Avadel Pharmaceuticals plc (AVDL) Earnings Call Transcript & Summary

Well, thank you, everyone, for joining us this afternoon. I'm Emily West. I'm a Managing Director as part of our Goldman Sachs Investment Banking Group. And I'm delighted to be joined today with the Avadel management team here. We've got CEO, Greg Divis, and Tom McHugh, CFO. So very nice to have you both. Thank you for joining us.

And just to start, it's been a transformational 12 months for Avadel and the company. Can you just kind of level set with us? Why don't we go through the narcolepsy market? How do you see the market? How is it sized today? And how do you see the market growing over time?

Yes. Well, first of all, thanks for the invitation and the opportunity to be here and part of the conference here with the Goldman team. From a narcolepsy market perspective, I think if you start at the highest level, and say, if you look at claims data, there's approximately 170,000 patients, who actually are diagnosed with a narcolepsy diagnosis code, and somewhere in the neighborhood of 130,000 who are on active pharmacologic treatments of some sort. But if you really get down to the oxybate market, if you will, it's been pretty consistent on average, in or around 15,000 to 16,000 patients a year, who are on an oxybate during the past number of years. But as we think about how we segment the market and how we look at the market, specifically for LUMRYZ, we really take that oxybate market and break it down into 3 different categories. We break it down to the -- what's probably now is closer to 14,000 or so patients who are on an oxybate today, actively being treated with a twice-nightly oxybate. And then, of course, there's the new patients every year. There's been a pretty consistent flow of 3,000 to sometimes 4,000 new patient starts a year that churn into that market each and every year. And then the third segment is really what we think about are patients who have previously been on an oxybate and have discontinued sometime over the last 3 to 4 years. And that market size is as much as 15,000 patients. So when we think about the opportunity for LUMRYZ and where our sources of business can potentially come from and actually where they're coming from, they're coming from all 3 of those segments. But we, in aggregate, think the market opportunity is closer to 50,000 potential patients for LUMRYZ in and of itself. We're just not competing for new starts. The other 2 segments are really the largest part of the market that are almost uniquely to us, a market for us and LUMRYZ.

Great. And maybe a little bit more on the competitive landscape. And anything else you can share in terms of how has LUMRYZ really going to fit within all of the competitors and what's coming to market?

Well, if you think about how patients are treated today and where oxybate fit in today, right? Almost every patient who goes on an oxybate has to fail at least to weight-promoting agents or stimulants. So patients who go on to an oxybate will had to go through a series of steps based upon payer policies and payer coverage decisions, right? So first-line treatments are predominantly the Modafinil of the world, the Ritalins of the world, the stimulants of the world where they have to go through a couple of those. I think in our -- and most patients who are on oxybate over -- almost 2/3 are on an antidepressant as well before they actually go on to an oxybate. So where LUMRYZ is set and our -- where we sit in the marketplace and where oxybate sits is predominantly a third line or second line agent based upon coverage policy decisions. Where we are positioning LUMRYZ is as the preferred oxybate, right? So in today's treatment armamentarium, we believe that for new starts for potential switch patients or previously discontinued patients, the benefit of once nightly, once at bed LUMRYZ is very compelling in terms of what it can do for patients and positioning as the first oxybate of choice. Now as you think about the market as we go into the future with agents that are in development, I think it's -- we'll see how some of those agents, the erections and all those related compounds develop and come into market, people are obviously interested in those agents, and we understand why. And I think there's a lot more to learn. But I was at the SLEEP meeting just less than 2 weeks ago, listening to really the person who discovered the orexin deficiency as an underlying cause for narcolepsy Type 1. And again, his view is that as treatment progresses, he sees in the future, the opportunity to combine orexin, should they get all the way to an approval with an oxybate, and we believe LUMRYZ has the potential to be the oxybate -- the preferred oxybate in the market leader.

Great. And maybe just a minute on clinical data and clinical evidence. How do you kind of explain to doctors, patients, the differentiation between the clinical data that LUMRYZ has shown versus others?

Yes. I think you really answered that in 2 ways. One, data and evidence is -- you have to lead with science and data to demonstrate your clinical value proposition for sure. And our pivotal Phase III trial was unique in and of itself in terms of statistically significant across all 3 co-primary endpoints at all doses and at all time frames, right, which includes showing a statistically significant effect as early as week 3. And actually showing an efficacy effect as early as week 1 in some of our post-hoc data analysis. But I think really where pivotal trials translate to how they -- what really matters is how that data translates into the real world. And how does that drug actually perform? We're not in a controlled setting but in the real-world setting. So we've a number of data points that have emerged in support of LUMRYZ even in a real-world setting. Whether -- when you look at our open-label extension study, called RESTORE, which included allowing patients to enter that study who were previously are currently on a twice-nightly oxybate and able to capture some real-world data 3 months enrollment into RESTORE, once they reach a stable dose, 94% of those patients preferred the dosing regimen of LUMRYZ over that of the twice nightly options. And then as we've closed that study out, most recently, we've released some data on a post end-of-study survey that showed those same patients who ended the study, the significant majority of which were switch patients. Over 90% would recommend LUMRYZ to another narcolepsy patient. Over 90% experienced better sleep at night. Over 95% said their LUMRYZ effect was satisfy -- they were satisfied or very satisfied with their treatment experience at LUMRYZ. So in the real world, we're seeing that manifest itself in terms of what we're capturing in those data and what we hear from patients that anecdotally as well.

