Esperion Therapeutics, Inc. Q2 FY2020 Earnings Call

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 call over to Ben Church, Corporate Communications at Esperion. Please go ahead, sir.

Good afternoon and welcome to the conference call. I am Ben Church from the Corporate Communications team at Esperion. Joining me today are Tim Mayleben, our President and CEO; Mark Glickman, our Chief Commercial Officer; and Rick Bartram, our Chief Financial Officer. I would like to remind everyone that the information shared during this call is subject to the Safe Harbor provisions of the Private Securities Litigation Reform Act. Please be aware that management will be making forward-looking statements, and actual results may differ significantly from those expected due to various risks and uncertainties. Our forward-looking statements are fully qualified by the cautionary notes included in today’s press release and SEC filings. This call contains time-sensitive information accurate as of August 10, 2020. We do not have a duty to update any forward-looking statements after this call. This conference call and webcast are being recorded and will be archived. We issued a press release earlier today highlighting the topics of this call, and it can be accessed on our website in the Investors and Media section. We will start with prepared remarks before opening up for questions. After the call, the team will be available for follow-up inquiries, and you can schedule a 15-minute discussion by emailing investorrelations@esperion.com. I will now turn the call over to our President and CEO, Tim Mayleben. Tim?

Thank you, Ben. Good afternoon and thank you to everyone joining us on today's conference call. As we all know the last several months of 2020 have been unlike any other time in history. We are living in unprecedented times, where we see life shifting almost daily as communities, states, countries and the world attempt to reduce the spread of COVID-19 while also minimizing the impact on everyday life. Our hearts go out to those who have experienced losses and we thank the healthcare workers, researchers and others serving on the front lines of this pandemic. During this time, we've also been reminded of the importance of managing chronic cardiovascular health conditions, given the recognition that cardiovascular disease is a co-morbidity for COVID-19 and that many people are less active due to stay-at-home orders and are reluctant to see or unable to see their healthcare providers. So more than ever, we view our singular focus on lipid management as a strength that will help us deliver on our commitment to bringing affordable and convenient oral once-daily non-statin LDL-cholesterol lowering medicines to the millions of patients who are not at goal despite the availability of statins. For Esperion, it was an extraordinary quarter. First, as you'll hear from Mark, we pivoted to a virtual launch at the height of the pandemic in order to make our medicines available to healthcare providers and patients as soon as possible. NEXLETOL was commercially available on March 30; NEXLIZET on June 4, which was ahead of schedule due to physician demand. We are making great progress. But as anticipated, COVID-19 has been a headwind for both launches in large part because it made healthcare provider offices inaccessible to patients and our customer-facing team, leading to lower new patient starts. In addition, wholesalers were more cautious in ordering, particularly for new products like ours, which impacted our net product revenue in the quarter. And while we can't control either of the issues I just mentioned, our team adapted and over-delivered on everything under our control. I want to highlight several positive tailwinds gaining momentum as we look ahead, and that Mark will provide more insights on shortly. So first, while there was certainly a major headwind from COVID-19, our new prescription volumes early in the quarter grew significantly since then, achieving a monthly average of almost 400% growth over the first four months, with more than 4,000 total prescriptions in July alone. Second, the COVID-19 pandemic impacted our customer-facing team early in the quarter. They could engage with healthcare providers virtually or through traditional in-person engagement at only about 5% in April, meaning 5% of the number of healthcare provider engagements we'd expect in a normal pre-COVID-19 environment, but reached about 70% of pre-COVID-19 levels by the end of July. Third, we have already achieved our one-year March 2021 managed care coverage goals for broad and high-quality commercial and Medicare Part D coverage. This formulary coverage provides the lowest possible cost to patients and the fewest obstacles for healthcare providers to prescribe our medicines. And finally, we see patients, healthcare providers, healthcare systems and payers having adapted. They are now better positioned to operate in this new normal than they were at the start of the pandemic. We also see public health policy experts and governments better positioned to implement policies that will balance public health needs and individual health needs. Turning now to business development. Our team continues to differentiate Esperion with potential partners, maximize the global value of our medicines and position our business for financial outperformance over the long-term through committed upfront payments, future development and revenue milestones, and ex-U.S. net product sales royalties. We announced a precedent-setting Japan development and commercial collaboration with Otsuka in April, and we received the second $150 million from DSE in June, resulting in more than $210 million in total revenue for the second quarter. DSE, which has responsibility for all commercial decisions in Europe, is on track to launch our medicines before the end of the year, providing another tailwind for our business. Let me turn now to CLEAR Outcomes—our 14,000 patient global cardiovascular outcomes trial of bempedoic acid in statin intolerant patients. I'm pleased to report that this landmark event-driven study has accumulated almost 50% of the four-component MACE primary endpoints. We remain confident that the successful completion of the CLEAR Outcome study on track for the second half of 2022 will be an important milestone for our medicines. And it goes without saying, but I'll say it, we truly appreciate all the efforts of our colleagues, the doctors and healthcare providers seeing the study, and healthcare providers and patients for their commitment to this landmark trial. Finally, as we think about what's ahead, we intend to remain focused on lipid management, a disease area where we still see severe underrepresentation of innovation and R&D spend, despite the continued ravages of cardiovascular disease in the U.S. and around the world. Beyond label expansion for cardiovascular disease risk reduction upon successful completion of clear outcomes and subsequent approval, we see multiple opportunities for expansion including other oral once-daily combination tablets with bempedoic acid that will expand the NEXLETOL franchise in 2023 and beyond. Overall, with record collaboration revenue, a very strong balance sheet, near-perfect pricing and positioning of our medicines, precedent-setting Managed Care coverage continuing to come online, and increasing access to healthcare providers by our customer-facing team, we are very well positioned to continue to accelerate prescription volume growth and our business. We have entered the second half of the year in a stronger position than ever before. And with that, I'll turn the call over to Mark Glickman, our Chief Commercial Officer to highlight the strong foundation and momentum we have on our launch of both NEXLETOL and NEXLIZET. Mark?

