ESPR - NASDAQ

Ladies and gentlemen, thank you for standing by and welcome. [Operator Instructions] Please be advised that today's conference may be recorded. I would now like to hand the conference over to Tiffany Aldrich, Associate Director, Corporate Communications, at Esperion. Please go ahead, Tiffany.

Thank you. Good morning and welcome to Esperion's First Quarter 2023 Earnings Conference Call. 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, presentation and 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 9, 2023. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We issued a press release this morning detailing the contents of today's call. A copy can be found at esperion.com, within the Investors & Media section. With us today are Sheldon Koenig, President and CEO; Ben Halladay, Chief Financial Officer; Dr. JoAnne Foody, Chief Medical Officer; Eric Warren, Chief Commercial Officer; and B.J. Swartz, Chief Strategy Officer. 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. I'll now turn the call over to Sheldon for some prepared remarks. Sheldon?

Thank you, Tiffany and good morning, everyone. Thank you for joining us today to review our first quarter results and significant recent achievements. We reported revenue of $24.3 million or growth of 29% year-over-year. Retail prescription equivalents grew by 15% year-over-year and new-to-brand subscriptions grew by 56% compared to the prior quarter. It's clear that we are off to a very strong start in 2023. Let me now share some of the highlights from the quarter that are driving this positive momentum. As you know, we recently presented impressive clinically meaningful cardiovascular risk reduction results from our landmark CLEAR outcomes trial at ACC in March as well as published these broadly disseminated data in the prestigious New England Journal of Medicine. This was a major accomplishment for Esperion that was years in the making and we're very proud of the team for their tireless work in achieving this milestone. I'll further discuss these positive results in a moment. Our entire organization is continuing to work expeditiously following our data announcement. And we remain on track for regulatory submissions both to the U.S. FDA and the European Medicines Agency in the first half of this year. Once we file, there is typically a 10-month review period, so our expectation is for the label change to become effective in the first half of 2024. As a reminder: Our sales reps are prohibited for mentioning anything beyond the current label, so we expect the label change to have a significant and positive impact on demand for our drugs. New-to-brand subscriptions spiked 88% in the 4 weeks following our ACC data presentation. And Eric will provide more color from the field to explain why we are seeing this trend so quickly and ahead of our initial expectations. We are also making swift progress in Europe. The International Lipid Expert Panel has updated the guidelines; and now recommends bempedoic acid ahead of PCSK9 inhibitor, either alone or in combination with ezetimibe. Next, our European partner has demonstrated persistent growth for the NEXLETOL and NEXLI

Thanks, Sheldon. I'm incredibly excited about the performance of NEXLETOL and NEXLI

Thank you, Eric. Earlier today, we issued a press release containing our financial results for the first quarter 2023 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, 2023. U.S. product revenue was $17 million, up approximately 27% year-over-year. Retail prescription equivalents for the first quarter increased 15% year-over-year and 7% quarter-over-quarter, reflecting very positive reception of the CLEAR Outcomes data. Our European partner continues to report strong NILEMDO and NUSTENDI growth in their European territories. A total of 97,000 patients have now been treated in Europe through February of 2023. As of March 31, 2023, cash, cash equivalents and investment securities available for sale totaled $162.3 million compared with $166.9 million on December 31, 2022. This cash includes the recent $56 million raised in a registered direct offering in March before deducting placement agencies and related offering expenses. Collaboration revenue which includes combined royalty and partner revenue, was $7.3 million, an increase of 33% year-over-year. Finally, total revenue for the first quarter ended March 31, 2023, was $24.3 million, an increase of 29% year-over-year. Turning to expenses. R&D expenses were $31.4 million, an increase of 29% year-over-year. The increase is primarily related to costs associated with our CLEAR Outcomes trial, including closeout activities, our ACC presentation and regulatory submission preparation as previously guided. SG&A expenses were $29.9 million, a decrease of 2% year-over-year reflecting our commitment to expense management while continuing to support the momentum seen following our ACC presentation. Our recent deal with Currax is a great example of how we can expand our commercial presence without significantly increasing our burn rate. We still expect full year 2023 operating expenses to be approximately $225 million to $245 million and we are tracking in line with that guidance. This total includes $25 million in noncash expense related to stock compensation and will be further broken out as $100 million to $110 million in R&D expense and $125 million to $135 million in SG&A expense. I'll note that our operating expenses are expected to be first half loaded, reflecting costs associated with the closure of our CLEAR Outcomes trial ACC presentation and regulatory filing submission work in both the U.S. and Europe, as previously mentioned. We expect second quarter expenses to be relatively in line with first quarter and then to moderate substantially in the second half of the year. Let me now hand it back over to you, Sheldon.

