Avadel Pharmaceuticals Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 12, 2024

There are 10 speakers on the call.

Operator

Good day, everyone, and welcome to today's Avadel Pharmaceuticals 3Q24 Earnings Call. At this time, all participants are in a listen only mode. Please note this call is being recorded. And I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Austin Murtaugh with Precision

Speaker 1

AQ. Good morning, and thank you for joining us on our conference call to discuss Avadel's Q3 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 ks for the year ended December 31, 2023, which was filed on February 29, 2024, and subsequent SEC filings.

Speaker 1

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 Davis, Chief Executive Officer Richard Kim, Chief Commercial Officer and Tom McHugh, Chief Financial Officer. Doctor. Jennifer Goodman, Senior Vice President of Medical and Clinical Affairs will additionally join us for the Q and A portion of the call. At this time, I'll turn the call over to Greg.

Speaker 2

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 Q3 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 LUMRISE launch, while making progress across a number of additional important fronts.

Speaker 2

As we detail our launch results today, including our key metrics and how our source of new LumenRice 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 BloomRise 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 30, and 700 patients who initiated LumenRise therapy in Q3, resulting in $50,000,000 in net revenue during the Q3. 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.

Speaker 2

Switch patients continued 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. 2nd, patients who are new to oxybates represent the fastest growing segment of LumRise patient starts, which is coming from both existing oxybate prescribers as well as prescribers who have never written an oxybate prior to LumRise'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 is 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 LumRise launch data, we can expect to see lower persistency rates in this new to OSTIBATE patient population. 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 LUMRIS.

Speaker 2

Furthermore, in October, we were pleased to announce receipt of FDA approval and orphan drug exclusivity for LumRise in treating cataplexy or excessive daytime sleepiness in pediatric patients 7 years and older with narcolepsy. As with adult patients, Lumine's is determined to be clinically superior to the twice 90 products in the pediatric patient population based on its major contribution to patient care. Specifically, FDA stated Lumines' 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 anoxetine. 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 the burden and limitations that 1st generation oxalates have on children with narcolepsy and their caregivers.

Speaker 2

We're proud to be able to offer LumRise to all eligible people with narcolepsy and in this regard LumRise is commercially available and is currently being prescribed to and used by children with narcolepsy. Lastly, turning into our indication and portfolio expansion efforts, enrollment is ongoing in our Phase 3 REVITALYTE study where we are evaluating LumRise's potential clinical benefit in adults with idiopathic hypersomnia or IH. We often hear from clinicians that IH patients have difficulties physically waking up for their second dose given the deep sleep inertia associated with IH. So potentially having new lines 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 Lumide and meets all FDA required standards.

Speaker 2

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 Lumine based on its unique once nightly dosing profile. We are pleased with this ruling 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 Q3 represented another consistent quarter of Lumine's launch execution bolstered by additional key developments. The pediatric approval along with the 2nd orphan drug exclusivity award granted by FDA for Lumine's, the initiation of our IH Phase 3 trial and the affirmative court decision in the District of Columbia APA litigation.

Speaker 2

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

Speaker 3

Thank you and good morning everyone. Echoing Greg's earlier sentiments,

Speaker 2

it continues to amaze

Speaker 3

us how much of an impact LumRise has made across the narcolepsy community and I'm excited to be here this morning to discuss our commercial launch in more detail. At the end of the Q3, 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 3rd quarter showing that demand has been consistent. Turning to the patient segments, we have always believed that growth for oxybates and narcolepsy will be driven by LumRise 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.

Speaker 3

For patients switching from 1st generation oxybates to LumRise 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 oxibates.

Speaker 2

With the growth in the new

Speaker 3

to oxibate patient segment, this does have an impact in terms of the overall persistency for patients on Lumeris. First and importantly, based on the data we have, we see that Lumerice has overall improved persistency compared to twice any oxibase. This is for both the switch and the new auto oxibate patients. However, not surprisingly, we are seeing lower persistency rates in new to oxubate patients versus switch patients. When patients do not have prior experience with oxubate 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.

