Avadel Pharmaceuticals PLC (AVDL) 2021 Q2 法說會逐字稿

Greetings. And welcome to the Avadel Pharmaceuticals second quarter 2021 earnings call.

(Operator Instructions)

As a reminder, this conference call is being recorded. It is now my pleasure to introduce Courtney Turiano. Thank you. You may began.

Good Morning and thank you for joining us on our conference call. This morning we issued our press release providing a corporate update and financial results for the quarter ended June 30, 2021. the release can be accessed on our website www.avadel.com.

As a reminder, before we began, the following presentation includes several matters that constitutes forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that can cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that product 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, 2020, which was filed on March 9, 2021, 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; Tom McHugh, Chief Financial Officer; and Richard Kim, Chief Commercial Officer. Dr. Jennifer Gudeman, our VP of Medical and Clinical Affairs, will additionally join us for Q&A following the call. At this time, I'll turn the call over to Greg.

Thank you, Courtney. Good morning, everyone, and thank you for joining us on our second quarter 2021 conference call. I will begin by providing an update on our business, highlighting the significant progress we continue to make towards the potential approval and commercialization of FT218 are once at bedtime treatment for managing the symptoms of narcolepsy. I will then turn the call over to Richard, who will provide an update on our commercialization and launch planning as we move closer to our October 15 PDUFA date. Lastly, Tom will review the financial results for the quarter. And we will conclude with a Q&A session, where we will be joined by Jennifer.

This has been an important quarter of progress for Avadel, particularly as we enter the final stages of NDA review and look toward our assigned PDUFA date of October 15. If approved, FT218 will be the first and only once-a-bedtime option for managing excessive daytime sleepiness, or EDS, and cataplexy in adults suffering from narcolepsy. We are excited that we are only just 2 months away from October 15, and I am incredibly pleased to report we remain on track across all of our business priorities, all aspects of our NDA progress, legal and regulatory planning and execution, organizational and capabilities expansion and of course, our launch preparation and readiness, continue to advance to support the future potential commercialization of FT218.

As a company and a team, we have consistently delivered against our key business objectives for the last 30-plus months to ensure we would be exactly where we are today. 60-plus days until our PDUFA date, and we are excited for the next 2-plus months and beyond have in store for Avadel, for patients living with narcolepsy and for our shareholders as we continue to advance our vision of bringing once-at-bedtime FT218 to the market. This, of course, starts with our FT218 NDA and related regulatory filing strategy. As we have stated before, we have developed and strategically executed our FT218 regulatory filing such to effectively navigate any potential barriers or regulatory issues related to this 505(b)(2) filing.

To date, and to be clear, we have not been asked by the agency to certify Paragraph IV against any Orange Book listed patents, and we don't believe, based on the data we have generated and the regulatory filing strategy we have deployed with our NDA submission, there is any basis to request such a certification. Said differently, as we have stated previously, on this matter specifically, no news is indeed good news, and I am pleased to share we have nothing new to report.

To date, our exchanges with the FDA continue to advance forward and are pleased with the progress and how the review has gone to date. Based on this, we remain confident in our regulatory filing strategy. In parallel, in anticipation of a potential FDA approval, we are diligently preparing to bring FT218 to market, and we remain on track with the launch and commercialization plans. We continue to be energized for the feedback and insights we are gathering on the importance of FT218 as a potential treatment option for people living with narcolepsy. As such, we remain confident in the market potential for FT218, if approved, and based upon our extensive research, the opportunity for FT218 to command a meaningful share of the narcolepsy treatment market.

On the clinical front, during Q2, we announced new data from the pivotal Phase III REST-ON trial at SLEEP 2021, all of which continues to support the clinical benefit of FT218 at all doses evaluated. As a reminder, we have previously shared the overwhelmingly positive top line data from the pivotal Phase III REST-ON trial which demonstrated the unequivocal statistically significant and clinically meaningful benefit of FT218. FT218 met all 3 co-primary efficacy endpoints compared to placebo for all 3 doses evaluated, was generally well tolerated and delivered clinical benefit as early as week 3 of treatment.

