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spk08: Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in listen-only mode. Following the presentation, there'll 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 Ben Church, Investor Relations and Corporate Communications at Esperion. Please go ahead, sir.
spk15: Thank you, operator. Good morning and welcome to Esperion's fourth quarter and full year 2021 financial results and company update conference call. I'm Ben Church, and I'm responsible for investor relations and corporate communications here at Experian. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that the 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 22, 2022. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We issued a press release this morning detailing the content of today's call. A copy can be found at www.asperian.com within the investors and media section. We will begin 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 corporate team at asperian.com to schedule time to speak with the team. With us today are Sheldon Koenig, President and CEO of Rick Bartram, CFO, Dr. Joanne Foody, our Chief Medical Officer, Eric Warren, our Head of Sales and Marketing, and Betty Jean Swartz, Senior VP of Market Access, HEOR, and Policy. I'll now turn the call over to Sheldon for prepared remarks. Sheldon?
spk03: Thanks, Ben, and good morning, everyone. Over this past year, the team at Aspirion worked diligently to rebuild a strong foundation and set a course for future success. As a result, we entered 2022 in the position of strength and re-energize for the opportunity that lies ahead. Through our transformational plan announced back in October, we have optimized our business to better align with the current healthcare environment. An extensive review of the organization and return on investment drove our decision to establish a new hybrid commercial model through which we are able to reduce our commercial footprint down to a core sales team of 80 territories while generating $80 million in annualized cost savings, maintaining our ability to drive consistent growth of our medicine and the flexibility to scale up in the future. During this transitional period, sequential demand of our medicines grew 9% in the fourth quarter, with U.S. net product revenue of $12.2 million, up 12% in the same period, and over 200% for full year 2021. These strong results were also the culmination of the enhanced product positioning and refined patient support programs we initiated in 2021. Further, in mid-January of this year, we deployed a contract sales organization on a trial basis to drive awareness among our targeted physicians within the white space between our 80 focus territories. This CSO can also be easily scaled up or down dependent on productivity and is something we view as a cost-effective growth resource. Overall, the results of the fourth quarter give us increased confidence that we'll continue to deliver consistent growth leading up to the top-line readout of the Clear Outcomes Trial in the first quarter of 2023. With the additional $209 million in net proceeds from our December financing, our cash runway now extends beyond this pivotal milestone. With $309 million in cash as of December 31st, Experion is well positioned to execute on its strategy in these current market conditions. More importantly, our unprecedented CLEAR outcomes trial continues to progress unencumbered. The trial reached 90% of its required major adverse cardiac events this February, indicating CLEAR is tracking in line to slightly ahead of expectations. With a top-line readout anticipated in Q1 2023, we are now less than one year away from a major inflection point in our growth trajectory. As such, in addition to executing on our plan to drive commercial growth of Nexlatel and Nexlovet, a major focus of Aspirion for 2022 is successfully closing out the Pivotal Clear Outcomes trial. As a reminder, CLEAR Outcomes is a 14,000-patient randomized outcomes trial, one of the largest outcomes trials of non-statin therapies yet, evaluating benpidoic acid ability to reduce incidence of adverse cardiovascular events in a unique patient population that is unable to adequately address their CV risk with the current standard of care. The trial design was developed in partnership with regulators, and is headed by the world-renowned trialist, Dr. Stephen Nissen. This, along with the size, scale, and scope of the study, gives us great confidence. A positive CVOT not only has the potential to expand our current label indication, but also to be practice-changing for physicians and life-changing for millions of patients around the world. During 2021, Daiichi Sankyo accelerated its commercial launch in Germany while also expanding into the UK and Austria, amassing over 45,000 patients on therapy through December. Even more so, we expanded our partnership with Daiichi to bring benfidoic acid and its combination with ezetimibe to the APAC region. Aspirion continues to evaluate any and all opportunities such as this to accelerate the distribution of our medicines to patients not being treated to LVLC goals. Otsuka, our partner in Japan, continues to progress along its clinical pathway. Its phase two study was initiated in Q1 2021 and was fully enrolled by end of December. While 2022 will be an important year for Aspirion as we prepare for several milestones, it also is critical for the millions of people living with heart disease and those recovering from COVID-19. In 