Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only. 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 operator. Good morning and welcome to Esperion's Second Quarter 2021 Financial Results and Company Update Conference Call. I'm Ben Church and I'm responsible for Investor Relations and Corporate Communications here at Esperion.

I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by our forward-looking statements due to the risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and SEC filings.

The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast August 3rd, 2021. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast.

As a reminder the conference call and webcast are being recorded and archived. We issued a press release this morning detailing the content of today's call. A copy can be found at www.esperion.com within the Investors & 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 a time to speak with our team. I'd now like to turn the call over to our President and CEO, Sheldon Koenig.

Sheldon?.

Thanks Ben and good morning everyone. With me today for prepared remarks are Rick Bartram, Chief Financial Officer; and Dr. Joanne Foody, Esperion's new Chief Medical Officer. Also on the line is Eric Warren, our Vice President of US Sales and Marketing. I brought Eric on board in January to integrate and lead a unified sales and marketing organization.

Eric, who is a pharmacist by training, has 25 years of commercial experience, focusing primarily on cardiometabolic and acute care medicine. He will be available for your questions at the end of this call as well. A special thanks to everyone joining us today for my first earnings call as President and CEO of Esperion.

I'm excited to share with you all the great strides taken by Esperion over this past quarter to position ourselves for long-term success as a nimble innovative organization solely focused on addressing cardiovascular disease which remains the number one killer in the United States and worldwide.

When I joined Esperion in December of last year, the company had recently launched the first oral non-statin LDL-C lowering medicine in nearly two decades, NEXLETOL and NEXLIZET. These are powerful first-in-class medicines with a novel mechanism of action and the potential to save patient lives.

However, the commercial strategy was not yet maximizing the full potential of these medicines on top of the persisting COVID-19 pandemic headwinds.

Having previously worked across many of the available LDL-C-lowering medicines, I have deep experience of what it takes to capture growth in the cardiovascular market and immediately recognize the untapped potential of NEXLETOL and NEXLIZET. Flash forward to today.

We have now made many of the changes that were needed to strengthen our foundation and begin to recognize the potential of NEXLETOL and NEXLIZET.

This includes bringing diverse experience to our senior leadership team, streamlining our commercial strategy, and implementing refined positioning for our medicines, all of which is moving this trajectory of NEXLETOL and NEXLIZET in the right direction.

Our results from the second quarter show that these initiatives are already gaining momentum and materializing into growth. Prescribing physicians and prescriptions per physician are at their highest yet and continue to demonstrate a consistent double-digit and high single-digit growth respectively.

In the quarter, NEXLETOL and NEXLIZET prescriptions grew 28% with accelerating month-over-month growth. But most importantly, our medicines have reached nearly 48,000 patients here in the US.

Since the mid-April introduction of the revised product positioning providers have expressed a clear understanding of where to prescribe NEXLETOL and NEXLIZET in patients that stand to gain the largest benefit.

The revised NEXLETOL and NEXLIZET positioning has resonated with payers as well and has been beneficial in our new market access approach focused on improving formulary status of our medicines specifically among Medicare Part D payers.

The success of these efforts is evident from the immediate response by Humana adding both NEXLETOL and NEXLIZET to their formulary as of May 1st. We continue to have promising conversations with payers, who acknowledge the need for additional treatment options on formulary, to tackle the large patient population not yet, at LDL-C goal.

A strong priority for the team this quarter was maximizing the awareness and value of NEXLETOL and NEXLIZET and driving quality prescriptions.

While our generous financial benefit co-pay programs, supported patients and encouraged adoption of our medicines throughout the first year of launch and the COVID-19 pandemic We believe the second quarter was the appropriate time to adjust both, the duration as well as the buy down magnitude of our co-pay card program to typical industry standards.

With our strong commercial coverage in place, in an improved economic environment, these adjustments resulted in limited impact to patient access to our medicines. Volume of payer covered prescriptions improved, and second quarter net price was more favorable contributing to the 67% sequential growth in U.S. net product revenue.

We continue to expect additional positive impact to net pricing over time as plans fully implement coverage and volumes scale up. Since assuming the role of CEO I've taken additional steps to position Esperion for long-term success one of that being the addition of prominent cardiologist, Dr. Joanne Foody as Chief Medical Officer.