The strength of these positive co-primary results are further bolstered by additional secondary end points as well as post hoc analysis presented at SLEEP 2021, showing a consistent positive effect of FT218 regardless of whether participants had narcolepsy type 1 or type 2 or if they were receiving a stable dose of stimulants or not. Additionally, patients dosed with FT218 experienced a significantly greater decrease in weight and body mass index from baseline to study end compared to placebo.

These additional data strengthen the body of evidence that if approved, FT218 has the potential to be a transformative treatment option. As we proceed through the remainder of 2021, we expect our pivotal Phase III data to be published in a leading peer-reviewed journal and expect additional FT218 clinical data to be presented at future scientific meetings in 2021 and 2022.

To sum up, I'm extremely proud of the tremendous progress we have made as we seek to establish our investigational once-at-bedtime FT218 as a treatment of choice for health care practitioners treating and for patients living with narcolepsy. Our plans to date remain on track, including our regulatory filing strategy, and we look forward to the next 60-plus days as we head toward the October 15 PDUFA date in our pursuit of FDA approval and a potential commercial launch.

With that, I will turn the call over to Richard. Richard?

Thank you, Greg. As I look back on what we have accomplished at Avadel, I continue to be extremely pleased that we are on track for our full launch execution and that we continue to hear from the customers that we are engaging with about the tremendous opportunity for FT218 to provide a meaningful treatment option for people with narcolepsy.

When I look at our overall launch preparations, we have made some significant progress in the last few months. First, we continue to build a top-tier team to support the potential launch of FT218. We are so impressed with the caliber of candidates and ultimately, the people who are joining us to deliver our launch. I am pleased to say our entire commercial leadership team is now in place with the recent additions of our heads of marketing, sales, market access, distribution and more.

This quarter, we also hired our first of regional sales directors, a key milestone as we begin to build out the direct customer-facing commercial team. Collectively, we are building a really strong team of highly experienced leaders who are also attracting even more talent to the company and furthering our objective of putting patient success at the core of what we do. Second, on the distribution front across REMS, our patient service hub and specialty pharmacy work, we are achieving all of our milestones to ensure our network is ready and will deliver customer-focused world-class support for our target full launch in 2022. Third, we are building the infrastructure needed to support our full launch team with both internal and external capabilities. We are building our CRM or Customer Relationship Management tools, as we continue to augment virtual customer enhancement tools, in addition to supporting face-to-face interactions and are building our data analytics platform that will enable us to leverage highly connected customer data in our efforts to make better and more timely decisions as we go through our launch.

As important as our launch build-out is, nothing is more important than the time we are engaging with physicians, payers and patients. When we have done our share of advisory boards and virtual meetings, we have really pressed to meet our customers where they are. For many of the leading narcolepsy physicians, we have now had several meetings face-to-face at their sites across the country, including Jennifer's MSL team which has been fully active since the SLEEP Congress in June.

From a patient perspective, in recent weeks, we have met with leaders from some of the key narcolepsy advocacy groups to really understand what is important to them in not only working to bring a new therapy to market but also in how to activate the narcolepsy community. With that in mind, we have just rolled out our first corporate narcolepsy campaign showing, that at Avadel, we are working to make the dreams of better days and nights a reality.

Also, as a reminder, World Narcolepsy Day is September 22, just a few weeks before our PDUFA date.

Turning to another core customer group. We have significantly stepped up our activity with payers. The discussions we are having with the GPOs and PBMs have been insightful as some of the largest payer groups across the country have expressed high interest in engaging with us to learn more about FT218 and Avadel as we prepare to come to market. While we continue to hear in our customer interaction is very consistent with our market research that shows that once-at-bedtime FT218, if approved, has the potential to address an unmet need that currently approved narcolepsy treatment options simply cannot. Additionally, our data shows that the introduction of a once-at-bedtime sodium oxybate have the potential to gain a meaningful share of the narcolepsy treatment market as well as expand the utilization of oxybate with current prescribers.