Speaker 3

These patients need more frequent engagement, especially during the 1st several weeks of therapy. We started to make key investments to address persistency. These efforts include doubling the number of nurse care navigators that rise up and increasing their overall education efforts regarding tolerability and efficacy. In addition, we've increased the cadence for patient engagement not only from Ryza but also from the specialty pharmacies. We are also doubling our field team that supports both offices and patients in initiating and refilling Lumerise.

Speaker 3

From an HCP perspective, we continue to increase Lumerise writers in the highest volume oxybate prescribers. There are about 500 HCPs who now make up 50% of the market volume and we are pleased that at September 30 that 90% is written for Lumerise. We also continue to see more lower volume oxybate prescribers begin to write for Lumerise and treat more eligible patients than prior to Lumerise's availability. Additionally, we have seen a continued expansion of healthcare practitioners who had never written for an occupied fire now right for Lumarize. This group now represents about 150 providers, which is up from more than over 100 last quarter.

Speaker 3

For these reasons, we have made the decision to expand our sales team to increase our coverage and frequency with moderate and lower volume OxoBate prescribers, as well as targeted prescribers who have previously not used OxoBates, 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 wave of growth and opportunity for continued market expansion based on what we have seen thus far in the launch. Further, we are also excited for and have already been executing against the recent approval for LUMIRIZE in pediatric narcolepsy patients 7 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.

Speaker 3

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 Lumarize 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?

Speaker 2

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.

Speaker 2

In the quarter ended September 30, we reported net revenue of $50,000,000 and gross profit of $43,900,000 and we estimate the number of weeks of inventory in the channel as September 30 was approximately the same as June 30. 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 LumRise 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 30. 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 $44,200,000 of GAAP operating expenses for the 3rd quarter, which includes $6,400,000 of non cash charges comprised of stock based compensation of $5,400,000 and depreciation and amortization of $1,000,000 After adjusting for these items, cash operating expenses were $37,800,000 and we expect that recurring quarterly cash operating expenses for the 4th quarter will be in the range of $40,000,000 to $45,000,000 which includes the additional patient and provider support investments Richard noted earlier.

Speaker 2

And non cash operating expenses will be in the range of $6,000,000 to 7,000,000 With respect to the balance sheet, we had approximately $66,000,000 of cash, cash equivalents and marketable securities as of September 30 compared to $71,000,000 as of June 30. The net use of cash during the quarter included $2,000,000 for the payment of the commitment fee due to not exercising the option to draw the 2nd 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 non cash operating expenses, adjusted EBITDA calculated as gross profit of $43,900,000 minus cash operating expenses of $37,800,000 was a positive $6,100,000 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 31 given that insurance plans reset deductibles and increase 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 Q4.

Speaker 2

Our expectations regarding financial results in the Q4 are based on a number of factors including the number of reimbursed patients on Lumerize,

Speaker 3

net

Speaker 2

pricing of Lumerize, 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 LUMISE pediatric approval, we've initiated our Phase III IH trial and we secured a favorable and strategically important court decision from the D.

Speaker 2

C. Court. With this substantial progress behind us and our transition into the next phase of the Lumine's 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 Lumine 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

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

Speaker 4

Hey, good morning. Thanks for taking my questions. I 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?

Speaker 4

Thanks.

Speaker 3

Thanks, Andrew. Richard? Yes. Hey, good morning, Andrew. Thanks for the question.

Speaker 3

Yes, thus far, I mean, we continue to see strong demand for, Lumalyze in this quarter as well. I think what Tom had commented 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 RolumRise 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 the business going forward. We have just seen some of a new dynamic with the trends for where we are right now in the launch.

Speaker 3

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

Speaker 4

Great. Thanks.

Operator

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

Speaker 5

Hey, thanks for the question. So just the first one, in terms of the new to oxybates, can you just help us understand with the AEGs and going forward, how that works in terms of insurance? Is there a step through to kind of deal with 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?

Speaker 2

Yes. Thanks, Frank. I think your first question centered around the role of AGs relative to new to oxibates and then how are we going to expand and continue to invest in our launch as it continues to progress. So Richard? Yes.