2022, the world hopes to finally see a retreat of the COVID-19 pandemic. However, this devastating disease has taken its toll on global health in longer term and insidious ways. Already the number one killer worldwide, cardiovascular disease was worsened by the COVID-19 pandemic, driving an acceleration of cardiac events and increasing the number of patients at risk. According to a recent study published by Nature Medicine, COVID-19 survivors are left with a 63% higher risk for heart attack and a 52% higher risk of stroke. Study researchers found COVID is an equal opportunity offender, increasing the risk of cardiovascular problems for all people, no matter age, gender, or health status. The time is now more than ever for increased efforts to protect our heart health and as such, we expect a renewed focus from physicians on cardiovascular health and a heightened sense of urgency in getting patients to goal. Nexlatal and Nexlavet are commercially available today to provide the necessary benefits to struggling, indicated patients immediately. As a leading biotech in cardiovascular disease prevention, our focus will remain steadfast on diligently completing the CLEAR Outcomes Trial educating doctors about its implications and continuing to progress our pipeline that includes an oral PCSK9 inhibitor and an ACL inhibitor platform in order to benefit more patients worldwide. I look forward to updating you on our continued progress throughout the year and demonstrating our commitment to innovation for patients. I'll now pass it over to Rick for additional commentary on our quarterly and annual results.
spk17: Rick? Thanks, Sheldon. Earlier today, we issued a press release containing our financial results for the fourth quarter and full year, which is available on our investment website. U.S. net product revenue was $12.2 million for the fourth quarter, up 12% from the third quarter, and $40 million for the full year, up over 200% compared to the prior year. Royalty revenue for the fourth quarter was approximately $800,000, and $3.6 million for the full year 2021. In the fourth quarter, net price for our medicines continued to improve, marginally yielding the benefits from the changes to the copay card program we made during the year. We expect incremental improvements to the net price of our medicines over time as plans fully implement coverage and volumes scale up, with significant opportunity to further improve our net price post clear outcomes results. I would refer you to the press release for additional details on our revenue performance as compared to prior periods. But overall, we're pleased with the growth of our brands over the last quarter and year, despite the disruption in our business that occurred during 2021. Turning to expenses, R&D expense for the fourth quarter totaled approximately $28 million, slightly up from the $25 million during the third quarter due to timing of CBOT related expenses. Full year 2021 R&D expense totaled $106 million, representing a 28% decrease year over year. Selling general and administrative expense for the fourth quarter was approximately $38 million, representing a 2% decrease from the third quarter. And SG&A expense for the full year 2021 was $185 million, down 7% year over year. We continue to anticipate that full year 2022 R&D expenses to be between $100 to $110 million and SG&A expenses to be between $120 to $130 million. These estimates are inclusive of approximately $25 million of non-cash stock-based compensation expense expected to be incurred during this year. Our cash balance as of December 31st was approximately $309 million inclusive of the proceeds from the December equity offering. We are now well capitalized and anticipate that our cash runway expense extends through the anticipated completion and readout of the clear outcomes trial and continues to fund continuing operations for the foreseeable future following those results. Historically, we've demonstrated our commitment to manage our cash expense and strengthen our financial position to ensure the completion of our clear outcomes trial and the continued advancement of the next Latal and next Lizette commercial launch. I'm proud of what our team has been able to accomplish on this front during 2021. With that, I'll turn it back over to Sheldon for closing remarks.
spk03: Thank you, Rick. I'll close with this. a reminder that cardiovascular disease, while already the number one killer across the world, has been worsened by the pandemic and requires immediate action. Post-COVID, more patients are living with cardiovascular disease than ever before, and our medicines have the potential to address this urgent need. We believe Nexlatal and Nexlavet can and will make a difference in the lives of patients around the globe. As February is American Heart Month, I'd like to reiterate the importance of raising awareness around heart disease and proactively taking steps to reduce your LDL cholesterol levels and cardiovascular risk. With the top line results of the CLEAR Outcomes Trial fast approaching and next steps to advance our pipeline insight, our team is energized to execute on our strategy and demonstrate the overall strength of our organization. I would like to thank our colleagues and partners for their continued dedication and hard work to make our vision a reality. Lastly, thank you all for joining today and for your continued support and interest in Aspirion. 2022 is sure to be an exciting year. Operator, we are now ready for Q&A.
