Good day everyone and welcome to today's Avadel Pharmaceuticals 3Q 2024 Earnings Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session.

[Operator Instructions] Please note, this call is being recorded and I will be standing by in case you any assistance. It is now my pleasure to turn the conference over to Austin Murtagh with Precision AQ..

Good morning and thank you for joining us on our conference call to discuss Avadel's third quarter 2024 results. As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements.

These risks and uncertainties are described in Avadel's public filings under the Exchange Act included in the Form 10-K for the year ended December 31st, 2023, which was filed on February 29th, 2024, and subsequent SEC filings.

Except as required by law, Avadel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. On the call today are Greg Divis, Chief Executive Officer; Richard Kim, Chief Commercial Officer; and Tom McHugh, Chief Financial Officer; Dr.

Jennifer Gudeman, Senior Vice President of Medical and Clinical Affairs, will additionally join us for the Q&A portion of the call. At this time, I'll turn the call over to Greg..

Thank you, Austin. Good morning everyone and thank you for joining us. Following my opening remarks, Richard will provide an update on our commercial progress and Tom will then review our third quarter financial results. We will then conclude with a question-and-answer session. As we begin today's call, let me start by summarizing our Q3 results.

Another quarter where once again, we delivered consistent patient growth in our LUMRYZ launch while making progress across a number of additional important fronts.

As we detail our launch results today, including our key metrics and how our source of new LUMRYZ patients continue to advance, it is clear that we have begun to make a real impact on the patients we are serving with the full recognition that we are moving to the next phase of our launch.

And as such, there remains much work to be executed to deliver on the full promise and potential of LUMRYZ for all stakeholders. Turning to the launch metrics that Richard will cover in more detail shortly.

We reported there were 2,300 active patients on therapy as of September 30th and 700 patients who initiated LUMRYZ therapy in Q3, resulting in $50 million in net revenue during the third quarter. More specifically during Q3, we saw the following trends.

First, we see continued strong representation from all three patient segments, switch due to oxybate and previously treated and discontinued patients.

Switch patients continue to make up the largest portion of new patient starts in Q3 with most switches coming from the mixed salt oxybate product, a trend that has continued since the beginning of launch.

Second, patients who are new-to-oxybate represent the fastest-growing segment of LUMRYZ's patient starts, which is coming from both existing oxybate prescribers, as well as prescribers who have never written an oxybate prior to LUMRYZ's availability.

And lastly, we believe these data points are important leading indicators of the potential emerging signs of expansion in the overall market which, despite not being a core focus of our initial launch, it's happening even earlier than we had previously anticipated.

With this emerging expansion of new-to-oxybate patient demand, it's important to note that based on historical twice-nightly oxybate trends and our early LUMRYZ launch data, we can expect to see lower persistency rates in this new-to-oxybate patient product.

Richard will provide more detail on this and the actions we are taking in this regard as we are making additional investments to support all patients transitioning on to LUMRYZ.

Furthermore, in October, we were pleased to announce receipt of FDA approval and orphan drug exclusivity for LUMRYZ in treating cataplexy or excessive daytime sleepiness in pediatric patients seven years and older with narcolepsy.

As with adult patients, LUMRYZ is determined to be clinically superior to the twice-nightly products in the pediatric patient population based on its major contribution to patient care.

Specifically, FDA stated LUMRYZ's dosing provides an opportunity to minimize sleep fragmentation and disruption of sleep architecture in a way that is not possible for a patient on a twice-nightly dosing regimen of an oxybate.

FDA went on to say, this is medically relevant because the goal for treating patients with sleep disorders is to restore a normal sleep pattern and a healthier sleep physiology.

We've always recognized based on direct feedback from providers, patients and their families for the burden and limitations that first-generation oxybate have on children with narcolepsy and their caregivers. We're proud to be able to offer LUMRYZ to all eligible people with narcolepsy.

And in this regard, LUMRYZ is commercially available and is currently being prescribed to and used by children with narcolepsy. Lastly, turning to our indication and portfolio expansion efforts. Enrollment is ongoing in our Phase 3 REVITALYZ study, where we are evaluating LUMRYZ's potential clinical benefit in adults with idiopathic hypersomnia or IH.

