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

Ladies and gentlemen, thank you for standing by. Welcome to Esperion's U.S. FDA Label Approval Investor Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to Alexis Callahan, Head of Investor Relations. Please go ahead.

Thank you, operator. Good morning, and welcome to Esperion's special investor call to discuss our recent U.S. FDA label approvals. From our executive team today are Sheldon Koenig, President and CEO; Dr. JoAnne Foody, Chief Medical Officer; and Eric Warren, Chief Commercial Officer. We're also grateful to have with us Dr. Payal Kohli. She is a Private Practice Preventive Cardiologist, an Associate Professor in Cardiology at both Duke University and the University of Colorado, and is widely known as an on-air medical correspondent. We issued a press release on Friday, announcing FDA approval of our expanded label. A copy of that release can be found on the Investor page of our website, together with a copy of the presentation that we will also be referencing. 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 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 in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 25, 2024. 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 will begin the call today with prepared remarks and then open the line for your questions. During which time, the members of the executive team will be available. I'll now turn the call over to Sheldon.

Thank you, Alexis, and welcome, everyone. On Friday, we received FDA approval for our new cardiovascular risk reduction labels for both NEXLETOL and NEXLIZET. This is a significant accomplishment for our organization and an especially exciting milestone for patients and physicians, who need additional treatment options to address cardiovascular disease, the leading cause of death globally. Critically, NEXLETOL and NEXLIZET are now the only LDL lowering nonstatins indicated for cardiovascular risk reduction in both primary and secondary prevention patients, a major differentiator among other currently available therapies. These new labels include several significant beneficial updates. First, based on the robust results seen in our CLEAR Outcomes trial, NEXLETOL and NEXLIZET now have a broad cardiovascular risk reduction indication. Second, NEXLETOL and NEXLIZET can now be used in primary prevention patients or those who have not yet had a cardiovascular event. And third, the statin use requirement has been removed, meaning that NEXLETOL and NEXLIZET can be used either with or without a statin. Together, these modifications position NEXLETOL and NEXLIZET, to be the non-statin of first choice in treating patients with or at risk for cardiovascular disease. The FDA approvals also come on the heels of a positive opinion from the European Committee for Medicinal Products for Human Use, or CHMP, last week, and we therefore expect a similar positive decision from the EMA on our European submissions by the end of the second quarter. NEXLETOL and NEXLIZET are available now to treat the significant number of patients who need to reduce their cardiovascular risk, whether they have had an event yet or not. These new labels are exactly what we set out to achieve and offer our organization the ability to unlock the significant commercial opportunity ahead. I'm grateful for the years of dedication, commitment and hard work of our employees, patients and partners that helped us get to this point. I'll now turn it over to Dr. Payal Kohli to provide her perspective on what these new labels mean from a clinical standpoint.