While our priority is steadfast on driving commercial excellence of NEXLETOL and NEXLIZET ensuring we are prepared to capitalize on our unprecedented cardiovascular outcomes trial and the potential of our early-stage pipeline is vital.

The importance of the CLEAR Outcomes study cannot be emphasized enough not just for Esperion but for the entire field of cardiovascular medicine.

Not only could our CLEAR Outcomes trial be monumental for encouraging late adopters, payers and a broader application of NEXLETOL and NEXLIZET, but a potential risk reduction label indicates acceptance of an entirely new patient population that past medicines could not benefit.

Historically, every LDL-cholesterol lowering therapy affecting the cholesterol synthesis pathway, as NEXLETOL and NEXLIZET do demonstrated consistent outcome improvements. This along with the unique and deliberate design of our CLEAR Outcomes trial gives me great confidence on what is to come.

All signs indicate that CLEAR Outcomes now a little more than a year away will make history in cardiovascular health and potentially further our leadership position in bringing innovation to underserved patients. If I could say only one thing, it would be this.

Esperion is evolving quickly to maximize the opportunities that lay ahead and is instilling a laser-focused mentality on driving operational excellence, throughout both, commercial side of the business and also in our clinical and development programs. I am proud of what this team has accomplished in this short amount of time.

And continually gain confidence in the trajectory of Esperion and our future as a company. Now I'll turn the call over to, Joanne to introduce herself and ask her to share with you all her motivation behind joining our team.

Joanne?.

Thank you, Sheldon and good morning everyone. I'm Dr. Joanne Foody Chief Medical Officer and the newest member of the, Esperion leadership team. I'm thrilled to join Esperion to strengthen its leadership team as we strive to provide lipid-lowering therapies to address the significant unmet need in heart disease.

For the last three decades, as a preventive cardiologist, I have dedicated my career to improving outcomes for patients with, or at risk of cardiovascular disease. When the opportunity to lead Esperion as its Chief Medical Officer arose, I knew that this would be the right place to follow my passion to make a difference for patients.

There is not one amongst us, who have not had a family member or friend affected by heart disease or high cholesterol. These silent killers have stripped love ones far too early and far too often from me as well as countless others including most of you listening. Despite existing therapies too many patients remain at risk due to high cholesterol.

As the first new oral lipid-lowering therapy in two decades bempedoic acid either alone or in combination with ezetimibe has the potential to transform patient care.

During my time as a practicing cardiologist at the Cleveland Clinic and when on faculty at Yale and Harvard, I learned firsthand how physicians and patients are frustrated by the lack of tools available to address and stop the progression of heart disease.

As I transition to industry, the lack of novel, accessible and patient-friendly therapies to reduce cardiovascular risk became only more apparent. The need for therapeutic solutions in cardiovascular disease has unfortunately not changed despite statins or even injectable PCSK9 inhibitors.

Recently JAMA Cardiology published that only one-third of patients with atherosclerotic cardiovascular disease reach their cholesterol goals. That means that two out of every three high-risk patients did not achieve their goals and are at higher risk than they should be for heart disease.

Esperion the only company focused singularly on oral lipid-lowering solutions is poised to tackle this problem head-on and transform clinical care with the CLEAR Outcomes trial. This is the largest cardiovascular outcomes trial to study patients not optimized on their statins or intolerant to statins.

CLEAR Outcomes is unparalleled in its size novel design and unique patient population. This trial has taken into account all the lessons and insights of decades of cholesterol-lowering trials and is being run by teams of experts and chaired by Dr. Steven Nissen, an exceptional cardiologist and trialist.

The trial's unique patient population and high starting baseline LDL cholesterol increases the likely probability of success. Further, given the unique mechanism of action of bempedoic acid and its known pleiotropic effects on inflammation and glucose we anticipate the potential of additive benefits for patients.

The thing is, I've been in cardiology for a long time. I've been involved in multiple global cardiovascular outcome trials across multiple big pharma companies. I've reviewed these trials as I wrote guidelines, but I have never seen a global trial of this quality, size and scope being run at a company our size. That's a big deal.

Our entire medical team is reenergized to bring NEXLETOL and NEXLIZET to all patients who can benefit from our indicated therapy today. And we are prepared to bring NEXLETOL and NEXLIZET to more patients who can potentially have outcomes benefit tomorrow.

