Avadel Pharmaceuticals at H.C. Wainwright Conference: Strategic Growth Insights

On Wednesday, 10 September 2025, Avadel Pharmaceuticals (NASDAQ:AVDL) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company highlighted its strategic growth driven by the successful adoption of its extended-release oxybate medication, LUMRYZ. While the company reported positive financial results and strong market positioning, it also acknowledged challenges and opportunities in expanding its product portfolio and market reach.

Key Takeaways

• Avadel Pharmaceuticals is experiencing strong demand for LUMRYZ, with increasing adoption among healthcare providers and patients.
• The company reported positive cash flow, operating income, and net income, with $82 million in cash reserves.
• Avadel reaffirmed its revenue guidance of $265 million to $275 million for the year.
• Future growth opportunities include expansion into idiopathic hypersomnia and development of VeloLoxibate, a sodium-free oxybate.
• The company is strategically focused on maximizing LUMRYZ’s potential and advancing its new programs.

Financial Results

• Avadel Pharmaceuticals reported being cash flow positive, operating income positive, and net income positive.
• The company has $82 million in cash on hand, providing a strong financial foundation.
• Revenue guidance for the year remains between $265 million and $275 million, reflecting confidence in continued growth.

Operational Updates

• LUMRYZ Performance:

- 1,600 healthcare providers account for about 80% of the oxybate volume, with an ongoing expansion of the writer base.

- In the first half of 2025, 600 new patients began therapy with LUMRYZ.

- There is a growing number of patient requests for LUMRYZ, indicating strong market demand.

Future Outlook

• Idiopathic Hypersomnia (IH):

- The market for IH is estimated at 40,000 potential patients.

- Enrollment in the IH trial is expected to complete by the end of 2025, with top-line data anticipated by mid-2026.

- A potential NDA filing is planned for the second half of 2026, with an action date in 2027.

• VeloLoxibate:

- This sodium-free oxybate treatment is in the final stages of formulation, expected to complete by Q1 next year.

- An NDA filing is projected for the second half of 2027.

Q&A Highlights

• LUMRYZ is increasingly chosen as the first treatment for new-to-oxybate patients.
• Approximately 10% to 15% of patients are sodium sensitive, which is driving interest in VeloLoxibate.
• The company is considering expanding oxybate use to additional indications, such as Parkinson’s disease.
• Capital allocation is focused on maximizing LUMRYZ’s potential and advancing the IH and VeloLoxibate programs.

In conclusion, Avadel Pharmaceuticals showcased a robust strategic plan and optimistic future outlook at the conference. For further details, please refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Susan, Avadel Pharmaceuticals: You know, looking at the response that physicians had to the very innovative profile of LUMRYZ, an extended release delivery technology that enables once at bedtime full therapeutic dose delivery with the dose delivered aligned with the patient’s natural sleep cycle and the opportunity for uninterrupted sleep on top of the very robust efficacy demonstrated, the daytime efficacy. We all know that oxybates have a reputation for being highly efficacious and safe. As an innovator in this space now, bringing forward an extended release oxybate that enables these advantages, we saw that right upon introduction, we were able to get a highly concentrated number of writers with 1,600 HCPs accounting for about 80% of the overall oxybate volume. We saw that out of the gate, we were able to really bring those on all as LUMRYZ writers.

Now that we’re nine quarters post-launch, we can really assess longitudinally how these writers have adopted LUMRYZ and consistently expanded their use. We’ve seen a very persistent pattern of every new writer cohort where there was a group of patients under their care that were not doing well on the older treatments. We all know that there are limitations to the older treatments. These patients are put on LUMRYZ right away. Based on a very positive experience with that initial bolus of patients, physicians then proceed to rapidly expand their use across to previously discontinued patients, patients who had been on therapy, who could now offer the innovation of LUMRYZ extended release oxybate, as well as new to oxybate patients.

We’re seeing, as a result, we have a very strong writer base foundation that is expanding their use, growing depth of use, and resourcing from all patient segments, which are all very important foundational aspects, and what’s driving the growth momentum for LUMRYZ. In parallel to that, we are continuing to add new writers. There is the remainder of the writing community that accounts for the rest of the oxybate volume. What we’re finding is that even these lower volume offices, physicians who treat a smaller number of patients, are highly receptive to the LUMRYZ message, really see it as a much easier drug to initiate. We’re finding that we’re getting those on board quickly every day.

