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spk34: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star one one.
spk31: 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 Aldrich, Associate Director, Corporate Communications at Asperian. Please go ahead, Tiffany.
spk05: Thank you. Good morning, and welcome to Asperion's 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 Asperion. 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, February 21st, 2023. 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 time to speak with the team. With us today are Sheldon Koenig, President and CEO, Dr. Joanne Foody, Chief Medical Officer, Ben Halliday, Chief Financial 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?
spk22: 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 Espirion. 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. And as such, we will keep today's remarks brief. We'll be able to provide more visibility on our plans and full year 2023 financial guidance after this important presentation for the company. We generated $15 million in U.S. net sales in the fourth quarter 2022, a 23% increase versus fourth quarter 2021. U.S. net 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. We are proud of these results and believe that we have a strong commercial infrastructure that is poised to expand and deliver significant franchise growth. Since the release of the positive top line clear results, we have had active outreach from payers and formulary decision makers already, resulting in significant wins with appropriate use criteria. Recent formulary additions at Tufts, Summa Healthcare, and Kinetic Care have expanded our access and reimbursement to help more patients reach their LDL-C goal. We established a scientific advisory board comprised of world-renowned experts to support our pipeline and lifecycle management efforts and we welcome Ben Halliday as our CFO. Internationally, our partner, Daiichi Sankyo, has demonstrated robust, persistent growth for the Nexotol and Nexoset 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. This includes appropriately building awareness of our clear outcomes results amongst doctors and patients and advancing our global regulatory filings to enable the company to collect milestone payments from our partners. Lastly, we are positioning the company for long-term growth by advancing our innovative pipeline assets and also maximizing the blockbuster opportunity for benbedoic acid. As I mentioned earlier, in 11 days, we are very excited to be presenting detailed results from our landmark CLEAR Outcomes Trial, which will demonstrate the cardiovascular risk reduction benefits of benfidoic acid. These practice-changing results will be discussed as the first late-breaking clinical trial by Dr. Nissen at ACC and published simultaneously in a top-tier medical journal. The positive results from the CLEAR Outcomes Study will have laid the foundation to reach our blockbuster sales potential. Plans are underway for the scaling of our commercial organization and the transition from our focused promotional approach to our future selling model, including positioning, targeting, messaging, and creative campaigns. 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 first half 2024. 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.
spk25: 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. U.S. net product revenue for the fourth quarter ended December 31, 2022, with $15 million, up 23% year-over-year, and $55.9 million for the 12-month 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. Our partner, Daiichi Sankyo, continues to report strong Nalemdo and Newstendi growth in their European territories with over 82,000 patients in the month of November 2022. As of December 31st, 2022, cash, cash equivalents, restricted cash, and investment securities available for sale totaled $166.9 million compared with $309.3 million on December 31st, 2021. Royalty revenue for the fourth quarter ended December 31, 2022, was $2.3 million, up 188% year-over-year, and $6.5 million for the 12 months ended December 31, 2022, up 81% year-over-year. Combined royalty and partner revenue was $3.9 million for the fourth quarter ended December 31st, 2022, an increase of approximately 22% year over year, and $19.6 million for the 12 months ended December 31st, 2022, a decrease of 49% year over year. 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 group. Finally, total revenue for the fourth quarter ended December 31, 2022, was $18.8 million, an increase of 22% year-over-year, and $75.5 million for the 12 months ended December 31, 2022, a decrease of 4% year-over-year. The decrease for the 12 months ended December 31, 2022, due to the aforementioned one-time milestone payment. Turning to expenses. R&D expenses for the fourth quarter 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. SG&A expenses were $24.1 million for the fourth quarter ended December 31, 2022, a decrease of 37% year-over-year, and $109.1 million for the 12 months ended December 31, 2022, a decrease of 41% 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.
spk22: 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 outcome study, we did what we said we would do. Throughout 2023, we will continue to ensure the data from clear outcomes serves as the catalyst for greater access to improve 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.
spk21: Operator, we are now ready for Q&A.
spk31: To ask a question, please press star 11 on your telephone and please wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Serge Balaget with Needham. Your line is now open.