Thanks, Tim. As Tim highlighted, COVID-19 has been a headwind against the initial trajectory of our launches, but there are many reasons for optimism about the accelerating growth of NEXLETOL and NEXLIZET in the second half of 2020 and beyond. As a reminder, we had just begun our commercial efforts last March right as COVID hit. We made the decision to transition to a completely virtual launch, which means we spent the first couple of months pivoting our strategy and training our customer-facing team. These are trying uncertain times, as we all experience. I am incredibly proud of how the team adapted during this crisis. The progress we made really demonstrates our team's grit and endurance. We are very well positioned with differentiated pricing and positioning of our medicines, the main focus of our pre-launch efforts. Our medicines complement standard oral, once-daily maximally tolerated statin therapy and are priced affordably. This was a deliberate strategy that aligns with our mission to remove barriers to access for our affordable, convenient oral, once-daily medicines. By successfully pricing and positioning our medicines, we have placed ourselves in a position to outperform on a critical component of any medicine’s success: Managed Care coverage. Payers have seen the clinical and economic value of our medicines and we have achieved both high-quality and broad coverage, approximately 80% commercial and approximately 50% Medicare Part D. This coverage as of July 1 and just three months after our initial launch in April, is up significantly from the 50% commercial coverage and 20% Medicare Part D coverage we spoke about in early May. The breadth and quality of Managed Care coverage is even ahead of our own very high internal expectations for this point of the launch and will only continue to improve as we progress through the second half of the year. The quality of coverage, as reflected by formulary tier, is the key to the economics of Managed Care coverage and where we are positioned strongly compared to other new medicines. On this slide, you'll find a graphical representation of the different tiers of coverage. As you'll see, not all coverage is created equally. As the tier increases, so does the financial burden to patients. Many companies emphasize the breadth of their coverage without discussing the quality of coverage. For Esperion, we're achieving high-quality coverage and preferred tiers, along with amazing breadth of that coverage. NEXLETOL and NEXLIZET are preferred brand medicines, meaning covered lives are almost exclusively Tier 2 with some Tier 3. Thus this makes them easy to prescribe by healthcare practitioners and readily available for patients. We've been very successful in our discussions with major payers, including Express Scripts, CVS Caremark, Prime Therapeutics, Cigna, and Anthem among others. Our goal is always to achieve formulary coverage at an optimal tier with the lowest possible financial burden, low out-of-pocket costs of co-pays for patients while also achieving attractive economics for Esperion. I couldn't be more pleased with the managed care relationships we've built. By the one-year anniversary of our launch date in March 2021, I expect we'll have virtually all covered lives on the contract. Now let's turn to the component of our commercial launch that was most impacted by COVID-19, the ability of our team to engage with healthcare practitioners early in the quarter. We were cautious at launch considering the pressures and needs of healthcare providers, and we have respected their time. Although we are now seeing improved trends, at healthcare systems, healthcare providers, and patients have adapted to the new normal. COVID certainly impacted all early field team efforts. As many of you have heard me say, pre-COVID our approximately 300-person customer-facing team would expect to have approximately 10,000 healthcare provider interactions each week. Instead, in April, due to stay-at-home orders in almost every state across the United States and time spent retraining our field sales team on virtual detailing, healthcare provider engagement by our customer-facing team was nearly non-existent. You heard me say it was up to 5% of normal. The prescription volumes, of course, reflected the lack of HCP interactions of our territory managers. By June, however, with states reopening, our territory managers averaged over 5,000 HCP engagements each week, about 50% of what we expect in pre-COVID levels. In addition, NEXLIZET was made commercially available on June 4, and our territory managers began to promote this important medicine on June 22, eight days before the end of the quarter. The positive momentum in June has continued into this quarter with our territory managers averaging almost 7,000 healthcare practitioner engagements each week, about 70% of what we would expect pre-COVID. During the quarter, we also saw increasing momentum with our virtual speaker bureau, what we call Smart Casts. These virtual meetings leverage national key opinion leaders to provide peer-to-peer education on NEXLETOL and NEXLIZET to other healthcare providers. We conducted eight of these meetings in May, 81 in June, and 148 in July. Cumulatively, well over 4,000 healthcare practitioners have participated in this important peer-to-peer education program, including more than 2,000 in July alone. So we’re seeing and hearing from healthcare providers that it’s still very early in the launch, only four months since our virtual launch in April, but here are a few anecdotes. Healthcare practitioners are receiving lab results from the early patients on our medicines and the feedback is incredibly consistent: NEXLETOL is meeting and most often exceeding the healthcare practitioners' expectations. We recently surveyed 100 healthcare practitioners. Amazingly, more than 90% of participants are familiar or aware of NEXLETOL and NEXLIZET. Similarly, healthcare practitioners in the survey say they intend to prescribe our medicine as soon as they’re able to meet with their patients. What does this all mean? There's a high level of interest in our medicines as we gain more exposure and access to healthcare practitioners. Historical industry trends show that it takes an average of about six territory managers and healthcare provider interactions for a healthcare practitioner to adopt a new medicine. To date, we have reached thousands of healthcare providers. Through the end of July, we’ve had over 2,100 unique healthcare practitioners writing prescriptions. Our increased interactions with healthcare providers are already translating into growth in our prescriptions, and this will continue. July prescription volume was 97% higher than June. Our medicines already account for almost 10% of new-to-brand prescriptions in the branded LDL-C lowering drug market. We surpassed 1,000 weekly retail prescription equivalents in July. What makes the prescription volume growth in July so impressive is that it was achieved despite the second wave of COVID-19 and additional closures in several states across the country. But perhaps the best context for the launch trajectory of our medicines is the comparison with the previous launches of other LDL-C lowering medicines, the PCSK9s. In July, the launch trajectory of our medicine is ahead of where the PCSK9 inhibitors were assessed at this point in their launches on a combined basis. Perhaps as importantly, we accomplished this with a focused, experienced field team of less than 300 territory managers, compared to the estimated 1,500 territory managers supporting the PCSK9 launches back in 2015, obviously, with no COVID-19 issues. Overall, we have just begun to scratch the surface of the potential of these medicines. We are confident that in the weeks and quarters to come, you will see the number of prescriptions further accelerate, which will in turn drive revenue growth through the increasing wholesale orders. We will continue to use Xarelto as a launch analog and are confident that we will file the assay curve on our path to peak penetration of approximately 1.8 million patients in the United States. This is exactly what you and we want to hear and see at this point in this COVID – in this COVID-19 environment. I'd like to now turn the call over to Rick Bartram, for our financial update and then Tim will provide closing remarks. Rick?