We made investments at the end of last year to expand our sales force and actually, as well as in the second quarter, to make sure to maintain that intensity of focus on those highest writers as they’re growing depth of writing, but also enable our continuation of expanding the writer base. We’re well on our way of, you know, establishing LUMRYZ across the entire writer base. Depth and breadth of use is what’s driving the growth momentum. In parallel to that, it’s really important to highlight the fulfillment side of the business in rare disease in this space and patients with narcolepsy, and working with sleep specialists. It’s really critical to have an in-office presence to support the fulfillment process, to work with the office on submitting the proper documentation to get those PAs approved the first time around and quickly.

At the same time, really manage that initiation of therapy with patients so that the office can guide the patient on what to expect on initiating oxybate therapy. That handoff to the nurse navigators who actually are engaged directly with the patient to drive that persistence and compliance. Overall, driving conversions to reimbursed therapy, you know, when the physician determines a patient needs LUMRYZ, really converting that to a revenue patient in parallel to driving that persistence and compliance and really getting the office comfortable with the level of service that Avadel Pharmaceuticals provides to their office and to these patients is another critical performance aspect of the launch. Being able to perform not only on driving that adoption and expanded adoption combined with the strong performance on the fulfillment side is really what’s fueling the positive revenue performance that we’ve been reporting.

On top of that, I’ll just add one more thing. A really exciting dynamic is the extent to which patients are increasingly requesting LUMRYZ to their sleep specialists. It’s a highly engaged patient community. The word is definitely out. Because we have established that foundation of writers who are quite comfortable with LUMRYZ and with Avadel Pharmaceuticals services, when a patient comes in and requests LUMRYZ, the physician’s very amenable to putting them on LUMRYZ. We actually have, additionally, increased our investment on our direct-to-patient efforts because they’re clearly generating results. That’s another growth lever that we have in place that we expect will continue to drive the healthy growth in the future.

Mark: On that note, I was wondering if you could maybe elaborate a little bit on where you expect the principal driver of underlying demand to come. Is it going to be primarily driven by patients who have historically been on oxybate therapy or from treatment-naive patients? Do you anticipate that on a go-forward basis, it’s going to be a mixture of both?

Susan, Avadel Pharmaceuticals: Yes, it’s the latter, in which we actually think really speaks well to the growth potential for LUMRYZ. I mean, the landscape overall is moving towards an extended release oxybate profile. What it delivers of once at bedtime, full therapeutic dose delivery, uninterrupted sleep, and daytime efficacy, this is where the landscape is going. This is what HCPs are selecting. What we’re finding increasingly, we get a lot of questions on patient type. What’s clear on the ground with these sleep specialists is that they’re just moving to a LUMRYZ mindset, that LUMRYZ is the oxybate of choice. It’s really not like they’re thinking about whether a certain patient has a differential benefit. It’s really all patients can benefit from being on an extended release oxybate. Increasingly selecting LUMRYZ as the first drug they go to for a new to oxybate.

Clearly, the previously discontinued have already discontinued the older therapies. Those are great candidates. What we’re finding as well is that the switch, we get them very early, the ones that are clearly in need of a better alternative. As physicians expand through the adoption curve, they actually, a patient they thought was doing well on the older therapies, they now see, wow, they could really be doing a lot better because they’ve seen how LUMRYZ performs in the real world with these patients. We continue to fill the funnel with switch patients as physicians realize that much more is possible when you use an extended release oxybate. We’ll source from all patient types, and that’s really going to be the key to our growth in addition to just cultivating that writer base we have and growing that depth of use and becoming the market-leading oxybate.

Mark: Just as an aside, I think you previously delineated how important the once nightly dosing frequency is. I assume that you would agree that that is probably the single most significant determinant with respect to which oxybate patients and prescribers select relative to sodium-free status or not sodium-free status.