spk30: Hi, good morning. Hi, Serge.
spk04: Hi. First one for Sheldon. I think you've been pretty consistent since December that this data set is statistically significant and clinically meaningful. 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? How do you think that changes?
spk22: Hi, Serge. Let me start and then I'll turn it over to Joanne Foodie 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 it for 34 years. And we've all seen many studies report out saying that they're clinically meaningful. We came out and we said that our study was positive. It was statistically significant at the primary endpoint, even across several 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 a way that they prescribe these types of lipid-lowering drugs, such as Nexlatol and Nexlazet. So, we've also have used the term practice changing. Because we do believe in the paradigm of treating LDL or bad cholesterol that 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 also have an effect on glucose. And that's something that our competition essentially does not have. So there's a lot of different things about benpidoic acid and even in the uniqueness of the study in itself. So we feel, again, that, you know, this is something that's going to be very meaningful in the practice of medicine. Joanne?
spk06: 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, and I would hope the investment community would do the same when they look at results, it's not a single number. It's the totality of the results. It's the importance of the unmet needs, and it's the importance of the question. So let me frame maybe the importance and meaningfulness as I think about it. As Sheldon mentioned, this will lead off the American College of Cardiology World Congress of Cardiology late breaking session with a simultaneous publication in the top tier journal. That speaks to the meaningfulness and clinical relevance of the study. Another point, benpidoic acid the compound in both Nexlatol and Nexlazet, will be the first LDL-lowering therapy since statin to decrease hard ischemic events in both primary and secondary prevention patients. That's the population studied in clear outcomes. Remember that PCSK9 inhibitors did not study this large population and were limited to ASCVD patients. Another point, 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. 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, you will see in 11 days that clear outcomes results, along with the totality of the CLEAR program, will position both Nexlatol and Nexlozet 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.
spk22: And I'd like to have Eric make a few comments about the research that we've conducted. Eric, thank you, Joanne.
spk17: 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 250 clinician quantitative market research project. looking at both current prescribers as well as non-prescribers of Nexotol and Nexozet. And the goal was to really assess the impact of potential CBOT data on willingness to prescribe as well as market share. Confirming everything that Joanne said, the primary key secondary endpoints, MACE4 and MACE3, as well as all the additional secondary endpoints evaluated or deemed clinically meaningful. I think it's important to say that 95% of clinicians, after being exposed to these data, said that they would prescribe Nexatol and Nexoset. Interestingly, non-prescribers to date said they would now prescribe for both primary and secondary prevention patients, and current prescribers would significantly increase their utilization for both primary and secondary prevention.
spk08: So, I'll turn it back to Sheldon.
spk31: Thanks, Eric.
spk21: All right, next question.
spk31: Please stand by for our next question. Our next question comes from Joseph Tom with Cohen. Your line is now open.
spk27: 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 payer coverage and then treatment guidelines, Will these also take into account C-reactive protein and glucose control in the overall package, or is it largely driven by MACE4 risk reduction? Thanks.
spk22: Joanne, do you want to start with HSCRP and education? I'll address just as it relates to HSCRP and payer.
spk06: Excellent. Excellent. Thank you, Joe. Thank you for the question. So, we, again, believe that Bempadolic acid is the first ATP citrate lyse inhibitor, has very unique properties. And like statins, reduces HSCRP and inflammation and markers of inflammation. But not like statins actually does not 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 pleiotrophic effects of statins were really critical 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 that looks to explore the relationship of LDL cholesterol inflammatory marker reduction and outcomes. As far as label 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. 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, do you want to cover the payer aspect?
spk22: Yeah, thanks, Joanne. Joe, as it relates to payers, so 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 these presentations, we really kind of reset up, if you will, our medical affairs group. 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. 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 in anticipation of the clear outcome study where the azetamide step edit, which used to be a headwind for us, this is agnostic of HSCRP lowering, they've been actually removed from the prior authorization process. So it's already, you know, we're getting some clear wins even before the actual presentation of the data. And one last thing there. 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. Thanks, Joe.
