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spk09: 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 Ben Church, Investor Relations and Corporate Communications at Esperion. Please go ahead, sir.
spk11: Thank you, operator. Good morning, and welcome to Aspirion's second quarter 2021 financial results and company update conference call. I'm Ben Church, and I'm responsible for investor relations and corporate communications here at Aspirion. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to the risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 3, 2021. 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, the conference call and webcasts 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.esperian.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 investorrelations at esperian.com to schedule a time to speak with our team. I'd now like to turn the call over to our President and CEO, Sheldon Koenig. Sheldon?
spk14: Thanks, Ben, and good morning, everyone. With me today for prepared remarks are Rick Bartram, Chief Financial Officer, and Dr. Joanne Fooding, Experion's new Chief Medical Officer. Also on the line is Eric Warren, our Vice President of U.S. Sales and Marketing. I brought Eric on board in January to integrate and lead a unified sales and marketing organization. Eric, who is a pharmacist by training, has 25 years of commercial experience focusing primarily on cardiometabolic and acute care medicine. He will be available for your questions at the end of this call as well. A special thanks to everyone joining us today for my first earnings call as president and CEO of Asperion. I'm excited to share with you all the great strides taken by Asperion over this past quarter to position ourselves for long-term success as a nimble, innovative organization solely focused on addressing cardiovascular disease. which remains the number one killer in the United States and worldwide. When I joined Aspirion in December of last year, the company had recently launched the first oral non-statin LDLC lowering medicine in nearly two decades, Nexlatol and Nexlavet. These are powerful first in class medicines with a novel mechanism of action and the potential to save patient lives. However, The commercial strategy was not yet maximizing the full potential of these medicines on top of the persisting COVID-19 pandemic headwinds. Having previously worked across many of the available LDL-C lowering medicines, I have deep experience of what it takes to capture growth in the cardiovascular market and immediately recognize the untapped potential of Nexlatal and Nexlozet. Flash forward to today. We have now made many of the changes that were needed to strengthen our foundation and begin to recognize the potential of Nexlatal and Nexlovet. This includes bringing diverse experience to our senior leadership team, streamlining our commercial strategy, and implementing refined positioning for our medicines, all of which is moving the trajectory of Nexlatal and Nexlovet in the right direction. Our results from the second quarter show that these initiatives are already gaining momentum and materializing into growth. Prescribing physicians and prescriptions per physician are at their highest yet and continue to demonstrate a consistent double-digit and high single-digit growth, respectively. In the quarter, Nexlatal and Nexluzet prescriptions grew 28 percent, with accelerating month-over-month growth. But most importantly, Our medicines have reached nearly 48,000 patients here in the U.S. Since the mid-April introduction of the revised product positioning, providers have expressed a clear understanding of where to prescribe Nexlatal and Nexlavet in patients that stand to gain the largest benefit. The revised Nexlatal and Nexlavet positioning has resonated with payers as well. and has been beneficial in our new market access approach focused on improving formulary status of our medicines, specifically among Medicare Part D payers. The success of these efforts is evident from the immediate response by Humana, adding both Nexotal and Nexoset to their formulary as of May 1st. We continue to have promising conversations with payers who acknowledge the need for additional treatment options on formularies to tackle the large patient population not yet at LDL-C goals. A strong priority for the team this quarter was maximizing the awareness and value of Nexotol and Nexozet and driving quality prescriptions. While our generous financial benefit copay programs supported patients and encouraged adoptions of our medicines throughout the first year of launch and the COVID-19 pandemic. We believe the second quarter was the appropriate time to adjust both the duration as well as the buy-down magnitude of our copay card program to typical industry standards. With our strong commercial coverage in place and an improved economic environment, these adjustments resulted in limited impact to patient access to our medicines. Volume of payer covered prescriptions improved and second quarter net price was more favorable. contributing to the 67% sequential growth in U.S. net product revenue. We continue to expect additional positive impact in net pricing over time as plans fully implement coverage and volumes scale up. Since assuming the role of CEO, I've taken additional steps to position Aspirion for long-term success, one of them being the addition of prominent cardiologist, Dr. Joanne Foody, as chief medical officer. While our priority is steadfast on driving commercial excellence of Nexlatal and Nexlavet, ensuring we are prepared to capitalize on our unprecedented cardiovascular outcomes trial and the potential of our early stage pipeline is vital. The importance of the clear outcome study cannot be emphasized enough, not just for Aspirion, but for the entire field of cardiovascular medicine. Not only could our clear outcomes trial be monumental for encouraging late adopters, payers, and a broader application of Nexlatal and Nexlozet, but a potential risk reduction label indicates acceptance of an entirely new patient population that past medicines could not benefit. Historically, every LDL cholesterol-lowering therapy affecting the cholesterol synthesis pathway, as Nexlatal and Nexlozet do, demonstrated consistent outcome improvements. This along with the unique and deliberate design of our clear outcomes trial gives me great confidence on what is to come. All signs indicate that clear outcomes, now a little more than a year away, will make history in cardiovascular health and potentially further our leadership position in bringing innovation to underserved patients. If I could say only one thing, it would be this. Asperion is evolving quickly to maximize the opportunities that lay ahead and is instilling a laser-focused mentality on driving operational excellence throughout both commercial side of the business and also in our clinical and development programs. I am proud of what this team has accomplished in this short amount of time and continually gain confidence in the trajectory of Aspirion and our future as a company. Now I'll turn the call over to Joanne to introduce herself and ask her to share with you all her motivation behind joining our team. Joanne?