Speaker 3

As far as the new tox based and any AGs are step throughs, Frank, our plan right from the beginning as far as the payers were concerned was to get carry access with the best of the ox based. We have the team has done a really excellent job with that with 85 percent commercial coverage. So it's very rare that an AG is a step for LumRise for us right now. So we see that care pathway to new to Oxbate 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 was clearly to get uptake with the highest volume oxybate prescribers and with 90% who have written through the Q3, we feel like we've done a really good job with that.

Speaker 3

It's really time now to continue to add to grow more of those moderate and low OxoVate users. So we're adding a little over 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 Oxivate before who are rated for LumineRise, about 150 of those now launched today. So we also would be targeting a select group of those to increase our mix of new writers for LumineRise as well.

Speaker 2

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 or switch patients, in particular and 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 a decision to write and treat with LumRise who have never before used Inoxubate predominantly based upon the dosing issues that they didn't want to have to deal with for their patients.

Speaker 5

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 $168,000,000 was the sales size consensus on the revenues. 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.

Speaker 5

Thank you.

Speaker 2

Thanks, Frank. I'm happy to handle legal time with you. I'm going to start. Yes, sure. No, thanks for the question, Frank.

Speaker 2

I appreciate it. I think with respect to our expectations in Q4, we're really pleased with our progress today through the 1st 5, 4 quarters of launch. And we do expect to see continued and consistent patient demand for Lumerize across all patient segments. With that said, we have seen an increase in the new to oxybate patient segment, which has an impact of persistency that we're in the process of assessing. So as we're looking at Q4 and our expectations for Q4, we're evaluating the growth in the due to Oxpace segment.

Speaker 2

It looks quite frankly as well as seasonality factors I mentioned during the call. And Frank, as it relates to legal, maybe I'll just kind of tick through kind of where things are from a legal perspective. 1st, obviously, as we noted, we're pleased with the DC court's 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 3. 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 a hearing regarding the future ongoing royalty rate.

Speaker 2

Neither of those have been scheduled yet. So that is pending, right? There is 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 in accordance to what needs to occur during this period of time.

Speaker 2

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

Speaker 5

Thank you. Sorry, if I could 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 are we not discussing that?

Speaker 2

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 how the FDA came to that decision.

Speaker 5

All right. Thank you. Congrats on the court.

Operator

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

Speaker 6

Thanks for taking the questions. So seeing 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 versus long time users of Twice Nightly or is it really just that every new patient is always more challenging?

Speaker 6

And I guess is the support services that you offer from RiseUp more important on an ongoing basis sort of long term to hold their hand? Or is it really just about expectation setting upfront 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 disincluations as well? And I have a follow-up.

Speaker 6

Thanks.

Speaker 2

Yes. Thanks, Oren. A lot there. So maybe Richard, you can start.

Speaker 3

Yes. Sorry. Yes, sorry. So, 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 are never been on Oxfate, they just don't know what to expect, right? Consider they come from taking skilience away from only agents that can work very quickly and new to Oxfate patients, they need to find their optimal dose overall.

Speaker 3

A lot of physicians actually do set expectations, but we also thought from market research, many do not. And also there's a lot of information generally shared with patients. So the Nurse Care Navigators at Arisa play an essential role in really helping support patients, really in managing expectations and helping them know what to expect, knowing that it may take several weeks for your efficacy to really kick in and knowing that as you change your dose, you may expect more experience, more tolerability issues. So, we see the Nurse Care 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.

Speaker 3

And also when it comes to reimbursement for the patients, it's maybe not so much the reauthorizations 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 Oxbridge 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.

Speaker 2

Yes. I think the only thing I would add, Lauren, 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 gotten much more kind of precise or surgical and how we engage different patient types, right? Because what happens with a switch patient and how you're helping them manage persistency is different early on in their experience with Lumine than it is with a new to oxalate 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.

Speaker 2

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 on.

Speaker 6

Yes. And regarding reimbursement in general, have there been any material changes going or are there any material changes going into 2025, both

Speaker 3

terms

Speaker 6

of standalone 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?

Speaker 6

Thanks.

Speaker 2

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

Speaker 3

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 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, going into 2025, we will be in a very strong position as far as our overall coverage is concerned.

Speaker 2

In terms of net value per patient, you can calculate out the numbers from your report and which in patient numbers we report includes patients on free drug. But with that said, Oren, the average net revenue per patient is right around $100,000 on an annualized basis. It could fluctuate a little bit quarter to quarter, but generally speaking about $100,000 per year per patient, including patients on free drug.

