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spk00: 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 Experian. Please go ahead, sir.
spk07: Thank you, Operator. Good afternoon, and welcome to Asperion's first 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 Asperion. With me on today's call are Tim Mayleben, President and Chief Executive Officer, Sheldon Koenig, Chief Operating Officer, and Rick Bartram, Chief Financial Officer. 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 SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 4, 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, this conference call and webcast are being recorded and archived. We issued a press release this afternoon 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 Asperian.com to schedule 20 minutes to speak with the team. I'd now like to turn the call over to our President and CEO, Tim Mayleben. Tim?
spk02: Thank you, Ben. Good afternoon, everyone. Thank you for joining us today as we review the progress made across our global business during the first quarter. I'll start today's call with a brief overview of progress, touching on the highlights from the quarter. Sheldon will review our recent US commercial initiatives in greater detail. And finally, Rick will provide additional color on our financial performance. For this stage of our US launch, our priority is to ensure that as many patients as possible have a positive experience with our medicines. From the start, we have purposely positioned our medicines to minimize barriers around price and access to enable that experience. We have been unwavering in this commitment to patients, following our mission of lipid management for everyone. We entered the year with new commercial leadership who quickly identified and implemented a refined strategy to position our medicines for both near-term and longer-term success. Today, we will highlight the great things happening across the business, but we'll also provide you insights into the US net revenue results for the quarter. As you saw in our press release, our commercial team continued to drive strong prescription demand growth for Nexplatel and Nexlazet in the U.S. during the first quarter. In fact, almost 50 percent demand growth. But net U.S. revenue was negatively impacted by first quarter net pricing. Rick will provide more detail on the factors influencing this result and their impact on this quarter's U.S. net revenue. He and Sheldon will also provide you insights into the moderating impact of these factors on future quarters. We continue to be optimistic that there is an easing commercial environment as we see statin new-to-brand prescriptions recovering and patients taking their first steps to reprioritize cardiovascular health by returning to their physician's offices. This reprioritization, combined with our newly implemented refined commercial strategy, provides us increasing confidence for a shift in demand growth in the second half of the year. I want to turn now to a couple of announcements we recently made to advance our global strategic priorities to expand the reach of our medicines through strong and experienced ex-US partners while simultaneously strengthening our balance sheet. Last week, we announced an expanded partnership with Daiichi Sankyo granting Daiichi exclusive rights to commercialize our medicines in select territories across the ASCA region, which includes countries across Asia, the Middle East, and Latin America. The agreement builds upon an already highly productive relationship and reinforces both companies' commitment to bringing novel cardiovascular medicines to patients globally. The $30 million upfront tied to the expansion of the Daiichi relationship came simultaneously with the announcement of Aspirion securing the remaining $50 million from Oberlin Capital under our existing revenue-based funding agreement. As a result, our pro forma cash at the end of the first quarter is around $300 million. Turning now to Europe, the depth of Daiichi's global cardiovascular expertise is evidenced by the success of their ongoing launch of our medicines in Germany which will be followed in other European countries later this year and into next year. The number of patients treated with our medicines in Germany during the first quarter increased significantly, already reaching near 14,000 patients by the end of the first quarter. Great progress continues in Japan as well. I'm pleased to report that Otsuka, which owns rights to the Bepidoic acid franchise in Japan, continues to advance the clinical development of our medicines. Otsuka initiated Phase II development in April, enrolling their first patient in a clinical study. More to come on this in future quarters. Finally, I want to highlight that Aspirion still retains full rights to China, among many other ex-U.S. territories, and of course, 100% commercial rights in the U.S., Now that the expanded partnership with Daiichi is in place, recall that we've already recognized approximately $400 million from our ex-U.S. partnerships. We'll be exploring all avenues to accelerate the speed and reach of our medicines to patients, physicians, and payers in the U.S. Importantly, we will do this in ways that are in the best interests of our long-term shareholders. I'd like to end with this. Aspirion, like most companies launching new medicines in the U.S. during the pandemic, has experienced both expected and unexpected commercial challenges since FDA approval of our medicines in the U.S. last February. More broadly, Aspirion has also experienced a number of important successes during this time, both in the U.S. and abroad. In our industry, there has been too little focus on the plight of people suffering from cardiovascular disease, still the number one killer worldwide. And as the lipid management company, we will continue pursuing our mission to provide these people with convenient oral LDL cholesterol lowering medicines. I am confident that our new commercial team is advancing Aspirin in the right direction here in the U.S., As a team, we're absolutely committed to taking the necessary steps to elevate the U.S. commercialization of NextLatal and NextLisette, and as I said a few moments ago, to do so in ways that are in the best interest of our long-term shareholders. And with that, I'll turn the call over to Sheldon. Sheldon?