Susan, Avadel Pharmaceuticals: Yes, exactly. It’s, you know, these sleep specialists are treating narcolepsy. What’s really notable is that it’s not just the dosing profile. What’s really driving the enthusiasm around growing use of LUMRYZ is its efficacy benefit, because there’s a linkage. To be able to dose once at bedtime and the dose is the full therapeutic dose once at bedtime, what physicians tell us is they’ve never seen a patient and how effective it could be when they really take their oxybate every night and the full therapeutic dose of the oxybate every night. No matter how much they tried to overcome some of the limitations of the older therapies, it was really not possible for a patient so repeatedly to realize the full therapeutic dose given the considerations with the dosing profile and having to get up in the middle of the night and measure your own dose.

The error range is there. What we’re seeing in the real world now is that the efficacy benefit for LUMRYZ linked to the dosing profile is really what’s fueling the enthusiasm. I would say that with all of that said, as innovators in this space, we estimate that 10% to 15% of patients are considered to be sodium sensitive. We understand that that is a consideration. That’s why we’re really enthusiastic about the licensing agreement that we just announced and the fact that moving forward, we will be able to add to our portfolio a no salt, extended-release oxybate so that a maximum number of patients can benefit from the once at bedtime dosing, full therapeutic dose benefits of an extended-release oxybate. It’s a consideration. It’s not the driving consideration that’s moving the landscape, but it’s important from a patient perspective that we offer choices.

Mark: Maybe Tom, you could comment on the following more financial and operational aspects, with respect to how many patients you anticipate to be on LUMRYZ by the end of this year, as well as the perspectives on an ongoing basis going forward, having reported the quarter you’ve just come out of for sustained profitability, as well as whether you think it might be possible, and I realize it’s a bit of a provocative question for you folks to positively update top line guidance again this year. You’ve already done it once.

Greg, Avadel Pharmaceuticals: Sure. I’ll take those in order. In terms of patients on therapy and expectations, we haven’t guided to that for expectations for the new year, but the goal is always to continue to drive demand as the team has been doing and increase the net patient as quarter over quarter. In the first half of 2025, we added 600 patients on therapy. It was a good first half of the year. With Q2 in particular, it was a good quarter. It was the eighth quarter of our launch. By any measure, I would say Avadel Pharmaceuticals was profitable. Whether it be cash flow, we were cash flow positive, operating income, operating income positive, and net income positive as well. It was a great turning point for us in terms of the financial statements. We ended the quarter with about $82 million of cash.

We had guided throughout the year to being cash flow positive for the year, and we’ll probably talk a little bit later, but even with the deal that was announced just last week, which requires about $20 million of upfront payments, our expectations will still be net cash flow positive this year. It’s a good year for us. Remind the third part of your question.

Mark: Do you think you might update the current guidance again this year?

Greg, Avadel Pharmaceuticals: Yeah. We’ve updated guidance twice this year already. We updated at the end of Q1 and at the end of Q2. Our most recent guidance is $265 to $275 million in net revenue. Listen, we’ll continue to evaluate as we go along. We have every bit of confidence in the revenue guidance we have provided, very clear line of sight to achieving that. As Q3 continues to unfold and we get into the early part of Q4, we’ll evaluate that decision.

Mark: Maybe we could talk a little bit about idiopathic hypersomnia now. Clearly, that’s a complementary indication to narcolepsy, a very closely related condition. LUMRYZ is currently in pivotal development for that indication. Maybe talk a little bit about the size of that market opportunity and also how you anticipate positioning LUMRYZ in the future in that arena beyond narcolepsy, assuming positive readout from the REVITALYZ study.

Susan, Avadel Pharmaceuticals: Yeah. First and foremost, it’s extraordinary the amount of questions we get from our current writer base treating narcolepsy patients with LUMRYZ and their high level of interest in being able to use LUMRYZ for their idiopathic hypersomnia patients. The value proposition for an extended-release oxybate to be able to be dosed once at bedtime with a full therapeutic dose delivery for this patient population, which really, the biggest challenge is being able to wake up, is even more amplified. The value proposition of LUMRYZ as the oxybate that is ultimately destined to be the oxybate of choice in that space is clear. In terms of the opportunity, there is a huge overlap in the sleep specialists who treat IH versus narcolepsy. We have a very strong presence today.

