Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q1 2020 Earnings Conference Call May 6, 2020 4:30 PM ET
Alex Schwartz – Head-Investor Relations
Tim Mayleben – President and Chief Executive Officer
Mark Glickman – Chief Commercial Officer
Rick Bartram – Chief Financial Officer
Conference Call Participants
Geoff Meacham – Bank of America
Michael Yee – Jefferies
Chris Shibutani – Cowen
Tom Shrader – BTIG
Gil Blum – Needham & Company
Jessica Fye – JP Morgan
Joel Beatty – Citi
Ladies and gentlemen, thank you for standing by, and welcome. At this time, all participants are in a listen-only mode. After the speakers’ 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 one of your speakers today, Mr. Alex Schwartz, Head of Investor Relations. Please go ahead, sir.
Thank you, Felicia. Good afternoon, ladies and gentlemen, and welcome to Esperion’s First Quarter Financial Results and Company Update Conference Call and Webcast. I’m Alex Schwartz, Head of Investor Relations at Esperion. At this time, all participants are in a listen-only mode. Later, we conduct a question-and-answer session, and instructions will follow at that time.
Joining me for 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 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 May 6, 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 esperion.com within 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 firstname.lastname@example.org to schedule 15 minutes for you to speak with the team.
I’d now like to turn the call over to our President and CEO, Tim Mayleben. Tim?
Thank you, Alex, and thanks to all of you joining us on the first of what will be our regular quarterly update calls for Esperion. And let me start by stating what we all know. These are truly unprecedented times we live in. Over the last few weeks, almost everything in our personal and professional lives has changed around us. And although we thankfully appear to have the worst days behind us, we will all continue to live in a COVID-19 world for many months to come.
Health care systems globally have been tested like never before, and we all owe a great deal of gratitude to the heroes in our own communities who have put themselves at risk for the benefit of all of us. Now more than ever, health is top of mind for all of us. While the world has been appropriately focused on combating the acute devastation brought by COVID-19, cardiovascular disease remains a serious and underlying health problem as ever. In fact, it remains the number one cause of death globally and the need for new therapies is as strong as ever.
The Esperion team has always been focused on lowering LDL cholesterol, a key risk factor for cardiovascular disease, and we, more than anyone, understand the importance of affordable, convenient, oral, once daily, non-statin medicines for patients today so they can best manage their bad cholesterol. I’m very proud of the continued accomplishments of our team during these unprecedented times, they’ve continued to execute in really an extraordinary way. As you know, years of tremendous mission-driven development work culminated in U.S. approvals for both NEXLETOL and NEXLIZET in late February as well as EU approvals for both NILEMDO and NUSTENDI in early April.
Last month, we announced the largest ever Japan development and commercial collaboration agreement in history. All in, Esperion has now attracted over $1.5 billion in current and future cash commitments with these precedent studying agreements for the EU and Japan. A true rest-of-world agreement is expected later this year all of these accomplishments showcase the global potential of our lipid management business over the long-term as we continue to deliver upon our commitments to all of our stakeholders.
Transitioning to our U.S. commercial efforts, we made NEXLETOL commercially available on Monday, March 30. Our territory managers initiated outreach to health care providers the week of April 20. So we’re just now seeing and realizing the benefits of their promotional efforts, which Mark will talk about. Given the current environment, we’re tremendously mindful of the circumstances, engulfing many health care providers today. We’ve respected their needs to prioritize resources and safety. As a result, we pledge to conduct what we called a conscientious launch. Mark will provide more details in his remarks, but what this means is that we are being very thoughtful about our interactions with health care providers and really tailoring our approach to the individual needs in individual geographies.
In fact, we’re finding circumstances very widely. And while some health care providers are not available to us currently, we have been able to begin to engage increasing numbers of health care providers each day and expect to continue to gain momentum in the weeks and months ahead. We’re also pleased to announce today that NEXLIZET tablets, a fixed-dose combination of bempedoic acid and ezetimibe, will now be available on Monday, June 4. And remember, this is the first non-statin combination tablet for lowering bad cholesterol ever approved.
Turning now to the managed care front, I just want to highlight really tremendous success here. We exceeded our highly ambitious managed care goals with over 50% commercial coverage and over 20% Medicare Part D coverage. I mean, this is an amazing result. And Mark will discuss this more in a few minutes, but I want to emphasize that this is high-quality formulary coverage, NEXLETOL. And once it’s available early next month, NEXLIZET, our preferred brand medicines with low patient out-of-pocket costs and prescribing our medicines requires minimal health care provider effort.
In addition to the excitement around our U.S. approvals and U.S. NEXLETOL launch, we have also made great progress in our global commercialization efforts. Last month, the European Commission granted full marketing approval to NILEMDO and NUSTENDI. NILEMDO is the first oral once-daily non-statin LDL-cholesterol lowering medicine approved in Europe in almost TWO decades for indicated patients. And NUSTENDI is the first non-statin LDL-cholesterol lowering combination medicine ever approved in Europe. Like their branded counterparts in the U.S., these medicines represent significant advancements for EU patients, health care providers and payers.
On our previous calls, we spent a great amount of time on the U.S. labels. So let me just briefly walk you through the key differentiating features of the EU labels, and there’s three. So first, I want to highlight that the EMA recognizes statin intolerance as a term to describe patients who can’t or won’t take statins. So as a result, we see in the labels, in the EU, statin intolerance used throughout and that indicated patients specifically includes statin intolerant patients in the EU.
Second, I’d highlight that the EU label includes all four of our Phase 3 clinical studies. As a result, the efficacy of NILEMDO is “up to 28% and LDL cholesterol lowering,” rather than the 18% LDL-cholesterol lowering efficacy that we see in the U.S. label. Why? Well, it’s because in studies three and four from our Phase 3 program. Patients were on no background statin therapy. And as you know from our prior reporting of these studies, the LDL-cholesterol lowering efficacy of bempedoic acid is greater, in fact, up to 28%, as stated in the EU label, when a patient is not on background statin therapy.
