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spk10: greetings and welcome to the avidel pharmaceutical second quarter 2023 earnings call at this time all participants are on 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 murtaugh with stern investor relations thank you you may begin good morning and thank you for joining us on our conference call to discuss second quarter 2023 earnings as a reminder before before we begin
spk11: 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 include risks regarding the success of commercialization efforts for Lumerize, expectations regarding the potential market impact anticipated market availability and sales opportunities of Lumerize, and the impact of competitive products and pricing. These and other risks are described more fully in Avidel'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 any subsequent SEC filings, except as required by law Avidel 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, Dr. Jennifer Goodman, Senior Vice President of Medical and Clinical Affairs, Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer. At this time, I'll turn the call over to Greg.
spk02: Thank you, Austin. Good morning, everyone. And thank you for joining us today to review our second quarter 2023 results. 2023 continues to be a transformational year for Avidel, which has only accelerated with the significant progress our team has delivered in the second quarter alone. And this all starts with our transition to a commercial stage organization and the launch of Lumerize, our once-at-bedtime oxybate therapy for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Following Lumerize's approval in May, along with the concurrent receipt of orphan drug exclusivity, we swiftly executed our launch strategy and since launch in June have seen impressive interest and initial uptake from physicians and a broad mix of patients. We recorded our first sales for Lumerize in June and based on our initial launch progress, we are trending well against our expectations at this very early stage in the launch. With clear and unwavering focus, we are honored to be able to bring forward our transformational once-at-bedtime therapy the narcolepsy community has long been waiting for. On today's call, I'm joined by Richard, who will be providing updates on our commercial launch progress. Following Richard, Jen will be discussing our robust clinical presence at the Sleep Conference and our recent publications. We will then turn the call over to Tom to update on the financial results. And lastly, we will close the call with a question-and-answer session. Before commenting on our launch progress, I want to take a moment to highlight the receipt of orphan drug exclusivity in May. At the same time, the FDA granted Lumerize final approval, as this is an important validation of the benefit of Lumerize. The FDA found Lumerize to be clinically superior to all twice-nightly OxyVe products in that Lumerize makes a major contribution to patient care by providing a once-nightly dosing regimen that avoids nocturnal arousal, which disrupts sleep architecture, when required to be forcibly awakened in the middle of the night to take a second dose. As many of you know, at the end of June, we held a widely attended Loon Rise commercial day, where we highlighted the significant opportunity of Loon Rise, demonstrated our history of resilience, showcased our talented team, reported initial launch metrics, and discussed how we were well positioned for future growth. In addition, we hosted two renowned sleep specialists who spoke about their extensive experience with treating narcolepsy patients and how they believe Lumerize will positively impact the treatment landscape for people with narcolepsy. We were also honored to have a person with narcolepsy in attendance who gave a firsthand account of her experience living with narcolepsy, first-generation oxybates, and how Lumerize positively transformed her life. Today, we are updating initial metrics previously reported. Specifically, the three most important early launch KPIs that we reviewed at our commercial day and are now reporting data through the first two months of launch. The significant progress we have seen across these important KPIs during these early weeks of launch are as follows. First, REMS certifications, which is the first step before a prescription can be written, are now greater than 1,000 targeted prescribers who are certified. That's up from 625, as previously reported. Second, new patient enrollments into Rise Up, our patient services center, which is the first step to a potential future dispense of Lumerize, are now greater than 400 patient enrollments, up from 140 as previously reported. And third, progress on the reimbursement front, which is also performing ahead of expectations. which now includes the addition of Loomrise to the Express Scripts National Formulary, and now, hot off the press, CVS Health has removed the new-to-market block for Loomrise on its commercial formularies in a non-preferred position. This decision now allows a pathway to coverage for more than 30 million additional commercial lines. In summary, from a leading KPI perspective, while recognizing we are only in the first full quarter of launch right now with significant work ahead of us, We are pleased with these early indicators of our launch progress. Looking at future quarters as our launch progresses, we expect the KPIs that provide a current picture of launch to evolve. And our goal, as it always has been, is to be transparent as we report metrics that capture our launch progress. Further, we expect to give all launch KPI updates on our quarterly earnings calls, where all data provided will be as of quarter end. Looking toward the future in the continued growth of Avidel, our strategy is to target opportunities that allow us to expand our patient reach in the rare sleep space with the goal to provide innovative therapies like Lumerize to more eligible patients. In this regard, our team is on track to submit a supplemental new drug application for potential FDA approval of Lumerize in the pediatric narcolepsy population before the end of the 2023 calendar year. Additionally, we are progressing the clinical planning to initiate a multicenter randomized controlled trial in idiopathic hypersomnia. And lastly, we continue our preclinical stage formulation work of a potential no or low sodium once-at-bedtime oxibate formulation for the small subset of sodium-sensitive oxibate-eligible patients who could potentially benefit from this type of innovation. We look forward to providing updates as appropriate as physicians and patients have expressed significant interest in Avidel developing these needed treatment options. Although it's very early with much more to accomplish during the first few full quarters of launch, we are very pleased based on our early launch KPIs with our initial execution and continued pursuit of greater than the $1 billion peak sales potential opportunity that is there for Luma. I will now turn the call over to Richard to provide an update on our launch progress. Richard. Hey, thanks, Greg, and good morning, everyone.