Great. And maybe we move to commercialization and the launch. And so you've done a fantastic job with the launch so far. Can you talk to us about where are these patients being treated? How has your kind of go-to-market strategy? How are you going about educating both providers and patients in the marketplace?

Yes. I would describe our go-to-market strategy when we launched about a year ago was really to target where the oxybate patients are today and where the oxybate opportunity is today. There's a lot of really good historical data that helped us understand who were the prescribers of oxybate because not every sleep specialist is a prescriber of an oxybate, right? And what we learned was, from a physician standpoint, it's a very highly concentrated prescriber audience, where there may be 4,500 physicians who actually write an oxybate in the first year, 470 of those physicians do 50% of that market and 1,600 represents 80% of that market. So it is a very, very concentrated prescriber universe. And even within that concentrated upper end, there's a very big distribution of wide variance, even in the top 500 physicians where the value of the docs in the top 100 are substantially greater than those in the doctors from 300 to number 400. So very top loaded. And so we're fishing where the fish are, so to speak. So our go-to-market strategy was to go there to educate to engage, to lead with science, to segment the market across news, currently on and previously treated and looking for opportunities for LUMRYZ to begin to establish itself. So we've had a lot of success in establishing our breadth of prescribing educating prescribers and their office staff, not only on the clinical benefits of LUMRYZ, but how to access LUMRYZ through our systems and our processes and our patient support programs. And that's been where we spent the better part and prioritization during the first 12 months of launch is really in those top 1,600 physicians with an over-index in the top 500 or so. When it comes to patients, I would say that we really launched some of our patient initiation activities late last year, but probably most germane is earlier in Q2, we actually launched our patient ambassadors. So again, another example of real-world evidence manifesting itself through the voice of the patient, where we actually have patients who are LUMRYZ patients, who are now part of our educational campaign to patients specifically and to doctors where they've had an opportunity to tell their story why they made the switch, how their life has changed as a result of going on LUMRYZ. And everything from what is their routine to administer the drug at night to the benefits they've been receiving and their experiences while being on LUMRYZ. So we think that education patients speaking to patients is an important next step in evolution of our continued go-to-market strategy.

Great. And what has been the general feedback when you talk to patients who have specifically switched over from first-generation oxybate? What are they saying? And what is the feedback that you're hearing?

Yes. I mean I think patient stories are the most important ones. As much as clinical data really matters. But what physicians and patients remember are the stories, the experiences that they've had and how they actually feel as a result of going on their treatment. And LUMRYZ is no different from that standpoint. You hear stories about how patients will tell you, they do things today that they haven't been able to do in the past or haven't done in a long time. They drive for 3 hours to go visit their boyfriend. They're able to go out and have dinner with their friends at night and not worry about what the middle of the night is going to be. The less anxiety about how they have to set an alarm or wake up in the middle of the night or be worried about missing that alarm and not getting a full therapeutic dose. A college student who can now have a roommate and begin to have a normal sort of college experience because they're in the freshman year, they had to live by themselves, they couldn't have the unattended dose sitting out on a nightstand with a roommate in the same dormitory room. So those are the sort of stories that matter the most because at the end of the day, it are those -- we'll continue to help educate and build awareness around the importance of LUMRYZ, not only for those who are on treatment, but those who are still either potential future new patients or those who are on another [Technical Difficulty].

It's certainly the patient feedback is the most important, but also the physician feedback we hear, who absent an alternative to the twice nightly use for nearly 20 years, that the physicians didn't realize how problematic waking up to take that second dose until the night really was. So now they have an option with LUMRYZ is a once-nightly treatment option, and they're compelled to ask the patients, whether they actually able to wake up and take that second dose.

Great. What about reimbursement? How have you seen kind of the reimbursement market evolving? How are you seeing pricing trending?