spk03: Thank you, Tim, and good afternoon, everyone. Last quarter, I outlined several operational and commercial initiatives related to our Medicare Part D market access approach, enhanced product positioning, and health economics and outcomes research, and scientific platform that would result in a more competitive go-to-market strategy. I'm happy to say that as of today, the majority of those initiatives are in place or in the final stages of implementation. Our new market access strategy has driven improved onboarding and pull-through of payer contracts. There is an opportunity to present a refined clinical profile to payers, combined with our new strategy to improve the formulary status of our medicines with the top Medicare Part D providers that account for approximately 80% of lives. Just this past quarter, two of our biggest commercial plans elevated Nexlatal and Nexlazet to preferred tiers. We anticipate a full re-engagement with these top providers by the end of this year, with potential ads throughout 2022 and possibly sooner. In addition, I'd like to highlight that as of May 1st, both NexLatal and NexLisette will be included on one of the largest U.S. payer formularies, adding roughly 8.5 million Medicare Part D lives and bringing our Part D coverage to near 60%, a great success for Aspirion and these patients. Turning next to our enhanced product positioning, throughout the first quarter, the team revitalized with great precision and simplicity the market positioning and messaging of Nexlatal and Nexlazette to ensure physicians are provided a clear guide on the appropriate patient population that will benefit from our therapies. This new package was rolled out to physicians mid-April. We also spoke about driving awareness of Nexlatal and Nexlazette. to bring physician attention back to the unmet need in cardiovascular disease and the benefits of our non-statin oral medicines. Within a few short months, our newly added health economics and outcomes research team, paired with our world-class development and medical affairs teams, launched a real-world evidence study in partnership with UT Southwestern Medical Center and Cerner Real World Data to complement our clinical work and strengthen our scientific platform. We expect this study to conclude in the first half of 2022 ahead of our CVOT. I am very proud of the headway made during the first quarter in putting the pieces in place to improve our commercial strategy, which we expect will demonstrate increased traction in the months ahead. In terms of our first quarter results, Nexlatal and Nexlazet averaged weekly growth of 3%, outperforming that of ezetimibe, statins, and PCSK9s on a unit volume basis during the period. Overall, prescriptions grew 46% quarter over quarter in spite of seasonal headwinds, adverse weather in select regions, and the apex of COVID cases in the first two months of the quarter. Some metrics that are encouraging from a broader market perspective are new-to-brand statin prescriptions, which are now down approximately 4% year-to-date compared to last year's pre-COVID levels, or January to early March 2020. By comparison, during most of last year, new-to-brand statin prescriptions were down 30%. Similarly, in-office patient visits to cardiologists and general practitioners have improved modestly relative to the late March to early May trough in 2020. We continue to hear in our conversations with leaders in the cardiovascular space, such as Dr. Peter Toth, the current president of the American Society for Preventative Cardiology, The patients who have returned to physician offices have lipid panels suggesting a time very soon where patients will be forced to address long-term cardiovascular health. While it is clear a gap in cardiology and general practitioner office visits and diagnosis still remain, we are encouraged that patients are beginning to take the first steps to reprioritize their cardiovascular health. Nexlatal and Nexlazet new-to-brand prescriptions grew 8% for the quarter, driven by 24% month-over-month growth in March alone. This is a very important metric for the launch, as these prescriptions compound over the life of the product. This has been more challenging during the pandemic, hence our generous $10 prescription copay card. Studies have shown nearly 25% of all new-to-brand prescriptions are abandoned when patients were asked to pay more than $20.00. This quarter, we saw an increased reliance on that copay program, more than expected reliance, actually. The majority of this is due to the fact our copay card supported patients during a time of increased economic hardship, along with seasonal first quarter insurance deductible resets and other insurance dynamics. As the economy continues to improve, we've adjusted and will continue to adjust the copay card program to align with more traditional measures. At this early stage of the launch, the importance of patients having positive experiences at every step of the process and remaining on therapy is key to establishing patient goodwill and building momentum. Having a co-pay assistance program was deeply valued by physicians and patients, especially during these difficult times. And while it adversely impacted net revenue for the first quarter, the underlying prescription demand growth of almost 50% was very strong, and it is a good indication for patients on therapy and future script volumes. I'd remind you that while patients have begun to return to physician offices, there is a natural lag from an office visit to a written Nexlatal-Nexlazet prescription, dependent on step-throughs, prior authorizations, and a number of other factors, such as the number of necessary lipid panels, patient history, and so forth. but it typically requires a few months from initial office visit to a filled prescription. However, as we progress into the second half of this year, based on current trends, we have an opportunity to make an accelerated impact with our strategic commercial initiatives as we all emerge from this pandemic here in the U.S. With that, I'll now turn the call over to Rick for remarks on our financial performance.
