Good afternoon. Welcome to the 2024 Jefferies Healthcare Conference in New York. My name is Dennis Ding, biotech analyst here at Jefferies. I have the great pleasure of having Esperion Therapeutics up here with me for this fireside. So, Ben, why don't we kind of kick things off with just giving a brief background, some of the tremendous progress you've made over the last 12 months? I mean, you know, we were all here 12 months ago, and the situation was very different than it is today. So maybe talk about some of the progress that you made so far.
Yeah, juxtaposed to where we were 12 months ago, I'm much happier to be sitting here now. You know, first off, Dennis, thank you for hosting us. I'm joined on stage by Eric Warren, our Chief Commercial Officer, because thankfully, this has turned into much more of a commercial story since we were here last year. I'm honored to be representing Esperion and the employees and all the good work that we're doing. So it's been a busy year for us. We hit the ground running very fast, and even in just the last 2 months, you know, the key things to note about Esperion: we received a label update for our expanded CV outcomes label in March, in late March of this year.
At the same time, our European partners also received their CV outcomes label, which both of those were kind of the last big step towards starting and accelerating the growth of what will be a blockbuster drug. And, you know, really moving this forward to the potential that we see. I will also be remiss if I don't mention our Japanese partner, Otsuka Pharmaceutical. They reported out their phase III a couple weeks ago and are on path to begin the regulatory filing process for, uh, getting that drug launched in Japan as well. And, you know, we're very excited for what's to come here. This is a very pivotal time for the company and something that I... you know, we think will be a large inflection point for the value to come.
Right. And with the new label that you got, that you guys got in the U.S. in late March, I mean, it's been, you know, a little bit more than two months. I know it's probably still kind of, quote-unquote, "early days," but talk about, you know, any changes that you've seen on the ground commercially.
I'll take that one.
Yeah.
Yeah, thanks, Dennis. Great to be here.
You bet.
So we've seen a lot of changes. So we've scaled up our sales team in advance of the label change. We trained the sales team, so mid-April, we actually deployed the team against a new set of promotional tools and new strategy. Over the course of the last 7 weeks, we've seen 6 of those weeks show progressive NRX improvement. We've also had a significant focus on increasing the level of preferred coverage that aligns with the utilization management criteria. I'm happy to say that prescribing NEXLIZET and NEXLETOL are a lot easier than they were before. So we've got, we've got a total of 9 wins that we've had. 2 of them came rather early after the label change, and 7 of them have come effective Monday.
So, we've got a lot to look forward to, but the team has done a great job at creating that incremental growth. Now, with these label improvement or with these UM improvements aligned to our label, anticipate even more accelerated growth.
Right. And previously, you guys have always talked about, "Oh, you know, let's track the weekly scripts," but until the UM criteria get updated to reflect, you know, a higher or greater number of lives, you're not gonna really see those script inflection, at least through, through some of the script platforms. So now that, you know, we have some positive indications that, I guess, is your expectation going forward for scripts to start inflecting?
Yes. Yeah.
Okay.
So, so we've seen some inflection, prior to the June 1 changes, where the seven plans came on board. But I fully anticipate additional acceleration to happen as a result, and that acceleration will close the second quarter, but ultimately position us in a great spot for Q3 and beyond.
Can you quantify for us how many... you know, with the new updated UM criteria, over the last few days, how many covered lives have you guys expanded into?
Yeah. So I think it's important. We're about 100 million lives covered under the new UM criteria, and I'll differentiate things a little bit differently. We've always had 90% commercial coverage, but this 100 million is now people who are covered and being reimbursed for the new label, but more importantly, an easier, more streamlined approval process from the payers. So prior authorizations have always been a big headwind for this drug. Now, you know, I think Eric mentioned it's much easier for a doctor to prescribe this, to get it in the hands of a patient and get through that approval process without, frankly, getting frustrated.
Yeah, yeah, to build upon that, actually, electronic look-back is a core component now for a lot of these plans. So in the past, where you had to provide prior authorizations with significant documentation, now, if a physician is prescribing, the product and it's for an appropriate patient, one plan, for example, has just created a electronic look-back looking at statin utilization. So if a patient was on a statin within the last six months, that script gets processed and filled. It doesn't require any additional documentation, prior authorization, so it's very seamless for the physician and the patient.
Okay, understood. And I guess when you—you know, ever since the new label got updated, you know, the big primary prevention market really kind of, sort of opened up for you.
Yeah.