spk31: Please stand by for our next question. Our next question comes from Michael Yee with Jefferies. Your line is now open.
spk13: Hey, good morning, guys. Thanks for the question. We had maybe two questions. One was in the definition of practice changing, how do you think about the scenarios? In other words, the primary endpoint, the importance of the primary endpoint, 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.
spk24: Thanks, Mike. Joanne, do you want to take that first question?
spk06: Thanks, Mike. Thanks for the question. So, as we think about the various scenarios, right, in the primary versus the key secondary endpoints, I think what's important to recognize is, you know, our primary, MACE4, as you're well aware, MACE4 includes coronary revascularization, which some folks might think is a more biased endpoint as a component of that composite of MACE4. 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 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 4, but then within that, the absolute risk reduction. With all cardiovascular outcome studies, there's a hierarchy of endpoints that we go through. And as you'll see at ACC, the robustness of these results include several key secondary endpoints. So, we think about it again in the totality of those results and the interpretation of all the numbers.
spk22: Ben, you want to speak to the milestones?
spk25: Yeah. Thanks, Mike. So, turning the milestones, as a reminder, the criteria for those is that the milestones are due upon inclusion of cardiovascular endpoints in the European label. Remind of the scale, you know, from with Daichi Sankyo, the 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 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.
spk10: Got it. Super helpful. Thanks, guys.
spk31: Please stand by for our next question. Our next question comes from Jason Butler with JMP Securities. Your line is now open.
spk14: 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 outcome was announced, any changes in prescriber practice, you know, happening before the data are presented, either current prescribers increasing or broadening their use or new prescribers becoming active? Thanks.
spk17: Yeah, I'll mention one key metric, Jason, that we keep a close eye on, and that's NBRX. 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. Great. Thanks for taking the question.
spk22: Looking forward to seeing the data. Jason, just one fun note for anyone watching. You know, we had the Daytona 500 this past weekend, and we sponsored the number six car, the next Lizette car, which led almost the entire race. Our pickup on that as it relates to website activity, et cetera, was like 100 times that we've ever seen before people wondering, asking what an expo that is, et cetera. But just a fun fact and a lot of exposure for the product this weekend with 9 million people watching that raise.
spk31: Please stand by for our next question. Our next question comes from Jeff Hung with Morgan Stanley. Your line is now open.
spk26: Thanks for taking my question. Last year you cut back on SGN 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?
spk22: Yeah, maybe I can start and I'll turn it over to Ben. We have, first of all, I think you asked We've said a couple of times now that obviously with the clear study 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, 6-0, somewhere between 60 and 65, who are actually selling more than the 300 that we had out there before. But with that said, And moving forward, we do see that we will be expanding our sales force later in 2023 in anticipation of our label from a 2024 perspective. Ben, any additional comments?
spk25: 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 significantly next year. You know, we've 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.
spk29: Thank you. Please stand by for our next question.
spk31: Our next question comes from Tom Schrader with BTIG. Your line is now open.
spk15: 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? And 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? What are your early signs? Thank you. Eric, do you want to take that?
spk17: 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 and then to what 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. We'll 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.
spk15: 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 know, you will translate.
spk17: I look at other markets that they utilize, and those shares are pretty consistent. So I feel very hopeful, Tom, based upon the profiles we're putting forward.
spk15: Okay, great. Thank you.
spk31: Please stand by for our next question. Our next question comes from Jessica Fye with JP Morgan. Your line is now open.
spk03: 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 Nexatol? 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 PCFK9? And can you remind us where you are with your own oral PCFK9 efforts? Thank you.
spk22: Yep. This will be a – hey, Jess, 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 Joanne can also speak to it. Go ahead, Ben. Yeah, thanks, Jess.
spk25: 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. Um, 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. Uh, we have not locked in any plan at this point. Um, I think even if we did nothing, we would have enough cash to last us through 2023. But we are looking to do something that would bridge us to those milestone payments that we mentioned earlier.