From a reimbursement perspective, if you step back and say, okay, what is the distribution and where are the primary sources of reimbursement for oxybate in the narcolepsy space, it's predominantly a commercial market. Between 80% and 85% of the lives who go on and oxybate [indiscernible] or commercial. And through the first few quarters, 3 quarters of launch, LUMRYZ is no different. 80% to 85% of all patients who have initiated therapy are commercial patients from that standpoint. The balance of it is really, as you would expect it to be, a combination of government-sponsored Medicare and Medicaid and then maybe DoD, military and those related segments as well. So for us, it's the same. So our emphasis and focus in terms of leading into approval and launch as well as post launch has really been around the commercial segment. And I'll touch about -- on the other 2 in a minute. But we feel really pleased with the progress we made in particular, with the 3 major GPOs, that being Ascent, Emisar and Zinc relating to 3 biggest -- representing the 3 biggest PBMs and their respective clients, that being UnitedHealthcare, Express Scripts and CVS. And so we've got contracts in place with all of them. We have good coverage -- parity coverage policy decisions across the board, predominantly that's equivalent to the oxybate. And that's really been our strategy from a payer standpoint was to go into the market with a parity access strategy, right? We weren't looking to get preferred status. We weren't looking to use payer strategy as a lever other than to create access and reimbursement in the commercial lives because we believe the clinical and patient value proposition of LUMRYZ would stand on its own and the patients themselves. And that's what we begin to see. So today, we sit with over 85% of all commercial lives with the coverage policy decision in place, and we'll continue to chip away at the balance of those 15%. I would also say that when it comes to the other segments, the other 15% to 20%, we certainly -- since we launched mid-last year, we were really contracting and bidding for Medicare access in 2025. So that has continued through the first part of this year. So I really believe as we get into 2025, the final kind of coverage positions of LUMRYZ across all payers will be much more clear. [Technical Difficulty] decisions later this year. And then I think when [Technical Difficulty] likes of Medicaid and whatnot, again, I think the price -- pricing of twice nightly makes getting a preferred status position in those states with the Medicaid state very challenging, but it doesn't mean you can't get a patient who is stepping through or want to try LUMRYZ. We've seen some Medicaid business. It's a very, very small number. We've seen some Medicare business as well from that perspective. And we certainly believe as we get closer to the balance of this year and into 2025, that segment will clear up a little bit more.

Great. And I realize it's an evolving topic, but any updates that you'd like to share on the litigation front?

Yes. So we are in active litigation. So my comments will be somewhat limited. But perhaps just to level set where we are and some upcoming decisions. There was a hearing on May 10 for an action that Jazz initiated against FDA. We believe that the judge will probably render a decision on that in probably the July, August, September time frame, we just call it sometime in Q3, if you will. There was also ongoing litigation with Jazz regarding a patent. There was a hearing on June 4. We're expecting a decision from the judge on that again in Q3 and there was a question around royalty rate on a go-forward basis, that probably won't be heard until or decided by the judge until early 2025. But listen, I think for us, both of those events are -- I view them as derisking events for Avadel and for LUMRYZ and the treatment of narcolepsy. And the heavy lifting is behind us in those particular cases. Another important case information that came out recently, [Technical Difficulty] we have litigation against Jazz that we initiated primarily around antitrust. So the judge denied Jazz's motion to dismiss that case. So now that is on schedule and will proceed with the trial date set for November of 2025. That's a large -- it's a significant matter. You measure the damages we're seeking relate to us being off the market for 18 months, as a result of a patent list in the Orange Book, that should have never been there. You measure damages in this case, on peak sales, not the first 18 months of your sales. And then it leads to trouble damages potentially as well. So it's a significant matter. And again, trial date set for November of 2025.

I just think the only thing, Emily, I would add to that is that we certainly -- we're in litigation -- there's not a lot we can say, but the most important comment I would make is we don't believe anything that's advancing in these cases today is going to preclude us from continuing to do what we're doing right now, launching in narcolepsy, preparing to initiate our IH trial -- our Phase III IH trial later this year. And the organization is incredibly focused on delivering value and continue building success in those 2 realms as we go forward.

Great. What, if anything, would you say can often be either misunderstood or underappreciated by investors when they're learning about the Avadel story?

