My name is Jason Gerberry. I'm one of the new midcap analysts here at B of A. I'd like to welcome you to the final morning of our 2023 healthcare conference. Very pleased this morning to be introducing Sheldon Koenig, President and CEO of Esperion Therapeutics. His first, I believe, conference pending, following the dispute. I think why don't we just dive in, and let me ask, you know, maybe to start things off, question on most investors' minds. I appreciate things are a little in flux, and there's some restrictions here, but can you provide a little color on what's going on thus far with the lawsuit and maybe potential timelines for resolution?
Yeah. First of all, Jason, thank you very much on behalf of all the employees at Esperion. We really appreciate the opportunity to be here at the Bank of America conference. As I said to you before you entered the room, you said we're the first conference post this conflict with DSE. As many of you know, we held earnings this week on Tuesday. We touched upon the suit. As you know, last week, we issued a press release, and we also filed a new complaint with our new attorneys, Gibson Dunn. We wanted to make sure we had the best litigators in the country to address this case. What you also noticed is that in the new complaint, we were very clear, no pun intended, to demonstrate why we believe we are in the right.
I think it's important to state that we are very confident that we will receive the $300 million that Daiichi Sankyo owes us. No question about that. Why is that? Why? Because they always felt that in their mind that this payment was due based upon a Phase 4 endpoint. It's very clear in the new complaint that they had asked for that language back in 2019. That language was struck, and the language of cardiovascular risk reduction endpoints was added. As it relates to timeline, they have till June 19th to respond because with the new complaint, they get an additional 45 days. We are in the process right now of, you know, waiting until June 19th, and, you know, we will go from there.
Great. Thank you for the color. You mentioned you are confident in eventually having a positive resolution here. In terms of the timing, you know, the milestone was expected, I believe mid-2024, in line with the label update, presumably. What is your confidence that you'll have that $300 million before that time?
Yeah. Really can't comment on what could happen before the payment is going to be due. What I can say is the fact that related to the label update both for the U.S. and the EMEA, we are on track, if anything, ahead of time on the filing for both the U.S. and the EMEA. We believe we'll have those labels sometime by the first quarter of 2024. That's when the payment was going to be due anyhow. We're confident based upon even these additional 45 days, it allows us to get to the first quarter. If we need to go into litigation, we will. It allows time for discovery, to look for bad emails and other evidence, et cetera, that supports our case. You know, we're very confident about the timing and where we'll be from a label perspective as well.
Again, we will update everyone accordingly as we get more information. That is something I promise.
Great. Let me be pivoting to some more positive news. Recently, you presented the positive CLEAR Outcomes study, which was a landmark study on the use of bempedoic acid. Let's get into details in a second, but can you put the study into context? I mean, what do you think are the key takeaways and why?
Sure. First of all, this is one of the first lipid outcome study that has in a non-statin that you've seen in over 22 years. What's really important about this study, to remind everyone, this is 14,000 patients studying a new differentiated mechanism of action. We showed not only statistical significance in MACE-4 and MACE-3 endpoints, but other endpoints that really matter. We showed that we reduced non-fatal and fatal MI by 23%. We showed that we reduced revascularization by 19%, that was only by using NEXLETOL. The reason why we studied it using NEXLETOL only is to show how the mechanism of bempedoic acid works on its own. As Steven Nissen would say, imagine if the study had been looking at NEXLIZET, which even shows, you know, much more efficacy.
I think the other points to remind everyone is that 49% of the study population were women, 18% were Hispanic. This is probably one of the most differentiated, diversified studies, that has really been seen and has really been desired by the cardiovascular community.
Great. The study had a somewhat of a unique design, specifically, unlike a lot of other outcome studies, you enrolled patients that were largely intolerant to statins rather than add-on therapy to statins. Can you discuss a little bit why that decision was made and what the implications are here?