Thank you, Ben. Let me share a brief corporate update. First, we raised nearly $56 million in capital at the end of March which extends our cash runway and enables us to fuel continued growth. Second, we announced that we'll be holding our Annual Shareholder Meeting later this month, on May 25. And third, we filed an amended complaint last week with the Southern District of New York with regard to European partner milestone payments which we believe we are owed. This amended complaint discloses new evidence we believe further supports our position. We feel confident in our legal standing and we'll keep you posted as things progress. NEXLETOL and NEXLI

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

Congratulations on all the progress. So 2 questions from me. Number one, on the Daiichi milestone could you -- you have previously mentioned you'll be speaking around $300 million in value. And that can obviously come in a variety of different ways, so can you give investors some clarity on what you mean by this? And what factors are you taking into account when it comes to pursuing a near- versus longer-term resolution? And then my second question is around OpEx. Can you remind us how much flexibility do you have on OpEx, on either SG&A and R&D; and if there is some level of conservatism baked into your guidance given your Currax co-promotion agreement?

Dennis, first of all, thank you so much for your questions. So I want to be clear as it relates to the Daiichi Sankyo milestone. Our goal is to secure the full $300 million in value for our shareholders. And that's what we will be pursuing. That's what we have always publicly stated. And I think it's also important to again recognize the fact that the $300 million milestone is due upon our label change which we expect to occur in the first half of 2024. So I know you used the word value. We are looking to seek the full $300 million payment and we'll just leave it at that.

Yes. And Dennis, this is Ben. I'll touch on OpEx. So as far as flexibility, I mean, we -- let me be clear. We will always -- we always have and always will meaningfully manage the expenses of this company. With R&D, yes, we have room to change and toggle up and down but with SG&A we want to make sure that we're funding the great momentum that we saw post ACC. And we don't want to derail that, so we will make sure that we're investing in the right areas but we're going to walk the fine line of managing our burn rate as well as trying to keep that momentum going. But to answer your question: Yes, there is room to scale up and scale down accordingly.

One moment for our next question and that will come from the line of Serge Belanger with Needham.

So I mean the first one is on the legal proceedings with your European partner. What's the next potential development on that front? And then maybe can you talk about the potential range of timelines for resolution here? And secondly, just you talked about additional data presentations over the rest of the year. Maybe just give us a preview of what those data could be.

Great. So as it relates to label negotiations and preparing for both the U.S. and also the EMA which would be the European submission, everything remains on track. In the U.S., we remain on track to file before this half of the year is over. And the same is true for Europe; and working with our European partners, Daiichi Sankyo. So all of that work, there's no change in any of the work or the submission time lines. Everything is on time; I would actually say, even a bit ahead of schedule. You may recall we even talked about accelerating time lines, so we are in good shape there. Regarding future presentations and data, we will keep everyone updated but there are some important meetings that will occur before the end of June. And we will be continuing to show data not only at those meetings but throughout the year as we go into even the fall, if you think about the European Society of Cardiology; and then after that, the American Heart Association, so stay tuned. We have some, again, really exciting data. As you know, this is a very large study. And it showed fantastic data that's important to both physicians; patients; and I'll add one more, all health care providers.

One moment for our next question. And that will come from the line of Jessica Fye with JPMorgan.

A few. First, can you elaborate on the economics of the Currax agreement? Second, can you talk about your expectations for the timing for inclusion in U.S. guidelines? Is fall of this year possible? And lastly, what do you see as the current cash runway after the recent raise?

Jess, it's Eric Warren. I'll take the first one, on the Currax financials. So we believe that this Currax arrangement is a wonderful win-win not only for the companies but for patients. So we did provide Currax with a small upfront but the majority of the revenue will come as they generate new prescriptions in the target of the universe that they're responsible for. And that is a unique group of primary care practitioners.

Jess, this is JoAnne. As we think about the incorporation of the data from CLEAR into guidelines, we anticipate that there would likely be updates to U.S. guidelines, presumably in the fall, based on the strength of the data. As you've already seen, we've had guidances up globally already updating their statements and positioning either NEXLETOL or NEXLI

Yes. Jess, this is Ben. And on cash runway, I think, after this last fundraise as well as some of the tailwinds we've seen after ACC, I think we're -- our cash runway now goes to about mid-2024.

Great. And just as a follow-up: What are the time lines we should expect for the litigation with DSE? And when can we expect clarity?

Yes. So Jess, DSE. As you know, last week, we filed a new complaint. They have until June 19 to respond to that complaint. Just keep in mind that the milestone payment is due upon our label change which we expect to occur in the first half of 2024, so even filing a new complaint, that does not delay anything. So after that, obviously we filed the new complaint. And we plan to ask the court to hold a trial in early 2024 and that's a standard time line for these types of cases. Again keep in mind the milestone payment is not due until early 2024.

