Esperion Therapeutics, Inc. (ESPR) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome to the Esperion NEXLETOL Approval Call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Alex Schwartz, Senior Director of Investor Relations. Thank you. Please go ahead, sir.

Thank you, Shannon. Good morning, ladies and gentlemen, and welcome. I'm Alex Schwartz, Head of Investor Relations at Esperion. At this time, all participants are in a listen-only mode. Later, we will 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; Ashley Hall, Chief Development Officer; Mark Glickman, Chief Commercial Officer; and Rick Bartram, Chief Financial Officer; as well as Bill Sasiela, Senior Vice President of Clinical Development. I'd like to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of this live broadcast, February 24, 2020. We take 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 on Friday detailing the contents of today's call. A copy can be found at 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 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. Good morning, everyone, and thank you for joining us. This is an important day. It's an important day for patients. Today is really for the millions of adults with ASCVD and heterozygous FH in the U.S. that struggle with bad cholesterol. It's an important day for health care providers. Health care providers in the U.S. finally, after almost 2 decades, have a once-a-day non-statin pill for lowering bad cholesterol to offer their patients with ASCVD or heterozygous FH. And it's an important day for payers. After almost 20 years, payers can now offer these patients and health care providers an affordable once-a-day, non-statin pill for lowering bad cholesterol. As we said consistently for the past 2 years now, we plan to make NEXLETOL available at a list price of around $10 per day to payers. However, as you'll hear from Mark, patients will pay far less. This is also an important day for our supporters. In today's environment, it takes courage, perseverance, fortitude and time to back a team and company like Esperion, which is focused on the development and approval of medicines to treat bad cholesterol. It's an area that has suffered from a lack of investment and a dearth of new medicines for patients until Esperion. And this is the day that our team of lipid management experts has been working toward for more than a decade. All of us at Esperion couldn't be more excited to be with -- here with you today. This is the day that marks the FDA approval of our first medicine, NEXLETOL. The approval marks the first oral, once-daily non-statin LDL-cholesterol lowering medicine approved in nearly 20 years. And this approval would not have been possible without the hard work, countless hours, perseverance and true grit from our team of lipid management experts. Grit is the passion and perseverance required to achieve long-term and meaningful goals, and our lipid management team at Esperion has grit. The time lines for development and approval of drugs to lower bad cholesterol and reduce the risks of cardiovascular disease are not measured in months or even years. With the support of our shareholders and partners, the Esperion team has been committed to a decade-long pursuit of the development and approval of NEXLETOL, and that commitment has been realized today with the approval of our once-a-day, non-statin pill to lower bad cholesterol, which will help appropriate patients reach their LDL-cholesterol goal. Let's turn now to the presentation and Slide 4. I want to start with our highly experienced leadership team at Esperion. First, I want to recognize Ashley Hall and Bill Sasiela who are here with me on the call this morning and Ken Fiorelli, all of whom led the development and approval for NEXLETOL. Though it received almost no attention, recall that our company made history last February with 4 regulatory submissions for marketing approvals, 2 to EMA and 2 to FDA, in a single month. And those submissions were initiated less than 100 days after our final Phase III results. We owe Ashley, Bill, Ken and their teams a great debt of gratitude, not only for their efforts, but more importantly, what they accomplished and continue to accomplish with their efforts. In recognizing Ashley, our Chief Development Officer, note that she previously led the successful regulatory process for evolocumab. With her deep experience, she has been able to lead Esperion through regulatory processes in both the U.S. and the EU. Similarly, in recognizing Bill, our Head of Clinical Development, note that prior to joining Esperion, Bill was the overall Program Head for Cardiovascular and Metabolism (sic) [ Cardiovascular Metabolism ] at Regeneron, which included leading the clinical development and approval for alirocumab. And finally, I want to recognize Mark Glickman who is also here with me today and the amazing health care provider, payer and patient-facing teams he has