From the moment I started, I have been thoroughly impressed by the incredible talent and expertise of this team and their passionate commitment to bring back a sense of urgency to lipid management and cardiovascular risk reduction and advocate for continued innovation to ensure that patients and physicians have best-in-class, highly effective convenient options to combat cholesterol.

Thank you again for your time and attention. I cannot say it enough. There remains much work to be done, but I am confident that driven by science, we will demonstrate continued progress in this mission over the quarters ahead. Now Rick will provide comments on the quarterly financial performance..

Thanks Joanne. Earlier today we issued a press release containing our financial results for the second quarter, which is available on our investor website. US net product revenue was $10.6 million for the second quarter compared to approximately $600,000 generated in the second quarter of last year and $6.4 million in the first quarter of this year.

Total revenue for the second quarter was approximately $41 million, which included $28.1 million in collaboration revenue related to the $30 million upfront payment received from our expanded partnership with Daiichi Sankyo that we announced in April.

And there was approximately $1 million of royalty revenue from our European collaboration with Daiichi. Net price for our medicines improved during the second quarter as the commercial team implemented a number of changes to the co-pay card program as Sheldon highlighted earlier.

Over time we expect our net price to continue to improve as plans fully implement coverage and volumes scale up. On expenses R&D expense for the second quarter approximated $25 million down 10% from the first quarter. SG&A expense was approximately $46 million for the second quarter down 24% from the first quarter.

The sequential decline in SG&A expense was driven predominantly by a onetime charge associated with a legal settlement in the first quarter. We continue to expect our full year 2021 R&D expenses to fall between $120 million to $130 million and SG&A expenses to be between $200 million and $210 million.

Note that these amounts are inclusive of approximately $30 million in noncash stock-based compensation expense for the full year. Our cash balance as of June 30 was approximately $219 million. We remain committed to prudently managing expenses and will ensure the organization is adequately funded to advance the business.

Going forward you should expect us to continue to balance cash spend against growth potential and the cash needs to ensure the business is resourced for future growth. Before handing the call back to Sheldon, let me summarize our financial progress.

First, we had 67% quarterly growth of NEXLETOL and NEXLIZET net revenue; second, we saw improved net price of our medicines through the adjustments of our co-pay card program highlighted earlier; and lastly, we remain extremely diligent managing our cash while supporting the commercial launch and our CLEAR Outcomes trial.

By maintaining this focus, we are confident our financial position will continue to strengthen throughout the remainder of the year. With that I will turn it back to Sheldon for closing remarks. .

Thanks Rick. I want to say again how proud I am of what the team has accomplished and the direction Esperion is headed in. While there is still a lot of work left to do we continue to drive a sense of urgency across the organization to bring value to our shareholders, health care providers and most importantly patients.

Our refined commercial strategy has begun to demonstrate traction across a number of fronts translating to expanded Medicare Part D coverage substantial prescription growth of NEXLETOL and NEXLIZET and other key commercial metrics including net pricing.

While we continue to work towards operational excellence, we remain steadfast on the true mission at heart an opportunity to transform the lives of millions of patients struggling to lower their LDL cholesterol. A big thank you to all our colleagues and partners for their hard work passion and commitment this quarter and every quarter.

And again, thank you all for joining today and your continued support and interest in Esperion. Operator we are now ready for Q&A. .

[Operator Instructions] Our first question comes the line of Michael Yee from Jefferies. Your line is now open..

Hi guys, good morning. Thank you for taking the question. We had two questions. One was your comments around gross to net which was great to hear that you think it will improve. Could you just maybe quantify that a little bit? In 2020, we think you were around 35, 40-something percent. It dropped a lot of in Q1.

You think the rest of the year is more like 50%? Is that a ballpark range to use? Maybe you could just comment on that. And then the second question was more of a macro which was -- we do know that COVID has impacted things over the last few quarters. Things obviously improved a lot and there's maybe some changes recently.

So maybe just comment about the environment you're seeing you feel like patient volumes are getting a lot better? Maybe just comment about that as well? Thanks..

Great. Good morning. Thank you Michael. This is Sheldon. And let me first comment on your first topic as it relates to gross to net. Again, I really want to emphasize and hopefully you can hear me okay here. We're in a new room. The fact that -- we noticed a net -- a notable improvement in our net price as you mentioned.