To summarize, I am really pleased with our progress in our launch preparations. We are on track for our launch readiness, and are now connecting with more of our core customers than ever. Throughout all of our conversations and data that I have looked at, I continue to appreciate the simplicity of what a once-at-bedtime treatment, if approved, could do to be so transformative for people living with narcolepsy. We plan to provide more detail on our commercial plans following potential approval of FT218, and I look forward to providing further updates on our progress throughout the year.

I will now turn the call back over to Tom to provide an overview of our financial results for the quarter.

Thank you, Richard. I'll provide a few highlights for the quarter and full financial results are available in the press release and the 10-Q. From a balance sheet perspective, we ended the quarter in a strong cash position with $202.8 million of cash, cash equivalents and marketable securities. And as a reminder, we have $143.8 million of convertible debt that matures in February of 2023.

Turning to our income statement. We did not record any revenue in the quarter ended June 30 2021, and we also do not record any expense for cost of products, intangible asset amortization and changes in fair value of contingent consideration as a result of divesting our portfolio of sterile injectable products on June 30 of last year. With respect to the change in our operating expenses on a year-over-year basis, R&D expenses were $6.8 million in the quarter ended June 30, 2021, compared to $4.1 million for the same period in 2020. The year-over-year increase resulted from pre-NDA approval activities, primarily the purchase of raw materials.

SG&A expenses were $15.2 million in the quarter ended June 30, 2021, compared to $7.1 million for the same period in 2020. The year-over-year increase is a result of a number of factors related to preparing for the approval of FT218, and if approved, its launch in 2022. These costs include marketing, market research and medical affairs activities as well as higher compensation costs associated with expanding our organization. As we continue our preparations for approval and launch, we have expanded our team. And as of June 30, we have close to 50 people versus a little over 30 a year ago.

Income tax benefit was $3.8 million in the second quarter of 2021 compared to expense of $5.3 million in the prior year. In the prior year, we recorded income tax expense due primarily to the gain recognized on the sale of the sterile injectable product portfolio.

Net loss for the second quarter of 2021 was $19.9 million or $0.33 per diluted share compared to net income of $30.9 million or $0.49 per diluted share in the same period in 2020. We reported net income and diluted income per share last year primarily due to the $45.8 million gain from the sale of the sterile injectable products.

Finally, as Greg and Richard both remarked, we are incredibly pleased with our progress and execution against our overall strategic plan. With a little over 60 days remaining until a potential approval, we believe we're in a strong financial position with over $200 million of cash on hand to fund the financial investments we need to prepare for the launch of FT218.

Before Greg provides his closing remarks, we're going to open the line for Q&A. Operator?

(Operator Instructions)

Our first question comes from Paul Matteis with Stifel.

Great. I was wondering if there's any more detail you can give on discussions with the FDA around things like drugs or interaction or just kind of what your REMS might look like. And then second, on launch timing, assuming the drug is approved on time, and that there's no 30-month stay holds, how are you guys thinking about when you actually would formally commence a launch? I guess there's 2 variables in our minds. One is obviously DEA scheduling, which is more administrative. But the other one is if there are any ongoing lawsuits that haven't been resolved, would you still kind of launch through that, I guess, so and so at risk?

Yes. Thanks, Paul. Thanks for your questions. As it relates to the NDA process and specifically around DDI and REMS, although we won't go into any specifics on any one of those, I think we remain very confident in the progress we've made on those 2 fronts and how that ties to the overall regulatory strategy as it relates to gearing us to a full approval. We remain quite confident that the FDA has looked at every aspect of our NDA to date. We certainly appreciate the engagement we've had with them on a number of topics and feel really good about both the content and the context of the questions we received to date and how we've progressed the NDA review to date going forward, recognizing we're down to the last kind of 60 days, which we're obviously very pleased about.