We also hear from clinicians that IH patients have difficulty physically waking up for their second dose, given the deep sleep inertia associated with IH. So, potentially having LUMRYZ available for IH patients is not only important, but also very much needed.

In addition to our IH Phase 3 study, we continue the preclinical development of our no or low-sodium, once-at-bedtime oxybate formulations, seeking a target product profile that is bioequivalent to LUMRYZ and meets all FDA required standards.

As this program remains in early preclinical formulation development stages, we will plan to provide future updates as and when these programs advance.

Beyond our commercial and clinical progress, we recently announced the District of Columbia Court's favorable ruling affirming the FDA's approval and clinical superiority decision for LUMRYZ based on its unique once-nightly dosing profile.

We are pleased with this room for a number of reasons as we continue executing our launch, while mitigating an important legal and business risk for the company.

In summary, the third quarter represented another consistent quarter of LUMRYZ launch execution bolstered by additional key developments, the pediatric approval along with the second orphan drug exclusivity award granted by FDA for LUMRYZ; the initiation of our IH Phase 3 trial; and the affirmative court decision in the District of Columbia ATA litigation.

As we look towards 2025 with a clear vision for growth, we remain focused on executing the near-term value drivers, including the continued launch of LUMRYZ and our lifecycle management efforts, all in our pursuit of realizing the full potential of LUMRYZ for all stakeholders. I'll now turn the call over to Richard for details on our launch products.

Richard?.

Thank you and good morning, everyone. echoing Greg's earlier sentiments, it continues to make us how much of an impact LUMRYZ has made across the market community and I'm excited to be here this morning to discuss our commercial launch in more detail. At the end of the third quarter, we had 2,300 patients on therapy.

We also saw a solid pace of new patient starts with 700 patients who had initiated therapy in the third quarter, showing that demand has been consistent. Turning to the patient segments. We have always believed that growth for oxybate narcolepsy will be driven by LUMRYZ growing in new-to-oxybate patients.

And now we are seeing the new-to-oxybate segment emerge as the fastest-growing segment for patient initiations. For patients switching from first generation oxybate to LUMRYZ launched to-date, they are our largest group of initiations and patients on therapy.

They will continue to be a key patient segment as the comparative value proposition for once at bedtime dosing is extremely compelling for these patients. We have also seen consistent trends quarter-over-quarter with patients who have tried and previously discontinued oxybate.

With the growth in the net in oxybate patient segment, this does have an impact in terms of the overall persistency for patients on LUMRYZ. First, and importantly, based on the data we have, we see that LUMRYZ has overall improved persistency compared to twice-a-day oxybate. This is for both to switch and the new auto oxybate patients.

However, not surprisingly, we are seeing lower persistency rates in new-to-oxybate patients versus switch patients. When patients do not have prior experience with oxybate, and are not clear that it can take some time to find their optimal dose, while balancing tolerability, this can lead to earlier and higher rates of discontinuation.

These patients need more frequent engagement, especially during the first several weeks of therapy. We started to make key investments to address persistency. These efforts include doubling the number of nurse care navigators that RYZUP, and increasing their overall education efforts regarding tolerability and efficacy.

In addition, we have increased the cadence for patient engagement, not only from RYZUP, but also from the specialty pharmacies. We are also doubling our field team that supports both offices and patients in initiating and refilling LUMRYZ. From an ACP perspective, we continue to increase LUMRYZ writers in the highest volume oxybate prescribers.

There are about 500 ACPs who now make up 50% of the market volume. And we are pleased that at September 30th, that 90% of rig for LUMRYZ. We also continue to see more lower volume oxybate prescribers begin to write for LUMRYZ and treat more eligible patients than prior to LUMRYZ's availability.

Additionally, we have seen a continued expansion of health care practitioners who had never written for an oxybate prior, now write for LUMRYZ. This group now represents about 150 providers, which is up from more than over 100 last quarter.