built over the past almost 2 years and who is now accepting the proverbial baton from the development team for NEXLETOL. As you'll hear later on in the call from Mark, we are totally focused on patient affordability and access for our medicine. I'll also note that while this is Esperion's first NDA approval, and this will be our first commercial launch, Mark and his team have led dozens of medicines through approval and commercialization. And as a result, our highly experienced and incredibly talented team is ready to lead us through the most anticipated commercial launch of 2020. Turning now to Slide 5. Let's look briefly at the current state of bad cholesterol in the U.S. It's estimated that almost 100 million people in the U.S. have high levels of bad cholesterol or LDL-cholesterol. Of these, approximately 34 million people are taking a statin. Statins are the gold standard treatment for the vast majority of patients with elevated LDL-cholesterol. Many people on our team were involved in the development of statins, and we believe that every person that can tolerate a statin should take a statin. But here's the thing. Not everyone can or will take a statin and not everyone who takes a statin can reach their LDL-cholesterol goal. So while statins help 8 out of 10 people lower their LDL-cholesterol and get to goal, that means 2 out of 10 people are not helped. And in the U.S., those 2 out of 10 people represent almost 18 million patients. These are patients that need a non-statin way to lower their LDL-cholesterol. Millions of people not taking statins most often due to tolerability and another millions of patients are taking their statin but still need more LDL-cholesterol, non-statin LDL-cholesterol lowering to achieve their doctor recommended LDL-cholesterol goal. Of these patients, about 15 million patients have ASCVD and heterozygous FH. These patients represent our addressable population with NEXLETOL. These are underserved patients who need additional non-statin LDL-cholesterol lowering. These are patients who are not adequately managed with statins or other currently available lipid-modifying therapies. These are patients who need the oral, once-daily, non-statin LDL-cholesterol lowering that comes with the approval of NEXLETOL. That is why it's so important for Esperion to be doing what we're doing. We do this for the millions of appropriate patients, the mothers, the fathers, the aunts, the uncles, the grandparents who need to get their cholesterol under control. Let's turn now to the NEXLETOL label. NEXLETOL is an ATP citrate lyase inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol. Note that the effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined. And NEXLETOL, as we've been saying, is the first oral, once-daily, non-statin LDL-cholesterol lowering medicine approved in the U.S. for heterozygous and ASCVD patients in almost 2 decades. Patients and their health care providers tell us there's an enormous need, and we expect strong demand for this new medicine. There's been a dearth of innovation, as I said earlier, in the development of affordable oral, non-statin medicines for patients with elevated LDL-cholesterol. Today's news is a big win for suitable patients, health care providers and payers. Also, as I said earlier, this approval is the result of many years of research and development. And this day would not be possible without the thousands of physician investigators, the many thousands of their support staff and perhaps, most importantly, the almost 20,000 patients who participated or are participating in our clinical development programs. We thank them all from the bottom of our hearts. Along with today's NEXLETOL approval, recall that we have a second oral, once-daily LDL-cholesterol lowering medicine that is currently under review by the FDA, the bempedoic acid/ezetimibe combination tablet. The FDA goal action date or PDUFA date is February 26. And if approved, it will be the first completely non-statin combination medicine ever approved by the FDA for LDL-cholesterol lowering. With that, let's turn now to Slide 7. Before I turn the call over to Ashley and Bill to talk about the label for NEXLETOL, I want to highlight that NEXLETOL will be available in the U.S. on March 30, 2020, just a few short weeks from today. And let me just emphasize a few key points about NEXLETOL. Our medicine is a once-a-day pill, which we believe makes it convenient to use. This is a non-statin LDL-cholesterol lowering medicine. This medicine is a first-in-class inhibitor of ATP citrate lyase. This medicine offers appropriate patients additional non-statin LDL-cholesterol lowering as an adjunct to diet and maximally-tolerated statin therapy. And finally, our medicine has a safety profile generally comparable to placebo. So with that, I'd like to pass the call over to Ashley Hall, our Chief Development Officer, who will briefly walk you through the approved label of NEXLETOL. Ashley?

