Q1 2022 Avadel Pharmaceuticals PLC Earnings Call

[music].

Greg Divis: Good morning, everyone, and thank you for joining us for our call. I'll start off by providing an update on our business and specifically providing additional commentary on the process and current status of the potential FDA approval and launch of FT218. I'll then turn the call over to Doug to give an overview of the data we have recently presented. Tom will review the financial results for the quarter, and Richard will share updates regarding our launch readiness plan.

Greg Divis: We will conclude with a Q&A session when we will be joined by Jennifer. Since the beginning of 2022, across many critical areas of the company, we have made significant and important progress. Our launch readiness has been exceptional.

Greg Divis: Our customer insights have informed us that the commercial opportunity for FT218 is significantly larger than the current oxybate-treated narcolepsy patient population, and the clinical data we have presented continues to be incredibly well received and confirmatory of the benefits of a once-at-bedtime OxyBay treatment. With that said, we fully appreciate the progress that everyone is most interested in is with the status of our NDA review and the potential FDA approval for FP2 and 8.

Ladies and gentlemen, thank you for standing by and welcome to the avid gel Pharmaceuticals first quarter 2022 earnings call. At this time all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session.

Greg Divis: Although we'll cover launch readiness and clinical data during our call today, we will begin with providing an update on the status of the FDA's ongoing review. We detailed in March 2022, on our call in March of 2022, the actions we have taken as of mid-March, including escalating the matter to more senior FDA staff, and as a result, we learned a number of important things, including there were not any additional questions or information requests for us, and as such, we believe that the substantive review of the NDA is complete. But the remaining matter under review were communicated to us by FDA as administrative and internal to the agency.

Ask a question during the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded.

Any further assistance. Please press star Zero I would now like to hand, the conference over to your Speaker Ms. Brandi Robinson Senior Vice President of Corporate Affairs. Please go ahead.

Good morning, and thank you for joining us on our conference call.

Morning, We issued a press release, providing a corporate update and financial results for the first quarter ended March 31st 2022.

Greg Divis: And we've been assured by FDA officials that work was occurring on our application and that we should expect to hear from them soon, including providing us further updates to our label and any associated questions they may have. Since our public commentary in March, we have had consistent communication and additional follow-up with the FDA, which has included further edits to and harmonization of the current draft FC-218 label and associated medication guide. Based on where we are today, if the label comes back to us from the FDA in its most recent form, or even close, we would be very pleased with that result.

And these can be found on our website www dot Avondale dotcom.

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.

1995.

The 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 information regarding products in the development stage may not.

<unk> achieved scientific objectives or milestones or meet stringent regulatory requirements and.

Uncertainties regarding market entry and acceptance of product.

Greg Divis: Furthermore, as a result of our ongoing efforts and persistent engagement, we now have clarity on who we believe are involved with the remaining administrative and internal matter to complete the review of FTQ&A. This includes not only senior members of the review division, but also FDA leadership and staff from the Office of Regulatory Policy and the Office of Chief Counsel.

The impact of competitive products and pricing.

These and other risks are described more fully in <unk> public filings under the Exchange Act included in the Form 10-K for the year ended December 31st 2021, which was filed on March 16, 2022, as well as subsequent SEC filings, except as required by law Avondale undertakes no.

Greg Divis: We are engaging directly with these staff, and based on very recent interactions, we expect further follow-up within this month in response to our repeated outreach regarding specificity on the remaining administrative review and timing to a final decision. Once again, the FDA has continued to inform us that at this time there are no additional questions, information requests, or data needed from us to help them complete the review. My final commentary on the status of the NDA before we move on to the other company updates is very straightforward.

Jason to update or revise any forward looking statements contained in this presentation to reflect new information future events or otherwise.

On the call today are Greg Davis, Chief Executive Officer, Dr. Doug Williamson Chief Medical Officer.

On the Q, Chief Financial Officer, and Richard Kim Chief Commercial Officer Dr.

Dr. Jennifer Bitterman, our vice President of medical and clinical affairs will be available for Q&A following the call.

At this time I'll turn the call over to Greg.

Greg Divis: We've worked directly with the review team, we've escalated to more senior FDA staff, and have worked very urgently, diligently, proactively, and professionally to advance FT218. As we have moved forward, we have not only escalated our direct engagement with the FDA, we've also escalated our related actions. This includes our expanded advocacy support and activation, broader key FDA stakeholder outreach and engagement, and all potential regulatory and legal actions as well. We are using all available options to advance FT-218 and address the current unmet needs of all eligible patients seeking a new treatment option within the narcolepsy community.

Thank you Brandy and good morning, everyone and thank you for joining us for our call.

I'll start off by providing an update on our business and specifically providing additional commentary on the process and current status of the potential FDA approval and launch of Etsy to any.

I'll, then turn the call over to Doug to give an overview of the data we have recently presented Tom.

Tom will review the financial results for the quarter and Richard will share updates regarding our launch readiness plans, we will conclude with a Q&A session. When we will be joined by Jennifer.

Since the beginning of 2022 across many critical areas of the company, we have made significant and important progress on.

Alas readiness has been exceptional our customer insights have informed us that the commercial opportunity for <unk> is significantly larger than the current occupant treated narcolepsy patient population.

Greg Divis: We understand and live the frustration all stakeholders have regarding the status of our NDA as we continue our efforts to bring FT21A to a full approval. As we have shared with the FDA, every day we disappoint patients who are contacting us wanting to know when FT-218 will be approved and available. The significant interest in Once-At-Bedtime FT-218 continues to remind us every day of how important and how valuable FT-218 is for patients, a company, and our shareholders.

And the clinical data we've presented continues to be incredibly well received and confirmatory of the benefits of a once at bedtime OXXO based treatment.

With that said we fully appreciate the progress that everyone is most interested in is what the status of our NDA review and the potential FDA approval for FTE Q&A.

Greg Divis: And to be clear, we will not relent in our pursuit to bring FT-218 to a full approval, nor will we relent upon approval in our commercialization efforts to build a blockbuster treatment for those we serve. First, the opportunity for all Oxybate-eligible patients, treated or untreated, is too important in helping them potentially live a more normal life. And second, the opportunity to build significant shareholder value is also too important to not use every internal and external resource available to us in our pursuit of approval and launch. Before I turn it over to Doug, I would like to extend my sincerest gratitude to our employees. I am extremely proud of their dedication, their resilience, and their tenacity during this period of time.

Although we will cover launch readiness and clinical data during our call today, we will begin with providing an update on the status of the Fda's ongoing review.

We detailed in March 2022 on our call in March of 2020 to the actions we have taken as of mid March including escalating the matter to more senior FDA staff and as a result, we learned a number of important things, including there were not any additional questions or information request for us.

As such we believe that the subsidy substantive review of the NDA is complete.

But the remaining matter under review were communicated to us by FDA as administrative and internal to the agency.

And we've been assured by FDA officials that work was occurring on our application and that we should expect to hear from them soon including providing us further updates to our label and any associated questions. They may have.

Greg Divis: I'm excited for what is to come for Avadel, and as importantly, excited about the prospect of providing a once-at-bedtime FT-2 and FT-8 to people living with narcolepsy. With that, I will now turn the call over to Doug. Doug?

Since our public commentary in March we've had consistent communication and additional follow up with the FDA, which has included further edits to and harmonization of the current draft F feature one eight label and associated medication guide.

Doug Williamson: Well, thank you, Greg. And good morning, everyone. I'd like to spend a few minutes detailing the growing body of evidence we continue to generate and communicate to support the overall value proposition of FT218. First at the World Sleep Congress in Rome in March, we presented eight posters on FT218, more than any other sleep company, and generating a high degree of interest from attendees. In the last couple of months, we've published two key peer-reviewed manuscripts, a discrete choice experiment highlighting the single dose at bedtime as the number one driver of patient choice.

Based on where we are today, it's a labor comes back to us from the S. P. A and its most recent form or even close we would be very pleased with that result.

Furthermore, as a result of our ongoing efforts and persistent engagement. We now have clarity on who we believe are involved with the remaining administrative an internal matter to complete the review of FTE Q&A.

This includes not only senior members of the review Division, but also FDA leadership and staff from the office of regulatory policy in the office of the Chief Counsel.

Doug Williamson: And a plain language summary of a review of 20 years of published data, which found that the sodium in sodium oxalate was not linked to increased cardiovascular risks in narcolepsy patients and concluded that the people who take sodium oxalate are unlikely to need to change their sodium oxalate medicine because of the sodium.

We are engaging directly with the staff and based on very recent interactions. We expect further follow up within this month in response to our repeated outreach regarding specificity on the remaining administrative review and timing to a final decision.

Doug Williamson: Additionally, we were thrilled to announce the publication in CNS Drugs, a peer-reviewed medical journal focusing on the treatment of psychiatric and neurological disorders, of positive secondary endpoint data from our Pivotal Phase III RESTON trial. In these published data, once-at-bedtime FT218 at all doses demonstrated clinically meaningful improvement in assessments of disrupted nighttime sleep and significantly improved sleep quality and refreshing nature of sleep compared to placebo in adults with narcolepsy. Post hoc analyses showed that significant improvements in disrupted nighttime sleep were observed regardless of concomitant stimulant use and that there were also improvements in sleep architecture.

Once again, the FDA has continued to inform us that at this time there are no additional questions information request or data needed our data needed from us to help them complete their review.

My final commentary on the status of the NDA before we move on to the other company updates is very straightforward.

We've worked directly with the review team we've escalated some more senior FDA staff and have worked very urgently diligently proactively and professionally to advance that P. Tierney.

As we have moved forward with not only escalated our direct engagement with the FDA. We've also escalated all related actions. This includes our expanded advocacy supported activation.

Water key FDA stakeholder outreach and engagement and all potential regulatory and legal actions as well.

Doug Williamson: These published clinical data demonstrate that FT218 had a positive impact on both daytime and nighttime symptoms of narcolepsy, and further bolsters the existing body of evidence for FT218. Recently at the American Academy of Neurology, we presented interim data from the Restore Open Label Extension Switch Study of FT218. These data included results from a questionnaire from 35 participants who switched from twice-nightly oxibates to once-at-bedtime FT218, assessing their preference for dosing measurements. Three months after switching to FT218, 94.3% of participants reported a preference for the once-a-bedtime dosing regimen.

We are using all available options to advance FTE Q&A and address the current unmet needs of all eligible patients seeking a new treatment option within the narcolepsy community.

We understand and live the frustration all stakeholders have regarding the status of our NDA as we continue our efforts to bring <unk> to a full approval.

Doug Williamson: This overwhelming preference is an integral part of our value proposition and continues to give us confidence in our market research as well as supporting our strategy. Additionally at AAN, we presented details from a nocturnal adverse event questionnaire completed by 60 participants who switched to once-a-bedtime FT-218 from twice-nightly Oxybates, assessing their experiences with the second nightly DORU. Of these participants, 63% had unintentionally missed their second twice-nightly oxafate dose, with 84% of those indicating that their narcolepsy symptoms were worse the next day. Forty percent of all participants reported they'd taken their second dose more than four hours after the first dose, and of those, 42 percent reported feeling groggy or unsteady the next morning.

Tom McHugh: For 73% of participants, taking a second nighttime dose was characterized as inconvenient, with 90% reporting they rose from bed after the second dose, 3 reporting associated falls, and 2 actually reporting injuries. The data we've presented so far not only gives a clear picture of the unmet needs that exist for narcolepsy patients, but also an equally clear indication of the ways in which FT218 can play an important role in meeting those needs.

As we have shared with the FDA everyday we disappoint patients who are contacting us wanting to know with F. T to when it will be approved and available.

The significant interest in once the debts on FTE Q&A continues to remind us every day of how important and how valuable ft. One at 821. It is for patients are.

The company and our shareholders.

And to be clear, we will not relent in our pursuit to bring you up to one eight to a full approval nor will we reliant upon approval and our commercialization efforts to build a blockbuster treatment for those we serve.

First the opportunity for all Octavate eligible patients treated or untreated is too important and helping them potentially live a more normal life.

And second the opportunity to build significant shareholder value is also two important to not use every internal and external resources available to us and our pursuit of approval and launch.

Before I turn it over to Doug I would like to extend my sincerest gratitude for our employees I'm extremely proud of their dedication their resilience and their tenacity. During this period of time.

I'm excited for what is to come for avid and as importantly excited about the prospects of providing a once a bedtime ft to donate to people living with narcolepsy.

With that I will now turn the call over to Doug Doug.

Okay.

Well, thank you, Greg and good morning, everyone.

I'd like to spend a few minutes detailing the growing body of evidence we continue to generate and communicate to support the overall value proposition of ft to one eight.

First at the World Sleep Congress in Rome in March we presented eight posters on FTE 218, more than any other sleep company and generating a high degree of interest from attendees.

Tom McHugh: Our data also aligns with the feedback we hear from other stakeholders, most notably payers and sleep specialists. We will continue to generate a constant flow of relevant information on the use and benefits of FT218 as we move through our potential launch and beyond. With that, I will now turn the call over to Tom to detail our financial results. Tom?

And the last couple of months, we published two key peer reviewed manuscripts and discrete choice experiment highlighting the single dose at that time.

The number one driver of patient choice.

And Ah Plain language summary of our review of 20 years of published data, which found that the sodium and sodium oxalate was not linked to increased cardiovascular risks in narcolepsy patients and concluded that the people who take sodium oxalate are likely to need to change necessarily remarks, they mentioned because of the sodium.

Tom McHugh: Thank you, Doug. I'll provide a few highlights for the quarter and also note that full financial results are available in the press release and the 10-Q. I'll start with the balance sheet, where we reported $123.5 million of cash, cash equivalents, and marketable securities as of March 31, 2022. Also, as a reminder, we recently completed an exchange and eight-month maturity extension of approximately 80% of the $143.8 million of convertible notes. As a result, $117.4 million now matures in October of 2023, and $26.4 million will mature in February of 2023. Total operating expenses in the quarter ended March 31, 2022 were approximately $28.6 million, which is a $13.8 million increase compared to the first quarter of 2021.