spk12: Our Lumary's launch is also a strong start and I'm excited to share our continued progress. Now, over the last 20 years, there has not been any innovation in improving the delivery of OxyBase to people with narcolepsies. The fundamental problem of forcibly waking patients who often already suffer from disturbances in nocturnal sleep existed until once-at-bedtime Lumerize was approved and launched in June. With Lumerize, we have a simple and compelling proposition, and what we are seeing and hearing in the early weeks of our launch is a validation of our brand proposition and the market insights we had pre-launch. Safe to say, we believe Lumerize provides a meaningful benefit to the narcolepsy community, And of course, this was further validated through the receipt of our orphan drug exclusivity from the FDA. Turning to the commercial launch itself, we are approximately two months in. We are encouraged by the strong progress thus far and the positive feedback we received from the narcolepsy community. Many from our leadership team and I have had this privilege of being on the road with members of our field force and speaking with sleep specialists and their teams firsthand. Considering that collectively we are a relatively new team in the sleep field, the energy of our team and the engagement of sleep specialists has been terrific. As our launch continues, we are focused on continuing to drive demand among high-volume oxidative prescribers, encouraging patients to advocate for the use of Lumerize, securing payer coverage, and delivering best-in-class patient services and reimbursement support. From a launch team perspective, as of the end of July, all roles are now filled and trained, and August will mark the first month with a fully deployed team. we continue to see very high interest and levels of engagement from sleep specialists and their staff. Our sales team impact continues to grow, and we have now engaged with a vast majority of the top 1,600 prescribing offices that represent roughly 80% of total Oxibate prescriptions. With the completion of our full team, we expect to continue to grow our reach and frequency to high-volume Oxibate prescribers. As a reminder, We see the market in three key segments. First, sixteen hundred patients who are currently treated with twice that the first generation. Second, around sixteen thousand patients from the last few years who have tried to discontinue that twice that the first generation. And third, around three thousand annual new patient starts who are naive treatment from the greater than twenty five thousand who are eligible for but have not yet been treated with an activate. We have seen high interest from our target HCPs and people with narcolepsy from all three patient segments, as evidenced by the greater than 1,000 REM certifications for HCPs and greater than 400 rise-up patient enrollments in the first two months of launch. For REMs, we are pleased to see the majority of certifications are coming from high-volume OxyVate prescribers, although we have also had HCPs certified who have never previously prescribed an OxyVate as well. Rise-up patient enrollments have also been impressive, as enrollment in this patient services program begins the process for having a lumerized prescription filled and delivered to a person with narcolepsy. Our data informs us that the majority of the greater than 400 rise-up enrollments are switches from first-generation oxidates, and that we are also getting patients naive to oxidates, as well as previously discontinued to oxidate patients. For Rise Up, while our processes are similar to what most offices do already to prescribe specialty, REMS, or controlled substances, systems and services can be viewed as different, and that is true for us with Rise Up. For example, we did extensive research to determine key services to offer through Rise Up, like our access and affordability programs, including a $0 commercial copay program for eligible patients, our patient and temporary assistance program, along with personalized Rise Up nurse care navigators individually assigned to each person with narcolepsy and their sleep specialist. It's been really great to see both people with narcolepsy and HCPs take advantage of our services and for our nurse care navigators, seeing them build relationships with the people they support. Before I provide a payer update, I'd like to summarize a few themes from the time I've been in the field and from speaking with sleep specialists. First, we have yet to meet a sleep specialist who does not see a need for Lumerize. In general, it's actually quite the opposite, where ACPs are really excited to learn about our once-at-bedtime sodium oxibate. Second, we encourage to see some offices bring in several patients quickly, but we believe that most patients will visit their sleep specialist in their standard follow-up period, which is typically every three to six months. And third, sleep specialists are getting used to our rise-up services, and they are trying them out to gain initial familiarity for themselves and their staff. Building the familiarity has been driven through our field reimbursement team, who have been instrumental in educating offices on our services. Let me now transition to the payer front. We're really