And finally, we’re very pleased that the effects on lowering HbA1c for both NILEMDO and NUSTENDI are included in the pharmacology sections of the EU labels. As we’ve highlighted, this is an important differentiator for our medicines and reflects the consistent positive effects on HbA1c that we saw throughout our Phase 3 clinical studies.
I want to turn now to our global partner. We have a strong experienced commercial partner in the EU, Daiichi Sankyo Europe. They have been preparing for the launch of our medicines for over a year now. And as a reminder, DSE has over 1,000 professionals in Europe dedicated to commercializing medicines for cardiovascular disease, with deep expertise in reimbursement, distribution and medical affairs. In fact, they’re responsible for one of the most successful recent cardiovascular launches in Europe, LIXIANA, which is a Factor Xa inhibitor and launched in 2015.
And last year, recorded over $500 million in product sales, and I just highlight that’s in less than four years. We have very high confidence in DSE’s commercial capabilities in the EU and expect both NILEMDO and NUSTENDI to be made available at the same time in key EU country markets starting next quarter.
Moving to Asia. We were excited to announce our newest collaboration agreement in Japan with Otsuka Pharmaceuticals just a couple of weeks ago. This agreement nicely extends the global reach of our medicines. Otsuka is a fantastic development and commercialization partner for us in Japan. They’re a top three pharmaceutical company there with a fully integrated commercial organization 1,300 sales professionals, deep expertise in reimbursement, distribution and medical affairs.
They’re particularly strong in cardiorenal drug development and commercialization and have recent experience in commercializing a number of important medicines in Japan, including Samsca, JINARC and most recently, Entresto. Otsuka also shares our enthusiasm for the commercial potential for NEXLETOL and NEXLIZET in Japan, which we think is reflected in the significant and really precedent setting financial terms of the agreement. And as a reminder, that includes a $60 million upfront, which we’ve already received. $510 million in total upfront and milestone payments, $100 million of Japan specific R&D costs that Otsuka will fund and tiered royalties on product sales in Japan of between 15% and 30%.
Now moving on to the rest of the world. We continue to actively pursue opportunities to further the reach of our medicines globally and we expect to complete a true rest of world deal, non-EU, non-Japan, non-U.S. by the end of the year. There’s tremendous interest in the remaining rights to NEXLETOL and NEXLIZET in these rest of world geographies, and we look forward to updating you later this year.
So with that, I’d like to turn the call over to Mark Glickman, our Chief Commercial Officer, who will provide you an update on our U.S. commercial activities. Mark?
Thanks, Tim. Obviously, as Tim highlighted, this has been a challenging time for the world, our country and our industry. Our hearts go out to all impacted by COVID-19, and we’re grateful for their heroic efforts of health care providers and others who continue to serve their communities at this time. Given this environment, which includes social distancing, our commercial team has been adapting extremely well. I’m tremendously proud of the Esperion team for our recent accomplishments.
First, for rapidly adapting to the current environment, creating significant virtual tools and digital assets and beginning our conscientious virtual launch. Our territory manager has completed all their training the week of April 13, and I’m happy to report, started making virtual calls to health care providers the week of April 20. Second, for our managed care successes, we exceeded our goals and achieved over 50% commercial coverage and up to 20% Medicare Part D coverage, providing excellent initial formulary coverage and patient access our medicine.
And third, we are beginning to see traction with health care providers with a high interest in peer-to-peer education on NEXLETOL and high interest in virtual meetings with our territory managers from health care providers. For my over 30 years of experience, these are early signals of success and why I’m energized on what I’m seeing. Our team has risen to the challenge as we make this pivot into a fully integrated commercial organization during this unique period of time, and we are all looking forward to getting our medicines to the patients that need them over the weeks, months and years ahead.
I’d like to now give you an update on our key U.S. commercial priorities and activities. First, let me focus on our number one priority, patient access and affordability of our medicine. You first heard from our managed care team, Jerry Penn, Rich Karelas and Roberta Peterson at Investor Day last year, where we outlined our highly ambitious managed care goals, having NEXLETOL in its own compendium class, achieving up to 50% commercial coverage and up to 20% Medicare Part D coverage at launch as well as low patient out-of-pocket costs.
We delivered on all key elements separate compendia classification as an ACL inhibitor, favorable formulary position and broad coverage, PA to label and low patient out-of-pocket costs. Each of these elements is incredibly important to ensure patient access to our medicine. To date, we have achieved managed care access for our medicines that we believe are industry-leading levels of patient access for newly launching medicines.
As I’ve already mentioned, NEXLETOL has over 50% commercial formulary coverage and over 20% Medicare Part D formulary coverage here in the U.S. When launched early next month, NEXLIZET will also enjoy even greater levels of managed care coverage as we continue to broaden that coverage. Not only have we secured a critical mass of formulary coverage for patients, the coverage is very high quality. NEXLETOL and NEXLIZET, our preferred brand medicine meeting covered lives are mostly in Tier 1 and some Tier 2, mostly covered lives in Tier 2, I apologize, with some Tier 3.
Most coverage requires only minimal to no steps to access NEXLETOL and NEXLIZET, a PA label, which for the majority of patients will mean that patients have to be on the massively tolerated statin or previously tried a statin. We have achieved low patient out-of-pocket costs. The average patient out-of-pocket cost is $10 or better to eligible commercial patients and it’s $45 for Medicare Part D. Of course, for Medicare Part D, the lowest possible co-pay for branded medicine is $45.
Overall, prescribing our medicines requires minimal to no paperwork. And finally, there are no moratoriums from the major plans at this time. So we believe that the vast majority of patients will be able to access our medicine. Early indications are that the percentage of successfully adjudicated prescriptions are significantly ahead of most recent launches. In fact, we’re showing adjudicated prescriptions that are approximately five times greater than recent cardiovascular launches.
In my personal experience, this is the best managed care coverage I’ve seen in the last 10 years. Bottom line, we achieved formulary coverage patient access is beyond even our own very high internal expectations. Patients who are prescribed our medicines can access them readily and at a low co-pay. Health care providers that prescribe our medicine to their patients can do so confidently. That is they know three things. First, the prescription will be covered since it has a high likelihood of being on formulary.