For these reasons, we have made the decision to expand our sales team to increase our coverage and frequency with moderate and lower volume oxybate prescribers as well as targeted prescribers who have previously not used oxybate. While at the same time, maintaining our continued focus on the highest volume prescribers.

We believe these moderate, low and new prescriber groups represent an additional way of growth and opportunity for continued market expansion based on what we have seen thus far in the launch.

Further, we are also stated for and have already been executing against the recent approval for LUMRYZ in pediatric narcolepsy patients, seven years of age and older. To close, we had another consistent quarter of increases in patient starts, and we have built a solid foundation for our launch going forward.

Now, successful launches are all about listening, learning, and adapting, and we are now in a new phase of the launch that comes with new challenges and new opportunities. There are dynamics in the launch with the source of patient initiations being driven more by new-to-oxybate patients.

And what comes with these patients is lower persistency rates, which can potentially impact the rate of quarter-over-quarter growth in net patient adds. We are making additional investments that we believe will drive demand, product fulfillment, and improve persistence rates over the long run.

The additional investments are with a clear goal to maximize the amazing opportunity we have for LUMRYZ to become the preferred oxybate among people with narcolepsy and providers. Now, I will turn the call over to Tom for an update on our financial results.

Tom?.

Thank you, Richard. Before I begin, please note that full financial results are available in the press release issued this morning and the 10-Q. I will also be reviewing non-GAAP financial results, which can be found on our Investor Relations website at investors.avadel.com. I'll start with our top line results.

In the quarter ended September 30th, we reported net revenue of $50 million and gross profit of $43.9 million, and we estimate the number of weeks of inventory in the channel at September 30th was approximately the same as June 30th.

With respect to gross profit, I'll further note that cost of goods sold includes a one-time adjustment for an estimated potential royalty on sales of LUMRYZ for the period February 2024 through June 2024 related to the ongoing patent litigation with Jazz, which impacted gross margin by approximately 3.5%.

Adjustment was reported as a non-cash true-up in the quarter ended September 30th. While we await a final disposition of that matter and any related appeals, this potential royalty has no near-term impact on cash, and we expect that gross margin going forward will be greater than 90% including an estimate of a potential ongoing royalty.

Turning to operating expenses. We reported $44.2 million of GAAP operating expenses for the third quarter, which includes $6.4 million of non-cash charges comprised of stock-based compensation of $5.4 million and depreciation and amortization of $1 million.

After adjusting for these items, cash operating expenses were $37.8 million, and we expect that recurring quarterly cash operating expenses for the fourth quarter will be in the range of $40 million to $45 million, which includes the additional patient and provider support investments Richard noted earlier, and noncash operating expenses will be in the range of $6 million to $7 million.

With respect to the balance sheet, we had approximately $66 million of cash, cash equivalents, and marketable securities as of September 30th compared to $71 million as of June 30th.

The net use of cash during the quarter included $2 million for the payment of a commitment fee due to not exercising the option to draw the second royalty tranche under the royalty financing agreement we entered into at the beginning of 2023.

With respect to achieving operating breakeven, we were just shy on a GAAP basis with an operating loss of $327,000. After adjusting for noncash operating expenses, adjusted EBITDA, calculated as gross profit of $43.9 million, the most cash operating expenses of $37.8 million, was a positive $6.1 million.

And as we look ahead to Q4 and entering the holiday season, we expect potential seasonal impacts, which include that patients may not visit their provider during the typical cadence and fewer shipping days.

Furthermore, we expect higher gross to net deductions, which will primarily impact inventory in the channel at December 31st, given that insurance plans reset deductibles and increased co-pay systems in the new year. Finally, based on our current plans and assumptions, we expect that cash flow will be positive during the fourth quarter.

Our expectations regarding financial results in the fourth quarter are based on a number of factors, including a number of reimbursed patients on LUMRYZ, net pricing at LUMRYZ, cash operating expenses and the seasonality factors I mentioned a few moments ago. And with that, I'll turn the call back to Greg for closing remarks..

Thank you, Tom. Q3 has been a quarter marked by a number of achievements and consistent progress across a number of key areas.

