Avadel Pharmaceuticals plc (AVDL) Earnings Call Transcript & Summary

Greetings, and welcome to the Avadel Pharmaceuticals business update conference call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Brandi Robinson. You may begin.

Good morning, and thank you for joining us on our conference call for Avadel's business update. 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 include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market entry and acceptance of products and the impact of competitive products and pricing. These and other risks are described more fully in Avadel's public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2021, which was filed on March 16, 2022, 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; and Richard Kim, Chief Commercial Officer. Tom McHugh, Chief Financial Officer, will also join us for Q&A following the call. At this time, I'll turn the call over to Greg.

Well, I think we lost Brandi, everybody. This is Greg Divis. I'll take it over from here. So thank you, Brandi, and good morning, everyone. And thank you for joining us on our call. The purpose of today's call is to provide an update on the actions we have taken since FDA notified us of their request to certify on the 963 REMS patent and our go-forward critical business priorities to ensure Avadel is positioned to fully capitalize on what we believe is a substantially larger narcolepsy treatment market for FT218, resulting in a potentially significant expansion in the number of oxybate-eligible patients who could be treated to the near exclusive benefit of FT218. Specifically, we will provide an update on the following key business matters. Number one, the status on the FT218 NDA and our plans to advance the final approval as soon as possible and we believe no later than June of 2023. Number two, we'll review the cost reduction actions we announced to ensure the company is in the financial position to bridge from today until mid next year and the potential final approval of FT218. And number three, we'll provide an update on our current view of the future once at bedtime oxybate market that we believe provides a significant opportunity to impact a larger potential patient population than currently being treated with twice-nightly oxybates. I'll wrap up with closing remarks, and we will open the call up for a brief Q&A session. Let me begin with the last topic because it is critical to understanding the true potential and value that FT218 offers. In short, we believe our launch and near-term target patient population who could benefit from FT218 is double that of the current twice-nightly oxybate market and ranges between approximately 30,000 to 35,000 potential eligible patients in the future once at bedtime oxybate treatment market. This total potential patient population comes from three distinct segments, which are as follows: number one, currently treated twice-nightly patients, which represents approximately 16,000 actively treated patients today; previously oxybate-treated patients who have discontinued therapy, which, in the last 3 years, we estimate at approximately 10,000 to 15,000 potential patients; and lastly, new to oxybate patient starts, which historically have averaged approximately 3,000 per year and is expected to grow by 25% to 50% over time with the introduction of FT218. We believe the once at bedtime narcolepsy oxybate market represents greater than $3 billion of potential value with all three patient segments expressing high levels of interest in FT218 and physicians and patients both clearly stating that once at bedtime dosing is the most important attribute, thus driving clear preference for FT218. If approved, we would expect to secure a meaningful share of this highly valuable and significantly larger future narcolepsy market. Richard will provide more details on this important market and patient segmentation analysis momentarily. So let's turn our attention to the status of the FT218 NDA and what we are doing to potentially accelerate FDA's decision on final approval. On May 26, 2022, we disclosed that FDA notified us of a requirement for the FT218 NDA to include a patent certification to a patent directed to a computer system for drug distribution, which expires June 17, 2023. We have submitted the requested certification while preserving our rights to challenge the agency with respect to its decision. We have been informed of no other remaining matters and have, we believe, agreed to final labeling and are completing the last edits to the REMS documentation, which FDA has recently requested. As such, we believe the granting of the tentative approval clears the path to a potential final approval no later than June of 2023 when this computer system patent expires and importantly so validates the clinical efficacy and safety profile of FT218 for people living with narcolepsy. In addition to certification, we have filed a motion to delist the REMS patent from FDA's Orange Book. We believe this computer system patent is wrongfully listed in FDA's Orange Book. And if the court agrees with us, the delisting of this patent could potentially accelerate a final approval of FT218. We filed this motion as part of the ongoing patent litigation in the U.S. District Court of Delaware. As a reminder, the court previously stated that claim construction would need to occur prior to making a decision on a delisting motion. In the litigation process, claim construction is currently scheduled for August 31, 2022, or in about 2 months. And lastly, we are evaluating other options to get to a final NDA approval before June 2023. And we will provide updates in the future if and when appropriate. So as we move forward, we are focusing our priorities and resources on the following. Number one, to evaluate and pursue all relevant strategies that can potentially accelerate the final approval of FT218 prior to June of 2023. This includes, but is not limited to, our recent motion to delist the REMS patent from the Orange Book. Number two, we will continue our key launch preparation activities with the objective of potentially shortening the time between final approval and commercial launch while maintaining mission-critical launch capabilities, including our work with patient groups, key opinion leaders and sleep specialists and, of course, payers. As we proceed forward, the certainty of labeling materials allows us to continue our manufacturing and inventory build of commercial supply. In addition, as we finalize the REMS program and related documentation, it will enable us to progress the build-out of our own proprietary REMS program, which also can potentially shorten the time requirements post approval. Number three, lastly, the third important priority is to ensure in all scenarios that we have the cash on hand to bridge us to what we believe is the outer date of a potential final approval in June of 2023. This includes the $26.4 million of convertible notes maturing in February of next year. We have already taken actions to optimize our cost structure, resulting in a $12 million to $14 million quarterly operating expense compared to our recent history of $21 million to $25 million per quarter. This includes a head count reduction of approximately 50%, which is designed to ensure we retain the required capabilities to achieve these near-term priorities. We expect to report over $100 million of cash on hand as of June 30, 2022, and the receipt of approximately $15 million of additional tax refunds. Thus, we estimate our cash runway will extend to a potential final approval in June of 2023. And finally, as noted in the press release, we expect to record a restructuring charge of $3 million to $4 million in the quarter ending June 30, 2022. Before I turn it over to Richard, I want to assure all stakeholders that we are determined and will not relent to bring FT218 to a final approval as soon as possible. We will take every appropriate action necessary to accomplish that and ensure the company is in a position to deliver on the promise of FT218 to all stakeholders, including patients, prescribers, our employees and, of course, our shareholders. To provide more details on our analysis and the market opportunity for FT218, I'll now turn the call over to Richard.