Thank you so much, Tim. Slide 8 outlines the efficacy profile of our first approved medicine, NEXLETOL. Our team has successfully completed a very large and robust Phase III clinical program, which included over 3,000 patients. As established in our Phase III clinical trials, CLEAR Harmony and CLEAR Wisdom, NEXLETOL 180 milligrams provides an average 18% LDL-cholesterol lowering on top of maximally tolerated statin therapy. Importantly, this efficacy is consistent across statin and statin doses. The label also notes the positive effects on other lipid parameters, including non-HDL-C, ApoB and total cholesterol. These results were consistent across all subgroup studies in any of the clinical trials, including history of diabetes, baseline LDL-C, BMI, HeFH status and background therapies. What this means is that NEXLETOL lowered LDL-cholesterol consistently across a wide range of patient demographics and patient baseline characteristics. On Slide 9, of course, we highlight the important safety information for NEXLETOL. Again, the safety of NEXLETOL was evaluated in more than 3,000 patients, which included over 2,000 patients treated with NEXLETOL, all of which took NEXLETOL for 52 weeks. The FDA determined that NEXLETOL has a positive benefit-risk profile in appropriate patients, and the label includes the following, no contraindications. In the warnings and precautions section, NEXLETOL may increase blood uric acid levels. Events of clinically significant hyperuricemia were 3.5% NEXLETOL versus 1.1% for placebo. And NEXLETOL is associated with increased risk of tendon rupture, though rates were low, at 0.5% for NEXLETOL versus 0% for placebo. And importantly, no causality for this event has been established. I'd also like to highlight that the side effects were all generally comparable to placebo. No dose adjustments are required in patients with renal or hepatic impairment. NEXLETOL has once-daily dosing with or without food, which we believe will provide a convenient option for patients along with simple room temperature storage conditions. Finally, I'll note that concomitant use with simvastatin greater than 20 milligrams or pravastatin greater than 40 milligrams should be avoided. The most common adverse events included in the label were incidents greater than or equal to 2% and also greater than placebo. You will note that the rates of occurrence are quite low in all cases. The AEs included in the label are of a respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes. And moving now to Slide 10, I'm very pleased after this overview of the label to turn it over to Mark Glickman, our Chief Commercial Officer, who will talk to you about how we are getting NEXLETOL to patients.