As we continue to execute on our launch and build our patient base, expanded the eligible target treatment population with the LUMRYZ pediatric approval, we've initiated our Phase 3 IH trial and we secured a favorable and strategically important court decision from the DC court.

With this substantial progress behind us and our transition into the next phase of a LUMRYZ launch, we believe we have built the foundation required to be on our way to transforming patient care for narcolepsy patients and fulfilling the promise of LUMRYZ for all stakeholders.

As always, we thank you for your support, and we look forward to providing future updates on our progress. With that, we will open the call for questions, and I'll turn it back to the operator..

[Operator Instructions] And we'll take our first question from Andrew Tsai with Jefferies. Your line is open..

Hey, good morning. Thanks for taking my questions. Appreciate the update.

Can you talk about the patient trends you're seeing so far, including the month of October and the parts of November? And your confidence around a strong Q4 growth trajectory despite, I think, in your prepared remarks some potential seasonality and higher gross to net deductions? And are you still confident you will continue gaining share from former oxybate users as well as existing switches, not just the naive oxybate group? Thanks..

Thanks Andrew.

Richard?.

Yes, hey good morning Andrew. Thanks for the question. Yes, thus far, I mean, we continue to see strong demand for LUMRYZ in this quarter as well. I think what Tom had comment on is just it's a shorter quarter as far as selling days and office visits and things like that. But interest in demand for the LUMRYZ remains very strong still.

And as far as sourcing business from switch patients, absolutely, we continue to sort of see that as a core part of our business going forward. We have just seen some of a new dynamic with the trends for where we are right now in the launch.

But to switch patients from the twice oxybate will continue to remain a very important part of our business going forward because the value proposition there is very compelling..

Great. Thanks..

Thank you. We'll take our next question from François Brisebois with Oppenheimer. Your line is open..

Hey thanks for the question.

So, just the first one, in terms of the new-to-oxybate, can you just help us understand with the AGs and going forward, how that works in terms of insurance? Is there a step through to kind of deal with this in this new stage of the launch? Can you just help us understand how much you're going to grow the sales force or just maybe a hierarchy of what's the most important thing to work on here to adapt to this new reality?.

Yes. Thanks Franç. I think your first question is centered around the role of AGs relative to new-to-oxybate and then how are we going to expand and continue to invest in our launch as it continues to progress.

So, Richard?.

As far as the new-to-oxybate and any ages or step through, Franç, our plan right from the beginning as far as the payers were concerned was to get early access with the best of the oxybate. We have -- the team has done a really excellent job with that with 85% commercial coverage. So, it's very rare that an AG is a step for LUMRYZ for us right now.

So, we see the care pathway to new-to-oxybate patients is very robust for us. And as far as the sales force is concerned, maybe I'll step back and sort of say, when we first launched, our goal is clearly to get uptake with the highest volume oxybate prescribers.

And with 90% who have written through the third quarter, we feel like we've done a really good job with that. It's really the time now to continue to add to grow more of those moderate and low oxybate users. So, we're adding a little over to 10% of our field force into the mix right now to increase our reach and frequency to those providers.

And also, as we stated in our prepared remarks, we're getting people who have never written oxybate before who have written for LUMRYZ, about 150 of those now launched today. So, we also would be targeting a slight group of those to increase our mix of new register LUMRYZ as well..

Yes. And I think the only comment I would add is that across these moderate to low prescribers, without compromising our focus and efforts on the highest value targets, there are also switch patients that exist in those practices as well.

So, I think the source of patient is -- doesn't change for us in terms of new-to-oxybate previously treated and discontinued for switch patients, in particular, in current oxybate prescribers, right? I think where we're adding some people to provide some additional coverage is in those physicians and physicians that look a lot like those physicians who have made the decision to write and treat with LUMRYZ who have never before used an oxybate, predominantly based upon the dosing issues that they didn't want to have to do for their patients..

Okay, great. And then maybe for Tom, you had talked about how you're tracking the sales. And I think -- on the last call, I think for the year, it looked like $168 million was the sell side consensus on the revenues.

I know you're not giving guidance, but any comments in terms of revenues and the sell side? And then I guess maybe lastly, there's been a lot of developments on the litigation front.