pleased with the progress we've made in achieving parity access with the first-generation Oxibates. The Lumerize payer channel mix has been estimated to be about 80% to 90% commercial, and the three GPOs, Ascent, Zinc, and MSR, collectively represent about 85% of those commercially covered lives. As a reminder, the Lumerize distribution network also includes all three specialty pharmacies from the GPO enterprises. At commercial day, we announced the first of three GPO contracts had been finalized and signed as we secured Express Scripts coverage on the national preferred formula effective July 1st. We have now been listed with the majority of sent PBM covered lives. And as Greg just mentioned, CVS Health has removed the new-to-market block for Luremise on its commercial formularies in a non-preferred position. Having secured the opportunity for commercial reimbursement in major PBMs from two of the three GPOs in the first two months of launch, in addition to the others previously announced from Kaiser and many of the Blue Cross Blue Shield plans, is certainly a leading positive performance indicator and a reflection of the great work done by our market access team. Up to now, the majority of early prescriptions are being processed through medical necessity for which there is usually more paperwork and more time required to navigate these prescriptions. We announced it at our commercial day that we are pleasantly surprised that in the first few weeks that we already had some reimbursed patients on Lumerize. And since then, we have been extremely pleased to see the increasing reimbursement success our teams are having with Lumerize in the first couple months of launch. And now, with more commercial reimbursement for Lumerize that has been secured, We look forward to even more people with narcolepsy who will be able to access Lumerize in the future. I covered a lot of ground today, and we believe that the early launch indicators have us well-positioned to have a significant impact and are confident that we will be able to capture a significant portion of the large OxyBait market opportunity. Our research shows us that the market opportunity for Lumerize could be much greater than that of current first-generation, 50,000 potential eligible patients for Lumerize, and a peak sales potential of greater than a billion dollars. Although these are still the first couple months of launch, we could not be prouder of the launch execution that our team is delivering and the receptivity we have received from the narcolepsy community. We look forward to providing more updates on future calls, and with that, I'll turn the call over to Jennifer for details on our recent scientific data presentations. Jennifer?
spk00: Thanks, Richard, and good morning. It's been a monumental quarter for us, supporting the Lumerize launch, along with our strong presence at Sleep 2023 and the publication of additional data that underscores the need for Lumerize. Starting with Sleep 2023, we were incredibly pleased to have delivered a leading clinical presence of 12 posters and six oral presentations. which collectively support the strong Lumerize clinical profile and insight into patient needs. For example, data from a social network study showed that more than 60% of people with narcolepsy consider, among their most troubling symptoms, various sleep disturbances, including poor quality sleep, disrupted nighttime sleep, fragmented sleep, and insomnia. Among all the narcolepsy treatments, only Lumerize does not cause insomnia or require chronic middle-of-the-night dosing. Once again, we presented ongoing data from RESTORE, the open-label study, which has now been underway for more than three years and continues to bolster the known safety and tolerability profile of Lumerize. Most importantly, 94% of those switching from twice-nightly Octavate preferred the once-nightly dosing regimen. Turning to two new peer-reviewed publications. First, we published in sleep a post-hoc analysis of Lumerize rest-on data divided by narcolepsy type. No published data previously existed prospectively evaluating oxibate treatment on NT2 or narcolepsy without cataplexy. We have demonstrated a consistent efficacy profile for Lumerize in both NT1 and NT2. These data are important as there is a perception of some sweet clinicians and patients that OxyBase should be reserved for NT1. With this publication, we have the clinical study data to show favorable efficacy in NT2 as well. Lastly, we published a new discrete choice experiment in Advances in Therapy. As you may recall, we previously published a DCE among patients showing that the number one driver of sodium octobate preference is the dosing regimen, with the scone preference identified for a single bedtime dose. We followed up with the second DCE, this time among 100 clinicians, and included sodium content as an attribute to assess. The once-nightly dosing, which only Lumerize provides, was more than twice as important for overall Oxibate choice than the next two attributes, which were adverse reactions and sodium content, respectively. Our scientific data aligns with what we are now seeing in the real world. Lumerize is fulfilling a significant unmet need. I will now turn the call over to Tom for an update on the company's financials. Tom?
spk13: Thank you, Jennifer. We are pleased to announce that we generated our first sales of Lumerize and reported $1.5 million of net revenue for the quarter ended June 30th, 2023, which represents initial stocking orders from all three of the specialty pharmacies in our distribution network. And while we are not providing revenue guidance at this time, I can share that subsequent to June 30th, we generated additional sales from all three of the specialty pharmacies as the launch of Lumerize has progressed. We also reported a total of $51 million of GAAP operating expenses during the quarter ended June 30, 2023, which is comprised of approximately $47 million of SG&A costs and $4 million of R&D costs. I want to highlight approximately $18 million of expenses that impacted the quarter that drove OpEx higher than what we expect our cash operating expenses will be on a go-forward basis. First, there was approximately $9 million of non-cash expenses. the majority of which is tied to stock-based compensation, which includes a cumulative catch-up adjustment of $6 million for previously granted equity awards. The $6 million cumulative catch-up adjustment was recorded upon reaching the milestone objective of our first commercial sale of Lumerize. Second, there was also a cumulative catch-up adjustment of approximately $2 million for cash incentive awards that were tied to reaching the same milestone. Third, We incurred approximately $5 million of legal and other professional fees, of which $3 million were contingent on receiving FDA approval and launching Lumerize. And finally, we expensed approximately $2 million of commercial Lumerize inventory through R&D that was purchased prior to receiving FDA approval. Post-FDA approval, commercial inventory purchases will be capitalized and expensed through cost of product sold. After adjusting to these items, Cash operating expenses in the quarter ended June 30, 2023 were approximately $33 million. We expect that quarterly cash operating expenses for the remainder of 2023 will be in the range of $35 to $40 million. Finally, just a few comments on the balance sheet. During the quarter ended June 30, 2023, we completed the exchange of 106.3 million convertible notes for 12.3 million common shares. Effective with this exchange, we have just $21.2 million of convertible notes remaining, which matures in October of 2023. And our intent is to sell the principal and interest in cash. And I'll wrap up with our cash position. At June 30th, we had approximately $161 million in cash, cash equivalents, and marketable securities. In addition to that, last week, we received $30 million from the first tranche of the $75 million royalty financing commitment we secured earlier this year. A second tranche of $45 million remains committed from the royalty financing and is available if we achieve $25 million of quarterly net revenue by June 30th, 2024. But as a reminder, we are not required to drive the $45 million into royalty. We believe, based on current plans and expectations, that cash on hand at June 30th plus the $30 million from the royalty financing and expected cash receipts from sales of Lumerize are sufficient to support the launch of Lumerize and bridge the company to cash flow breakeven. For additional detail on our financial results for the quarter ended June 30th, 2023, please refer to the 10Q or the press release issued earlier this morning. And I'll now turn the call back to Greg for closing remarks.
spk02: Thank you, Tom. We believe our strong foundation has supported our successful initial and very early launch of LumeRise, and we remain laser focused on continuing to execute the commercial launch. We believe we've made significant progress in this area and look forward to potentially expanding our pipeline to reach more patients in the future. We're excited to be in the field and actively changing the treatment paradigm for patients and are fully committed to realizing the value of LumeRise, which we believe has the potential to achieve peak sales greater than $1 billion. We thank you for your support and look forward to providing future updates on our progress. And with that, let's open up the call for questions. Operator?
spk10: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 1-1 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Francois Brisbois with Oppenheimer. Your line is open.
spk09: Hi, thanks for taking the questions. Congrats on the progress here. So the first, I just want to better understand Rise Up and just that metric, you have 400, sorry, yeah, 400 from the 140 that you had shared previously. I just want to understand how should we think about those numbers and how they correlate to ultimately sales?
spk02: Yeah, thanks, Frank. Richard, do you want to talk about that?
spk12: Yeah, sure. Hey, good morning, Frank. Thanks for the question. So first, we're super pleased with the progress that we've been making so far. And, you know, although we're not providing specific guidance, you know, what we are doing right now is it's hard to predict exactly how many of those patients will convert into sales. But what we can say, and as I mentioned on our prepared remarks, is we have been really having increased success in getting reimbursement. In fact, one of the things I can mention as well is we're probably not using our temporary assistance programs as much as we thought early on. So although it's difficult to predict how many of those patients will convert, what I can say is no one is more motivated than us to get those patients on to product, to lumerize for field for them as well.
spk09: Great. And then in terms of, are you ever going to share the average number or you know, exit number of patients that are on drug, or should we expect these metrics to be the metrics going forward? And then just maybe a quick comment on the CVS news. Is that earlier than expected or kind of in line here? Thank you.
spk02: Yeah. On the metrics, you know, again, as we shared back in the commercial day, you know, we believe during these first few months, the most important leading indicators for us were REM certifications, write-up enrollments, and reimbursement, because those all feed into ultimately converting someone into a paid drug. We absolutely agree that as we go forward and in future quarters, reporting patients on therapy is an important metric, right? And as Richard noted, and as what we said back in June, we were pleased just in the first month to see some patients already convert in a much sooner way than we thought. We've only seen that accelerate, and as Richard noted, we haven't been required or necessary to use our temporary assistance programs as much as we thought we may need. So, again, I think everything from our perspective is on track, and that will be a metric as we go forward. We certainly will report. And I'll just remind you that we're two months into the launch, and this is our second update, and we haven't had our first full quarter yet. So, again, I think you'll see those data points start coming out in the future. In terms of your comment on CVS, Richard, you know, is that on course and timing-wise or earlier than what we may have thought? Richard, feel free to answer.
spk12: Yeah, no, we're thrilled. You know, to actually have two significant payer reimbursement wins this early on, two months post-launch, it's really been impressive to see. I think it's a real testament to the work that both our medical and our market access team have been explaining the proposition of boomers to the payers. and clearly them sort of seeing our value proposition and great negotiations. So the fact that we have two big wins already this quickly, amongst many other smaller ones, is a real testament to sort of the early performance from our team.
spk10: Thanks, Frank. Thank you. One moment for our next question. Our next question comes from Andrew Sy with Jefferies. Your line is open.
spk07: Hey, thanks. Congrats on the progress. Appreciate the updates, and thanks for taking our questions. You know, appreciating you do not necessarily want to share too much, but I'll try to ask in another way. Of the 140 patients who have signed up as of June end, how many of them have been converted to treated patients, just so we can gauge the speed as well as the depth of conversions? And secondly, can you just also remind us, How many patients remain in your open-label study right now, and when could they start rolling over to being a commercial patient? And if they were to be rolled over, would they be counted as a new patient in Rise Up, or would they automatically be classified as a treated patient? Thank you.
spk02: Yeah, thanks, Andrew. Again, I think, you know, we're early into the launch and the specific metric around actual patients on therapy will be something we talk about in subsequent quarters. We're very focused on, you know, the leading indicators into that, and we've made great progress there. I would say that we've seen, you know, what we noted at the end of June was we were pleasantly surprised, again, to see, you know, patients begin to get reimbursed in a fairly efficient way. and go on commercial drug. And again, in July, that's only accelerated. And in many ways, and Richard, you can comment, it's just these patients take some time. So the earlier patients are likely the ones converting sooner, unless you're converting unless you're in a benefit design that adjudicates fairly quickly. And we have a few of those, for sure, but I think what you're seeing is the time that requires the move from the top of the funnel, which is what we'll characterize rise up as, to out as a dispense, takes time navigating the medical necessity process until these more formal coverage policy decisions begin to take hold. But at this point, I would say we're very pleased with how we're seeing that conversion occur, even back to the 140 versus what we had assumed, and perhaps equally as important is the less dependency on what we call our temporary assistance program, which you may refer to as some sort of bridging or free drug program, but not being required to use that at a level that we had assumed because of the team's ability to navigate the reimbursement process. terms of your open label question as we previously talked about we had a little under 100 who were still in the trial at the time i would say of the of the rise up enrollments they represent a very small minority today they are being processed into this into the into the system they would count technically as a new rise up enrollment because it's it's independent of that we've seen some of those already transition into commercial drugs But, you know, I would say that that's in the works now and with a whole lot more to actually process through and ultimately move on to commercial drugs.
spk07: Very clear. Thank you again.
spk10: One moment for our next question. Our next question comes from Amifadia with Needham & Company. Your line is open.
spk03: Thanks for taking my question. I guess I'm going to try to understand that same metric in a slightly different way. Can you talk about what are the steps that are required from the time a patient gets enrolled in the Rise Up Hub and goes through all the steps before they can start to receive drugs? And at which point do you need to make the decision of whether you want to support that patient with free drugs? If you could sort of talk to that process. And of the patients that are receiving drugs today, what percent are receiving free drugs? That would be helpful.
spk02: Yeah. So, Richard, do you want to take those?
spk12: Yeah, sure. Thanks for the question, Ami. So, you know, I always remind myself that getting a new specialty product to a patient early in launch is just as complicated for any product launch, right? And that's why we really overinvested in our services through Rise Up and our reimbursement team. So the general process is this. You have to send in a Rise Up enrollment form. That will begin the process. Sometimes the information is complete and sometimes it isn't. Benefits investigation will begin. We'll start to identify, Rise Up will identify which specialty pharmacy is used. That will be done, and then a prescription will be sent in that can now go through the process. But especially before any criteria is set for prioritization from a payer, it generally is going to go through medical necessity, which is a much more manual process where an office has to write specific reasons why they're looking to use this product. It goes to the payer, goes back and forth a couple of times. So the point is it takes a while. Once that is approved, then of course the pharmacy has to line up when that prescription will actually be fulfilled. So prior to any coverage decisions being made through medical necessity, this takes well over a month for those things to happen in general. You know, so not measuring in a few days or a few weeks, but definitely several, several weeks. And that's why getting some of these reimbursement wins with the pairs is so important because that should decrease the time of sort of going through the process as well. So We're super pleased with how it's working because it is complicated. But at the same time, as Greg and I have mentioned, we're also super pleased to sort of see the level of reimbursement that we're getting. And to your point, I won't comment on the percentage of free product, but what we're seeing is a lot more reimbursement wins than we had expected or projected at least. And in general, The decision about when someone goes on to our temporary assistance program is really the decision between the patient and the provider. Because oftentimes if they're existing switch patients, they will have other product already or there's other things going in their life. So it is there to be offered. But a lot of times the decision of the patient and the provider, that's what we listen to and figure out when should we kick in a lot of these programs as well. And the last comment I can give is we actually have had drug that we were about to administer to our temporary systems program where we did get a approval for reimbursement right before we were about to send it out as well so this is a very dynamic period of launch and like i said we're just really excited that a we're getting patients onto lumeritis and b uh we're getting more reimbursement success than maybe we had first anticipated maybe a follow-up to that which is is just to sort of understand how um
spk03: you guys are trying to make sure that you don't lose these patients while some of these steps are being undertaken. You know, it's good to see that over 400 patients are enrolled in Rise Up, but what I'm trying to understand is, are those going to eventually convert into patients on drug, or is there, you know, is it likely that a percentage of those patients will maybe get lost through the process, either because the process was taking time or at some point the patient changes their mind of, you know, what drug they want to be on.
