Esperion Therapeutics, Inc. Q3 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 over to Ben Church, Investor Relations and Corporate Communications at Esperion. Please go ahead, sir.

Thank you, Patricia. Good afternoon, and welcome to Esperion's Third Quarter 2020 Financial Results and Company Update Conference Call and Webcast. I'm Ben Church. I'm responsible for Investor Relations and Corporate Communications here at Esperion. With me on today's call are Tim Mayleben, President and Chief Executive Officer; Mark Glickman, Chief Commercial Officer; and Rick Bartram, Chief Financial Officer. I’d like 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 as of the date of the slide broadcast, November 2, 2020. 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.esperion.com within the Investors and Media section. We will begin with prepared comments and then open the call for your questions. Following today's call, the team will be available for follow-up questions. Please e-mail investorrelations@esperion.com to schedule 15 minutes to speak with the team. I'd now like to turn the call over to our President and CEO, Tim Mayleben. Tim?

Thank you, Ben, and good afternoon, everyone. We appreciate you joining our third quarter conference call and thank you for your continued interest in Esperion. We know it is an incredibly busy and historic week, and we will be watching the election results closely, along with the rest of you. And in case you need one final nudge, I want to encourage everyone to go vote, if you haven't already. Today, I'll share our progress on our mission to bring new and innovative oral medicines to patients with uncontrolled high cholesterol. Our commitment is to lipid management for everyone. And at a high level, we are seeing an increasing need for our medicines. Report after report highlights the ever-widening need to refocus and reeducate about cholesterol, as patients are increasingly neglecting their long-term health for a myriad of reasons. We're seeing significantly fewer visits to primary care physicians and increased reliance on telemedicine, which has limitations in assessing cardiovascular risk factors like bad cholesterol, all while we are often more sedentary than ever. This long-term opportunity to improve cardiovascular health of millions of patients continues to energize and motivate us, as we navigate through a dynamic environment for companies, health care providers, and patients. The go-to approaches of commercial launches past are just no longer relevant. With this backdrop in mind, we believe Esperion is very well positioned as the only commercialized public company with a singular focus on lowering bad cholesterol. We have an entire company waking up every morning to do whatever we can to help patients and their health care providers with bad cholesterol. A key element to building a strong foundation for any commercial launch is educating health care providers and patients about our medicines and our company. When we have this opportunity with health care providers, we find that we have an interested audience that recognizes the need for our non-statin, easily accessible once-daily pills and appreciates our focus on battling bad cholesterol. This was confirmed by a survey we recently conducted with cardiologists and primary care physicians regarding the types of interactions with companies they prefer. When asked if they would rather see a specialist in a disease area with a new medicine or a big pharma representative that carries a bigger bag, they overwhelmingly prefer specialists right now. It's a small sample, but it gives us tremendous optimism in our near and long-term plans to build our company around both innovation and a focus on cholesterol. Cardiovascular disease remains the number one killer in the world. As the only company truly focused on LDL cholesterol, the bad cholesterol, we have much to contribute to changing this tragic course. The scary reality is that cardiovascular disease is increasing. In fact, in 2017, even before the pandemic, the U.S. CDC said they expected deaths from cardiovascular disease to increase by 25% by 2030. Despite this, there has been a serious lack of innovation in addressing the need for cholesterol lowering, especially convenient oral, non-statin medicines. Each new medicine that comes to market has the potential to really make a major impact. We're building a company that knows our focus on bad cholesterol and non-statin medicines will deliver tremendous societal and financial value, a company that overcomes adversity, a company that partners with like-minded companies at times, but also confidently takes the road alone at other times. We embarked on this journey over 10 years ago by disrupting the neglected area of non-statin oral LDL cholesterol-lowering medicines. Our goal is to fulfill unmet patient needs, not conform to a traditional well-worn path. So with that in mind, I'd ask you to consider what short-term and long-term success looks like in this environment. In an industry with countless examples of historical launches and launch metrics, how do we measure success when all bets are off? As one of the few, very few companies truly launching new medicines in this environment, we simply do not have the luxury to keep our customer-facing teams at home. A little later in the call, we'll provide you our insights into what short-term and long-term success looks like. Right now, I'd ask you to consider the power of momentum. While we are hyper-focused on getting our medicines into the hands of all who need them in the short term, we are facing some temporary obstacles in accomplishing that. However, there's a broader story of progress that demonstrates our team's ability to influence key stakeholders. I'd like to highlight a few additional proof points on our progress as a company. First, today marked the European launch of our medicines. This is an incredible milestone that significantly expands the number of patients who will benefit from our medicines and opens a new revenue stream for us. We've been working very closely with our partner Daiichi Sankyo Europe to prepare and share best practices for launching in this unprecedented environment. Our medicines are now available in Germany, the biggest country in the region. The U.K. launch is planned for early next year, followed by a staggered launch to the rest of Europe in line with the country-by-country process for access and reimbursement. We participated in their virtual prelaunch meetings, which were attended by their more than 1,000-person European cardiovascular team, and one thing is certain; Daiichi Sankyo Europe is highly optimistic about the need for our medicines in the EU and is extremely well-prepared for the launch there. Next, I'd like to share some more news that shows the progress our team is making in the U.S. The American Association of Clinical Endocrinologists recently published their updated lipid guidelines, which now include bempedoic acid. As many of you know, the incorporation of new medicines like ours in professional guidelines provides a key and enduring source of validation for any new medicine. This is the first lipid guideline from a major medical society to include bempedoic acid, which is an important step in coalition building. I'm also pleased to report that across the board, we are hearing from health care providers that our medicines are meeting or even exceeding their expectations. Third, I'm incredibly proud of how we are partnering with patient groups to establish Esperion as a patient-centric organization with value and access as core values. All companies say this, but how many get to start from initial launch like we do? This is something big pharma is backing into after years of reputation degradation. We are literally rallying around it from the start. Our purpose, as I said earlier, is lipid management for everyone, meaning we don't stop until everyone has achieved their recommended LDL levels. Just a couple of examples of our patient group partnerships are our work with both HealthyWomen and the FH Foundation. We are generating joint content to reach distinct patients together. These patient groups echo the need for additional non-statin medicines to fight bad cholesterol, which is a powerful surround-sound approach to reaching patients. Finally, I want to highlight that last week, the American Heart Journal published the CLEAR Outcomes CVOT Study design paper. This article underscored the importance of demonstrating cardiovascular risk reduction for patients who are considered statin-intolerant. You heard us say for years that nearly 10 million patients in the U.S. with high LDL cholesterol levels are not taking statins due to tolerability issues. In fact, never before have patients unable or unwilling to take statins been the focus of a cardiovascular outcome study despite the clear need for non-statin treatment options. We believe the CLEAR Outcomes study will provide added confidence in bempedoic acid's potential for patients and their physicians whose ultimate objective is to reduce the risk of cardiovascular events in this underserved patient population. Our team, which has a proven record of execution, continues to create momentum around our singular purpose. We're building a company for the long term and have laid the critical foundation on which we can continue to grow. We can't deny, however, that we are facing headwinds in this environment, but we're keenly aware of the patient need. We understand the urgency, we're listening to stakeholders, adapting to the environment, and we are confident in our path ahead. With that, I'll turn the call over to Mark to share more color on our commercial efforts. Mark?