Tom McHugh: The year-over-year increase is due to increases in SG&A of $10.6 million and R&D of $3.1 million. R&D expenses were $7 million and the quarter ended March 31, 2022, compared to $3.9 million for the same period in 2021. The year-over-year increase resulted primarily from the purchase of active pharmaceutical ingredients used in the production and R&D activities of FG218. SG&A expenses were $21.6 million in the quarter end of March 31, 2022, compared to $11 million for the same period in 2021.

Additionally, we were thrilled to announce the publication in CNS drugs, a peer reviewed medical journal focusing on the treatment of psychiatric and neurological disorders.

Secondary endpoint data from our pivotal phase III rest on trial.

In these published data once your bedtime F. T 218 at all doses demonstrated clinically meaningful improvements in assessments of disrupted nighttime sleep and significantly improved sleep quality and refreshing nature of sleep compared to placebo in adults with narcolepsy.

Tom McHugh: The year-over-year increase is attributable to a number of factors, including FT218 commercial launch preparation costs, higher legal and professional, and higher compensation costs associated with higher head.., primarily in the areas of commercial and medical affairs. Net loss for the first quarter of 2022 was approximately $26.4 million, or $0.45 per diluted share, compared to net loss of approximately $13.4 million, or $0.23 per diluted share in the same period in 2021. The year-over-year increase in net loss and loss per share results primarily from the increase in operating expenses.

Post hoc analysis showed that significant improvements in disrupted nighttime sleep were observed regardless of concomitant stimulant use and there were also improvements in sleep architecture.

These published clinical data demonstrate that ft to ornate had a positive impact on both the daytime and nighttime symptoms of narcolepsy and further bolsters the existing body of evidence for ft to morning.

Recently at the American Academy of Neurology, we presented interim data from the restore open label extension switch study of F. T 218.

These data included results from our questionnaire from 35 participants who switched from twice nightly ox abates to once a bedtime FTE 218, assessing that preference for dosing regimen.

Three months after switching to FTE 218, 94, 3% of participants reported a preference for once a bedtime dosing regimen.

This overwhelming preference is an integral part of our value proposition and continues to give us confidence in our market research as well as supporting our strategy.

Additionally, at AAN, we presented details remain nocturnal adverse event questionnaire completed by 60 participants who switched to warm some bedtime FTE 218 from twice nightly automates assess their experiences with the second nightly dose.

Richard Kim: As the review of our NDA for FTQ&A progresses, and our preparations for launch continue, we believe we're in a strong financial position with $123.5 million of cash on hand, coupled with the 8-month maturity extension on 117.4 million of the convertible notes to fund the financial investments needed to complete the review of the NDA and prepare for the potential launch of FG218. I'll now turn the call over to Richard for an update on Avadel's commercial progress this quarter. Thank you, Tom.

All of these participants 63% had unintentionally missed their second twice nightly auction paid donors with 84% of those indicating that that narcolepsy symptoms worse. The next day.

40% of all participants reported they've taken the second door was more than four hours after the first or routes and of those 42% reported feeling groggy or unsteady. The next morning.

Richard Kim: I'll provide an update on Avadel's continued progress towards our launch ready. For launch preparations, it's been a really exciting start to the year. First, our insights and beliefs about the significant unmet need that once at bedtime FE 2 and 8 will be able to address continues to grow. When we look at the current twice-nightly oxalate narcolepsy market, we see that even with the launch of the mixed salt formulation, that the total market has not shown growth over the last, And our product switches from the Twice Nightly Sodium Oxidate to the Twice Nightly Mixed Salt version has slowed significantly. Current Total Narcissus V-Arxivate market is flat.

For 73% of participants taking a second night time dose was characterized as inconvenient with 90% reporting they rose from bad after the second dose three reporting associated falls in to actually reporting injuries.

The data we presented so far not only give us a clear picture of the unmet needs that exist for narcolepsy patients, but also and equally clear indication of the ways in which FTE to Nate can play an important role in meeting those needs are.

Our data also aligns with the feedback we hear from other stakeholders, most notably payers and sleep specialists.

We will continue to generate a constant flow of relevant information on the use and benefits of ft to one eight as we move through our potential launch and beyond.

Richard Kim: And we believe, based on our research, The community is really looking for a truly innovative and novel Occupate that will address key unmet needs for people with narcolepsy. From our patient research, we know that people previously treated with Oxibates, as well as those currently on twice-nightly formulation, have self-reported as being interested, or significantly interested, in learning about a once-at-bedtime option like FT2-NH1. Now this also includes those who have recently switched to the Twice Nightly Mixed Salts formulation as well.

With that I will now turn the call over to Tom to detail our financial results Tom.

Thank you Doug.

I'll provide a few highlights for the quarter and also note that full financial results are available in the press release and the 10-Q.

I'll start with the balance sheet, where we reported $123 5 million of cash cash equivalents in marketable securities as of March 31, 2022.

Also as a reminder, we recently completed an exchange in eight months maturity extension of approximately 80% of $143 8 million of convertible notes.

Richard Kim: Beyond the current Octobit market, we also believe the introduction of a once-at-bedtime FT-2 and FT-8, if approved, can significantly grow the overall occupant market, predominantly to the benefit of FT. In previous research, as many as 40% of patients stated that when they were offered twice-nightly Oxybate, that they refused, in large part due to the complexity of those.

As a result of $117 4 million now matures in October of 2023, and $26 4 million will mature in February of 2023.

Total operating expenses in the quarter ended March 31, 2022 were approximately $28 6 million, which is a $13 $8 million increased compared to the first quarter of 2021.

Richard Kim: So upon our full launch, we see the opportunity to grow the overall utilization of OxyBase with current OxyBase prescribers, and, in a focused manner, gain more new OxyBate prescribers over time. This year, we increased our disease state messaging to address key unmet needs in narcolepsy treatment by focusing on the impact that disrupted sleep-wake cycles can prevent people with narcolepsy from getting refreshing and restorative sleep, and Duff have a disrupted life. This has been primarily executed through our Narcolepsy Disrupts disease state.

The year over year increase is due to.

Increases in SG&A of $10 6 million and R&D of $3 1 million.

R&D expenses were $7 million in the quarter ended March 31, 2022, compared to $3 9 million for the same period in 2021.

The year over year increase resulted primarily from the purchase of active pharmaceutical ingredients used in the production and R&D activities of Etsy to one eight.

SG&A expenses were $21 6 million in the quarter ended March 31, 2022 compared to $11 million for the same period in 2021.

Richard Kim: Through our targeted digital messaging and narcolepsydisrupts.com, customer engagement has seen a significant increase in patient and healthcare provider digital, with over 4,000 patients having already enrolled in our program since the end of last year. From our initial assessment of these opt-ins, based on patient self-reporting, we are seeing current OxyBate patients represented in our database. And we are also seeing a very large portion of OxyBate 90 people who are engaging through our campaign.

The year over year increase was attributable to a number of factors, including F. T 218, commercial launch preparation costs higher legal and professional fees and higher compensation costs associated with higher headcount, primarily in the areas of commercial and medical affairs.

Net loss for the first quarter of 2022 was approximately $26 4 million or <unk> 45 per diluted share compared to net loss of approximately $13 4 million or <unk> 23 per diluted share in the same period in 2021.

The year over year increase in net loss and loss per share results, primarily from the increase in operating expenses.

Richard Kim: Now this is an early sign that our disease state and medical messaging is reaching both Occuvate Experienced and Occuvate Naive. Our team has made great progress in advancing all launch readiness deliverables, across the key components of distribution, including REM. Patient Services.

As a review of our NDA for Etsy, Q&A progresses, and our preparations for launch continue we believe we're in a strong financial position with $123 5 million of cash on hand.

Coupled with the eight months of maturity extension on $117 4 billion of convertible notes.

Richard Kim: Specialty Pharmacy Partnerships, we are fully on track with our progress, and are ready for an FDA decision that would allow us to advance to the final stages to be launched. Another important example of our launch readiness has been our enhanced customer engagement, to raise awareness about Avadel and our disease education about the impact of disrupted sleep-wake. We have had significant representation at key sleep specialists and pair meetings, and will have a major presence at the biggest lead medical meeting of the year. Inaugurated CLEAP 2022 Meeting in Charlotte, North Carolina in early 2020.

And the financial investments needed to complete the review of the NDA and prepare for the potential launch of <unk>.

Now I'll turn the call over to Richard for an update on Avondale commercial progress this quarter Richard.

Thank you Tom I'll provide an update on Avondale continued progress towards our launch readiness.

For our launch preparations it's been a really exciting start to the year.

First our insights and beliefs about the significant unmet need that once at bedtime FTE Q&A will be able to address continues to grow.

Richard Kim: We have had a very busy and productive start to the year, and are pleased with the continued launch readiness progress, with a clear focus on understanding, Engaging with and prioritizing the needs of people with narcolepsy and the sleep specialists who manage them. I will now turn the call back to Greg for closing comments before we open the line for Q&A. Thank you, Richard, and thank you all for taking the time to join us today and for your continued support of Avadel.

When we look at the current twice nightly Octavate narcolepsy market, we see that even with the launch of the mixed salt formulation that the total market has not shown growth over the last year.

And that product switches from the twice nightly sodium off the bag to the twice nightly Methought version has slowed significantly.

The current total narcolepsy arcs of ate market is flat and.

And we believe based on our research the community is really looking for a truly innovative and novel off debate that will address key unmet needs for people with narcolepsy.

Richard Kim: As you have heard, we're laser focused on getting FT-218 approved and preparing to launch as soon as possible thereafter. Our top priority is to advance FT-218 to a full approval, and we will use all resources and strategies, both internal and external, to achieve this.

From our patient research, we know that people previously treated with the Octavate as well as those currently on twice nightly formulation have self reported it being interested or significantly interested in learning about our once at bedtime option like ft Q&A.

Greg Divis: The combination of our clinical profile and the clear unmet need, with over 90% of patients who have switched, preferring once-at-bedtime FT-218, coupled with a market opportunity that our research has continued to inform us is potentially significantly larger than the currently treated patient pool, only continues to support why FT-218, upon approval and launch, has, we believe, blockbuster potential to command a meaningful share of the narcolepsy market. We look forward to providing additional updates and remain committed to keeping you informed as appropriate.

This also includes those who have recently switched to the twice nightly mixed thoughts formulation as well.

Beyond the current occupant market. We also believe the introduction of once that bedtime Effie Q&A if approved.

Significantly grow the overall occupancy market predominantly to the benefit at the Q&A.

In previous research as many as 40% of patients stated that when they were offered twice nightly octavate that they refused and.

Greg Divis: We thank you for your time today and your support. And with that, let's open the line for Q&A. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone.

In large part due to the complexity of dosing.

So upon our fall launch, we see the opportunity to grow the overall utilization of Octavate with current occupancy prescribers and focused manner gain more new ocwen prescribers overtime.

This year, we increased our disease state messaging to address key unmet needs in our narcolepsy treatment by focusing on the impact that disrupted sleep wake cycles can prevent people with narcolepsy from getting refreshing and restorative sleep.

Operator: We ask that you please limit yourself to one question and one follow-up question. To withdraw your question, please press the pound, Please stand by while we compile the Q&A roster. Our first question comes from Francois Brisebois with Oppenheimer.

Francois Brisebois: Please go ahead. All right, thanks for taking the questions here. So just one that, you know, I think we touched on a little bit here, but maybe just a little more color on any comments or thoughts on on the Oxybate market here, especially based on the recent results from Jazz. Thanks Frank, maybe Richard, I'll maybe turn that over to you. Yeah, sure. Hey, Frank, good morning.

Have a disrupted life.

This has been primarily executed through our narcolepsy disrupts disease State campaign.

Through our targeted digital messaging and narcolepsy disrupts dot com customer engagement has seen a significant increase in patient and healthcare provider digital options with over 4000 patients having already enrolled in our program since the end of last year.

Richard Kim: Nice to hear from you. So, yeah, you know, I guess when we look at the current Oxybate marketplace, we really see it very flat. Over the last four quarters, there's been no growth in the overall Oxybate and R-Cups in the marketplace.

From our initial assessments of these opt ins based on patient self reporting we are seeing current octavate patients represented in our database.

And we are also seeing a very large portion of octavate naive people, who are engaging through our campaign.

Now this is an early sign better disease state and medical messaging is reaching both octavate experienced and Octavate naive people.

Richard Kim: And, you know, this is despite the fact that the mixed salt Oxybate has joined the marketplace as well. So, what we really read into that is there is a clear and unmet need for a once-at-bedtime FD2 and FD8. And people are really looking for something that will make a meaningful clinical difference to the way their narcolepsy is managed. So, you know, we clearly see the opportunity to grow well beyond this current Oxybate marketplace. We know there is folks who have previously tried and discontinued twice-nightly Oxybates.

Our team has made great progress in advancing all launch readiness deliberate bowls.

Across the key components of distribution, including Rems patient services and specialty pharmacy partnerships, we are fully on track with our progress.

And are ready for an FDA decision that would allow us to advance to the final stages to be launch ready.

Another important example of our launch readiness has been our enhanced customer engagement to raise awareness about <unk> and our disease education about the impact of disrupted sleep wake cycle.

We have had significant representation at key sleep specialist and payer meetings and we will have a major presence at the biggest lead medical meeting of the year.

Richard Kim: And we also know that there are physicians within Oxybate prescribers who are likely willing to try once-at-bedtime, and also our ability to grow beyond the current Oxybate treater base. So, you know, despite the fact that the marketplace is currently flat, we see the introduction of FD2 and FD8 really having the chance to grow well beyond where the current marketplace is. Okay, thank you. Anything, Greg, you all said on your side too. Yeah, I'm all set.

Greg Divis: Yeah, thanks, Richard. Okay, okay, great. And then it's maybe a last question here in terms of, you know, the data that's been coming out a lot of very interesting data, especially the interim recently. Does this help maybe build a case for superiority?

<unk> 2022 meeting in Charlotte North Carolina in early June .

We've had a very busy and productive start to the year and are pleased with the continued launch readiness progress with a clear focus on understanding.

Engaging with and prioritizing the needs of people with narcolepsy and the fleet specialists, who manage them.