We estimate that around 40,000 patients, the size of the opportunity is 40,000, and having a new, the first approved drug for this condition really is notable. As a result, physicians are getting even more focused on properly diagnosing it now that there’s an approved drug on the market. Jazz has only skimmed the surface. They report just over 4,000 patients on treatment. Our view forward is that if you look at a 40,000 potential patient market landscape, it’s really almost as big as the narcolepsy opportunity. We see with the value proposition that LUMRYZ brings to that space, assuming positive results in our pivotal trials and approval, that we will really hit the ground running with the familiarity that these physicians have in using LUMRYZ and in treating these patients, that we would be in a very strong position to cultivate a market-leading position in IH.

Greg, Avadel Pharmaceuticals: There is a lot of greenfield there for us, a lot of market, a lot of treatment expansion opportunities for sure. We’re excited about it.

Mark: Can you just remind us, Greg, of the timeline to top line data from REVITALYZ and ultimately the potential timeline to approval extension for LUMRYZ in idiopathic hypersomnia?

Greg, Avadel Pharmaceuticals: Yeah, current expectations will complete enrollment by the end of this year, which means we should have last patient out by the end of Q1, in 2026. Database lock, database work, and then, you know, top line probably mid-2026, which will then lead us into, you know, all the preparation work to file an NDA in the second half of 2026. We would expect an action date in 2027.

Mark: On that note, perhaps we can talk a little bit about your expected timeline, anticipation for VeloLoxibate, which is a product candidate that, as Susan mentioned, you just recently licensed from XW Pharma for regions outside Greater China. Perhaps also how you anticipate VeloLoxibate and LUMRYZ complementing each other on a go-forward basis. Perhaps maybe give us a sense of how cost-effective and capital-efficient the clinical development program for VeloLoxibate going through to potential NDA filing might look like.

Greg, Avadel Pharmaceuticals: Yeah, we’re really excited about this opportunity because, you know, this is not a situation where we’re at the end of the life of our LUMRYZ franchise and are trying to extend it. We’re actually introducing a portfolio expansion strategy at the beginning of our life to really create where the market is going and the treatment landscape is going relative to extended-release oxybates to have a complement of extended-release oxybates with LUMRYZ and VeloLoxibate in the future to give patients the choice that they’re looking for to best manage their condition and have the best optimal treatment experience that they can have with our extended-release franchises between LUMRYZ and VeloLoxibate. We’re really excited about it. We’ve been monitoring and following this program for quite some time.

Over the last number of months, we’ve had a chance to gain a lot of intel and insight in terms of both the continued development work that our partners have done over the last number of years, their engagement with the FDA, and actually spend some time with some of their molecule to understand it, to see how it works, to see how it’s been developed, to see how the technology is deployed to it. Our team became very highly confident and convicted based upon all those things that there’s a clear pathway for us to prosecute this opportunity and advance this opportunity through a bioequivalence-only pathway. From a timeline standpoint, it’s incredibly time-efficient and very capital-efficient from a use of capital standpoint, both in the deal itself and in the development program.

Major milestones for us are we’ll move into final formulation work later this year that will take us through the beginning of Q through into Q1 of next year. As we get out of Q1, we should be with our final formulation, which will then put us on two paths. The first path will be to make what we call registration batches, which are a commercially sellable product that we need to put up on stability for our NDA filing. We also need to use that product to do our registrational pivotal trial, which will run in parallel with that. All of that staying on track as we currently expect it to, we should have that work completed and the stability data completed roughly 12 to 14 months after we start that process. Let’s call it Q2.

In the second half, mid-2027, we should have all of that work completed based upon our current planning. That would then lead us into a potential NDA filing in the second half of 2027 for VeloLoxibate using a bioequivalence pathway as our current approach. Any indication that LUMRYZ has achieved, whether it’s narcolepsy or in the future, potentially idiopathic hypersomnia, those would also transfer to VeloLoxibate as well. Excited about where we are in the program and the partnership and the opportunity for VeloLoxibate because when you talk to clinicians, the profile resonates quite compelling as the first and only extended-release, no salt, no artificial sweetener, oxybate treatment option for patients with narcolepsy and potentially in the future, idiopathic hypersomnia and other indications that we may consider as we continue to build our franchise.