And this is something that we've been consistently saying since the last quarter this is something that we would continue to work on feverishly and the team has done a great job in really-- in a little less than two months. And we believe that improvement will continue going into the third quarter and quarters beyond.

I'm not going to comment on the specific percentages. We don't give out our gross to net. We don't speak to that or advise on that. But again, I want to just state that something we are committed to as it relates to reducing our exposure, making sure that we would have quality prescriptions. Again, we -- our demand grew by 28%.

And I think, as I mentioned before, I know that as we move into third and fourth quarter, we will see the improvement. As it relates to COVID, obviously, this is something that we're following with the Delta variant. Our reps have always been committed and have been out in the field, even since COVID hit last March of 2020.

Reports we get back from the field is that individuals are returning to the office, physicians are returning. More and more patients are getting vaccinated. I think with the Delta variant, more folks are realizing they need to get vaccinated, if they're not. But slowly, but surely, folks are returning to the office.

I'll ask Eric Warren, who's here if he has any additional comments..

Thanks, Sheldon. Nice to meet you, Michael. My name is Eric as Sheldon mentioned. I have responsibility for our sales and marketing teams at Esperion. I'm a pharmacist by training, 25 years in the industry and most of my experience has been in cardiometabolic disease. I came here just a few months ago. And really three reasons behind that.

Really the people here have been incredible; the medicines have been inspirational; and the clear focus on cardiovascular disease is to be complemented. So with regards to the sales force activity, we've seen a significant increase in the number of calls per day that our team has been able to make.

They're seeing more targeted customers and they're able to increase their frequency on customers. We've also seen a really significant increase in the number of peer-to-peer programs from Q1 to Q2, so all those are good signs from a COVID perspective. Now yes, the Delta variant is on our minds. We're keeping a close eye on that.

We can't predict where it will pop up and where it will go down. But we are making sure that our teams are armed with the proper safety equipment and masks have always been a mandate as they are with our HCP offices.

And we're really committed to making sure that our team is out there, they're communicating the benefits and risks of our compounds and that they're making sure that appropriate patients to receive our product..

Thank you..

Thank you. Our next question comes from the line of Joseph Thome from Cowen and Company. Your line is now open..

Good morning. Thank you for taking my questions. The first one, I know you did mention sort of that you're now honing in on sort of the heavy prescribers are targeting those accounts.

Can you comment a little bit on the blend of sort of specialty cardiology accounts versus primary care physicians and maybe where you are seeing that -- that higher prescribing rate? And then second, maybe in those docs that aren't immediately reaching for the therapy right now, what else do they need to see? Do they want to see that CV outcomes data, or is there anything that you can provide that -- maybe ahead of that that could drive additional adoption? Thank you..

Great. Thanks, Joe. Our microphone is a little jumbled here, but I think I got the first part of your question.

And that is, who do we really see prescribing NEXLETOL and NEXLIZET? What's that breakout between primary care and cardiologists? And what we're seeing is that, there's more primary care physicians that are writing both NEXLETOL and NEXLIZET than cardiologists. That's probably closer to a 60% to 40%; 60% primary care, 40% cardiology.

This is not unexpected. This is -- as you may or may not be aware, I ran the brand of Zetia Vytorin while I was at Merck and we saw that majority of prescribing of ezetimibe was in primary care. And we're starting to see the same here as well as it relates to NEXLIZET and NEXLETOL. And the second part of your question is....

Yes. I can try and repeat it if....

What else do they need to see? Sorry Yes. So -- yes -- so actually, for us one of the things that we mentioned last quarter was awareness. And we're starting to see awareness of these brands improving.

The CLEAR Outcomes study, which I will have Joanne comment briefly on in just a second, is definitely something that's going to be very important for us.

But again, looking at other products and analogies, there's a lot of patients, close to 18 million patients in the United States, who have a lipid abnormality, are not achieving their LDL-C goal and they need treatment now.

So our physicians realize this and physicians also – they don't want a delay in trying to get their patients to their LDL target. So we believe we have a lot of room to grow. As we mentioned in the script, we have 48,000 patients currently on these drugs. I mentioned the number of 18 million.