Thank you so much, Sheldon. Good morning, everyone. I'm so excited to be here to offer some perspective to you all as a practicing cardiologists, about why the cardiovascular prevention community is just so excited about this medication and about these new indications that the FDA has approved. Now we all know that heart disease is the #1 killer of men and women, both here in the U.S. and worldwide. Many of us may also know that 80% of heart attacks and strokes are preventable, with optimal risk factor management. Yet, every 40 seconds, somebody in the U.S. has a heart attack. So where is the disconnect here? We have the recipe to prevent heart disease and why are we failing at doing it? One of the big explanations for this disconnect is the fact that LDL-cholesterol is mostly under-treated. And statins, which are a great medication, there's a workhorse of lipid lowering therapy, but they just aren't enough to address the problem. And there are many reasons for that. So some people start out just having a very high LDL or they just don't respond that robustly to statins, after starting statins to lower their LDL. Now we all know patients who refuse to take a statin. We know that the popular media has created a lot of fear around statins. We also know that there's a whole bunch of patients that stop taking statins after they start them. Some patients try to do the right thing. They try to take the statin, but they have myalgias or muscle aches, and then yet there are others that worry about cognitive impairment or diabetes. It's no doubt that statins are the foundation of preventive cardiology. But one thing we have become painfully aware of in 2024 is that they're just not enough. We need more tools in our toolbox. And I always say this to my patients, when it comes to being a doctor, I'm only as good as the medication that I can prescribe. And that's why I'm so excited about this new medication because it makes me a better doctor, having access to something that allows a whole new indication for primary prevention, something that no other non-statin medication to date has been able to do. I hope I've shown you today that there's a huge unmet need in needing new therapies to lower LDL-cholesterol. And I have to say, incidentally, over the weekend, my social media was really blowing up, because our entire preventive cardiology community was so excited about this new label, which I really think is going to help to address this critical gap in LDL under treatment that has persisted for so many decades here in the United States. So now that I've highlighted the problem for you. I want you to meet 3 patients, who represent the patients that I see in my clinic every single day as a preventive cardiologist. These are patients that I struggle with, and now I want to show you how this new label will allow me to treat these patients and allow me to reduce their cardiovascular risk. So first is Nick. He's an undertreated secondary prevention. He already has diagnosed cardiovascular disease and I've maxed out his statin, but I haven't been able to get his LDL below the treatment goal. So where do I go from here? Well now, I have a great new oral option, rather than having to reach for injections. And I have to say, as a clinician, starting a pill is a lot easier than getting a patient to agree to an injection, and also educating them about how to use injections. There is now also a growing belief in the preventive community about this hypothesis called the residual inflammatory risk of atherosclerosis beyond just LDL. This is basically saying we've already treated their LDL and yes, they continue to have risk. And a biomarker of this risk is often the high-sensitivity CRP. We know that both NEXLETOL and NEXLIZET, which have bempedoic acid, can reduce CRP by 22%. So I think this is a great option in my patients with atherosclerosis who have elevated inflammatory markers. And even those that don't, because of its efficacy and because of the fact that it targets that residual inflammatory risk. And I know that the injection agents do not target that inflammation marker. Now there's 10 other million Nicks out there who are waiting to benefit, 10 million. I'm also especially excited about the next 2 patients that I want you to meet because up until now, I didn't have a single option that was not a statin that has cardiovascular outcomes benefit in these patients. We had just been ignoring these patients and essentially leaving them untreated or undertreated. And I have to tell you, one of the hardest things to do as a doctor is to know what the right thing to do is, but not be able to have the tool to get it to your patient. So this drug has really changed that whole paradigm. It changed the landscape of preventive cardiology because it's the first ever cardiovascular outcomes proven drug in primary prevention after statins. So let's meet Nora next and others like her which I see every single day. She's an undertreated primary prevention. Now she is a diabetic. So I worry about pushing her statin dose up higher, because it may have raised her hemoglobin A1c but she still needs more LDL-C lowering. So here's a situation where I'm stuck between a rock and a hard place. We got to get that LDL down, but I'm worried about the A1c. Now I have this agent with outcomes benefit that doesn't impact hemoglobin A1c, that I can really hang my hat on and one that I know has been studied in a diverse population, including women and I can prescribe that for Nora. Finally, Naomi, and the 40 million patients like her are the types, these are really the patients that have kept me up at night, because they're unwilling to take a statin and they desperately need their LDL lower. Now in the past because their primary prevention, they haven't had an event yet, we just let them be. We literally turn our backs on them, knowing that their train is headed towards a destination of heart disease. But now with this new label, I can offer her a nonstatin option that reduces her LDL and also reduces her risk. In fact, I feel confident in saying that a sub-analysis of the CLEAR Outcomes trial in the primary prevention cohort showed a 39% reduction in 3 point MACE for primary prevention patients. Now literally, in television, we'd like to call that a mic drop moment because, boy, has it gotten the attention of the preventive cardiology community across the country. So I've got 60 million Noras and Naomis that I can now offer its primary prevention patients and medication, which I had not been able to do up until now after statins. Now not pictured on this slide are all the other patients with primary hyperlipidemia, which is now obviously also part of the label, including those with FH and others. So you can imagine now we have more than 70 million patients out there who are waiting to benefit from this medication. And this medication is available today. It's not in the pipeline, it's not coming. It's not under investigation. It's available today to me as a cardiologist. And I have to say with this incredible impact that it's made, I just can't wait to start using it, especially in my primary prevention patients. I'll now turn it over to JoAnne to provide you some more details about the new indications.

