Avadel Pharmaceuticals plc

Q3 2024 Earnings Conference Call

11/12/2024

spk08: about to begin. If you need assistance during your conference today, please press star zero. Good day everyone and welcome to today's Avedale Pharmaceuticals 3Q24 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. You may register to ask a question at any time by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing star two. 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 you, Austin Murtagh with Precision AQ.
spk03: Good morning and thank you for joining us on our conference call to discuss Avedale's 3Q24 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 Avedale's public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2023, which was filed on February 29, 2024, and subsequent SEC filings. Except as required by law, Avedale 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. Dr. Jennifer Goodman, 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.
spk06: 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 future results. Another quarter where, once again, we deliver consistent patient growth in our randomized 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 randomized 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 Loomrise 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 Loomrise 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, new to OxyBate, and previously treated and discontinued patients. Switched to new to OxyBate, we see a trend that has continued since the beginning of launch. Second, patients who are new to OxyBate represent the fastest growing segment of Loomrise patient starts, which is coming from both existing OxyBate prescribers as well as prescribers who have never written an OxyBate prior to Loomrise's availability. And lastly, we believe 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 Loomrise launch data, we can expect to see lower persistency rates in this new to OxyBate 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 onto Loomrise. Furthermore, in October, we were pleased to announce receipt of FDA approval and orphan drug exclusivity for Loomrise in treating cataplexy or excessive daytime sleepiness in pediatric patients seven years and older with narcolepsy. As with adult patients, Loomrise was 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 Loomrise'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 have always recognized, based on direct feedback from providers, patients, and their families, the burden and limitations that first-generation OxyBates have on children with narcolepsy and their caregivers. We are proud to be able to offer Loomrise to all eligible people with narcolepsy, and in this regard, Loomrise 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 III Revitalize study where we are evaluating Loomrise'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 Loomrise available for IH patients is not only important, but also very much needed. In addition to our IH Phase III study, we continue the preclinical development of our no or low sodium once a bedtime OxyBate formulations seeking a target product profile that is bioequivalent to Loomrise 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 Loomrise 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 third quarter represented another consistent quarter of Loomrise's launch execution bolstered by additional key developments, the pediatric approval along with the second orphan drug exclusivity award granted by FDA for Loomrise, the initiation of our IH Phase III trial, and the affirmative court decision in the District of Columbia APA litigation. 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 Loomrise and our lifecycle management efforts, all in our pursuit of realizing the full potential of Loomrise for all stakeholders. I'll now turn the call over to Richard for details on our launch progress. Richard.
spk05: Thank you and good morning, everyone. That's what engraves earlier sentiments. It continues to amaze us how much of an impact Loomrise has made across the Narcissistic 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 oxidative narcolepsy will be driven by Loomrise growing in new to oxidative patients. And now we are seeing the new to oxidative segment emerge as the fastest growing segment for patient initiations. For patients switching from first generation oxidative to Loomrise launched today, 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 oxidates. With the growth in the new to oxidative patient segment, this does have an impact in terms of the overall persistency for patients on Loomrise. First and importantly, based on the data we have, we see that Loomrise has overall improved persistency compared to twice in the oxidative. This is for both the switch and the new to oxidative patients. However, not surprisingly, we are seeing lower persistency rates in new to oxidative patients versus switch patients. When patients do not have prior experience with oxidative and are not clear that it can take some time to find their optimal dose, while balancing colorability, 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 CIFS a key investment to address persistency. These efforts include doubling the number of nurse care navigators that rise up and increasing their overall education efforts regarding colorability and efficacy. In addition, we have increased the cadence for patient engagement, not only from Rise Up, but also from the specialty pharmacies. We are also doubling our field team that supports both offices and patients in initiating and refilling Loomrise. From an HCP perspective, we continue to increase Loomrise writers in the highest volume oxidative prescribers. There are about 500 HCPs who now make up 50% of the market volume, and we are pleased that at September 30th, that 90% had written for Loomrise. We also continue to see more lower volume oxidative prescribers begin to write for Loomrise and treat more eligible patients than prior to Rise Up. Additionally, we have seen a continued expansion of healthcare practitioners who had never written for an oxidative prior, now write for Loomrise. 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 oxidative prescribers, as well as targeted prescribers who have previously not used oxidabase, 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 Loomrise 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 oxidate patients, and what comes with these patients is lower persistency rates, which can potentially impact the rate of -over-quarter growth in net patient ads. We are making additional investments that we believe will drive demand, product fulfillment, and improve persistency rates over the long run. The additional investments are with a clear goal to maximize the amazing opportunity we have for Loomrise to become the preferred oxidate among people with narcolepsy and providers. Now, I will turn the call over to Tom for an update on our financial results. Tom?