Thank you, Ashley. We are very excited about the U.S. approval for NEXLETOL. We have already built an incredibly experienced commercial team at Esperion, most recently bringing on almost 300 best-in-class territory managers along with 30 regional directors with significant cardiovascular expertise and experience. We're in the process of finalizing those offers to those 300 representatives that have just been recruited. I'll provide greater detail into this team in just a few minutes. Slide 11, please. We believe that NEXLETOL will provide a simple and convenient way to get patients with ASCVD or HeFH on maxi-tolerated statins to their LDL-cholesterol goals. Let me turn to a few patient profiles I want to highlight for now as there are many, many patient profiles that overlap. As health care providers know, each patient is unique. I'm talking with you about patient profiles only as a mean to help you gain a better understanding of the appropriate patient population. We are confident that NEXLETOL will fit many different patient profiles, including: patients whose LDL-cholesterol levels have resulted in events like heart attacks and strokes; patients who were genetically predisposed to very high cholesterol levels, so-called HeFH patients; patients with ASCVD or HeFH who still need additional LDL-C lowering on top of their maxi-tolerated statins. Again, these are just a few patient profiles that will be appropriate for NEXLETOL. Now on to Slide 12 to discuss a topic very important to Esperion, our commitment to affordability and patient access. Patient access combines several key elements: compendia class, formulary position and coverage and list or WAC price. Patient co-pays or out-of-pocket costs round this out. Each of these elements is incredibly important when ensuring access to medicine in our health care system. We've been focused on each and every element with each of the different constituents in the health care system to help ensure patients and their health care providers have access to our medicine. NEXLETOL is a first-in-class medicine. It's an ATP citrate lyase inhibitor, which is a non-statin mechanism of action. As a result, we are confident that NEXLETOL will be placed in its own compendia class, and this is critical. Formulary tier would be important in the successful adoption of NEXLETOL. Based on our market research and the preliminary feedback we've received from payers, we expect up to 50% commercial formulary coverage at launch. Our goal is to have a majority of this coverage in lower branded out-of-pocket tiers. In addition to our intense focus on securing managed care coverage, we have equally focused on commercial patients' out-of-pocket exposure. We are thrilled to announce that NEXLETOL will be available to eligible patients for as little as $10 for as much to a 90-day supply. This access strategy ensures that for patients who require the additional LDL-cholesterol lowering that NEXLETOL provides, cost will not be an issue. Lastly, we care deeply about the Medicare population, and we are highly committed to achieving the lowest branded tier coverage for those patients. Our expected compendia class, formulary position and coverage and pricing strategy bolster our confidence that we will have broad patient access for NEXLETOL. I will now transition to the next critical aspect of a successful product launch, health care provider education. Health care providers will need education to become comfortable with any new medicine. And we believe we put together the very best team in the industry to ensure that we educate health care providers on the appropriate use and benefits of NEXLETOL. We have created a very thoughtful commercial strategy using our team's past successful cardiovascular launches as our guide. As we've discussed, we have determined that an initial field commercial team of approximately 300 representatives is ideal for the first phase of our launch. By being strategic, hiring highly experienced territory managers and regional directors as well as being highly focused on cardiologists, lipidologists, endocrinologists and high cardiovascular script writing primary care health care providers, we will reach prescribers who account for 40% of the LDL-cholesterol lowering scripts. This amounts to 36,000 high-prescribing health care providers that we can educate. As a reminder, we partnered with ZS and Associates (sic) [ ZS Associates ], an industry leader, to develop this extensive reach and frequency plan. I want to highlight that we have just hired the best health care provider facing team in the industry. Just to note, our team consists of approximately 300 industry-tenured territory managers with an average of 13 years cardiovascular experience, and the 30 regional directors that we had hired have an average of 15 years of sales leadership experience. The industry tenure and experience of this team has exceeded our initial hiring criteria by 50%, punctuating what an awesome offering NEXLETOL provides to patients and health care providers. This initial field team size will give us the initial coverage to be successful. Additional territory managers will be added as prescription milestones are achieved. Our progress will be very transparent. Look for prescription volume data in both Symphony and IQVIA on or about Friday, April 10. We expect these databases to capture 95% or greater of all NEXLETOL scripts. To be clear, we will be sampling to health care providers, but the samples will be 7-day blister packs and will not be included in the prescription volume you see in these databases. On this next slide, you see we have left no stone unturned in our plans for a successful launch of NEXLETOL. We have a highly experienced launch team, and our early focus will be to increase awareness and drive adoption of NEXLETOL. To date, we have built and are now ready to launch critical corporate and advocacy campaigns, peer-to-peer educational programs, Congress exhibit and educational efforts and finally, a full health care branded marketing initiative. Believe me, this is not an all-inclusive list, but a glimpse into the extensive effort going into this launch. Just as a clarifying note. While our multichannel approach includes direct-to-consumer, this is not TV direct-to-consumer campaign like you would see in the past. This will be a highly targeted digital and print direct-to-consumer approach with TV potentially coming in the future. Through all these efforts, you could see that we are 100% committed to ensure the right patients will have access to the NEXLETOL. At the end of the day, everything we do, every campaign we run, every call we make is to ensure that the appropriate patients, the patients that will benefit from the LDL-cholesterol lowering provided by NEXLETOL, will have access to this important new medicine. Health care providers awareness in prescribing, pharmacy availability and managed care access are just a few areas that we need to ensure are working in conjunction to ensure patients will have a chance with NEXLETOL. A tremendous amount of research has gone into the preparation phase of launch. And as I've said in the past, we research to get to the truth. We have an incredible product and an experienced, successful, passionate, motivated team. There's a major need in the treatment paradigm for NEXLETOL. After all of our research, we have a plan that will maximize the number of patients that will benefit from NEXLETOL. At peak, we believe 1.8 million patients will be on our medicine. While this is an impressive number, we believe that with real-world use, potential for our medicines may be higher. Additionally, me, my team and Esperion will never be satisfied until every single patient that needs NEXLETOL will be able to benefit from this important medicine. As Tim mentioned, this is a monumental day for millions of patients still in search of LDL-C -- cholesterol-lowering medicine that is accessible, convenient and effective. We believe NEXLETOL is a win, win, win: a win for health care providers as it offers a new medicine for their toolkit; a win for patients because it can provide an affordable non-statin alternative for those who are frustrated, and in some cases, giving up hope that they are not reaching their LDL-cholesterol goals with existing medicines along with a low-cost option to eligible patients; a win for payers as it provides solutions that address the need for efficacious, safe, tolerable and affordable LDL-cholesterol management. Finally, here's an important slide I'd like you to see. These statements you see here are verbatim quotes, unedited quotes, spoken or written directly by health care providers over the past few weeks. These are derived from our most recent market research and advisory boards. What you see here is there are a lot of patients not making goal. Numerous patients that I'm going to use this for. A lot of patients are afraid of needles. It's nice to have a change of pace. These reactions from health care providers say it all. I couldn't have said it any better. Tens of millions of patients are taking statins and realizing the benefits of LDL-cholesterol lowering with statins. I believe in statins. I promoted statins for a good portion of my career, and now we have a medicine that will complement the results of statins in an affordable, once-a-day, non-statin pill. NEXLETOL provides additional hope to patients looking to get their LDL to their LDL-C goal. Payers have seen the benefits, physicians have seen the benefits and soon patients will see the benefits. We are thrilled by the approval of NEXLETOL and what it means for millions of patients, their health care providers, their families and their communities. With that, I will turn it over to Tim for closing remarks.