spk12: Yeah, Ami, it's a great question. And, you know, unfortunately for any product that's prescribed in the United States, there is abandonment that goes on from either the provider or the patient. But once again, that's why we invested as much as we did into our Rise Up services. You know, our nurse care navigators have individual relationships with both patients and with the office because that communication, I think where people struggle the most is when they don't know what's going on. And that's why our nurse pre navigators really take the time to invest in the relationship, follow up with those those patients as well. So they understand where they are in their process. So it's really hard to sort of say what patient, what percent will stay on right now. But what we can say is that's why we really invested as much as we did into our services because holding patients and offices, especially early on is so important so that they have a good experience and likely are more likely to stay in the process than get, than want to give up as well.
spk02: Yeah, the only thing I would add is that we've built our programs to support patients at any point along this process. We're prepared to initiate our temporary assistance program as early as that patient and provider wants. The good news for us, and that's what we assumed was going to be happening, the good news for us is that that's not what's happened. We've been able to keep them on, and no one's more incentivized to keep them in that kind of system than us. to keep them on and through the process and getting to a reimbursed product without having to use our temporary assistance program at a much, much lower rate than what we had originally assumed.
spk03: Got it. Thank you. I'll jump back in the queue.
spk10: One moment for our next question. Our next question comes from Mark Goodman with Lyric. Your light is open.
spk08: Yes, good morning. First, anecdotal stories that your reps are talking about, just what's going on in the marketplace. You know, just you got generics out there for Zywave, how Zywave is doing. You're taking share, obviously. Just, you know, any stories that you're hearing out there. And secondly, Tom, can you talk about what are sales that are needed to break even for the company? Thank you.
spk12: Richard, do you want to start? Yeah. Hey, Mark, thanks. You know, anecdotes are awesome. And that's why also getting in the field has been terrific. Overall, what I can sort of say is there's been just really great receptivity from the offices that we have been in. Maybe a couple, one I could also share that's happened several times across the country is, you know, we're a relatively new company. And, you know, our representatives go speak to the receptionist and they don't know the doctor yet. And we leave their call. They say, come back in a few weeks. And then we've had doctors literally call or chase our reps in the parking lot to sort of say, can you please come in if you've got that once a bedtime therapy? So I think it's just been really cool to see. Clearly, we're in a very competitive marketplace, but, you know, we have a very clear strategy. We have very clear messaging and, you know, we really think the conversations have been great. So thus far, I think it's been really a thrill and an honor to be out there. And there's a lot of energy from our team because the receptivity from the specialist offices has been great. And I guess we'll turn the next question over to Tom.
spk13: Yeah. Hey, Mark. Thanks for the question. You know, I think rather than thinking about it in terms of sales, which I, of course, understand your question, I think about it in terms of paid patients on therapy. You know, if I use what I described as our expected cash run rate of $35 to $40 million per quarter, You've annualized that. You know, you think about the number of patients, paid patients on therapy of, you know, something in the range of about 1,500 patients. At that level, you know, we're probably in the sales required to achieve break-even profitability.
spk10: Thanks. One moment for our next question. Our next question comes from David Amsell with Piper Stanley. Your line is open.
spk05: Hi, thanks. This is Skylar on for David. Just a couple questions. First, realizing it's still early, but just based on some early feedback, can you comment on the patient types where you've seen the most actual uptake or demand so far, whether this is patients that are currently on twice-nightly OxyBait but just prefer the once-nightly or have been on twice-nightly in the past or OxyBait naive? And then in terms of the payer landscape, I'm wondering what your current expectations are for whether Any plans or making patients step through generic oxibate or if you're expecting that in the future? Thanks.
spk02: Thanks. Richard, those are, you know, for you. No problem.
spk12: Hey, thanks for the question. So, yeah, as far as the patient types we're sort of seeing coming into RISA, the majority thus far are patients who are currently on a first-generation twice-limit oxibate. However, we are also seeing patients who are naive to oxibates and also patients who have previously discontinued. So a nice mix overall, but the majority thus far are patients who are previously on, or sorry, currently we're switching from a first-generation oxibate. And as far as your second question is concerned, you know, our whole strategy has been to get parity access with the best of the first-generation oxibates. Thus far, we are not seeing any impact for a step through a generic fur lumerize. Our strategy has been for that not to happen. So, and thus far, the plans that we have been listed with do not require a step to go through any oxovate prioritize as well. So that's really our strategy. is to really make sure that the payer, we're not disadvantaged through a payer perspective from an occupant access. And we're really focused on sort of the communications and what we do in the offices with the suite specialists as well.
spk05: Great. Thank you. That's helpful. And if I could just ask one more, just how are you thinking about the opportunity for MRIs and IH? Do you think that a one-nightly option is more suited to this population? Do you have any thoughts on that?
spk02: Richard, do you have any commentary? And then maybe Jen?
spk12: Yeah, you know, for IH, you know, through our ad boards and speaking to our top specialists, the general feedback we receive is as strong as our value proposition is in narcolepsy for lumerize. It may even be slightly stronger in IH, especially when you consider the sleep inertia that patients with IH have and sometimes their inability to wake up and take their medication or another dose. So I think there's a lot of interest in that. And that's why, you know, we have been spending collective time really looking at the opportunity to get our clinical program going. But Jen, anything you'd like to add?
spk00: I'll just emphasize what you mentioned, Richard, and that is the sleep inertia. That is the reason with the twice nightly formulation, they allowed for one nightly dose up to six grams. because patients simply could not wake up to take the second dose. But it is really important to note that you could only go to six grams, and that is sub-therapeutic for a number of patients. And so we certainly hear through our MSLs, through all of our interactions, that there is a massive need to have Lumerize available for the IH population.
spk05: Helpful. Thank you all.
spk10: One moment for our next question. Our next question comes from Matt Kaplan with Leidenberg-Dahlman. Your line is open.
spk01: Thanks for taking the questions. Just a quick follow-up on the prior question on IAH opportunity. Can you talk a little bit about the timeline that you envision for new lines to develop in this syndication?
spk02: Yeah, I think, Matt, it's a little early right now to be precise on that. There's a number of steps we have to go through from clinical supply quota to getting our protocol finalized and approved and filing our IND and all that. We're in all the works of that now. And we'll certainly update as we, you know, cross through key milestones. It's certainly going to be an event that, you know, I would envision to kind of level set that we would be initiating a clinical trial in 2023. There's just a lot more work that has to be done to get us to that point. And we certainly wanted to make sure we got to our approval with Lumerize and narcolepsy first. So that's in full force with our team. And so we'll update as we go forward.
spk01: Great, great. And then a question maybe for Richard, in terms of the mix of patients, understanding that what you're seeing mostly now, or the majority, are the switches. How do you see that evolving over time? Are the switches kind of, let's call them a low-hanging fruit, or are the patients who were previous on Octobate therapy and coming back to therapy, do you see a shift to those being the majority of patients over time?
spk12: Yeah, Matt, great question. And yeah, you know, if we just think about our patient segments, there are more patients who have been on an Oxivate than the other segments right now. So, yeah, you know, right now, just from the sheer number of patients who sort of go through, there's probably more of those patients currently on therapy. I think over time, we will start to see a little bit more of a balance across the three different segments there. So, you know, I think early on, we're sort of seeing a lot of the usage being consistent with the market research that we've done. And what that showed us is over time, we should also be able to grow sort of the new patient segment as well beyond the 33,000 patients who currently go on annually for first-generation Oxyvates.
spk01: Okay, thank you. And then last question in terms of, you know, on the theme of anecdotes in the field, what are you hearing in terms of counter-detailing from Jazz in the field on you guys?
spk12: Well, you know, I think those are always better questions to ask them. But I think in general, they've been very consistent. I think the message is mostly focused on sodium. And clearly as a new company, just, you know, the challenges and getting a new product sort of reimbursed. But we are so well prepared for that. We've been clear and focused on that from day one. So Matt, what I can sort of say is nothing unexpected, and our team is in a great position to handle any objections that come to them clinically or from the competition as well. So just happy to be out there and having our teams in front of a seat specialist, Matt.
spk01: And maybe just one more follow-up. I guess, given the significant amount of awareness of Lumize prior to the launch, do you think the rate of patients enrolling into the Rise Up system will, I guess, was there a warehousing of patients waiting for the approval and kind of eager to get in the line there? Or do you think that pace of enrollment should continue or accelerate it?
spk02: Yeah, I think, Matt, I think as we shared, I think some of our insights from being in the field is that there are certainly examples of an office who has a number of patients who they are processing and prosecuting. I don't know if I'd call them warehouse, so to speak, but I think our view is that what we've heard in the field, at least from treaters, is that they'll see patients in their ordinary course, which is why it's important for us to execute on our direct-to-patient campaigns and to really deploy our strategies and tactics to activate patients to advocate for their therapy and go seeking out Lumerize as well. So those are things that we're doing, of course, that will have impact over time. But I think our view is that, and we've seen this early in the launch, like you would expect, we've seen a cumulative increase kind of as time going on in terms of enrollments and dispenses and things like that. So our view is that that should continue. And listen, if somebody has a large bolus that are ready to come into our system and into Rise Up, we will deploy our resources to support them. And we're prepared and have the capabilities to handle that. But I think our assumptions are that things will happen in the ordinary course.
spk01: Great. Thanks for taking questions.
spk10: One moment for our next question. Our next question comes from Chase Knickerbocker with Craig Callum. Your line is open.