spk05: Thanks, Sheldon. I'll now provide some commentary on our first quarter financial results that were highlighted in our press release from earlier today. As Tim and Sheldon touched upon, our U.S. net product revenue during the quarter were adversely impacted by lower net price driven by higher copay card utilization and increases in managed care rebates. Copay card usage was a contributing factor as a high number of patients remained on therapy and utilized the copay card as insurance deductibles reset. Last year, we designed our copay card program to prioritize patient access and affordability during the pandemic. In addition, there was also an impact from additional formulary coverage that came into effect during the first quarter. Based on the timing of the various payer contract start dates, Aspirion kept the original launch strategy buy-down design of the copay card in place as a bridge to ensure that patients under these plans could get on treatment with ease and stay on therapy, reinforcing our commitment to ensuring patients have a positive experience in accessing our medicines. Managed care rebates also increased during the quarter based on the timing of the various start dates of the payer contracts. And again, as Sheldon noted, two of our biggest commercial plans elevated Nexlatal and Nexlazet to preferred tiers. We do not provide our gross to net discount rates for competitive reasons, but as I've stated previously, gross to nets for our medicines will fluctuate due to seasonality as additional Medicare Part D contracts are implemented, coverage expands, and prescription volumes increase. Over time, as we complete our contracting, plans fully implement coverage and volume scales up, We anticipate our gross to net for our medicines will normalize and net price will improve. Accordingly, in the first quarter, U.S. net product revenue was $6.4 million, and total revenue amounted to approximately $8 million. This includes approximately $600,000 of royalty revenue from our collaborations. On expenses, R&D expense for the first quarter totaled approximately $28 million, down 33% sequentially and 19% year over year. SG&A expense was approximately $61 million for the first quarter, which included a one-time charge of $13.3 million related to the settlement of a 2016 lawsuit. Adjusting for the one-time settlement costs, SG&A expense was approximately $48 million for the first quarter, up 15% year-over-year due to the commercialization of Nexlatal and Nexlazet, and down 22% from the fourth quarter of 2020. We continue to expect full-year 2021 R&D expense to fall between $120 to $130 million, and SG&A expenses to be between $200 to $210 million. Note that these amounts are inclusive of approximately $30 million in non-cash expense for the full year associated with stock-based compensation. Our pro forma cash balance as of March 31st is approximately $300 million, including the funds to be received from the expanded Daiichi-Saint-Pierre partnership and the third tranche of our agreement with Oberlin Capital. With the additional milestones associated with the expanded Daiichi-Sankyo relationship, Aspirian now has over $1.2 billion in future milestone payments from our collaborations that we expect will feed our balance sheet with continued execution by our partners. We remain committed to prudently managing expenses and ensuring the organization is adequately funded to advance the business. In the second quarter, we once again demonstrated our ability to fund our company in an advantageous manner. Going forward, you should expect us to continue to balance cash spend against growth potential and the cash needs to ensure that the business is adequately resourced for future growth. With that, I will turn it back over to Tim for closing remarks.
spk02: Thank you, Rick. The first quarter was one of implementation and execution by our new commercial leadership team. We remain optimistic for a shifting tide in the US as these new initiatives gain traction and the conditions for improved uptake of our medicines continues to improve. I want to thank our colleagues and partners for their unwavering dedication and hard work week in and week out, and especially to our shareholders for their continued support and fortitude, especially over the past year. With that, operator, please poll for questions.
