ESPR - NASDAQ

Ladies and gentlemen, thank you for standing by, and welcome. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question-and-answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference over to Tiffany Aldrich, Associate Director of Corporate Communications at Esperion. Please go ahead.

Thank you, operator. Good morning, and welcome to Esperion's First Quarter 2024 Earnings Conference Call. With us today are Sheldon Koenig, President and CEO; and Ben Halladay, CFO. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. 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 provision 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, May 7, 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 with prepared remarks and then open the line for your questions. I'll now turn the call over to Sheldon.

Thank you, Tiffany, and good morning, everyone. Thank you for joining us today to discuss our first quarter results and the meaningful progress we continue to make. We are proud to report that we drove strong growth this quarter to start 2024 and positioning us for long-term growth and success. In the first quarter, we delivered total revenue of $137.7 million, which includes the $100 million litigation-related settlement received from DSE in January. I'll note that even excluding this payment, this was the highest revenue-generating quarter for ongoing business in our company's history. U.S. net revenue was $24.8 million, which represents a 46% increase year-over-year, driven by a 43% increase in retail prescription equivalents. On March 22, we received FDA approval of broad new labels for NEXLETOL and NEXLI

Thank you, Sheldon. Earlier this morning, we issued a press release containing our financial results for the first quarter, which is available on the Investor page of our website. Please note that unless otherwise specified, my comments reflect results for the first quarter ended March 31, 2024. As Sheldon mentioned, we are proud of our performance and strong results we delivered in the first quarter, including new-to-brand prescription. Our momentum continues to accelerate, which underscores the fact that outcomes data matters, and we're thrilled that data is now incorporated into our new label, which means we can now actively promote that data for the first time and that we'll now be able to reach millions more patients in need. For the fifth quarter in a row, we again delivered continued growth in retail prescription equivalents, which increased 43% year-over-year and 6% quarter-over-quarter, and as a reminder, almost entirely dependent on our prior label and promotional footprint that has only recently ramped up. The weekly RPE trend again reflects this momentum and remained above the 12,000 RPE mark for all of March, a new high for us. Growth outside the U.S. also continued at an impressive clip. Our partner DSE delivered yet another strong quarter of sales growth in its territories, highlighting the value and growth of potential of our global franchise. At the end of February, approximately 255,000 patients have now been treated with our therapies in Europe, representing a sequential 3-month growth of 26% since November. While most of this growth was generated from existing territories, DSE continues to expand, launching in the Czech Republic in the first quarter. I'll also note progress by our Asia region partner, Daiichi Sankyo Company Limited, which gained approvals in Myanmar and Thailand in the first quarter. Turning to our financial results for the quarter. We reported U.S. net product revenue of $24.8 million, representing an increase of 46% year-over-year. Collaboration revenue, which includes combined royalty and partner revenue was $113 million, an increase of 1,148% year-over-year. This growth includes the $100 million settlement received in January in connection with our litigation revolution. Excluding milestone payments, combined royalty and partner revenue grew 110% year-over-year. Finally, total revenue for the first quarter was $137.7 million, an increase of 467% year-over-year. I'll note that this includes the previously mentioned $100 million milestone settlement. Excluding milestones, total revenue grew 65% year-over-year. Turning to expenses. Cost of goods sold for the first quarter was $10.1 million, a decrease of 14% year-over-year driven primarily by lower unit tablet costs for sales in the U.S. and supply to our international partners. R&D expense was $13.4 million, a decrease of 57% year-over-year, reflecting substantially lower costs following the closeout of our CLEAR Outcomes trial. SG&A expense was $42 million, an increase of 40% year-over-year, reflecting a higher head count as we began to ramp up our in-house sales force, bonuses and promotional costs in anticipation of the launch of the expanded labels from NEXLETOL and NEXLI

Thank you, Ben. In closing, we continue to deliver on our commitments and execute on our strategic plan to achieve the blockbuster status who we know our franchise is capable of. We delivered another strong quarter of growth and ended the quarter with sufficient capital to support our commercial initiatives and drive continued long-term growth. We received approval for broad new labels and launched commercial initiatives to capitalize on the opportunity we now have to reach the millions of patients in need of our therapies. In summary, I remain extremely confident that we will continue to drive patient and shareholder impact and value creation by capitalizing on this momentum throughout this year and into the future, and I thank the entire Esperion team for helping us get to this pivotal moment. Operator, we are now ready for Q&A.