One moment for our next question and that will come from the line of Jason

Let me echo my congratulations on the progress. Look, I recognize there are some sensitivities regarding the ongoing legal dispute but to the extent that you can comment, is there any ongoing open, active dialogue between you and your European partner? Are there any negotiations that -- in terms of potential near-term settlement, whatever that looks like? And then regarding the Currax deal, when do you expect that to hit? Should we expect the near-term impact, or is that going to kind of come on more steadily over the course of the year?

Jason, first of all, thank you for the congratulations. So as it relates to commenting on ongoing negotiations, discussions, et cetera, unfortunately, we cannot comment on this, as I'm sure you can appreciate. I will say, though, that keep in mind, as I said earlier, it's business as usual, though, with our partners as well as it relates to working on the label, our joint commercialization sub teams, et cetera but we cannot comment on anything regarding the litigation as it currently stands. As it relates to Currax, so the Currax folks: So the deal is done. We're in the midst of preparing them now to begin training which is something that they will do in their free time. Again just be reminded there's about 72 of these folks across the country. And we see them engaging with customers with our products on July 1. And I would go as far as to say that we think that -- we believe that we'll have -- as we've said previously, we're effectively doubling our sales force, so we see having meaningful results as they get started. And we'll continue to update you as we go through the next few months. So we're very excited about the partnership. And it's really going to help us, again, continue the momentum that we generated from ACC.

And today's final question will come from the line of Troy Langford with TD Cowen.

Congrats on all the progress. Just one quick commercial question: Can you provide a little bit of additional color on the feedback from physicians that have tried bempedoic acid since the data at ACC? Have physicians seemed to care at all about the specific level of risk reductions seen in the CLEAR Outcomes study, or have they mainly just seemed happy that it showed a positive result?

Troy, it's Eric. Yes, the physician reaction to our products in general has been fantastic. And that's been before ACC as well as ACC. ACC just opened the eyes to many positions that we're waiting for outcomes data. As a reminder: We're not able to talk about those data but I have done lots of market research projects where physicians are incredibly positive about these data. So they care about the presence of data but they actually care about the actual data that we generated from CLEAR Outcomes. So they're impressed with the data and we've already seen some of the impact. And again that's pre commercialization. And JoAnne?

And Troy, thank you again for the question. This is JoAnne. I think, as we look at the very highest level of key opinion leaders, scientific leaders, particularly in the cardiovascular community, that these data have had a profound impact not only on their awareness but their ability to have a new tool to address cardiovascular risk. So excited about the oral, excited about the differentiation in the study, not only lowering LDL cholesterol but also [indiscernible] protein. And its statin-like property, consistency with statin and its impact on outcomes have really been looked at very favorably and has really driven awareness, particularly in the cardiovascular.

And JoAnne, I'll just add one more comment. Troy, this is a question that, of course gets us excited because -- I was actually just at a dinner with a few physicians in Washington, D.C. And what they stated and we've heard this numerous times, is that this drug is a game changer. This drug for patients who can only take a maximum tolerated dose of a statin but still need to get to goal or for patients who cannot take a statin. And it's documented. They have something now they can turn to. So I've heard the word game changer, real-life discussions, numerous times. Again, very exciting. The study obviously unlocked a lot of potential for us, created a tremendous amount of awareness, as we stated in our comments earlier this morning. So again thank you.

Okay, great. And I actually have just one quick follow-up, if I can. Have you all seen a shift in the type of prescribers who have tried to use bempedoic acid or where the prescribers have tried to use the product at all in the treatment paradigm?

It's pretty consistent. We're still seeing about 60% of our prescriptions come from primary care.

And we do have time for one final question and that will come from the line of Judah Frommer with Credit Suisse.

I apologize if we missed this but do you have any updates on how kind of post-ACC payer conversations have been going? Do you get the sense that the ACC data was enough or that they might be waiting for label change? And how are, I guess, the existing reimbursement challenges still affecting scripts? And how could you see those potentially being lifted as reimbursement widens?

Yes. Thank you, Judah. Post ACC, we have presented the CVOT data to probably over 12 of the largest payers that account for half of all payer lives. The receptiveness has been incredibly positive. We have commitment to actually look at the UN criteria prior to label. And we really -- what we're really excited about is in the Medicare, it's 34% coverage now. And we've had that commitment to take that to almost 70% and we think that, that could possibly happen before the end of the year, even before label change. The prior authorizations continue to improve. We see an overall improvement of rates of -- growing at the 3 payers, probably with the largest, CVS, ESI and Optum. We're probably seeing approval rates 15% and higher at this point.

B.J., can I just add one more thing? And that is that we don't even have the label yet; and we see our reimbursement rates, both from a commercial and from a Medicare basis, very similar to that of what PCSK9 has. So I think that gives you a good idea of the success that we're seeing as it relates to the detail that B.J. provided.