5: And again, that's the benefit of Bempedoic Acid. You heard Joanne speak about, what's next in prescribing therapy after statin, it's going to be next was all this thought and next was that. So I can only worry about right now the products that are out there. That's what we are competing against or working with. There's a lot of business out there and it remains to be seen these other products, if they make it, that they have a much longer way to go. Joanne, your thoughts? Yeah, thank you, Sheldon. Thank you, Jeff, for the question. Obviously, I think with outcomes data, we really...
Speaker 4: now much earlier in the treatment pathway and much better positioned from a competitive perspective. I think what's important, whether we think about Merck's oral PCSK9 development program or CETP, as Sheldon mentioned, there's a long road ahead. And I think that when we look at the oral PCSK9 programs, I think it really speaks to the fact that injectable PCSK9s have really underperformed. They've underperformed scientifically with respect to the pathway. I think some may have suggested that that's because they don't affect inflammation. And so we'll have to see with Merck. The results so far are quite good and impressive with respect to LDL lowering, but they will present—and I look forward to the results at ACC, their Phase IIb dose-finding study in patients at risk. But again, we already have outcomes. We have climbed that very long, hard arduous hill to get there.
Speaker 4: And we believe we have a competitive advantage with the profile of our drugs today. We have our own oral PCSK9 inhibitor that, in contrast to Merckx, is not a peptide, is a small molecule based on allosteric inhibition with presumably much better COGS. But we also recognize, being in this space, that one of the main issues with PCSK9s, whether oral or injectable, has been the COGS, right, and how that fits. So we're well aware.
Speaker 5: And we look forward to Merck's results. And that should inform our development program, which right now is pre-IND. Great. Thank you. Please stand by for our next question. Our next question comes from Judith Ramer with Credit Suisse. Your line is now open. Hi. Good morning, guys. Thanks for taking the question. Just a couple to follow up on the survey that Eric mentioned. I'm just curious if the DAS surveyed, is there a lack of awareness on Bepidolic acid? Does it seem like they're aware of the LDL lowering, but they're waiting on outcomes data? Is there potentially a reimbursement?
Speaker 6: T data really did ignite a significant change. As far as where, as Joanne mentioned, next. So next treatment after sentence is really where the positioning is likely to land based upon what we've seen in this research.
Speaker 5: And that really is consistent across the primary and secondary prevention based upon this unique and distinct trial, which included patients again that were at risk or had established cardiovascular disease. Please stand by for our next.
Speaker 3: question. Our next question comes from Paul Chao with Goldman Sachs. Your line is now open.
Speaker 6: Hi, good morning and thank you for taking our questions. We have two. The first is for Sheldon and Joanne. With regard to the presentation at ACC, can you maybe comment on any subgroup analyses, whether diabetics or whatever population that might be included that you'll be presenting and how you're potentially thinking about the shape of the label in the US and Europe and potential inclusion of specific claims for these subpopulations? And my second question is, has your European partner, Gai Chi San Quio, sort of indicated maybe how the...
Speaker 5: the data so they do know what the data is and as it relates to them and the work that they're doing. So they're going to continue to file in different countries and expand their launch. We know like the latest country that they launched in with Spain, they also will be in Taiwan. The quality, the performance of all of our raw uh basic systems is much greater based
Speaker 5: excuse me, in Vietnam. And they have been doing quite well and the markets are already launched on. They've already had somewhat of a large team, over 300 people over there. They also co-promote a drug called Civesa, which is essentially a Doxaban, which is a DOAC, which is actually the market leading DOAC in Germany. So they always have a high call point overlap with their target audience right at the time of launch, which has helped them to be successful. But they are really committed to this product. They're really committed to making it a success. We work with them. We have a joint commercialization team as well. And the staff that they have, which is a big one, is ready to go.
Speaker 4: upon label change. We do the label submission for them, but of course, you know, we're coordinated with them. Joanne, do you want to speak to the presentation at ACC? Yeah, sure, Sheldon. Thank you, Paul, for the question. So, our presentation at ACC is only 12 minutes, and because of that, really, it'll focus predominantly on the totality of the results across the primary and key secondary endpoints. Just know that we have multiple planned presentations and publications over the course of the next year, amounting to almost eight or nine presentations that'll be coming up that'll address some of these sub analyses. Also, we look forward to chatting with regulators prior to the ACC and sharing our top line. So, again, we will have more information for you in the subsequent months with respect to the presentation.
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