Thanks, Mark. I'll now provide some comments on our financial results for the second quarter ended June 30th, along with our robust capital position with over $300 million in cash as highlighted in our press release from earlier today. First, I'll start with total revenue, which was $212 million for the second quarter, our highest quarterly to-date revenue. This includes approximately $211 million of collaboration revenue and over $0.5 million of net product revenue. Total revenue for the first six months of 2020 was approximately $214 million and again was the highest first half revenue recognized to-date in our company's history. For comparison, we recorded $146 million of revenue during the first six months of 2019. This represents an increase of almost 50% in total revenue from the prior year, driven by our robust business development performance, as well as sales of NEXLETOL and NEXLIZET. Let me also take a moment to put our launch to-date net product revenue of $1.5 million into context for you. But before I do that, I want to remind everyone that we recognize product revenue at the point in time when our direct customers, our wholesalers receive the product at their distribution centers. Since NEXLETOL was not commercially available until March 30th, the $1 million of net product revenue we recorded in the first quarter were initial stocking orders from our wholesalers to support the commercial availability of NEXLETOL. Second quarter net product revenue was impacted by COVID-19 and by more measured wholesaler inventory management and reordering patterns. We believe this cautious behavior was intensified for NEXLETOL and NEXLIZET because they are newly launched products with limited prescription history. At this point in time, we will not be providing additional commentary on sell-side consensus revenue estimates or providing guidance on full-year 2020 net product revenue. As you heard from Mark, the launch trajectory of our medicines in the midst of this pandemic is enviable and we have confidence in the current and future trajectory of prescription volumes. I encourage you to follow the weekly prescription volumes reported by Symphony and IQVIA since these represent an 80% to 90% capture rate of weekly prescriptions of our products. Let me now turn briefly to expenses. R&D expenses totaled $35 million for the second quarter compared to $43 million for the comparable period last year. The decrease was attributable to the completion of the enrollment of the CLEAR Outcome study last year; R&D expenses have now come generally to a steady-state level due to the full enrollment of CLEAR Outcomes and we're seeing this result reflected in the second quarter R&D expense. SG&A expenses were $48 million for the second quarter compared to $13 million for the comparable period last year. The increase was primarily attributable to the cost to support the commercialization of NEXLETOL and NEXLIZET, the build-out of our 300-member customer-facing team, and other costs to support our rapid growth as a commercial organization. Esperion reported net income of approximately $125 million, or diluted net income per share of $4.32 for the second quarter ended 2020. As our country came out of stay-at-home orders during late Q2, we have begun to resume our planned level of spending. Consistent with our prior quarter's guidance, we expect R&D expenses to be between $135 million and $145 million, and SG&A expenses to be between $200 million to $210 million. These are full-year estimates, but do not include the expected $30 million of non-cash expenses, primarily associated with stock-based compensation, non-cash interest expense. So those amounts will need to be added back to your models as you look to estimate the full-year operating expense. Lastly, turning to liquidity and cash resources. During the second quarter, we continued to strengthen our balance sheet and had over $300 million in cash at the end of the period. Our cash position was strengthened from milestone payments from Otsuka and the DSE collaborations along with net product revenue, and we also remain on track to complete a rest of world collaboration by year-end. Finally, recall there's an additional $50 million available to us at our option under the Oberland agreement that is expected to be accessible next year. As a result, these existing and future cash resources are expected to provide us with the necessary cash flows to continue to support the U.S. commercial launch and operational profitability. So to summarize, we're in a very strong financial position, even taking into consideration the impacts of COVID-19. And with that, I'll turn it back to Tim for closing remarks. Tim?