[Operator Instructions] Our first question comes from the line of Dennis Ding with Jefferies.

Two for me. Maybe one on the -- if you guys can just comment on the prescription habits from doctors since the label update. Have you seen any shift in PCPs versus cardiologists that you want to call on and if you're seeing any enthusiasm among the primary prevention doctors? And then secondly, on scripts, they've kind of look generally flat since the label update. So I'm just wondering if you have a comment on what happened over the last month? And when do you expect that script -- that weekly script growth to reaccelerate?

And Dennis, it's Eric. I'll take this one. So first of all, yes, there's a lot of enthusiasm for the new label. And that primary prevention is generating a lot of enthusiasm as well. Just a reminder that we are the only non-statin that's FDA approved to lower LDL-C and to decrease the risk of MI and coronary revasc in those primary prevention as well as secondary prevention patients. So enthusiasm is strong. We see right now a balanced prescribing between primary care and then cardiologists, but I do expect that primary care prescribing to increase. And remember, it's about utilization management criteria as well. So those progressive increases that we'll see as payers start to enable prescribing for those populations. I'm encouraged by the early qualitative feedback. And then the last 2 weeks, as you've probably seen, we have seen week-over-week growth. So expected to take a little bit of time but expect progressive increases, again, as those payer changes increase, but customer enthusiasm is incredibly high.

And Dennis, I just wanted to add that we're super early in the game. Our representatives were trained on the label, actually received the first view of the label early April. And then they're essentially off territory for 2 weeks in April because we had an all-company meeting, we also had our training, and they actually received the full detail aid in the third week of April. They were detailing off of the label. So just to reiterate what Eric is saying, we're actually very encouraged in what we're seeing right now. And as we said in our prepared remarks, we're very confident about growth as we continue through the quarters.

Got it. And then maybe if I can follow up. In terms of the script re-acceleration, around when do you expect that to curve? Because when you look at the last 2 weeks, they have been growing 1% to 5%, but I'm just wondering if that could grow more and when the soonest that could happen?

Yes, Dennis, so again, progressive increases are what I would anticipate. And it really will be as the bulk of utilization management changes, we anticipate about 2 quarters to get the majority of UM aligned with the new label. So progressive increases with full kind of growth realization when we have that UM alignment.

Our next question comes from the line of Serge Belanger with Needham.

First one, as the utilization management gets updated across the payers with the new label, can you just remind us what it's going to look like and whether you expect it to be pretty standard, all the payers covering bempedoic acid? And then secondly, I think Medicare coverage for the product has lagged the commercial coverage. Can you just give us an update on when you expect Medicare coverage to pick up on the product?

Yes. Thanks, Serge. So as you're aware and as we've stated in the past that the prior utilization management criteria has required patients to have ASCVD or be a secondary prevention patient. When the utilization management changes, start to happen, we will see the primary prevention patients included as well. We've also had pretty significant statin requirements or maximally tolerated statin requirements that we anticipate to ease as well based upon the outstanding new label that we have. With regards to Medicare, as Sheldon mentioned in the opening remarks, we did see already a Medicare payer change and update their utilization management criteria. And there will be many more of those on the horizon over the course of the next 2 quarters. So very encouraging. And hopefully, that answers your question, Serge.

Eric, if I could just add. This was a new. So we had one that updated the UM criteria and then we had one that is one of the largest Medicare providers. That was an absolute new win. So it gets our coverage closer to 50% in Medicare. So we're very happy about that.

Great. And then maybe just one follow-up. So as the Medicare coverage ramps up, do you expect any impact to gross to net going forward?