As it relates to launch timing, I think there's a couple of things that you referenced that are things that we have to do to be ready to launch, whether that be DEA related or whether that be the build-out of our REMS related, a lot of that dependent upon completion of the label and to a certain extent, the final approval. And I think there's good analog data relative to the references to drug and the time it takes from approval to launch to complete some of that work. And obviously, we're building something from the beginning. So again, we feel really great about the team. We've assembled the progress they've made and where we are at this stage relative to that.

As it relates to the legal considerations, although we won't speak specifically about the litigation, our strategy or whatnot. What we will say is that should we -- upon a full approval, absent a judge telling us otherwise, even if the final patent matter is not resolved as we sit here today, we intend to launch.

Our next question comes from David Amsellem with Piper Sandler.

So one wildcard in the oxybate space is that, as you know, as Xywav gained share. It is possible that authorized generics for Xyrem could enter the market earlier than 2023. So assuming you're able to launch in a timely manner, there's no 30-month stay, et cetera, but also assuming that there's an early entry of AGs, how does that change market dynamics, if at all? Or how do you think about launching into a space where there are AGs of the legacy (inaudible) and your view at all on how aggressive you'd be with payer contracting, et cetera. Just help us understand your process in that scenario.

Yes. Thanks, David. Appreciate it. Richard, do you want to start on that, perhaps, and I'll add any commentary?

Sure. No problem here. Thanks, Dave. So yes, it's a great question. Obviously, we won't comment exactly on when an AG could be on market. However, we've been making our launch preparations with the assumption that there either will be one or there will not be one by the time we come to marketplace. And I guess what we can say overall is if there is an AG, even with both Xyrem and Xywav by the marketplace, they're all clearly still going to be constrained by being a twice-timely oxybate.

We've had really, really good engagement with the payers thus far and we're only stepping it up. And we are absolutely clear that the Paris definitely see the clinical value proposition, the strength of the data that we're bringing to the table. And we've been very clear, and I think they've received that this is clearly not a convenience play at all. So our conversations go very well. And at best, we sort of see the AG still being like most being potentially a high-cost generic in the marketplace. And overall, it doesn't really change the treatment landscape dynamics. So we're ready for it if it comes or if it doesn't, and it really won't meaningfully change what we do in the marketplace, maybe with the exception of a few insights that we have with our payers. And I know Greg if there's something for you to add.

Yes. I think David, at the -- in all of our work we've done, we've contemplated, as Richard noted, that event is going to occur. We're not sure when or what the trigger is, that's not information that we would know. But as we engage with all stakeholders, we're obviously considering that -- And when you think about how it affects our pricing, our contracting strategy, a large part of that, if that AG comes before us, will be predicated on what that net pricing or the net cost of the plan is going to be relative to the oxybate category. We saw earlier this year an 8.5% increase in price on the twice-nightly Xyrem product. And so we now know there's a price differential that exists. And we certainly have come to appreciate that it sounds like there's going to be a sharing of whatever margin is left on that AG between the references to drug holder and their AG distributor. So I think our current assumption in talking to payers is that pricing is likely going to be more typical from an AG perspective, which may be 15% to 20% off of where the brand is, and that will establish a price point to get into the marketplace. So...

Okay. And if I may just sneak in a second question on, in terms of the commercial landscape with Xywav continuing to take patient share, do you intend to focus on patients that have not yet been switched over? Do you think there is potential to pull from patients who had been switched to Xywav. Help us understand how you think about where you can grab patients or oxybate experience.

Thanks, David. Richard, do you want to start again?

Sure. Yes. No, once again, so I think overall, what we see generally with people with narcolepsy, they are generally interested in adjusting their treatments until they really get to a certain level of satisfaction with the results that they're getting from their therapy. So it's not a surprise to us at all that there has been some shift from Xyrem to Xywav. Overall, we absolutely are here to see the opportunity still to have those patients be considered for FT218, if approved -- the reality, as you know, David, is they're still receiving a twice-nightly oxybate, and that really doesn't change the fundamentals of their treatment. So despite the fact that there has been some switches, we see opportunities definitely within patients who have already made the switch to Xywav and also patients who have not. Anyone who's on twice-a-night oxybate, we'd absolutely consider for a key target to be considered for treatment with FT218 once approved.