Can you talk about over the last few months, you know, as you think about the different buckets of where bempedoic acid could be used, like where do you see the most enthusiasm, the most traction, and is it in the primary care segment?
Yeah, I'll, I'll start this one, Ben. So obviously, the primary prevention is a really significant opportunity for us, and it's an opportunity of significant unmet need. Prior to our product, it was statins that were the LDL-C-reducing agent that had an outcomes benefit in the primary prevention patient. With these outcomes data and ultimately with the label change, we become the only non-statin LDL-C reduction agent to improve cardiovascular outcomes in primary and secondary prevention. That's huge, right? So this gives the primary care physician the power to taking control of that patient, prevent the event before it even happens. So we've seen progress and growth from both cardiology and primary care, but the primary care growth is outpacing that of the cardiology.
What's the current prescriber mix right now, between PCPs and cardiologists?
It's a little bit more skewed towards primary care, but it's close, 55-45.
Okay, and you know, you mentioned that you guys have deployed a new sales force or a greater expanded sales force. Is there a priority for the, you know, the sales force right now to focus a little bit more on one over the other?
Yeah
given the opportunity there, with PCPs?
Yeah. So our sales team is 150 strong. A very dedicated group of individuals, very balanced group. They're deployed against about 20,000 HCPs, of which those HCPs were selected carefully, based upon their having the right patients and their likeliness or willingness to prescribe. We have about 10,000 cardiologists within that universe and 10,000 primary care physicians.
Are you confident that with the expansion, that the sales force is, you know, optimized or that's the right size for you guys, or could there be opportunities to grow even further?
It's the right size for us now. You know, so based upon the budgets that we have, we've got a model that I feel really confident in, that we can deliver on that growth that we've promised.
Okay. And then given that, you know, with the new label, this updated UM criteria that just kicked in this week, you know, there's an element of growth acceleration in top-line revenue, right? But at the same time, you guys are also spending a lot on OpEx and things like that. So can you comment on profitability, how much of a priority that is for you, and when can that kind of come into play?
Yeah. So that's a huge priority for us. I think it's a major milestone for the company and one that really shows the progress that we've made, both in growing this product but also in kind of controlling our own future. So I would say profitability is much sooner than I think a lot of people anticipate. We see it as a late this year, early next year milestone. And, you know, you mentioned OpEx. If you look at our Q1 OpEx, that's very indicative of what this company will look like going forward for the foreseeable future. We've already staffed up the commercial organization. Our R&D expense is very manageable, and I don't see that growing much this year or even into next year to support the growth that we need to make this company profitable.
Okay, got it. How do you think about consensus for 2024? I think it might be around 155-160, somewhere in that ballpark. Are you still comfortable with that?
Yeah, it's, it's in line with how we're picturing for the year. And, and I'll be candid, you know, it may vary quarter to quarter, but I think from a total year perspective-
Sure
... that's in line with our thinking.
Sure. And you know, clarify, you know, when you talk about profitability, right? Like, do you include milestones? How does that look like in, you know, later this year or 2025 even, because your Japanese pro-
Yeah
... partners are making a lot of progress there. Do you include that in your profitability timelines? And even if you strip that out, like, how likely could you achieve profitability?
Yeah. No, I don't consider us profitable until it's ongoing business that makes us profitable. You know, those milestones are, you know, one time, they're somewhat out of our control. So, for me, I'm not checking that box until it's ongoing operations, which is US sales, royalty sales, and partner tablet sales that make us profitable.
Okay. Got it. Very helpful. And then, you know, there's been this discussion around your convertible note situation. Those are due, I believe, November of 2025. So, maybe remind, you know, the folks in the audience and for those who are listening, what is that situation like? How do you feel like you're gonna address that?
Yeah. I mean, I'll, you know, kind of lump this together, is that we still have work to be done to clean up our capital structure, and that work is ongoing. It's a priority for myself and the management team and the board. You know, with the convertible notes, I think we have ample opportunity to go through a refinancing and extend the maturity on those. It's a very supportive base and great people to work with. So, our goal is to have something done before they turn current, and we will work towards making sure that that happens.
Okay, before they turn current, you mean 12 months from now?
Yes, 12 months before they mature.
By November of 2024, you guys would hope to refinance?
Yes, have a path forward with those. That's correct.
Okay. And then obviously, there's this Oberland situation that's going on. Maybe, you know, comment on, on that and some of the progress you guys are making there.