I think maybe just an update on what's next? What is still up there in terms of litigation would be helpful?.

Thanks, Franç. I'm happy to handle legal.

Tom, if you want to start?.

Yes, sure. No, thanks for the question, Franç. I appreciate it. I think with respect to our expectations in Q4, we're really pleased with our progress to date through the first five full quarter launch. And we do expect to see continued and consistent patient demand for LUMRYZ across all patient segments.

And with that said, we have seen an increase in the new-to-oxybate segment, which has set to persistency that we're in the process of assessing. So, as we're looking into Q4 and our expectations for Q4, we're evaluating the growth in new-to-oxybate segment. It looks quite as well as seasonality factors I mentioned during the call..

And Franç, as it relates to legal, maybe I'll just kind of tick through kind of where things are from a legal perspective. First, obviously, as we noted, we're pleased with the DC court decision, which aligns with what we have stated all along from that perspective. On the other legal matters, which are really Delaware-related, really, there's three.

The first one is the ongoing patent trial, for which the next steps in that case are anticipated to include post-trial motions, that whole process, as well as a briefing and hearing regarding the future ongoing royalty rate. Neither of those have been scheduled yet.

So, that is pending, right? There's the IH injunction, which is under appeal at the Federal Circuit. And briefing for that matter, is scheduled to be complete next week with oral arguments currently scheduled for the February 2025 docket, but a date not yet set.

And then lastly, and equally as important is our antitrust action against Jazz, that's progressing. And across -- in accordance to what needs to occur during this period of time.

And I'll just remind everybody that is really about what we believe to be wrongfully delayed during the NDA review process based upon the wrongfully listed [Indiscernible] pattern and the impact that it's had, and that is currently scheduled with a jury trial beginning November 3rd of next year. So, that's where we sit on the legal matters..

Thank you. Sorry, if I just jump in here, your recent win with the District Court of Columbia in terms of clinical superiority.

Can that read through to the appeal that you guys have with IH or we -- is it -- are we not discussing that?.

Yes, I don't think it's appropriate to comment on the specifics of that. Other than that, we're pleased that the FDA has now granted us an orphan exclusivity twice and the court -- the DC Court has affirmed that decision and what -- how the FDA came to that decision..

All right. Thank you and congrats on the quarter..

Thank you. We'll take our next question from Oren Livnat with H.C. Wainwright. Your line is open..

Thanks for taking the question. So, since your new patient starts are actually running ahead of our expectations, but obviously, the discontinuation is something we're digging into more. So, just -- can you talk about why new patients are discontinuing more? I mean you talked about education about tolerability and dose titration.

Is there actually any difference do you believe, in the tolerability for these patients and -- versus long-time users of twice-nightly? Or is it really just that every new patient is always more challenging? And I guess, is the support services that you offer from RYZUP more important on an ongoing basis, sort of long-term to hold their hand? Or is it really just about expectation setting up front and doing a better job there? And I think someone asked about reimbursement for new patients.

Do you see any issues with reauthorization being needed early on and that is a source of new patient differentiations as well? And I have a follow-up. Thanks..

Yes, thanks Oren. A lot there so maybe Richard, you can start..

Yes. As far as the higher discontinuation rates, I think the biggest way we would really sort of frame this is a lot of these patients who have never been on oxybate, they just don't know what to expect, right? Consider they come from taking stimulate to wake from the agents that can work very quickly.

And in new-to-oxybate patients, they need to find their optimal dose overall. A lot of physicians actually do set expectations, but we also thought for market research, many do not. And also, there's a lot of information generally shared with patients.

So, the nurse for navigators at RYZUP players and its essential role and really helping support patients really in managing expectations and helping them know what to expect. Knowing that may take several weeks for your efficacy to really kick in and knowing that as you change your dose, she may extend some more experience, more tolerability issues.

So, we see the nurse for navigators as not only critical at the beginning, but really in building those relationships with patients longer term as well. That's really why we've made the investments holistically across the board there.