Yes. I think the only thing I would add to that is we obviously continue to assess the marketplace and have recently come off of really large, very recent research projects, talking to hundreds of physicians explicitly around this topic. And we feel really good about where the source of business can come from, both in terms of patients who are de novo or naive to sodium oxybate, but also those patients on a twice-nightly product. So again, I think relative to how the landscape has changed recently. So I think all of that, again, bodes well for the commercial opportunity for once-at-bedtime FT218 to take our fair share of the narcolepsy market at large and be a meaningful contributor to patients and obviously, to value creation for our shareholders.

Our next question comes from Francois Brisebois Oppenheimer.

Just a couple here. I was just wondering, obviously, cross comparisons are difficult, but from all these conferences, the SLEEP conference, for instance, anything come out of the fact, what -- why is it so important that it's showing results as early as week 3. And then on the BMI side, bringing down the BMI, is that something that specialists are talking about?

Thanks, Frank. Jennifer, do you want to weigh in?

Sure. Absolutely. So we're certainly very pleased with the fact that patients reported significant results at week 3. That is the earliest that has been shown in randomized controlled trials. And we don't have a definitive reason as to why this is. But certainly, with sodium oxybate, the fact that FT218 is given just once-nightly without that forced interruption could be a plausible reason for why the onset of effect occurs earlier than has been demonstrated with twice-nightly. And then as far as the weight loss, patients who are living with narcolepsy do have a high degree of comorbid obesity. And the reduction in weight and BMI is viewed by many clinicians as a positive associated with FT218.

Okay. If I could just sneak a quick second one in there. What other conferences are there? You talked about in 2021, there's still some conferences out there where we can expect some data. Which ones are out there that maybe we can expect something at?

Absolutely happy to share that we have been accepted to present at the TEST Congress, which begins October 17. It's a mix of a virtual and live meeting in Orlando. And in the ANA, the American Neurological Association, we've also been accepted to present, and that meeting also begins October 17. So both start a couple of days past our PDUFA.

Okay. Great. And from the RESTORE trial, what would we like to see from that trial?

So with RESTORE, what we're already accumulating is very important information related to long-term safety, tolerability, efficacy. It allows for participants who are in the original pivotal trial to continue on with once-nightly. And most importantly, it is allowing for patients who are on the twice-nightly oxybate to transition into once-nightly FT218. And in addition to the efficacy and tolerability and safety, we're also accumulating information about patient preference regarding the dosing regimen, and we're very pleased with the results so far, which we expect to share closer to the launch.

Our next question comes from Oren Livnat with H.C. Wainwright.

I had a couple. Obviously, a lot of people are interested in what the recent granting of Xywav Orphan Exclusivity might mean for you, if anything. So I was just wondering if you could talk a little bit about what conversations with the FDA did you have. And what is in your NDA with regards to safety or a major contribution to patient care? What do you think the hurdle is to get to market? And I guess related to that question is, is the hurdle to what was probably originally to get your own orphan exclusivity. Is that the same criteria that theoretically would be to get around someone else's Orphan Exclusivity? And I have a separate question.

Yes. Thanks, Oren. I think first and foremost, as a reminder, in 2018, FDA granted FT218 orphan drug designation for the treatment of narcolepsy based on the plausible hypothesis that 218 may be clinically superior to the twice-nightly formulation of sodium oxybate. That was already approved for those narcolepsy symptoms despite having to wake up in the middle of the night, right? So we believe, as we sit here today, that the exclusivity that was granted for the mix salt product does not impact our designation and it should not prevent us from obtaining full FDA approval, right? The R&D is clearly under review, as you noted. And we provided a full submission to support the data that we generated to support our actual Orphan Drug designation in our efforts to secure our own orphan drug exclusivity from that standpoint. In terms of what we shared explicitly and how that interaction has gone with the FDA, we won't certainly speak to specifics other than that, as we sit here today, we certainly have been pleased with how the review has gone to date.