spk22: Great. Thanks, Ben. Regarding the competitive landscape, Jess, something we're always looking at, obviously, there's a couple of products out there. There's Obacetrapib, which is a CETP inhibitor from New Amsterdam. There's the Merck Oral PCSK9. You know, in a nutshell, these drugs are essentially, you know, 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 Obacetrapid. If you look at, I remember even the first CETP inhibitor, Torsetrapid, at the time I was at Merck, and we had a non-flushing niacin that we were looking at. My goodness, we're going to have to compete against this. and the effects were amazing, et cetera. And then the 11th hour, they had an off-target aldosterone effect, and the drug never came to fruition. As it is, the non-flushing niacin and Merck also never came to fruition. So we're operating in the 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. And, you know, again, that's the benefit of benpidoic acid. You heard Joanne speak about, you know, what's next in prescribing therapy after a statin. It's going to be Nexazol, Nexazol, and Nexazet. 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, you know, these other products, if they make it. They have a long, they have a much longer way to go. Joanne, your thoughts?
spk06: Yeah, thank you, Sheldon. Thank you, Deb, for the question. You know, obviously, I think with outcomes data, we really position 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 PCSK9 development program or CETP, as Sheldon mentioned, there's a long road ahead, right? And I think that, you know, 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 2B 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. 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 Merck's, is not a peptide, is a small molecule based on allosteric inhibition with presumably much better cause. But we also recognize, being in this space, that one of the main issues with PCSK9s, whether oral or injectable, has been the cause. right, and how that fits. So, we're well aware, and we look forward to Merck's results, and that should inform our development program, which right now is pre-IND.
spk29: Great. Thank you. Please stand by for our next question.
spk31: Our next question comes from Judah Frommer with Credit Suisse. Your line is now open.
spk19: Hi, good morning, guys. Thanks for taking the question.
spk18: Just a couple to follow up on the survey that Eric mentioned. I'm just curious if, you know, the DOF surveyed, is there a lack of awareness on bepidoic acid? Does it seem like they're aware of the LDL lowering, but they're waiting? on outcomes data? Is there, you know, potentially a reimbursement dynamic that they're waiting for it to change? And then, secondarily, have they indicated what types of patients they would potentially move benpidoic acid up for in their prescription paradigm? Are they max-tolerated statin, statin-intolerant patients, or any other detail you have there? Thank you.
spk17: Yeah, thanks, Judah. Thanks for the question. So, awareness is still lower than we would like to be, but obviously there's good reason for that based upon our scaled back, if you will, promotional efforts. In this research, we did expose them to our current profile, and just seeing or being exposed to our profile did create some favorable impact. But as mentioned, the CBOT data really did ignite significant change. As far as where, as Joanne mentioned next, So, next treatment after statins is really where the positioning is likely to land based upon what we've seen in this research. 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. Thank you.
spk31: Please stand by for our next question. Our next question comes from Paul Chow with Goldman Sachs. Your line is now open.
spk09: 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, you know, subgroup analyses, whether diabetics or whatever population that might be included that you'll be presenting and, you know, how you're potentially thinking about the shape of the label in the U.S. and Europe and potential inclusion of specific claims for these subpopulations? And my second question is, has your European partner, Daichi Sankyo, sort of indicated maybe how they're thinking about resourcing and bandwidth and, you know, increasing intensity of promotional efforts starting next year after the CV label is added to the MAA filing. Thank you very much.
spk22: Hey, Paul. And for the operator, it's Paul Choi. Sorry about that, Paul. Let me answer the second question. Turned over to Joanne for the first. So, first, I just wanted to state, you know, at the time of JP Morgan, we were also asked the question of have our partners, have they seen the data yet? And our partners, Daiichi Sankyo, they have seen 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 was Spain. They also will be in Taiwan, 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 Cevesa, which is essentially a Doxaban, which is a DOAC, which is actually the market-leading DOAC in Germany. So they always have a 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 upon label change. We do the label submissions. for them, but of course, you know, we're coordinated with them. Joanne, do you want to speak to the presentation at ACC?
spk06: 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 potential for the label. But in general, Paul, we are looking to a broadly expanded label, as we mentioned, in a population that was studied in clear outcomes across both primary and secondary prevention. And we'll share in the simultaneous publication some of the subgroups I think you're interested in.
spk11: Thank you.
spk31: At this time, there are no further questions. This concludes today's conference call. Thank you for participating. You may now disconnect.
spk34: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 11. The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1 1 1. The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1 1. I'm going to take a quick look at this. Thank you. Thank you. Thank you.
spk31: 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 Aldrich, Associate Director, Corporate Communications at Asperian. Please go ahead, Tiffany.
spk05: Thank you. Good morning, and welcome to Asperion's fourth quarter and full year 2022 financial results and company update conference call. I'm Tiffany Eldridge, and I'm part of corporate communications here at Asperion. 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, February 21st, 2023. 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 time to speak with the team. With us today are Sheldon Koenig, President and CEO, Dr. Joanne Foody, Chief Medical Officer, Ben Halliday, Chief Financial 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?
spk22: 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 Asperion. 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. And as such, we will keep today's remarks brief. We'll be able to provide more visibility on our plans and full year 2023 financial guidance after this important presentation for the company. We generated $15 million in U.S. net sales in the fourth quarter 2022, a 23% increase versus fourth quarter 2021. U.S. net 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. We are proud of these results and believe that we have a strong commercial infrastructure that is poised to expand and deliver significant franchise growth. Since the release of the positive top line clear results, we have had active outreach from payers and formulary decision makers already, resulting in significant wins with appropriate use criteria. Recent formulary additions at Tufts, Summa Healthcare, and Kinetic Care have expanded our access and reimbursement to help more patients reach their LDL-C 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. Internationally, our partner, Daiichi Sankyo, has demonstrated robust, persistent growth for the Nexotol and Nexoset 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. This includes appropriately building awareness of our clear outcomes results amongst doctors and patients and advancing our global regulatory filings to enable the company to collect milestone payments from our partners. Lastly, we are positioning the company for long-term growth by advancing our innovative pipeline assets and also maximizing the blockbuster opportunity for benpidoic acid. As I mentioned earlier, in 11 days, we are very excited to be presenting detailed results from our landmark CLEAR Outcomes Trial, which will demonstrate the cardiovascular risk reduction benefits of benpidoic acid. These practice-changing results will be discussed as the first late-breaking clinical trial by Dr. Nissen at ACC and published simultaneously in a top-tier medical journal. The positive results from the CLEAR outcome study will lay the foundation to reach our blockbuster sales potential. Plans are underway for the scaling of our commercial organization and the transition from our focused promotional approach to our future selling model, including positioning, targeting, messaging, and creative campaign. 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 first half 2024. 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.
spk25: 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. U.S. 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. Our partner, Daiichi Sankyo, continues to report strong Nalemdo and Newstendi growth in their European territories with over 82,000 patients in the month of November 2022. As of December 31st, 2022, cash, cash equivalents, restricted cash, and investment securities available for sale totaled $166.9 million compared with $309.3 million on December 31st, 2021. Royalty revenue for the fourth quarter ended December 31, 2022, was $2.3 million, up 188% year-over-year, and $6.5 million for the 12 months ended December 31, 2022, up 81% year-over-year. Combined royalty and partner revenue was $3.9 million for the fourth quarter ended December 31st, 2022, an increase of approximately 22% year over year, and $19.6 million for the 12 months ended December 31st, 2022, a decrease of 49% year over year. 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 group. Finally, total revenue for the fourth quarter ended December 31, 2022, was $18.8 million, an increase of 22% year-over-year, and $75.5 million for the 12 months ended December 31, 2022, a decrease of 4% year-over-year. The decrease for the 12 months ended December 31, 2022, due to the aforementioned one-time milestone payment. Turning to expenses. R&D expenses for the fourth quarter 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. SG&A expenses were $24.1 million for the fourth quarter ended December 31, 2022, a decrease of 37% year-over-year, and $109.1 million for the 12 months ended December 31, 2022, a decrease of 41% 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.
spk22: 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 outcome study, we did what we said we would do. Throughout 2023, we will continue to ensure the data from clear outcomes serves as the catalyst for greater access to improve 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.
spk21: Operator, we are now ready for Q&A.
spk31: To ask a question, please press star 11 on your telephone and please wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Serge Balaget with Needham. Your line is now open.
spk30: Hey, good morning. Hi, Serge.
spk04: All right. First one for Sheldon. I think you've been pretty consistent since December that this data set is statistically significant and clinically meaningful. 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? How do you think that changes?
spk24: Hi, Serge.
spk22: Let me start, and then I'll turn it over to Joanne Foodie 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 it for 34 years, and we've all seen many studies report out saying that they're clinically meaningful. We came out, and we said that our study was positive. It was statistically significant at the primary endpoint, even across several 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 that the way that they prescribe these types of lipid-lowering drugs, such as Nexlatol and Nexlazet. So, we've also have used the term practice changing, Because we do believe in the paradigm of treating LDL or bad cholesterol that 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 also have an effect on glucose. And that's something that our competition essentially does not have. So there's a lot of different things about benpidoic acid and even in the uniqueness of the study in itself. So we feel, again, that, you know, this is something that's going to be very meaningful in the practice of medicine. Joanne?
spk06: 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, and I would hope the investment community would do the same when they look at results, it's not a single number. It's the totality of the results. It's the importance of the unmet needs, and it's the importance of the question. So let me frame maybe the importance and meaningfulness as I think about it. As Sheldon mentioned, this will lead off the American College of Cardiology World Congress of Cardiology late breaking session with a simultaneous publication in the top tier journal. That speaks to the meaningfulness and clinical relevance of the study. Another point, benpidoic acid the compound in both Nexlatol and Nexlazet, will be the first LDL-lowering therapy since statin to decrease hard ischemic events in both primary and secondary prevention patients. That's the population studied in clear outcomes. Remember that PCSK9 inhibitors did not study this large population and were limited to ASCVD patients. Another point, 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. 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, you will see in 11 days that clear outcomes results, along with the totality of the CLEAR program, will position both Nexlatol and Nexlazet 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.
spk22: And I'd like to have Eric make a few comments about the research that we've conducted. Eric, thank you, Joanne.
spk17: 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 250 clinician quantitative market research project. looking at both current prescribers as well as non-prescribers of Nexotol and Nexodet. And the goal was to really assess the impact of potential CBOT data on willingness to prescribe as well as market share. Confirming everything that Joanne said, the primary key secondary endpoints, MACE4 and MACE3, as well as all the additional secondary endpoints evaluated or deemed clinically meaningful. I think it's important to say that 95% of clinicians, after being exposed to these data, said that they would prescribe Nexatol and Nexoset. Interestingly, non-prescribers to date said they would now prescribe for both primary and secondary prevention patients, and current prescribers would significantly increase their utilization for both primary and secondary prevention.
spk08: So I'll turn it back to Sheldon.
spk31: Thanks, Eric.
spk17: All right, next question.
spk31: Please stand by for our next question. Our next question comes from Joseph Tom with Cohen. Your line is now open.
spk27: 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 payer coverage and then treatment guidelines, Will these also take into account C-reactive protein and glucose control in the overall package, or is it largely driven by MACE4 risk reduction? Thanks.
spk22: Joanne, do you want to start with HSCRP and education? I'll address just as it relates to HSCRP and payer.
spk06: Excellent. Excellent. Thank you, Joe. Thank you for the question. So, we, again, believe that Bempadolic acid is the first ATP citrate lye's inhibitor, has very unique properties. And like statins, reduces HSCRP and inflammation and markers of inflammation. But not like statins actually does not 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 pleiotrophic effects of statins were really critical 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 that looks to explore the relationship of LDL cholesterol inflammatory marker reduction and outcomes. As far as label 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. 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, do you want to cover the payer aspect?
spk22: Yeah, thanks, Joanne. Joe, as it relates to payers, so 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 these presentations, we really kind of reset up, if you will, our medical affairs group. 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. 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 outcome study, where the azetamide step edit, which used to be a headwind for us, this is agnostic of HSCRP lowering, they've been actually removed from the prior authorization process. So it's already, you know, we're getting some clear wins even before the actual presentation of the data. And one last thing there. 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. Thanks, Joe.
spk31: Please stand by for our next question. Our next question comes from Michael Yee with Jefferies. Your line is now open.
spk13: Hey, good morning, guys. Thanks for the question. We had maybe two questions. One was in the definition of practice changing, how do you think about the scenarios? In other words, the primary endpoint, the importance of the primary endpoint, 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.
spk24: Thanks, Mike. Joanne, do you want to take that first question?
spk06: Thanks, Mike. Thanks for the question. So, as we think about the various scenarios, right, in the primary versus the key secondary endpoints, I think what's important to recognize is, you know, our primary, MACE4, as you're well aware, MACE4 includes coronary revascularization, which some folks might think is a more biased endpoint as a component of that composite of MACE4. MACE 3 has typically been the hard ischemic endpoint, 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 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 4, but then within that, the absolute risk reduction. With all cardiovascular outcome studies, there's a hierarchy of endpoints that we go through. And as you'll see at ACC, the robustness of these results are, includes several key secondary endpoints. So, we think about it again in the totality of those results and the interpretation of all the numbers.
spk22: Ben, do you want to speak to the milestones?
spk25: Yeah. Thanks, Mike. So, turning the milestones, as a reminder, the criteria for those is that the milestones are due upon inclusion of cardiovascular endpoints in the European label. Remind of the scale, you know, from with Digest Bank, they 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 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.
spk10: Got it. Super helpful. Thanks, guys.
spk31: Please stand by for our next question. Our next question comes from Jason Butler with JMP Securities. Your line is now open.
spk14: 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 outcome was announced, any changes in prescriber practice, you know, happening before the data are presented, either current prescribers increasing or broadening their use or new prescribers becoming active? Thanks.
spk17: Yeah, I'll mention one key metric, Jason, that we keep a close eye on, and that's NBRX. 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. Great. Thanks for taking the question.
spk22: Looking forward to seeing the data. Jason, just one fun note for anyone watching. You know, we had the Daytona 500 this past weekend, and we sponsored the number six car, the next Lizette car, which led almost the entire race. Our pickup on that as it relates to website activity, et cetera, was, you know, like 100 times that we've ever seen before people wondering, asking what an expo that is, et cetera. But just a fun fact and a lot of exposure for the product this weekend with 9 million people, you know, watching that race.
spk31: Please stand by for our next question. Our next question comes from Jeff Hung with Morgan Stanley. Your line is now open.
spk26: Thanks for taking my question. Last year you cut back on SGN expenses. I guess with the positive clear outcomes data at hand, how are you thinking about spending on sales? You know, do you need to ramp that back up to meet expected demand from physicians and patients or to increase that for additional educational efforts?
spk22: Yeah, maybe I can start and I'll turn it over to Ben. We have, first of all, I guess, We've said a couple of times now that obviously with the clear study 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, 6-0, somewhere between 60 and 65, who are actually selling more than the 300 that we had out there before. But with that said, And moving forward, we do see that we will be expanding our sales force later in 2023 in anticipation of our label from a 2024 perspective. Ben, any additional comments?
spk25: 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 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.
spk29: Thank you. Please stand by for our next question.
spk31: Our next question comes from Tom Schrader with BTIG. Your line is now open.
spk15: 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? And 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? What are your early signs? Thank you. Eric, do you want to take that?
spk17: 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 and then to what a potential post-CVOT 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. We'll 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.
spk15: 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 know, you will translate?
spk17: I look at other markets 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.
spk31: Please stand by for our next question. Our next question comes from Jessica Fye with JP Morgan. Your line is now open.
spk03: 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 Nexatol? 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.
spk22: Yep. This will be a – hey, Jess, this will be a trifecta of an answer. Ben, if you want to go first, and then I'll make some comments around competitive landscapes, and then Joanne can also speak to it. Go ahead, Ben. Yeah, thanks, Jess.
spk25: 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. Um, 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. Uh, we have not locked in any plan at this point. Um, I think even if we did nothing, we would have enough cash to last us through 2023. But we are looking to do something that would bridge us to those milestone payments that we mentioned earlier.
spk22: 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. You know, in a nutshell, these drugs are essentially, you know, 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 Obacetrapid. If you look at, I remember even the first CETP inhibitor, Torsetrapid, at the time I was at Merck, and we had a non-flushing niacin that we were looking at. My goodness, we're going to have to compete against this and the effects were amazing, et cetera. And then the 11th hour, they had an off-target aldosterone effect, and the drug never came to fruition. As it is, the non-flushing niacin and Merck also never came to fruition. So we're operating in the 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. And, you know, again, that's the benefit of benpidoic acid. You heard Joanne speak about, you know, what's next in prescribing therapy after a statin. It's going to be Nexazol, Nexazol, and Nexazet. 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, you know, these other products, if they make it, they have a much longer way to go. Joanne, your thoughts?
spk06: Yeah, thank you, Sheldon. Thank you, Jeff, for the question. You know, obviously, I think with outcomes data, we're really positioned 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 PCSK9 development program or CETP, as Sheldon mentioned, there's – there's a long road ahead, right? And I think that, you know, 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 2B 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. 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 Merck's is not a peptide, is a small molecule based on allosteric inhibition with presumably much better cause. But we also recognize being in this space that one of the main issues with PCSK9s, whether oral or injectable, has been the cause, right, and how that fits. So, we're well aware, and we look forward to Merck's results, and that should inform our development program, which right now is pre-IND.
spk29: Great. Thank you. Please stand by for our next question.
spk31: Our next question comes from Judah Frommer with Credit Suisse. Your line is now open.
spk19: Hi. Good morning, guys. Thanks for taking the question.
spk18: Just a couple to follow up on the survey that Eric mentioned. I'm just curious if, you know, the DOF surveyed, is there a lack of awareness on Bepidoic Acids? Does it seem like they're aware of the LDL lowering, but they're waiting? on outcomes data? Is there, you know, potentially a reimbursement dynamic that they're waiting for it to change? And then, secondarily, have they indicated what types of patients they would potentially move benpidoic acid up for in their prescription paradigm? Are they max-tolerated statin, statin-intolerant patients, or any other detail you have there? Thank you.
spk17: Yeah, thanks, Judah. Thanks for the question. So, awareness is still lower than we would like to be, but obviously there's good reason for that based upon our scaled back, if you will, promotional efforts. In this research, we did expose them to our current profile, and just seeing or being exposed to our profile did create some favorable impact. But as mentioned, the CBOT data really did ignite significant change. As far as where, As Joanne mentioned, next, so next treatment after statins is really where the positioning is likely to land based upon what we've seen in this research. 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. Thank you.
spk31: Please stand by for our next question. Our next question comes from Paul Chow with Goldman Sachs. Your line is now open.
spk09: 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 U.S. and Europe and potential inclusion of specific claims for these subpopulations? And my second question is, has your European partner, Daichi Sankyo, sort of indicated maybe how they're thinking about resourcing and bandwidth and increasing the intensity of promotional efforts starting next year after the CV label is added to the MAA filing? Thank you very much.
spk22: Hey, Paul. And for the operator, it's Paul Choi. Sorry about that, Paul. Let me answer the second question, turned over to Joanne for the first. So first, I just wanted to state, you know, at the time of JPMorgan, we were also asked the question of have our partners, have they seen the data yet? And our partners, Daiichi Sankyo, they have seen 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 the latest country that they launched in was Spain. They also will be in Taiwan, 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 Cevesa, which is essentially a Doxaban, which is a DOAC, which is actually the market-leading DOAC in Germany. So they always have a 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 upon label change. We do the label submissions. for them, but of course, you know, we're coordinated with them. Joanne, do you want to speak to the presentation at ACC?
spk06: 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 plan 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 potential for the label. But in general, Paul, we are looking to a broadly expanded label, as we mentioned, in a population that was studied in clear outcomes across both primary and secondary prevention. And we'll share in the simultaneous publication some of the subgroups I think you're interested in.
spk11: Thank you.
spk31: At this time, there are no further questions. This concludes today's conference call. Thank you for participating. You may now disconnect.
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