And also when it comes to reimbursement for the patients, it's maybe not so much the authorizations for some of these patients, and they do come to the mix from time-to-time. But clearly, for these patients and others, there are patients who may change their insurance from time-to-time that can have an impact.

So, overall, the reimbursement and payer mix can have an impact. But I think for the new-to-oxybate patients, it's really about establishing expectations, providing much more frequent support for them and being there not only at the beginning, but through their whole journey of treatment as well..

Yes, I think the only thing I would add, Oren, to Richard's comment, is that as we've gone through the launch and our source of business has changed, we've had to get -- and we've gotten smarter, we've got much more kind of precise or surgical in how we engage different patient types, right? Because what happens with the switch patient and how you're helping them manage persistency is different early on in their experience with LUMRYZ and it is with a new-to-oxybate patient.

So, kind of the one size fits all doesn't really work in totality. So, we've gotten much more sophisticated in that regard. And as a result of that, we've expanded our nurses that allows them to reduce their caseload and spend more time with patients as required to help them navigate through these periods of time.

So, again, we have -- we think the right insights, taking the right actions, and have the ability to impact it. And I think all of our data to-date has demonstrated that although we have better discontinuation rates relative to the historical twice-nightly trends, it's just -- it's not the right standard.

We want to do better than that because we work really hard to get a patient on therapy, and we want to help them stay..

Yes.

And regarding reimbursement in general, have there been any material changes going? Or are there any material changes going into 2025, both in terms of stand-alone coverage and maybe relative formulary positioning versus competition? And how much of a tailwind should Medicare coverage be in 2025 and beyond? And just overall, can you remind us where you stand on, I guess, an annualized net value per patient now and going forward? And does that already sort of bake in bridging or free drug supply? Or is that just a separate line item? Thanks..

You want, Richard, take the first part? Tom, second?.

Sure. Yes, we're super pleased with the coverage that we have with the payers holistically. We don't want to tip our hand totally, but we expect that to continue to have very strong coverage as we go into 2025 across the board. And in 2025, we should pick up some more Medicare lives overall.

And -- so we believe ending 2024 range 2025, we will be in a very strong position as far as our overall coverage is concerned..

Yes, in terms of net value per patient, you can calculate out the numbers for report and -- which in patient numbers report includes patients on free drug. But with that said, Oren, the average net revenue per patient, it is right around $100,000 on an annualized basis.

It could fluctuate a little bit quarter-to-quarter, but we kind of sticking about $100,000 per year per patient, including patients on free drug..

Perfect. Thanks so much. I don’t want to be greedy, I'll hop back in the queue..

Thank you. We'll take our next question from Ami Fadia with Needham. Your line is open..

Hi, good morning. Thanks for taking my question.

Can you talk about what percent of new patients start currently, you're seeing that are coming from completely new patients was the switch patients? And in terms of switch patients, can you give us some color around the dynamics in terms of whether they're coming from the highest sodium Xyrem or the AG or the low sodium oxybate? And as you think about investing behind more detailing efforts here, can you just talk about how the growth rate of the overall oxybate market has evolved since the launch of LUMRYZ? Thank you..

Thanks Ami. Maybe I'll take it then Tom comments and turn it over to Richard.

In terms of the mix of patients that we're seeing coming in, I think our friends would tell us that we continue to see an increase in the new-to-oxybate patients representing a larger portion -- a growing portion of our -- of patients coming in at the top of the funnel through Q3.

Again, the largest portion in Q3 of patient starts were switch patients with the new-to-oxybate, I would say, closing the gap on the switch patient in terms of the percent mix. In terms of the dynamics of the switch, I'll maybe turn it over to Richard and from the--..

Yes. As far as the switch patients are concerned, the majority is still coming from the mix false patients overall here and we continue to see -- expect that trend to continue. And as far as the marketplace as far as the growth of oxybate, we don't have visibility in some of the twice-nightly sodium oxybate data at this point now.

But we could see clear indicators that the overall narcolepsy market is growing. First, we have the new-to-oxybate prescribers who have never written for a twice-nightly oxybate, around 150 of those now.