spk07: Thank you, Sheldon, and good morning, everyone. I'm Dr. Joanne Foody, Chief Medical Officer and the newest member of the Asperian Leadership Team. I'm thrilled to join Asperian to strengthen its leadership team as we strive to provide lipid-lowering therapies to address the significant unmet need in heart disease. For the last three decades as a preventive cardiologist, I have dedicated my career to improving outcomes for patients with or at risk of cardiovascular disease. When the opportunity to lead Asperion as its chief medical officer arose, I knew that this would be the right place to follow my passion to make a difference for patients. There is not one amongst us who has not had a family member or friend affected by heart disease or high cholesterol. These silent killers have stripped loved ones far too early and far too often from me as well as countless others, including most of you listening. Despite existing therapies, too many patients remain at risk due to high cholesterol. As the first new oral lipid-lowering therapy in two decades, benpidoic acid, either alone or in combination with ezetimibe, has the potential to transform patient care. During my time as a practicing cardiologist at the Cleveland Clinic, and went on faculty at Yale and Harvard, I learned firsthand how physicians and patients are frustrated by the lack of tools available to address and stop the progression of heart disease. As I transitioned to industry, the lack of novel, accessible, and patient-friendly therapies to reduce cardiovascular risk became only more apparent. The need for therapeutic solutions in cardiovascular disease has unfortunately not changed despite statins, or even injectable PCSK9 inhibitors. Recently, JAMA Cardiology published that only one-third of patients with atherosclerotic cardiovascular disease reach their cholesterol goals. That means that two out of every three high-risk patients did not achieve their goals and are at higher risk than they should be for heart disease. Aspirion, the only company focused singularly on oral lipid-lowering solutions, is poised to tackle this problem head-on and transform clinical care with the CLEAR Outcomes Trial. This is the largest cardiovascular outcomes trial to study patients not optimized on their statins or intolerant to statins. CLEAR Outcomes is unparalleled in its size, novel design, and unique patient populations. This trial has taken into account all the lessons and insights of decades of cholesterol-lowering trials and is being run by teams of experts and chaired by Dr. Stephen Nissen, an exceptional cardiologist and trialist. The trial's unique patient population and high starting baseline LDL cholesterol increases the likely probability of success. Further, given the unique mechanism of action of benpidoic acid and its known pleiotrophic effects on inflammation and glucose, we anticipate the potential of additive benefits for patients. The thing is, I've been in cardiology for a long time. I've been involved in multiple global cardiovascular outcome trials across multiple big pharma companies. I've reviewed these trials as I wrote guidelines. but I have never seen a global trial of this quality, size, and scope being run at a company our size. That's a big deal. Our entire medical team is re-energized to bring Nexlatol and Nexlazet to all patients who can benefit from our indicated therapy today. And we are prepared to bring Nexlatol and Nexlazet to more patients who can potentially have outcomes benefit tomorrow. From the moment I started, I have been thoroughly impressed by the incredible talent and expert team of this team and their passionate commitment to bring back a sense of urgency to lipid management and cardiovascular risk reduction and advocate for continued innovation to ensure that patients and physicians have best-in-class, highly effective, convenient options to combat cholesterol. Thank you again for your time and attention. I cannot say it enough. There remains much work to be done, but I am confident that driven by science, we will demonstrate continued progress in this mission over the quarters ahead. Now, Rick will provide comments on the quarterly financial performance.