Thanks, Tim, and good afternoon, everyone. There are many perspectives about how our launch is going, and I'm looking forward to sharing mine. Our experienced commercial team, while new, is overcoming daily obstacles to deliver double-digit monthly growth. Is it slower than we'd expect pre-COVID? Yes. Are we building a steadily growing sustainable business that can quickly accelerate when conditions improve? Absolutely. Our team is out there every day doing absolutely everything they can while many of their peers stay at home along with many of us. That's true grit and dedication. Our team's tenacity and sense of urgency is paying off. Last quarter, we highlighted the three pillars we are building on to drive a successful launch: managed care coverage, pricing and positioning, and health care provider engagement. We are in a strong position on all three pillars. We have established broad, high-quality managed care coverage. Our medicines have low list prices aligning with our mission to provide affordable, convenient, oral once-daily medicines to patients. Regarding health care practitioner engagement, there are push and pull factors to getting a prescription ready. The push can be equated to our representative walking into a health care provider's office to promote our medicines. The pull can be represented by a patient not at goal and going to their doctor for a new approach. The key intersection of this push-pull is the health care provider. This slide highlights how COVID has hampered both sides of this dynamic. On the left, we see the old normal—a full waiting room where a representative could break through a known environment and see an opportunity in the clinic where health care providers were seeing dozens of patients a day. On the video looping by the side, you can see the new normal showing what has become all too familiar to us: near-empty waiting rooms with reduced capacity to allow for social distancing and primary care visits down overall. Additionally, many in-person visits are being replaced by telemedicine, which has limitations in the management of cardiovascular health. This trend was highlighted recently in a JAMA study, which showed that cholesterol levels and blood pressure are falling through the cracks in virtual interactions. In fact, blood pressure monitoring was down approximately 15% in this patient population. I'll also note that while we saw physician offices reopening in some regions this quarter, this was often for patient visits and not for industry representatives. As a result, average weekly interactions remained flat from Q2 at about 70% of what we would expect for pre-COVID levels. The good news is that despite these dynamics, we are growing demand. Throughout the third quarter, we saw growth in scripts for both NEXLETOL and NEXLIZET while encouraging our representatives to engage with health care providers where and how they can. We have seen consistent double-digit prescription growth month after month, which was over 40% for both August and September. In fact, quarter 3 script volume in terms of RPEs is up over 500%, despite significant headwinds impacting every aspect of the promotion of our products, including our own commitment to making a conscientious launch during Q2 in the U.S. For comparison, year-to-date in 2020, the entire LDL-cholesterol new-to-brand prescription market, a critical driver of new drug launches, is down approximately 30%. As we think about the launch more broadly, there are no analogs to what we're doing that will accurately capture our opportunity, but we remain confident in the long-term success of NEXLETOL and NEXLIZET based on the following. For starters, our managed care coverage continues to impress. We now have the majority of payer contracts in place, covering over 90% of the commercial and 50% of Medicare Part D plans. We are confident that within a year, our initial launch will have nearly all relevant lives covered, with the vast majority of preferred brand tiers offering the lowest patient out-of-pocket costs. As the last bit of coverage comes online, especially on the Part D side, we expect to see continued improvements in prescription volume and the elimination of any friction from prescribing and accessing our medicines. Second, feedback on our medicines continues to be very positive. As we shared last quarter, we hear of results exceeding label expectations and positive comments on ease of access and use by patients. Encouragingly, early adopting physicians have increased the number of written prescriptions over time, which we believe reflects the positive results achieved by the initial patients they’ve started on therapy. Third, our field force continues to expand the breadth and frequency of their health care practitioner interactions. We are committed to reaching health care providers on their terms as we outlined when we launched conscientiously a few months back. You would expect we are especially focused on health care providers in the higher deciles who represent the most significant opportunity in volume of prescriptions and likelihood of prescribing, and we believe we are likely one of the leaders in terms of in-person visits right now. I want to emphasize again that our representatives are doing this responsibly and following all safety protocols. I wanted to share a couple of additional highlights that give us confidence in our future growth. In October, we introduced an important element to our U.S. launch strategy, our DTC, or direct-to-consumer campaign, which is named Break the Cycle. This campaign intends to increase awareness of the never-ending cycle patients experience with lowering bad cholesterol and how NEXLETOL provides an innovative solution to help break that cycle. We are very pleased with the responses to the DTC campaign so far, and we'll take an adaptive approach to managing that campaign, listening to the market to inform strategic decisions on how to advance the program. As Tim mentioned, another highlight is the AACE's published update to the lipid guidelines, giving further credibility and validation to bempedoic acid's inclusion in the cholesterol treatment paradigm. We believe this guideline update will resonate. Overall, this patient population needs convenient, non-statin oral, once-daily medicines such as NEXLETOL and NEXLIZET now more than ever. If the pandemic has done anything, it has brought a heightened sense of focus on individual health, and as the country and world recover, so too will Esperion. We look forward to providing you with additional updates on commercial progress in the months to come. With that, I will now turn the call over to Rick.