Yes. I think there's a few things that are underappreciated. And listen, part of it is just us proving to the market that we can do what we say we're going to do. I'll start with narcolepsy. We believe it's $1 billion-plus opportunity for narcolepsy -- for LUMRYZ for the treatment of narcolepsy. Greg mentioned earlier, the size of the patient population of 50,000 patients, we think is the opportunity. To put it in context, $1 billion of revenue is about 8,000 patients on therapy -- reimbursed patients on therapy. So every quarter, we're putting up numbers. We see the momentum building, incremental and positive progress quarter-over-quarter. So we'll continue to prove that. And part of that thesis for achieving the $1 billion was our ability to expand the market. And we have certainly seen those -- that data start to emerge. One of them is -- one of the patient segments that Greg mentioned, which is patients who had previously tried to discontinue it is one of the first-generation oxybate. There was some skepticism with those patients come back. The fact of the matter is they are coming back, and they are trying LUMRYZ. So we think that's a growth opportunity is truly unique to LUMRYZ and perhaps ours exclusively. And we'll also seeing progress in de novo patients, patients who never been exposed to an oxybate. And another data point that we're seeing is new prescribers coming in. So prescribers who had never written an oxybate prescription are now enrolling in our REMS program. And as most recently, there's over 100 of those prescribers. I think what's important about this, these are prescribers that were not in our call plan. These were unsolicited. They took their own action to enroll and everybody to prescribe for LUMRYZ for narcolepsy. I think another underappreciated opportunity is IH in idiopathic hypersomnia. As Greg noted, we are all systems go to enroll first patient in the second half of this year. Proceed with that trial, get the readout and then proceed with an approval process with the FDA. It's a significant opportunity. We hear quite a bit from the prescriber community in KOLs about the unmet need for the treatment of IH for an option like LUMRYZ to be taken once nightly. So we think it's a tremendous opportunity, and it's probably perhaps as big as narcolepsy itself. And we are [indiscernible] systems go.. And I think the third, I guess we'll take some self-credit for this is the work that's been done by Avadel over the last 4 years to build the foundation. It's been a tremendous amount of work. We're tremendously proud of bringing LUMRYZ to the market and the launch progress we've made so far. But as we're sitting here today, we have a very leverageable platform. We're going to stay and remain laser-focused on the launch, right? That's the most important thing for us. But we have a super clean balance sheet. We have no debt in our balance sheet. We have a commercial team with tremendous capabilities that we can add assets to our portfolio and expand our commercial portfolio and advance the growth of Avadel.

Maybe I'll just emphasize one of Tom's points just again state it because I do think it's maybe fundamentally one of the things that's most not appreciated. And that is the fact that we are not competing in the category of 3,000 new starts a year and that's it, right? Like our market size is substantially larger than that. And it's really unique to us, right? So whether it's switch patients who step through a twice-nightly oxybate or previously treated, like those market opportunities are almost exclusively unique to us. So in the presence of whatever market dynamics occur, we believe that our base of patients we can pull from all 3, which creates an opportunity to build the franchise and build LUMRYZ, then you add IH to that. And again, I think you've got a really robust platform, which is why what we've done in the last 4 years to get us to this point and why we have to keep executing the way we have.

And Tom, maybe just spend a minute just on the cash needs of the business and realize you ended with about $90 million of cash for Q1. How are you thinking about the cash needs going forward?

We think about it quite often. We do our fair share of forecasting. But as we sit today and with the cash balance that Emily just mentioned, we believe we have the ability to support the launch of LUMRYZ, fund the IH study from cash on hand plus incoming receipts from continued sales of LUMRYZ without the need for additional capital. But need for additional capital is something we do think about. And we think about that in terms of, again, the growth of Avadel for that opportunity that exists out there to expand our portfolio. But we believe we hit cash flow breakeven this year. And again, that cash flow breakeven point that we see in our forecast, along with the cash on hand and continued inflows from sales of LUMRYZ is sufficient for this year.

Great. And maybe to close off, I'll ask each of you. What really kind of excites you about Avadel as you think about the next 12, 24 months, what's getting you most excited about the opportunity you're going after? .

Listen, for me, it may sound strange coming from a finance guy, but it is a patient feedback. We know we're changing people's lives. And when you hear the feedback from the patients about how fundamental things in a person's life, like being able to wake up for breakfast, being able to drive their car, being able to attend classes. That is what excites me about Avadel coming to work every day.

Yes. Of course, as a company, we're in this business to change the lives of patients, and that's certainly part of our inspiration as an organization. But where we are today, from where we were a year ago or 24 months ago, has been quite transformational. But the opportunities in front of us and the market opportunity in front of us, to transform our business to create value in a meaningful way, many ways in the narcolepsy space and in the oxybate space today, there's no other place that has no other product or opportunity has what we have in front of us. And we've just begun to execute, right? We were building the plane early on in launch while we were flying it and the team has gotten better and smarter and sharper and more precise to what we've done, and we expect that business to continue to perform and the growth to continue to perform. And there's a lot of more patients that we need to help. As we like to say, we've got a lot more wood to chop as an organization to build a franchise. But when you think about the launch of LUMRYZ in narcolepsy, the opportunity in IH, some of the other work we're doing on life cycle management, we've got a platform here to build a lot of value in the near term that only strengthens our strategic optionality as an organization as we go forward and really provides a clear opportunity to create value for all stakeholders, patients and shareholders.

Great. Well, thank you, both, Tom and Greg. Really appreciate you taking the time joining us here at the conference, and we're really excited about the next journey and next step of the journey here for Avadel. Thank you.

Thank you.

Thank you.