Doug Williamson: Or what is the ultimate goal of having this data continuously come out? Thank you. So maybe I'll let Doug and Jen comment on that, Doug. Yeah, I mean, I think the, The point of the data, if that's your question, is we really believe that the profile of FT218 Unknown Attendee, Ashwani Verma, Lin Tsai, Guofang Li, Jennifer Gudeman, Myriam Belghiti, Austin Murtagh, Richard Kim, Jason Gerberry, Avadel Livnat, Thomas McHugh, Gregory Divis, Gregory Davis, Unknown Attendee, Ashwani Verma, Unknown Attendee, Ashwani Verma, Unknown Attendee, Ashwani Verma, Yes, maybe I'll just add that, you know, part of our strategy in continuing to publish these data is the great interest that we have from key opinion leaders.

I will now turn the call back to Greg for closing comments before we open the line for Q&A.

Thank you Richard and thank you all for taking the time to join US today and for your continued support of avid al as you have heard we're laser focused on getting <unk> approved and preparing for launch as soon as possible thereafter, our top priority is to advance etsy Q&A to a full approval and we will use all resources and strategies both.

Internal and external to achieve this.

The combination of our clinical profile and the clear unmet need with over 90% of patients who have switched preferring once at bedtime ft Q&A, coupled with a market opportunity that our research has continued to inform us is potentially significantly larger in the currently treated patient pool only continues to support why FTE.

Upon approval of launch has we believe blockbuster potential to command a meaningful share of the narcolepsy market.

We look forward to providing additional updates and remain committed to keeping you informed as appropriate. We thank you for your time today and your support and with that let's open the line for Q&A.

Doug Williamson: There is a tremendous amount of data that they're interested in seeing beyond just the conversations that we're having with them one-on-one via scientific exchange or via advisory boards. And so we've gotten great advice from these KOLs that there is a benefit to externalizing the type of data that you see coming out, whether it's the improvements in disruptive nighttime sleep. Responding to questions about sodium with a plain language summary, affirming the second discrete choice experiment that again shows us the number one driver of choice is once nightly versus twice nightly. So we've only just begun and we expect to continue with more relevant data to come in the months and years looking forward. Okay, that's it for me.

Thank you as a reminder to ask a question you will need to press star one on your telephone we ask that you. Please limit yourself to one question and one follow up question.

So withdraw your question please press the pound key.

Please standby, while we compile the Q&A roster.

Our first question comes from Francois brief points with Oppenheimer. Please go ahead.

Alright, thanks for taking the questions here, so just one that.

I think we touched on a little bit here, but maybe just a little more color on any comments or thoughts on on the oxalate market here, especially based on the recent <unk>.

Results from from jazz here.

Thanks, Frank maybe Richard I'll, maybe turn that over to you.

Doug Williamson: Thank you and looking forward to news shortly. Thank you. Our next question will come from David Amsellem with Kuiper Spandler. Please go ahead. Hey guys, this is Isaac Han for David. Just two from me.

Sure Hey, Frank Good morning, Nice to hear from you. So yeah I guess when we look at the Oxiclean Oxiclean marketplace, we really see it very flat over last four quarters. There has been no growth in the overall octavate narcolepsy marketplace and this is despite the fact that the mixed halt octavate has joined the marketplace as well.

David Amsellem: So we wanted to get your latest thinking on really the overall opportunity for FT218. Given that at this point, you'll presumably be launching the product with the AG of Xyrem already on the market. So, I mean, do you envision the payer landscape becoming more challenging in response to the evolving market?

Well, we really read into that is there is a clear unmet need for a once at bedtime Effie Q&A and people are really looking for something that will make a meaningful clinical difference to the way. They are narcolepsy is managed so.

We clearly see the opportunity to grow well beyond this current occupancy marketplace. We know there is folks who have previously tried and discontinued oxyt twice nightly ox debates and we also know that there are physicians within Octavate prescribers, who are likely willing to try once at that time and also our ability to grow beyond the current ox speak treater base. So despite the fact.

Isaac Han: And I mean, do you envision a dynamic where payers will force patients through the AG before FT-218, specifically oxidate naive patients? And then I have a follow-up. Yeah, thanks, Isaac. Richard, do you want to start?

Richard Kim: Yeah, hey, Isaac, thanks for the question. So yeah, you know, first, we're very excited to get FD218 to the market as quickly as possible. When we really think about the AG, we really do not see the AG as significantly impacting the potential for once at bedtime FD218. You know, you know, consider that this is a, you know, an AG that the current company will actually mostly benefit from. And at the end of the day, it's still a twice nightly sodium oxalate as well.

That the marketplace is currently flat, we see the traditional reduction of FTE, Q&A really having a chance to grow well beyond where the current market places today.

Okay. Thank you Greg.

Greg I'll set on your side too.

Yeah, I'm all set yeah. Thanks, Richard Okay. Okay, Great and then just maybe a last question here in terms of the data that's been coming out a lot of very interesting data, especially the interim recently it does this help maybe build a case for superiority or what is the ultimate goal of having this data continuously come out.

Greg Divis: So, you know, we don't really see the many of the step edits coming through to force people through, mainly because we also don't anticipate there to be much of a price difference. So there's, for the payers themselves, there's not a huge motivation for them to actually consider a step through an AG at this stage. So we really feel like we're still very well poised with the payers, even if an AG comes to the marketplace, Yeah, I think in short, Isaac, it doesn't change our opportunity at all.

Thank you.

So maybe outlet Gorgon and Jan comment on that Doug.

Yeah, I mean I think the.

The point of the data that's your question as well.

We really believe that the profile of ft to ornate.

Greg Divis: So unlike, you know, the mixed salt product, which is predominantly getting its volume from the other twice nightly formulation, all 16,000 of those patients or 15,900 who are treated with narcolepsy are all options for us. But for us, the good news about the opportunity for FT218 is it's not restricted to just those 16,000, as Richard noted. The market is much larger than that.

Lend itself not just torque convenience our preference, but also results in meaningful differences to the patients through the effect. It has on nighttime symptoms as well as daytime symptoms. So.

Clearly.

A safety issue with the twice twice nightly dosing.

Greg Divis: And our research has told us that whether it's previously treated patients or those who are sitting on the sideline, but are Oxybate eligible, all of those are potential opportunities for us to expand the Oxybate patient pool to almost exclusively to our benefit. Okay, I mean, that's helpful. And I think you kind of touched on this, but I just kind of wanted to clarify. So I mean, with all that in mind, do you see your overall approach to pricing and strategy changing?

So.

<unk> debate.

So that's.

That's an advantage.

We will have and we will continue to.

Explore meaningful differences in outcome from the once nightly regime.

Just preference Jan do you have any.

Yes, maybe I'll just add that.

Part of our strategy and continuing to publish the data is the great interest that we have from key opinion leaders.

Greg Divis: I think you touched on pricing briefly, but I just wanted some clarity on this. Thanks. Yeah, I think our thoughts on pricing haven't changed. We've done a tremendous amount of research in this regard and have engaged with payers, you know, for quite some time. And, and our expectation as we sit here today is that our pricing, you know, will likely be in the zone of the branded Oxibate products. That's how we think about it today.

There is a tremendous amount of data that they are interested in seeing beyond just the conversations that we're having with them one on one via scientific exchange or the advisory board and so we've gotten great.

From these kols that dairy the benefit you're externalizing the type of data that you see coming out whether it's that.

Greg Divis: It's where we think the AG is going to land. It's where we, you know, and obviously where the other, where the current Oxibates are. So there's been no change to our strategy from that standpoint. And of course, access is what is key. And our access strategy really centers around parity access, because based upon our research, we believe when it comes to physician choice and patient choice, as we've communicated to you, it's pretty clear to us that once at bedtime, dosing is by far the preferred option. And thus we believe we can be successful in the market. Great. Thank you. Very helpful.

<unk> and disrupted nighttime sleep.

Responding to your question about sodium with the plain language summary, affirming the second discrete tweak experiment that again shows that the number one driver.

Our choice is once nightly versus twice nightly. So we've only just began and we expect to continue with that more relevant data to come in the months and years looking forward.

Okay. That's all for me thank you.

And looking forward to news I'm sorry.

Thank you. Our next question will come from David <unk> with Piper Sandler. Please go ahead.

Greg Divis: Thanks so much, guys. Thank you. Our next question will come from Mark Goodman with SVB Security. Go ahead. Thanks. Yes, good morning.

Hey, guys. This is isaac on for David.

Just two from me.

Mark Goodman: So I guess, Greg, my question is obviously, frustrated and a little probably a little talk about like what's changed in the past three months, like just give us. Is the label done? Are we done with labeling and we're just sitting on an administrative, Just like months ago, you were talking about it. What could be this administrative issue, and why is it?

So we wanted to get your latest thinking on on really the overall opportunity for <unk>.

Given that at this point, you will presumably be launching the product with the AG of Xyrem already on the market.

So I mean do you envision the payer landscape, becoming more challenging in response to the evolving market.

I mean do you envision a dynamic where payers will force patients through the AG before FTE Q&A, specifically ox state naive patients and then I have a follow up.

Greg Divis: Well, I think the most important... I'm not sure why there's an echo, but... The most important comment, that I can make relative, to, you know, you know, comment area, sort of a lot of you, is really centers are constantly notified of an issue. We've only been communicated at the initiative group, that there's no questions for us, no damning information requests. And we should get another laptop.

Yeah. Thanks, Isaac Richard do you want to start.

Yeah, Hey.

Thanks for the question. So first we're very excited to get after Q&A to the market as quickly as possible. When we really think about the AG, we really do not see the AG is significantly impacting the potential for once at bedtime Effie Q&A.

Consider that this is a.

In AG that the current company will actually multi benefit from and at the end of the day, it's still a twice nightly.

Third remarks debated as well so.

We don't really see the.

Greg Divis: As that process sweeps. Now over the last couple of months, we have had a change on our label. We've updated our label. We've updated our medical office. And at this stage, we've communicated with people to understand where we're at with the ADA. Review is ongoing, and and and we've been we've been short and feedback that we should expect follow-up specifically on this within this month. Hello? Mark, you still there?

Many of these step edits coming through to force people through mainly because we also don't anticipate there to be much of a price difference. So there is for the payers themselves, there's not a huge motivation for them to actually consider a step through an AG at this stage. So we really feel like we're still very well poised with the payers, even if an AG comes to the marketplace.

Before us.

Yes, I think its short is it doesn't change our opportunity at all so unlike.

The mix of product, which is predominantly getting its volume from the other twice nightly formulation. All 16000 of those patients or 15900, who were treated with narcolepsy are all options for us but for US. The good news about the opportunity for <unk> is it's not restricted to just over 16000 as Richard noted the market is much larger than that.

Operator: His line needed to be closed because it was causing an echo. Oh, okay. Okay, so we'll move on to the next participant. It's Paul Matias with Steeple.

Our research has told us that whether its previously treated patients or those who are sitting on the sideline butter oxidate eligible all of those are potential opportunities for us to expand the octopus patient pool to almost exclusively to our benefit.

James: Please go ahead. Hi, this is James on for Paul. Thanks for taking our question. You mentioned that the Office of Regulatory Policy and Chief Counsel are among the stakeholders that still need to review the application. Does that suggest that it's related to ZyWave's ODE?

Okay. That's helpful and I think you kind of touched on this but I just kind of wanted to clarify so I mean with all of that in mind do you see your overall approach to pricing and strategy changing.

Greg Divis: And I guess if so, what would be the timeline to a resolution there? Well, as it relates to timeline, you know, we've, as we've just discussed and disclosed, that we would expect follow up on this on this matter, this administrative matter within this month. So, you know, our expectation is we're going to gain more clarity and advance the NDA, right? As it relates to your comment, James, about orphan drug exclusivity, again, there hasn't been a week that hasn't gone by that we haven't requested specificity on timing and on, on, on, you know, where the administrative review sits.

I think you've touched on pricing briefly but I just wanted some clarity on this.

I think our thoughts on pricing hasn't changed we've done a tremendous amount of research in this regard and have engaged with payers.

You know for quite some time and our expectation as we sit here today is that our pricing will likely be in the zone of the branded ochs of big products. That's how we think about it today, it's where we think the <unk>.

He is going to land, it's where we and obviously where the other one.

The current ox debates are so theres been no change to our strategy from that standpoint and of course access is what is key in our access strategy really centers around parity access because based upon our research. We believe when it comes to physician choice and patient choice as we've communicated to you it's pretty clear to us at once at bedtime.

Greg Divis: From that standpoint, what we can say is that we've had numerous interactions with the agency on every section within the NDA, including orphan drug exclusivity. And although we although we can't speculate on what's happening behind the scenes, so to speak, but this review division in particular has certainly demonstrated when ODE is the matter in question, that they certainly aren't shy to communicate that directly to the sponsor, because we've seen that be communicated publicly by at least one other company in this regard.

Dosing is by far the preferred option and thus we believe we can be successful in the market.

Great Thats very helpful. Thanks, so much guys.

Thank you. Our next question will come from Marc Goodman with SBB Security can you go ahead go ahead.

Greg Divis: They've confirmed there's no questions around ODE from us, they've confirmed there's no data they needed from us regarding orphan drug, because we continue to generate data to make your decision. So again, I guess until we have the final piece of paper that says here's your approval and your orphan drug, your, our orphan drug exclusivity, we can't rule it out in totality. But at this point, from our standpoint, given the nature of the exchange we've had to date, and kind of the history of this review division relative to ODE, you know, we certainly believe that there aren't any questions that are pending in this regard.

Yes. Good morning, So I guess, Greg My question is obviously everybody's.

Frustrated and a little probably a little confused on what's going on but can you just talk about like whats changed in the past three months, but just give us a sense of.

No.

The label done are we done with labeling and we're just sitting on an administrative issue. It seems like months ago, you were talking about an administrative issue. So it's a little confusing.

What could be this administrative issue and why is it taking so long.

Well I think the.

But most of them.

Sure wasn't sure why those macro but.

Greg Divis: Okay, thanks. And maybe just one other quick question. I know, I think it was last month, JAV got new patents listed in the Orange Book around drug-drug interactions. And I know you mentioned you were going to, your plan was to carve them out.

The most of those component comment.

That I can better relative.