As my partner here Eric Warren would say, we're just scratching the surface. And we think that we can again really grow and have an inflection point and a CLEAR study, as I've always said, will provide us maybe a secondary inflection point.

Joanne, any color you'd want to add on the CLEAR Outcomes study?.

Thank you, Sheldon. And thank you, Joseph for your question. I think as Sheldon mentioned, the CLEAR Outcomes trial will be an important inflection point.

However, over the next 15 months as we anticipate that study close, we have developed a very significant integrated evidence approach that will leverage real-world data to provide information for providers, clinicians and ordinary payers with respect to our value proposition.

And so there is as Sheldon mentioned, a significant amount of work that will be ongoing to refine our understanding of treatment gaps, patient phenotypes, those who might be most likely to benefit today from our therapy and ultimately do this all to have certain grounds for the CVOT.

What you may not be aware is as an Outcomes researcher in my academic career for many years and having reasonably been Head of Data Science for Johnson & Johnson in the cardiovascular space and most of that work was really on how we could leverage big data, how we could leverage electronic health records and all the data that exist in the real world to help providers understand the value.

And all this ultimately drives our commercial utilization.

So as Sheldon mentioned, I think right now we want to continue to work to improve patient identification, improve understanding and awareness of those patients most likely to benefit from NEXLETOL and NEXLIZET today, while we anticipate the data generated from the CV Outcomes trial in the future..

Great. Thank you..

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

Great. Thanks. Thanks for taking my question. You talked a little bit about in mid-April revising your product positioning. Just wondering if you could talk a little bit to how that has affected sort of the patients that are using [indiscernible].

So even anecdotally, as you talk to the physicians, what patients would be using your drug and maybe how it changed with the new positioning?.

Yes. So, thanks Chad for the question. Let me just start off quickly. One of the things that we introduced was the new positioning in April. One of our bellwethers testing to say is this the right positioning was the win that we had with Humana, which is one of the largest Medicare Part D providers with close to 9 million patients.

And I think what was important there is that it was obvious that the position was clear and understood. We had a quick turnaround as it relates to an answer from Humana. So that was the test of it. I'm going to ask Eric to comment on what he's seeing in the field. He's the one who's been deploying this positioning and working closely with the field.

Eric?.

Great. Hi, Chad, Nice to meet you. So yes, we deployed some revised positioning in April. And really the goal was to hone in on a specific patient type where our success would be evident. Rather than talking about five or six patient types that may not stick with our clinicians, really driving one where we know and that we see success.

And the team has been doing a great job at executing that. It's all about building confidence and momentum. The population again that we focused on as consistent with our indication ASCVD HeFH patients that aren't at goal they're on other therapies and statin therapy they've obviously maxed that out. There is an intention to do more for the patient.

And that's where NEXLETOL and NEXLIZET come into play. It's a sizable population kind of gives opportunity to demonstrate the efficacy as well as the safety profile of the compound and then it creates a base for us to expand. And we've got two phases of expansion planned a phase that happens before CVOT and then a phase that happens after CVOT.

And as Sheldon mentioned from a payer perspective that strategy has been resonating well. From a practitioner perspective it's been resonating well. And also from an internal perspective I think our sales team appreciates the clarity that we've provided. .

Okay. Great. I appreciate that.

Is it -- I mean is it fair to say based on your guy's experience that the idea of statin intolerance just hasn't gained the traction we once all thought it might?.

Let me speak to that. And so statin intolerance I think is something that's been ongoing since statins have been launched. More so I think after lovastatin and going into ZOCOR there's always been a thought that there's a rate of anywhere between 16% and 20% of all patients who are statin intolerant. That doesn't mean they can't take a statin at all.

It means that they can only take maybe even a certain dose of statin. So this isn't really about just that intolerance but it's really about patients achieving LDL goal. And the treatment paradigm has become a step guided treatment. I'm not a physician, Joanne is but I'll just make this comment.

It evolved from a statin to then a statin plus ezetimibe and now it's a statin plus ezetimibe and something else. And we believe that something else is NEXLIZET and NEXLETOL pre-CVOT. As I mentioned there's millions of patients who are taking statins and statins and ezetimibe and are still not at LDL goal.

And as we mentioned earlier cardiovascular disease is the number one killer. So there's definitely a place for NEXLIZET and NEXLETOL. Again we've seen that in this quarter. We had 67% growth in revenue, we had 28% growth in demand. We're calling these quality prescriptions. And again I think there's a lot of potential for these brands. .