Thank you, Mark. Now that NEXLETOL is an approved medicine, I want to ask you to look at the details of NEXLETOL's important safety information and also recommend that you visit our website for NEXLETOL's full prescribing information. Now before we take your questions, I want to take a few minutes to summarize the highlights from the NEXLETOL approval announcement along with a look at what's ahead. So first and foremost, we're excited, we're enormously pleased, we're thrilled to announce the FDA approval of NEXLETOL with a positive benefit-risk profile confirming our internal expectations and certainly exceeding external expectations. Second, we're moving at warp speed now, as you heard from Mark, and our team will make sure that NEXLETOL is commercially available in the U.S. by March 30, approximately 5 weeks from now. This is the first oral, once-a-day, non-statin LDL-cholesterol lowering drug approved in the U.S. in almost 20 years for patients with ASCVD and heterozygous FH. There are 2 key patient populations that are underserved: the millions of patients that can't take statins, that is those patients for whom maximally-tolerated statin may be no statin at all; and the millions of patients currently taking their maximally-tolerated statin but needing additional non-statin LDL-cholesterol lowering to get to their goal. Third, our team, as you heard from Mark, has addressed every key element to help make NEXLETOL affordable and accessible for patients. Again, first, we plan to offer a low list price. We're confident that NEXLETOL will have its own compendia listing. We're also confident that NEXLETOL will have an attractive formulary positioning in both commercial plans and Medicare Part D. We're targeting 50% commercial formulary coverage at launch and 25% Medicare Part D coverage. And that means for eligible commercial patients, we're targeting co-pays as low as $10 per prescription for up to a 3-month supply. For Medicare, we're targeting the lowest tier and related co-pay. Next, in terms of our cash position, I want to remind you that we are fully funded with over $200 million in cash on the balance sheet at the end of 2019. Also, recall that we will receive another $175 million in cash from our collaborations over the next few months, $25 million from Oberland next month under the revenue-based funding agreement for achieving FDA approval of NEXLETOL and then $150 million from our European commercial partner, DSE, upon the first commercial sale in the EU. We are expecting full marketing authorization by early April and first commercial sale shortly thereafter. All in, this provides us funding through profitability. Now looking ahead. The PDUFA date, as I mentioned earlier, for the bempedoic acid/ezetimibe combination tablet is February 26, and so we expect to be talking with you again very soon. As many of you know, the American College of Cardiology Meeting is March 28 in Chicago, and we will have our first commercial presence there for NEXLETOL, along with a number of posters and presentations. And finally, NEXLETOL will be commercially available in the U.S. by March 30, which turns out to be the Monday of the ACC Meeting. And with that, we'll open the call to your questions. Shannon, if you would, please poll for questions.