Two.

<unk>.

What are your local accretively.

As well as original centers.

Greg Divis: And just curious, has that, you know, already happened? And the carving out in that process of dealing with the new patents has already kind of happened and you've moved on from that? Or is that still kind of in play?

The nature of an issue.

We've only we've only indicate indicated.

The administrative related.

Yes.

But theres no theres no questions for us.

Greg Divis: Just curious there. No, it's complete. It was, you know, again, it was much more procedural in nature than anything.

Danny Danny for me last request.

And we feel like we should expect updated.

Okay.

Greg Divis: And it, you know, it took us a matter of hours to complete that on our end. Okay, okay, great. Thanks, that's helpful.

Yes.

Across the fleet.

Over the last couple of that model of months.

We have we haven't helix Jean Martin April April we've labeled label.

James: Thanks, Gene. Thank you. Our next question will come from Ami Fadia with Needham. Please go ahead. Hey guys, this is Amin for Asking for Ami.

Yeah.

And at this stage.

Ami Fadia: Thank you for taking the question. I wanted to know a little bit more on, building the REMS, and how long do you take, it will take from the approval until you build the REMS and get to the commercialization site. Yeah, thanks Amin. Richard, maybe I'll turn that over to you. Sure, great question. So yeah, as far as timing, in terms of timing of building out the REMS, you know, REMS is complicated.

Understood.

Yes.

The review is ongoing.

And we've been we've been.

And feedback that we should expect follow up specifically on this within this month.

Hello, Mark is still there.

His line needed to be close because it was causing an echo.

Richard Kim: It's a very important program to support the launch of Once at Bedtime, FD2 and FD8. And for us, as everything we do, it's really important that we get it done right. So because it's going to become the first entry point for physicians and obviously for patients on their journey to be able to get access. So we have partnered with the leading REMS provider in the industry, and they've been with us on this journey for well over a year at this point.

Oh, okay.

Okay. So let's say we go to the next question is Jason It's Paul Matteis with Stifel. Please go ahead.

Hi, This is James on for Paul Thanks for taking our question.

You mentioned that the office of regulatory policy and Chief Counsel Council are among the stakeholders that still needs to review the application does that suggest that it's related to <unk> and I guess, what would be the timeline to a resolution there.

Richard Kim: So once we get the label, it will be clear the final steps that we'll have to take. That will be built into the program. And then beyond just building the program, after that, then we obviously need to go out there and get physicians trained and certified in our program as well.

Well as it relates to timeline.

As we've just discussed and disclosed that we would expect follow up on this on this matter this administrative matter within this month so.

Richard Kim: That will be supported a lot by our field force. Also, we'll have to make sure that the specialty pharmacy is on board as well. So that will take a few months, at least a couple months to get that going.

Our expectation is we're going to gain more clarity and advanced the NDA right as it relates to your comment James about orphan drug exclusivity again.

Richard Kim: And then from that point forward, post the approval, then we can actually go out there, begin this training, and then get people certified in our program. So overall, it will take us several months to get that going. But at the same time, that gives us a chance to really engage with and interact with.

There hasn't been a week that hasnt gone by that we havent requested specificity on timing and on on.

Where the administrative review sits from that standpoint, what we can say is that we've had numerous interactions with the agency on every section within the NDA, including orphan drug exclusivity and.

Richard Kim: And as I said, as always, it's really important that we get this done right, because this will be the cornerstone to make sure that the safe and effective... Bonnet is done from day one. Thanks, Richard. The only thing I would add to Richard's comment is nobody has more of an incentive to get it done right and get it done as fast as they can than us.

We can't speculate on what's happening behind the scenes so to speak but this review division in particular has certainly demonstrated with OA is the matter in question.

They certainly arent shy they communicate that directly to the sponsor because we've seen that be communicated publicly by at least one other company in this regard they've confirm theres no questions around o'dea from us they would confirm theres no data they needed from us regarding orphan drug because we continue to generate data to make their decision. So again I guess until we have the final piece of paper that says here's <unk>.

Greg Divis: So we certainly will do it right, but we have all the necessary sense of urgency as well. Because of what we see is the clear, clear need in the marketplace, and we want to be able to serve that need as soon as we possibly can. Thank you, that was very helpful.

Approval in your orphan drug.

Oren Livnat: Thank you. Our next question will come from Oren Livnat with H.C. Wainwright. Please go ahead.

Our orphan drug exclusivity.

We can't rule out in totality, but at this point from our standpoint, given the nature of the exchange we've had to date.

Oren Livnat: Hi, thanks for taking the question. I can hear the frustration in your voice, and it's not lost on me a couple of times in this script that you've mentioned that you will, you are or will use all internal and external resources available to you. So I'm wondering if you could, maybe you can't, but I'm wondering if you can expand on, you know, what sort of pressures you can or cannot bring to bear on this process, or if it's really just, you know, until you hear something, it's, you know, wait and see.

And kind of the history of this review division relative to O D.

We certainly believe that there arent any questions that are pending in this regard.

Okay. Thanks, and maybe just one other quick question I know I think it was last month.

<unk> got new patents listed in the Orange book around drug drug interactions and I know you mentioned youre going to plan with the cargo mountain and just curious has that already happened in the carving out in that process.

Dealing with the new patents is already kind of happened and you moved on from that or is that still kind of in place just curious there.

Oren Livnat: And just to follow up, I think on, you know, what Francois was asking up front regarding, you know, orphan and data. Can you confirm, have there been any information requests, I guess, from Regulatory Affairs or Council, I guess, since you filed that might relate to ORFIN, or have you submitted any, you know, can you make unsolicited submissions of all this, you know, interesting data you've been publishing to support your case regarding, you know, major contribution to patient care or safety advantages? Thanks.

No it's complete it was.

Again, it was much more procedural in nature than anything.

And it took us a matter of hours to complete out on our end.

Okay. Okay, great. Thanks, that's helpful. Thanks.

Thanks James.

Thank you. Our next question will come from any <unk> with Needham. Please go ahead.

Greg Divis: Sorry about the multi-part question. No, Oren, thanks, appreciate the question. I think, you know, to your first comment, I think most importantly is, you know, we're directing all of our energy, sparing no effort, and deploying whatever resources we need to to bring 218 to an approval as quickly as we can. We do expect to gain insight and make progress this month. And where we go from here will, in some part, be predicated by what we learn.

Hey, guys. This is Andrew.

Asking for Ami.

Thank you for taking the question I wanted to.

Two knowing a little bit more on.

Building drams, and how long do you take it will take some the app too well until you build it they'll go in and.

And get to the commercialization side.

Yes, Thanks, Aman, Richard maybe I'll turn that over to you.

Greg Divis: And, you know, we won't talk specifics about what we will or won't consider doing. But, you know, rest assured, you know, that whatever options are out there for us, we have done our work and are prepared to, you know, you know, pull those as necessary, recognizing that we're doing everything we think we should be doing right now to continue to move this forward. As it relates to your comment about ODE, we haven't talked specifically about what areas of the NDA we've gotten IRs on or not. We can say we have said we haven't had any questions on orphan drug.

Sure Great question, Amit So, yes first timing in terms of timing of building up the ramp a ramp is complicated it's a very important program to support the launch of once at Bedtime FTE Q&A and for US as everything we do it's really important that we get it done right.

So because it's going to become the first entry point for physicians and obviously for patients on their journey to be able to get access to Effie Q&A. So we have partnered with the leading rents provider in the industry and they've been with US on this journey for well over a year at this point so.

Greg Divis: But even more relevant, I think, in that regard is, is we've had an opportunity to ask very specific questions about, to your exact point, there is an opportunity to provide more data if we so choose to. And as we probed about providing more data, it was made clear to us that, you know, we're happy to, you know, to provide more data. We can provide more data. That option exists for us.

Once we get the label it will be clear the final step that will have to take that will be built into the program and then beyond just building. The program. After that then we obviously need to go out there and get physicians trained and certified in our program as well that will be supported a lot by our field force also will have to make sure that the specialty pharmacy is on board as well.

So that will take a few months at least a couple of months to get that going and then from that point forward post. The approval. Then we can actually go out there begin this training and then get people certified in our program. So overall it will take us several months to get that going but at the same time that gives us a chance to really engage with any can interact with.

And as I said, it's always it's really important that we get this done right. Because this will be the cornerstone to make sure that D. C for effective use of <unk> is done from day, one as well.

Okay. Thanks, Richard the only thing I would add to Richard's comment is nobody has more of an incentive to get it done right and get it done as fast as we can as they turned it off so we certainly will do it right, but we have every cent that necessarily sense of urgency as well.

Greg Divis: But we also learned that more data wasn't necessary for a decision to be made. So from that standpoint, you know, we, based on, you know, the time period that has passed and the consistency of engagement we've had with the FDA, and the fact that we continue to be told that there's no, there's no outstanding IRs, that we should expect to get a turn on the label, and that we expect to get, you know, you know, this administrative review, more clarity and insight, you know, within this month, we remain highly confident, based upon all of this exchange we've had on the full approvability of FT218 and the commercial opportunity that it can bring for patients and for the company and our shareholders. All right, appreciate the help.

Oren Livnat: Thank you. Our next question will come from Matt Kaplan with Lattenberg. Please go ahead.

What we see is the clear a clear need in the marketplace and we want to be able to serve that need as soon as we possibly can.

Matt Kaplan: I thanks for taking the questions. Um, just a quick follow up, um, from the prior question, um, with your expectation in terms of, uh, you know, follow up expected in May, what, what, what do you think this follow up will be? Will this be the kind of the final turn of the label? Um, or will this put to rest the, uh, the outstanding administrative issues at this point? Yeah, I think to speculate or speak on behalf of the FDA, I don't think it's appropriate from that point. We can only base our view of what they've communicated to us.

Thank you.

We will.

Thank you.

Thank you. Our next question will come from Oren <unk> with H C. Wainwright. Please go ahead.

Hi, Thanks for taking the question I can hear the frustration in your voice and it's not lost on me a couple of times in this script that you've mentioned that you will you or will use all internal and external resources available to you. So I'm wondering if you could maybe you can't but I'm wondering if you can expand on.

Greg Divis: And we have specifically requested clarity on this matter and on timing. And that's what we expect to get. And yes, the short answer is that it could be, it's also been told to us that this is the final matter.

What sort of pressures you can or cannot bring to bear on this process or if it's really just.

Until you hear something.

Greg Divis: So we're looking forward to gain more insight and have this follow up to be able to advance to the next stage from that standpoint. And again, they can continue to communicate it to us that we should expect a follow up labeling as well. So again, we're encouraged that we should gain more insight this month, for sure. And we believe that we see it as progress.

Wait and see and just to follow up I think on what Francois is asking upfront regarding.

Orphan and data.

Can you confirm have there been any information requests.

Guess from regulatory affairs or counsel I guess since you filed that might relate to orphan or have you submitted any can you make unsolicited.

Submission of all this interesting data <unk> been publishing to support your case regarding a major contribution to patient care or safety advantages. Thanks, sorry about the multi part question.

Greg Divis: And we'll certainly update as appropriately as that advances. Perfect. Thank you. And then, um, I guess, uh, a market question. Um, what do you think FT2N8 will take market share?

No. Thanks, John appreciate the question I think to your first comment.

Matt Kaplan: I guess that we would be from new patient starts or from, do you expect a significant amount of patients switching from the twice nightly form? Maybe I'll, you know, aside from the short answer of yes, I'll turn it over to Richard and, and, and let him weigh in on that. Greg and Matt, I'll confirm that yes as well.

Most importantly is we're directing all of our energy sparing no effort and deploying whatever resources, we need to to bring 202 and approval as quickly as we can.

We do expect to gain insight and make progress as months and where we go from here.

Poppy predicated by what we learn.

And we won't talk specifics about what we will or won't consider doing but rest assured that whatever options are out there for us we have done our work and are prepared to.

Richard Kim: So now, you know, Matt, I think with us, with FE218, we have a very unique opportunity to clearly grow significant share within the current oxybate marketplace. But, you know, clearly there's a lot of patients and physicians who have been sitting on the sidelines because the current oxybates haven't met their current needs. So, you know, we're quite fortunate to sort of see the opportunity within the current Occupy Marketplace to grow share within those who discontinued over the last couple of years of the twice monthly formulations, and also potentially to really accelerate the growth of de novo patients who have just not been satisfied with the options available. So we definitely sort of see a three-pronged approach to sort of gain share and grow this market well beyond the current Occupy Market today. All right.

Pull those that's necessary recognizing that we're doing everything we think we should be doing right now to continue to move this forward.

As it relates to your comment about we haven't talked specifically about what areas of the NDA. We've gotten IR is on or not we can say we have said, we havent had any questions on orphan drug.

But even more relevant I think in that regard is as we've had an opportunity to ask a very specific questions about to your exact point. There is an opportunity to provide more data if we so choose to and as we probe about providing more data. It was made clear to us that we're happy to.

Matt Kaplan: Thanks. Thanks for taking the questions. Thanks, Matt.

To provide more data we can provide more data that option exists for us, but we also learned that more data wasn't necessary for a decision to be made so from that standpoint.

Robin Garner: Thank you. Our next question will come from Robin Garner with Craig Hallam. Please go ahead. Good morning, everyone.

Robin Garner: Just a question on the market opportunity, perhaps as a follow-up to the last question, how do you quantify the Octobate Naive group? And I ask because it seems that your messaging has deviated a little bit from years past where the focus was more on the commercial opportunity and that low-hanging fruit of patients already on Octobate therapy. So it seems that this is really encouraged by recent data, and it seems to be just kind of more comfort by management to explore and expand into some of these new areas, specifically those de novo patients. Thanks. Thanks, Robin. Go ahead, Richard.

Based on.

The time period that has passed and the consistent engagement, we've had with the FDA and the fact that we continue to be told that there is no. There is no outstanding IRS that we should expect to get a turn on the label and that we expect to get.

This administrative review more equipped more clarity and insight within this month, we remain highly confident based upon all of this exchange we've had on the full approval ability of ft, Q&A and the commercial opportunity that it can bring for patients and for the company and our shareholders.

Alright I appreciate it.