Okay. And I guess on that same line of questioning, after -- I guess, Xywav had already been approved, correct? When you filed your NDA though, I guess, hadn't received officially our fitting exclusivity yet. Should we assume that there is information addressing low sodium or not in your existing or original NDA?

Yes. Again, since it had been approved, where it was appropriate, given it's still twice-nightly versus once-at-bedtime, you should assume that where the mixed salt product could be incorporated into our submission, it certainly was.

Okay. And then I can just move on to commercial. Obviously, the faster -- the fast Xywav switch is an encouraging data point in my view that there are patients willing to switch therapy. And I'm just curious, based on your understanding of the market, do you think that's a reflection simply of an improved product profile, which obviously you will have as well? Or do you think it really just represents also that there's this -- and/or does it represent a large, I guess, unserved market. Do you think there's patients -- warehouse patient population that maybe we're seeing go and Xywav because they were either inappropriate patients for Xyrem or just unsatisfied in general and looking for something new?

Richard, do you want to take that?

Sure. Yes, great question. So I think it's a little bit of everything. Clearly, as we talk about people with narcolepsy generally are seeking more ways to improve their overall treatment. So something new even as maybe potentially small as a mix salt version is something different. We also know that there is a lower differential on co-pay assistance as far as commercial patients are concerned. But I think it just bodes relatively well that people are seeking new therapies in the marketplace. So there are probably a few patients who are out there who are benefiting from a lower salt version from the mix salt and therapy. However, overall, I think this generally speaks to the fact that patients are seeking more relief from the narcolepsy. And to your point, are, I think it really bodes well for us once we have a once at-bed time therapy that can get to the marketplace.

Our next question comes from Robin Garner with Craig-Hallum.

You've had a few comments on the shift to Xywav. Just curious if you could comment specifically on the net product sales that have been mentioned, I guess, in total for Xyrem and Xywav at this point.

Richard, do you have any comments?

Yes. I mean I think overall, Robin, we still see that the marketplace, what we see reporting from others is that there's still about 15,000 to 16,000 overall patients who are on -- currently on oxybate therapies. So that's been relatively stable for about the last year plus. Obviously, there's a bit of transition going from the sodium oxybate to mix salt version here as well. But as we know, that's probably a good base to build off of. But as we know from our research, almost half of the patients who are offered in oxybate today are actually not taking it because of the challenges of taking it twice-nightly oxybate. So we clearly see both a good stability to the overall marketplace. But as far as our prospects are concerned, we also see the opportunity for growth in patients where twice-nightly oxybate really haven't sort of addressed the needs of the patients today.

Yes. I'll just add one comment to Richard, which I agree with, is that what we've seen with the introduction of other products is no impact on really the oxybate market, whether you're looking at pitolisant as an example, but that hasn't had effect despite having the same indications on the oxybate franchise, which continues to be relatively robust relative to its historical performance. And again, when you couple that with the untapped patient potential for our once-at-bedtime FT218. Again, we remain really bullish and excited about the commercial opportunities.

Okay. Last question, is there any more detail you can provide to us on your distribution efforts and you're building out of the REMS program?

Go ahead, Richard, if you want to start?

Yes. Yes, Robin. So we're really pleased with all aspects of what we're doing to ensure that we can get once-at-bedtime FT218 market once approved. So across our REMS our patient services hub and our SPs, we are clearly developing a strong network that will ensure that we can get the therapy out there. So we're fully on track across all of our milestones for our buildout right now. We've had excellent discussions with our partners. And our goal is to deliver world-class support to offices and to patients. To get a scheduled product in United States, it is not easy. However, we do believe that with really the focus on the patient support, we can really provide outstanding customer service to all and throughout the circle. So we are fully on track to deliver upon our full commercial launch.