Second, the healthcare practitioner have little to any people work, it’s a PA to label. And third, their patients have a high likelihood of being able to afford their medicines because everything we’ve done ensures low out-of-pocket cost for the patients. This is truly an incredible result delivered by a managed care team. Also importantly, formulary coverage will still continue to improve in the months ahead.
Now I’d like to share with you our customer-facing team and how we have adapted to the current environment. As Tim highlighted earlier, we are currently living in unprecedented times due to a global pandemic. Given the COVID-19 influence environment, which includes social distancing, we’re taking innovative measures to engage our health care providers. First, we’re giving the health care providers on the front lines of the COVID-19 crisis, the space they need to do their work.
Second, in some geographies, where appropriate, our territory managers are making virtual outreach to health care providers. For these HCPs, we’re utilizing text, e-mail and phone outreach with health care providers with whom we already have an established relationship. Personalized e-mail and video introductions to new health care providers that request information. Digital welcome kits and digital lead behind, virtual detailing through our established CRM platform.
To quantify this for you, in a little over two weeks, our territory managers have already virtually interacted with over 1,500 health care providers across the U.S. The health care providers ready to prescribe NEXLETOL for their patients we’re providing them one touch online and direct sample shipments, co-pay cards for their patients and, of course, availability of NEXLETOL on pharmacy shelves.
And finally, we’re leveraging Speaker Bureau what we call Smartcast and web meetings. To pause for a moment at the Speaker Bureau. This is where key opinion leaders provide peer-to-peer education on NEXLETOL to other health care providers. We had our first Speaker Bureau web meeting last week.
The KOLs are doing peer-to-peer education on NEXLETOL virtually to what we call smartcast using technology solutions like Zoom. This has proven to be an amazing tool. Over 150 health care providers have already participated in these web meetings, and we are seeing robust interest in these educational opportunities. We have called this a conscientious launch. We are thoughtfully and respectfully engaged with health care providers at a challenging time, understanding their individual needs and preferences while also beginning the process of awareness building and education required to get NEXLETOL to indicated patients that could benefit from it.
One additional point, we built our commercial team’s unparalleled success. We focus on experienced professionals, those with significant expertise and deep relationships with key health care providers. We have highly tenured territory managers who average 12 years of cardiovascular sales experience. In this current environment, this deep experience has proven to be critical. Our team has adopted extremely well to this time.
At the same time, we continue to make plans for a traditional launch when we are all in a more normal environment. We are starting to see some states are easing so-called stay at home restrictions each week. You may have heard comments from both Dr. Scott Gottlieb and Dr. Fauci, that they expect some return to normalcy for many geographies across the U.S. by sometime in June.
Overall, I’d like to highlight that each state of geography is not the same, and we will not same. Some health care providers and their patients are experiencing minimal impact. Others, like, health care providers and patients in the New York area are unbelievably impacted. Most health care providers and their patients are experiencing some impact, and that varies both by health care provider’s specialty and by geography.
With these points in mind, we have built what we are referring to as a reentry plan, broken down into three tiers. The reentry plan reflects our assumptions about when and where face-to-face interactions are likely to resume. When we talk about this reentry plan, we are also assuming social distancing measures will remain in place for an extended period of time and that most interactions will now be protected.
That is most people, including members of our team, will use personal protective equipment or PPE, that is mask, glove, hand sanitizer, disinfecting wipes, all to ensure the safety of health care practitioners, patients and our colleagues. Tier 1. For this tier, the expected timing for the resumption of face-to-face interactions is mid-May. This tier includes states and geographies that have announced they are reopening and have ended the so-called stay at home orders. We estimate Tier 1 represents approximately 25% of our target HCP audience.
Tier 2. For the second tier, the expected timing for assumption of face-to-face interactions is June, and includes states and geographies that have announced or expected to announce the end to so-called stay at home orders over the next 30 days or so. We estimate Tier 2 represent approximately an additional 40% of our target HCP audience.
Tier 3. This tier includes those states that are true hotspots around the United States. These states and geographies still have significant stay at home orders in place. We estimate this tier represents the final one-third of our target HCP audience. Face-to-face interactions with these HCPs will come at a later date. Instead, we will continue to rely on the virtual tools that we developed and refined to interact with these HCPs. As I said earlier, we will ensure all of our territory managers utilize PPE and other safety measures to ensure colleague, HCP and patient safety.
Turning now to NEXLIZET. As Tim highlighted, we’re announcing today the acceleration of the availability of NEXLIZET, the combination tablet of bempedoic acid and ezetimibe to early June. Recall, this is the first non-statin combination tablet ever approved for lowering bad cholesterol and has even greater non-statin LDL-C lowering efficacy to NEXLETOL. Our education efforts with HCPs is about NEXLETOL, and its mechanism of action, ACL inhibition have gone very well over these first few weeks.
We’ve had unbelievable interest in the digital materials and information on NEXLETOL, especially the peer-to-peer education opportunities through the key opinion leader Speaker Bureau I referred to earlier. As a result, we are now confident that HCPs are well prepared to welcome the commercial availability of NEXLIZET on Monday, June 4.
I want to leave you with a few key points. We are in the very early stages of our commercial launch. We are just beginning to scratch the surface, both in terms of geographies and reaching our target health care providers. And we are operating in an unprecedented period for which there’s no comparison. We are prepared to assist health care providers and their patients in every way possible. We have great managed care coverage.
We have been heavily focused on health care provider education, and this is paying off. We’re confident that when the current health care crisis passes, health care providers will be fully educated and ready to prescribe our medicines. We are starting to see signs of improvement in certain states and geographies. Health care providers already being responsive to our messaging and approach. With the early work our team has done, I believe, we’re in a great position for future success.