Thank you, Rick. Before we close, I want to emphasize the accomplishments of our lipid management team in the second quarter and first half of the year laying the groundwork for long-term success for our business. As I said earlier, while we expect some continued headwinds to our business from COVID-19, as you heard today, our company has a number of tailwinds that are gaining strength and we're in a stronger position than ever. This is a defining time for Esperion, one we’ve built toward for more than a decade. We’ve developed practice-changing non-statin oral once-daily medicines for lowering bad cholesterol and we are now getting them into the hands of healthcare providers and patients in the U.S. who need them. Outside the U.S., we have very strong and capable development and commercialization partners that will follow in the same footsteps in the months and years ahead. This is what motivates us every day. I can tell you, there is a tremendous sense of urgency at Esperion. We are all eager, we are determined, and we are looking forward to the growth ahead of us. With that, Mark, Rick, and I will now take your questions. Howard, please open the line for questions.

Yes sir. Our first question comes from Michael Yee from Jefferies. Your line is open.

Hi guys. Thanks for the question and congrats on the progress so far. Hey Tim, it looks like the message is you've got a lot of payer coverage 80% commercial lives, scripts exceeding PCSK9, all of the things you talked about there and highlighted. But on the other hand, as you've noted before, analysts have a ramp at $8 million to $9 million in the third quarter, $15 million or something in the fourth quarter. So, is the message something that you're not commenting on those numbers necessarily in light of COVID, but you feel that the fundamentals and the launch are going well? So, let it play out, but we need to reflect some of this COVID stuff in the models. Can you just maybe tie those two things together prior to the messages you've said in the past about consensus? Thank you so much.

Sure. Yes. Thank you, Mike for the question and I appreciate that being the first question because it's one that Mark, Rick, and I have spent a fair amount of time on as we were leading up to this call. So, I think the best thing for me to do is to maybe tip it to Rick to start. And so Rick why don't you provide comment? And then I'll follow up.