(Operator Instructions) Our next question comes from Matt Kaplan with Ladenburg Thalmann.

Just wanted to see what you're hearing out there in terms of the research you've done on doctor preference and patient preference for once-nightly sodium oxybate product. And I guess kind of dovetailing with that, what you're seeing so far in the RESTORE open-label study in terms of the switching from twice-nightly to once-nightly and patient preference there.

Yes. Thanks, Matt. Maybe Richard, you can take the first part, and Jen, you the second part?

Yes. Absolutely. So Matt, as far as the market research that we've done, it's been pretty darn extensive. We've spoken to hundreds and hundreds of physicians and patients. It's pretty clear. What's really great to see from the insight work that we do is our proposition is relatively simple to understand, first and foremost, supported by outstanding clinical data. And secondarily, of course, the proposition of a once-at-bedtime therapy. It's not a hard thing for people to understand and comprehend. And clearly, what we see is when physicians and patients are actually given an option, they tend to give us a really leading share of what the opportunity is within the overall oxybate marketplace. So we've done multiple reports of market research and the insights that we receive are very consistent around the strong value proposition that once-at-bedtime FT218 could mean to both physicians and to patients. Jen, would you like to take the next part of the question?

Absolutely. We're very pleased with what we're seeing thus far in terms of which dosing regimen patients prefer, a once-at-bedtime oxybate or twice a night. I can't share the specifics right now because we are planning in the fall to submit those for consideration at springtime congresses, which would coincide with our launch. So I'll ask you to stay tuned for more details. But I can say unequivocally that we are very, very pleased with what we're seeing.

Great. Great. Fair enough. And then a question for Greg. I guess current thoughts on pricing of FT218 going into the October PDUFA?

Yes. Matt, thanks. Again, I think that although I would say that there's no final decisions that have been made. I think it's safe to assume, as we've looked at a number of different factors across different variables and a lot of price ranging work. Given how this category is managed at the payer front, there certainly doesn't. And we certainly have no intention to price it at a premium. So I think the zone, I would describe it as would be kind of in the area of where current oxybate treatments are currently priced.

Our next question comes from Jason Gerberry with Bank of America.

Just one, I know you're confident on FT218 approval. Just curious about the mechanics and sequencing with ODE approval. Do you think the FDA needs to reach a concurrent ruling on the clinical superiority of once-nightly dosing and thus issue ODE at the time of approval to sidestep, Jazz's ODE? And the other reason I ask is Jazz got ODE like something like more than 6 months after the initial approval. So just wondering, in this instance, your ODE is more intertwined with ultimate drug approval and that is a decision that needs to be rendered at the time of approval.

Yes. Thanks, Jason. Again, I think from our perspective, where we sit today, we believe that the ODE of Xywav doesn't impact our designation and shouldn't prevent us from obtaining potentially full FDA approval of FT218. That being said, to specifically ask your question, our expectation is those decisions on both approval and the orphan submission that we provided specifically for FT218 would be arbitrated and decided in or around the same time period. It wouldn't be an 11-month delay that you saw with the other product. That's our current view.

Thank you. And this concludes the answer session. I would now like to turn the call back over to Greg Divis for closing remarks.

Thank you, operator, and thanks, everyone, for joining and your continued support of Avadel. Let me just wrap up again by restating some of our views, which is really the strong position we find ourselves in, particularly at this time, where we're just 2 months away from our October 15 PDUFA date. I know a date that many of you have waited a long time for. So as we stated prior, all plans to date are on track. That includes our regulatory filing strategy, and we really are excited about what the next 60-plus days has in store for Avadel, for patients and for our shareholders as we head towards this potential FDA approval and subsequent commercial launch of our once-at-bedtime FT218.

So thank you, everyone, for joining us today on the call. We wish you all to stay safe and be healthy and all the best, and have a great day. Thank you.

This concludes today's conference call. Thank you all for participating. You may now disconnect.