spk08: Thank you. Ladies and gentlemen, if you'd like to ask a question, please press star then 1 on your touchtone telephone. Again, if you would like to ask a question, please press star then 1. One moment, please, for our first question. Our first question comes from Michael Yee of Jefferies. Your line is open.
spk10: Hi, guys. Thanks for the question, and congrats on the recent capital additions. That's great. I had two questions. One was, can you better explain the difference of net price change on the impact of total revenues? In other words, if you take your script growth and look at the consensus numbers, I think you would have been around $11 or $12 million, but you reported $6.4 million. Is the difference there essentially all rebating? And I should think about net price going forward as 30%, 40%, 50% lower. Can you just talk about that and if we're thinking about it right? Question two is for Tim. You mentioned many times you would love to do everything that are in the best ways of long-term shareholders. Can you just shed some light on what that means? Are there scenarios or options or things you're thinking about and help point us in the right direction? Thank you.
spk02: Sure. Thanks. Thanks, Mike. I will answer your second question first and then provide some commentary. So on your first question, I think with the recent expansion of the relationship with Daiichi, that is another ex-U.S. deal that, as you noted, has fortified the balance sheet, also expanded this partnership with Daichi Sankyo, who has amazing strength in commercializing cardiovascular therapies. We've already seen that in Europe, and we will see it in the ASCA region as they get traction there. I think I emphasized, and you certainly caught as well, our focus now is on this improving U.S. environment. It's You know, we see it. I think we all see it with the vaccination rates and other things that are developing here. Patients, as Sheldon said, returning to their physicians. And so we need to accelerate the speed and reach of our medicines to patients, physicians, and payers. But again, we have to do that in ways that are in the best interest of our shareholders. So I don't think we can be more specific than that. But, you know, We absolutely have an interest in expanding the reach and speed of our medicines, but again, balancing that with doing what's best for our long-term shareholders. With respect to the comment about net pricing, maybe I'll just highlight again something that both I said and Sheldon said as well, which is the very best indicator of the health of our franchise here in the U.S. is that prescription demand growth? Best indicator of our progress and the health of the franchise. We are going to, as you correctly highlighted, we are going to see some variation in net pricing, but it will normalize, so I don't think you should think of this as what we saw here in the first quarter as continuing, but I'll pivot to Sheldon and Rick for a bit more detail on that. Mike.
spk05: Tim Stenzelman, Yes. Thanks, Tim. Thanks, Mike. So I'll start. As we highlighted in the prepared remarks, the impact on net price was really twofold, increases in rebates and utilization of the copay card. So again, first on rebates and again specifically going back to comparisons, of prior quarter, it's, you know, not necessarily apples to apples. There's a seasonality impact, but there is additional coverage coming online, naturally increased rebate expense, and that's a good thing. It's indicating pull-through on the payer contracts. And as Sheldon mentioned, two of our biggest plans, you know, just elevate our medicines So that had an increase in rebate expense as well. On copay, I'll start, but I'll ask Sheldon to provide a little bit of commentary there. But during the quarter, we did see some seasonality in the first quarter, increased benefits on the copay card, really reinforcing our commitment to making sure that patients remain on therapy and have a good experience with our medicine. With that backdrop, as Tim mentioned, as we complete all of our contracting, plans have fully implemented coverage, net prices for our medicines will normalize and improve. But, you know, there is a variability aspect given some seasonality. Sheldon, anything to add on the copay card? Yes, great.
spk03: Thanks, Rick. And, Michael, thank you for the question. First of all, again, I think one thing that we're very encouraged by was, as Tim mentioned, the 46% growth that we saw quarter over quarter. And that was even keeping in mind that both January and February were two months where COVID was spiking. So we're pleased to see that. The copay card program was designed right from the start of the launch. It was to ensure that pricing and access were not deterrent in patients taking their medicines nor physicians prescribing. Due to COVID, we actually extended the program. It included additional benefits to support patients during what we thought were generally economic hardships. So it was extended for months beyond what normally would be typically planned. And as Rick mentioned, even with commercial coverage in place, as we know, first quarter is always a tricky quarter. The copay card was a priority. We know that with managed care programs, they're adjudicating, they're going through prior authorizations, et cetera. And we didn't want patients to wait for their medication. So it was a way to bridge patients over to the medication while waiting for insurance coverage to be pulled through. So although it negatively impacted revenues for the first quarter, It's a good indication of future prescription volume. Moving forward, we are adjusting our copay card to better align with industry standards now that the market and the economy are improving. Just yesterday, we heard over 100 million people in the United States are now vaccinated. And as we've said in the past, we always felt that we'd be moving more to normalcy as we got to the second half of the year.
spk02: So let me just summarize that. because we gave you a lot of information, but highlighting that script and demand growth, which was almost 50%, best indicator of the health of the franchise. We expect net pricing to normalize, though, and what that means is that we're going to see some of these effects moderate going forward, better economy, Q1 seasonality behind us, And then as you just heard Sheldon say, lower utilization of the copay card.
spk10: Got it. Thank you guys very much.
spk08: Thanks, Mike. Thank you. Our next question comes from Jason Butler of JMP Securities. Your line is open.
spk04: Thanks for taking the questions. I had two also. Sheldon, you talked about the enhanced product positioning. Can you give us any more information granularity there about what your message now is. And was this a case of a lack of awareness or do you think there was any confusion with prescribers or potential prescribers that needed to be fixed? And then second question, it looks like that the prescription growth in the last few weeks of the first quarter, first couple weeks of the second quarter has come down somewhat. Any color there? And is it in any way tied to the rollout of the new commercial strategies? For example, as that works through, you'd hope to see a return to the growth rate you saw earlier in the first quarter. Thanks.
spk03: Great, yes. Hi, Jason, and thank you for the question. Let me start first with your first question regarding positioning. I won't go into all the specifics of positioning, but the two areas that you mentioned, one being awareness, two being confusion – and in light of the company actually launching in a COVID environment, amplified both of those as issues. What we've done now is we truly have simplified our message, and we really have the ability now to tell physicians in what the appropriate patient is where both Nexlozet or Nexlital can be used. You know, there's many patients out there that are taking a statin and they're taking ezetimibe and they are still not at LDL goal. There's a significant opportunity there for Nexlatol and Nexlazet to play a role. And with our favorable commercial coverage and also now with our improving Medicare Part D coverage with over 60% of Medicare patients covered, we feel that we have a significant opportunity. As it relates to prescription volume in the first quarter, so what we have seen is that in the first few weeks of April, when you looked across the market, all products were relatively flat. We were actually exhibiting approximately a 3% week-over-week growth. And our hypotheses there was that it was flat due to Easter and many vacations, et cetera, that were taking place. That hypothesis was actually proven via some IQVIA data that we received, which essentially showed that. I would say in the later weeks of April, we've actually seen momentum continue as it relates to growth of Nexlozet and Nexlatal. As a matter of fact, in the week ending April 23rd, we actually were surpassing most other products that you would compare Nexlatal in the lipid market and actually some products even in the diabetes market as well. So we have seen momentum starting to pick up and we'll continue to monitor as the months go by.
spk04: Okay, that's great. Thanks for the color. Thanks for the questions.
spk08: Sure. Thank you. Our next question comes from Jeff Meekin of Bank of America. Your line is open.
spk09: Hey, guys. Thanks for taking the question. I just had a couple. So when you think about the pricing environment, what would give you more leverage with payers aside from higher volume? Would the outcomes data next year, for example, have an impact? I'm just trying to think about, you know, the pricing picture in the next year or two. And then just from a competitive standpoint, you know, I just wanted to know on Inquisiran, is there any kind of warehousing effect or any sort of pause you think ahead of that launch and maybe just help us with kind of how you would expect that to shake up competitively. Thank you very much.
spk02: Yeah, thanks, Jeff. I'll answer the second question first on Inclisarin and then ask Sheldon to comment on pricing. I think like many of you, we're following development in the space. I guess like most folks don't know when the other injectable PCFK9 will launch. I think for the longest time we've been suggesting that that will be a competitive factor in the injectable PCFK9 space. But as we've talked about previously, the positioning of our medicines is as oral once daily therapies that are far more affordable than the injectable therapies, more convenient, more traditional therapies, if you think about the LDL cholesterol lowering space. And again, thinking about how other medications in not only in our therapeutic category, in diabetes category, The philosophy is exhaust all oral options before going to injectables. So we think that could be a potentially wonderful medicine for patients. It's another win there, but we think it is in that category of injectable PCFK9s. And our medicines are clearly positioned as efficacious, tolerable medicines that are oral convenient. used before injectable therapies.
spk03: Thanks, Tim. Jeff, let me speak to payer perspective and messaging to payers and also your question related to CBOT, all this related to pricing. So the first thing I would say is from a pricing perspective, in all my years in commercializing products, this is the first time that nobody has ever come to us to say you're priced too high. I think for us, we have an impeccable market access team combined with an HEOR team where we have been able to successfully position Nexlazet and Nexlatal not only based upon the price but the value that that product brings to not only the payers and the patients. This is really also the last oral therapy before you'd have to go to an injectable PCSK9 and there's advantages to that as well. Of course, CVOT will be an additional benefit in the future, but something that we've actually have done, we've gone back to payers, and the strategy that I talked about in the last question and that I talked about also when we did our announcement, that strategy is a clear strategy that payers understand, and they now have a better appreciation of the fit of where Nexla's at and Nexla Tall falls. So that in combination with, as I mentioned, our health economics outcomes research story really helps solidify the positioning of this product. It's the reason why Humana added it to their formulary as well. And as we mentioned, that increases our Medicare lives to, you know, by 9 million, almost 60%. So that message has really resonated.
spk09: Okay, great. Thanks, guys. I appreciate it. Thank you, Jeff.
spk08: Thank you. Our next question comes from Joe Thome of Calvin & Company. Your line is open.
spk06: Hi there. Thank you for taking my questions. First one, just on any additional ex-U.S. partnership deals, how big of a priority is getting a partnership deal for China in reference to kind of balancing out the U.S. landscape first? How are you prioritizing that? And then second was just on sort of the cadence of the copay card. If you can give us any additional details in terms of how many patients are using the copay card. And you did mention that $20 copay amount, that 25% of new-to-brand prescriptions were abandoned. In patients that do have full insurance coverage, is there still going to be some sticker shock here if the copay card program is removed? Just how should we be thinking about that cadence? Thank you.
spk02: Thanks, Joe. I'll take your first question then. Again, I think the expanded partnership with Daiichi outside the U.S., the so-called Ask a Region, provides us with the other ex-U.S. geographies, as you highlighted. And that gives leading companies in those geographies. But I think as we've highlighted, really an emphasis here on this improving U.S. market. And our real focus is going to be on our medicines to patients, healthcare providers and payers in ways I think that's a focus, but I think, as you highlighted, there's certainly a focus has to be now on the U.S. Sheldon? Thank you.
spk03: ...to the copay card, and will those adjustments have any effect on pay... ...simply saying, no, we do not believe so. The copay card, what we're going... In the past, it included additional months of benefit. And what we want to do now is to normalize the copay card, put less reliance on the copay card. Again, we have over 90% coverage. We're past that aspect of we have to go through prior authorizations, and they are delayed. So we see minimal disruption. The copay card will still be available. And to the question of how many patients were using it, again, it was mostly due to the fact of, you know, these patients not having... Great.
spk09: Thank you.
spk08: Thank you, Joe. Thank you. Our next question comes from Derek Archula of People. Your line is open.
spk12: Hey, guys. Good evening. Thanks for taking the questions, and congrats on the progress here. So just a couple questions from us. Maybe the first one for Sheldon, as you think about, you know, kind of the easing of COVID restrictions and more people kind of going into the offices, do you have any specific commercial initiatives planned as you kind of move into, you know, that timeframe and certainly into the second half? And the second question is probably for Rick. You talked about the milestones that you've piled up here through some of these transactions and deals that you've done. Any color on when we could see another milestone? Would it be more commercially driven or would it be something regulatory driven around the outcomes data? Thanks.
spk03: Great. Yep. So... what will we be doing as we emerge from COVID. Obviously, the focus is on pulling through our new strategy and also going to position and redefine our targeting list based upon our new positioning. This is effective May the 1st, a few days ago, so really making that a priority are really within our demographic. We're also amplifying our medical science liaisons. We're rolling out a new scientific platform. We're also amplifying our education at two major meetings, both ACC and AHA. So really creating that surround sound and that awareness that we was launched, and we're excited about these programs. I mentioned the real world Southwest with Dr. Eric Peterson, formerly of DCRI. Physicians will be involved in the study, touching the product, et cetera.
spk05: So that's... And Derek, to cover off the question on the collaboration milestone, of the completion of this expanded relationship with Daiichi over 1.2 billion to expect in the future. In terms of context, there's a mix between milestone-based, but then there's also a healthy portion related to sales-based milestones. We'll continue to come in and feed our balance sheet as one... completion, finalization of the cardiovascular outcomes trial execute commercially in their respective territories. on the timing of when those are expected to be received, but obviously everyone as we report quarterly.
spk12: Thank you.
spk08: Thank you. Our next question comes from Jeff Hung of Morgan Stanley. Your line is open.
spk01: Thanks for taking the questions. Sorry if part of this is a repeat. Part of it was breaking out, so I'm not sure if it's just my line. You mentioned plans to adjust the copay card going forward. Would that decision point be triggered by some metric like time on market or a number of scripts, or is it something else? And then I have a follow-up.
spk02: Yep.
spk03: Yeah, we just heard – I just got a message as well that we're – I apologize for that. I'm just going to check to see if you can hear me clearly for just a second. Can you?
spk01: Yeah, it faded out a little bit, but I can hear you. Okay, great.
spk03: Maybe I'll – I'm going to switch positions here. Sorry. Okay. Okay. We're in a room here, and I'm ruining my boss's glasses. Okay. So, for your question, as it relates to the copay card program, the program, it was really to provide access to patients. We kept it going. There was economic pressures, hardship, et cetera. Typically, the copay card is extended months beyond that, months beyond what was typically planned. I think with the commercial coverage that we have in place, we can rely more on receiving the coverage through their insurance companies. As we went into the first quarter, or I should say the first quarter and prior authorizations to get their prescription. So we wanted to make sure they had a bridge to get... Now we feel that based upon our coverage as it relates to... That, you know, we're going to be focusing more on utilizing our contracts... And hence, we better adjusted our copay card to align with essentially industry standards improving as well.
spk01: We will not have to rely on that benefit as much. Okay. I think I got that. Thanks. And then can you talk about how the DTC campaign has gone relative to your expectations and what kind of decision factors remain to determine if you might run a traditional consumer TV campaign, if that's even something you're considering? Thanks.
spk03: Sure. Yeah. I think there's a time and a place for DTC, but now... active DTC campaign currently ongoing or planned. We're really just focusing on our recommendations and thought leaders to pull through our products.
spk01: Thank you.
spk08: Thank you. Thank you. One moment, please. I'm going to check to see if we can get that fixed for you. It'll just be one moment. Thank you. Looks like our next question comes from Paul Chow of Goldman Sachs. Your line is open.
spk12: Paul, are you there?
spk11: Yes, I'm here. Can you hear me? Yes. Okay, great. Thanks. So, first question is just on the prescription side. update us on what the current refill rate is and, you know, just how it's been trending over the prior quarters, and then I had a follow-up.
spk03: Yes. Hi, Paul. Our refill rate actually looks comparable to other products. We've benchmarked it to products such as Entresto, Jardian, Tribelsis, et cetera, and it's in the high 50s. Of course, you're never going to get 100% from a refill perspective, but we're encouraged by our refill rates.
spk11: Okay. Thanks for that detail. Then as a follow-up on the co-pay program, you know, given the sort of payer framework you've laid out with 90%, you know, commercial and the 60% and growing Medicare, just in terms of the timeframe for sort of the fading or transition of the co-pay program, is that over the course of 21 really the right timeframe that you're trying to guide the street to or will this continue to be still a factor or a driver in the 22 timeframe as well? Thank you very much.
spk03: Sure. Let me just speak to the copay card itself, and I'll ask Rick if he has any additional questions. But as it relates to the copay card and what we're doing to essentially better align it with industry standards, that's happening immediately. We're doing that right now. We're working on that, and that's something that we should have completed earlier. will be completed in the next few weeks or so.
spk05: Yeah, Paul, and this is Rick. Just to follow up on the question on the, you know, copay card gross to net, you know, again, just kind of coming back, you know, we don't provide gross to net estimates or rates, obviously, for competitive purposes. Those will continue to vary. So, you know, we're not providing guidance on that topic. And then, obviously, as it relates to revenue, you know, no revenue guidance this year, but you should expect that next year.
spk11: Okay. Thank you.
spk08: Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating, and have a great day. You may all disconnect.
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