Thank you, Dr. Kohli for those really meaningful clinical insight. As Sheldon mentioned, we are absolutely thrilled with the new FDA approved labels for both NEXLETOL and NEXLIZET. We have achieved our new broad indication for cardiovascular risk reduction, for both primary and secondary prevention patients, irrespective of statin. We've also expanded our LDL lowering indications to include the broad primary hyperlipidemia population, again, irrespective of statin use. As Dr. Kohli has discussed, these new labels dramatically expand the patients eligible for our therapies, including tens of millions of patients at risk for cardiovascular disease, not taking recommended statin therapy. As has been said, these FDA approvals were based on the robust totality of evidence generated through our clinical development program, including the landmark CLEAR Outcomes study. The label to represent a significant advance in the treatment paradigm for patients with or importantly at risk of cardiovascular disease. These new approvals will make NEXLETOL and NEXLIZET, the non-statin of first choice for the majority of patients at risk or with CVD, and add critical tools in combating cardiovascular disease. On this slide shown here at the top is the original indication for NEXLETOL. As we've discussed, it was highly restricted to use with diet and maximally tolerated statin in heterozygous FH and ASCVD. Below, you can see a dramatically expanded indication for NEXLETOL. NEXLETOL is now indicated to reduce the risk of MI and coronary revascularization in adults unable to take recommended statin therapy, including those not taking a statin and indicated for those who have already had an event as well as those who are at risk but who have not yet had an event. The new label also includes expansion of the original LDL-lowering indication to a much broader group of patients with primary hyperlipidemia, again either alone or in combination with a statin. As has been said, this is the first non-statin approved for primary prevention of CV events. And unlike statins, it does not raise glucose or cause statin-associated muscle symptoms. But like a statin, it reduces LDL cholesterol, hsCRP, a marker of cardiovascular risk. The U.S. approval for NEXLIZET and NEXLETOL for cardiovascular risk reduction were based on data generated from the CLEAR Outcomes trial. This label importantly allows us, shown on the right of the slide, to highlight the important aspects of this trial including a 15% MACE-3 reduction, death from a cardiovascular cause, nonfatal stroke, nonfatal MI, as well as, importantly, a 27% reduction in nonfatal myocardial infarction, a 19% reduction in coronary revascularization and as Dr. Kohli mentioned and highly differentiated, a 39% reduction for MACE-3 in our primary prevention patients. As we turn now to NEXLIZET, it's important to understand that this indication has also been granted to NEXLIZET. It is not always the case that a combination therapy receives a similar indication. But in this instance, NEXLIZET has virtually an identical indication. This indication again highlights that NEXLIZET can be used in both primary and secondary prevention as well as primary hyperlipidemia, with or without a statin. The label for NEXLIZET now combine the important cardiovascular risk reduction based on the bempedoic acid component of NEXLIZET, with the additional LDL lowering efficacy of ezetimibe, bringing a clinically important therapy capable of reducing risk as well as lowering LDL by 38% to primary and secondary prevention patients. Based on these indications, we are confident that NEXLETOL and NEXLIZET should be the nonstatin of first choice for the reduction of cardiovascular risk and LDL-cholesterol in a broad population of both primary and secondary prevention patients. Compared to all other existing LDL-lowering therapies, NEXLETOL and NEXLIZET are now clearly differentiated, offering the cardiovascular risk reduction and LDL lowering benefits of a statin, lowering hsCRP, but without raising glucose or causing patients the same side effects as statin. Importantly, and unlikely PCSK9 and ezetimibe, NEXLETOL and NEXLIZET, are now indicated for the primary prevention of cardiovascular events. This is an amazing achievement and represents a significant advance in the treatment paradigm, as NEXLETOL and NEXLIZET can provide significant risk reduction in a once-daily oral and accessible therapy for physicians and patients, who need effective options for the reduction of both cardiovascular risk and LDL, whether those patients have already had an event or are at risk of an event. I will now turn it over to Eric.