[Operator Instructions] Our first question comes from Jason Butler with JMP Securities.

Congrats on the approval. First one, can you just speak to where you think physician awareness is now broadly and the work that you've done to establish already some awareness and then the work that you'll do throughout the launch to build it? And then, secondly, can you just talk about the work you've done to make sure the drug is broadly available in pharmacies and any work you've done to -- in the event that a patient cannot get the drug at their regular pharmacy?

Jason, thanks for the question. I'll start out and then I'll tip it to Mark. So we have had our medical affairs team in the field since -- and that's more than a dozen folks in the field since last July 1. And so they have been meeting with literally hundreds of physicians and providing medical education. So I would say that the awareness has increased significantly over the last 7 or 8 months, and we expect that, that will continue to increase. We're on a very nice trajectory there. And of course, we're measuring that with survey work that we do pretty regularly. Mark, can I tip it to you?

Sure, and Tim -- on top of the great job the medical liaisons are doing, Jason, we've had really an incredible publication plan over the last several years. So I do believe, at this point, as we go into launch, there is a buzz out there. Obviously, no promotion at this point, but there's definitely a buzz that something new is coming. Regarding pharmacies, so we plan on March 30 to be widely available. So what I mean by that is the -- we've already completed -- we've completed some time ago the negotiations with the big 3 wholesalers, and we've also met with each of the major chains in -- supermarket chains, pharmacy chains. So we feel very confident. They're aware that NEXLETOL is coming. It will be loaded into their systems appropriately. I think we'll have wide coverage at all the major chains and supermarkets. I think your last question was pertaining to if a patient cannot receive NEXLETOL at their pharmacy, through our website and call center they'll be directed to exactly where they can pick up. But I have to say, with the way distribution works in the industry right now for a simple retail product like NEXLETOL, I really don't have any -- I can't think of a situation where a pharmacy would not be able to access within 24 hours.

Our next question comes from Michael Yee with Jefferies.

Congrats on the approval, Tim. I know it's been a long time coming. 2 questions. One is, maybe you can comment on the concept of clinical ASCVD versus established ASCVD. How you believe or what you believe the impact of that is or would be for payers? Maybe there's a perception of secondary prevention versus primary prevention. This was a discussion also with PCSK9. So maybe just talk to that and if there's any impact or view by payers. And then the second question is related to reimbursement and coverage. You made a comment about 50% commercial formulary access at launch, which sounds like a lot, and I know the PCSK9s had a lot of formulary and access issues at the start. I think 7 out of 10 scripts were rejected. Can you just maybe compare and contrast your access to PCSK9, so we could perhaps baseline ourselves to what happened there and compare to what you might have?

Thank you, Mike. I'm going to tip it to Bill to address your first question about established versus clinical.