Sure. Yes. Thanks Mike. So, as we mentioned, we're not providing qualitative or quantitative commentary on sell-side models, quarterly, full commentary, and that not providing guidance on the full year net product revenue. This is pretty typical for companies that are at similar stages in their commercial evolution. Now with good intent, we acknowledged some comfort in May, but we don't believe it's going to continue to benefit anyone in a continuous shifting dynamic in COVID. But I think the key piece is you heard from us the launch trajectory of our medicines in the midst of this pandemic is enviable and we've got confidence in the current and future trajectory of the prescription volumes. And also just following the weekly prescription volumes, those are highly visible in Symphony and IQVIA and represent a pretty good capture rate of the weekly prescriptions of our products.

I want to remind everyone that COVID-19 is a once-in-a-century pandemic; it hasn't happened for 100 years. Therefore, we cannot compare Q2 to anything from the past. I've mentioned that we should set Q2 aside and not use it as a measure of our medicines' attractiveness and growth during this initial launch period, for all the reasons Mark discussed on the call. Importantly, if you look at July, we had significantly more prescriptions, over 4,000, which exceeds the total for all of Q2 by about 35%, and that was just in one month. So, I emphasize that we should focus on the weekly data and trajectory, as these are the best indicators of our launch's progress. Pay attention to the recent indicators Mark has highlighted, like the level of healthcare professional engagements and weekly prescription volumes; these give a clearer picture of where we are heading.

Yes. Got it. Thank you guys.

Thank you. Our next question or comment comes from the line of Geoff Meacham from Bank of America. Your line is open.

Hi, guys. This is Geoff. Thanks for the question.

Hey, Geoff.

Just had a couple of questions. Tim, who would you say is the biggest swing factor to the launch? Just between now and year-end, I know you made a lot of success with payers and that's probably the answer. And then the second question is, when you look at the outcome study, is the event rate kind of in line with what you're thinking from a time perspective? And is there a chance for perhaps an earlier data disclosure based on the events? Thank you.

Thanks for the question, Geoff. I'll address the second question first and then Mark, I'll pass the first one over to you. Regarding the CV outcomes trial, we've accumulated nearly 50% of the events, which is slightly ahead of our projections. An ongoing concern is that some patients are delaying visits to their physicians and neglecting their health care compared to pre-COVID-19, resulting in missed or unmade appointments. This has raised worries within the healthcare community about health deterioration, including cardiovascular health. We certainly do not wish this situation on anyone, but individuals with severe cardiovascular disease do experience events, and we track those for the patients enrolled in our study. Therefore, it is quite possible that we may see an increase in event accumulation in this 14,000 patient landmark study of statin-intolerant patients. As we gather more events, whether it reaches 75% or 100%, we will update you. In this current environment, it might lead to an acceleration of events, but we are not relying on that. We still anticipate results in the second half of 2022, but if there is an acceleration, we will definitely inform you. Mark, can I turn the first question over to you?

Thank you, Tim and Geoff. What we observed in July is precisely what we need for the remainder of the year. We do not want to see another spike, but during the previous one, both my marketing and sales teams were able to adapt in real time. This adaptability is crucial for us, as we need more physician contacts. We noticed a significant increase in July in our interactions with physicians, along with more physicians beginning to prescribe NEXLETOL and NEXLIZET. As we progress into the second half of the year, regardless of potential spikes, the sales team is now operating in a hybrid mode. They are ready to engage through virtual calls, peer-to-peer contacts, live calls, or a combination of these methods to maintain momentum in contacting physicians. The marketing team is also continuously adapting their tools to keep pace with the evolving situation. In summary, our focus is on physician contacts, touch points, and encouraging physicians to start prescribing and adopting the product. We witnessed considerable progress in July, and we remain optimistic about this trend continuing throughout the rest of the year.

Okay, great. Thanks guys.

Thank you, Geoff.

Thank you. Our next question comes from the line of Chris Shibutani from Cowen. Your line is open.

Thanks very much. As we think about kind of the back half of this year and into 2021 and kind of intermediate to longer term, the level of spending and investment that you're going to need, particularly on the sales and marketing of this, to achieve the kinds of objectives that not just for 2020, but also for 2021 that everyone is thinking about. Tim, and then as well, Rick, can you comment on what you think it’s going to take? I know you've committed to initiating this launch with your targeted sales force in the U.S. But what kind of milestones do you expect you need to get a sense for whether something more is going to need to happen, whether it's a partnership? And, Rick, sort of, where the Street is thinking about and we appreciate the 2020 guidance on the $200 million or so OpEx spend for this year. That does imply, if I look at what we've done so far, a step-up in the second half. Should that trajectory continue into the next year as well, framing it against the background of this question? I'm asking about, kind of, the intermediate term outlook and how you'll achieve that? Thank you.