Richard Kim: Hey Robin, really insightful. So yeah, you're spot on. So I think, you know, clearly we will be focused really around driving opportunity within the current Oxybate marketplace. We know that there are less than 5,000 prescribers who prescribe all Oxybates on an annual basis here as well.

Thank you. Our next question will come from Matt Kaplan with Ladenburg. Please go ahead.

Hi, yes, thanks for taking the questions.

Just a quick follow up.

The prior question.

With your expectation in terms of.

Follow up expected in May.

Richard Kim: But as to your point, as we've grown in our market research and just engagement through various forms with HCPs, We definitely sort of see a lot of the physicians sort of A, who have been lower volume prescribers of OxyBase and who haven't prescribed OxyBase as telling us that the value proposition of FD-2 and A would either get them into the game more or get them into the game to finally prescribe an OxyBase. We also sort of see from our patient research, those patients who are currently not on OxyBase who are narcolepsy patients today, being very intrigued by the FD-2 and A value proposition as well.

What do you think this follow up will be let's see the kind of the final turn of a label.

Or will this put to rest.

Outstanding administrative issues at this point.

Yes, I think.

Speculate or speak on behalf of the FDA I don't think its appropriate from that point, we can only base share our view of what they have communicated to us and we have specifically requested clarity on this matter and on timing and Thats, what we expect to get and yes. The short answer is that it could be it's all.

Richard Kim: So I think very astute observation that we have grown in our confidence that our market opportunity goes well beyond the current OxyBase marketplace. And we absolutely see those other growth opportunities. Now, we're gonna balance those to make sure that we don't lose too much focus at the beginning of launch because we absolutely see our base to grow within the Octobit marketplace and then grow well beyond it for years to come as well. So, thanks. Okay, thank you.

<unk> been told to US that this is the final matter. So we're looking forward to gain more insight and <unk>.

The follow up to be able to advance to the next stage.

So from that standpoint, and again, they can continue to communicated to us that we should expect.

Follow up labeling as well so again, we're encouraged that we should gain more insight this months for sure and we believe that we see it as progress and we'll certainly update as appropriately that advances.

Robin Garner: And as a quick follow up, should we expect to see new data at the sleep meeting in June? There will be some encoring of some of the data that's been presented earlier this year and one new data set out of the restore data, yes. Okay, thank you so much.

Perfect. Thank you and then.

I guess.

A market question.

What do you think the Q&A, we'll take market share on cash.

It would be.

Adam Everett: Thank you. Our next question will come from Adam Everett with Lifesci Capital. Please go ahead.

New patient starts or Keith.

Do you expect to see.

Within that a patient switching from the twice nightly forms.

Greg Divis: Great, good morning. Quick one from me, just a reminder on the approval timeline and how that might impact any hearing procedures, preliminary injunction, and so forth. Yeah, from, you know, I guess the first question in there, Adam, is, will there be a PI? You know, that's a question for the other party than it is for us at this stage, although we clearly have to be prepared for that.

Maybe I'll aside from the short answer of yes, I'll turn it over to Richard.

And let him weigh in.

Gregg and Matt I'll confirm that yes, as well so.

I think with us with Q&A, we have a very unique opportunity to clearly grow significant share within the current auction marketplace, but.

Clearly there is a lot of patients and physicians who've been sitting on the sidelines because the current octavate haven't met their current needs.

Greg Divis: You know, I would say as relates to the PI, if there is a PI motion, based on the court's scheduling order, our expectation is that that actual process will occur relatively quickly post-approval, right? So, we don't think that the timing of the potential PI, if there is one, will be any rate limiting in any way for us relative to coming to market, both from a timing perspective and or, you know, a legal barrier perspective. So, we continue to prepare and, you know, if it's something we have to deal with, then we're certainly well prepared to deal with it. Great, thank you.

We are quite fortunate to receive the opportunity within the current orthopedic marketplace to grow share within those who discontinued over the last couple of years of twice nightly formulations and also potentially to really accelerate the growth of de novo patients, who just not been satisfied with the options available. So we definitely see a three pronged approach to sort of gain sharing.

Grow this market well beyond the current <unk> market today.

Alright.

Thanks, Thanks for taking the questions.

Thanks Mark.

Thank you. Our next question will come from Robin Garner with Craig Hallum. Please go ahead.

Greg Divis: Thanks, guys. Operator Thank you. We do have a follow-up from Franois Brisebois with Oppenheimer. Please go ahead.

Francois Brisebois: Operator Thank you. We do have a follow-up from Franois Brisebois with Oppenheimer. Hey, thanks for just taking a follow up here. So I was just wondering, in terms of the patients on the market side, in terms of the patients that are treated and diagnosed, clearly, there's been kind of a flatness in terms of the Oxybate market, at least from a competitor. But is it that, you know, do you ever quantify the amount of patients maybe that are okay and happy with the generic stimulants or weight promoting agents that they currently are on? Or is this just a fear of different products that maybe aren't generic?

Good morning, everyone. Just a question on the market opportunities, perhaps as a follow up to the last question. How do you quantify the activate naive group and I ask because it seems that your messaging has deviated a little bit from years past, where the focus was more on the commercial opportunity in that low hanging fruit of patients.

Already on oxygen therapy. So it seems that this is really encouraged by recent data and it seems to be just kind of more comfort by management to expand into some of these new areas specifically those de novo patients.

Yes.

Thanks Robin go ahead Richard.

Hey, Robyn really insightful, so yeah, you're spot on so I think.

Richard Kim: Richard, do you want to start there? Yeah, Francois, it's a great question. I think we're continuing to grow and learn about the marketplace. What we can sort of say is, you know, if you look right now, there is an opportunity for pretty much any, you know, a lot more patient, who are not on Oxybates but being treated with stimulants, weight-promoting. Unknown Attendee, Ashwani Verma, Lin Tsai, Guofang Li, Jennifer Gudeman, Myriam Belghiti, So, you know, I think right now we're still in the midst of starting to quantify some of those opportunities, but what we do see is physicians managing those patients showing an interest in considering using Oxybate when in the past they hadn't on a twice-nightly Oxybate.

We will be focused.

Early around driving opportunity within the current occupant marketplace. We know that there are less than 5000 prescribers who prescribed.

Oxybutynin in annual basis here as well, but to your point as we've grown in our market research and just engagement through various.

Forms with Acp's.

We definitely see a lot of the physicians sort of a who had been lower volume prescribers of OXXO base, and who haven't prescribed box base is telling us that the value proposition of ft, Q&A would either get them into the game more or get them into the game. Finally prescribing ox abate. We also see from our patient research dose patients work.

Currently not on oxo b to R&R 50 patients today being very intrigued by the Effie Q&A value proposition as well so I think various to the observation that we have grown and our confidence that our market opportunity well beyond the current auction marketplace in narcolepsy, and we'd absolutely sort of see those other growth opportunities and then we're going to balance.

Richard Kim: Yeah, I think the only thing I would add to that is to just, you know, in the simplest terms, is that there's really three opportunities for us to grow FT218 in the market. One is obviously those, you know, little under 16,000 patients who are on the twice-nightly products. Two is those who have been previously treated, which is measured in the thousands and thousands of patients, some of which you've discontinued because of dosing-related issues or compliance-related issues or perhaps adverse event-related issues, all potentially are opportunities maybe we can help with. And then there's the de novo patient population, right?

Those to make sure that we don't lose too much focus at the beginning of lunch, because we actually see our base to grow within the marketplace and then grow well beyond it for years to come as well. So thanks for the question.

Okay. Thank you and as a quick follow up should we expect to see new data at the sleep meeting in June .

Greg Divis: And clearly our research has told us there is a subset of patients sitting on the sideline due to dosing-related issues. And as Richard noted, the opportunity to bring more patients and prescribers into the mix by, you know, bringing to market a once-at-bedtime FT218. So all three of those combined create a much larger opportunity than just, you know, having to convert existing treated patients. Yet we hear in our research and in our switch study that those who have switched over 90% said they prefer the once-at-bedtime.

There will be there will be some on coring up of some of the data that's been presented earlier this year and.

One new dataset out of the restore data yes.

Okay. Thank you so much.

Thank you. Our next question will come from Adam Edwards with lifestyle capital. Please go ahead.

Great. Good morning quick one for me.

Just a reminder, on the approval timeline and how that might impact and the hearing procedures preliminary injunction.

Fourth.

Yes from I.

I guess, the first question and there Adam is whether it be a pie. That's a question for the other party than it is for US at this stage, although we clearly have to be prepared for that.

I would say as it relates to the pie. If there is a motion based on the court's scheduling order our expectation is that actual process will occur relatively quickly post approval right. So we don't think that the timing of the potential. If there is one will be any rate limiting in any way for us relative to coming to market.

Both from a timing perspective <unk>.

Illegal barrier perspective, so we continue to prepare and.

If it's something we have to deal with and we're certainly well prepared to deal with it.

Great. Thank you.

Thanks, Ed.

Thank you and we do have a follow up from Francois brisk voice with Oppenheimer. Please go ahead.

Hey, Thanks for taking the follow up here. So I was just wondering in terms of the patients on the market side in terms of the patients that are.

Treated and diagnosed.

Clearly theres been kind of a flatness in terms of the oxidate market at least from a competitor but is it do you ever quantify the amount of patients may be that are okay, and happy with the generic stimulants or wake promoting agents that they currently are on or is this just a fear of different products that.

Maybe arent generic here.

Richard you want to start there.

Yeah first of all it's a great question I think we're continuing to grow.

And about the marketplace, what we can say is.

If you look right now there is an opportunity for pretty much any a lot more patients who are not on oxalates, but being treated with stimulants wake promoting agents to potentially consider the benefit of an observation. So we actually sort of see all those patients who are on either branded or generic as good growth opportunities for us in the future we know that from restaurant.

That patients, who either with or without <unk> had about the same sort of effectiveness from the clinical study across all three endpoints. So I think right now we're still in the midst of trying to quantify some of those opportunities, but what we do see is physicians manage with patients showing an interest in considering using oxidate, where in the past they hadn't on a twice nightly okta.

Before.

Yes, I think the only thing I would add to that is is to just in.

In the simplest terms is that theres really three opportunities for us too.

To grow FTE 218, and the market. One is obviously those little under 16000 patients who are on the twice nightly products to as those who have been previously treated which is measured in the thousands and thousands of patients some of which you've discontinued because of dosing related issues or compliance related issues or perhaps adverse event related issues.

Potentially are opportunities maybe we can help with and then there is the de Novo patient population right and clearly our research has told US there is a subset of patients sitting on the sidelines due to dosing related issues.

And as Richard noted the opportunity to bring more patients and prescribers into the mix by bringing to market once at bedtime FTE Q&A. So all three of those combined create a much larger opportunity than just having.

Having to convert existing existing treated patients, yes, we hear in our research and in our switch study that those who have switched over 90% said they prefer that once at bedtime. So again, we feel really good about the opportunity and to make a tremendous difference in the lives of a lot of patients with people living with narcolepsy and thats. It.

Platform to drive significant.

Our market penetration and associated revenue and financial performance of the company.

Great Alright, thank you.

Thank you.

Ladies and gentlemen, thank you for participating in today's question and answer session I would now like to turn the call back over to Mr. Greg Davis for any closing remarks.

Yes, Thank you and again, thank you everybody for joining us and the.

For us to provide this update will certainly in the spirit, we've always been continuing to be as transparent as we can be on where things sit in the <unk> and the progress we're making we certainly will do so as appropriate in that regard and again.

We remain highly confident in the full approve ability of ft, Q&A and on the opportunity to serve a lot of patients and make a difference in their lives and obviously create a tremendous amount of value for our shareholders. So with that we will certainly look forward to future updates and we thank you for your time today.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Okay.

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Yes.

Okay.

Hum.

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Greg Divis: So again, we feel really good about the opportunity and to make a tremendous difference in the lives of a lot of patients, people living with narcolepsy and as a platform to drive significant, you know, market penetration and associated revenue and financial performance of the company. Great. All right.

Francois Brisebois: Thank you. Thank you. And ladies and gentlemen, thank you for participating in today's question and answer session. I would now like to turn the call back over to Mr. Greg Divis for any closing remarks. Yeah, thank you.

[music].

Greg Divis: And again, thank you, everybody, for joining us. And the opportunity for us to provide this update will certainly in the spirit, we've always been continuing to be as transparent as we can be on where things fit in, and the progress we're making, we certainly will do so as appropriate in that regard. And again, what you know, we remain highly confident in the full approvability of FT218.

Operator: And, and on the opportunity, you know, to serve, you know, a lot of patients and make a difference in their lives, and obviously create a tremendous amount of value for our shareholders. So with that, we will certainly look forward to future updates. And we thank you for your time today. Ladies and gentlemen, this concludes today's conference call. Thanks for your participation. You may now disconnect.

Operator: Ladies and gentlemen, thank you for standing by and welcome to the Avadel Pharmaceuticals first quarter 2022 earnings call. At this time, all participants are on a listen only, After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star, then zero. I would now like to hand the conference over to your speaker, Ms. Brandy Robbins.

Brandy Robbins: Senior Vice President of Corporate Affairs. Please go ahead. 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 first quarter ended March 31, 2022. The release can be found on our website, www.avadel.com. 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. The forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from those contemplated in such forward-looking statements.

Brandy Robbins: These risks include information regarding products in the development stage that 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 prices. 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, as well as subsequent SEC filings.

Brandy Robbins: 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, Dr. Doug Williamson, Chief Medical Officer, Tom McHugh, Chief Financial Officer, and Richard Kim, Chief Commercial Officer. Dr. Jennifer Gudeman, our Vice President of Medical and Clinical Affairs, will be available for Q&A following the call. At this time, I'll turn the call over to Grace.

Ladies and gentlemen, thank you for standing by and welcome to the avid Dell Pharmaceuticals first quarter 2022 earnings call. At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone please be.

Greg Divis: Thank you, Brandy. Good morning, everyone, and thank you for joining us for our call. I'll start off by providing an update on our business and specifically providing additional commentary on the process and current status of the potential FDA approval and launch of FT218. I'll then turn the call over to Doug to give an overview of the data we have recently presented. Tom will review the financial results for the quarter, and Richard will share updates regarding our launch readiness plan.