Sheldon, if I could just add I think from a physician perspective and again speaking as a cardiologist on this I think statin intolerance definitely exists. I think the challenge is that it is underrecognized because patients have had to suffer with their muscle symptoms because there were not therapies available.

So I think to your point, some of this has not been fully leveraged and I think we do now have a compound and a combination of compounds in NEXLETOL and NEXLIZET that can address this. I think you also have to recognize that, when statins were really and still are the only game in town as an oral therapy for this, people do suffer with it.

And we have the opportunity I think to expand. But importantly as Sheldon mentioned, it's not just statin intolerance. There's also statin hesitancy that people decide to vote with their feet and not take any therapy and leave their cardiovascular risk high due to that.

There's also lack of optimization of statins So people can be on smaller doses than they should be to achieve their goals to reduce their cardiovascular risk. So there's a whole host and a range of patients who cannot take what should be the optimal dose of a statin for a variety of reasons.

And we think this is where NEXLETOL and NEXLIZET could fair squarely..

Great. Thanks. Appreciate it [indiscernible]. Thank you.

Thank you, Chad.

Thanks, Chad..

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

Hi. Thanks for taking my question.

First one with the focus on the high-quality prescriptions are you continuing to evaluate sales force sizing and territory prioritization? And then secondly, can you just give us an update on the launch in Europe how that's progressing?.

Sure. Great. Thank you, Jason. So as it relates to the sales force size where we are at right now, we do believe that we do have the right sales force and the size. I'm going to ask Eric to comment in a bit, but let me just first talk about Europe. So in Europe, we continued to see strong performance from Daiichi Sankyo.

They launched both of these products in October of 2020 and they've continued to see -- have seen growth. They're currently launched in Germany. They're also launching in the UK and a handful of other smaller countries. We meet with them on a weekly basis. We have a great partnership with Daiichi Sankyo. And again, performance is doing quite well there.

Eric, do you want to talk about how we evaluate sales force size?.

Sure. Sure absolutely. And nice to meet you, Jason. So right now, our sales force is approximately 200 territory managers been stable through Q2 which is a good sign. And I do think right now it is right size to support the near-term opportunity.

However, in order to really reach the maximum potential, there are a lot of customers specifically primary care physicians that we intend to be able to cover constantly evaluating appropriate ways to reach these practitioners. But we have to do so obviously in a cost-effective manner..

Great. Thanks for taking the questions..

Hey, Jason..

Thank you. Our next question comes from the line from Tom Shrader from BTIG. Your line is now open..

Good morning. I'm getting long patches of silence. I can't tell if it's me or the general call, but I wanted to re-ask a piece of Chad's question.

Is the majority or the vast majority of your users now people already on ezetimibe?.

Hey, Tom. First of all -- yeah, we're not getting reports. Maybe it might be your connection. I know last quarter we had some issues and people were telling us right away. But we're not getting those reports. I just wanted to be FYI. And if other people aren't please ping or chat to the operator.

We actually specifically picked the new room to make sure we wouldn't have that this time. So as it relates to patients, currently on NEXLIZET and NEXLETOL. I think we see a good mix of patients who are on statins and who are on statins and ezetimibe that are taking both of these products.

So our positioning of course right now as we've mentioned is talking about those patients who are on a statin plus ezetimibe. And then before you would actually go to an injectable PCSK9, we think there's the room and ability to use NEXLIZET and NEXLETOL. There are other doctors who are -- just use statins and they have added NEXLETOL or NEXLIZET.

So -- and right now the split of those two drugs when you look at NEXLETOL and NEXLIZET is approximately 50-50 in the use of both of those drugs..

All right. And then just one housekeeping question.

Are the co-pay cards greater than three months? Are they completely gone? And did they have any impact this last quarter and second quarter?.

Yeah. So, I'll have Eric comment on the co-pay cards..

Sure. Hi, Tom, nice to meet you. So as Sheldon mentioned earlier, profitable growth is really important to us.

And yes, in the past we've leveraged co-pay cards for multiple purposes, not only to lower the out-of-pocket cost that a patient pays for an approved -- or a commercial patient pays for an approved script, but also to create a bridge if you will for those patients that are awaiting prior authorization approval.