Thanks, Mark. I'll now provide some comments on our financial results for the third quarter ended September 30, 2020, as highlighted in our press release from earlier today. Total revenue for the third quarter was $3.8 million. That includes $3.3 million of net product revenue, which is five times that of the second quarter and approximately $0.5 million in collaboration revenue. As Tim mentioned, our partner Daiichi Sankyo Europe initiated their launch of NILEMDO and NUSTENDI in Germany this week. Going forward, we expect to recognize increasing royalty revenues and tiered sales milestones from the execution of our European partner, whom we do not doubt will be very successful. We chose Daiichi Sankyo Europe as our commercial partner due to their long and strong track record in growing cardiovascular medicines and their ability to drive impact with physicians and patients across Europe in the cardiovascular space, exemplified by their continuing success with LIXIANA. We look forward to continuing our successful partnership with them for years to come. Continuing on, R&D expenses for the third quarter totaled $35 million, flat when compared to the second quarter of 2020. We expect R&D expenses to remain at a steady-state level for the remainder of 2020 and into 2021, as a result of CLEAR Outcomes becoming fully enrolled in August of last year. SG&A expenses were about $49 million for the third quarter. This was up slightly from the $48 million in the second quarter, reflecting a small increase in selling and promotional activity expenses related to the U.S. launch of NEXLETOL and NEXLIZET. The net loss for the third quarter of 2020 was approximately $85 million, or a basic and diluted net loss per share of $3.07. When we look ahead to the full year, we continue to expect R&D expenses will be between $135 million to $145 million, as well as SG&A expenses will be between $200 million to $210 million, which will incorporate costs related to our recently launched DTC campaign. Additionally, we still expect $30 million of non-cash stock-based compensation for the full year on top of the previously mentioned amounts. As a topic, I know you're all very interested in, it's worth noting that generally it is atypical for a company to provide revenue guidance this early in the launch. Further compounded by the ongoing COVID-19 pandemic and the resulting uncertainty, predictability is limited at this stage. Therefore, we do not plan to provide revenue guidance prior to 2022. On cash resources, we ended the third quarter with about $216 million in cash on hand and continue to be very confident in our financial strength given the multiple funding sources we have at our disposal. As a reminder, we have an existing revenue-based funding agreement with our partner Oberland Capital. As part of that agreement, there is an incremental $50 million we expect to become available to us next year. As we've also over-delivered on past ex-U.S. collaboration agreements, you should have great confidence in our ability to deliver on the final rest-of-world agreement or agreements, which remain on track for the end of this year. As a reminder, the upfront payments from a rest-of-world deal and the Otsuka agreement put in place in the second quarter are expected to total nine figures. Similarly, I want to highlight for all of you that Esperion has over $1 billion in future milestone payments from our existing collaborations that will continue to feed our balance sheet as our partners continue to execute over time. Of course, there's also the potential to monetize these substantial future milestones over time as well. We've demonstrated our ability to fund the company in a very advantageous manner over the last eight years, particularly as evidenced by the non-equity dilutive funding solutions we've implemented over the past couple of years. We will continue to ensure the organization is adequately funded to advance and create value with a clear and continued preference for non-equity dilutive financing sources. We are fully committed to maintaining appropriate cash balances through profitability and for the long-term business opportunities. With that, I will turn it back over to Tim for closing comments.