Great. Thank you, JoAnne. The significant changes to NEXLETOL and NEXLIZET labels remove meaningful limitations and serve as the catalyst for the exponential growth that we anticipate going forward. Up until this point, our commercial team has been limited to promoting NEXLETOL and NEXLIZET only for LDL-C lowering in patients with ASCVD that are on maximally tolerated statin doses and are not at their LDL-C goal or roughly 10 million patients. Our new labels not only enable us to promote the robust and compelling data from our CLEAR Outcomes trial, but they also meaningfully expand our eligible patient population to roughly 70 million patients with or at risk of cardiovascular disease or unable to achieve the risk reduction goals on current therapies alone. Now we become the only FDA-approved LDL-C lowering nonstatin for cardiovascular risk reduction in both primary and secondary prevention patients. This is a meaningful distinction and a clear differentiator within the treatment paradigm. From an execution standpoint, we've been preparing for these new labels and are ready to hit the ground running. During our fourth quarter earnings call last month, we touched on 5 core pillars that will enable us to deliver significant growth, which I'll reiterate again for you now. First, it all starts with the expanded labels, which serve as the backbone of all commercial activities going forward; second, all new promotion. We've created a powerful suite of promotional tools that communicate the CLEAR Outcomes data across our greatly expanded patient population. Now we've conducted extensive market research to ensure the right data is communicated at the right time. We're excited to kick off promotion this week. Third, deeper reach. We've recently expanded our sales force, deploying about 60 new territory managers into the field and bringing our team up to approximately 150 representatives. Together, with updated digital resources, we are able to reach a target universe of approximately 45,000 health care providers, comprised of both primary care and specialists. Fourth, patient activation. We will also be launching a new consumer campaign to drive patient awareness and prompt discussions about NEXLETOL and NEXLIZET with health care providers. We are excited to launch this engaging campaign this week. I've attached the slide that shows a preview of our coming soon teaser for this lipid lurker consumer campaign. And fifth, payer access and reimbursement. Our managed care team have been working continuously to align utilization management criteria with our new labels. In addition to ensuring the right patients are covered, the team is also focused on ensuring health care providers can simply attest to any prior authorization requirements. Knowing that it may take a few months for changes to be implemented, we've partnered with a specialty pharmacy to offer patient support to facilitate that critical first spell. We've also partnered with Currax to provide a cash payment option for patients without insurance coverage. And lastly, I wanted to share results of a market research study we just conducted with over 70 HCPs, which include both primary care providers and cardiologists. We think it's important to hear directly from our customers and wanted to test the reception to our new labels. As you can see on the slide, it was overwhelmingly positive, indicated an anticipated increase in prescribing across each patient type. I'll now turn it back over to Sheldon.

Thank you, Eric. In summary, these approvals are a significant win for Esperion, for health care providers and for the countless patients who will now be able to benefit from our life-saving medications. NEXLETOL and NEXLIZET are now the only, I'm going to say that one more time, the only nonstatins to be indicated for use in primary prevention patients. This is the future of medicine to prevent events before they occur versus waiting until they do. As you've heard, NEXLETOL and NEXLIZET will serve as critical tools to treat patients before a life-changing event occurs. I again want to express my gratitude to the entire Esperion organization, the nearly 14,000 patients who participated in our CLEAR Outcomes trial, our trial investigators and the countless other individuals involved in making this achievement a reality. We look forward to continuing to execute on our plan and keeping you apprised of our ongoing progress. And with that, operator, we are now ready for Q&A.

[Operator Instructions] The first question comes from Serge Belanger with Needham.

Congrats on the FDA label. First question, I know you've had numerous conversations with payers, but maybe just update us on when you expect them to update their own policies and coverage regarding this new label. Is something that could be done by midyear? Or is it more -- should be expected to be complete by the second half of the year? And then second question, I think in the past, you've talked about your expanded sales force allows you to cover about 85% to 90% of your opportunity. Should we take as that opportunity as the additional 20 million patients or the whole of 70 million patients?