Greg Divis: We will conclude with a Q&A session when we will be joined by Jennifer. Since the beginning of 2022, across many critical areas of the company, we have made significant and important progress. Our launch readiness has been exceptional. Our customer insights have informed us that the commercial opportunity for FT218 is significantly larger than the current Oxybate-treated narcolepsy patient population. And the clinical data we have presented continues to be incredibly well-received and confirmatory of the benefits of a once-at-bedtime OxyBay treatment.

Greg Divis: With that said, we fully appreciate the progress that everyone is most interested in is with the status of our NDA review and the potential FDA approval for FP2 and 8. Although we'll cover launch readiness and clinical data during our call today, we will begin with providing an update on the status of the FDA's ongoing review. We detailed in March 2022, on our call in March of 2022, the actions we had taken as of mid-March, including escalating the matter to more senior FDA staff, and as a result, we learned a number of important things, including there were not any additional questions or information requests for us, and as such, we believe that the substantive review of the NDA is complete. But the remaining matter under review were communicated to us by FDA as administrative and internal to the agency.

You're advised that today's conference is being recorded if you require any further assistance. Please press Star then zero I would now like to hand, the conference over to your Speaker Ms. Brandi Robinson Senior Vice President of Corporate Affairs. Please go ahead.

Good morning, and thank you for joining us on our conference call. This morning, we issued a press release, providing a corporate update and financial results for the first quarter ended March 31st 2022.

Greg Divis: And we've been assured by FDA officials that work was occurring on our application and that we should expect to hear from them soon, including providing us further updates to our label and any associated questions they may have. Since our public commentary in March, we have had consistent communication and additional follow-up with the FDA, which has included further edits to and harmonization of the current draft FT-218 label and associated medication guide. Based on where we are today, if the label comes back to us from the FDA in its most recent form, or even close, we would be very pleased with that result.

The release can be found on our website www dot Avondale dotcom.

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.

1995.

The 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 information regarding products in the development stage that may not achieve scientific objectives or milestones or meet stringent regulatory requirements and.

Uncertainties regarding market entry and acceptance of product.

Greg Divis: Furthermore, as a result of our ongoing efforts and persistent engagement, we now have clarity on who we believe are involved with the remaining administrative and internal matter to complete the review of FTQ&A. This includes not only senior members of the review division, but also FDA leadership and staff from the Office of Regulatory Policy and the Office of Chief Counsel.

The impact of competitive products and pricing.

These and other risks are described more fully in <unk> public filings under the Exchange Act included in the Form 10-K for the year ended December 31st 2021, which was filed on March 16th 2022, as well as subsequent SEC filings, except as required by law Avondale undertakes no.

Greg Divis: We are engaging directly with these staff, and based on very recent interactions, we expect further follow-up within this month in response to our repeated outreach regarding specificity on the remaining administrative review and timing to a final decision. Once again, the FDA has continued to inform us that at this time there are no additional questions, information requests, or data needed from us to help them complete the review. My final commentary on the status of the NDA before we move on to the other company updates is very straightforward.

Jason to update or revise any forward looking statements contained in this presentation to reflect new information future events or otherwise.

On the call today are Greg Davis, Chief Executive Officer, Dr. Doug Williamson Chief Medical Officer.

Mchugh, Chief Financial Officer, and Richard King Chief Commercial Officer Dr.

Doctor, Jennifer Bitterman, our vice President of medical and clinical affairs will be available for Q&A following the call.

At this time I'll turn the call over to Greg.

Greg Divis: We've worked directly with the review team, we've escalated to more senior FDA staff, and have worked very urgently, diligently, proactively, and professionally to advance FT218. As we have moved forward, we've not only escalated our direct engagement with the FDA, we've also escalated our related actions. This includes our expanded advocacy support and activation, broader key FDA stakeholder outreach and engagement, and all potential regulatory and legal actions as well. We are using all available options to advance FT-208 and address the current unmet needs of all eligible patients seeking a new treatment option within the narcolepsy community.

Thank you Brandy and good morning, everyone and thank you for joining us for our call.

I'll start off by providing an update on our business and specifically providing additional commentary on the process and current status of the potential FDA approval and launch of Etsy Q&A.

I'll, then turn the call over to Doug to give an overview of the data we have recently presented <unk>.

Tom will review the financial results for the quarter and Richard will share updates regarding our launch readiness plans.

We will conclude with a Q&A session, we will be joined by Jennifer.

Since the beginning of 2022 across many critical areas of the company, we have made significant and important progress.

Greg Divis: We understand and live the frustration all stakeholders have regarding the status of our NDA as we continue our efforts to bring FT218 to a full approval. As we have shared with the FDA, every day we disappoint patients who are contacting us wanting to know when FT-218 will be approved and available. The significant interest in Once-At-Bedtime FT-218 continues to remind us every day of how important and how valuable FT-218 is for patients, a company, and our shareholders.

Its readiness has been exceptional our customer insights have informed us that the commercial opportunity for F. T. T. One eight is sick.

That's generally larger than the current occupant treated narcolepsy patient population and the clinical data. We've presented continues to be incredibly well received and confirmatory of the benefits of a once at bedtime akshay treatment.

With that said we fully appreciate the progress that everyone is most interested in is what the status of our NDA review and the potential FDA approval for etsy to on it.

Greg Divis: And to be clear, we will not relent in our pursuit to bring FT-218 to a full approval, nor will we relent upon approval in our commercialization efforts to build a blockbuster treatment for those we serve. First, the opportunity for all Oxybate-eligible patients, treated or untreated, is too important in helping them potentially live a more normal life. And second, the opportunity to build significant shareholder value is also too important to not use every internal and external resource available to us in our pursuit of approval and launch. Before I turn it over to Doug, I would like to extend my sincerest gratitude to our employees. I am extremely proud of their dedication, their resilience, and their tenacity during this period of time.

Although we will cover launch readiness and clinical data during our call today, we will begin with providing an update on the status of the Fda's ongoing review.

We detailed in March 2022 on our call in March of 2020 to the actions we have taken as of mid March including escalating the matter to more senior FDA staff and as a result, we learned a number of important things, including there were not any additional questions or information request for us and that.

As such we believe that the substance substantive review of the NDA is complete.

But the remaining matter under review were communicated to us by FDA as administrative and internal to the agency.

And we've been assured by FDA officials that work was occurring on our application and that we should expect to hear from them soon including providing us further updates to our label and any associated questions. They may have.

Greg Divis: I'm excited for what is to come for Avadel, and as importantly, excited about the prospect of providing a one-set bedtime FT-2 and FT-8 to people living with narcolepsy. With that, I will now turn the call over to Doug. Well, thank you, Greg. And good morning, everyone.

Since our public commentary in March we've had consistent communication and additional follow up with the FDA, which has included further edits to and harmonization of the current draft F feature one eight label and associated medication guide.

Doug Williamson: I'd like to spend a few minutes detailing the growing body of evidence we continue to generate and communicate to support the overall value proposition of FT 218. First, at the World Sleep Congress in Rome in March, we presented eight posters on FT218, more than any other sleep company, and generating a high degree of interest from attendees. In the last couple of months, we've published two key peer-reviewed manuscripts, a discrete choice experiment highlighting the single dose at bedtime as the number one driver of patient choice, and a plain language summary of a review of 20 years of published data, which found that the sodium in sodium oxalate was not linked to increased cardiovascular risks in narcolepsy patients and concluded that people who take sodium oxalate are unlikely to need to change their sodium oxalate medicine because of the sodium.

Based on where we are today, it's a labor comes back to us from the FDA and its most recent form or even close we would be very pleased with that result.

Doug Williamson: Additionally, we were thrilled to announce the publication in CNS Drugs, a peer-reviewed medical journal focusing on the treatment of psychiatric and neurological disorders of positive secondary endpoint data from our Pivotal Phase III RESTON trial. In these published data, once-at-bedtime FT218 at all doses demonstrated clinically meaningful improvement in assessments of disrupted nighttime sleep and significantly improved sleep quality and refreshing nature of sleep compared to placebo in adults with narcolepsy. Post hoc analyses showed that significant improvements in disrupted nighttime sleep were observed regardless of concomitant stimulant use and that there were also improvements in sleep architecture.

Furthermore, as a result of our ongoing efforts and persistent engagement. We now have clarity on who we believe are involved with the remaining administrative an internal matter to complete the review of Ft Q&A.

This includes not only senior members of the review Division, but also FDA leadership and staff from the office of regulatory policy and the office of the Chief Counsel.

We are engaging directly with the staff and based on very recent interactions. We expect further follow up within this month in response to our repeated outreach regarding specificity on the remaining administrative review and timing to a final decision.

Once again, the FDA has continued to inform us that at this time there are no additional questions information request or data needed our data needed from us to help them complete their review.

My final commentary on the status of the NDA before we move on to the other company updates is very straightforward.

We've worked directly with the review team we've escalated to more senior FDA staff and have worked very urgently diligently proactively and professionally to advance <unk>.

As we have moved forward with not only escalated our direct engagement with the FDA. We've also escalated all related actions. This includes our expanded advocacy supported activation broader key FDA stakeholder outreach and engagement and also types of regulatory and legal actions as well.

Doug Williamson: These published clinical data demonstrate that FT218 had a positive impact on both daytime and nighttime symptoms of narcolepsy, and further bolsters the existing body of evidence for FT218. Recently at the American Academy of Neurology, we presented interim data from the Restore Open Label Extension Switch Study of FT218. These data included results from a questionnaire from 35 participants who switched from twice-nightly oxidates to once-at-bedtime FT218, assessing their preference for dosing measurements. Three months after switching to FT218, 94.3% of participants reported a preference for the once-a-bedtime dosing regimen.

We are using all available options to advance Etsy, Q&A and address the current unmet needs of all eligible patients seeking a new treatment option within the narcolepsy community.

We understand and live the frustration all stakeholders have regarding the status of our NDA as we continue our efforts to bring <unk> to a full approval.

Doug Williamson: This overwhelming preference is an integral part of our value proposition and continues to give us confidence in our market research as well as supporting our strategy. Additionally at AAN, we presented details from a nocturnal adverse event questionnaire completed by 60 participants who switched to once-a-bedtime FT-218 from twice-nightly Oxybates, assessing their experiences with the second nightly DORU. Of these participants, 63% had unintentionally missed their second twice-nightly oxafate dose, with 84% of those indicating that their narcolepsy symptoms were worse the next day. Forty percent of all participants reported they'd taken their second dose more than four hours after the first dose, and of those, 42 percent reported feeling groggy or unsteady the next morning.

As we have shared with the FDA everyday we disappoint patients who are contacting us wanting to know with FTE to when it will be approved and available.

A significant interest and once it does on FTE Q&A continues to remind us every day of how important and how valuable ft chew on it as to what it is for patients the.

Our company and our shareholders.

And to be clear, we will not relent in our pursuit to bring <unk> to a full approval nor are we reliant upon approval and our commercialization efforts to build a blockbuster treatment for those we serve.

First the opportunity for all Oxidate eligible patients treated or untreated is too important and helping them potentially live a more normal life.

And second the opportunity to build significant shareholder value is also two important to not use every internal and external resource available to us and our pursuit of approval and launch.

Before I turn it over to Doug I would like to extend my sincerest gratitude to our employees I am extremely proud of their dedication their resilience and tenacity. During this period of time.

I'm excited for what is to come for avid out and as importantly excited about the prospects of providing our once a bedtime ft Q&A to people living with narcolepsy.

Doug Williamson: For 73% of participants, taking a second nighttime dose was characterized as inconvenient, with 90% reporting they rose from bed after the second dose, 3 reporting associated falls, and 2 actually reporting injuries. The data we've presented so far not only gives a clear picture of the unmet needs that exist for narcolepsy patients, but also an equally clear indication of the ways in which FT208 can play an important role in meeting those needs.

With that I will now turn the call over to Doug Doug.

Okay.

Well, thank you, Greg and good morning, everyone.

I'd like to spend a few minutes detailing the growing body of evidence we continue to generate and communicate to support the overall value proposition of FTE to one eight.

First at the World Sleep Congress in Rome in March we presented eight posters on FTE 218, more than any other sleep company and generating a high degree of interest from attendees.

Doug Williamson: Our data also aligns with the feedback we hear from other stakeholders, most notably payers and sleep specialists. We will continue to generate a constant flow of relevant information on the use and benefits of FT218 as we move through our potential launch and beyond. With that, I will now turn the call over to Tom to detail our financial results. Tom?

And the last couple of months, we published two key peer reviewed manuscripts and discrete choice experiment highlighting the single dose at that time as Lee number one driver of patient choice.

And Ah Plain language summary of our review of 20 years of published data, which found that the sodium and sodium oxalate was not linked to increased cardiovascular risks in narcolepsy patients and concluded that the people who take sodium oxalate are unlikely to need to change necessarily remarks, they mentioned because of the sodium.

Tom McHugh: Thank you, Doug. I'll provide a few highlights for the quarter and also note that full financial results are available in the press release and the 10-Q. I'll start with the balance sheet, where we reported $123.5 million of cash, cash equivalents, and marketable securities as of March 31, 2022. Also, as a reminder, we recently completed an exchange and eight-month maturity extension of approximately 80% of the $143.8 million of convertible notes. As a result, $117.4 million now matures in October of 2023, and $26.4 million will mature in February of 2023. Total operating expenses in the quarter ended March 31, 2022 were approximately $28.6 million.

Tom McHugh: This is a $13.8 million increase compared to the first quarter of 2021. The year-over-year increase is due to increases in SG&A of $10.6 million and R&D of $3.1 million. R&D expenses were $7 million and the quarter ended March 31, 2022, compared to $3.9 million for the same period in 2021. The year-over-year increase resulted primarily from the purchase of active pharmaceutical ingredients used in the production and R&D activities of FT218. SG&A expenses were $21.6 million in the quarter end of March 31, 2022, compared to $11 million for the same period in 2021.

Additionally, we were thrilled to announce the publication in CNS drugs, a peer reviewed medical journal focusing on the treatment of psychiatric and neurological disorders of positive secondary endpoint data from our pivotal phase III rest on trial.