spk06: Thanks, Joanne. Earlier today, we issued a press release containing our financial results for the second quarter, which is available on our investor websites. U.S. net product revenue was $10.6 million for the second quarter, compared to approximately $600,000 generated in the second quarter of last year, and $6.4 million in the first quarter of this year. Total revenue for the second quarter was approximately $41 million, which included $28.1 million in collaboration revenue related to the $30 million upfront payment received from our expanded partnership with Daiichi Senkyo that we announced in April. And there was approximately $1 million of royalty revenue from our European collaboration with Daiichi. Net price for our medicines improved during the second quarter as the commercial team implemented a number of changes to the copay card program as Sheldon highlighted earlier. Over time, we expect our net price to continue to improve as plans fully implement coverage and volumes scale up. On expenses, R&D expense for the second quarter approximated $25 million, down 10 percent from the first quarter. SG&A expense was approximately $46 million for the second quarter, down 24 percent from the first quarter. The sequential decline in SG&A expense was driven predominantly by a one-time charge associated with a legal settlement in the first quarter. We continue to expect our full year 2021 R&D expenses to fall between $120 to $130 million, and SG&A expenses to be between $200 and $210 million. Note that these amounts are inclusive of approximately $30 million in non-cash stock-based compensation expense for the full year. Our cash balance as of June 30th was approximately $219 million. We remain committed to prudently managing expenses and will ensure the organization is adequately funded to advance the business. Going forward, you should expect us to continue to balance cash spend against growth potential and the cash needs to ensure the business is resourced for future growth. Before handing the call back to Sheldon, let me summarize our financial progress. First, we had 67% quarterly growth of Nexlatal and Nexlazet net revenue. Second, we saw improved net price of our medicine through the adjustments of our copay card program highlighted earlier. And lastly, we remain extremely diligent managing our cash while supporting the commercial launch and our clear outcomes trial. By maintaining this focus, we are confident our financial position will continue to strengthen throughout the remainder of the year. With that, I will turn it back to Sheldon for closing remarks.
spk14: Thanks, Rick. I want to say again how proud I am of what the team has accomplished and the direction Aspirion is headed in. While there is still a lot of work left to do, we continue to drive a sense of urgency across the organization to bring value to our shareholders, healthcare providers, and most importantly, patients. Our refined commercial strategy has begun to demonstrate traction across a number of fronts, translating to expanded Medicare Part D coverage, substantial prescription growth of Nexlital and Nexlivet, and other key commercial metrics, including net pricing. While we continue to work towards operational excellence, we remain steadfast on the true mission at heart, an opportunity to transform the lives of millions of patients struggling to lower their LDL cholesterol. A big thank you to all our colleagues and partners for their hard work, passion, and commitment this quarter and every quarter. And again, thank you all for joining today and your continued support and interest in Aspirion. Operator, we are now ready for Q&A.
spk09: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Michael Yee from Jefferies. Your line is now open.
spk10: Hi, guys. Good morning. Thanks for the question. We have two questions. One was your comments around gross-to-net, which was great to hear that you think it will improve. Could you just maybe quantify that a little bit? You know, in 2020, we think you were around 35%, 40-something percent. It dropped a lot off in Q1. You think the rest of the year is more like 50%? Is that a ballpark range to use? Maybe you could just comment on that. And then the second question was more of a macro, which was, you know, do you know that COVID has impacted things over the last few quarters? Things obviously improved a lot. Then there's maybe some changes recently. So maybe just comment about the environment you're seeing. Do you feel like patient volumes are getting a lot better? Maybe just comment about that as well.
spk14: Thank you. Great. Good morning. Thank you, Michael. This is Sheldon. And let me first comment on your first topic as it relates to gross to net. Again, I really want to emphasize, and hopefully you can hear me okay here. We're in a new room. The fact that, you know, we noticed a notable improvement in our net price, as you mentioned. And this is something that we've been consistently saying since the last quarter. This is something that we would continue to work on feverishly. And the team has done a great job and really in a little less than two months. And we believe that improvement will continue going into the third quarter and quarters beyond. I'm not going to comment on the specific percentages. We don't give out our gross to net. We don't speak to that or advise on that. But again, I want to just state that, you know, something that we are committed to as it relates to reducing our exposure, making sure that we would have quality prescriptions. Again, our demand grew by 28%, and I think, as I mentioned before, I know that as we move into third and fourth quarter, we will see the improvement. As it relates to COVID, obviously this is something that we're following with the Delta variant. Our reps have always been committed and have been out in the field even since COVID hit last March of 2020. Reports we get back from the field is that individuals are returning to the office, physicians are returning, more and more patients are getting vaccinated. I think with the Delta variant, more folks are realizing they need to get vaccinated if they're not But slowly but surely, folks are returning to the office. I'll ask Eric Warren, who's here, if he has any additional comments.