In summary, we priced and positioned our medicine extremely well. As a result, we have significant managed care formula coverage for our medicines as a further result, we have the lowest possible patient out-of-pocket costs, and we have great HCP interest in peer-to-peer education with over 150 HCPs participating in smartcast in less than two weeks, and we have already achieved over 1,500 HCP interactions. As a result, I’m confident that we will see a terrific trajectory on prescription activity in the weeks and months ahead.
With that, let me turn the call over to Rick for a financial review. Rick?
Thanks, Mark. I’ll now provide some comments in our financial results for the first quarter ended March 31, 2020, as highlighted in our press release from earlier today. First, regarding revenue. Total revenue for the first quarter was $1.8 million. This includes $1 million of collaboration revenue and a very significant milestone for the company, which was the recognition of approximately $900,000 of net product sales revenue from NEXLETOL. This is the first time in our history that we were reporting net product revenue.
While the amount is modest, just under $1 million, the significance of this milestone and what it means for the company, as a commercially thriving research-driven pharmaceutical company cannot be overstated. For comparison, total revenue for the first quarter of 2019 was $145.4 million, which was all collaboration revenue as a result from the recognition of the upfront payment from the Daiichi Sankyo Europe collaboration.
As a quick reminder, we recognize product sales revenue following us GAAP ASC 606X factory and recognized product sales revenue at the point in time when customers, wholesalers, in our case, received product at their warehouses. More detailed information is provided in our Form 10-Q filed with the SEC.
I want to remind everyone that Esperion is and has been a revenue generating company. As I mentioned, last year we recorded $148 million of annual revenue. This year, we’re on track to record at least $200 million in total revenue, an increase of more than 35%, even before factoring in any net product sales revenue. These are diversified revenue streams consisting of U.S. net product sales, ex-U.S. collaboration and royalty revenues, which are also diversified geographically in some key markets, but not yet all worldwide markets.
This has been accomplished through our ability to over deliver and secure to precedent setting commercial collaborations for the EU and Japan, on time and above expectations, all while maintaining 100% rights to the United States, the most valuable market for our medicines in the world.
Next, research and development expenses totaled $34.7 million for the first quarter compared to $46.3 million for the comparable period in 2019. The decrease was primarily related to a decline in costs related to the enrollment, completion of clear outcomes last year and a decrease in regulatory costs associated with submission activities that were incurred last year.
As we’ve been saying for a couple years now, you can expect to see research and development expenses come to a lower steady state level in 2020 and 2021, as a result of clear outcomes being fully enrolled in August of last year. Selling, general and administrative expenses were $41.6 million for the first quarter compared to $12.2 million for the comparable period in 2019. The increase was primarily related to cost to support the commercialization of NEXLETOL and NEXLIZET increases in our head count resulting from the build out of our 300 member customer facing team during the quarter, stock-based compensation expense and other costs to support our rapid growth as a commercial organization.
Net loss was $78.2 million for the first quarter of 2020 compared to net income of $87.4 million for the comparable period in 2019. Esperion had a net loss per share of $2.84 for the first quarter of 2020 compared to a diluted net income per share of $3.07 for the comparable period in 2019. Let me make a few comments on our expectations about the future.
As you saw in our press release today, we are updating our full year 2020 expense guidance to reflect the expense experience we saw in the first quarter and that we expect to continue into the second quarter. Previously, we were guided research and development expenses for the full year to be $145 million to $155 million. We’re updating and slightly lowering our full year R&D expense estimates to be between $135 million to $145 million, or a decrease of $10 million at the midpoint of the range.
In addition, we previously guided selling, general and administrative expenses for the full year to be between $225 million to $235 million. We now expect SG&A expenses to be between $200 million to $210 million or $25 million lower at the midpoint of the range. To be clear, these updates to our expense guidance are not a result of us cutting programs, personnel or planning to run the business any differently once we get back to normalcy.
However, due to the COVID-19 pandemic, there has been a natural slowing of operating expenses experienced in the first quarter and as we begin the second quarter, as both R&D and SG&A have changed. This includes adjustments to virtual launch programs, tools and marketing tactics versus in office promotional activities. And as a result, we believe this revised spend guidance reflects how the full year is expected to play out.
Let me comment on liquidity and cash resources now. Despite inherent challenges in the current COVID-19 environment, our balance sheet and future cash flows from our precedent setting partnerships remains very strong. Our cash was most recently strengthened as a result of the Otsuka partnership we announced just last month. As of March 31, 2020, cash and investments available totaled $158.2 million. I will note this amount includes the $25 million funding from Oberland Capital upon FDA approval of NEXLETOL, but does not include the $60 million upfront payment we received from Otsuka in April.
Factoring in the recent payment from Otsuka, our pro forma cash balance as of March 31 totals over $218 million. Next quarter, we expect to receive the $150 million milestone payment from Daiichi Sankyo Europe upon first commercial sale in the EU, which will further strengthen our cash balance.
Keep in mind, we expect incremental capital to add to our already strong cash balances. This will result from an upfront in near-term payments from a true rest of world agreement ex-U.S., ex-EU, ex-Japan, which we expect to close before year-end. Having over delivered on the EU and Japan agreements over the past 16 months, you should have great confidence in our ability to deliver on this final agreement.
Finally, recall there’s an additional $50 million available at our option under the Oberland Capital agreement that we expect in early 2021. Given our current cash balances expected U.S. product sales EU royalties and future milestones, we remain confident that the cash resources available to us are sufficient to fund operations and will allow us to continue to over deliver on the business plan through profitability.
From a liquidity standpoint, I want to assure you that we are committed to maintaining the appropriate cash balances to support our rapidly growing business. In the near-term, we think that appropriate amount is greater than $100 million as we look towards the end of the year.
Finally, I want to comment on 2020 net product sales revenue expectations. We have consistently said we would not provide net revenue guidance for 2020. In normal times, we would maintain that position and as we know, these are not normal times. We’re not providing formal U.S. product sales revenue guidance for 2020 today, but I want to say that we are comfortable with current sell side consensus U.S. product sales revenue estimates for 2020.