In these published data once your bedtime FTE to one eight at all doses demonstrated clinically meaningful improvements in assessments of disrupted nighttime sleep.

And significantly.

Crude sleep quality and refreshing nature of sleep compared to placebo in adults with narcolepsy.

Post hoc analysis showed that significant improvements in disrupted nighttime sleep were observed regardless of concomitant stimulant use and there were also improvements in sleep architecture.

These published clinical data demonstrates that <unk> had a positive impact on both the daytime and nighttime symptoms of narcolepsy and further bolsters the existing body of evidence for ft to one eight.

Recently at the American Academy of Neurology, we presented interim data from the restore open label extension switch study of FTE to one eight.

These data included results from our questionnaire from 35 participants who switched from twice nightly ox abates to once a bedtime FTE 218, assessing that preference for dosing regimen.

Tom McHugh: The year-over-year increase is attributable to a number of factors, including FT218 commercial launch preparation costs, higher legal and professional, and higher compensation costs associated with higher head.., primarily in the areas of commercial and medical affairs. Net loss for the first quarter of 2022 was approximately $26.4 million, or $0.45 per diluted share, compared to net loss of approximately $13.4 million, or $0.23 per diluted share in the same period in 2021. The year-over-year increase in net loss and loss per share results primarily from the increase in operating expenses.

Three months after switching to ft to one 894, 3% of participants reported a preference for once a bedtime dosing regimen.

This overwhelming preference is an integral part of our value proposition and continues to give us confidence in our market research as well as supporting our strategy.

Additionally, at AAN, we presented details remain nocturnal adverse event questionnaire completed by 60 participants who switched to once a bedtime FTE 218 from twice nightly oxalates.

Tom McHugh: As a review of our NDA for FT21A progresses, and our preparations for launch continue, we believe we're in a strong financial position with $123.5 million of cash on hand, coupled with the 8-month maturity extension on 117.4 million of the convertible notes to fund the financial investments needed to complete the review of the NDA and prepare for the potential launch of FG218. I'll now turn the call over to Richard for an update on Avadel's commercial progress this quarter.

Turning their experiences with the second nightly dose.

All of these participants 63% had unintentionally missed their second twice nightly, Oxford, <unk> dose with 84% of those indicating that that narcolepsy symptoms worse. The next day.

40% of all participants reported they've taken a second doors more than four hours after the first or approach and of those 42% reported feeling groggy or unsteady. The next morning.

Tom McHugh: Thank you, Tom. I'll provide an update on Avadel's continued progress towards our launch ready. For launch preparations, it's been a really exciting start to the year. First, our insights and beliefs about the significant unmet need that once at bedtime SE 2 and 8 will be able to address continues to grow. When we look at the current twice-nightly octobate narcolepsy market, we see that even with the launch of the mixed cell formulation, that the total market has not shown growth over the last, And our product switches from the twice nightly sodium oxibate to the twice nightly mixed salt version has slowed significantly. Current Total Narcolepsy Arxivate Market is flat.

For 73% of participants taking a second night time dose was characterized as inconvenient with 90% reporting they rose from bad after the second dose three reporting associated falls and to actually reporting injuries.

The data we presented so far not only give us a clear picture of the unmet needs that exist for narcolepsy patients, but also and equally clear indication of the ways in which <unk> can play an important.

Potent role in meeting those needs.

Our data also aligns with the feedback we hear from other stakeholders, most notably payers and sleep specialists.

We will continue to generate a constant flow of relevant information on the use and benefits of <unk> as we move through our potential launch and beyond.

Richard Kim: And we believe, based on our research, The community is really looking for a truly innovative and novel Octobate that will address key element needs for people with narcolepsy. From our patient research, we know that people previously treated with Oxybates, as well as those currently on twice-nightly formulation, have self-reported as being interested, or significantly interested, in learning about a once-at-bedtime option like FD2-NF. Now this also includes those who have recently switched to the Twice Nightly Mix-Alts formulation as well.

I will now turn the call over to Tom to detail our financial results Tom.

Thank you Doug.

I'll provide a few highlights for the quarter and also note that full financial results are available in the press release and the 10-Q.

I'll start with the balance sheet, where we reported $123 5 million of cash cash equivalents in marketable securities as of March 31, 2022.

Also as a reminder, we recently completed an exchange in eight months maturity extension of approximately 80% of the $143 8 million of convertible notes.

Richard Kim: Beyond the current occupant market, we also believe the introduction of a once-at-bedtime FT-2 and FT-8, if approved, consistently, significantly grow the overall oxy-fate, predominantly to the benefit of FTD. In previous research, as many as 40% of patients stated that when they were offered twice-nightly Oxybate, that they refused, in large part due to the complexity of those.

As a result of $117 4 million now matures in October of 2023, and $26 4 million will mature in February of 2023.

Total operating expenses in the quarter ended March 31, 2022 were approximately $28 6 million, which is a $13 $8 million increased compared to the first quarter of 2021.

Richard Kim: So upon our full launch, we see the opportunity to grow the overall utilization of OxyBase with current OxyBase prescribers. And, in a focused manner, gain more new OxyBate prescribers over time. This year, we increased our disease state messaging to address key unmet needs in narcolepsy treatment by focusing on the impact that disrupted sleep-wake cycles can prevent people with narcolepsy from getting refreshing and restorative sleep, and thus have a disruptive life.

The year over year increase is due to.

Increases in SG&A of $10 6 million and R&D of $3 1 million.

R&D expenses were $7 million in the quarter ended March 31, 2022, compared to $3 9 million for the same period in 2021.

The year over year increase resulted primarily from the purchase of active pharmaceutical ingredients using the production and R&D activities of Etsy to one eight.

SG&A expenses were $21 6 million in the quarter ended March 31, 2022 compared to $11 million for the same period in 2021.

Richard Kim: This has been primarily executed to our narcolepsy disrupts disease state. Through our targeted digital messaging and narcopsydisrupts.com, customer engagement has seen a significant increase in patient and healthcare provider digital options, with over 4,000 patients having already enrolled in our program since the end of last year. From our initial assessment of these opt-ins, based on patient self-reporting, we are seeing current OxyBate patients represented in our database. And we are also seeing a very large portion of OxyBate 90 people who are engaging through our campaign.

The year over year increase was attributable to a number of factors, including <unk> commercial launch preparation costs higher legal and professional fees and higher compensation costs associated with higher headcount, primarily in the areas of commercial and medical affairs.

Net loss for the first quarter of 2022 was approximately $26 4 million or <unk> 45 per diluted share compared to net loss of approximately $13 4 million or <unk> 23 per diluted share in the same period in 2021.

The year over year increase in net loss and loss per share results, primarily from the increase in operating expenses.

Richard Kim: Now this is an early sign that our disease state and medical messaging is reaching both octavate experienced and octavate naïve. Our team has made great progress in advancing all launch readiness deliverables, across the key components of distribution, including RAM. Patient Services.

As a review of our NDA for Etsy, Q&A progresses, and our preparations for launch continue we believe we're in a strong financial position with $123 5 million of cash on hand.

Coupled with the eight months of maturity extension on $117 4 billion of the convertible notes.

Richard Kim: Specialty Pharmacy Partnerships, we are fully on track with our progress, and are ready for an FDA decision that would allow us to advance to the final stages to be launched. Another important example of our launch readiness has been our enhanced customer engagement, to raise awareness about Avadel and our disease education about the impact of disrupted sleep-wake. We have had significant representation at key sleep specialists and pair meetings, and will have a major presence at the biggest lead medical meeting of the year.

And the financial investments needed to complete the review of the NDA and prepare for the potential launch of <unk> eight.

Now I'll turn the call over to Richard for an update on Avondale commercial progress this quarter Richard.

Thank you Tom I.

I will provide an update on avid <unk> continued progress towards our launch readiness.

For our launch preparations it's been a really exciting start to the year.

First our insights and belief about the significant unmet need that once at bedtime FTE Q&A will be able to address continues to grow.

Richard Kim: Incredible, David Amsellem, Franois Brisebois, Matthew Kaplan, Oren Livnat, Thomas McHugh, Gregory Divis, Gregory Davis, Ami Fadia, Austin Murtagh, Richard Kim, Jason Gerberry, Avadeli, We have had a very busy and productive start to the year, and are pleased with the continued launch readiness progress with a clear focus on understanding, Engaging with and prioritizing the needs of people with narcolepsy and the sleep specialists who manage them.

When we look at the current twice nightly Octavate narcolepsy market, we see that even with the launch of the mixed salt formulation that the total market has not shown growth over the last year.

And that product switches from the twice nightly sodium octavate to the twice nightly mixed solid version has slowed significantly.

Richard Kim: I will now turn the call back to Greg for closing comments before we open the line for Q&A. Thank you, Richard, and thank you all for taking the time to join us today and for your continued support of Avadel. As you have heard, we're laser focused on getting FT-218 approved and preparing to launch as soon as possible thereafter. Our top priority is to advance FT-218 to a full approval, and we will use all resources and strategies, both internal and external, to achieve this.

The current total narcolepsy arc debate market is flat and.

Richard Kim: The combination of our clinical profile and the clear unmet need, with over 90% of patients who have switched, preferring once-at-bedtime FT-218, coupled with a market opportunity that our research has continued to inform us is potentially significantly larger than the currently treated patient pool, only continues to support why FT-218, upon approval and launch, has, we believe, blockbuster potential to command a meaningful share of the narcolepsy market.

And we believe based on our research did.

Community is really looking for a truly innovative and novel Octavate that will address key unmet needs for people with narcolepsy.

From our patient research, we know that people previously treated with <unk> base as well as those currently on twice nightly formulation have self reported as being interested or significantly interested in learning about our once at bedtime option like ft Q&A.

Now. This also includes those who have recently switched to the twice nightly mixed thoughts formulation as well.

Beyond the current Octavate market. We also believe the introduction of once at Bedtime Effie Q&A, if approved consistently and significantly grow the overall occupant market predominantly to the benefit of the Q&A.

In previous research as many as 40% of patients stated that when they were offered twice nightly octavate that they refused and.

Greg Divis: We look forward to providing additional updates and remain committed to keeping you informed as appropriate. We thank you for your time today and your support. And with that, let's open the line for Q&A. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone.

In large part due to the complexity of dosing.

So upon our fall launch, we see the opportunity to grow the overall utilization of off the base with current occupancy prescribers and in a focused manner gain more new Oxford prescribers over time.

This year, we increased our disease state messaging to address key unmet needs in architect narcolepsy treatment by focusing on the impact that disrupted sleep wake cycles can prevent people with narcolepsy from getting refreshing and restored in fleet and.

Operator: We ask that you please limit yourself to one question and one follow-up question. To withdraw your question, please press the pound, Please stand by while we compile the Q&A roster. Our first question comes from Francois Brisebois with Oppenheimer.

Have a disrupted life.

This has been primarily executed through our narcolepsy disrupts disease State campaign.

Through our targeted digital messaging and narcolepsy disrupts dot com customer engagement has seen a significant increase in patient and healthcare provider digital opt ins with over 4000 patients having already enrolled in our program since the end of last year.

Francois Brisebois: Please go ahead. All right, thanks for taking the questions here. So just one that, you know, I think we touched on a little bit here, but maybe just a little more color on any comments or thoughts on on the Oxybate market here, especially based on the recent results from Jazz. Thanks, Frank. Maybe, Richard, I'll maybe turn that over to you. Yeah, sure. Hey, Frank, good morning.

Richard Kim: Nice to hear from you. So, yeah, you know, I guess when we look at the current Oxybate marketplace, we really see it very flat. Over the last four quarters, there's been no growth in the overall Oxybate and R-Cups in the marketplace.

From our initial assessments of these opt ins baseline patient self reporting we are seeing current octavate patients represented in our database.

And we are also seeing a very large portion of oxalate 90 people who are engaging through our campaign.

Now this is an early sign that our disease state and medical messaging is reaching both octavate experienced and Octavate naive people.

Richard Kim: And, you know, this is despite the fact that the mix called Oxybate has joined the marketplace as well. So, what we really read into that is there is a clear and unmet need for a once-at-bedtime FD2 and FD8. And people are really looking for something that will make a meaningful clinical difference to the way their R-Cups is managed. So, you know, we clearly see the opportunity to grow well beyond this current Oxybate marketplace. We know there is folks who have previously tried and discontinued twice-nightly Oxybates.

Our team has made great progress in advancing all launch readiness deliver bowls.

Across the key components of distribution, including Rems patient services, and especially pharmacy partnerships. We are fully on track with our progress and are ready for an FDA decision that would allow us to advance to the final stages to be launch ready.

Another important example of our launch readiness has been our enhanced customer engagement to raise awareness about <unk> and our disease education about the impact of disrupted sleep wake cycles.

Richard Kim: And we also know that there are physicians within Oxybate prescribers who are likely willing to try once-at-bedtime, and also our ability to grow beyond the current Oxybate treater base. So, you know, despite the fact that the marketplace is currently flat, we see the introduction of FD2 and FD8 really having a chance to grow well beyond where the current marketplace is. Okay, thank you. Anything, Greg, you all said on your side too. Yeah, I'm all set.

We have had significant representation at key fleet specialists and payer meetings.

Greg Divis: Yeah, thanks, Richard. Okay, okay, great. And then it's maybe a last question here in terms of, you know, the data that's been coming out a lot of very interesting data, especially the interim recently. Does this help maybe build a case for superiority? Or what is the ultimate goal of having this data continuously come out?

And we will have a major presence at the biggest fleet medical meeting of the year. The sleep 2022 meeting in Charlotte North Carolina in early June .

We have had a very busy and productive start to the year and are pleased with the continued launch readiness progress with a clear focus on understanding <unk>.

Engaging with and prioritizing the needs of people with narcolepsy and the fleet specialists, who manage them.