Mark: Two questions there. Firstly, maybe you could comment a little bit on what potential additional indications might be applicable for VeloLoxibate beyond idiopathic hypersomnia and narcolepsy in the future based on, for example, some of the work that XW Pharma was previously doing. Maybe Susan, you could comment a little bit on the degree of fine control Avadel might ultimately expect to have, assuming LUMRYZ and VeloLoxibate are both commercially available to stream patients to one versus the other and optimize the commercial value of both products without having to see any cannibalization.

Greg, Avadel Pharmaceuticals: Yeah, we’ve been looking at other areas for oxybate use well before we ventured into this collaboration. The team at XW had done quite a bit of work on Parkinson’s as a potential opportunity. We will clearly continue to evaluate that opportunity. The lens at which we look at it is through, let’s look at all the data that’s been generated where there’s been more than just a proof of concept done in other indications and really begin to evaluate where are logical, really good opportunities to consider expanding indications. You go through the work of establishing the clinical profile, talking to clinicians and understanding, you know, the prospects and the potential for this sort of treatment for LUMRYZ or VeloLoxibate and then develop a strategy. You start to work with the FDA to determine if there’s a pathway.

As those things mature, as we’re doing this work now, it will certainly become more clear, we’ll be more clear in terms of what are our priority areas. We’re still doing that work now. The XW team has obviously done some work in Parkinson’s, which is something we certainly will be and have been evaluating.

Susan, Avadel Pharmaceuticals: Yeah, in terms of optimizing the opportunity for Avadel Pharmaceuticals with the oxybate portfolio of choice, we see that, clearly, this brings an incrementality to us in terms of the total number of patients that can access an extended release delivery oxybate. We anticipate that we would actually significantly grow our footprint and the use of an extended release oxybate. With the portfolio that we offer, there would be no reason to use any of the older products. We see that we’re going to have a leading position and treating physicians will decide which therapy that they would select. We would be agnostic to that, but implicit in that will be an incrementality because we’ll be able to penetrate a larger population.

Mark: I think for our audience, what I would say is that obviously the oxybate class has been around for a long time, but Avadel Pharmaceuticals is really the first company, the only company to bring a comprehensive solution that provides the once nightly dosing potential. You really are no longer the new kid on the block. You potentially are the new chef in town.

Susan, Avadel Pharmaceuticals: Exactly. We are the innovator.

Mark: Last thing, maybe Greg, you could provide us with some perspectives on what future directions Avadel Pharmaceuticals might look at taking beyond the sleep disorder space, and to what extent you might look at additional business development opportunities in the future. I think Tom’s previous remarks clearly underlined that the company remains in a very strong financial position even after the in-licensing of VeloLoxibate. Potentially there are other opportunities to explore.

Greg, Avadel Pharmaceuticals: Yeah, I think most importantly, if you look at the next 12 to 15 plus months, we have a number of catalysts for the business that will keep us very focused and very busy in the near term to really continue to build the strategy out going forward, whether it’s finishing the IH trial by the end of this year, reading that out by mid next year, getting to our final formulation for VeloLoxibate, filing our IH NDA, getting to a pivotal registration trial for our VeloLoxibate in the back half of next year as well. A lot of really important catalysts, not to mention legal related ones with an important antitrust trial coming up in under two months in the Delaware courts. All of that is very important.

Our focus in terms of deployment of capital is how do you ensure that we fully realize the potential in LUMRYZ and investing in the launch, execute our IH strategy, and execute our VeloLoxibate program. To be really clear, that’s where capital is primarily focused on. We have a team who’s looking for opportunities that fit into the square of where we’re working today, what opportunities there may be to leverage the investments that our shareholders allowed us to build in terms of our commercial and medical and clinical capabilities.

We’ll continue to look at those opportunities for sure and searching for things that we think are undervalued or an opportunity where we can deploy our capabilities and make something more valuable, but all through the lens of what is the right deployment of capital to get a return to our shareholders and do what’s in the best interest of our investors.

Mark: I think just to close, once again, thank you to our audience for their attention. I think you can clearly see that Avadel Pharmaceuticals is a company entering in very exciting times with a rich pipeline of upcoming potentially value-driving catalysts, as well as profitability, which we can only expect them to build upon going forward. Congratulations on all the recent progress, and thank you for your participation.

Greg, Avadel Pharmaceuticals: Thank you. Thank you, Mark.

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