Thank you, Rick. So I would just like to close with this. You've heard us stress a number of times the importance of medicines such as ours. Our mission is to ensure patients at the center of what we do are not forgotten. Those who either cannot tolerate a statin or require additional non-statin LDL-cholesterol lowering should be a priority. And they are with us. They deserve to have an easy, once-daily oral non-statin medicine that's priced appropriately and available to them. We're driving towards this mission every day. The third quarter was a continuation of that. We made several steps forward positioning Esperion for long-term success on our way to becoming the lipid management company. Before we turn to Q&A, I just want to say again, stay safe, stay healthy and go vote. With that, Patricia, if you would please pool for questions.

Thank you. Your first question comes from Jessica Fye from JPMorgan. Your line is open.

This is Daniel for Jessica Fye. Last quarter, you stated that the current cash, coupled with revenue, is sufficient to fund continued operations through profitability. Today's press release just states sufficient to fund continued operations without qualifying until when. So, first, do cash and revenue fund Esperion to profitability? And second, if so, does that assume you'll have access to the next $50 million milestone from Oberland?

Thanks, Daniel. Rick, can you take that one?

Sure. Yes. Thanks, Daniel for the question. So, as we stated in the prepared remarks, we ended the quarter with over $215 million. We also stated that we expect that we're going to have access to the additional $50 million under the Oberland agreement next year. I just want to bring you back to, we are highly conscious of the burn rate. We have a Midwest conservative mentality, and we've always managed the burn appropriately for the organization. We've demonstrated our ability to fund the company in a very advantageous manner over the last eight years and it's recently evidenced by the non-equity dilutive solutions. So as of the quarter, we have a very strong cash balance and the additional $50 million from Oberland. We have the rest-of-world deal proceeding very well where that will yield an upfront payment. To remind you, we've already received over $360 million in payments from our collaborations. We have another $1 billion remaining of those milestones due to us. Again, this is before any double-digit royalty payments we will receive. We're going to continue to ensure the organization is adequately funded to create value with a clear preference for non-equity dilutive sources. We're committed to maintaining the appropriate cash balances.

Thank you. And if I can sneak one more. You mentioned how should we think about R&D next year. But in terms of SG&A, how should we think about the run rate into 2021?

Yes. Rick, do you want to keep going?

Yes, sure. So, Daniel, I think on the SG&A side, as you've seen this year, SG&A has steadily increased. Some of the spend has been decelerated due to the pandemic. But in terms of spend next year, you can look at quarterly builds for our full year guidance to give you estimates for next year at this time. Then next year on the annual report, we'll provide full year burn guidance as we usually do at that timeframe.

Great. Thanks for taking our questions.

Thanks, Daniel.

Your next question comes from Michael Yee from Jefferies. Your line is open.