Serge, it's Eric. I'll take these questions. So first, from a payer perspective. So the team started engaging with payers to provide them with the clinical data, last year right after ACC when the data were presented. These payers did want to have confirmation that the label would actually change what happened. So we anticipate in the next 1 to 3 months, that we'll start seeing these significant changes that we've talked about. But in the meantime, we have stood up the specialty pharmacy. So we've got a mechanism by which our clinicians can e-prescribe directly to Aspen Pharmacy, and that will result again in that first fill occurring. With regards to the sales force that we've stood up, so yes, we've got a team of about 150 people calling about 20,000 HCPs. That gives us a good coverage of the population that we've talked about, this 30 million population. We also have our digital efforts, which enable us to broaden that reach to about 45,000. And that gets us about that 80% coverage that we've talked about. Now that's on the 30 million base of patients, but we'll be working to expand that reach and capture that additional 40 million population as well.

The next question comes from Joe Pantginis with H.C. Wainright.

Congratulations as well. This is definitely a great win for patients. So curious, it's great to see the last slide you put up, with regard to the marketing research that you completed here, very encouraging. I guess the question would be, up until this point in the approval, how would you describe sort of the pent-up demand, if you will, from physicians? And what -- and has the approval been an impediment? I mean, obviously, you've had a unique path up until now. You recently had those updated labeling before you been getting the approval. So how would you describe the pent-up demand?

Yes, I'll take this one again, Joe. It's Eric. So there's been a lot of interest in our product. Obviously, the timing of initial approval wasn't ideal. I've talked about the label that we had prior to Friday and the fact that it did require us to focus only on LDL-C reduction in those ASCVD patients that were on maximally tolerated statins and not if they're both. A great population, a significant population with opportunity. But as Dr. Kohli mentioned, there's been a lot of desire by the clinicians in the community to be able to prescribe for primary prevention. So for those patients that have risk factors but haven't had an event, that has been a very difficult population prior to this label change and the pending utilization management changes from our payers. So pent-up demand high, clinicians want to use us for primary prevention, they haven't been able to. They want to use us in those patients that can only tolerate some or no statins. They haven't been able to because of utilization management restrictions. Those will start to change effective right away.

The next question comes from Jason Zemansky with Bank of America.

Congratulations on the label update. Just to -- couple of questions from me. To circle back on previous comment here, previously, you had mentioned that the initial focus of the sales force was on the 30 million rather than the entire 70 million. So I'm just curious, with the sales force, what is the I mean, are you still thinking of targeting that 30 million is kind of the primary and then whatever happens, ancillary to that is kind of a benefit? Or are you targeting the entire 70 million?

Jason, it's Eric. I'll take this one again. So the team has been focused on that 10 million population. That's the ASCVD population, where they're on maximally tolerated statins and they're [indiscernible]. We're expanding our focus to cover that 30 million population, which pulls in those primary prevention patients as well as the statin intolerant. The additional 40 million will serve as our, what we call a spillover population. So as we gain momentum in the 30 million population, we'll start to naturally see some of those 40 million crossover, and with that momentum, we'll be able to expand our digital presence to be able to actually target those.

And if I could just add, Jason, this is Sheldon. Is that in our prepared remarks before we started, Eric also went through the different pillars. So obviously, we have the personal promotion of approximately 150 representatives. But we also have the digital campaign, which will be a consumer campaign. And what we found last year after ACC is that many consumers are actually driven to the doctor's office actually after they heard the news of the CLEAR Outcomes study and heard about these products. So we're using many different mediums, if you will, to get to as broad of an audience as possible.

Got it. And then maybe this is a good segue into my next question, and perhaps Dr. Kohli can weigh in on this as well. But can you speak to maybe some of the difficulties of the challenges and primary prevention and accessing this market? I'm sure everyone saw there was a recent paper [indiscernible] of internal medicine, discussing about how challenging it's been for statins to get a leg up in here, despite the 2013 ACC/AHA guidelines. And what are your plans for accessing this market?

JoAnne, do you want to take that?

Yes, I'll take that. Jason, thank you so much. Having been in the space prior to moving the industry as a Preventive Cardiologist myself, the primary prevention has several aspects. I think in that group, the majority of patients are, in fact, being cured by primary care doctors, right? And as they look at therapy, their guiding principle is, first, do no harm. And I think there's been a real challenge with statin because of some of the side effects and some of the concerns. Our hope in this market is that now having a therapy or therapies in NEXLIZET and NEXLETOL that provides statin-like effects without the statin side effect, that primary care physicians will see this as an opportunity to lower LDL, either in addition to statins or as an alternative to statin, where patients in that lower risk profile, you need to have a better risk/benefit ratio. So it's very easy, for example, to give someone a statin and have them accept the side effects when they've had a myocardial infarction or heart attack. It's harder to tell someone who's 40, who is at risk for an event, to take a medication that will give them side effects, when they may not see the potential benefit. So we believe that this is a tremendous advance and opportunity to really provide other tools with a better risk-benefit profile in primary prevention for those individuals. So I hope that context helped. Payal had to go to clinic. So no longer on.

The next question comes from Tom Shrader with BTIG.

Congratulations. Looking at the labels closely, do you see the NEXLIZET label as significantly better? It's really the only one where the indication has no mention of statins. And then maybe from JoAnne a little color, is there any issue with the fact that 3 of the 4 indications have some statin mentioned, but the primary prevention indication, as far as I can tell, is exactly what you wanted and much cleaner. Is that an issue?

JoAnne?

Yes. So as far as the label, I think that as we look at NEXLIZET, because of the additional LDL lowering in combination with ezetimibe, it does provide greater efficacy and still allows for risk reduction in both primary and secondary prevention. I think as we think about this issue of statin or no statin, in the labels, it is very clear that first and foremost, providers should try a statin. Although the label has been very specific in both labels to say, in patients not taking or including not taking a statin. So we view that as a tremendous optionality across all the indications. And remember that this is the U.S. prescribing information. This is really meant for providers and prescribers to come to terms with the individual needs of an individual patient, whether or not they're taking a statin, can take a statin, unable or unwilling to take a statin. So we see this as a big opportunity for us based on the language.

Got it. I mean, do you agree that the primary prevention label is kind of the best thing here?

We believe that, that is truly a game changer. That is truly unique paradigm shifting and no other nonstatin therapy has that. It really makes this very statin like and is incredibly unique. And I think that's why we're putting so much emphasis on it. And that's where the unmet need is. And that's where we believe our therapies will provide the greatest benefit. And as much as the market focuses on that secondary prevention, that's the smaller part of the market. This opens us up to millions and millions of diabetics, who are at very high risk for cardiovascular events, but in whom we haven't had an alternative therapy, that again provides great LDL reduction, CV reduction, risk reduction, now without worsening glucose. So again, we think that primary prevention really is a game changer.

The next question comes from Jessica Fye with JPM Chase.

This is Na Sun on for Jessica Fye. Congratulations on the updated label. Just looking at the NEXLETOL label. It's very interesting that the language calls out specifically to reduce the risk of myocardial infarction and coronary revascularization. Was this expected for you? How does this play into how you plan to promote this product? And the fact that the CHMP opinion does not call out MI and coronary revascularization, can you talk about just the differences here? And what that means as you go out and try to promote the drugs on the updated label?

Yes. Thank you so much. A lot of this reflects the very different approaches that regulatory agencies take, as well as the approaches of different divisions within the FDA with respect to how they utilize either MACE or major adverse cardiovascular events like you'd see in cardiorenal or how an individual division, like the one in which we were evaluated, pulls out the components of the composite that were statistically significant. So this FDA label, for us, was completely expected, once we saw the data from CLEAR Outcomes, that we would promote on the components of the composite, that being myocardial infarction and revascularization. Recall, though, that within the label, we have our Kaplan-Meier curves for both our MACE-4, our MACE-3, and have the ability to promote the MACE event. So extensively, it is more semantics than a difference in promotability, if you will. So I hope that helps as you think about it, but that is really very typical for how this division of the FDA works versus others.

The next question comes from Jason Butler with Citizens JMP.

Congrats on the approval. Just wondering if you could give us some of your thoughts on the types and number of interactions it will take to get a physician, both a new and currently prescribing physicians, to start writing for primary prevention patients. Anything in your market research that supports this. And again, ultimately, how long do you think it will be before we can really start to see the traction in this patient population?

Thanks, Jason. It's Eric. Yes, we anticipate traction starting in second quarter, and it will take a few interactions, somewhere in the neighborhood of 5 interactions, to start to really change behavior. For us, it also is that managed care change that needs to happen to fully realize the complete benefit. But recall, there's been a lot of pent-up demand, if you will, for this type of patients, the primary prevention patients. So second quarter, you'll start to see some inflection.

Our next question comes from Dennis Ding with Jefferies.

Congratulations on both very positive regulatory update last week. So if I can have 2 questions, one for management and one for Dr. Kohli. Number one, can you just talk about the cadence of the revenue growth that you expect this year? And when should people expect an inflection? And I know you made a little bit of comments around Q2. But when you look at consensus, it seems like more of a second half weighted revenue ramp? And how is management thinking about that? And then number two for Dr. Kohli, I'm really curious about where do you realistically see the biggest untapped opportunity for bempedoic acid? like I appreciate the primary prevention market is much, much larger than secondary. But realistically, where do you think bempedoic acid be used in either? And if you can kind of give us a little bit of color around how many patients you have right now on bempedoic acid in primary versus secondary? And where do you see that number going with the expanded label?

Dennis, first of all, thanks for the question. Dr. Kohli, we only had her for a short time today. So JoAnne can address some of those questions, and we can also maybe set up some time for you to specifically have a chat with her. As it relates to revenue ramp, et cetera, as you know, we have not given guidance, we're not giving guidance. What we've been saying is that we're comfortable with consensus this year. And as what we mentioned earlier as well is that we've always said that the label would be the inflection point for continued or acceleration of growth, and we think that we'll start seeing that in the second quarter. I think also as more payers utilization management criteria is updated over the next few months, we'll also see the ability for physicians to get this drug to be much easier. So it will be a very steady growth throughout the year until the end of the year, as we keep getting out there with our new representatives, et cetera. Eric showed a slide from a market research perspective that talked about where physicians think that they would utilize the drug and maybe he can review that again. And then JoAnne, maybe you could speak from your experience as a physician of how you see the drug is going to be used too. So maybe just a quick refresh, Eric, on the research.

Yes, absolutely. So 70 HCP is conducted with the new label. And we asked for the gamut of patient types and the impact that these labels would have on their willingness to treat these patients with NEXLETOL and NEXLIZET. And you can look at the slide again, but primary prevention, secondary prevention patients, obviously with the experience that they've had, and those patients that are unable to take any statin and those patients unable to take but the lowest doses of statin, are where we get the most kind of traction. So primary prevention patients, the labels really resonate strong. And remember, we're the only data or the agent that has data now, besides statins, to show this cardiovascular risk reduction in primary prevention. So we're really confident in our ability to get out there and drive change and as Sheldon mentioned, starting in the second quarter.

And if I could just add, and again, I appreciate that Dr. Kohli is in here. As I think about it or would have thought about this as a clinician in preventive cardiology, I really start and say, well, let's think about statin eligible patients. In those individuals that can take enough statin to adequately address their LDL and their risk reduction, great. Those people do not need us. For the millions of people, however, who either can't achieve their LDL or can't adequately achieve their cardiovascular risk reduction, I believe that these therapies are next. And it really is a tremendous opportunity. It is a huge clinical paradigm shift for the opportunity. As Eric mentioned, that Dr. Kohli mentioned in the millions of patients who haven't had an option other than statin to prevent their first event. In the group where there are other therapies injectable, I still believe that with the outcomes benefit, the LDL lowering and acting like a statin with reductions in CRP and not raising glucose as a positive that, again, this positions NEXLETOL and NEXLIZET next after a statin in your consideration of what to grab as a clinician to help the patient achieve their LDL and CV risk reduction goals.

I show no further questions at this time. I would now like to turn the call back over to Sheldon for closing remarks.

Thank you, everyone, for your time and interest today. Again, we couldn't be more pleased with these label approvals, after what they mean for millions of primary and secondary prevention patients, who are unable to achieve their LDL-cholesterol goals with current therapies alone. We look forward to executing on our commercialization plan and keeping you posted on our progress in the weeks and months ahead. Look for us at ACC 2024 next week in Atlanta and at a host of investor conferences in the weeks following. Take care, and I hope to see and talk to all of you soon. Have a great week.

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