So the co-pay card will continue to last for an extended time for those patients that are commercially approved and that we are paying down the prescription to make it more affordable.

However, we've made some changes to the co-pay card and no longer will we be creating that bridge if you will to cover those patients that are awaiting their prior authorization. Instead, we've implemented additional programs including something requiring the prescription support program to support those patients..

Got it. Thank you..

You're welcome, Tom..

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

Hi guys. This is Olivia Brayer. Thanks for the questions. Sheldon, can you give us an update on where you are in conversations with payers on the Medicare coverage side? I know you've been added by Humana and that obviously took some time to play out.

So how do you think about timelines for getting added to other major formularies and whether that's something that could realistically play out this year? And then I have one follow-up after that..

Okay. So first of all thanks for your question. Again just to reiterate, we're really happy about the win with Humana. I know I mentioned it a lot but that was a big win for us, again the largest Medicare Part D provider and a good test of our positioning.

As it relates to -- Olivia, sorry -- as it relates to the contracting where we are today, so we're currently in talks with other providers. I think it's important to note though that while we're also in talks with other providers, we can still do pull-through of both contracted and non-contracted accounts.

And that is something that we are really concentrating on and focusing on really driving demand while we have those discussions. We're happy where we sit today as it relates to our commercial coverage with greater than 90% and our Medicare coverage is 60%. We'll continue to update you as we go through the third and in the fourth quarter.

I'm not going to comment on when we actually think we would have contracts. We want to make sure that whatever we do is very well-thought out, make sense and in the meantime still be able to drive demand, which we are able to do. And Olivia your follow-up. Yeah sorry..

Yeah. And then my second question is really around opportunities for partnerships beyond what you've already been able to establish. I know you guys have talked about China and other geographies that could help drive growth over the longer term.

But are there certain countries that are maybe more of a priority at this point or more of a near-term focus than others?.

Yeah. So first, again, I want to reiterate as you know we have an agreement with Daiichi Sankyo for Europe. We expanded that agreement with the ASCA region. So that allowed for a partnership of different markets, not only in Asia but some also in Latin America. China and Canada are two that still stand out that we have complete ownership of.

And I think the best way to think about this is our focus really is on the US. Right now we're focusing on the US and continuing to drive performance and drive the growth of NEXLETOL and NEXLIZET. And that's where we will be spending the majority of our focus as we move throughout this year..

Okay, great. Thank you..

Sure..

Thank you. Our next question comes from the line of Jeff Hung from Morgan Stanley. Your line is now open..

Thanks for taking the questions. You've talked about addressing the co-pay card and then in the past the need for greater touch points with physicians to generate written scripts.

What additional levers do you have to impact the trajectory of scripts?.

Hi, Jeff, I'm actually going to have Eric speak to that.

Eric?.

Thanks Sheldon, and nice to meet you as well, Jeff. Yes, obviously, scripts come from awareness of our compounds. So being able to have live interactions is critical. As I mentioned, we've been able to increase the number of direct engagements we've had with our customers and not only our customers but our targeted HCPs, which is really important.

And we've had double-digit improvement from Q1 to Q2 in terms of our reach. We've seen increased frequency. I've also mentioned that we've improved our ability to reach our customers from a peer to peer perspective.

We had a significant bolus of activity in June, not only smaller programs of about 10 in size, but we did two national programs where we're able to engage more than 1000 HCPs in peer-to-peer activity. So that's important to us. And that's -- we see that as a mechanism to drive scripts.

In addition, I mentioned the prescription support program is going to be critical. Obviously with prior authorizations for some plans, it's important that our customers are prepared to be able to complete those to maintain timely access. And as I mentioned August 1, we have implemented this prescription support program.

This program includes a dedicated support team that works both with the patient as well as the office to ensure that all the proper documentation is processed and that the prior authorization is approved..

Thanks. And then, you've indicated that Esperion could only get to about half of the physicians it needed to cover in June.

How has the ratio of reached versus targeted physicians changed over the last few months?.

Yeah. So we've actually been able to reach more than half of our targeted HCPs. We're closer to two-thirds of those targeted HCPs.

And what was the latter part of the question?.

I was just curious, how that's changed over the last few months and if that changed over the....