We are seeing growth in the lower and moderate oxybate users, including patients who had previously wouldn't have been treated with a twice-nightly oxybate. And we also have the segment of patients who are previously discontinued on the twice-nightly oxybate coming in for LUMRYZ as well.

And maybe the last of point that we have for us is there's almost 20% of the HCPs that have written for LUMRYZ that we either don't call on or have very minimal effort on. That's part of our plan with increasing our efforts to reach more of those providers.

So, we definitely see opportunities to continue to build upon our foundation and continue to grow this market beyond where it has been with the twice-nightly oxybate..

Yes, I think the only comment I would add, and maybe it's just putting a little bit of a different point on what Richard stated was, there's no doubt since our launch, we have added patients into the oxybate pool that previously were not, right? And that's coming from both prescribers who have never written oxybate and prescribers who wrote very minimal oxybate and are writing more.

So, by nature of that, we believe LUMRYZ is adding new patients into the oxybate pool. But to Richard's point, we don't have great visibility on what's happened with kind of the AG and Xyrem in that regard in terms of their volumes. But we feel confident we'll continue to expand those who are eligible and want to go on LUMRYZ..

Thank you..

Thank you. We'll take our last question from David Amsellem with Piper Sandler. Your line is open..

Thanks. So, a couple for me. First, I don't know if you mentioned this earlier, but can you go through the mix between NT1 and NT2 for LUMRYZ and what you're seeing there? And then secondly, looking longer term, it looks like what we're seeing now is that the oxybate market is expanding.

Your competitor continues to grow patients in the narcolepsy setting as well. So, I guess the question is, as you think about the orexin longer term, how are you thinking about the oxybate footprint once if and when, Takeda and others come into the market with [Indiscernible] and agonist several years from now? Thanks..

Thanks David.

Richard, do you want to take those?.

Yes. David, as far as the mix of NT1, NT2, what we see from prevalence is about 30% NT1, 70%, NT2. And what we see for oxybate use which has been consistent with LUMRYZ, it was about 70% used in NT1 and about 30% in NT2. So, we would agree with you.

As we just sort of -- from the earlier question, we definitely see very solid signs that the oxybate market in narcolepsy is growing. And as far as the directors are concerned, clearly, we have more to learn about their overall profile.

I think our view on it as we speak to thought leaders is they probably will have an important impact on how weak [indiscernible] are used. But our feedback that we see in general is a lot of the providers say a nice combination would really be an orexin along with an oxybate.

And clearly, LUMRYZ having the taking away the need to sort of dose during the middle line is important.

But to sort of be able to address those time issues and potentially with those patients who may have challenges with their sleep, potential insomnia as well that there is room for a growing marketplace, and there's potential room for an orexin to be used along with an oxybate feature as well..

Jen, anything you want to add to that?.

Sure. Sorry, about the technical difficulties. So, a couple of comments to add to what Richard said. And specifically on the NT1, NT2 mix, we're really pleased that we are the only oxybate that has published data demonstrating consistent efficacy in both subgroups.

This is certainly important based upon what Richard has said, where historically, oxybate have been more reserved for narcolepsy type 1 and yet narcolepsy type 2 is the larger type of narcolepsy. In regard to the orexin agonist, we're certainly a company that is always going to recognize more options patients are better.

We continue to monitor the progress. And of course, the focus with the orexin agonist as far as what is out in front is NT1 only. And the focus is also on the daytime symptoms. So, we have published data looking at the impact of LUMRYZ on the nighttime symptoms specifically on disrupted nighttime sleep.

And so as Richard had mentioned, we continue to speak to leading KOLs to emphasize it. It's a matter of using both in the future and specifically LUMRYZ to avoid the middle of the night dose..

Thanks, Jen. Thanks, David. And again, I apologize for the disruption technically..

Thank you. The question-and-answer session is now concluded. I will now turn the program back over to management for any additional or closing remarks..

Thank you, operator. And again, thank you, everyone, for your time and joining us today for our third quarter 2024 earnings call. Have a great rest of your day and we look forward to catching up with you throughout the course of the next few days. Thanks..

That concludes today's teleconference. Thank you for your participation. You may now disconnect..