Hi, everyone. Thank you for the question. Following that, you might understand that there is a focus on the balance sheet. It seems like everyone is considering the operational expense run rate and the cash balance, suggesting that with the anticipated revenues next year, you could potentially fall below one year's worth of cash, even with all the milestones you discussed. Given this, there’s been a shift in how cash sources to profitability and operations are communicated. Can you clarify if equity financing is an option you would consider? Also, could you confirm that it’s still on the table? That’s my first question. My second question is more strategic, Tim. As we look toward 2021, with the uncertainty surrounding COVID, it's possible that the situation could extend into next year, and trends may remain consistent. Are you open to considering all options, including strategic U.S. assistance, acquisitions, or anything that serves the best interests of shareholders? The financing aspect is a concern for many, and I think there's curiosity about how this evolves in 2021. Thank you.

Sure, Mike, I'll address the second question first. As we've mentioned before, the management team owns close to 20% of the company, so we certainly share the same concerns as other shareholders. We've been managing this business for nearly a decade, and I want to emphasize that we have historically funded the company well, initially through equity financings. Over the past couple of years, we've secured over $360 million in non-equity dilutive capital, and with the Oberland partnership, that figure exceeds $500 million. It surprises us that some in the investment community see equity financing as the sole means of funding for companies at our developmental stage. We have over $1 billion in future milestones ahead of us, excluding royalties, which gives us various options moving forward. We recognize that our timelines might differ from those of the investment community, and we will be mindful in our approach to bridging that gap. Regarding strategic options, we have continuously explored partnerships both in the U.S. and internationally. We will keep these alternatives in mind as we move forward. Now, I'll turn it over to Rick for any further insights.

Yes, Tim. Just to add, Mike, as Tim mentioned, there's optionality. We're conservatively managing the business, making sure that we have the appropriate cash balances on the balance sheet and we'll continue to do that like we always have over the last eight years or so.

Thanks.

The next question is from Geoff Meacham from Bank of America. Your line is open.

Hey, guys. Thanks a lot for the question. Just had a couple. Commercially, can you talk a little bit about the NEXLIZET versus NEXLETOL split? I think if you look at the scripts, NEXLIZET has been outpacing. I just wanted to view it from the ground up in terms of a demand perspective. And then to follow on a previous question, when we see the COVID case accelerations of late, just help us with how that informs your commercial investments in 2021? Do you feel like it's going to be more of the same? Is there any leverage that you could get from brand awareness, etc., in 2021 that you don't have to fight the sort of virtual launch, if you will, and the investments you have to make there today? I just want to know how that picture looks commercially in 2021. Thank you.

Yes. Sure. So, maybe I'll take the second question first. As both Rick and Mark highlighted, COVID-19 is this pandemic that we're all living with and no one is working like they did before COVID. I think we would expect that, like perhaps many of you, that COVID will continue to have an impact. I think like many of you, we're also expecting that we've all gotten a little bit smarter about how to adapt to this pandemic. What’s safe, what are safety protocols, and what are safe activities to pursue and which ones aren't? I think we're all smarter about those things. As we think about the future, we think there's certainly a degree of uncertainty about the future. But as 2021 unfolds, as you've heard Mark refer to when conditions improve, this is really going to be a very strong recovery story because the early indications from physicians, our health care providers that are prescribing our product is that it's easy to use, easy to get approved by payers. The efficacy they're seeing is, as I think both Mark and I highlighted, as good or better often than they expected. All the things we've been talking about for years: it's oral, it's once daily, it's non-statin, and it doesn't have the muscle aches and pains frequently associated with statins. All of those things are coming into reality. As the effects of the pandemic dissipate, I think it's reasonable to expect sometime in 2021 when they will, then this is really a strong recovery. Patients will start to go back to their physicians. They will, as we've been saying, pay attention to their cardiovascular health, which they're not doing as much today. I think you heard Mark say that when you look at script volumes for new script volumes for statins, even they're down 30% since the beginning of the year. If you look at PCSK9 volumes, they're down 40% since pre-COVID. A lot of folks are practicing medical distancing in this area, but it also implies that as this dissipates, it's an incredibly strong recovery as patients and their physicians return to addressing their cardiovascular health. Mark, do you want to take the first question?

Sure. Thanks, Tim. NEXLIZET, just to remind everyone, we launched approximately two months after NEXLETOL hit the market. Despite that slight delay, that also led to managed care. We didn't go for the managed care contracts until about two months later as well. Despite that, NEXLIZET is now approaching 50% of the business on a weekly basis. We anticipate that by year-end, NEXLIZET will be the predominant prescribed product. I'm not sure there's more that you want from that question. It's consistently in the mid-40s each week. We've gone over 50% once or twice. It clearly is going to be our workhorse. As managed care catches up to NEXLETOL, we can expect it to accelerate from there.

Okay. Now that's helpful. Thanks, guys.

Yeah. You’re welcome.

Thanks, Geoff.

Your next question is from Joseph Thome from Cowen and Company. Your line is open.