Yeah. It's improved. Yeah, we're seeing significant improvements in our ability to get to our targeted customers. And have meaningful discussions on our products. And that's really a testament to the salesforce and their passion and dedication out there. They've been out there consistently, throughout the COVID time if you will.

And they've seen significant improvements now, because of I think their persistence, but also because of the quality of the compounds that we have..

And I would also add Eric I think just the introduction of data analytics. And how you've applied analytics to really territory targeting and performance measurement has also been keen in doing that..

Okay. Thank you..

Thank you. Our next question comes from the line of Jessica Fye from JPMorgan. Your line is now open..

Hey guys. Good morning. Thanks for taking my question.

First question is, can you talk about how the franchise is doing in Europe, maybe translate what the royalty revenue means for overall sales in Europe, so we can get a sense of how the business is doing there?.

Hi, Jess, let me first say that, Europe has been performing well. Our partners with Daiichi Sankyo, as I mentioned earlier, they continue to see growth in number of patients on a monthly basis. I'll have Rick comment on, -- as it relates to royalty aspects..

Yeah. Thanks Jess. So we did communicate that we had about $1 million of royalty revenue from the European collaboration. That collaboration is available publicly. We're not commenting on the actual revenue dollars. You can do calculations. But given some of the exchange rates, we're not commenting on that..

Okay. And next one is just on the cash runway, either for Sheldon or Rick. I think Sheldon in the prepared remarks you mentioned the CLEAR Outcomes data is a little over a year away.

So is it your expectation that, you have the cash to get to that data readout? And can you talk about strategies you might use to top off the balance sheet so you get to that CLEAR Outcomes data with a little cushion?.

I'll have Rick comment on that.

Rick?.

Yeah. Thanks Jess. Yes. So as we mentioned in the prepared remarks. And as you saw in the press release we had about $220 million in cash, when we look at the business and we look at the cash available to us, I just want to point out and reiterate we have about $1.2 billion of future milestones.

We do expect those to continue to feed our balance sheet overtime. We're constantly evaluating cash runway looking for ways to not only optimize costs in our expenses, but just be thoughtful about, how we bring additional capital into the organization.

As you know, we capitalized on two non-dilutive funding sources this past quarter, the expansion with Daiichi under that partnership and then with our financial partners Oberland Capital. We're going to continue to have that mindset evaluate options. And just make sure that the business is funded to deliver the business plan and grow our products..

Okay, great.

And then, just lastly on the progress of CLEAR Outcomes, as we try to think about maybe when in the second part of 2022 that could come, is there any next communication that we should be anticipating from you guys on maybe the proportion of events that have occurred? Just anything we should be kind of watching for on progress updates there?.

Let me have -- I'll have Joanne comment on that. Just as it relates to events we're at a 75% right now.

But Joanne do you want to comment to that?.

So thank you Jess for the question and clearly just to first say that the CLEAR Outcomes study is currently on track to execute and close out at the end of 2022. Importantly we have accumulated 75% of our MACE event. It's important for people to recognize. I think there's a lot of concern about COVID.

But remember again that the study was fully enrolled prior to COVID in 2019 and has not seen any impact from COVID. We will continue to report out accumulation of MACE event next year. And otherwise the study is fully on track. And when we compare the study to other studies and historical benchmarks we are in a good place to execute on this study. .

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

Hi everyone. Thank you so much for taking the question. This is Charlie on for Paul. I think just one from us at this point just regarding adjustments that have been made to improve the net price as the launch continues.

Can you give us a sense of like the timing of those adjustments throughout the quarter? Does the entire quarterly revenue kind of reflects those adjustments, or was that something that kind of arose as time went on throughout the quarter such that maybe only a portion or half of the quarter really reflects the improvement in that price? Thank you so much..

Thanks Charlie. So as it relates to the improvement it was something that was done over a couple of months honestly. And still as I mentioned earlier and also in our prepared remarks, we still see further improvement that can be attained as we move into third and fourth quarter. Again, this is something that we are looking at very diligently.

And the fact that we could say that we had a notable improvement in net price in such a short amount of time was very important for us. It was something that we set out to do. We said we would do it and we're going to continue to do it as each and every day goes by wherever we can look for those type of efficiencies. .

Got it. Sounds good. Thank you so much for taking that question..

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect..