Avadel Pharmaceuticals - Q3 2023

Transcript

Operator (participant)

Greetings, and welcome to the Avadel Pharmaceuticals Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations. You may begin.

Austin Murtagh (Senior Account Supervisor)

Good morning, and thank you for joining us on our conference call to discuss Avadel's third quarter 2023 earnings. 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 31, 2022, which was filed on March 29, 2023, 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 join us for Q&A. At this time, I'll turn the call over to Greg.

Greg Divis (CEO)

Thank you, Austin. Good morning, everyone, and thank you for joining us to review Avadel's third quarter 2023 results. We're excited to share the progress we have made with the launch of LUMRYZ. Following my opening remarks, Richard will provide an update on our launch progress. Tom will provide a review of our Q3 financial results, and we will conclude with a question and answer session. The third quarter was transformational for Avadel as we fully transitioned to a commercial-stage company and are very pleased with the robust early demand generated and important emerging launch trends we are seeing. There is a tremendous opportunity for LUMRYZ and Avadel that lies ahead as we execute our launch. We believe the foundation we are building during these early months positions us incredibly well for continued success, building on the momentum built during this first full quarter of launch.

During Q3, this momentum resulted in growth across all key launch metrics, representing strong demand across all three patient segments of the eligible narcolepsy patient population and generated $7 million in LUMRYZ net revenue. There's no better evidence of this than the early launch KPIs we announced this morning. Greater than 1,000 patients enrolled in RYZUP and more than 400 patients who initiated therapy during the quarter, the majority of which are fully reimbursed. Expanded LUMRYZ payer coverage with key health plans, representing approximately 60% of all commercial lives. This progress on the payer front continues to create even greater access for the 600 patients enrolled in our RYZUP patient services program and in process of obtaining coverage and getting on LUMRYZ as of September 30th.

Additionally, there are nearly 1,400 healthcare providers who have now completed the LUMRYZ REMS certification process, including providers who have never previously prescribed an oxybate. We're very encouraged by these early KPIs and believe they are indicators of the strong interest and positive engagement we have had with all stakeholders as we've advanced the launch of LUMRYZ. Furthermore, to support the robust clinical data of LUMRYZ, our team recently attended World Sleep in Rio de Janeiro, Brazil, where we shared 15 poster presentations and two oral presentations detailing new and encore data, further demonstrating the clinical profile and clear benefit of LUMRYZ for potential eligible patients.

Looking forward to the future, our team is also advancing our lifecycle management opportunities, as we believe this has the potential to expand the patient population who could benefit from LUMRYZ and provide long-term value to the company and our stakeholders. We are pleased to announce that yesterday we submitted a supplemental new drug application to the FDA for LUMRYZ in the pediatric narcolepsy population for the treatment of cataplexy or EDS, and currently expect an approval decision in the second half of 2024. Comprising approximately 4%-5% of the current total oxybate-treated narcolepsy population, expanding availability into the pediatric population not only increases the total addressable market for LUMRYZ, but also has the potential to greatly alleviate the burden on families and caregivers who support children living with narcolepsy.

We believe these families and caregivers will welcome a once-at-bedtime oxybate treatment option, as the twice-nightly dosing regimen of first-generation oxybate inevitably requires potentially multiple people in the household to chronically wake up night after night to administer the second dose for their children. Additionally, we're making progress with our clinical planning to initiate a multi-center randomized controlled trial for Idiopathic Hypersomnia or IH. We believe, based upon our interactions with key opinion leaders, that the value proposition of once-at-bedtime LUMRYZ could be very compelling for those suffering from the deep sleep inertia associated with IH. Lastly, on the lifecycle management front, we are continuing our preclinical development of our potential no or low sodium once-at-bedtime oxybate formulation for the small subset of sodium-sensitive oxybate-eligible patients. As always, we intend to provide updates on these programs as appropriate.

With a strong balance sheet to support ongoing operations and the significant progress achieved in the initial months of the launch, we remain hyper-focused on the LUMRYZ launch and expanding our reach and our impact. We are committed to and remain relentless in delivering on the promise of LUMRYZ for all stakeholders. And with this positive momentum coming out of Q3, we believe we are on track to command a meaningful share of the multi-billion dollar oxybate market and maintain our view that LUMRYZ is a greater than $1 billion annual revenue opportunity. With that, I'll turn the call over to Richard for details on our recent commercial progress. Richard?

Richard Kim (Chief Commercial Officer)

Thanks, Greg, and good morning, everyone. It's so great to be on this call today to discuss our first quarter of launch. Let me start by saying it's a real privilege to bring LUMRYZ to the narcolepsy community. Since August, our full commercial team has been in the field seeing sleep specialists across the country, and the overall feedback has been extremely positive. We've heard for a long time about the impact of a once-at-bedtime oxybate that it could have for people with narcolepsy, and now we are proud to see that impact that LUMRYZ is having each and every day. We consistently hear from the narcolepsy community that LUMRYZ has the potential to take people with narcolepsy beyond their expectations of other available treatment options. I'd like to start with one example of the many interactions we've had with sleep specialists and the impact LUMRYZ is having.

During a recent field ride, we met with a sleep specialist who enrolled his first person in RYZUP in August. The patient started on LUMRYZ a few weeks later. Now, this patient was previously taking the first-generation mixed salt product and switched to 7.5 g of once-at-bedtime LUMRYZ. The patient has remained on 7.5 g of LUMRYZ per night, is consistently sleeping through the night, and she says, wakes up more refreshed in the morning, ready to start her day. LUMRYZ has been an absolute game changer for this patient. While this is just one example of the journey to gain initial hands-on clinical experience, this sleep specialist had great initial success with LUMRYZ and subsequently submitted four more patient enrollments into RYZUP.

To echo Greg, we are super excited about this strong start we've had and believe our progress reflects the clinical benefit of LUMRYZ, our strategic preparation, and the hard work and dedication of our team. We're pleased to share today that through our first full quarter launch, there were greater than 1,000 patient enrollments into RYZUP, our patient support center. From our RYZUP data, enrollments and patients on therapy are coming from all three of our target patient segments: switch patients from first generation oxybate, patients who previously tried and discontinued first generation oxybate, and oxybate-naive patients. Thus far, we are seeing an early trend that the majority are being sourced from first generation oxybates, with slightly more coming from the twice-nightly mixed salts product compared to the twice-nightly sodium oxybate products. Through the end of September, there were nearly 1,400 HCPs who were RYZUP certified.

As a reminder, our core target HCPs includes the 1,600 high-volume oxybate prescribers, who make up 80% of the total market prescription volume. The greatest penetration of RYZUP certified HCPs has come from these high-volume oxybate prescribers, and they account for about three-quarters of all RYZUP enrollments thus far. Although the trends from RYZUP are early, with patients coming from previously discontinued first-generation oxybate patients, also oxybate-naive patients and prescribers who have previously never prescribed an oxybate, our early data supports LUMRYZ going to market beyond the limitations of where first generation twice-daily oxybates, oxybates were used. Supported by the increasing number of RYZUP enrollments, today, we also announced in the third quarter we had greater than 400 patients who initiated treatment on LUMRYZ. We saw the number of patients on LUMRYZ grow within a quarter as more payer coverage began to come online.

The majority of patients initiated with LUMRYZ are commercially reimbursed. Additionally, and although early in launch, we're seeing discontinuation trends that are lower than the 25% discontinuation rate at one month from first generation oxybates. When we think about all the time it takes to fulfill enrollment and get patients shipped LUMRYZ, there are generally two main patient segments that are emerging. First, those who have coverage with prior authorization criteria. These patients can be processed and shipped product on average in about a month. As our coverage of payers expands, this segment of patients will continue to grow. Now, for patients going through medical necessity without a formal coverage policy decision, this generally consists of payer denials and HCP appeals, a process that can take longer, more like a couple of months on average, with some occurring a bit sooner and some taking even a bit longer.

This segment is getting smaller as our coverage grows. However, and very importantly, despite these cases taking longer to fulfill, we also see very few people dropping out of the RYZUP process. At the end of September, approximately 600 patients were in the RYZUP process, though, going through the benefits investigation or pending their first shipment. Based on early launch trends through Q3, we currently anticipate that the majority of these patients will convert onto LUMRYZ as they complete their RYZUP process. Product fulfillment is very dynamic, and we are in a fundamentally stronger place with the use of RYZUP and our services than we were just a couple of months ago. More important is that sleep specialist offices are getting increased experience with the enrollment process and are beginning to send additional patients to RYZUP.

Now, that's a nice segue to transition to payers, where we continue to make strong progress in securing broad coverage for LUMRYZ. Currently, LUMRYZ has coverage policies with over 100 million insured lives, representing approximately 60% of the totally commercially covered lives. We recently added coverage with policies in place with key national insurers like Aetna and Cigna, in addition to several regional and state plans. We also completed the Zinc GPO contract, where importantly, LUMRYZ will be moved to a preferred status within CVS commercial formularies, effective January 1st 2024. Currently, LUMRYZ is in a non-preferred position. We are very pleased with our payer progress, and importantly, feedback from sleep specialist offices has generally been very positive for the early success rate from reimbursement they've been seeing. These first few months have set a great foundation for our launch.

As we see demand for LUMRYZ continue to grow, our field offices and our teams improving the efficiency for getting patients started and staying on LUMRYZ, and more covered lives with private payers. We could not be prouder of the collective work of our teams, and in bringing LUMRYZ to the narcolepsy community, along with the progress and trends we've seen to date. We look forward to providing more updates on future calls. Now, I will turn the call over to Tom to discuss our financials. Tom?

Tom McHugh (CFO)

Thank you, Richard. I'll note that full financial results are available in the press release and the 10-Q. We're pleased to report that we generated $7 million in net revenue for the third quarter, ending September 30th, 2023, and $8.5 million in total revenue since our launch began in June 2023. We're continuously monitoring inventory levels in the channel, and during the course of the third quarter, we estimated that it was consistently between three to four weeks of demand, including as we exited the quarter. Turning to operating expenses, we reported a total of $42 million of GAAP operating expenses during the quarter ended September 30th, 2023, which includes $39.2 million of SG&A costs and $2.8 million of R&D costs. Operating expenses includes $4.6 million of non-cash charges for stock-based compensation and depreciation and amortization.

After adjusting for these items, cash operating expenses were $37.4 million for the quarter. We are currently expecting cash operating expenses in the fourth quarter to be in the range of $38 million-$40 million. With respect to the balance sheet, we exited Q3 in a strong position. As of September 30th, 2023, we had $153.2 million of cash, cash equivalents, and marketable securities, which includes $30 million received in August from the first tranche of the $75 million royalty financing commitment we secured earlier this year. A second tranche of $45 million is available if we achieve $25 million of quarterly net revenue by June 30th, 2024. As a reminder, while the $45 million could be available, we are not required to draw the second tranche.

As we look ahead, we believe based on current plans and expectations, that we can achieve cash flow breakeven from operations when there are approximately 1,300-1,500 reimbursed patients being treated with LUMRYZ. Our expectation is taking into account a number of assumptions, including capital resources currently available to us, patient demand, net pricing of LUMRYZ, and ongoing cost structure to support the launch of LUMRYZ. Actual results versus these assumptions, in addition to ongoing planning for growth initiatives, such as an IH study, could impact our expectations regarding future capital requirements. On a final note, at September 30th, we had approximately $21 million of convertible notes shown as debt on the balance sheet. This last remaining tranche of debt was settled in cash at the beginning of October, and effective with that paydown, the balance sheet is now completely free of convertible debt.

I'll now turn the call back to Greg for closing remarks.

Greg Divis (CEO)

Thank you, Tom. We believe our strong foundation has supported our successful initial launch of LUMRYZ, and we are laser focused on continuing to execute on all our priorities. Our goal since the inception of Avadel has been to provide treatment that can transform the lives of those living with narcolepsy, and we believe we've made significant progress in this area and look forward to our continued launch execution and positively impacting even more patients. We thank you for your support and look forward to providing future updates on our progress. With that, we will open the call for questions. Operator?

Operator (participant)

Thank you. In order to answer, or excuse me, in order to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We do ask that you limit yourself to one question and a follow-up. Please stand by while we compile the Q&A roster. Our first question comes from Ami Fadia from Needham. Your line is open.

Ami Fadia (Senior Analyst)

Hi, good morning. Congrats on the nice update on the launch. I have one or two quick questions. Firstly, can you talk about the rate at which you're seeing enrollment in RYZUP? And maybe give us some more color on where these patients are coming from in terms of, you know, whether they're coming from Xyrem, Xywav, or new patients. If you can give us some more color there.

Greg Divis (CEO)

Yeah. Thanks, Ami. Richard, do you want to?

Richard Kim (Chief Commercial Officer)

Yeah. Hey, thanks, Ami. Yeah, it's really been fantastic to see the interest that sleep specialists have had in LUMRYZ. And, you know, we're super pleased that when we gave our first update about two months into launch, there were about 400 patients enrolled into RYZUP. And then in the next two months, about an extra 600 patients have come on board. So, really good momentum. You know, maybe, holistically, as we start to think about the launch, the first thing we'd sort of say is, when we see sleep specialists, we have really yet to see one who hasn't seen the clinical value proposition of LUMRYZ....

And, you know, when we think about the trends going forward, we haven't really sort of seen what we describe as boluses in many offices, but really more of a sort of steady influx of patients being seen in their regular course of follow-up, which is about every three to 9 months. So when we start to think about sort of going forward, we just continue to sort of see continued steady demand for LUMRYZ. We also know that the holidays are coming up, sort of as we get into November, December, so it's just something to account for. But our focus remains very much on the launch execution and obviously, patient activation.

I will also say in the future, we do think things we've seen when coverage policy changes have occurred, they can act as catalysts, as we saw for CVS early, earlier. That's going to preferred should help us as we go into January and also the continued work that we have with our Zinc GPO contract as well. Now, speaking to the types of patients, we consistently sort of see sourcing from all three patient segments, which discontinued previously and naive. And thus far, through the launch, we're seeing the majority coming from previously experienced oxybate or currently on oxybate patients, with more tending towards coming from the mixed-salt and the twice-nightly sodium oxybate as well. So, it's out there, Ami, it's real.

It's been awesome to be in this field for all of us, and there's always more that we can do, but we're super pleased with the progress we've made so far.

Ami Fadia (Senior Analyst)

Great. And maybe just on the payer coverage front, you know, you talked about currently having over 100 million insured lives. How should we think about the remaining and then when, you know, give us some sense of the time frame into 2024, where we could see coverage expand. Thank you.

Richard Kim (Chief Commercial Officer)

Yeah, sure. We're pretty selfish. We want as many covered lives as we possibly can get, because that's really the gateway to getting patients onto therapy. So, you know, the general process is you get the GPO contracts signed, then we have to pull through with the major PBMs underneath that. So we've been doing that under both the Ascent or the ESI contract, now the Zinc CVS contract as well. The third one is the Emisar, sort of Optum United lives. It always takes the longest, but we've made very good progress there, and we fully anticipate growing our covered lives as we go forward here as well. So I mean, to be where we are, sort of through our first quarter launch and have this coverage has been pretty impressive.

And I think what's really played on the marketplace is, the general feedback we hear from providers being, maybe pleasantly surprised with the reimbursement rates that they're seeing. So, sort of like many of our metrics, we're looking sort of upward and to the right to grow our covered lives going forward.

Ami Fadia (Senior Analyst)

Great. Thank you.

Operator (participant)

Thank you for your question. One moment, please. Our next question comes from Andrew Tsai with Jefferies. Your line is open.

Andrew Tsai (Senior Biotech Analyst)

Hey, just wanted to say congrats, myself as well. It's really great to see the launch going very well. So, first question on the conversion rate. You know, it looks like you got, you know, 1,000 sign-ups in the quarter, 400, essentially, you know, getting treatment. So loosely speaking, seems like a 40% conversion rate, give or take. And I think you said in the prepared remarks, the majority, will, will convert from RYZUP. So is it fair to assume that 40% conversion rate moves up meaningfully going forward? And then secondly, if you were to take another cut of the, you know, KPIs as of today, November 8, how would those leading indicators look?

Just want to make sure these numbers are not a one-time bolus, that you're seeing even more patients signed up and treated, and things are moving up and to the right. Thanks.

Greg Divis (CEO)

Yeah. Thanks, Andrew. Here's how I'm going to answer those questions. First off, is in terms of your 40%, it's really apples to oranges a little bit. And the 40% is certainly not the majority, and our commentary is what we've seen for patients who have been in the system for, you know, for at least some period of time, that our conversion rates to on therapy is certainly the majority of patients. So we would expect 40% not as the right proxy currently, in terms of what we're seeing early on in the launch. And obviously, that's a number we want to continue to improve on, and payer coverage decisions and whatnot are really important advances.

But the progress made on the payer front has certainly been beneficial to us in seeing a majority of patients converting onto therapy and the majority of those converting on to reimbursed drug. Secondly, to your comment about, you know, how does the early part of Q4 look? Again, I think we've seen, we continue to see more enrollments and more people go on therapy and growth continue. So, yeah, I mean, I think we feel really good where we sit and the progress we're making across all fronts and knowing that there's a whole lot more to do, but we're really pleased where we sit today.

Andrew Tsai (Senior Biotech Analyst)

Thanks very much.

Greg Divis (CEO)

Thanks, Andrew.

Operator (participant)

Thank you. Our next question comes from Marc Goodman with Leerink Partners. Mark, your line is open.

Rudy Li (Equity Research Analyst)

Hi, thanks for taking the question. This is Rudy on the line for Marc. So I have a question regarding your patient dynamic here. So you mentioned that most of the patients switching from first gen oxybate products. Just curious, what are the feedbacks you've been hearing from these patients, especially those who switch from Xywav? And what are your strategy to penetrate patients who are oxybate naive and who previously treated and discontinued? Thanks.

Richard Kim (Chief Commercial Officer)

Yeah, no, hey, thanks for the question. Yeah, you know, as we talked about in our prepared remarks, when we think about the source of patients, thus far, the majority are from those first-generation oxybates. You know, the patient narrative that I gave early on was one that represents many of the conversations we've had about patients switching from Xywav.

You know, one of the insights we had from that, even a couple years ago, were a lot of the patients who had gone on to the mixed salt version early on, they tended to be early adopters of product. They tend to be diagnosed for a shorter period of time, switching, looking for more to do for their treatment. So we haven't been horribly surprised the fact that we've had mixed salt patients coming on to the rate that we have thus far. And as I think about going forward, you know, the really nice thing about our execution is when we think about narcolepsy treaters and prescribers, it's a very concentrated physician base. 4,500 make up the entire universe, 1,600 make up 80% of the volume.

So those extra naive and discontinued patients generally are in the same offices as the people that we're seeing where these switch opportunities are as well. So, I think what we've seen is, it sort of depends where the patient, the physician is on their journey, but, we've also sort of seen a nice uptake in both the previously discontinued and the naive patients as well. So, we're just very pleased to sort of see the culture of our strategy and, growth coming from all three patient segments.

Greg Divis (CEO)

Yeah, I think, Rudy, in some extent, it's also a bit of a math equation as well, because, you know, there are just meaningfully more patients in offices who are on existing therapies today than those who are truly newly diagnosed. If the average annual, you know, newly diagnosed rate is around 3,000 patients per year, and 80% of those are on our primary targets, the average target has, you know, 1 or 1.5 patients per year. So again, those will continue to come in the ordinary course as they come in, and we certainly are messaging around the importance of LUMRYZ for new starts as well.

But I think also you're seeing just a manifestation of early in the launch, kind of the math equation of more intervention opportunities for those who are on therapy than those who are coming in as potential new starts.

Rudy Li (Equity Research Analyst)

Got it. That's very helpful. Can you also talk about the gross and net? Any color would be helpful.

Greg Divis (CEO)

On the gross and net?

Rudy Li (Equity Research Analyst)

Yes.

Tom McHugh (CFO)

Yeah. So listen, at this stage of the launch, you know, we're early, and, you know, we're we haven't quite reached a steady state in gross nets. You know, there's more payer contracting to be done. You know, payer mix is certainly gonna affect the gross and nets. You know, but as we're looking forward, you know, what we think continues to be a reasonable target to assume, really on a net revenue per patient basis, is about $120,000 per year. You know, we're not there today, just to be clear. You know, we have patients that are, you know, starting therapy, going through a titration schedule on lower doses, but ultimately, as we move forward to a steady state, we think that $120,000 per year per patient is a reasonable assumption.

Rudy Li (Equity Research Analyst)

Got it. Thank you.

Operator (participant)

Thank you for your question. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open.

Matt Kaplan (Managing Director of Biotechnology Equity Research)

Hey, good morning, guys, and congrats on the nice quarter. Just wanted to dig a little bit more into the process of patients passing through or working their way through the RYZUP system. And can you give us a little bit more detail in terms of the percentage of patients that start in RYZUP that actually initiate therapy?

Richard Kim (Chief Commercial Officer)

Yeah. Hey, Matt, thanks for the question. As far as the process is concerned, it's really sort of broken up into three key steps. The first is really the enrollment form, which is almost synonymous with the prescription, really beginning the process. And that really gets things going, where then the next phase is really the benefits investigation, really sort of checking out the insurance that the patient has. And including that amount of time is gonna be varied depending on whether or not there's coverage or not. But then the third step in the process is when the specialty pharmacies get to be involved, and they begin to triage the patients to ultimately confirm the shipment date with the patients. So those are what we call our really three standard processes.

Maybe one that's a little bit unique to us is one last requirement that is aligned to our REMS process, as well as our... The specialty pharmacies for LUMRYZ have to confirm whether or not there's an overlapping treatment with another oxybate. So that does take a little bit longer, adds a little bit to the process, but those are really the three key steps that go forward. And what we can say is our processes are working very well. We're seeing that with the fulfillment today, and we do expect the timelines for fill rates to continue to improve as well. And your second question again, Matt?

Matt Kaplan (Managing Director of Biotechnology Equity Research)

And kind of the percentage of patients that actually enter the RYZUP and then initiate therapy at this point.

Richard Kim (Chief Commercial Officer)

Yeah, I mean, the way we can sort of maybe do the math right now to sort of go through where we are thus far is like, you know, we have a, we announced over 1,000 enrollments through September, 400 initiated, and I think Greg could have some comments for us on the 600 patients who are still in the process. What we would first see first is we've seen very few of those drop out, and we do expect going forward that the majority of these remaining 600 patients to be initiated onto LUMRYZ. So, the numbers are some of the math is somewhere between those numbers there as well. We also expect the majority of those to be initiated on to reimbursed product as well.

So, once again, these are probably the parts that are the most focal point for us early on the launch, but we're really pleased with the progress that we've made. We're pleased that we're actually getting patients onto LUMRYZ, and as we said, we believe that our conversion rates will just improve as time goes on as well.

Matt Kaplan (Managing Director of Biotechnology Equity Research)

And in terms of the time through to move through the RYZUP process, do you expect that to improve, as you know, similarly with getting the preferred position with CVS starting at the beginning of the year, with other payers coming online as well and moving to a preferred position? Or do you think it would kind of still remain the same in terms of kind of one month to treatment for prior auth patients?

Richard Kim (Chief Commercial Officer)

Yeah, it's a great comment, Matt. Yeah, I think you sort of nailed it. First is sort of that mix, the sort of patients coming through with coverage versus those who don't. And obviously, we sort of see the covered lives continue to improve as we go forward here as well. So yeah, that should absolutely improve our overall timelines. And then, you know, what happens as well is the offices just get more experienced and more familiar with our process. So both of those are occurring. It's very dynamic, but we see both of those as drivers for us to improve our efficiency going forward.

Matt Kaplan (Managing Director of Biotechnology Equity Research)

And then, maybe last question. One of the goals you have is expanding the existing oxybate prescriber base. Obviously, that's a longer-term goal. You're very early on launch. But can you tell us a little bit about what you're seeing so far early on the launch in terms of expanding the prescriber base to new prescribers?

Richard Kim (Chief Commercial Officer)

Yeah, sure, Matt. You know, right now, at the beginning of the launch, we're much more hyper-focused on those with oxybate experience than the 1,600 who manage 80% of the total prescription volume. But here's what's been going on. First, you know, you go into office, there may be someone who had previously never prescribed, that now wants to come to the mix when we've been going in to see one of the more highly experienced oxybate prescriber. But the other thing that's been going on is we've just started seeing spontaneous people come into our REMS certification that we hadn't called on, who have put their hand up and then begun the enrollment process as well.

So although it's not been a focal point for us, it's been nice for us to sort of see people coming out of the woodwork that maybe weren't really our intention to call on as well. So, you know, we're going to stay hyper-focused on where sort of the oxybate volume is today, but clearly, as time goes on, we see the opportunity to gain more people to come into the prescribing mix as well.

Matt Kaplan (Managing Director of Biotechnology Equity Research)

Okay, makes sense. Thanks. Thanks.

Operator (participant)

Thank you, Matt. Our next question comes from François Brisebois from Oppenheimer. Your line is open.

François Brisebois (Managing Director and Senior Analyst)

Hi, thanks for taking the questions, and congrats on the early progress here. Can you maybe touch on, we talked about the three buckets of patients and where they're coming from, but can you maybe help us understand how the AGs are maybe affecting each bucket and what you're seeing so far in terms of, you know, a patient going through an authorized generic first?

Richard Kim (Chief Commercial Officer)

Yeah. Hey, Frank, thanks for the question. So yeah, super pleased with the progress so far, and, you know, it's nice that we are seeing enrollment and someone coming from all three of those patient buckets, as you mentioned. So, you know, obviously what's been nice is we're seeing them from all three segments, but the AG overall, we are actually also converting patients who are currently on an AG coming onto LUMRYZ. And as far as discontinued, we haven't really seen that many AGs who have discontinued; they've been relatively new. So the source of the AGs is predominantly coming from those who are switching from an oxybate. And, we are also seeing clearly naive patients never being exposed to any first-generation oxybate as well.

It's still a bit early, but the real source for us, if where AGs are concerned, are these switching from current oxybate patients. We really haven't sort of seen what I would call an impediment of AGs impacting the ability to get onto LUMRYZ thus far.

François Brisebois (Managing Director and Senior Analyst)

Great. Thank you.

Richard Kim (Chief Commercial Officer)

No problem.

Operator (participant)

Thank you very much. Our next question comes from Myriam Belghiti, with LifeSci Capital. Your line is open.

Myriam Belghiti (Equity Research Analyst)

Hi, good morning. Thank you for taking my question, and congratulations on the progress. So my question is around payers, and congratulations again on gaining preferred status with CVS. Just can you provide a little more detail with regard to discussions with payers? And if you have any kind of, what's your expectation for other payers when it comes to preferred status? Is this something you're actively trying to achieve? And a quick other question, just more color on the pediatric opportunity. What are the main reasons there for not taking oxybate, and are the dynamics different from adults, when it comes to both sodium and middle of the night dosing?

Richard Kim (Chief Commercial Officer)

Sure. Hey, Myriam thanks. I'll start with the payer question. So yeah, our overall strategy with payers has been to sort of have unencumbered access through any oxybate to sort of be at the best sort of status with the best of the oxybates thus far. So thus far, with the first two or three of the GPO contracts, that's what we've achieved, and that is our goal going forward as well. I mentioned the fact that we have ongoing conversations with MCR and the United Optum. So whatever is the best status, which is generally a preferred status for the oxybate, that is our goal, and thus far we've been very pleased with what we've been achieving thus far. I'll turn the pediatric question over to Jen.

Jennifer Gudeman (SVP of Medical and Clinical Affairs)

Thanks so much for the interest in pediatrics. We have heard for years now of the desperate need for a pediatric form of sodium oxybate that does not require waking up in the middle of the night. That has been the primary driver for us seeking this expanded indication. In regard to whether it's different, the clinical needs compared to adults, while it's really important for adults to not have to chronically wake up, and it's true that sometimes in an adult patient waking up, they also wake up their bed partner, the reality is, for children who are seven to 17, they are typically having at least one parent, if not both parents, chronically waking up in the middle of the night to administer the dose.

I've had conversations with parents who were happy to submit letters of support for the pediatric supplement, describing how challenging it was to never have an uninterrupted night's sleep for both their children and for themselves. For the second part of the question in regard to sodium, what we see with clinicians is they may identify a very small subset of their adult population who they consider to be sodium sensitive. This has not been an issue as we've been discussing sodium with the many KOLs who implore us to bring this option to them as quickly as possible.

Greg Divis (CEO)

Yeah. The only thing I would add regarding pediatrics is really just I would characterize it as unbelievably consistent, albeit anecdotal, which is every time you talk to a physician about LUMRYZ narcolepsy, the next two questions you get from them universally is, "When are you going to get pediatrics, and when are you going to study it in IH?" So it's very consistent when we talk to doctors about that. So hence why we're going down those paths.

Myriam Belghiti (Equity Research Analyst)

Thank you for the clarity.

Operator (participant)

Thank you for your question. Our next question comes from David Amsellem, from Piper Sandler. Your line is open.

David Amsellem (Senior Research Analyst)

Hey, just a few here. One is, can you talk about sales force sizing longer term, and also how you're thinking about any DTC spend review that your competitor disease awareness laid the groundwork for you with this initiative? So talk about that. That's number one. Number two is, I may have missed this. Can you talk about the mix between Narcolepsy Type 1 and Narcolepsy Type 2? You getting any traction in one subgroup versus another, and what's your expectation regarding the mix between the two going forward? Thank you.

Richard Kim (Chief Commercial Officer)

Yeah. Hey, thanks, David. So, as far as sales force size is concerned, to your point, today, we're at 49 sales representatives. We also have our field reimbursement team. You know, one, can we size really going against the opportunity for our space right now, that 4,500 prescribers. Our 49 representatives sort of allow us to cover up to about 6,000, maybe 6,500 physicians. So that gives us the space to cover our current opportunity and benefit. I'd say longer term, I mean, right now, we... That's really where our focal point is, is getting oxybate experience prescribers comfortable with using LUMRYZ as well.

Longer term, we'll sort of see what the mix is, but I would say for at least the foreseeable future, we really don't see the need to expand the size of our sales force. Now, when it comes to DTC, so we would really call it more sort of patient activation and patient media here. First, any news and media on narcolepsy, we think, is a good thing for a rare condition. Secondarily, our plans have really been to try to meet patients where they are, and they spend a lot of time digitally being active as well. So we've been very targeted about paid media and engagement through the sources where they go, Reddit, Facebook, and other sources. And we have a couple of other novel approaches that we're doing in and around sleep specialist offices as well.

So our approach with patients is, I would say, a little bit more surgical than a, than as opposed to shotgun approach. And then as far as the NT1, NT2 mix is concerned, it's a little bit muddled from our data as we're looking into that. But what we know historically is even though the prevalence shows about a 30% NT1 to 70% NT2, for oxybate, it actually historically has been the exact opposite, use of 70% NT1 usage and 30% NT2. So I think maybe in the future, we can provide some insight into some of those trends as more usage with LUMRYZ increases.

David Amsellem (Senior Research Analyst)

Okay. Thank you.

Operator (participant)

Thank you. Our next question comes from Chase Knickerbocker with CH. Your line is open.

Chase Knickerbocker (Senior Research Analyst)

Good morning, guys. Thanks for the questions. Just first, I wanted to ask another question, sorry to belabor the point here, on pull-through from RYZUP. Maybe just asking in a different way, if we look specifically at the patients within the, you know, the 400 that were on RYZUP, that exited Q2, not on therapy, what was the conversion percentage, specifically with those patients within Q3?

Richard Kim (Chief Commercial Officer)

Yeah. Hey, Chase. You know, the majority of those patients who were enrollments at the end of our Q2 or going for Q3 did convert onto product. Now, we haven't given specifics on the exact percentage because some of it's dynamic. I'll give you one example. We have patients who enrolled in June who just got reimbursed and shipped product in October. So you know, when we think about the two sort of buckets of covered lives versus not, the covered lives going through will be quicker than those who aren't. Our general philosophy is if a physician prescribes LUMRYZ, we're gonna go to the ends of the earth to get them on it, if we see a clear pathway forward.

Like I said, we have examples of June enrollments taking, unfortunately, several months, but actually getting them across the finish line as well. I think it's still dynamic. The majority did, and we just sort of see with more time that that number should be increasing from that cohort and every cohort as well.

Chase Knickerbocker (Senior Research Analyst)

Is there an amount of time where they're on, you know, within RYZUP that you do start to see some dropouts? Is there like, is it three months, is it four months? And then just another quickly, any feedback from the field as far as anecdotal kind of experiences with how the titrating has gone for new patients?

... and whether or not there's a difference for, you know, whether or not a patient's been, you know, experienced with the first-gen sodium oxybate for, you know, years versus, you know, they've been on for six months. Any sort of color there would be helpful.

Richard Kim (Chief Commercial Officer)

Yeah, you know, starting with the titration for the new patients, I would sort of say it, from the physicians, it tends to be a bit of a mix. Sometimes you have slow titrators who wanna sort of take their time to sort of get up to that. And I think on the other side, you have people who get there a little bit more quickly, and I think that's predominantly physician-dependent on sort of their approach. So it's been a bit of a mix, mixed bag. And sorry, Chase, what was your first question again?

Chase Knickerbocker (Senior Research Analyst)

Just for the patients that you do see drop out of RYZUP, even if it is a small number, is there, like, a number of months that, you know, that you start to see some fallouts, or is, has there not really been a clear trend there?

Richard Kim (Chief Commercial Officer)

Yeah, no, no, you're I mean, I mean, we're sort of getting to that time where some of these early enrollments, they may tend to drop off a bit. Some of that may be after exhaustion of going through the medical necessity pathway or from the patient. So we will start to see some of those patients start to drop off here as more time has gone by. From past launches, what may happen is they may revisit the conversation again in their next visit with their sleep specialist again. But definitely after some period of time, the success rate, you know, after sort of four or five months, definitely starts to go down.

Greg Divis (CEO)

Yeah, I would just add that, you know, to your question around the 400 cohort, we're very pleased with, you know, the percent that has converted. We've described it as the majority. But I think across all cohorts, there's an opportunity to continue to get better. And when someone decides to--predominantly when someone decides to exit RYZUP, it, it really is one of two reasons. It's just a payer denial that we haven't been able to get over, or that patient has gone through the process and then at the end decided they're not gonna go on therapy, right? Which happens, it happens, for all therapies.

So, but again, that's a relatively small percentage, as we've described, and we're pleased with, you know, you know, people sticking with it and the conversion rates we've seen early on, and knowing that, you know, those opportunities will only get better, and they're already coming from a really good place.

Chase Knickerbocker (Senior Research Analyst)

Great. Congrats again on the latest progress.

Greg Divis (CEO)

Yeah. Thanks.

Operator (participant)

Thank you. This concludes our question and answer session. I would now like to turn it back to Greg Divis for closing comments.

Greg Divis (CEO)

Thank you. Thanks, everyone, for your time and for joining us today on our third quarter of 2023 call. We wish you a great rest of the day and look forward to follow-up. Take care.

Operator (participant)

This does conclude the program. You may now disconnect.