Thank you, Chris, for the questions. I'll start, but Rick will follow up. Regarding the U.S. launch, I want to reiterate that we know these medicines thoroughly and understand the labels completely. We have assembled a highly experienced field sales team, with our territory managers averaging about twelve years of sales experience, particularly in cardiovascular sales. They are well-acquainted with their territories and the healthcare providers within them. Similarly, our marketing team is also very experienced and innovative. We are extremely confident in our team’s ability to implement our commercial business plan. There's a history, as Mark mentioned regarding the PCSK9s from August, where allocating many resources did not prove effective. However, we now have strong Managed Care coverage and signed contracts that are currently being implemented and will continue to be throughout the year. As this coverage expands, we expect to see increasing momentum, not only from our field force engaging more with healthcare providers but also on the Managed Care front. We remain very confident in our launch and its metrics. As Mark and Rick said, we should monitor the weekly prescriptions, which will help us track the growth of our products. With that, I’ll pass it to Rick to add further insights and to discuss the expense side.

Yeah. Sure. Thanks Chris. So on SG&A expense, yeah. So as we've said, full year $200 million to $210 million. Again that's sort of excluding some of the non-cash items. And as you look at the first two quarters, not necessarily representative of the quarterly run rate for a number of factors; didn't onboard the sales force until March. Second quarter expenses had some optimization due to COVID. So we do think that Q3 and Q4 are going to be more of a return to normalcy as we get back to our spending. And we'll be pretty good proxies for representative quarterly run rates. I haven't provided formal guidance in 2021. That's something that we'll provide next year. But what I want to bring everyone's attention back to is just the funding status and over $300 million in cash as of this quarter. And as we look ahead, the expected U.S. product sales, along with the cash flows from our collaborations are more than sufficient to fund operations and allow us to continue to deliver on the business plan through profitability. Also, draw your attention that there's the additional $50 million under the Oberland agreement. And then we're on track for a rest of the world agreement by the end of the year. So given those funding sources, now that we're generating product revenues, we've got a lot more optionality in our business plans to maximize shareholder value.

Great. Thanks for the additional commentary.

Thank you, Chris.

Thank you. Our next question comes from the line of Marty Auster from Credit Suisse. Your line is open.

Thanks for taking my question. I wanted to follow-up maybe briefly on Chris' question, the last question there. I was curious if you could help clarify what triggers to enable you to access the $50 million from Oberland? And then also on the rest of world agreement that you're anticipating, could you frame that in terms of kind of relative size to the recently signed a super deal, for example? And then finally, if you could comment on over the balance of 2020 and 2021, are there any milestones you might be eligible for from either the Daiichi or the Otsuka transaction? Thanks.

Thank you, Marty. This is Tim. I'll start with the last couple of questions and then tip it to Rick. So with respect to a rest of world deal, we said when we started on our discussions again about rest of world, non-U.S., non-EU that we would expect a nine-figure upfront from the collaboration if it was one, or whether it was two potential partners. So I think as we highlighted, we got $60 million from the Otsuka collaboration upfront. So doing the math, you'd expect something in the same ballpark for a rest of world deal, perhaps, so tens of millions of dollars. And then with respect to additional milestones, the Otsuka collaboration does not have milestones, but keep in mind that they're paying all of the development expenses, which we estimate over the next two to three years is going to be around $100 million. And then with respect to DSE, we expect to obviously starting later this year start to realize royalties from the EU revenue that they produce. So I'll pause there and tip it back to Rick.

Yeah. Thanks, Tim. Yeah, so Marty, I think the only open question was just around the Oberland agreement. So under that agreement, that $50 million is available to us upon meeting certain sales objectives, which in the agreement is $100 million of trailing six months of sales.

Okay. Thanks. And then, Tim maybe as a follow-up, I think in the past we've talked about whether there might be additional capital needs ahead of CVOT readout. I'm curious how you're thinking about that now and kind of what the preferred mechanism might be to kind of excess capital that would do through debt equity further royalty range something like that?

Yeah. Rick, do you mind if I tip it to you on that?

Yeah. Sure. So thanks, Marty. Again, just going back, robust cash position right now, $300 million in cash. We talked about the cash flows available to Esperion. So we feel very confident that we're funded through profitability. And now that we are generating revenue, we have a lot of optionality. So it's a great position that we're in financially as well as these precedent-setting business development deals that have some cash flows coming through steadily.

Got it. Thanks, Rick.

Okay. Thanks, Marty.

Thank you. Our next question comes from the line of Jason Butler from JMP Securities. Your line is open.