Yeah, absolutely. If you actually look at the epidemiology of cardiovascular disease, there's between 7% and 29% of patients that are identified as statin intolerant. In our study alone, 20% of the patients were on a low-dose statin. 11% of the patients were on ezetimibe. These are patients that can either not take a statin at all or they can only take a minimal dose of a statin. There's close to 30 million patients out there currently today that fit in 1 or 2 of those categories. Keep in mind also in the CLEAR Outcomes study, we studied not only secondary prevention, but we studied primary prevention, and that's a huge differentiation versus any other studies currently out there with non-statins. If you look at PCSK9, they only studied secondary prevention. If you look at ezetimibe, they only studied secondary prevention.
The fact that we've studied both primary prevention and secondary prevention, you know, really goes a long way in not only differentiating the product but the population. Again, if you think about close to, you know, 30% of the population, is statin intolerant, you know, that's a big market for us. Again, this is also an add-on strategy where you can add this drug onto existing therapy, whether it's statins, whether it's PCSK9. With our label change, you'll be able to actually use the drug on its own.
Great. Let's talk just a little bit more about the study. One of the confounding features I think was the dropout rate, where patients who went on another LDL C lowering agent impacted the results. That improved the performance of the placebo arm and sort of also negatively impacted the relative rate of risk reduction. Can you talk a little bit about the implications there and...
Absolutely.
some takeaways?
Sure. Unlike, or not unlike any other cardiovascular studies currently out there today, there's ethics involved with studies, and physicians have that ability to make sure that they're taking care of their patients. We always knew that there would be drop-ins into the study. I think on the placebo side, it was greater than 11%. With that said, it actually almost reinforced just how efficacious our drug is because even with those drop-ins, it created more of a headwind for us to actually achieve statistical significance, and we were still able to achieve statistical significance in every category that we tested from a statistical hierarchical perspective. Just wanna go one step further. What we've seen from physicians currently, today with prescribing, as you know, in first quarter, we showed a significant increase in prescribing.
We saw an 88% increase in new-to-brand prescriptions only three weeks after we showed the data. We showed a 56% increase overall when you look at it quarter-over-quarter. Why is that? Physicians, key opinion leaders, academics, they see the value of the study. They see how important the totality of the data of the study is. Nobody's questioning percentages, et cetera. What they're looking at is that this drug saves lives, and that's what's important.
About 7% of these patients went on a statin despite, you know, ostensibly being statin intolerant. Do you think that's gonna weigh on the minds of prescribers at all?
Not at all. No. It's not even an obstacle that's been brought up to us. As I mentioned before, the beauty about NEXLETOL or NEXLIZET is it can be added to a statin. My own personal case, I don't have my bottle, I was prescribed NEXLIZET 4 weeks ago. I take 10 mg of rosuvastatin. That's the maximum. I'm a big runner, anytime I try to do something more, I get this nephropathy feeling in my legs, et cetera. My cardiologist at Penn said, "You need to go on your drug," which she would never prescribe me until we had outcomes. Once we had the outcomes data, she came into the office. I was in the waiting room or, well, I guess it was a waiting room. She said, "Congratulations on the study.
By the way, I already prescribed your drug." What's interesting there is she didn't realize she had to do a prior authorization. I think in the marketplace, that's still one of our biggest headwinds, is that physicians need to identify the right patients, and they need to fill out the prior authorization appropriately. What we've seen out in the field is when physicians do that, the drug gets approved. That's with the current label that we have today. There'll be less of that headwind once we have our new label come first quarter of next year.
Gotcha. Well, I think that's a great segue. Can you just give us a brief update on where you are with label expansions, and then we'll move from there?
Sure, yeah. Currently, as I mentioned earlier, we're in the process right now. We have a team of eight people who are doing a tremendous job. As a matter of fact, we had an all-company meeting, and they graciously decided to stay back and work on the filing to accelerate the filing. We're on track to have both the EMEA and the US filing done before the first half of this year, which gets us right in a nice spot for first quarter of 2024, which is where we've always said that we would be, maybe even a little bit ahead of that.
Okay. Where do we stand with the guidelines?