Hi, there. Thank you for taking my questions. The first one is just sort of on the initial patient response in the patients that have received therapy. Is the initial population those that want or need additional treatment on top of statins versus statin-intolerant patients? How is that mix playing out? And then in terms of providers in the primary care setting versus specialists, are you seeing some that are more early adopters than others? One more just on reimbursement, are there any hurdles that you hadn't anticipated prior to launch that have come up? Or are most patients that want the therapy able to get it reimbursed? Thanks.

Yes. Thanks, Joseph. Mark, do you want to take all three of those?

I will, thanks. Regarding patient response, it really is a split between physicians who are putting patients on very high doses of statin. We've heard great responsiveness on top of even 80 mg of atorvastatin. Those come in fairly regularly from physicians. We're hearing again just incredible results from statin-naive patients who just failed or can't tolerate a statin at all. We're even hearing anecdotes on top of even PCSK9s. So we're actually hearing strong efficacy regardless of the background of the patient. It’s been very consistent throughout the entire country since launch, especially now that patient labs are coming back. Regarding early adopters, I think cardiologists—this is COVID-driven—the cardiologists are definitely earlier adopters right now than primary care. We would expect, typically, the higher decile primary care to be slightly earlier adopters. And by early adopters, I'm referring to how many calls to adoption. We are seeing the cardiologists throughout each of the deciles adopting quicker than primary care. They're starting to catch up there, but clearly, cardiologists are the early adopters and moving quickly, putting patients on, with primary care coming on board a little bit later. Finally, your question was regarding coverage. There are no—patients can and do readily receive the medicines on the commercial side, both in our coverage and with our $10 maximum co-pay card. Everything is working according to plan. No real surprises there. In Part D, it’s not really a surprise, but in the COVID environment, it's definitely a little slower coming on board. The negotiations are pretty much exactly what we expected. I would say the results are very close to what we expected. It's just the timing of the execution and loading the contracts that's been a little bit of a disappointment, but it's absolutely tied to COVID and the fact that folks are not working in their offices at this point. I think I addressed all three; any additional questions?

No. That's perfect. Thank you very much.

You’re welcome.

Thanks, Joseph. Thanks, Mark.

Your next question is from the line of Marty Auster from Credit Suisse. Your line is open.

Thank you, operator. Thanks for taking the call. Most of my questions have been asked. I might try a different angle on them a little bit. Tim, first of all, thanks for the shoutout to remind everyone to vote. I voted early, so I appreciate you doing that. I guess like several of the questions, like I'm thinking back to Mike Yee's question, I guess, on kind of the path forward view and whether you're ruling anything out. It sounds like you're not ruling anything out. But from the best what I can tell from this conversation, you're thinking about the potential of equity financing, of strategic partnerships in the U.S., of pulling forward future milestones or royalties from other territories. Maybe could you talk about what the time frame is, where you need to make a decision about what to do to ensure adequate capital to achieve breakeven results in the future? And then amongst those, I just—I guess, preferentially, I don't know if I have a great feeling for how you’re thinking about what the kind of better outcomes versus other outcomes or what you're more sensitive to, if it's losing some of the longer-term value from one of the existing partnerships by pulling forward some royalty or milestone payments, or if it's strategically maybe sharing the U.S. part of this opportunity. Where are your sensitive points? And where do you think—what do you think creates the best long-term outcome for investors, if that's where your focus is? It sounds like?

Yes. Yes. Thanks, Marty. Rick, maybe I'll ask you to start on this and then I will end my comments as well.

Yes. So, I think, you rattled off a good set of items. As we said, our preference is for non-equity dilutive solutions. We've been focused on those in the past and will continue to be focused on those. I do want to bring everybody back to, I think, the long-term view. We are confident that the 1.8 million patients that we stated will be treated at peak with our medicines. That remains intact. While near-term revenue expectations have been adjusted as a result of COVID, the long-term potential of our medicines still holds true. As Mark mentioned, we're ready to strike when the environment returns. We will continue to maintain appropriate cash balances. We're actively monitoring those balances on a day-to-day basis. I'm not going to comment on the timing of when things would happen. But just reminding back, we are on track for a rest-of-world deal by the end of the year. That's going to bring additional funding into the organization, just added to the other already in place funding solutions that we have. We have a high degree of confidence in the cash runway and in our ability to execute.

Yes. Thanks, Rick. I think that was well said. Marty, I think, on the strategic front, again, I think in a—over time, of course, folks will look back on this time and say, 'Gee, what was all the fuss about?' Because, again, I think, as Rick highlighted, the track record that we have of not only executing on milestones, saying what we're going to do and doing those and then keeping the company adequately funded is as good as anybody out there. Again, reasonable people can disagree on how that should be done and when it should be done. I think, again, our track record is such that we've demonstrated the ability to do that and to do it consistently. I think we feel confident, as Rick said, that we'll be able to continue to do that. The pandemic has certainly shifted our plans as it has for almost every business and views of businesses, but we will certainly overcome this just like the rest of the country is going to overcome the effects of the pandemic over time.