Hi, thanks for taking the question, and congrats on the progress in the quarter. Just one for Mark in terms of the quality of coverage, obviously, you've had success in achieving your goals with Tier 2 and Tier 3 coverage. But can you talk a little bit about how the effort or documentation from the healthcare providers and their office has played out relative to your expectations going in?

Sure. Mark, since Jason asked that to you directly. Please go ahead.

Absolutely. Thanks, Jason. When we sign the contracts for managed care coverage, we consider all paperwork and prior authorizations. The negotiations are upfront, so over time the prior authorizations and the paperwork need to align with our expectations since that's the basis for the rebates. We are improving, but due to COVID, not all managed care plans are moving as quickly as we would like. For example, there is a longer gap between signing the contract and the actual paperwork and adjudication of products. This takes weeks, not months. However, from a contracting and communication standpoint, the prior authorizations are aligned. We are essentially looking for prior authorizations to match the labels in most cases, which has been true for all contracts. As the plans are implemented and contracts are activated, we expect to see minimal prior authorizations, if any, throughout the process. We are negotiating, and there has been little pushback on an aggressive prior authorization process; it's been relatively passive. That’s our expectation going forward. The timeline is slightly delayed after we sign the contract, but as I mentioned, it’s weeks, not months.

Okay. Great. And then just any update you can give us on your plans to start incorporating DTC and digital marketing programs? Thank you.

Yes. Mark, go ahead.

So we're already doing both DTC and all the digital media aspects currently. So that was always planned for the fourth quarter as far as we'll conduct online, media outreach, social media and all those aspects. Regarding ASCVD, which I think may have been part of that question, we're evaluating that. We do look for metrics as far as coverage, which we could check on. And we're just keeping a very close eye on patients returning to physicians' offices, physicians' offices opening up before we proceed with that. So we'll watch those metrics very closely. And we'll be reevaluating that throughout the third and probably the fourth quarter to make that decision. But again, I want to stress as far as media consumer that's all starting or been implemented now all the social media aspects.

Great. Thanks again for taking my question.

Thanks, Jason.

Thank you. Our next question or comment comes from the line of Chad Messer from Needham & Company. Your line is open.

Great. Thanks. Good evening. Thanks for taking my questions. And congrats on the progress in a tough environment. I'm interested in anything you can share on sort of the difference in profile between patient or prescriber between NEXLIZET and NEXLETOL? I know you only had a couple months with the combo and it's not the most ideal circumstances. But just wondering if that split is going sort of as expected? Or if there's anything that's not expected that you've kind of learned now that you've got both the monotherapy and a combo pill out there. And then I was also wondering if you have any insight into who are taking these products? Are they being prescribed by themselves or on top of statins both? Any clue what the mix is? Thanks.

Sure. Hey, thank you, Chad. I think those are – again, I think as you said at the start of your questions, it's still early. So I think I'm going to tip this to Mark, but just recognize that it's more anecdotal than tremendous amounts of data. But I think as we say, we have almost 300 intelligence officers out in the field in the form of our very experienced territory managers. And so we do have some insights which Mark is closest to and I'll ask him to take it from here.

So thanks, Tim. Thanks, Chad. So regarding NEXLIZET, it's progressing beautifully. I would say a bit ahead of where we would expect and when we conducted the market research and the positioning, NEXLETOL was really for those patients who tolerate a statin who – but needed additional LDL lowering, but could take really could ramp up a statin and still need more. Whereas NEXLIZET was where that patient couldn’t get to a higher statin where massive tolerated statin much lower. Managed Care coverage came on board soon after the launch of NEXLIZET closely watching and closely matching that of NEXLETOL, but it was a little bit delayed, so to see NEXLIZET catching up so fast despite Managed Care coverages coming on just it is timing of the launch and it has really been exciting. In that – I referenced the market research that we recently conducted with 100 health care practitioners. What we heard loud and clear, physicians are already seeing LDL levels starting to rise in this COVID environment. And I think it's not necessarily a surprise Chad, but it's going to change I think the use profile for NEXLIZET is going to probably expand as patients have been a bit sedentary due to maybe shelter-in-place not working and just the stress of COVID. So they're already reporting, they're seeing significant increases in LDL. I think that that's going to lead itself to more of NEXLIZET and the heavier LDL reduction. I want to stress physicians. The early feedback has been mostly on NEXLETOL. And the feedback on the efficacy and safety profile has been really positive. So everything is according to plan. I do think NEXLIZET is going to be the workforce. I think it may be quicker than we anticipated due to COVID. One last point I want to stress here is also physicians did ask us to accelerate NEXLIZET as they anticipated that LDLs would start increasing in this COVID environment. And they just were unsure if they'd be able to initiate any type of injections or any type of therapies for the PCSK9s in patients who so desperately need additional LDL lowering. And that's why we went ahead and offered NEXLIZET about a month earlier than we had originally planned. We want to make sure that we did have the offering out there for those patients who need that additional lowering in these trying times. So it's progressing beautifully, mostly according to plan. NEXLIZET is a little bit ahead.