With the guidelines, we seem to think that, from a U.S. perspective, the AHA and ACC guidelines could come as early as November. I do want to again point to the fact that 5 days after we announced the CLEAR Outcomes study, the European lipid community offered a consensus where they actually changed their guidelines. I've never seen a guideline group change guidelines 5 days after a study and position recommended bempedoic acid before PCSK9. Pretty monumental move. As you and I have discussed, guidelines make a difference. If you look at drugs like ENTRESTO, it wasn't until the guidelines changed in May around 2016, and you saw yet another inflection point. We believe not only our label change, but guidelines will give us that increased inflection.
There's other analogies that we can speak to, you know, going way back, clopidogrel is one. Even statins where guidelines changed and are used, and it showed, again, more of a dramatic uptake. We're confident about the guideline changes.
Remind us, what's the lag time like there between the guideline change and the inflection in TRx?
You know, I think with a guideline change, it allows us to get out immediately and use those guidelines. Right now, we use the consensus guidelines from ACE that are currently out there, but it's pretty quick because you have a lot of individuals, cardiologists, academics to go to these association meetings. But now, with digital media, Facebook, Instagram, you name it, outreach, just like we did with The New England Journal of Medicine, we're able to distribute that very widely. We'll do the same thing with guidelines. Awareness happens overnight. That doesn't mean the prescribing will happen overnight, but it'll be another tool in our bag that we can use to show physicians why you'd wanna use NEXLETOL and NEXLIZET.
Well, maybe you can briefly touch upon some of the biggest commercial hurdles and challenges you see.
I think the biggest hurdle right now is what I mentioned earlier, and that is prior authorizations. You know, it's interesting, something that we really looked at. We looked at the pass-through rate of us versus, say, injectable PCSK9s. What you see is that approval rates for both commercial and Medicare business is very similar, and we don't have our label yet. Why is that? It's because physicians are identifying the right patient. They're filling out the prior authorization for those patients who have ASCVD, who've been on a statin, who may or may not have had to be on ezetimibe. One big obstacle was, you had to be on ezetimibe first, and we're already seeing payers remove that there's no need for that based upon we have the outcomes.
both from a commercial and a Medicare perspective, we're seeing very high approval rates, and we've seen that ever since we put the study out there.
Great. We recently completed a prescriber survey, and one of the problems that they flagged was potentially being patient out-of-pocket costs. Can you comment on that and why you don't think that'll be necessarily a big issue?
Yeah. It won't be a big issue because if you look from a commercial perspective, the average copay is between $25 and $35 for this drug. That's, you know, that's for a preferred position, of which that's most of the position we have from a commercial perspective. Medicare is $45. That's pretty standard, that's a preferred position as well. One thing we do all the time is monitor the field from what they're hearing from a pushback perspective. It's not bad. We have affordable copays for patients to get this drug. We did a payer meeting a few weeks ago, payers said, "Why are we spending so much time even trying to regulate this?" This drug's only $400 a month, that's cash. These patients, you know, where it's on, they're paying their copay.
Gotcha. Well, we're just about out of time, but maybe even talk a little bit about, you think the biggest competitive challenges down the road.
Well, I think what you're mentioning is the Merck compound MK-0616 and obviously CETP inhibition. What I'll say, Jason, is we have a drug, as I mentioned, has fundamental results, significant results. I would say to anyone in the audience who are listening, if you have heart disease, do you wanna wait 3, 4, 5 years for something that might not come out? Do you wanna take a drug that's available right now? That's the point. NEXLIZET and NEXLETOL are next after a statin. It's available now. I worked at Merck for 27 years. A lot of great drugs. A lot of drugs in development had great promise, they failed. They didn't make it. It's a high hurdle to get a drug approved, it's a higher hurdle to get outcomes data. We have all of that now.
Great. Well, thank you so much for joining us.
Thank you.
Thank you, everyone, for joining us as well. Thank you.
I really appreciate it. Thank you so much.