Yeah. I mean, we're in constant dialogue with them and, and working towards having you know, an amenable solution there, where we can sort of do what we need to do with the convertible notes, and also just have the flexibility to control the capital structure in a way that's beneficial to Esperion. And, you know, it's, again, I would say positive discussions that we hoping to have a resolution to soon.
Okay. Is there any... You know, because the Oberland agreement is actually quite long and-
Yeah.
a little bit dense to kinda get through, but are there any specific things that you feel like are overly restrictive for you guys, or, you know, maybe you can or cannot comment?
I think it'd be nice to have flexibility on the convertible refinancing as opposed to how it's written right now, and being able to go out and get a more economically beneficial deal for the company than what the agreement would currently allow for. And, you know, ultimately, that's the goal, is just being able to have the flexibility that we need to do what we need to do to address the convertible notes.
... Do you mean that in the sense that right now, the agreement as it stands, you can't issue notes to new-
That's correct.
-holders?
Yeah, it would have to be with existing current holders. We couldn't go out and do a publicly marketed deal. You know, it'd have to be with existing, you know, its existing holders. And I'm not saying that's not a possible deal. If we did that, it would be fine. You know, we could just get better economics if we were able to go out and issue new notes.
Sure. Okay, so then, would we expect some progress made on those two fronts, the Oberland situation as well as the notes over, let's say, the next six months?
Yes, that's correct. I think that's a good time frame. Maybe a little bit long for the convertible notes, but ballpark, close enough.
Okay. Got it. And if we kinda go back to commercial business, remind us your IP situation. I think you had some positive developments on IP that, you know, you may remind us of, of that.
Yes. So yeah, so, composition of matter until December of 2030 with a six-month pediatric extension, so that puts us into the middle of 2031.
Okay, and then how do you envision the revenue growth from now until that period?
Yeah, I mean, Everyone in this company fully believes that these are blockbuster drugs, both in the U.S. and in Europe, and I think that is enough time that we can demonstrate that that's possible and that we will reach there. I know people think that's a short time frame horizon, but I'll also point to the fact that we now have the outcomes trial behind us. We have what I would say is one of the most broad cardiovascular labels that's ever been given, and, you know, we have ample opportunity to get there.
I'll just say those, obviously, those late years are incredibly valuable. So anything that we can do to extend from an IP perspective beyond that, and our general counsel's actively working on other patents that we have that could extend us into the mid-2030s.
Got it. You know, maybe talk about the competitive landscape here, right? Because I appreciate the patents go out till 2031 as a base case-
Yeah.
Or maybe even 2035, you know, if you feel good about the patents. But there's, you know, you guys are not alone, right? There are others in development. So talk about how you plan to position yourselves when some of these new players come onto the market.
Yeah. So we're positioning ourselves as next after statin, and that's as simple as that. So, everyone is entitled and should have the opportunity to try a statin. For some patients, they can't tolerate it at all, some can't maximize the dose of statins, and some do, but still don't achieve their LDL-C goal. So that's really where we fit in. We're an oral agent, we have proven outcomes in a primary and secondary prevention population. I know there's a lot of other competitive products in the mix, but getting to the market and then actually demonstrating that outcomes are two different tasks. So, you know, until those agents have demonstrated that, you know, I kind of bring it back to our focus, there's plenty of opportunity for us to be successful.
I think of our true competition as ezetimibe. Ezetimibe commands a 68% adjunct market share. So, you know, to the extent that we could position ourselves, and we will position ourselves next after statin directly takes share from ezetimibe. Ezetimibe is about a 15% LDL-C reduction with no indicated outcomes benefit. So we're well-positioned to take considerable share.
Can you comment on how quickly ezetimibe is growing in terms of volume or script?
Ezetimibe, since going generic, took off like a rocket and continues to be the number one adjunct product by far. So, ezetimibe is significant. Again, that 68% share has been pretty consistent, but as we successfully gain traction, we'll start to see that come down, and that was confirmed by quantitative research that we did. So our 300 HCP quant showed that the number one source of business was ezetimibe.
Okay, and then the other, the remaining 32% is presumably the injectable PCSK9, or?
Yeah, the injectable PCSK9, Repatha, is about a 12% adjunct share, and then there's a whole slew of other agents.
Okay. So with bempedoic acid, because, you know, I think we all appreciate the injectable PCSK9s, they have very high or very strong LDL reductions.
Yeah.