Serge, this is Ben. I'll take that. Not a meaningful one. I would say Medicare coverage gap is always something that affects us and has in the past. But I think as a sort of distribution of the total, it's not going to be a meaningful impact to gross to net.

Our next question comes from the line of Tom Shrader with BTIG.

Congratulations. It looks like we're close now. So I had sort of a very general question. You're in the market with a statin alternative. I think we all use this vague number of 10% of patients have some troubled statins. Do you have updates on that number? Are you finding that, that number is close or very off or -- and does it differ between under-treated and treated patients? I'm just wondering if we could borrow some of your market surveillance.

So Tom, this is JoAnne Foody. From the standpoint of statin intolerance, I think what we're understanding is that statin intolerance is a broad range. So your 10% number may speak to individuals who are completely unable or unwilling to take a statin. When we look at the opportunity for our therapy, it is in individuals who can't take a statin at all, right, which has that kind of number of 10%. But in fact, in individuals who can't escalate their dose of a statin, a lower dose to maximally tolerated, and those taken together start to get its numbers closer to the 30%. I can't speak to the market. Eric, if you'd like to speak to that, that's fine. But from a clinical perspective, the numbers are closer, and we'll be publishing data and have published data in that realm, showing that it's probably closer to 30% if we think about complete and partial statin intolerance.

And that's part of our education process, Tom, as well as to let HCPs know that statin intolerance isn't just the inability to take any statin, but it is that inability to maximize statin doses. And that's something that HCPs have been very receptive of. It rings the bell as they're starting to think of patients. And as we go out and communicate appropriate patients, that is definitely a patient that we're focused on.

And just a quick follow-up. So we under-treated the bigger opportunity, because they're clearly under the care of a physician and know their lipid numbers?

Yes. It's -- I mean, there's clearly a recognition that patients can't achieve their goals with current therapies. So those that are actively treating are our primary focus. As we've said, there is roughly a 70 million eligible patient population as a result of our label change. We're focused on 30 million of those patients, and those are patients that are actively engaged in therapy.

Our next question comes from the line of Jessica Fye with JPMorgan.

I wanted to ask about volume trends. So we saw a clear inflection in volume on the back of ACC last year, and we're sort of just starting to annualize over that, albeit with the approval now in hand. So should we expect another inflection in volume, thanks to the ability to promote or maybe more of a continuation of the trajectory the franchise has been on? Or is it reasonable to think about a deceleration given just the tougher comps? Maybe I'll stop there.

Jess, it's Sheldon. I'll start with this. So we've always said that with our label, you would see a meaningful inflection of our business. Even before our label, we said that we would show continued quarterly growth. Again, keep in mind, in the first quarter, the results that we're showing today, it doesn't even include what we -- we didn't have the new label yet. So I think if I understand your question correctly, the outlook is, we will continue to show acceleration in the growth of our products based upon the new label that we have. As Eric just previously mentioned, we know that we have a patient population of close to 70 million patients who could benefit from this drug in additional LDL lowering and risk reduction. What we haven't talked about is the actual pace of that growth. It's not going to happen as a quick inflection, but we're going to see meaningful growth, more aggressive growth as we march through the quarters.

Our next question comes from the line of Jason Butler with Citizens JMP.

This is [indiscernible] for Jason. Just a very quick one from us. Have any of the payers pushed back an increase in access following the label expansion?

Yes, it's Eric. I can start this one off. So I'd say our discussions have been very positive so far. I haven't heard of any negative receptivity from a payer perspective. Obviously, payers have their own time lines. So some of them may operate sooner than others. But based upon the cadence of how this was handled, initially, there were medical discussions and then those translated into confirmation post label change and then business discussions. And so far, all these discussions have been very favorable.

Very helpful. And just a very quick one on the commercial effort. So now that all the commercial efforts are in place, how are you gauging success of the commercial investment in the U.S.? And do you expect to make any adjustment to the sales force accordingly?