Esperion has an unbelievably strong history of delivering results. Our track record includes for product marketing approvals, exceeding our own very high goals on the managed care coverage and the continued over performance on global business development. Recall that in 2020, we delivered – in 2019, we delivered the largest EU licensing agreement and at least the last 10 years. Already this year, we delivered the largest Japan licensing agreement in history. And all in, we’ve secured over $1.5 billion in current and future cash commitments from these collaborations. Just like we’ve delivered on these fronts, you should have the confidence that we’ll deliver on U.S. net product sales revenue.
So with that, I’ll turn it back over to Tim for closing comments.
Thank you, Rick. Before we take your questions, let me just recap today’s first quarter update call. So NEXLETOL and NEXLIZET were approved in the U.S. in February and NEXLETOL is available by prescription now in the U.S. NILEMDO and NUSTENDI received full marketing approval in Europe last month. We’ve already achieved excellent managed care coverage in the U.S. with over 50% commercial formulary coverage and over 20% Medicare part D formulary coverage.
Mark and our customer facing team have adapted extraordinarily well to the current environment with the implementation of a broad suite of virtual detailing and education tools and that began April 20. We have a phased reentry plan as Mark described for our territory managers to be back in most healthcare providers’ offices in the months ahead. As you heard from Rick, we have a diversified and rapidly growing revenue stream, almost $150 million in 2019 over $200 million this year consisting of U.S. net product revenue ex-U.S. upfront and milestone revenue and of course royalty revenues starting this year.
We also affirm that we’re comfortable with current consensus sell-side net product sales revenue estimates for 2020. We remained very well funded with strong liquidity and capital resources available to us and are in an excellent position to execute on our business plans for the year.
Now looking ahead, as Mark and I both highlighted NEXLIZET is now going to be commercially available in the U.S. on June 4. In the third quarter, DSE will launch NILEMDO and NUSTENDI in the EU and as a result we’re on track that received the $150 million milestone payment from DSE at that time. During the fourth quarter, we expect to complete a true rest of world development and commercial collaboration agreement and we look forward to connecting with many of you at upcoming virtual healthcare conferences in the weeks ahead.
So with that, I’d like to ask Felicia to now open the line for your questions. Felicia?
[Operator Instructions] And your first question comes from the line of Geoff Meacham of Bank of America.
Hey, guys. Thanks so much for the question and congrats on all the progress. I wanted to ask you, what are the decisions behind the early NEXLIZET launch? And obviously, it’s very early days, but what have been some of the takeaways from the initial launch vis-à-vis telemedicine that maybe you can imply to the June launch?
Yes. Thanks for the question, Geoff. And Mark, why don’t I tip that to you? Please?
Geoff, can you just clarify the question? I’m not sure I understood the question exactly. I heard the NEXLIZET piece. Can you just clarify the question for me?
I just want to know the decision behind the earlier moving up NEXLIZET launch. And then just my commercial experience, right, vis-à-vis telemedicine today? And how can that be applied for launches for essentially, both products for the balance of the year? Thanks.
Okay, sure. Thanks. Okay. Now I have a full understanding. So NEXLIZET was driven by a few things. As we said in the prepared statements, we do believe physicians have become – they become quite confident about the ability to launch to right NEXLETOL. So that was what we were looking for to see if there was a comfort level. But additionally, physicians right now, they are – the physicians we’re calling on are incredibly worried about cardiovascular disease and how COVID is going to affect overall this in other areas.
So obviously, with NEXLETOL, we already have one product out there that could help in LDL. But the feedback has been that they feel as though this environment where people locked down and more sanitary lifestyle, there may be a need even earlier for more aggressive LDL lowering. And that was part of the driving behind NEXLIZET as well. We just think that physicians need as many tools in the armamentarium to battle of the high cholesterol, especially now. So we went ahead and moved it up.
So it was a combination of comfort with NEXLETOL and – which we wanted to see and then really the needs of the physicians asking for more tools right now. So that’s what’s driving NEXLIZET. We touch base with key opinion leaders from various specialties and geographies pretty regularly. And telemedicine is going to be here to stay one way or the other. They all agree, whether it’s primary care, cardiology, academic based or office space, that there’s going to be an aspect of telemedicine that’s going to be utilized for the foreseeable future. I think it’s in the early stages, comfortable [Technical Difficulty]
I think, did we lose Mark?
Yes, I think we – part of the future of medicine and physicians seem to be adapting and patients fairly rapidly to this new way of administering medicine and care.
Mark, everybody, apologies, we’re, like many of you, all virtual and often relying on cell phone coverage, which I’m sure you’ve all experienced is sometimes spotty. So bear with us. We will obviously do our best to respond to questions. But if you can’t hear or we’re not answering the question, please perseverate and stick with us on it, we’ll definitely get you an answer. Mark, you just blanked out for a little bit while you were talking.
Felicia, can we go to the next question.
Yes, sir. Your next question comes from the line of Michael Yee of Jefferies.
Thank you for the question. Tim, hopefully you can hear me, okay? Two questions. One is, can you talk to some of the early third-party script data, how accurate you think that those are compared to what you’re seeing, whatever information you see with scripts? And do you expect those to surpass PCSK9 scripts, which everyone have looked at and can try and translate sales from? So maybe talk to that dynamic over the course of the next one, two, and three quarters to get to the consensus? And then the second question relates to sampling. What do you know about sampling? How much sampling is going on out there versus the script numbers, which would be interesting because that’s kind of a leading indicator? Thank you so much.
Yes, yes. No, thanks for the question. This is Mark – or Mike, sorry, I was going to tip the questions to Mark. Mark, can you hear that okay? Did we lose Mark? Maybe I can chime in. Yes. Let me go ahead and try to respond to your questions. So on sampling the second question, your second question, we are seeing some good sampling. What I would say is, as Mark was saying, about the overall launch, we’re still in the early days yet but we’ve seen robust demand from physicians for samples, along with the copay cards. I think one of the comments that Mark made in our prepared remarks was that he feels confident. And again, he’s been doing this for 30 years. He’s launched more than a handful of cardiovascular products, chronic disease therapies.
And so I think his insights about this are really spot-on. But as I said, we’re only, I think, in the third week of actual virtual detailing. But – and then the other thing that I would say is it took an extra week for us to get the virtual sample ordering that Mark talked about. So that has certainly facilitated increased sample demand and accounting when you’re – I think during the first week, we were doing it by paper.
So it was a little bit less easy to follow, but now we can track it. And again, we’re seeing robust demand for samples. I can’t quantitate it for you, but I would agree with you that it is a good indicator. As a reminder to everybody, we are sampling, but our samples are seven-day blister packs so they will not show up in any of the data. And of course, the seven-day blister packs, they will not replace a 30-count bottle.
With respect to the Symphony data and IQVIA data that is publicly available, as you mentioned, we’re just in the third week now. I think on Friday, we’ll get our third – or fourth week, rather, of data. And we’re seeing nice progress there week to week. And certainly, like the overall trajectory, it’s lumpy because it’s early. It’s small numbers because it’s early. But the HCP or health care provider engagement, as Mark said earlier, is really robust.
And so with the combination of the state’s reopening and the engagement that we’re getting with health care providers, even through these virtual tools, much less before our team gets out and starts engaging physically. I think we’re encouraged. But I think the tale of the tape, Mike, I think, for you and for everybody else, we’ve said is going to be the prescription data that comes out week-to-week and then month-to-month and, of course, quarter-to-quarter.
And while it’s early, we like the trajectory. And we think that, that is representing 90% plus of the prescription volume. You had asked how it compares to the PCSK9s, and it caused me to smile a little bit because recall that the PCSK9s did not launch during a pandemic. And so much less the Xarelto launch, which we have highlighted that we’d like to have you and others use as a comparator for our launch once we get back to some normal state of affairs. But I think if you’d like me to comment a little bit about how it compares with the PCSK9 launch. I think a few things that I’d highlight.
One, as Mark said, we have extraordinary managed care coverage right from the launch, and that is only going to gain momentum. And I think as most folks know that have dealt with formulary coverage in the past, once you reach a certain critical mass, you effectively have the broadest coverage, even if it’s increasing by 10% or 20% in future years.
So we – I think the managed care coverage is phenomenal. And as it relates to PCSK9, I think as Mark said too, the adjudicated prescriptions is 5 times what the PCSK9s were experiencing during their first of launch. So that’s a very bullish indicator as well. But I think long-term, we do not see the PCSK9 launches as a good comparator that we will we will far exceed what the PCSK9s were able to do.
Okay. Thank you so much, Tim. Appreciate it.
Yes, thank you, Mike.
And your next question comes from the line of Chris Shibutani of Cowen.
Great. Thank you very much. Congratulations on all the updates and progress. It sounds like you’re making a lot of objectives met. And to that extent, and since we’re all kind of milestone junkies, particularly on the coverage front. It sounds as if your goal is at the beginning of the launch were to hit that 40% to 50% range and 20% on Medicare Part D. So certainly, kudos to the team for achieving that. Can you sort of bar for us for where you think you’ll be, say, in three months and perhaps, to the end of the year, recognizing that there’s a lot of uncertainties out there. But can you use the phrase a certain critical mass? So when might we get there? Help us get a sense for what this could look like?
Sure. Mark, are you back on?
I am. Sorry about that, guys. Yes, I’m on going to get…
Excellent. It’s nice to hear your clear voice. Okay. Why don’t I tip that to you?
Sure, thanks. Hey, Chris. Thanks for the question. So we had discussed earlier before the launch that we had anticipated for the year-end to be in that 75%-ish commercial and up to 50% range for Part D. I now expect that as opposed to the end of the year, to be sometime on this quarter. So that’s how we’re ahead of schedule. We are right now, Chris. So a lot of work being completed. So I think the next milestone will be – by the next call, we do anticipate we’ll have very close to what we were communicating for year-end sometime during this quarter.
Started on the Medicare Part D coverage front, 20% could go to what?
We should see upwards of near 50% over that period of time.
Terrific. I love the confidence. And then to follow-up, again, you guys have been very successful in the partnership front, again, really matching your time lines, which is always kind of a delicate dance. Curious to know, I think you guys have talked about in the U.S. How your initial focus is on more of a targeted physician launch with the 300 folks that you have. But thinking longer term, ultimately, you could see the need to really expand that sales force effort to go more towards the general practitioner or really broaden out the potential audience of physicians and patients.
Can you help us understand, is there a revenue level? Is there a metric that we should be thinking about to when that’s something that you’ll begin to contemplate, i.e., when we should start bugging you about whether that’s something you’re going to move forward on? And I talked about this again since you seem to be so astute at gauging when and where and how and timely execution on your partnerships? Thanks.
Yes. Thanks, Chris, for the question. I should say, thanks, I think, for the question. So the way we think about business development as it relates to this bempedoic acid franchises, I think as we said earlier, first of all, this year, we’re focused on true rest of world deal, non-U.S., non-Japan, non-EU. So that’s going to occupy us for this year. And then, of course, on the commercial front, we have built, I think, as we’ve talked about, we have this incredibly experienced commercial team, customer facing team.
The success that we’ve had on the managed care front, I think, exemplifies, I think you heard Mark say last year that each of our – each of the members of our managed care team have 30 years of experience. And we had said with a little bit of pride, which had to be proven, but a little bit of pride saying, we think we have, if not the best, one of the best managed care teams in the industry. And I think this early result, as Mark said, best managed care coverage that he’s seen with the drug launch in, at least, the last 10 years, I think we would put our achievement on the managed care formulary side up against anybody and – or any recent drug launch.
And of course, that’s a result of pricing decisions, positioning decisions, relationship decisions, actually partnering with payers and that’s all part of our philosophy, mine, Mark’s, Jerry’s, the team’s philosophy about how to engage to maximize the benefit for the overall industry and obviously, especially for patients.
So perhaps a different philosophy, but I think it’s yielding the result that we wanted. And so our focus is to continue to let our team perform here in the U.S. Everybody is going to be able to assess how we do because the prescription data is going to be very broadly available and regularly available, but we have confidence in our team’s ability to execute.