spk06: Morning, everyone. Thanks for the question. Just another one on Rise Up for me. Maybe hit a different vein. Talk us through the patient mix you have converted onto the drug at this point. I understand it's a fair mix of switch, naive, previous discontinuation in the funnel, but maybe talk us through the mix you've pulled out of the funnel at this point. Is it a much easier process, I would imagine, from the medical necessity and PA process?
spk02: um for switch patients and then but you know is it slightly less success you have pulling naive patients or discontinued patients out of the channel or is it a fairly similar process that is being required thanks yeah um i think the short answer that is richard feel free to weigh in but i think it's reasonably representative of how they've come into the funnel and and some of that is time dependent right so if there's more you know when they come in and how long it takes them is is individual from that standpoint. We've had patients come in early who maybe come from all three of those groups that have prosecuted quickly. But I think generally, given how it's been distributed coming in at the top of the funnel, I think, you know, directionally it represents that coming out of the funnel. So Richard, feel free to weigh in more.
spk06: Yep. Spot on.
spk02: Yep.
spk06: I mean, maybe talk just to the, you know, the difference in medical record requirements and in the process between the three and, you know, they're kind of a, If they're kind of a similar pull through the bottom, is it fair to think that one in particular is a lot more cumbersome than the rest?
spk12: Richard, feel free to. It's hard to get into that level of detail because here's what happens in medical necessity. You may actually deal with one insurer, but you may actually deal with many different case reviewers. So it's a little bit of who do you get on what day of the week do you get? So I think overall, we've just been very impressed that we have been able to get as many through as we have already. And I think that really talks to both payers and actually clinicians being very clear about the clinical value proposition that Lumerise has. So, you know, the fact that this isn't a me too, that fact that this isn't me is the fact that this is fundamental to how narcolepsy should be managed. To us, that's really been maybe the best upside is the fact that it appears to us that both the clinicians and the people reviewing these cases understand our clinical value propositions.
spk02: Yeah, I think the other way to think about it, Chase, is that if there's not a formal coverage policy decision, then we're going through medical necessity, and it's going to go through those steps, whether it's a de novo, naive, or a previous, or a switch. So in many ways, it kind of operates the same way. Until there is this decision that the prior authorization criteria is set, the coverage policy is in place, then it operates differently from that standpoint.
spk06: Okay, that makes sense. Yeah, that's helpful, Culler. And maybe just one on another kind of vein on Culler from the field. Maybe talk about, you know, sort of additional boon you've received from, you know, the clinically superior opinion from the FDA that's implied in the orphan designations. you know, maybe feedback from the reps and how, you know, they've been effective at kind of outlaying that message and the receptivity of physicians.
spk12: Richard? Yeah, no, it's a great question, Chase. You know, to be very candid, it's a little bit overwhelming for some of our customers to hear that because they're not used to hearing that. And What we've really had to do is break down why we received not only our drug exclusivity through the major contributions to patient care, but in essence, almost get into the steps of why we were deemed to be clinically superior. The fact that it's important not to disrupt nocturnal sleep, you're trying to avoid sleep fragmentation, and with Lumerize, you can avoid that. I think once you explain the steps, it becomes a lot more digestible because the statement on its own is almost, in some ways, almost too powerful, right? So we've really had to make sure we can explain the why behind it as opposed to just the statement itself. And I think once the why is explained, there's a lot more head nodding that goes on than just giving a statement on its own. So, you know, it's a great message for us, clearly, and we're just learning how to make sure it is better digested from our customers as well.
spk06: Got it. That's it for me. Thanks, guys.
spk10: One moment for our next question. Our next question comes from Mary in Belgium with LifeSite Capital. Your line is open.
spk04: Hi. Good morning, and congrats on the progress. Just one quick question for me. What color can you provide on the one-month discontinuation rate in these early adopters of LumeRise? Thoughts on how this compares to Xyrem or ZyWave?
spk02: Yeah, Richard or maybe Richard, do you have any commentary on that first?
spk12: Yeah. Hey, Miriam. Good morning. Thanks for the question. It's really early, right? So, you know, we're just beginning to get patients on. So it's, you know, what's difficult when you look early on is sort of at what point in time do you consider someone discontinued? And generally, most of our rules, we sort of have step up rules once a month has gone by without a refill or three months has gone by or six months. But You also have to recall that not every patient does get things in a standard order. So it's really too early for us to comment on this. And I think we're going to have to sort of get through probably a couple of quarters before we'll really understand a lot more of what that looks like.
spk04: Got it. That makes sense. Thank you.
spk10: And I'm not showing any further questions at this time. I'd like to turn the call back over to Greg Divis for any closing remarks.
spk02: Well, thank you, everyone, and thank you for your time and for joining us today on our second quarter call. Have a great rest of the day. We look forward to providing updates as we go forward. Thanks.
spk10: Ladies and gentlemen, so that concludes today's presentation. You may now disconnect and have a wonderful day.
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