Yes. So we've made the adjustments to the sales force. So we're at the number that we anticipate staying at for a while, which is at 150. As a reminder, with the sales force or personal promotion as well as our digital footprint, we're able to cover about 45,000 HCPs. So we've got a good infrastructure in place. In terms of how do we measure success? Well, first of all, we have to have discussions with our HCPs. So we're looking at both the commercial, actually the digital reach as well as the personal reach, and our teams have been very successful in having those discussions with the targeted HCPs. The digital footprint has been strong. We've seen over 19 million impressions between HCPs and consumers over the first 5 weeks. So those are very encouraging metrics. So obviously, those are some early indicators. But the significant indicators will be actually watching those share increases happen over the upcoming weeks and quarters.

Our next question comes from the line of Joe Pantginis with H.C. Wainwright.

So I wanted to approach the question also from the statin intolerance or long-term side effects and sort of overall concern from some patients in general, where right now, all the focus is on HCPs and their views about the new label, and we're expecting to see that growth inflection as you guys are as well. So I guess I would ask the question from the following standpoint. Are you going to collect data? Or do you even want to sort of pontificate, if you will, about the role of patients in helping to drive those decisions. As you know, they're much more savvy. They have Google and what have you, or they're saying, "I haven't had an option for a statin up to this point doctor, but this really looks interesting". How -- what role do you think patients' feedback will have in changing their treatment guidelines?

It's going to have a significant role, Joe. So as Sheldon mentioned in the opening remarks, we do have a consumer-based campaign that we've deployed as well. We call these little creatures, the Lipid Lurkers, and they're out there. They're present raking havoc. And we've put those forward in the digital universe. Just from a meta campaign perspective, we've seen 1.6 million exposures with the lipid lurkers and they're present in many other platforms as well. So consumers play a significant role. Obviously, we've got to be very targeted. We don't want to go to the broad consumer universe. We want to go to those who are target patient, and I think the team has done a great job so far at doing just that.

And Joe, just the -- no, first of all, good morning. What we saw last year or two after ACC, we did collect data, is that consumers really went out there. When they saw information, et cetera, to your point, consumers are very different. They're well informed now. They want to find out more. And we saw a lot of them post ACC head out into their physicians' offices and ask about NEXLI

Our next question comes from Jason

I apologize if I missed this, but to what extent did stocking and inventory build contributed to the quarter's total? And then a follow-up, if I may.

[indiscernible] That's a short answer, Jason. It was none. No effect on quarterly revenue.

Got it. Perfect. And then what should we be thinking about gross to net trends as you start to bring more payers online, especially given the sizable patient population in primary prevention?

Yes, I can take that one also. So as far as gross to net goes for the year, we expect it to follow the same cyclicality that we've seen in prior years. And as a reminder, Q1 is our best quarter and Q4 is our worse. So it gets progressively worse of the year, largely driven by the Medicare coverage gap. As far as the actual percentage year-over-year, I would say it's going to be consistent. The payers updating towards the UM criteria and adding that primary prevention doesn't necessarily change the rebate or any of the amount paid to them. It's just the indication that's covered. So as far as the actual gross to net number, we don't really see that changing materially year over year. Just, it will follow the same cyclicality that it does every year.

Got it. I guess I was looking for more color as to whether or not payers were looking for more concessions, again, given kind of the sizable shift in overall population, I guess, overall moving forward?

I can take that, Jason. I mean, we've been very pleased, as Eric mentioned, with our interactions with our payers, and the short answer to that is also no. So and I think part of it is just based upon the alignment that we gained when we presented the data at ACC and went to them immediately. This is something that they've been prepared for. But there has not been a meaningful request as it relates to what our new label update is, is the best answer I can give you.

Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Sheldon for his closing remarks.

Great. Thank you, Towanda. Thank you, everyone, again, for your time and interest today. Again, we couldn't be more pleased with our first quarter performance. Our label approval and for 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 continuing to execute on our commercial plan and keep posted on our progress in the weeks and months ahead. Look for us at the host of conferences in the upcoming weeks. We have a real busy May in front of us. Take care and see all of you soon. Thank you again.