So we will, to come back to your question about partnering for the U.S., it’s not current top of mind for us. We certainly recognize that 2021, 2022, we will have some business decisions to make about how we build our customer facing team, whether we do that ourselves or whether we do that with a partner, and that’s a future decision that I don’t want to speculate on today. So it’s – like I said, it’s a future decision for us, Chris. And I think one that we’re just not prepared to make yet because we have tremendous confidence in the performance capabilities of our team.
Got it. Appreciate it.
Thank you, Chris.
Your next question comes from the line of Tom Shrader of BTIG.
Hi, good afternoon. Congratulations, must be great to finally be selling this stuff. I’m just wondering really, for Mark, two questions. Now that you’re on the ground, do you have a strong sense as to which drug is going to be more important? And do you have any sense that people are waiting for the combination, Phil?
Yes. Mark, please.
Hey, Tom. Hope you’re doing well. Absolutely. I mean, there’s a – we started signaling a few months back that we do anticipate NEXLIZET will be more of the workhorse. And there are absolutely a few of the key opinion leaders and top prescribers that were kind of aware that we were going to accelerate, and they are waiting for NEXLIZET to come out, absolutely.
And just on your wish list, is there any clinical data you wish you had beyond clear outcomes? Is the diabetes signal worth chasing down? Or just your thoughts on whether you’d like to see more data there to sell?
So this is Tim. One of the things that we’re – we have a very active program now is the potential for investigator initiated studies. And so we’re getting some very interesting proposals, Tom, that we’re shifting through and haven’t reached a conclusion on. But it’s certainly one of the top of mind things that we’re talking about, of course, that is talking about internally, we’re getting input from those outside, our MSL team is talking to KOLs, our medical affairs team.
And again, just hearing what they had to say about additional data that might be interesting for them. So we’re shifting through. I would say, stay tuned, probably second half of the year. We’ll have more to say about that, Tom.
Great. Thanks a lot, and congratulations again.
Your next question comes from the line of Chad Messer of Needham & Company.
Hello everyone. This is Gil on for Chad, and I’d like to add my congratulations for the earlier availability of NEXLIZET. Kind of adding on all the milestones, and it seems like you have a pretty strong cash position. Are you guys considering further business development or acquisitions considering?
Gil, this is Tim. I’ll take that. So we are entirely focused on executing on the successful U.S. launch of NEXLETOL and NEXLIZET this year. And then, of course, the ex-U.S. I’m sorry, ex-U.S., ex-Japan, ex-EU, so true rest of world deal from a business development standpoint. So I would say an emphatic no at this point. But certainly, as we continue to evolve the business, get the traction that we’re expecting this year that those kinds of things will be under consideration for us.
But in the near-term, I think we’ve been incredibly successful by focusing on a few key things, and we’re going to continue to do what has driven our success historically, which is to bring that focus to these few activities.
Thank you for that. As to your interactions with physicians these days, do you believe that some of it has to do with the fact that physicians are currently more available because they’re not going into clinic?
That is a very good question. Gil, Mark, can I tip that to you?
Yes. Thanks, Gil. There’s definitely some aspect of it, but it really depends on the geography. Cardiologists in the New York area are being – were actually being called in to hospitals to help on the front lines. But I think in most parts of the country, yes, there’s definitely an aspect where the physicians are a little more available. Particularly with the representatives, again, they have the relationships with the physicians.
So there’s a comfort level there. And then for the virtual speaker programs at night, yes. I think what we’ve heard is that our target audience, they’re really appreciating discussing something other than COVID, and this gives them that outlet to have those conversations. So it’s part of it, maybe not being in clinic, but I also think part of it, they need a break from the day-to-day from both patients, the press and also their own pressures on dealing with COVID. So I think it’s all of the above.
Don’t we all? Mark, if I still have you.
If I still have you, you gave really great granularity regarding Tier 1 and the different HCPs and accessibility. What are you guys thoughts about a second wave?
Yes. Mark, do you want to speculate on that a little?
I’m sorry. Second wave, what was the question, second wave of what?
Of the COVID, yes.
I think the close I’ll come to that is, again, I want to go back to a comment I made earlier. Physicians are prepared for this new environment for the foreseeable future. While they’re opening up their offices to patients now in certain areas, it’s very, very restricted. And I think it’s going to stay that way, whether we have a second wave or not, I think they’re treating it like a second wave. So there’ll be some returns to normality.
But what we’re hearing is telemedicine and by nature, teledetailing will be a part of their future. And I think that they’re just planning on operating this way for a while until they could take a crack and say, “now we’re done.” I think they’re all anticipating a second wave. And I think that’s why they believe that this is the mainstay for the foreseeable future.
Got you. And one just last housekeeping question. Did I hear you correctly about starting to recognize royalties from the EU in the second quarter? Or was that a third quarter?
On the second half.Yes, sorry, second half.
Yes, okay. All right. That’s it from me. Thank you very much for taking my questions.
Yes. Thank you, Gil.
Your next question comes from the line of Jason Butler of JMP Securities.
Hi, this is Ron for Jason. Thanks for taking the question. I might have missed this one earlier, but you guys have any early data on the co-pay program, but what percentage of prescriptions are using that program?
Yes. Mark, is that something you can comment on?
Yes, absolutely. For the – thanks, Tim. For the commercial side, a vast majority of the prescriptions are going through with the co-pay card attached to it right now. And in the early launch, that’s exactly what we would anticipate. Until physicians are comfortable with the coverage, they’re going to make sure that the co-pay card. And keep in mind, we also make it available passively for eligible commercial patients. So if they don’t have the card, we’re going to intervene anyway, and that will stay until we are sure that all the contracts are signed and that everything – we indicated we’re seeing this great adjudication as we get more confident, that number will drop, but right now, a vast majority has been attached. And that is as planned.
Got it. And then another one for Mark. I guess, the – so with the reimbursement coverage you have already achieved, can you give us a sense of what the average co-pay is going to be with longer-term therapy after they get past the co-pay card? Thanks.