Speaker 7

Drug. We'll

Operator

take our next question from Amy Fadia with Needham.

Speaker 7

Hi, good morning. Thanks for taking my question. Can you talk about what percent of new patient starts currently you're seeing that are coming from completely new patients versus 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 high sodium Xyrem or their AG or the low sodium oxidates? And as you think about investing behind more detailing efforts here, can you just talk about how the growth rate of the overall oxalate market has evolved since the launch of Lumarize?

Speaker 7

Thank you.

Speaker 2

Thanks. Maybe I'll make a couple 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 oxfate patients, representing a larger portion, a growing portion of our 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 from the SIP.

Speaker 3

Yes. As far as the switch patients are concerned, the majority are still coming from the mixed 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 oxibates, We don't have visibility in some of the twice only sodium oxybate data at this point now, but we clearly see clear indicators that the overall narcolepsy market is growing. First, we have the new to oxibate prescribers who have never written for twice only oxibate, around 150 of those now.

Speaker 3

We are seeing growth in the lower and moderate oxbate users, including patients who had previously wouldn't have been treated with the twice only oxbate. And we also have the segment of patients who are previously discontinued on twice in the oxibates coming in frelimarize as well. And maybe the last proof point that we have for us is there's almost 20% of the HCPs that have rated frelimarize 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 twice only Oxibate.

Speaker 2

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 is 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 on oxybate and prescribers who wrote very minimal oxybates and are writing more. So, by nature of that, we believe Lumerize 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 numerous.

Speaker 2

Thank you. Thanks, Allen.

Operator

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

Speaker 8

Thanks. So, 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 LumRise 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 Oraxans longer term, how are you thinking about the OXO BATE footprint once if and when Takeda and others come into the market with Aerex and agonist several years from now?

Speaker 8

Thanks.

Speaker 2

Thanks, David. Richard, you want to take those?

Speaker 3

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 oxalate use, which has been consistent with LumRise, is about 70% use in NT1 and about 30% in NT2. So we would agree with you. We just sort of from the earlier question, we definitely see various solid signs that the oxbate market in our epilepsy is growing. And as far as the neurexis are concerned, clearly we have more to learn about their overall profile.

Speaker 3

I think our view on it as we speak to thought leaders is they probably will have an important impact on how WIC promoting agents are used. But our feedback that we see in general is a lot of the providers say a nice combination would really be anorexant along with an oxybate and clearly, luvramide is having the taking away the need to sort of dose during the middle of night is important. But to sort of be able to address for those daytime issues and potentially with those patients who may have challenges with their sleep, or potentially insomnia as well that there's room for a growing marketplace and there's potentially room for an orexin to be used along with an OXTA beta in the future as well.

Speaker 2

Jen, anything you want to answer that?

Speaker 9

Sure. Happy to. One comment first, what's unique to our

Speaker 2

for And I'm

Operator

sorry, Jen, you did cut out. Would you mind restating your sentence, please? And pardon the interruption. This is the conference operator. Jim, if you could please restate your statement, please.

Operator

Pardon your interruption. This is the conference operator. Our speakers have rejoined the conference.

Speaker 2

So good morning again everyone. We apologize. We lost connection, had a technical issue and couldn't dial back in, so had to get called directly. So maybe we'll just wrap up with where we finished and Jen just responding to David's last comment from that standpoint.

Speaker 9

Sure. Sorry again 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, oxybates have been more reserved for narcolepsy type 1 and yet narcolepsy type 2 is the larger type of narcolepsy.

Speaker 9

In regard to the orexin agonist, we're certainly a company that is always going to recognize more options for 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 in T1 only. And the focus is also on the daytime symptoms. So we have published data looking at the impact of Lumarize on the nighttime symptoms, specifically on disrupted nighttime sleep.

Speaker 9

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

Speaker 2

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

Operator

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.

Speaker 2

Thank you, operator. And again, thank you everyone for your time and joining us today for our Q3 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.

Operator

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

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Earnings Conference Call
Avadel Pharmaceuticals Q3 2024
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