Tim, again, I agree. You couldn't imagine a more challenging scenario to be launching sort of a drug into. Just I'll try one. Just in terms of the—I understand you can't predict the timeline of making important strategic decisions, but do you have any sort of guidance you can offer investors in terms of how you're thinking about kind of quarters of capital on hand to kind of buttress against COVID laying your plan just under further? Or you're not seeing the ramp-up you might expect to see next year in revenue? Is there any guidance you can provide around that?

Yeah. So, there's lots of precision on quarters of capital on the balance sheet to try to identify when additional sources would come in. Again, I just want to bring everybody back. We had over $215 million of cash on the balance sheet. We have multiple funding sources in front of us. Timelines of harvesting those funding sources, some of them are very transparent on the timelines. Others are available to us. We’ll continue to make sure the organization is adequately funded. We're not going to run the cash balance down to low levels, and we'll continue to ensure that we have the ability to execute on the business plan.

Great. Thanks so much for your color, guys. Appreciate it.

Okay. Thanks, Marty.

Your next question is from Jason Butler from JMP Securities. Your line is open.

Hey. It's Roy in for Jason. Thanks for taking the question. I just had a couple of quick ones. Just curious, if you guys have added TV into the direct-to-consumer initiative yet? Or is that coming later this quarter? And then, I guess, I was a little bit maybe puzzled, but if you expect NEXLIZET to become a front-runner, it looks like the DTC is emphasizing NEXLETOL. Does that become confusing later? I know we discussed this a little bit before the launch, but any thoughts around that? Thanks.

Yeah, sure. Mark, can I tip those to you?

Sure. We have not introduced traditional TV into this. We're taking a very smart approach with the DTC, and there's other aspects where we get on localized TV through different aspects, but not full-scale consumer TV, like you would expect from watching TBS at night. And it's not—it may not be next quarter either. We're still evaluating the right time to go into this. We're looking at how other brands are performing. Regarding confusion in the market, no. In fact, I think starting the DTC and the campaign for NEXLETOL, we do think that physicians still need to become comfortable with NEXLETOL, the innovative product. But as they get more comfortable with NEXLETOL, and start with it, they will quickly move to NEXLIZET for those patients that aren't at goal. Eventually, as the comfort grows, they'll continue to just start on NEXLIZET. I don't think there's any confusion at all. We always knew that anytime you have a new product launch, and it's an innovative product, they need to become comfortable with that. The transition to NEXLIZET is happening rapidly, and we anticipated that would happen. I don’t think there’s any chance of confusion at all.

Okay. That makes sense.

Yeah, thanks.

I just wanted to add a couple points. One is again just for everybody's reference that we're seeing NEXLIZET at about 45%. So almost half of prescriptions are for NEXLIZET now. We've been saying for a couple of quarters now that by the end of the year, we expect that to be about 50%. About half by the end of the year will be NEXLIZET, the other half will be NEXLETOL. All the while, we're continuing to grow. So I think that's important. Long-term, as Mark was saying, we expect NEXLIZET to be the dominant medicine in the franchise, perhaps as much as two of every three prescriptions written for the products will be for NEXLIZET. The only other thing I'll leave you with before we take the next question is that if you recall on our last quarterly call in August, we mentioned that the NEXLETOL franchise was about 10% of new-to-brand prescriptions for the non-statin LDL cholesterol-lowering medicine class, and that has increased now; in fact, it has doubled to 20% of new-to-brand prescriptions. So, I think Mark spoke in his prepared comments about the green shoots we're seeing. I spoke about the momentum that we're seeing. Even in the midst of launching in a pandemic, we are seeing this really nice growth in physicians prescribing our medicines in really increasing numbers. With that, Patricia, if you would go to our next question?

Your next question is from Derek Archila from Stifel. Your line is open.

Hey, thanks for taking the question, and good evening, guys. Just two from us. Can you just remind us on the Oberland, $50 million? Are there requirements around revenue thresholds associated with that next tranche? And then I might have missed this, but the step-up in SG&A in 4Q, is that the best way to think about the run rate for 2021? Thanks.

Rick, that sounds like two questions made for you.

Yes. So thanks, Derek. On the Oberland, you're correct; there is sales requirements, $100 million of worldwide sales six months trailing, so not just those associated with the United States. Now that Europe is launching, those revenues will start to continue to count towards the $50 million, which we're confident we'll have access to next year. On SG&A-wise, I think I had mentioned that SG&A is building. Using the full year closing run rates should give you generally good estimates for next year. Obviously, next year when we report year-end results, we'll be giving firm expense guidance like we always have on both R&D as well as SG&A.

Okay, great. Thank you.

The next question is from Chad Messer from Needham & Company. Your line is open.

Hello. This is Gil on for Chad. And again, congratulations on all the progress. Maybe a slightly different tack about the COVID-19 effect. Do you guys expect some patient warehousing, maybe a bolus of patients appearing when things improve? Is that the kind of dynamic we're thinking of, or would it be more gradual?

Gil, interesting that you asked that. Mark, do you want to take a first crack at that?

I do. Thanks, Tim. It's interesting, and it's a great timely question. My head of analytics and I were just going through this a little earlier today. When you see where page 8, we have office visits, you see this dramatic drop come in exactly into COVID. This is from the Symphony Health COVID update recently. We do—while we have seen this heavy, heavy bit down—office visits down to about 25% across some specialties; you see this movement to try to get back to normal. But what was not taken into account is all those visits that were lost. I actually do believe that all those visits lost will create a bolus of people coming back into the office. I think it's going to happen either after there's some comfort that this spike is done and completed or a vaccine is something else. Those are lost visits and those patients do have to come back in. It was a dramatic loss, and we do anticipate there'll be some type of bolus. The question is when, but those visits do have to come back at some point.

Thank you. That makes a lot of sense. A bit of a housekeeping question. So there is a non-cash spend of about $30 million. Is most of that expected in the third—sorry—in the fourth quarter? How should I think of the split between SG&A and R&D there?

Rick?

Yes. So those are full year estimates, generally straight-lined for the full year. The general allocation is about one-third of that expense hits R&D, two-thirds of that expense hits SG&A.

Thanks. Very helpful, and good luck with the rest of the launch.

Hey. Thanks, Gil.

Your next question is from Tom Shrader from BTIG. Your line is open.

Hi. This is Julian on for Tom. Thank you for taking my question. I'm curious, how much visibility do you have on geographic trends regarding in-person versus virtual patient visits? And how informative is this to your sales efforts over the next couple of months?

Thanks, Julian. Mark, will you take that one?

Sure. To answer the second part of the question first, it's not really—we're not dependent necessarily on the physician-patient telehealth aspect. As long as that office could see a rep, and our rep gets in there, the chances of a physician prescribing are much, much higher. So our focus really is on having our representatives focused on the right targets and gaining access regardless of what the physician's practice is looking like at that time. As far as geographic reach, I wouldn't say we have great visibility because it's changing so rapidly. Much of the virtual versus in-person health care is being driven by health care systems and IDNs, not by geographic location. It’s not quite 100% tied to hotspots or spikes; it's really about the governance of the health care systems. But as far as we're concerned, really the most important interaction is between the representative and the physician, and that's where our focus is. When we have access and can gain access on a regular basis, that's where the prescriptions are coming from.

Okay. Great. Thank you. That's very helpful.

The next question is from Paul Choi from Goldman Sachs. Your line is open.

Good evening, and thanks for taking our questions. I have two. First for Rick, just on the OpEx. With regard to your guidance and thinking about next year, what percentage of your OpEx right now is fixed versus variable? Is it 80-20? 75-25? Just how much of that could you—could discretionary spending potentially be pushed off to help the cash position? Then my second question is for Mark. Just with regard to insurance and coverage, can you maybe just provide some color as to what are the insurance approval versus rejection rates? And how—the progress has been there over the course of the quarter and looking into this quarter as well? Thank you very much for taking our questions.

Yes. So to get a good gauge of generally what's fixed in SG&A, you could just generally look back at prior quarterly reports prior to the launch to get a sense of generally their fixed numbers. But overall, the vast majority of costs in SG&A have some variable component to it. But we always manage the business pretty conservatively and make sure that we're prudent in the spend and we have a lot of optionality in ensuring that the spend is appropriately modulated.

So, Paul, what I would—our approval rate is exactly where we would expect it to be right now and very much in line, if not better than other recent launches regardless of industry. We're seeing improvement week by week, both in commercial and Part D. Again, Paul, it's a—well over a majority of all prescriptions are being approved. It's pretty much exactly where we would expect it to be at this point of coverage and prescriptions being generated.

Great. Thanks for taking our questions.

Thanks, Paul.

I'm showing no further questions at this time. I would like to turn back to the speakers for any further comments.

Patricia, thank you for helping us facilitate the call this evening. To everybody listening, thanks very much for spending some of your Monday before Election Day with us. As I suggested earlier, please go vote if you haven't already. Stay safe through all of this, and we'll certainly be in touch with you again soon with our Q4 results. Thanks so much. Stay safe.

Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.