Yes. Yes. So you did note that there is a slight difference in wording, but I think it has no difference in terms of the intended patient population. It's basically identifying patients who have clinical manifestations of ASCVD in some form of a clinical event. So whether you use the term clinical or whether you use the term established, you're essentially talking about the same patient population.

And just to pick up on what Bill was saying, as -- I think we mentioned in the script a couple of times, that patient population represents somewhere around 15 -- perhaps 15 million -- perhaps higher. So this is a really significant patient population. And again, also keep in mind, as we've been saying, cardiovascular disease is still the #1 cause of death in the U.S. and around the world. So 15 million sounds like a lot, but there's a lot of people dying from cardiovascular disease. Mark, can I tip it to you to talk about the reimbursement?

Sure. Michael, good to talk to you again. So the 50% coverage, commercially, Mike, it's a big number, and we're highly confident, my team, led by Jerry Penn, we -- now that we're approved, conversations are out there. We're highly confident about that number at this point. So I want to make sure that you hear that. We did have the opportunity to -- for a few of the managed care plans to see the final label. We had a feel for the label over the last couple of weeks. I would say the excitement, enthusiasm, formulary coverage stays identical to label the way it was. It's not tremendously different than we had positioned to them in the first place. So no, there's no change in philosophical uptake by managed care at this point. I didn't launch the PCSK9. So I certainly wouldn't want to comment on what their coverage was at launch. What I can tell you is the anecdotes for managed care that we've done everything right to-date, that we are pricing this as appropriate, that we are having conversations well in advance. We are thinking about the patients. We are thinking about the health care system appropriately. So what I will tell you is, for the people on the team here who did work with PCSK9s, the feedback to us has been this is a very different feel than it was in the negotiation process for PCSK9.

Our next question comes from Martin Auster with Crédit Suisse.

This is Mark on for Marty. Congratulations on the news. So I know we've spoken before about how you guys guided for an S-shaped launch curve. Besides scripts, what are the other specific metrics you're monitoring in the early months of launch? And are there any specific bars that you've set for yourself at various time points? And then second, you also mentioned internal prescription milestones as being -- once you achieve those, you'd add territory managers. Are you willing to disclose at this time what those milestones are or at least speak in more depth about them?

Yes. Thanks, Mark. Our Mark, please.

Yes. So to answer the first question, so obviously, prescriptions, which we have been pretty clear about will be quite transparent, that is the key metric. Some other areas we'll be looking at specifically internally, we will look closely at abandonment rates. This is critically important. We want to make sure that, as physicians are writing prescriptions, that patients are picking them up at the pharmacy. And there's a lot of driving factors why a patient could walk away for a prescription, out-of-pocket is probably the #1 reason. And as you've heard from myself and from Tim, I mean, us being able to offer $10 for commercially insured -- eligible commercially insured patients for up to 3 months, we really want to keep that advantage down. We want patients to benefit from NEXLETOL. So patient abandonment will be a large one. And then there's a whole host of internal metrics that we look at. Sampling, physician calls, request for information, all these type of things are internal that we watch on a daily basis as well as we will be able to see actual bottles going from the wholesaler to the retail chain -- to the retail outlets in real time. So that's all the metrics we'll be looking at. Regarding the metrics for additional reps, when we put together the forecast, these are both market share and revenue driven. And for competitive reasons, we're not going to share that. We feel that, that would hurt us competitively out there to know when we would be adding representatives. So we'll keep that as our knowledge, but it's totally driven by market share and uptake metrics.

Our next question comes from Chad Messer with Needham & Company.

Great. And let me add my congratulations on the approval. Appreciate all the work that went into that. You've mentioned a couple times your goal of getting eligible patients to a $10 per up to 90-day prescription. Can you just talk in a little bit more detail about sort of strategy to get there? Obviously, there's the tier reimbursement that you negotiate your way into, but are you also looking at some of the other things we've seen out there like rebating co-pays and the like?

Yes. Thank you, Chad. Mark?