Yes. So the co-pay card, we’re going to continue – we’re committed to be as low as $10 for 90 days on the co-pay card for the foreseeable future. As far as peers, as I said, we anticipate a majority of our, let’s say, non-card commercial coverage to be in Tier 2. And those co-pays are typically $25. So – but we do anticipate utilizing the card and passive programs and make sure patients have an affordable option. But the tier of – second tier is typically $25. And third tier is typically $50, but we’re shooting for as much Tier 2 coverage as possible. Regarding Part D, that branded co-pay is $45, and that stays that way, there’s no buy down there.
Great, thank you.
And your next question comes from the line of Jessica Fye of JP Morgan.
Hey guys, good evening. Two quick questions for me, just about the model. How much of the first quarter revenue was stocking? And you trimmed R&D expense by $10 million. I think you said something about it being related to the completion of enrollment in the outcomes trial, but I think that was known when you gave guidance. So I want to make sure I understand the reason behind the R&D guidance cut. Thank you.
Yes. Thanks, Jess. Rick, can I hit those questions to you?
Yes, sure. Yes, so Jess, on the revenue front, since NEXLETOL was available on the 30th, what’s reflective in the income statement is representative of those initial orders from our wholesalers. And then on the R&D expense may have been a bit confusing in the prepared remarks. Year-over-year, the cost expense have came down, primarily related to the completion of the outcomes trial last year.
In terms of updates for the year, we do expect given the COVID environment, some of the pass-through costs that we anticipated in incurring this year related to those – that study has slowed a bit on the higher end of the new range, it’s consistent with the low end of our prior range. But do feel like it’s reflective of where we’ll shake out for the full year on the R&D side, primarily related to the outcome study?
Okay. So it is related to outcome study expenses and not the result of, like, lower manufacturing spend running through that line prior to approval in the first quarter?
No. So what we expect for the full year is the primary expenses that are running through R&D are outcomes related. Obviously, we have some background R&D activities, timing of activities for manufacturing have moved around, but it hasn’t had a significant impact on cash burn or expenses that we expect to incur this year.
Got it, thank you.
Yes. Hey, thanks.
Your next question come from the line of Joel Beatty of Citi.
Hi, thanks for taking the questions and congrats on the launch. First question is, can you provide any information or context on the gross to net revenue that you’ve been seeing or anticipate?
Yes. Rick, can you take that?
Yes, sure. So Joel, as we’ve said for, consistently for some time. We haven’t disclosed gross to nets, and we don’t plan on disclosing gross to nets, really that this is for competitive purposes. We do expect our gross nets to be comparative with other analogs in the space for oral once-daily small molecule chronic therapies. But overall, we won’t be getting into the level of specificity on hard and fast amounts.
Okay, got it. And that could you maybe describe a typical prescribing experience for physician or what the typical range is in terms of as easy as writing a script in most cases? Or the amount of paperwork that’s done? Is Zetia typically required before approval? I’d be interested to learn more about that.
Yes. No, it’s a great question. And one that, Mark, I’m going to ask you to because I think you’re closer to it and can provide the right context around this. But it is – Joel, this is one that we smile about. So Mark?
Hey Joel, thanks for the question. Thanks, Tim. Yes. So it’s really easy. So right now, I think what physicians are really doing everything, especially right now is electronic. So from the video conference with our representative to e-prescribing and even the PA process. And what we are hearing from prescribing physicians is that everything that they’ve real far has gone through incredibly well. So we’re not really seeing any real blockades or obstacles, we’re not seeing any significant PAs outside of the label, and this is early, and we anticipate that keeping up. So Joel, the doctor – the physicians literally going into their iPhone or their EMR system. They’re prescribing electronically, it’s going right to the pharmacy. PAs could adjudicate electronically, and it goes to the pharmacy that way and then the patient is notified via text. It’s really simple. And we’re really doing well.
I want to also stress here, the way our products are adjudicating right now is exactly what we had anticipated by pricing the right way. I will say recent launches did not enjoy this level of ease and electronic PAs and things of that nature. It was much more paper intensive and even going into clinical records. So this is very different and very refreshing for the physicians who are writing the prescription so far.
Great to hear. And I know you mentioned earlier that the adjudicate prescription rate is around 5 times higher than PCSK9s. Can you help quantify what that level actually is?
Yes. So we’re seeing – right now, we’re seeing adjudications around that 50% mark, so successful adjudication going through. And keep in mind, this is really early. I mean, some contracts were just signed last week, the data that we have that utilizes this adjudication type messaging indicated that PCSK9s during their launch were at about 10%.
And we will now conclude the Q&A portion of the call. As mentioned earlier, please e-mail email@example.com to schedule a follow-up call with management if there are any questions from today’s discussion. Now I would like to turn the call back over to Tim Mayleben for closing remarks.
Thank you, Felicia. And in closing, I want to thank everybody for joining our first quarterly conference call. And I especially want to thank you for supporting Esperion. So in particular, for our shareholders, we know that you make all of this possible. Your belief in our team, our mission has brought us to this point. We have had a long relationship with many of you and candidly, could not have done this without you.
For the Esperion team, those that are listening or will listen, there are no words or enough words to say how proud I am of your continued accomplishments during these unprecedented times, marketing approvals, precedent setting, collaboration agreements, unparalleled patient access and now, our commercial launch of NEXLETOL and NEXLIZET. Accomplishments that reinforce our focus on lipid management for everyone. And I’m proud to be on this mission with you, proud of what we’ve accomplished together.
For those just hearing about Esperion for the first time, I encourage you to get in touch with our team, learn about how we can help so many patients in need together. And even to our skeptics, I hope you can see our unexpected accomplishments, our dedication and a word that I love, our grit. And see how we have overcome so many obstacles to be here today and hope you’ll have another discussion with us. So with that, we look forward to sharing further updates with you as the launches of our medicines progress in the weeks and months ahead. Thanks again, and have a good evening.
And ladies and gentlemen, this concludes today’s conference. Thank you for your participation, and have a wonderful day. You may all disconnect.