Thank you, Greg. I'd like to take a few moments to highlight the importance of what FT218, if approved, can mean for people with narcolepsy and to reinforce its long-term commercial value. Since the announcement of the FDA's decision, we have had the opportunity to speak with numerous patients and sleep specialists. What is unmistakably clear is their frustration regarding the FDA's decision to require certification to a REMS computer system patent. Also clear is the number of people who tell us they do not want to wait until next summer to have access to once at bedtime FT218 and have to wait longer for the opportunity to manage EDS and cataplexy without impacting the middle of the night that the dosing of twice-nightly oxybate do today. Their support, encouragement and recognition of the critical need to bring FT218 to market will continue to drive us forward. Today, we want to spend some time on this call to more deeply describe the different types of patients who could benefit from an innovative once at bedtime oxybate therapy and why we will not relent in our efforts to get FT218 to people with narcolepsy. We estimate that the current 16,000 patient twice-nightly oxybate market is worth roughly $1.8 billion annually. However, the patient volume in the market has been relatively flat. We believe the once at bedtime oxybate market with FT218 could be more than double the size of today's twice-nightly market. As Greg previously shared, there are three fundamental narcolepsy patient segments for the once at bedtime oxybate market, actively treated, recently discontinued, and new to oxybate patients, for each of which FT218 is exceptionally well positioned. First, the opportunity with approximately 16,000 active patients on twice-nightly oxybates for FT218 is an intuitive proposition for patients to reduce the nighttime burden of twice-nightly dosing with the potential for improved compliance and that could ultimately lead to more consistently receiving the full amount of daily prescribed oxybate therapy. We know from our patient research that twice-nightly oxybate patients show great interest in FT218 with 8 out of 10 Xyrem and 9 out of 10 Xywav patients being very interested in learning more about FT218. We conducted a second discrete choice experiment earlier this year that confirmed once at bedtime dosing when compared to either the twice-nightly dosing options was the most important attribute of driving both patient and clinician preference as well as patient quality of life and the reduction of patient anxiety. We clearly see in the market that the introduction of Xywav did not change the total number of patients receiving twice-nightly oxybates. And in fact, the oxybate narcolepsy market has been flat since its launch. To us, this is just another indicator that the market is still waiting for a transformative oxybate therapy. Now through our open label RESTORE study, we are learning about more of the specific challenges with twice-nightly dosing in patients who have now used both the twice-nightly oxybate and once at bedtime FT218. Our most recent poster at SLEEP show that 2 out of every 3 patients reported missing their second dose within the last 3 months, and that 86% of them felt worse the next day. Data points such as these and the future availability of once at bedtime FT218 will raise awareness as to the substantial problems middle of the night dosing poses to patients with a chronic oxybate therapy. One more data point that gives us even more confidence about how FT218 will be received by people with narcolepsy and sleep specialists is the clinical data we have on patients who switched from twice-nightly oxybate in the RESTORE open label expansion switch study of FT218. These things include results from polling 75 participants who switched from twice-nightly oxybate to once at bedtime FT218, assessing their preference for the dosing regimen. 3 months after switching to FT218, 93% of patients noted a preference for the once at bedtime versus the twice-nightly dosing regimen. Now our second key patient segment are those who have, over the last 3 years, discontinued twice-nightly oxybate therapy, of which we believe there are 10,000 to 15,000 patients. From our research, the biggest reasons for discontinuing therapy are lack of efficacy and the challenges with dosing, which we believe are very intertwined. We saw from RESTORE that when patients missed their second dose, the vast majority felt worse the next day. Our patient research shows that oxybate discontinued patients show a very high level of interest in FT218 with 6 out of 10 wanting to learn much more. The third segment are patients who are new to oxybates. Currently, our data analytics show that there are approximately 3,000 new to twice-nightly oxybate patients a year. These patients come from an even larger untreated oxybate patient pool, which represents a large segment for long-term growth in the once at bedtime oxybate market. In our discussions with sleep specialists, they tell us that FT218 would likely become the first oxybate offered to naive patients because let's face it. After 20 years of trying to normalize a person with narcolepsy, having to wake up 2.5 to 4 hours later to take a second dose, option to give patients the chance of a less interrupted night sleep is very appealing to people who are already suffering from inconsistent sleep. Furthermore, FT218, based on our research with patients and low or no oxybate prescribing sleep specialists, has the potential to expand the new-to-oxybate treatment patient population. Upon future availability of once at bedtime FT218 over the next 3 to 5 years, we could expect new-to-oxybate patient starts to grow by up to 25% to 50%. Surprisingly, but positive from our patient research, interest levels for patients who have never been treated for oxybate is also very high, with 7 out of 10 stating a very high level of interest in FT218. The #1 reason sleep specialists stated that patients refuse to take twice-nightly oxybate is that the dosing is inconvenient, and they feel patients could not handle a twice-nightly dose product. The current twice-nightly oxybate market really looks to a peak, which is really not a surprise after 20 years. All of our data and analysis shows the market is really looking for true innovation that will address the most fundamental constraint of current immediate-release oxybate that must be dosed twice a night. When we look at how once at bedtime FT218 is positioned across the three segments of patients, the actively treated segment or about 16,000 patients today, the recently discontinued segment of about 10,000 to 15,000 patients and the new-to-oxybate patients which we estimate at 3,000 and will grow to as much as 4,500 patients annually, we see the once-nightly oxybate market to be potentially be twice the size it is today at around 30,000 to 35,000 patients treated annually. FT218, if approved, is uniquely positioned to make therapy available to many more patients who currently can't or won't take a twice-nightly oxybate. My last and most important perspective is from the vantage of a patient. Let me share one of the many patient examples that we have of patients who have switched from a twice-nightly regimen to participate in RESTORE. We spoke with a young woman who is diagnosed as a teenager and cycled through a number of treatments as we know often occurs. Twice-nightly sodium oxybate was prescribed and helped but as she began college she would often sleep through her alarm for the second dose. As it relate to us, she was then faced with a decision. Skip the second dose altogether and experience debilitating symptoms or take the second dose and miss her morning classes. This patient has been in RESTORE since late 2020 and the difference in her life is profound. Now in this young women's case, she is currently attending college full-time. She is working, has taken her first overseas trip and is doing even more of the things she has wanted to do. She is one of the many voices we hear and are focused on for why we must get FT218 to the market so that people like her have an option -- a new option and new hope for new life experiences. Thank you. And now I'll turn the call back to Greg.

Thank you, Richard. The value proposition from a clinical perspective of FT218 has always been described to us as being quite obviously -- quite obvious. Not having to forcefully awaken in the middle of the night for a patient population already suffering from a condition that is hallmarked by disrupted nocturnal sleep is, as we have heard, a no-brainer. However, the commercial value proposition from just a pure market perspective has until recently been far less understood. And we spent the better part of the last 2 years confirming and validating these findings. So as I wrap up, let me leave you with a few key takeaways on why the Avadel investment thesis and specifically FT218 remains a highly attractive and underappreciated opportunity that we believe has the potential to make a difference in the lives of people living with narcolepsy who we are committed to serving. First, we believe FT218 has become a significantly derisked opportunity as based on what we currently understand all that remains between today and a potential final approval is a REMS patent, which expires in June of next year and may be disposed of potentially sooner. Number two, the potential number of people who could benefit from FT218 is well above the number who are currently treated with a twice-nightly oxybate and really represents a once at bedtime oxybate market opportunity that is approximately twice as large as the number of patients currently on the twice-nightly oxybates. Based on extensive patient and physician response to FT218, if approved, we would expect to earn a meaningful share of the potential $3 billion plus market opportunity. Number three, the runway for the FT218 franchise, including its current intellectual property portfolio, which extends out to mid-2037, coupled with the life cycle management opportunities, including the preclinical stage program we are advancing as a proprietary once at bedtime no sodium oxybate formulation, plus the prospects of other indications to be studied in the future, creates a potential meaningful runway of value creation for all stakeholders from patients to shareholders for what could be the next 2 decades. And finally, we have urgently taken the necessary actions to create a cash runway to bridge to a potential final approval in June of next year. This opportunity is too significant to not do all we can to accelerate FT218 to a final approval and realize our mission of transforming medicines to transform lives by serving this narcolepsy community with the innovation and opportunity they are looking for and the potential value creation that our shareholders deserve. I'll finish my remarks by extending my sincere gratitude to our employees who have worked with tenacity and passion and dedication to bring FT218 to this stage. All of your efforts and accomplishments will be used to get FT218 over the finish line and to the patients that we intend to serve. So thank you all for joining our call. And with that, we'll open it up for questions.

[Operator Instructions] Now the first question coming from the line of François from Oppenheimer.

So just the first one here is if you're already kind of agreeing upon the REMS and the final label, can you just help us understand what a tentative approval would add on top of that? And then I guess 2 part to it is, in general, from certification, how long does it usually take? Obviously, timing has been complicated, and we never quite know. But in general, how long would it take before we hear about a tentative approval?

Yes. Thanks. Frank, as we continue what we describe these last remaining administrative matters related to -- prior to receiving a tentative approvals such as completing the REMS, what tentative approval grants is, in essence, an agency action. It deems that we should be fully approvable, but for the matters that are described in the actual tentative approval communication, which, at this point, we expect to be just the 963 patent that we've referenced relative to the certification that we have filed to that patent. And thus, we should be able to move to a full approval when that patent expires or dispose of or dealt with in another manner. So the benefit of tentative approval is finalizing much, if not all, of the NDA, but for the remaining matters described in the TA which also we've been communicated to at this point as been this 963 patent. In terms of timing, we certainly believe, as we complete these final matters, there's -- we should be in a position to be granted a tentative approval at any time, right? We don't believe there's -- we've done all the requisite administrative, if you will, requirements from a certification standpoint that are necessary before TA can be granted. So those things have been completed. So there's nothing left in front of us at this stage, but for completing these final related documentation matters that we've described. So in terms of timing, again, that's in the hands of the FDA. And we'll certainly communicate as that happens, and we'll certainly continue to press to get this done as soon as we can.

Okay. Great. And then just on the -- so just to be clear, the tentative approval doesn't necessarily change your chances of getting an approval before this June '23, correct?

Yes. I think, again, what it does is says that, but for that matter, you're fully approvable. And when that matter is resolved, we can take the action to move to a final approval.

Okay. And then on the other case of -- can you tell us when you filed the motion to delist the current REMS?

Yes. It was refiled again at the -- last week, I think last Thursday, at the -- towards the end of the day last Thursday. And there is a process that proceeds as it relates to that, which coincides in parallel with, if you will, the Markman hearing that's occurring on August 31.

Understood. And just -- sorry for all these questions on timing here. But in terms of -- from that -- from the Markman hearing at the end of August, is there usually kind of a window of how quickly something can get approved after a hearing like this?

Yes. So maybe we'll try to generally describe kind of the timing of what could potentially happen, recognizing that those are decisions and timing that are in the hands of, in this case, would be the court. And certainly, we'll be at their discretion. But on August 31, there will be a hearing on claim construction and -- which will cover a number of different terms that will be assessed, including this 963 patent. The court could rule on that matter specifically on that day. They may take a little bit of time, but it really is a two-step process. One is the Markman hearing, which, if the court agrees with our position on the claim and the terms related to the 963 patent, then the next step would be, which we will have filed, a motion for the court to rule on delisting that patent. Once that occurs, whether it occurs at that point in time or shortly thereafter or some other time, once the court issues the -- if they agree and issues the order to delist the patent, the other party has 2 weeks, as we understand it, to actually take that action.

And our next question coming from the line of David Amsellem with Piper Sandler.

So just had a couple. First, as far as the actual approval itself, the final approval, can you talk about the turnaround time to actually implementing the REMS and then being in a position to launch? So let's just say that you don't accelerate the approval and you just get the final approval next June, do you think that -- with this delay, if you will, you will have had some time to work through some of the -- at least some of the REMS implementation? And I guess the bottom line, the question is, how should we think about the lag time between final approval and your launch? So that's number one. And then number two, and I know you've talked through this a number of times but I think it'd be helpful to further elucidate this. With an authorized generic in the market at some point next year, how do you think that changes, if it changes at all, your view regarding payer contracting? And what do you think -- does that change -- sorry, does that change how you think about net realized price, if you enter the market with an AG that already has a more established presence?

Yes. Thanks, David. So from a timing perspective, if we go to June of next year, there's a lot we can get accomplished between now and June, in particular, around our commercial supply and around our -- the build out, if you will, of the REMS. What we won't be able to do until we have a final approval is go out and train and certify physicians to be able to use our program. So assuming -- previously, our assumption was we weren't going to start to build until post approval, which would take us a handful of months and then a couple of months and thereafter to get everything kind of fully operational and physicians in a place to be able to prescribe. Ideally, assuming things go as they could potentially go, we could build it in advance and then spend a couple of months certifying and training as we build the organization accordingly and be in a position sometime after that to come to market. So I do think we can reduce the time period from what was going to be 6 months or so to something less than that for sure. It really will depend on how much we can get accomplished during that window, recognizing that we should be able to buy some of that time back. We're not going to be able to buy it all back, but we should be able to buy a good piece of it back. As it relates to your question on AGs, again, I think the first comment I'll make is that we've always contemplated in all of our research with all physicians and patients and payers that we will be in the market with the presence of an authorized generic, whether it's at the same time, before us or if there was a case it was ahead of us or we were ahead of them. So that was always going to be a situation for us. So from our perspective, it doesn't change our view on the market opportunity and how we view it. It's still a twice-nightly product. Again, I think that we'll have to see what the net pricing is of that authorized generic when it does come to markets from that standpoint. As we talk to payers today, I think their expectation is that it will be priced similarly to a typical authorized generic, if not a little bit higher. And therefore, we expect it to be treated comparable to the current oxybate access within payers today, which is what our strategy is, is to be at parity access. So from our perspective, we've had a lot of good discussions with payers from that. We don't view the AG as a barrier to us from that standpoint, and we view those patients every bit an opportunity to potentially come on FT218 as we come to the market as well. So let me just see if Richard -- I should ask, Richard, if you have any comments. Richard?

No, I think that really highlights well. And we also know that the economics of the AGs really are not that generally attractive for the payers as well. So to Greg's point, we have built all of our plans, assuming it's going to be there. So this timing really won't affect any of our plans to come to market.

Our next question coming from the line of Ami Fadia with Needham.

Can you hear me okay?

Yes, we hear you, Ami.

Okay. Great. Can you give us a sense of, in your viewpoint, what's the likelihood of being able to get the patent delisted and be able to launch earlier than the June -- well, at least have the final approval earlier than the June time frame? And how much earlier would that be, if that's possible?

Yes. Well, I think the first answer to that is that we wouldn't be filing this motion if we didn't think that it was inappropriately listed in the Orange Book and we didn't believe there was a basis for that -- for our action. So we do believe our view on that. I won't try to speak for the court, but we wouldn't be taking this action if we didn't think that we were in the right relative to our position on that patent specifically as it relates to what our eligible Orange Book listable patent. In terms of timing, again, I think the way a scenario -- whenever the court -- if the court rules in our favor, and there's a final action where the patent is delisted, in parallel, we would be communicating the status of this with the review division because there is a process that you formally take as you move from tentative approval to final approval that is really at the responsibility of the sponsor, in this case, us, to advance the NDA from its current state to a final state. So if we were thinking about doing what the timing of that would be leading up to, say, if it went all the way to June, we would start that process a few months before the actual date of June. So if you assume it's going to take the FDA some period of time, at least that's what's described to us, it could come -- again, it depends on when the final action is made and how long the FDA has, but it perhaps could come as early as by the end of next year -- of this year. Maybe it will trickle into the first quarter of next year. But in any case, it's obviously before June of next year.

Got it. And you've obviously announced a sort of a cost rationalization effort today. How does that impact your readiness prior to getting final approval? And also conducting some of these prelaunch activities such as building on the REMS program to the extent you can, supply -- launch supply, so on and so forth, are those activities included as part of your revised spending projection?

Yes. The restructuring activities and the unfortunate decision on some of our team members, it really has been done from a perspective of making sure we retain the necessary capabilities that -- to continue to progress our launch readiness. All of those things you described from REMS to supply, payers and whatnot are all part of our -- of the plan as we go forward to ensure we have the capabilities and the requisite expertise to execute those from that standpoint. So we do believe we continue to make progress. There's been a lot of launch-related investment made over the last 18 months to put ourselves in a position to go to the next stage when we head toward a, if you will, a final approval. . A lot of that is ready to go. Some of that will be paused now as we progress through the next number of months to get to a final approval, but it's certainly in a position where it can be reactivated accordingly. And we certainly are retaining the requisite capabilities to really lead that and move that and advance that. There certainly is going to need to be some building back of capabilities and the addition of kind of our customer-facing roles, our reps and whatnot as we head toward an approval as well. But we do believe that the way we've structured going forward, we can execute on these near-term priorities.

And our next question coming from the line of Paul Matteis with Stifel.

This is Alex on for Paul. I guess to follow up on the last set of comments, I was wondering if you could talk a little bit more specifically on expectations for how much it actually cost to set up a REMS program and whether you're working on doing that now or it's gated for some time in the future and what that gating is in your view? Along with that, I was also wondering if you could talk a little bit about your expectations for inventory build and when you might start building that commercial inventory up?

Yes. So there's been a lot of work done already, Alex, on both of those. And what we plan to do going forward as we advance with final labeling, final packaging, final artwork and whatnot and a final REMS program as we finish this last negotiation, if you will, and back and forth with the FDA on these final edits, what that provides us with a tentative approval is those final documentations that will allow us to advance those programs beyond where they are today. So there's been a fair amount of investment already in both of those. Let's take each of them, respectively. We've gone as far as we can on REMS without having final documentation. Once we have final documentation in the form of a tentative approval, at the right time, we'll begin to build that. I think we would measure that. And there's kind of two stages to that, right? The first one is actually kind of operationalizing the program, which will take us 3-plus months, 3 to 4 months. It would cost us likely in the low -- very low single-digit millions of dollars and -- as we would estimate it. And so that will be something we will take to the next stage as we -- during this period of time that's contemplated. Again, the next phase after that, once it's built and validated, would be the training of physicians and certification of them, which won't happen until after a final approval. As it relates to inventory, we've been making a lot of -- as we've said previously, we've been making supply in the form of what we'll just characterize as our bulk immediate release and controlled release beats. So we've been making a lot of that to support the market. What we haven't done yet until we have final artwork and packaging, which we do believe we'll have now and we'll have upon tentative approval, is, again, begin to blend that into daily stick packs and our daily primary packaging. So that will be the things we work on between now and a final approval. And then upon final approval, we should be in a position thereafter to have inventory ready to go for the market. But what we didn't want to do now until we have final approved packaging is put bulk product that's been made into a final packaging that isn't confirmed, right, because then that product is lost. So as we go to tentative approval, we get final artwork and packaging, we'll be able to go to the next step on supply as well.

Great. And maybe one follow-up. Could you give us an update on the status of some of the other patents that Jazz has filed over the last year or so? And whether you view those as a risk moving forward? Or is this sort of cleared the deck in your view?

Yes. So I won't speak on anything related to those patents or the ongoing litigation, as it relates to those other patents outside of the REMS patent. But none of those patents are related to their current product in the marketplace and, therefore, aren't -- currently aren't listed patents or any patents related to our current application.

Our next question coming from the line of Oren Livnat with H.C. Wainwright.

I have a couple. Firstly, upon tentative approval, whenever that comes, hopefully very soon, should we expect to see that final label?

I don't know if we will actually provide a final label at this point -- at that point in time. I would say probably not likely until we have final approval. But we do believe the label is in a good place now.

Okay. And just to confirm. You talked about doing the final edits on the REMS, but -- and maybe it's in the PR, I apologize. Is that label, as far as you know, finalized pending approval, like you've accepted final edits, et cetera?

Yes. Yes. From our perspective, and our exchange with the FDA, we've accepted their final edits. As part of that, we confirmed clearly that there isn't -- the way our label is drafted effectively navigates and deals with appropriately the other Orange Book listed patents around drug-drug interaction. And we view that, that is in its final form. And now we're wrapping up REMS-related documentation.

Okay. And I know we've talked about how, in your mind, this is extremely derisked now at this point despite the headaches of a potential delay. But just to confirm, is it your understanding that upon final approval -- or sorry, tentative approval, does that put the orphan drug issue to rest as well, both from the perspective of whether you are blocked -- not blocked by Xywav exclusivity and also maybe whether you'll secure your own upon final approval?

Yes. We don't believe there'll be a final arbitration or decision on orphan drug until we're at a stage of final approval. And the reason for that, in our view, are quite obvious because between now and then things could change. Regulatory policy or law could change that may affect the way FDA looks at orphan drugs on a go-forward basis. That being said, I would say that we certainly believe FT218 will be granted its orphan drug exclusivity. During the review of FT218, we've had the opportunity to engage on this specific matter directly with the FDA. And we've always stated, even during the pendency of the delay, when many people thought the delay was due to orphan drug, we never believed it was due to orphan drug based upon that interaction with the FDA. So we believe the orphan review is complete from a substantive nature. We haven't been informed of any issues or concerns, nor do we expect it to be referenced in our tentative approval. But at this stage, we don't believe that is a barrier, but it's not formally decided upon or ruled on officially we believe until there's a final approval.

Okay. And lastly, just as we talk about sort of derisking and your freedom to operate, I guess, assuming that 963 patent is either delisted sooner or we're sitting in June and it's expired and is irrelevant, are you prepared -- since we all know there's ongoing litigation, the merits of that can be debated from Jazz asserting other patents, are you prepared to launch upon final approval at risk such that do your legal advisers give you -- and your advisers give you confidence that there would not be any TRO or preliminary injunction that could lock you once approved?

Well, we can't speak to whether a PI will be filed or not. We don't expect if one is filed it will be a barrier to us coming to market. And the short answer to your question is, yes, we will launch at risk.

Our next question coming from the line of Matt Kaplan with Ladenburg Thalmann.

Just wanted to dive a little bit more into some of your guidance with respect to operating expenses of $12 million to $14 million per quarter. If we think about the inventory purchases, can you quantify those for us on a quarterly basis or over -- what you're expecting into next June over the next 12 months in terms of those expenses?

Yes. Well, I'll turn to Tom and ask Tom to answer that.

Yes. So with respect to the $12 million to $14 million of -- it's cash operating expenses. It's probably going to take 2 to 3 months to get to that lower run rate. On the inventory purchase, we haven't quantified that at this point, Matt. We certainly have baked it into our cash forecast, and those expenditures should get us to a final approval, potentially as late as June 2023. I would say that if you look at our historical purchases of API, which get reflected in R&D, it's probably representative of what you might see on a quarter-to-quarter basis.

Okay. That's helpful. And then thanks for all the detail in terms of the process associated with the Markman hearing and the potential motion to delist the REMS patent afterwards. Can you give us a little bit more detail in terms of what other levers you could potentially pull beyond that avenue, that pathway to potentially have approval before next June?

Yes, Matt, thanks for the question. I would say at this stage, we're probably -- it's not probably appropriate to discuss that at this stage. But when and if that becomes relevant, we'll certainly let everybody know.

Our next question coming from the line of Robin Garner with Craig-Hallum.

You mentioned the expense reduction that you will be able to achieve in 2 to 3 months. Can you share how much cash is needed to be on hand for a successful launch? Whether that's now or next year?

Tom, do you want to address that?

Yes, sure. Yes. So Robin, very fair question. I would answer it this way. We're not, at this point, going to provide specific guidance on how much cash we need to raise. I just leave it as that we certainly -- we can't contemplate the capital raise in our future. Our focus right now is making sure we have the cash runway to get from now to a final approval. And then when the time's appropriate, we'll be looking at different types of financing opportunities for the company.

Okay. And additionally, do you have any update on your notes and whether any of them have been further made exchangeable notes? And an update on the sub '23 notes coming due?

So we have -- nothing has really changed with respect to the convertible notes. We have $143.8 million in total. And to your point, $26.4 million of those mature in February. We -- as Greg mentioned during the prepared remarks, we have contemplated that in our cash planning scenario. $117.4 million we had extended the maturity out to October 2023. I would say with the potential for final approval in June 2023 or earlier, the maturity of those dates coming after final approval is an important thing to note. But nothing has changed with respect to -- really with respect to those notes since they were issued, and then when the maturity was extended.

And our next question coming from the line of Adam Evertts with LifeSci Capital.

On the commercial side, can you give any more details on the 5,000 narcolepsy patients enrolled in the disease state program? Are those oxybate-naive, currently on oxybate or have tried and stopped in the past?

Yes. Richard, do you want to answer that?

Sure. Thanks for the question, Adam. Yes. I mean, it's been really quite overwhelming to sort of see the response to our disease campaign, Narcolepsy Disrupts, and to narcolepsydisrupts.com. So yes, when we look at the thousands of patients in there, what we have is a representation of who is in there. And what's really cool to see is we do have, I would say, a decent portion of currently on oxybate patients. But by far and away, the largest segment of identified patients who have enrolled or enlisted are patients who are de novo to oxybate as well. So it really gives us confidence in the fact that we're -- we have mechanisms to get to -- and we have, at least up to this point, been in the offices of the current oxybate prescribers, have met with them at congresses. But I think what we're feeling very good about is that our digital campaign is reaching beyond the oxybate experience patients and also getting to current narcolepsy patients who are de novo to oxybate. So that's why we also feel good about the potential for the future growth of that segment as we go forward as well.

And maybe to follow-up on that, Richard. I guess, what's sort of different about your approach for the unique segments of patients? Is there something -- some strategy you'll use to go out and access this sort of larger additional population that has maybe tried an oxybate product in the past, didn't work for them? What sort of techniques or levers can you use there to fully engage those patients?

Yes. Adam, I think what we've really done, if we really think about sort of our culture at Avadel is we're just being very authentic in our communications to folks. If you look at our narcolepsydisrupts.com, we've just released a new video that really describes the life of a person with narcolepsy and sort of all the challenges they have. And I'll tell you, Adam, we had a patient group that actually gave us input into the video. And they were curious when we showed them afterwards because they said in less than 60 seconds, that's maybe the most concise way I can describe what happens to me when I plan for something that I can't do and people text me saying where are you? Why aren't you here for this meeting that we're having? And I really think it's that. So the good news for us when we get there is like we know where these oxybate experience patients are because there are less than 5,000 physicians who have prescribed any oxybate in the United States. But what we're seeing now is our digital reach is being able to go beyond that as well. So coupling our ability to sort of target those oxybate offices and then go beyond with our digital experience as well, we feel like there's great ways we can communicate to both those who are oxybate experience and those who aren't. And it's really like -- I think it's just the tone of our messaging when we give it to the different segments as well. But the underlying commonality across all these segments, as these people who are cycling with narcolepsy, they want the option to actually have a greater opportunity to have more normalcy in their life. And we believe that if FT218 is approved, this clearly gives them that opportunity to manage the daytime symptoms without sacrificing as much in the evening.

I am showing no further questions at this time. I will now turn the call back over to Mr. Greg Divis for any closing remarks.

Yes. Thank you, and thank you, everyone, for joining us today. We appreciate the opportunity to share this update. And we're certainly available for any follow-up as necessary. Maybe the last closing remarks I'll make is that we are committed to doing all we can to put the company in the best possible position to bring FT218 to the market as soon as we possibly can, supporting the patients who are in need of this treatment and doing what we can that will create the necessary and requisite and well-deserved value for our shareholders. And we'll certainly keep you updated as we go forward. And again, appreciate the time this morning and look forward to any follow-up. Thank you, and have a great day.

Ladies and gentlemen, that does conclude the conference for today. Thank you for your participation. You may now disconnect.