How do you position bempedoic acid relative to that and-
Yeah. So it just goes back to that simple statement, we're next after statin. So if patient is unable to achieve their goals on a statin or is unable to tolerate or maximize, come to us, hopefully, we will meet their, their needs. If they require something additional, then PCSK9s could be a viable option, for them. There's a lot of patients that don't want to inject. And they've been on the market for 12 year- or 10 years, 11 years, and, they've commanded a 12% adjunct share.
I'll go back and point out, you know, we keep harping on primary prevention as a main value driver for this drug. PCSK9s are not indicated for primary prevention. That's not even a market that they can play in, and it's by far the larger driver value for bempedoic acid.
Yeah. Okay. And I think, you know, in a lot of our investor discussions, we feel like this whole dynamic around ASPN-
Yeah
... is perhaps underappreciated. So can you just clarify and help us understand what that is and-
Yeah.
Yeah.
Yeah. So, so we have a specialty pharmacy relationship. It's called ASPN. It's again a specialty pharmacy. It's embedded into the EMR, so the electronic medical records. So any HCP that is e-prescribing has the ability to send their scripts to this specialty pharmacy called ASPN. The partnership that we have with them allows the physician to make that prescription. They'll reach out to the physician, they'll reach out to the patient. They will navigate the reimbursement process along with those two constituents. Their goal is to get a positive reimbursement for that patient. They typically can do that within a 3-day period of time. If they're unable to get that reimbursement, they have the ability to issue what's called a quick start.
So they give the first month free for the patient, and then they're continuing to work behind the scenes to get that as a paid script. If they're unable to do it, there's the potential for some patients to go into what we call a bridge, where there's some payment that comes in to us, but it's a deep discount to keep that patient active while ASPN continues to tend to that script, trying to get paid reimbursement. So it creates a very simple process where the HCP can prescribe to one place, knowing that the patient is going to get access to the product, and we know that there'll be someone working to navigate the reimbursement.
So it's kind of important to put this into context, right? And the reason I bring it up is, you know, even though you got the new label in late March, it took a few months for the payers to update their UM criteria.
Yeah.
In the meantime, you guys have this program to help bridge the access there. I think the nuance-
Mm-hmm
... there that, people may not fully appreciate is that, you know, these are free scripts, right? They're non-revenue generating scripts or-
Discounted. Discounted scripts.
Discounted. And what's reported through IQVIA is only revenue-generating-
That's correct
... scripts. And you guys have been growing generally between 1%-5% over the last two months, and none of that is capturing some of the patient flow that's going through ASPN. Is that, is that fair?
Yes, that's. And, you know, there is a portion, like you mentioned, that are not captured in IQVIA, that we see internally as kind of a metric that we're tracking and monitoring, and it's not an insignificant amount of scripts.
It's not insignificant. Can you refine that a little bit internally?
We'll likely give-
It's growing.
It's growing. It is growing.
Yes.
It's a growing portion. Not just a growing portion, but also just a growing total number. We'll likely give updates during earnings to show how that ASPN has affected us over the quarter.
Yeah. Yeah, and, and we've put forth KPIs for our sales team. So there is a targeted amount of HCPs within their geography that we're looking for them to gain ERX-ing to ASPN. So it's a critical priority for us.
Okay. I think what's also important here is that this ASPN/bridging program, it does not go on indefinitely.
Yeah.
No, the selfish CFO in me loves this program because every time that prescription comes up for renewal, they try and convert it to a paid prescription, and at which point it would be reported through IQVIA. But, you know, hypothetically, if someone who was on one of the payers that just updated yesterday on June 1st, if they come up for their 30 day this week, that will now become a paid fill.
Mm-hmm. Okay, so not only do you have... I guess, you know, from a script reporting perspective, not only will you have this inflection coming from new patients getting access, but you also have this kind of rollover effect of people on ASPN/bridging program being included in IMS, right?
Yes. Yeah.
When you put those two together, that's what kind of underlies your confidence that script growth should accelerate meaningfully.
Couldn't have said it better myself, Dennis.
All right. And you, you know, you obviously expect that to go through the second half of the, you know, the year, right?
Yes.
Okay. Lastly, in the, you know, last minute or two, can you just remind us of your cash position?
Yeah. We had $227 million at the end of Q1. I will note that does not include a $25 million payment from Daiichi Sankyo that's associated with their label expansion. I sent them the invoice a couple weeks ago. That should be in the bank soon. But the long and short is we are in a very, very good cash position to capitalize on this launch, and we're funded for the foreseeable future.
Got it. Very cool. Well, thank you guys so much for the time. This has been great. Hope you have a good rest of the conference.
Thank you, Dennis.
Thanks, Dennis.