Yes. Thanks, Chad, for the question. So this is one tool that we have. So you're right. We will, obviously -- working close with managed care. There will be a rebate off of WAC to get to the proper formulary position. And based on our anticipated coverage, that allows us to do more for patients. So quite honestly, if the product was one that we didn't feel would be widely covered, it would be more difficult to try to get it to the $10, but we do feel we have excellent coverage. So what happens now is there's passive and active ways to get this down. We want to make sure patients don't miss the opportunity to have this affordable price. So they'll have -- through our website, they could download a coupon to get to the $10. Through their physician, they could receive again a coupon. But we also have mechanisms behind the scenes that work with the pharmacies that even if they don't have the co-pay card, they will still have the buy down to $10. So this is not something that we're trying to minimize. This is something that we're trying to maximize, so that more patients could get on NEXLETOL. So it's a whole host of different activities. Mostly formulary coverage starts with that. And then we have these passive and active co-pay mitigation programs.

Okay. Yes, appreciate that extra detail. Just 1 more for me. On the combo pill, we're expecting PDUFA here in a couple days. Anything to look for in that label? Or do you mostly expect it to be exactly the same? And does your March 30 launch date also apply to the combo pill or are there additional steps to getting that out there?

Yes. So thanks, Chad. So we won't and can't comment on the label for a combination tablet until it's published. So too close to that to want to speculate on that. But I think, as you noted, it's just a couple of days away. So none of us have long to wait. And then your second question was about availability, and perhaps I can tip it back to Mark to talk about availability for NEXLIZET if it is approved.

So our strategy for NEXLIZET would be -- we believe NEXLETOL is the innovative product. It's critical that physicians have the opportunity to have comfortable -- to get comfortable with writing NEXLETOL, seeing patient response to it and seeing the results on top of the various medicines that are currently out there. For that purpose, I want my sales force focusing 100% of their efforts for the first quarter on NEXLETOL. So if approved, we will switch them to the next product on around July 1. But until that -- for that first quarter, we really want the sales force laser-focused on educating on NEXLETOL and physicians gaining comfort with the uptake of NEXLETOL.

Our next question comes from Chris Shibutani with Cowen.

Congratulations as well for this long effort and long time funding. With that in mind, thinking longer term, you sort of identified 300 folks targeting cardiologists. Perhaps, can you give us any sense for what sort of threshold level of penetration or revenues that you think you would need to sort of take it to that next level in terms of the amount of marketing effort? I think you guys have spoken in the past about potentially being open to partnering to reach out to a broader potential patient audience and physician audience. Can you just update us on your thoughts there?

Mark?

Yes. So Chris, we -- since I joined Esperion two years ago, Tim and I have been steadfast in the belief that we wanted to launch this on our own, and we have never looked back and second-guessed that. So here we are, looking to contingencies on all the representatives and managed care team, the pricing the appropriate way, having control of all this and seeing the vision of an affordable, efficacious, safe product that has come to market is happening. Now that being said, obviously, we want to make sure that we can maximize the number of physicians that will be educated. So right now, I'm very comfortable that this 300 -- approximately 300 person sales force will get us to that 40% of the LDL-cholesterol market. That's exactly not only where ZS had guided us to start to launch that, but also with our analog with Xarelto that's where they had launched as well, and that's the analog we'll be following. So as far as now from this point forward now that once we're launched successfully, and if we have approval of the second product, getting that out there and getting the pricing all set, of course, we would have conversations. But I'm very confident in what we have right now and the team that we put together here will exceed expectations. Did I answer both questions? Chris, I'd say, I wasn't exactly sure on the first question, the metric question you're looking at. Were you looking for the 40% or was there something else you were looking for?

Well, I think that there's potential clearly for this product to be introduced to a broader physician and patient population. And trying to just get a sense for perhaps the revenue level that you think that the 300 reps that you'll have to start with would be kind of capped out in terms of how much potential that would have and you would feel the need to invoke additional resources on the commercial effort.