spk09: If you would like to ask a question, please press star then one. If your question hasn't answered and you'd like to remove yourself from the queue, press the pound key. Our first question comes from Michael Dye with Jefferies. Your line is open.
spk04: Hey, guys. Good morning. It's Mikey from Jefferies. Can you hear me?
spk03: Hi, Mike. Yes.
spk04: Hey, good morning. We were thinking about the chronology of 2022, 23, and 24. And so far, that 22, you'll finish the outcomes. Q1, 23, you'll get the data. file the data mid-23, and then there's, I guess, an approval in 24. Can you talk about how you would expect scripts and uptick, sales to uptick as you go through that and how important actually getting the label is versus just getting the top-line data and talk about that? Because when we go back to, like, PCSK9, they were sort of alluding to the fact that you kind of need the label because that's where you get the contracts and the data and the publications and all that. And that's really what drives the uptakes. So maybe you could clarify how you think about the importance of just getting the data versus getting the approval and the label. Thank you.
spk03: Great. Thanks, Mike. So first of all, good morning. And just to reiterate, the timing that you denoted in the beginning of your question is absolutely correct. So getting the data is extremely important. As a matter of fact, once we have the data, we can actually go out and speak to payers at the time when we do have data. We don't necessarily need the label to speak to payers. That's important for us because, as we mentioned before, one of the strongest headwinds for us are prior authorizations. And we believe that the data that will come out of the CBOT outcome study will really help minimize those headwinds as it relates to prior authorizations. As it relates to having the data and it being important right away, that's going to be a huge shot of awareness for us. We believe that the study, once it's presented at a major meeting, and again, we mentioned in our prepared remarks, Dr. Steve Nissen is the primary investigator. As you know, Dr. Nissen loves to get behind the podium and talk about the studies that he's behind. And that awareness is really going to, I think, send a message and really bring to the forefront what Nexlazet and Nexlatal can offer. Related to prescriptions and inflection, I'll have Eric comment on that.
spk02: Great. Good morning, Mike. Good to hear your voice. So yeah, I'll just bring it back to your chronology, your timing. So 2022, expect consistent growth from us leading up to clear outcomes. 2023 Q1, clear is revealed at a Congress happening in the first quarter. Expect to see a growth and bump associated with that as well as the publication. And then 2024, we unlock our ability to have broader promotion. So, that's when the sales representatives can communicate to HCPs aligned with label. So, expect the next wave of growth to happen. Good. Thank you.
spk12: Mike? Mike, this is Joanne Foody. From the standpoint of your comment regarding the PCSK9s and how long that took, I think if you may remember, there was a significant delay in the final publication of the results on the order of eight months beyond that. We don't anticipate that. We anticipate a simultaneous presentation and publication as soon as possible, as Sheldon mentioned. And again, that will assist in the dissemination of the results and our opportunity, given our existing label, to increase awareness while we await the final label in 2024, as you mentioned.
spk04: Thank you.
spk09: Our next question comes from Joseph Tome with Cohen and Company. Your line is open.
spk16: Hi there. Good morning, and thank you for taking the questions. The first one, just on the slides themselves, indicates that increasing access is kind of one of the key focus areas. Can you dive into that a little bit more? What can you do ahead of the clear outcomes data to increase access? Are you able to adjust kind of timing or severity of prior authorizations before that point? Is it just getting to more centers? And then second, on the treatment guidelines, I know you previously outlined from low-risk patients to extremely high-risk patients. Is this sort of a light switch that, you know, once you get the label expanded, you're going to get on All these treatment guidelines, is it possible to get on one and not the other? How does that process shake out? Thanks.