spk06: Thank you, Richard. Before I begin, please note that full financial results are available in the press release issued this morning and the 10Q. I will also be reviewing non-GAAP financial results, which can be found on our investor relations website at .avidel.com. I will start with our top-line results. In the quarter into 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 that September 30th was approximately the same as June 30th. With respect to gross profit, I will further note that cost of goods sold includes a one-time adjustment for an estimated potential royalty on sales of Loomrise 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 into 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 to $45 million, which includes the additional patient and provider support investments Richard noted earlier, and non-cash operating expenses will be in the range of $67 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 from the royalty finance agreement we entered into at the beginning of 2023. With respect to achieving operating break-even, 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 its gross profit of $43.9 million, minus 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 increase co-op 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 the number of reimbursed patients on LUMARIZE, net pricing on LUMARIZE, cash operating expenses, and the seasonality factors I mentioned a few moments ago. And with that, I'll turn this 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 LUMARIZE pediatric approval, we've initiated our phase three IH trial, and we've secured a favorable and strategically important court decision from the D.C. court. With this substantial progress behind us and our transition into the next phase of the LUMARIZE 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 LUMARIZE 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.
spk08: At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star and one to ask a question. We will pause for a moment to allow questions to queue. And we'll take our first question from Andrew Tsai with Jeffreys. Your line is open.
spk09: 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 growth to net deductions? Are you still confident you will continue gaining share from former Oxabate users as well as existing Switches, not just the naive Oxabate group? Thanks.
spk05: Thanks, Andrew. Richard? Yeah, hey, good morning, Andrew. Thanks for the question. Yeah, that's far. I mean, we can see strong demand for Loomrise 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 and demand for Loomrise 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. But the Switch patients from the -the-lox base will continue to remain a very important part of our business going forward because the value proposition there is very compelling.
spk09: Great, thanks.
spk08: Thank you. We'll take our next question from Frans Wauber-Boys with Elpenheimer. Your line is open.
spk04: Hey, thanks for the question. So just the first one, in terms of the new to Oxabate, 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 new stage of the business? 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?
spk06: Yeah, thanks, Frank. I think your first question centered around the role of AGs relative to new to Oxabates and then how are we going to expand and continue to invest in our launch as it
spk05: is, Frank? Our plan right from the beginning, as far as the pairs were concerned, was to get security access with the best of the Oxabates. 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 the rise for us right now. So we see the care pathway to new to Oxabate patients as 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 to get uptake with the highest volume Oxabate 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 Oxabate users. So we're adding a little over 10% of our field force into the mix right now to increase our reaching frequency to those providers. And also, as we stated in our preparatory remarks, we're getting people who had never written an Oxabate before who have written for Lumenrise, about 150 of those now launch today. So we also would be targeting a slight group of those to increase our mix of new writers for Lumenrise as well.
spk06: Yeah. 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 doesn't change for us in terms of new to Oxabate, previously treated and discontinued, or switch patient in particular, and current Oxabate prescribers. 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 Lumenrise, who had never before used an Oxabate, predominantly based upon the dosing issues that they didn't want to have to deal with for their patients.
spk04: Okay, great. And then maybe for Tom, you had talked about how you're tracking the cell side. And I think on the last call, I think for the year, it looked like 168 million was the cell size and census on the revenues. I know you're not giving guidance, but any comments in terms of revenues and the cell 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. Thank you.
spk06: Thanks, Frank. I'm happy to handle legal time with you on the start. Yeah, sure. No, thanks for the question, Frank. I appreciate it. I think with respect to our expectations in Q4, we're really pleased with the progress today through the first five full quarters of launch. And we do expect to see continued and consistent patient demand for Lumenrise across all patient segments. And with that said, we have seen an increase in the new to-oxidate patient segment, which has an impact of persistency that we're in the process of assessing. So as we're looking ahead to Q4 and our expectations for Q4, we're evaluating the growth in new to-oxidate segments. It looked quite happy as well as seasonality factors I mentioned during the call. And Frank, as it relates to legal, maybe I'll just kind of kick through kind of where things are from a legal perspective. First, 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 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 a 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 JAAS. That's progressing. And across, in accordance to what needs to occur during this period of time. 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 3rd of next year. So that's where we sit on the legal matters.
spk04: 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
spk00: through to
spk04: the appeal that you guys have with IH, or are we not discussing that?
spk06: Yeah, 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 orphanage exclusivity twice, and the court, the DC court, has affirmed that and what how the FDA came to that decision.
spk04: All right, thank you. Thank you.
spk08: We'll take our next question from Oren Livnart with HC Wainwright. Your line is open.
spk02: Thanks for taking the questions. So things your new patients starts are actually running ahead of expectations, but obviously the discontinuation is something worth 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. You know, 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? And I guess, is the support services that you offer from Rise Up 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 discontinuations as well? And I have a follow up.
spk01: Thanks. Yeah, thanks, Oren.
spk06: A lot there. So maybe
spk05: Richard, you can start. Yeah, sorry. Yeah, no. Sorry. So yeah, no, 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 inoculated, they just don't know what to expect, right? Consider they come from taking skin leads away from one agent that can work very quickly. And new to oxygen, or oxygenated patients, they need to find their optimal dose overall. A lot of physicians actually do set expectations, but we also found from market research, many do not. And also, there's a lot of information generally shared with patients. So the nurse can navigate the Rise Up players in its 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 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. And also when it comes to reimbursement for the patients, it's maybe not so much the reauthorizations for some of these patients. They do come to the MIPS 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 MIPS can have an impact. But I think for the new to oxygenate 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 during of treatment as well.
spk06: Yeah, 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 in how we engage different patient types. Because what happens with a switch patient and how you're helping them manage persistency is different early on in their experience with lumen management than it is with a new to oxygenate patient. So kind of the one size fits all doesn't really work in fatality. 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 today has demonstrated that although we have better discontinuation rates relative to the historical twice nightly trends, it's just, you know, it's not, 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.
spk02: 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 standalone coverage and maybe relative formular 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?
spk06: Thanks. Yeah, you want to, Richard, take the first part, sound second? Sure.
spk05: Yeah, we're super pleased with the coverage that we have with the payers holistically. We don't want to slip our hand totally, but we expect that 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 any 2024 going into 2025, we will be in a very strong position as far as our coverage is concerned.
spk06: In terms of net value per patient, you can calculate off the numbers for your report and which patient numbers were reporting, includes patients on free drug. But with that said, the average net revenue per patient is right around $100,000 on an annualized basis. It could fluctuate a little bit, you know, quarter to quarter, but the agenda is about $100,000 per year for patients, including patients on free drug.
spk02: Perfect. Thanks so much. I don't want to be greedy. I'll hop back into the queue.
spk08: Thank you. We'll take our next question from Amy Fadia with Needham. Your line is open.
spk07: Good morning. Thanks for taking my question. Can you talk about what percent of new patients that 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 xyrum or the low sodium oxidase? And, you know, as you think about investing behind more detailing efforts here, can you just talk about how the growth rate of the oxidase market has evolved since the launch of LUMRI? Thank you.
spk06: 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 oxidase 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 patients starts were switch patients with the new to oxidase, you know, 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 SIP.
spk05: Yeah, as far as the switch patients are concerned, the majority are still coming from the mixed false patients overall here. And we continue to expect that trend to continue. And as far as the marketplace, as far as the growth of oxidase, we don't have visibility in some of the twice-minty sodium oxidase data at this point now, but we clearly see clear indicators that the overall narcolepsy market is growing. First, we have the new to oxidase prescribers who have never written for a twice-minty oxidase, around 150 of those now. We are seeing growth in the lower and moderate oxidase users, including patients who previously wouldn't have been treated with the twice-minty oxidase. And we also have the segment of patients who are previously discontinued on twice-minty oxidase coming in for lumen rise as well. And maybe the last proof that we have for us is there's almost 20% of the HCPs that have written for lumen rise that we either don't call on or have very minimal effort on. That's part of our 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-minty oxidase.
spk06: Yeah, 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 oxidase pool that previously were not. And that's coming from both prescribers who have never written an oxybate and prescribers who wrote very minimal oxybates and are writing more. So by nature of that, we believe lumen rise 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 and and and and and and Xyrum in that regard in terms of their volumes. But you know, we feel confident we'll continue to expand those who are eligible and want to go on lumen rise.
spk01: Thank you.
spk06: Thank you.
spk08: We'll take our last question from David Encelam with Piper Sandler. Your line is open.
spk01: Thanks. So a couple from me first. I don't know if you mentioned this earlier, can you go through the mix between NT one and NT two for for lumen rise and what you're seeing there? And then secondly, looking longer term, it looks like what we're seeing now is that the oxidase market is expanding, your competitor continues to grow patients in the narcolepsy setting as well. So I guess the question is, is you think about the orexins longer term, how are you thinking about the oxybate footprint once if and when Takeda and others come into the market with their orexin agonists several years from now?
spk06: Thanks. Thanks, David. Richard, you want to take those?
spk05: Yeah, you know, David, as far as the mix of NT one and NT two, what we from prevalence is about 30% NT one, 70% NT two. And what we see for oxybate use, which has been consistent with lumen rise is about 70% use in NT one and about 30% in NT two. So we would agree with you. As we just heard from the earlier question, we definitely see very solid signs that the oxybate market in narcolepsy is growing. And as far as the orexins 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 wig 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 an orexin along with an oxybate. And clearly lumen rise having the taking away the need to sort of dowsing middle line is important. But to sort of be able to address those daytime issues and potentially with those patients who may have challenges with their sleep, 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 oxybate in the future as well. Jen, anything you want to answer?
spk08: Sure, happy to. One comment first, what's unique to our
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