spk02: Thanks, Sheldon. Nice to meet you, Michael. My name is Eric, as Sheldon mentioned. I have responsibility for our sales and marketing team at Asperion. I'm a pharmacist by training, 25 years in the industry, and most of my experience has been in cardiometabolic disease. I came here just a few months ago. And really, three reasons behind that. Really, the people here have been incredible. The medicines have been inspirational. And the clear focus on cardiovascular disease is to be complimented. So with regards to the Salesforce activity, we've seen a significant increase in the number of calls per day that our team has been able to make. They're seeing more targeted customers. They're able to increase their frequency. On customers, we've also seen a really significant increase in the number of peer-to-peer programs from Q1 to Q2. So all those are good signs from a COVID perspective. Now, yes, the Delta variant is on our minds. We're keeping a close eye on that. We can't predict where it will pop up and where it will go down. But we are making sure that our teams are armed with the proper safety equipment. Masks have always been a mandate, as they are with our HCP offices. And we're really committed to making sure that our team is out there as they're communicating the benefits and risks of our compounds and that they're making sure that appropriate patients do receive our product. Thank you.
spk09: Thank you. Our next question comes from the line of Joseph Fone from Cowan & Company. Your line is now open.
spk04: Good morning. Thank you for taking my questions. The first one, I know you did mention sort of that you're not honing in on sort of the heavy prescribers or targeting those accounts. Can you comment a little bit on the blend of sort of specialty cardiology accounts versus primary care physicians and maybe where you are seeing that higher prescribing rate? And then second, maybe in those docs that aren't you know, immediately reaching for the therapy right now, what else do they need to see? Do they want to see that CB outcomes data, or is there anything that you can provide them maybe ahead of that that could drive additional adoption? Thank you.
spk14: Great. Thanks, Joe. Our microphone's a little jumbled here, but I think I got the first part of your question, and that is, who do we really see prescribing Nexlazette and Nexlatol what's that breakout between primary care and cardiologists? And what we're seeing is that there's more primary care physicians that are writing both Nexlazet and Nexlatal than cardiologists. It's probably closer to a 60 to 40%, 60% primary care, 40% cardiology. This is not unexpected. This is, as you may or may not be aware, I ran the brand of Zetia Vitorin, while I was at Merck, and we saw that the majority of prescribing of ezetimibe was in primary care. And we're starting to see the same here as well, as it relates to Nexlozet and Nexlatal. And the second part of your question is... Yeah.
spk04: I can try and repeat it. Oh, at the end.
spk14: What else do they need to see? Sorry. Yeah. So, yeah. So actually, for us, one of the things that we mentioned last quarter was awareness, and we're starting to see awareness of these brands improving. The Clear Outcome Study, which I will have Joanne comment briefly on in just a second, is definitely something that's going to be very important for us. But again, looking at other products and analogies, there's a lot of patients, close to 18 million patients in the United States who have a lipid abnormality are not achieving their LDL-C goal and they need treatment now. So physicians realize this and physicians also, you know, they don't want to delay in trying to get their patients to their LDL target. So we believe we have a lot of room to grow. As we mentioned in the script, we have 48,000 patients currently on these drugs. I mentioned the number of 18 million. As my partner here, Eric Warren, would say, we're just scratching the surface. And we think that we can, again, really grow and have an inflection point. And a clear study, as I've always said, will provide us maybe a secondary inflection point. Joanne, any color you'd want to add on the clear outcome study?
spk07: Thank you, Sheldon, and thank you, Joseph, for your question. I think, as Sheldon mentioned, the clear outcome trial will be an important inflection point. However, over the next 15 months, as we anticipate that study closed, we have developed a very significant integrated evidence approach that will leverage real-world data to provide information for providers, clinicians, and, importantly, payers with respect to our value proposition. And so there is, as Sheldon mentioned, a significant amount of work that will be ongoing to refine our understanding of treatment gaps, of patient phenotypes, those who might be most likely to benefit today from our therapy, and ultimately do this all to have fertile ground for the CBOT. What you may not be aware is as an outcomes researcher in my academic career for many years and having recently been head of data science for Johnson & Johnson in the cardiovascular space, most of that work was really on how we could leverage big data, how we could leverage electronic health records and all the data that exists in the real world to help providers understand the value. And all this ultimately drives our commercial utilization. So as Sheldon mentioned, I think right now we want to continue to work to improve patient identification, improve understanding and awareness of those patients most likely to benefit from Nexotol and Nexobet today while we anticipate the data generated from the CV outcomes trial in the future.
spk05: Great. Thank you.
spk09: Thank you. Our next question comes from the line of Chad Messer from Needham & Company. Your line is now open.
spk12: Great. Thanks. And thanks for taking my question. You talked a little bit about, you know, in mid-April revising your product, your positioning. I'm just wondering if you could talk a little bit to how that has affected sort of the – the patients that are using . So anecdotally as you talk to physicians, what patients are using the drug and maybe how it's changed with the new physician?
spk14: Yeah, so thanks Chad for the question. Let me just start off quickly. One of the things that we introduced was the new positioning in April. One of our bellwethers of testing to see is this the right positioning was the win that we had with Humana, which is one of the largest Medicare Part D providers with close to 9 million patients. And I think what was important there is that it was obvious that the positioning was clear and understood. We had a quick turnaround as related to an answer from Humana. So that was the test of it. I'm going to ask Eric to comment on what he's seen in the field. He's the one who's been deploying this positioning and working closely with the field. Eric?
spk02: Great. Hi, Chad. Nice to meet you. So, yeah, we deployed some revised positioning in April, and really the goal was to hone in on a specific patient type where our our success would be evident. Rather than talking about five or six patient types that may not stick with our clinicians, really driving one where we know that we see success. And the team's been doing a great job at executing that. It's all about building confidence and momentum. The population, again, that we focused on as consistent with our indication, ASCVD, HGFH patients that aren't at goal, They're on other therapies, statin therapy. They've obviously maxed that out. There's an intention to do more for the patient, and that's where Nexplatel and Nexplazet come into play. It's a sizable population. Again, it gives opportunity to demonstrate the efficacy as well as the safety profile of the compound, and then it creates a base for us to expand. We've got two phases of expansion planned. a phase that happens before CBOT and then a phase that happens after CBOT. And as Sheldon mentioned, from a payer perspective, that strategy has been resonating well. From a practitioner perspective, it's been resonating well. And also from an internal perspective, I think our sales team appreciates the clarity that we've provided.
spk12: Okay, great. Thanks. I appreciate that. Is it? I mean, is it fair to say, based on your guys' experience, that the idea of statin intolerance just hasn't gained the traction we once all thought it might?
spk14: Let me speak to that. And so statin intolerance, I think, is something that's been ongoing since statins have been launched, more so, I think, after lovastatin and going into Zocor. there's always been a thought that there's a rate of anywhere between 16% and 20% of all patients who are statin intolerant. That doesn't mean they can't take a statin at all. It means that they can only take maybe even a certain dose of statin. So this isn't really about just statin intolerance, but it's really about patients achieving LDL goal. And the treatment paradigm has become a step-guided treatment I'm not a physician, Joanne is, but I'll just make this comment. You know, it evolved from a statin to then a statin plus ezetimibe, and now it's a statin plus ezetimibe and something else. And we believe that something else is Nexlazet and Nexlatal pre-CVOT. As I mentioned, there's millions of patients who are taking statins and statins and ezetimibe and are still not an LDL goal. And as we mentioned earlier, Cardiovascular disease is the number one killer. So there's definitely a place for Nexlazet and Nexlatal. Again, we've seen that in this quarter, you know, we had 67% growth in revenue. We had 28% growth in demand. We're calling these, you know, quality prescriptions. And, again, I think there's a lot of potential for these brands.
spk07: Sheldon, if I could just add, I think, you know, from a physician perspective, and again, you know, speaking as a cardiologist on this, I think statin intolerance definitely exists. I think the challenge is that it is under-recognized because patients have had to suffer with their muscle symptoms because there were not therapies available. So I think to your point, some of this has not been fully leveraged, and I think we do now have a compound and a combination of compounds in Nexlatal and Nexlazet that can address this. I think you also have to recognize that when statins were really, and still are, the only game in town as an oral therapy for this, people do suffer with this. And we have the opportunity, I think, to expand But importantly, as Sheldon mentioned, it's not just statin intolerance. There's also statin hesitancy, that people decide to vote with their feet and not take any therapy and leave their cardiovascular with CHI due to that. There's also lack of optimization of statin. So people can be on smaller doses than they should be to achieve their goals to reduce their cardiovascular risk. So there's a whole host and a range of patients who cannot take what should be the optimal dose of a statin for a variety of reasons. And we think this is where Nexplatel and Nexpluzet fit very squarely.
spk12: All right. Thanks. Appreciate it. Look, I'm a wholehearted believer that more options . Thank you. Thank you, Chuck. Thanks, Chuck. Thank you.
spk09: Thank you. Our next question comes from the line of Jason Butler from J&P Securities. Your line is now open.
spk13: Hi. Thanks for taking the questions. First one, with the focus on the high-quality prescriptions, are you continuing to evaluate Salesforce sizing and territory prioritization? And then secondly, can you just give us an update on the launch in Europe, how that's progressing? Thanks.
spk14: Sure, great. Thank you, Jason. So as it relates to Salesforce size, where we're at right now, we do believe that we do have the right Salesforce and the size. I'm going to ask Eric to comment in a bit, but let me just first talk about Europe. So in Europe, we continue to see strong performance from Daiichi Sankyo. They launched both of these products in October of 2020, and they've continued to have seen growth. They're currently launched in Germany. They're also launching in the UK and a handful of other smaller countries. We meet with them on a weekly basis. We have a great partnership with Daiichi, thank you. And again, performance is doing quite well there. Eric, do you want to talk about how we evaluate Salesforce? Sure, absolutely.
spk02: And nice to meet you, Jason. So right now our sales force is approximately 200 territory managers. It's been stable through Q2, which is a good sign. And I do think right now it is right-sized to support the near-term opportunity. However, in order to really reach the maximum potential, there are a lot of customers, specifically primary care physicians, that we could stand to be able to cover. I'm constantly evaluating appropriate ways to reach these practitioners, but we have to do so, obviously, in a cost-effective manner.
spk13: Great. Thanks for taking the questions. Thanks, Jason.
spk09: Thank you. Our next question comes from the line from Tom Schrader from VTIG. Your line is now open.
spk03: Good morning. I'm getting long patches of silence. I can't tell if it's me or the general call, but I wanted to re-ask a piece of Chad's question. Is the majority or the vast majority of your users now people already on ezetimibe?
spk14: Hey, Tom. First of all, yeah, we're not getting reports. Maybe it might be your connection. I know last quarter we had some issues, and people were telling us right away, but... We are not getting those reports. I just want to be FYI. And if other people are, please ping or chat to the operator. We actually specifically picked a new room to make sure we wouldn't have that this time. So as it relates to patients currently on Nexlazet and Nexlatal, I think we see a good mix of patients who are on statins and who are on statins and ezetimibe that are taking both of these products. So, you know, our positioning, of course, right now, as we've mentioned, is talking about those patients who are on a statin plus azetamide. And then before you would actually go to an injectable PCSK9, we think there's, you know, the room and ability to use Nexlazet and Nexlatal. There are other adopters who just use statins, and they have added Nexlatal or Nexlazet. And right now, the split of those two drugs, when you look at Nexlatal and Nexlazet, is approximately 50-50 in the use of both of those drugs.
spk03: All right, and then just one housekeeping question. Are the copay cards greater than three months? Are they completely gone, and did they have any impact this last quarter and second quarter?
spk02: So I'll have Eric comment on the copay cards. Sure, sure. Hi, Tom. Nice to meet you. So as Sheldon's mentioned earlier, profitable growth is really important to us. And yeah, in the past, we've leveraged copay cards for multiple purposes, not only to lower the out-of-pocket cost that a patient pays for an approved or a commercial patient pays for an approved script, but also to create a bridge, if you will, for those patients that are awaiting prior authorization approval. So the copay card process will continue to last for an extended time for those patients that are commercially approved, that we are paying down the prescription to make it more affordable. However, we've made some changes to the copay card, and no longer will we be creating that bridge, if you will, to cover those patients that are awaiting their prior authorization. Instead, we've implemented additional programs, including something we're calling the prescription support program to support those patients. Thank you.
spk03: You're welcome.
spk09: Thank you. Our next question comes from the line of Jeff Meacham from Bank of America. Your line is now open.
spk08: Hi, guys. This is Olivia Barrett. Thanks for the question. Sheldon, can you give us an update on where you are in conversations with payers on the Medicare coverage side. I know you've been added by Humana, and that obviously took some time to play out. So how do you think about timelines for getting added to other major formularies and whether that's something that could realistically play out this year? And then I have one follow-up after that.
spk14: Hi, Jess. So first of all, thanks for your question. Again, just to reiterate, we're really happy about the win with Humana. I know I mentioned it a lot, but that was a big win for us. Again, the largest Medicare Part D provider and a good test of our positioning as it relates to the contracting where we are today. So we're currently in talks with other providers. I think it's important to note, though, that while we're also in talks with other providers, we can still do pull-through of both contracted and non-contracted accounts. And that is something that we are really concentrating on and focusing on, really driving demand while we have those discussions. We're happy where we sit today as it relates to our commercial coverage with greater than 90 percent, and our Medicare coverage is 60 percent. We'll continue to update you as we go through the third and into fourth quarter. I'm not going to comment on, you know, when we actually think we would have contracts. We want to make sure that whatever we do is very well thought out, makes sense, and in the meantime, still be able to drive demand, which we are able to do. Okay, great.
spk04: Yeah, sorry.
spk08: Yeah, and then our second question is really around opportunities for partnerships beyond what you've already been able to establish. I know you guys have talked about China and other geographies that could help drive growth over the longer term. But are there certain countries that are maybe more of a priority at this point or more of a near-term focus than others?
spk14: Yeah. So first, again, I want to reiterate, as you know, we have an agreement with Aichi Sankyo for Europe. We expanded that agreement with the ASCA region, so that allowed for a partnership of different markets, not only in Asia, but some also in Latin America as China and Canada are two that still stand out that we have complete ownership of. And I think, you know, the best way to think about this is our focus really is on the U.S. Right now, we're focusing on the U.S. and continuing to drive performance and drive the growth of NexLatal and NexLisette. And that's where we'll be spending the majority of our focus as we move throughout this year.
spk08: Okay, great. Thank you.
spk09: Thank you. Our next question comes from the line of Jeff Hung from Morgan Stanley. Your line is now open.
spk15: Thanks for taking the questions. You've talked about addressing the copay card and then in the past the need for greater touch points with physicians to generate written scripts. What additional levers do you have to impact the trajectory of scripts?
spk14: Hi, Jeff. I'm actually going to have Eric speak to that.
spk02: Eric? Thanks, Sheldon, and nice to meet you as well, Jeff. Yes, obviously scripts come from awareness of our compounds, so being able to have live interactions is critical. As I mentioned, we've been able to increase the number of direct engagements we've had with our customers, and not only our customers, but our targeted HCPs, which is really important. We've had double-digit improvements from Q1 to Q2 in terms of our reach. We've seen increased frequency. I've also mentioned that we've improved our ability to reach our customers from a peer-to-peer perspective. We had a significant bolus of activity in June, not only smaller programs, about 10 in size, but we did two national programs where we were able to engage more than 1,000 HCPs in peer-to-peer activities. So that's important to us, and we see that as a mechanism to drive Scripps. In addition, I mentioned the prescription support program is going to be critical. Obviously, with prior authorizations for some plans, it's important that our customers are prepared to be able to complete those to maintain timely access. And as I mentioned, August 1, we have implemented this prescription support program This program includes a dedicated support team that works both with the patient as well as the office to ensure that all the proper documentation is processed and that the prior authorization is approved.
spk15: Thanks. And then you've indicated that Aspirion could only get to about half the physicians it needed to cover in June. How has the ratio of reached versus targeted physicians changed over the last few months?
spk02: Yeah, so we've actually been able to reach more than half of our targeted HCPs. We're closer to two-thirds of those targeted HCPs. And what was the latter part of the question?
spk15: I was just curious how that's changed over the last few months.
spk02: Yeah, it's improved. Yeah, we're seeing significant improvements in our ability to get to our target customers and have meaningful discussions on our products. And that's really a testament to the sales force and their passion and dedication out there. They've been out there consistently throughout the COVID time, if you will, and they've seen significant improvements now because of, I think, their persistence, but also because of the quality of the compounds that we have.
spk14: And I would also add, Eric, I think just the introduction of data analytics and how you've applied analytics to really territory targeting and performance measurement has also been key in doing that.
spk15: Thank you.
spk09: Thank you. Our next question comes from the line of Jessica Pye from J.P. Morgan. Your line is now open.
spk01: Hey, guys. Good morning. Thanks for taking our questions. First question is, can you talk about how the franchise is doing in Europe maybe translate what the royalty revenue means for overall sales in Europe so we can get a sense of how the business is doing there.
spk14: Hi, Jess. Let me first say that Europe has been performing well. Our partners with Daiichi Sankyo, as I mentioned earlier, they continue to see growth in number of patients on a monthly basis. I'll have Rick comment as it relates to royalty aspects. Yeah, thanks, Jess.
spk06: So We did communicate that we had about $1 million of royalty revenue from the European collaboration. That collaboration is available publicly. We're not commenting on the actual revenue dollars. You can do calculations, but, you know, given some of the exchange rates, we're not commenting on those.
spk01: Okay. And next one's just on the cash runway. either for Sheldon or Rick. I think, Sheldon, in prepared remarks, you mentioned the clear outcomes data is a little over a year away. So, is it your expectation that you have the cash to get to that data readout? And can you talk about strategies you might use to top off the balance sheet so you get to that clear outcomes data with a little cushion?
spk06: Dr. You'll have Rick comment on that. Dr. Yeah, thanks, Jess. Yeah, so as we mentioned in the prepared remarks and as you saw in the press release, we had about $220 million in cash When we look at the business and we look at the cash available to us, I just want to point out and reiterate we have about $1.2 billion of future milestones. We do expect those to continue to feed our balance sheet over time. We're constantly evaluating cash runway, looking for ways to not only optimize cost in our expenses, but just be thoughtful about how we bring additional capital into the organization. As you know, we capitalized on two non-dilutive funding sources this past quarter, the expansion with Daiichi under that partnership, and then with our financial partners, Oberlin Capital. We're going to continue to have that mindset, evaluate options, and just make sure that the business is funded to deliver the business plan and grow our products.
spk01: Okay, great. And then just lastly, on the progress of clear outcomes, we try to think about maybe when in the second part of 2022 that could come. Is there any next communication that we should be anticipating from you guys on maybe the proportion of events that have occurred? Anything we should be kind of watching for on progress updates there?
spk14: Let me have Joanne comment on that, just as it relates to events. We're at 75% right now, but Joanne, do you want to comment to that?
spk07: So thank you, Jess, for the question. And clearly, just to first say that the Clear Outcome Study is currently on track to execute and close out at the end of 2022. Importantly, we have accumulated... 75% of our MACE events. It's important for people to recognize, I think there's a lot of concern about COVID, but remember again that the study was fully enrolled prior to COVID in 2019 and has not seen any impact from COVID. We will continue to report out accumulation of MACE events next year. And otherwise, the study is fully on track. And when we compare the study to other studies and historical benchmarks, we are in a good place to execute on this study. Great. Thank you.
spk09: Thank you. Our next question comes from the line of... Our last question comes from the line of Paul Choi from Goldman Sachs. Your line is now open.
spk05: Hi, everyone. Thank you so much for taking that question. This is Charlie on for Paul. I think just one from us at this point, you know, just regarding the adjustments that have been made to improve the net price as the launch continues. Can you give us a sense of like the timing of those adjustments throughout the quarter? Does the entire quarterly revenue kind of reflect those adjustments or was that something that kind of a load as time went on throughout the quarter, such that maybe only a portion or half of the quarter really reflects the improvement in that price. Thank you so much.
spk14: Thanks, Charlie. So as it relates to the improvement, it was something that was done over, you know, a couple of months, honestly, and still, as I mentioned earlier, and also in our prepared remarks, we still see further improvement that can be attained as we move into third and fourth quarter. Again, this is something that we are looking at very diligently. And, you know, the fact that we could say that we had a notable improvement in net price in such a short amount of time was very important for us. It was something that we set out to do. We said we would do it, and we're going to continue to do it as each and every day goes by, wherever we can look for those type of efficiencies.
spk05: Got it. Sounds great. Thank you so much for taking our questions.
spk09: This concludes today's conference call. Thank you for participating. You may now disconnect.
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