spk03: Great. Yes, hi. First of all, hi, Joe. Thank you. So as it relates to prior authorizations and access, let me just start with a summary of access. We actually have very good access for NexlaZet and Nexlatal. Our commercial access is approximately 90%. and our Medicare access is 60%. Even in accounts where we don't have active Medicare contracts, we're actually seeing growth in these accounts as well. They're not denoted in the slides that you see before you on the corporate deck, but it's something that we monitor. As it relates to prior authorizations, we're always looking and working with accounts to see if we can streamline these prior authorizations. I think one of the biggest obstacles for prescribing physicians is remembering that in our current label, patients who have ASCVD must be documented. And physicians are still learning on how to actually provide that documentation on prior authorization. It's really no different that was also found with PCFK9 when they launched. Again, as I mentioned earlier, Once we have the outcome study, that's going to significantly reduce that barrier. But right now, we actively work with accounts and our field teams. All of our field teams have individualized selling plans to the accounts that they deal with in order to help physicians inform them on how to get through these prior authorizations. We also have the support of a third party called Assembia. And Assembia acts as a facilitator to help physicians and their staff also get greater prior authorizations for our product. As it relates to guidelines, I'm going to have Joanne address guidelines.
spk12: Well, thank you. So currently, we are in a significant number of guidelines. However, as you mentioned, right, there's an asterisk, if you will, that we don't have outcome data. We anticipate with outcomes data that the majority of guidelines, important guidelines, whether they be the European Society of Cardiology as well as the American Cardiology and American Heart Association guidelines, those will likely be updated quite quickly. I think to your other comment around expansion, you know, currently we do have a great label for LDL reduction, but it does target patients, as Sheldon mentioned, with ASCVD. and on a background of maximally tolerated statins. With the CVOT, we will likely be able to remove the ASCVD and expand to a population of both primary and secondary prevention, those without existing cardiovascular disease, as well as remove the maximally tolerated statins so we can be a therapy irrespective of statins. We anticipate that in contrast to the PCSK9s, given that we are an oral easily accessible therapy at lower cost, that we would have the opportunity for significant expansion of use, not only based on guidelines, but with our payers and providers as well.
spk16: Perfect. That is very helpful. Thank you very much.
spk09: Our next question comes from Jason Butler with JMP. Your line is open.
spk06: Hi. Thanks for taking the question. You've had a little more than a quarter since you announced the organizational changes. Can you just speak to where you are today in terms of the experience with the hybrid business model and how much data you have that can kind of speak to how you make adjustments to the model throughout 2022?
spk03: Hi, Jason. Good morning. So as it relates to the restructuring that we announced back in October, we've come a long way since then. It doesn't seem that long ago, and maybe it wasn't from a couple of months' perspective. But what I'm proud of as it relates to this organization is we really haven't missed a beat as it relates to our performance and our plan that we're executing. And I say that because, as you remember, we had about a 40% reduction in our workforce. It's highly disruptive. And, you know, typically when you have those types of large events, there's disruption in the field, there's disruption in the organization, et cetera. I think the organization as a whole has done an outstanding job really working together, keeping on track, keeping with our claim that we will, you know, always have consistent growth. keeping on track with our clear outcome study, which we have done. And so it's coming along nicely as it relates to today and how it's all working and what we've seen so far as it relates to the hybrid model. I'll have Eric comment on that.
spk02: Great. Thanks, Jason. And, yeah, so our model consists now of this balanced approach with three prongs. We've got the personal promotion, we've got digital promotion, and we've got peer-to-peer. We made these changes in the beginning to middle part of October, and I'm pleased so far with the results. So Q4, you saw the impact of the model, our ability to deter the disruption and still deliver on our commitment for consistent growth. We have the ability to flex up and down elements of this model. We recently, in the middle of January, deployed the contract sales organization. So far, we're seeing a good level of engagement, as we would expect with that team virtually engaging HCPs. Our digital activities, we've been able to flex and increase. That is composed of several components. And then from a peer-to-peer perspective, we're actually seeing increased in-person peer-to-peer as well as our ability to digitally leverage peer-to-peer. So, so far, so good, Jason.
spk06: Great. Thanks for taking the question.
spk09: Our next question comes from Judah Frummer with Credit Suisse. Your line is open.
spk01: Hi, thanks for taking the question. Just curious as kind of, you know, hopefully this Omicron wave wanes across the U.S., are you seeing or maybe have any anecdotes around return to patients returning to docs offices? Is that impacting Scripps in any way? It seems like it's impacting, you know, sales reps' ability to interact with docs. And then anything, you know, Insights from the Daiichi side in terms of how they're handling kind of return to office, they may be a little bit behind us in some of their territories, but kind of any pent-up demand that they'll be able to get at as people return to offices.
spk03: Hi, Judah. Yeah, I think, you know, most of us believe that the Omicron variant is pretty much dissipated. Hopefully, you know, we put COVID in the rearview mirror for everybody. You know, where we live right now, where we're coming from in Pennsylvania, you know, masks aren't required. California masks aren't required. So, you know, this is continuing to be a trend. We were just on a call yesterday with our sales leader. And he also discussed that, you know, they're seeing more and more folks return to the office, patients, physicians, et cetera. So I do think that, you know, with Omicron dissipating, COVID maybe dissipating, we're seeing this return to the office. And you may recall in my prepared notes, even with the snippet that I mentioned out of Nature magazine, you know, more now than ever, there's so many patients with either long-haul COVID who have, you know, significant cardiovascular issues as well as the patients who've already had cardiovascular issues who were not getting those issues addressed because of COVID. You know, they're afraid to go to their doctors. They're afraid to go to the hospital, et cetera. We do think that, you know, patients will hopefully start readdressing their cardiovascular health. Again, cardiovascular disease is the number one killer in the United States and the world. We have two drugs today, Nexlizet and Nexlital, that can treat and lower LDL cholesterol. And, you know, we're hoping now will be a time that we can make more awareness because of the fact that patients will have more freedom to return to their physician's offices. Eric, anything that you'd want to comment?
spk02: Judah, yeah, I would just say back to the balanced model. So having a balanced model gives us the flexibility to weather spikes in COVID. And can't predict the future, but it's good to know that we've got a model, again, that isn't overly dependent upon in-person personal promotion, but we have the other pillars to help navigate whether spikes happen or not. Great, thanks.
spk09: Our next question comes from Serge Bellinger with Needham. Your line is open.
spk07: Hey, good morning. My first question is on the net price per Rx. I think Rick talked a little bit about that in his prepared comments and his expectations that it would increase over the coming years. Just curious about the cadence of that increase for 2022 given the 10% price increase that was implemented on June 1st. And then secondly, for 2022 expectations, I know you guys don't provide sales guidance, but curious if you care to comment on street consensus numbers. There is a wide range right now, but depending on where you look at, they tend to average out between 65 and 70 million for 2022 expectations. curious if that's a number you're comfortable with. Thank you.
spk17: Thanks, Serge. This is Rick. So on your first question on net price, I think as we go back from where we were in the first quarter of last year, we're really pleased with the adjustments that we made to to the design of these copay card programs, which, as you know, really had a pretty impactful erosion in our net price in the first quarter. So, with those adjustments that we made through the year, we're pleased where we improved the net price throughout the year. It's definitely something that we are constantly evaluating. As we sort of think about 2022, There will be ebbs and flows in net price. As you all know, the seasonality of the business, the first quarter, there's a lot of commercial plans with deductible resets second half of the year you know Part D patients you know get into the coverage gap so there'll be a little bit of seasonality we're focused on you know improving net price but we think that you know post outcomes that's going to provide some some opportunity for us to to improve net price beyond what we've been able to do so far and then your point on you know sales guidance We're not providing guidance and we're not commenting on where consensus is. As Eric has mentioned previously, we're focused on growing the brands and executing on the sales model to drive top line growth.
spk09: Our next question comes from Tom Schrader with BTIG. Your line is open.
spk05: Good morning. Thank you for taking the question. I wanted to see if you can give a little more detail on the prior auth process. Do you have a sense of what fraction of patients can meet with their doctor and simply get a prescription, or how many of them then have to get another test and come back and maybe come back twice? Just a sense of how onerous the process is and how meaningful the CVOT will be on that front. Thank you.
spk03: Tom, good morning. Yeah, let me, I just want to introduce BJ Schwartz. He's in charge of our market access and each of our group as well as strategy. So BJ, if you want to comment on that.
spk10: Sure, Tom, nice to hear from you. As far as the prior authorizations, what we can tell you is literally there is a prior authorization for Nexatol and Nexazet for all the prescriptions, but it is to our exact label. And so whether we are preferred or non-preferred, we're required to submit prior authorizations to the labels. With that said, obviously it's an onerous process, and that is why we put together our prescription support program. And with that program, we work with providers and the offices to ensure that they get the prior authorization completed and on time so the patients get the prescriptions in the shortest period of time. And with the cardiovascular outcomes trial, we certainly believe that the prior authorizations will be lessened, and we look forward to that as the trial is read out.
spk05: And do you have any insight how often that requires a second visit or a third visit?
spk10: From visits to the office, it doesn't require the patient to visit the office. It is more the onerous process of the physician providing the right documentation. So it's not necessarily on the patient, but it's more on the office to make sure they provide the right information. That happens almost for every prescription, but because of the process we have in place, so long as they have the right diagnosis, the patient will get the product again in the shortest period of time.
spk03: Yeah, and I think also, Tom, in your question, you mentioned around lipid tests, if I understood that properly, and how often do patients maybe come back? And if that was also part of your question, typically, when a patient goes on the drug, they usually take the drug for about two months, get their lipid test, and then come back after that. But I thought that was also one of your questions as well.
spk05: Yep. Thank you.
spk03: Sure.
spk09: Our next question comes from Jessica Phi with J.P. Morgan. Your line is open.
spk11: Hey, guys. Good morning. Thanks for taking my questions. Question on clear outcomes. So from the time the last MACE is hit in the study, can you talk about what you will need to accomplish to be able to report top line data and what you estimate for how long it'll take to release top line data from whenever you hit that last event?
spk12: Yeah, so, Jess, this is Joanne. Thank you for the question. So, it's a quite complicated process. In fact, we are looking to begin close out operations for the study, in fact, before we actually achieve that final 1,620 events. We'll do that through modeling and prediction and begin that process hopefully at the beginning of Q2 this year, start bringing patients in for their end of study visits and anticipate that we would have a database lock fully by the end of this year. Obviously then we need to clean the data, adjudicate the data, make sure that we have everything in regulatory grade, publication grade data and confident of a top line result that can be communicated in the first quarter of 2023. Got it.
spk11: And do you guys have any reason to think that the MESA accrual in CLEAR will slow down?
spk12: You know, no. We've been tracking right online as predicted from the beginning of the study, in fact. Irrespective of COVID, if anything, we've been tracking slightly ahead on a month-to-month basis. And as Sheldon mentioned, just put in our 90% of our MACE4. As you may recall from prior conversations, we're well above 100% on our MACE3 accumulation, which is our secondary endpoint.
spk11: Got it. And last one, can you talk about the pushes and pulls that might put you at the higher or lower end of your OpEx guidance ranges this year?
spk17: Yeah, Jess, this is Rick. So as we sort of think about, you know, the business and with the adjustments that we made in the fourth quarter of last year, You know, the bands are fairly tight. You know, as you know, we're in, you know, a relatively steady state on R&D, principally related to the cardiovascular outcomes trial. And, you know, there'll be some ebbs and flows on the timing of, you know, CRO-related expenses, trial expenses quarter to quarter. But for the most part, those costs will be in line with the guidance as well as where we were for the full year, On SG&A, those are also reflective of the adjustments that we made in the fourth quarter. We've realized those savings in the fourth quarter of this year and now have a new steady state for the business. So we do expect that it will be, you know, fairly tight in those bands that we provided. And to the extent that we can refine those further throughout the year, we will to make it most helpful for everyone.
spk12: Great. Thank you.
spk09: Our next question comes from Jeff Hung with Morgan Stanley. Your line is open.
spk14: Hey, everyone. Thanks for taking the questions. A follow-up question on the price increase earlier this year. Do you see this as a regular percentage increase going forward? Is that a one-time thing ahead of outcomes data, or how are you thinking about price increases over time?
spk03: Hi, Jeff. Thanks for your question. So we don't really comment on our pricing strategy. Where we think it's appropriate based upon economic conditions, demand, et cetera, you know, there's actually a very strategic approach of when we decide on when we'll take pricing and what that price increase will be. But we did feel this was the appropriate time based upon recent data that had been presented at several meetings. As we move forward and have other price increases, we'll certainly keep everyone updated.
spk14: Okay. And then they're still on partner geographies. Any update on how you're thinking about partnering additional regions or how those conversations may be going? Thanks.