Great. Thanks. Appreciate that.

Thank you. Our next question comes from the line of Joel Beatty from Citi. Your line is open.

Hi. Thanks for taking the question. This question is on the expectation that cash will be sufficient through profitability. Could you discuss whether the outlook is achievable if the coronavirus pandemic persists or even worsens or does that assume a resolution better some point in time? Thanks.

Hi, Joel. Thanks. This is Tim. I'm going to start, but I'll quickly pass it to Rick. You've been following the company for many years, so you know our team well. We always remind everyone that we've been managing this business through various market cycles for a long time, both in good and bad economic times. Our track record is strong. Additionally, we have a Midwestern mindset, which means we are naturally conservative in how we operate and fund the business. These principles are always at the forefront of our thoughts when considering the business. With that, I’ll hand it over to Rick for more detailed responses to your question.

Yes. Thanks. So Joel, obviously, we're running a multitude of scenarios as we look at our financial runway and financial health. COVID is unpredictable. So we can't possibly run every single scenario that could be a possible outcome. But what we expect is the continued trend that we've demonstrated in July of prescriptions building. And that gives us confidence to continue to deliver the business plan. As well as the financial strength that we currently have as well as the cash resources that we expect to be coming in in the future. So feel confident saying today we're funded through profitability. Obviously, the COVID environment that we're all going through is not sustainable. And we think that that's going to be something that is overcome in the near-term.

Okay. Thank you.

Thanks, Joel.

Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your line is open.

Hi, thanks. Good afternoon, everyone. My first question is for Mark. And I was just wondering if you could maybe either provide qualitative or quantitative data on just with the availability of NEXLIZET how your touch points with physicians have either changed or increased? Have docs who have been just sort of waiting for it who are now responding to your salesforce? Or any color along those lines would be helpful.

Yeah. So, Paul, thanks for the question. We absolutely have positioned waiting for it. Again, that was part of the drive. Even at the key opinion leader level, where they just really wanted – they knew that in this situation that NEXLIZET was coming and they really didn't want to wait for NEXLIZET to come to start – stop prescribing. It's really early to have specifics yet as to who's exclusive to NEXLETOL and NEXLIZET. What we do see is an acceleration of physicians prescribing NEXLETOL since we've offered NEXLIZET, but I won't be able to have acquisition level data. And when I do receive it, it will just be for July and that would be the first month. But as far as the physicians that were at the cardiologists and the physicians that we're getting into as part of our regular call list, I think they were very comfortable to initiate NEXLETOL knowing that NEXLIZET was coming and thinking that they could always switch over later on, so I don't think it was an impediment. But like I said, we definitely have physicians who say hey it's going to be so close, I'll just wait for NEXLIZET. And again, part of the reason to accelerate it. The uptake and understanding of NEXLETOL was really, really quick regarding the educational process and we accelerated it. I'll have more data over the next few months about the actual makeup of the prescribers for each product.

Great. Thanks for that color, Mark. And maybe just as a follow-up, just with regards to insurance and payer dynamics. I recognize some of this has only flipped online quite recently, but could you maybe also comment just on the rate of approvals and how much – what sort of changes you've seen in terms of paid or covered drug versus medical exception versus what you saw in the second quarter more recently? Thank you very much.

Hey, thank you, Paul. And Mark I'll tip this to you again.

Thanks, Tim. And thanks, Paul. Yeah. So we're just now starting to see – we signed contracts really soon after launch. And we've actually had a very respectable approval rate for managed care. And we've been running ahead of other recent launches. So we were very pleased, but then it did level off although we were signing more contracts, we were just seeing now – and again, I'm positive this is just a COVID loading contract situation. And we're seeing now in the plans that we signed, we're starting to see the approvals start to come up, and the rejections come down. So like I said before, this is a weeks delay, not months, but over the last, I would say two to three weeks, we started to see an improvement in actual managed care approvals and we expect to see that all throughout the second half of the year down to a high single-digit or very low double-digit rejection rate. So we feel like we're on that path now. It was definitely a little bit delayed throughout June, but we feel like we're back on track now.

Okay. Thank you very much.

Hey, thank you, Paul.

Thank you. That concludes our question-and-answer session and our conference for today. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a wonderful day.