spk03: Sure. Yeah. So right now, we're really focused on the U.S., and I'm really focused on the consistent growth that we talked about before. Again, NexlaZen and NexlaTol are available today. So it's really driving that consistent growth today. And then as we get to CBOT, of course, we'll have the inflection point Related to unpartnered geographies is something that, you know, we do have discussions about. We do have a strategy around it. Right now, though, it's more of a secondary priority for us. And, again, you know, I think as we go through the next year or so, we can provide more updates of what we're doing with those geographies. And that reminds me, by the way, the question was asked earlier about Daiichi Sankyo. So, of course, Daiichi Sankyo, has Europe and also the ASCA region, and they're doing quite well. They've been doing very well in Germany. They recently launched in the UK as well. They have over 49,000 patients on drug. And it was asked earlier about Omicron having an effect, and they've really been able to navigate around COVID, get to see physicians, et cetera. So in those partner geographies with Daiichi Sankyo, they're doing very well. But I just wanted to get back to the answer of a question that was also asked earlier about Daiichi Sankyo territories.
spk14: Thank you.
spk09: Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
spk13: Thank you. Good morning, and thank you for taking our questions. Most of my commercial questions have been answered, but I want to maybe ask Joanne just to revisit clear outcomes for a moment here, which is congratulations on achieving 90% of your target. I guess my question here is, as you think about the impact from COVID and so forth, any other puts or takes that you would comment on, just how to think about your primary endpoint here since the trial is designed to have 95% power to detect a 17% risk reduction. Any commentary on just how the backdrop and the environment might be affecting that from your perspective? Thank you.
spk12: Paul, thank you so much for your question. I think, obviously, it's top of mind. You know, has COVID impacted the study? Just, you know, I'll give you some thoughts on that. So first of all, remember that the entire trial was enrolled well before COVID in 2019. We've worked tirelessly throughout the study, working with our CRO, our ARO, and multiple vendors to ensure the integrity of the trial and really minimize impact from COVID. We've been working with regulators as well, tracking that throughout the study. And in fact, the study has been identified, if you will, as a best practice for how unfortunately to conduct a large cardiovascular outcome trial during COVID. In general, yes, there are individuals that have COVID within the study. The events have not been significantly changed in either type or proportion relative to COVID. And that gives us really great confidence. The study has been running To all our surprise, but due to a lot of hard work, as we would have anticipated this study to run prior to COVID. So the events are tracking as we would have anticipated, as you can see with the accumulation of 90%. They're not overly enriched by COVID-related events. And again, we're looking for a successful closeout of the study and hope that this really becomes, again, a best practice of how to engage patients, keep these patients in trials through multiple challenges. Remember that the randomization, right, 14,000 patients randomized really also gives us great certainty and confidence that COVID would affect both sides of the equation and would not impact the study of this size, scale, or scope.
spk13: Great. Thanks for that, Joanne. And maybe just as a follow-up, since you are talking about presentation at a medical conference soon after the top-line result in the first quarter. I think the American College of Cardiology is in early March. Is that probably the right venue for us to look at?
spk12: Well, it certainly could be. The timing seems to make sense, Paul, as you know. And it is a major international cardiovascular congress that could be a potential.
spk13: Okay, great. Thank you very much.
spk09: There are no further questions. I'd like to turn the call back over to Sheldon Koenig for any closing remarks.
spk03: Great. Thank you so much. And again, thank you for everyone for participating. Just a few closing remarks. Again, just want to reiterate, again, the news of the fact that we have 90% accumulation of our MACE IV endpoint. And with over $309 million on the balance sheet, Aspirion is well capitalized and positioned to execute on its strategy. You know, we know, even going back to October, our business has been optimized to deliver consistent growth up to the results of our CVOT, which will be key in unlocking exponential future growth of our Nexlatal and Nexlazet brands. But again, I want to remind everyone, again, with Nexlazet and Nexlatal being available now, the need that we mentioned earlier to address cardiovascular health, we again reiterate that we want to provide consistent growth throughout the year. And then lastly, this is just an exciting time for Asperion, and we look forward to updating you in the coming months. And again, thank you so much for today's participation, and this is the end of our conference call for today. Have a great day and talk to you soon.
spk09: This concludes the program. You may now disconnect.
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