Doug Williamson: Thank you. So maybe I'll let Doug and Jen comment on that, Doug. Yeah, I mean, I think the, The point of the data, if that's your question, is we really believe that the profile of FT218 Unknown Attendee, Ashwani Verma, Lin Tsai, Guofang Li, Jennifer Gudeman, Myriam Belghiti, Austin Murtagh, Richard Kim, Jason Gerberry, Avadeli Verma, Lin Tsai, Guofang Li, Ami Fadia, Austin Murtagh, Richard Kim, Jason Gerberry, Avadeli Verma, Lin Tsai, Guofang Li, Ami Fadia, Unknown Attendee, David Amsellem, Oren Livnat, Thomas McHugh, Gregory Divis, Gregory Davis, Yes, maybe I'll just add that, you know, part of our strategy in continuing to publish these data is the great interest that we have from key opinion leaders.

I will now turn the call back to Greg for closing comments before we open the line for Q&A.

Thank you Richard and thank you all for taking the time to join US today and for your continued support of avid al as you have heard we are laser focused on getting <unk> approved and preparing for launch as soon as possible thereafter, our top priority is to advance <unk> to a full approval and we will use all resources and strategies both.

Internal and external to achieve this.

The combination of our clinical profile and the clear unmet need with over 90% of patients who have switched preferring once at bedtime Etsy Q&A, coupled with a market opportunity that our research has continued to inform us as potentially significantly larger in the currently treated patient pool only continues to support why.

<unk> upon approval of launch has we believe blockbuster potential to command a meaningful share of the narcolepsy market.

We look forward to providing additional updates and remain committed to keeping you informed as appropriate. We thank you for your time today and your support and with that let's open the line for Q&A.

Doug Williamson: There is a tremendous amount of data that they're interested in seeing beyond just the conversations that we're having with them one on one via scientific exchange or via advisory boards. And so we've gotten great advice from these KOLs that there is a benefit to externalizing the type of data that you see coming out, whether it's the improvements in disruptive nighttime sleep, Responding to questions about sodium with a plain language summary, affirming the second discrete choice experiment that again shows us the number one driver of choice is once nightly versus twice nightly. So we've only just begun and we expect to continue with more relevant data to come in the months and years looking forward. Okay, that's it for me.

Thank you as a reminder to ask a question you will need to press star one on your telephone we ask that you. Please limit yourself to one question and one follow up question.

To withdraw your question. Please press the pound key.

Please standby, while we compile the Q&A roster.

Our first question comes from Francois <unk> with Oppenheimer. Please go ahead.

Alright, thanks for taking the questions here, So just wanted to.

I think we touched on a little bit here, but maybe just a little more color on any comments or thoughts on on the oxalate market here, especially based on the recent.

Results from from jazz here.

Thanks, Frank maybe Richard.

Maybe turn that over to you.

Doug Williamson: Thank you and looking forward to news shortly. Thank you. Our next question will come from David Amsellem with Kuiper-Stanler. Please go ahead. Hey guys, this is Isaac Han for David. Just two from me.

Sure Hey, Frank Good morning, Nice to hear from you. So yes, I guess when we look at the ox current octavate marketplace, we really see it very flat over last four quarters. There has been no growth in the overall octavate narcolepsy marketplace and this is despite the fact that the mixed halt octavate has joined the marketplace as well.

David Amsellem: So we wanted to get your latest thinking on really the overall opportunity for FT218. Given that at this point, you'll presumably be launching the product with the AG of Xyrem already on the market. So, I mean, do you envision the payer landscape becoming more challenging in response to the evolving market? And I mean, do you envision a dynamic where payers will force patients through the AG before FT218, specifically oxidate naive patients?

What we really read into that is there is a clear unmet need for a bedtime FUT Q&A.

People are really looking for something that will make a meaningful clinical difference to the way they're narcoses managed so we clearly see the opportunity to grow well beyond this current occupant marketplace. We know there is folks who have previously tried and discontinued oxyt twice nightly oxo Bates and we also know that there are physicians within Octavate prescribers who are.

Isaac Han: And then I have a follow-up. Yeah, thanks, Isaac. Richard, do you want to start?

Likely willing to try it once at that time and also our ability to grow beyond the current occupancy treater base. So despite the fact that the marketplace is currently flat we see the introduction of epic Q&A really having a chance to grow well beyond where the current market places today.

Richard Kim: Yeah, hey, Isaac, thanks for the question. So yeah, you know, first, we're very excited to get FD-218 to the market as quickly as possible. When we really think about the AG, we really do not see the AG as significantly impacting the potential for once-at-bedtime FD-218. You know, you know, consider that this is a, you know, an AG that the current company will actually mostly benefit from. And at the end of the day, it's still a twice nightly sodium oxalate as well.

Okay. Thank you Greg you all set on your side Sir.

Yeah, I'm all set yeah. Thanks, Richard Okay. Okay, Great and then just maybe a last question here in terms of the data that's been coming out a lot of very interesting data, especially the interim recently.

Richard Kim: So, you know, we don't really see the many of these step edits coming through to force people through, mainly because we also don't anticipate there to be much of a price difference. So there's, for the payers themselves, there's not a huge motivation for them to actually consider a step through an AG at this stage. So we really feel like we're still very well poised with the payers, even if an AG comes to the marketplace.

Does this help maybe build a case for superiority or what is the ultimate goal of having this data continuously come out. Thank you.

So maybe I'll, let Doug and Amgen comment on that Doug.

Yes.

Think the.

The point of the data that's your question as well.

Richard Kim: Yeah, I think in short, Isaac, it doesn't change our opportunity at all. So unlike, you know, the mixed salt product, which is predominantly getting its volume from the other twice nightly formulation, all 16,000 of those patients or 15,900 who are treated with narcolepsy are all options for us. But for us, the good news about the opportunity for FT218 is it's not restricted to just those 16,000, as Richard noted. The market is much larger than that.

We really believe that the profile of ft to ornate.

Lends itself not just convenience our preference, but also results in meaningful differences to the patients through the effect it has on.

Nighttime symptoms as well as daytime symptoms so.

There's clearly.

A safety issue with the twice twice nightly dosing.

So.

Greg Divis: And our research has told us that whether it's previously treated patients or those who are sitting on the sideline, but are Oxybate eligible, all of those are potential opportunities for us to expand the Oxybate patient pool to almost exclusively to our benefit. Okay, I mean, that's helpful. And I think you kind of touched on this, but I just kind of wanted to clarify. So I mean, with all that in mind, do you see your overall approach to pricing and strategy changing? I think you touched on pricing briefly, but I just wanted some clarity on this.

Forms of oxalate.

So.

That's that's an advantage that we will have and we will continue to.

Explore meaningful differences in outcome from the once nightly regime.

Just preference Jan do you have any.

Yes, maybe I'll just add that.

Part of our strategy and continuing to publish these data is the great interest that we have from key opinion leaders.

There is a tremendous amount of data that they are interested in seeing beyond just the conversations that we're having with them one on one via scientific exchange or the advisory Board and so we've gotten great advice from these kols that Gary the benefit you're externalizing the type of data that you see coming out whether it's that.

Greg Divis: Thanks. Yeah, I think our thoughts on pricing haven't changed. We've done a tremendous amount of research in this regard and have engaged with payers, you know, for quite some time. And, and our expectation as we sit here today is that our pricing, you know, will likely be in the zone of the branded Oxybate products. That's how we think about it today.

Greg Divis: It's where we think the AG is going to land. It's where we, you know, and obviously where the other, where the current Oxybates are. So there's been no change to our strategy from that standpoint. And of course, access is what is key. And our access strategy really centers around parity access, because based upon our research, we believe when it comes to physician choice and patient choice, as we've communicated to you, it's pretty clear to us that once at bedtime, dosing is by far the preferred option.

<unk> and disrupted nighttime sleep.

Responding to your question about sodium with the plain language summary, affirming the second discrete twice experiment that again shows that the number one driver.

Choice is once nightly versus twice nightly. So we've only just began and we expect to continue with that more relevant data to come in the months and years looking forward.

Greg Divis: And thus we believe we can be successful in the market. Great. They're very helpful.

Okay. That's it for me.

Thank you and looking forward to news I'm sorry.

Thank you. Our next question will come from David <unk> with Piper Sandler. Please go ahead.

Greg Divis: Thanks so much, guys. Thank you. Our next question will come from Mark Goodman with SVB Security. Go ahead. Yes, good morning.

Hey, guys. This is Isaac on for David just just two from me.

Mark Goodman: So I guess, Greg, my question is obviously, frustrated and a little probably a little talk about like what's changed in the past three months, like just give us. Is the label done? Are we done with labeling and we're just sitting on an administrative, Just like months ago, you were talking about it. What could be this administrative issue, and why is it?

So we wanted to get your latest thinking on.

And really the overall opportunity for FTE Q&A.

Given that at this point, you will presumably be launching the product.

AG of Xyrem already on the market.

So I mean do you envision the payer landscape, becoming more challenging in response to the evolving market.

And I mean, do you envision a dynamic where payers will force patients through the AG before FTE Q&A, specifically oxalate naive patients and then I have a follow up.

Greg Divis: Well, I think the most important... I'm not sure why there's an echo, but... The most important comment, that I can make relative, to, you know, comment in what area, what sort of a lot of you, is really centers are not notified of an issue. We've only been communicated at the initiative group, that there's no questions for us, no standing information requests. Unknown Attendee We should expect feedback from the Chesonists, as that process sweeps.

Yeah. Thanks, Isaac Richard do you want to start.

Yeah, Hey.

Thanks for the question so.

First we're very excited to get FTE Q&A to the market as quickly as possible. When we really think about the AG, we really do not see the AG is significantly impacting the potential for once at bedtime FTE Q&A.

Consider that this is a.

<unk> that the current company will actually most of the benefit from and at the end of the day, it's still a twice nightly.

Octavate as well so we don't really see the.

Many of these step edits coming through to force people through mainly because we also don't anticipate there to be much of a price difference. So there is for the payers themselves.

Greg Divis: Over the last couple of months, we have had a change on our label. We've updated our label. We've updated our medical office. And at this stage, we need to understand where the VA, VA. Review is ongoing, and and and we've been we've been short and feedback that we should expect follow-up specifically on this within this month. Hello? Mark, are you still there? His line needed to be closed because it was causing an echo.

Not a huge motivation for them to actually consider a step through and AG at this stage. So we really feel like we are still very well poised with the payers, even if an EG comes to the marketplace before us.

Yes, I think its short is it doesn't change our opportunity at all so unlike.

The mix of product, which is predominantly giving its volume from the other twice nightly formulation. All 16000 of those patients or 15900, who are treated with narcolepsy are all options for us but for US the good news about the opportunity for <unk> as it is not restricted to just those 16000 as Richard noted the market is much larger than that.

And our research has told us that whether its previously treated patients or those who are sitting on the sidelines, but are <unk> eligible all of those are potential opportunities for us to expand the octavate patient pool to almost exclusively to our benefit.

Operator: Oh, okay. Okay, so we'll move on to the next participant. It's Paul Matias with Steeple.

Paul Matias: Please go ahead. Hi, this is James on for Paul. Thanks for taking our question. You mentioned that the Office of Regulatory Policy and Chief Counsel are among the stakeholders that still need to review the application. Does that suggest that it's related to ZyWave's ODE?

Okay.

Helpful and I think you kind of touched on this but I just kind of wanted to clarify so with all that in mind do you see your overall approach to pricing and strategy changing.

James: And I guess if so, what would be the timeline to a resolution there? Well, as it relates to timeline, you know, we've, as we've just discussed and disclosed, that we would expect follow up on this, on this matter, this administrative matter within this month. So, you know, our expectation is we're going to gain more clarity and advance the NDA, right? As it relates to your comment, James, about orphan drug exclusivity, again, there hasn't been a week that hasn't gone by that we haven't requested specificity on timing and on, on, on, you know, where the administrative review sits from that standpoint.

I think you've touched on pricing briefly but I just wanted some clarity on this.

Yes, I think our thoughts on pricing hasn't changed we've done a tremendous amount of research in this regard and have engaged with payers.

You know for quite some time and our expectation as we sit here today is that our pricing will likely be in the zone of the branded Oxidate products. That's how we think about it today, it's where we think the.

AG is going to land, it's where we and obviously where the other where the current ox debates are so theres been no change to our strategy from that standpoint and of course access is what is key in our access strategy really centers around parity access because based upon our research we believe when it comes to physician choice and patient choice as we.

James: What we can say is that we've had numerous interactions with the agency on every section within the NDA, including orphan drug exclusivity. And although we, although we can't speculate on what's happening behind the scenes, so to speak, but this review division in particular has certainly demonstrated when ODE is the matter in question, that they certainly aren't shy to communicate that directly to the sponsor, because we've seen that be communicated publicly by at least one other company in this regard. They've confirmed there's no questions around ODE from us.

<unk> communicated to you, it's pretty clear to us at once at Bedtime dosing is by far the preferred option and thus we believe we can be successful in the market.

Great Thats very helpful. Thanks, so much guys.

Our next question will come from Marc Goodman with SBB Security can you go ahead go ahead.

Greg Divis: They've confirmed there's no data they needed from us regarding orphan drug, because we continue to generate data to make your decision. So again, I guess until we have the final piece of paper that says, here's your approval and your orphan drug, your, our, our orphan drug exclusivity, we can't rule it out in totality. But at this point, from our standpoint, given the nature of the exchange we've had to date, and kind of the history of this review division relative to ODE, you know, we certainly believe that there aren't any questions that are pending in this regard.

Yes. Good morning, So I guess, Greg My question is obviously everybody's frustrated and a little probably a little confused on what's going on but can you just talk about like whats changed in the past three months, but just give us a sense of.

<unk>.

It's the label's done are we done with labeling and we're just sitting on an administrative issue. It seems like months ago, you were talking about an administrative issue. So it's a little confusing.

What could be this administrative issue and why is it taking so long.

Well I think the most.

Yeah.

I'm not sure what the sort of wide open echo but.

Greg Divis: Okay, thanks. And maybe just one other quick question. I know, I think it was last month, Jazz got new patents listed in the Orange Book around drug-drug interactions. And I know you mentioned you were going to, your plan was to carve them out.

The most of the growth comment.

But I can tell.

Relative.

Two.

Two.

What area of Accretively.

Greg Divis: And just curious, has that, you know, already happened? And the carving out in that process of dealing with the new patents has already kind of happened and you've moved on from that? Or is that still kind of in play?

It's really a centers.

Recognition of an issue.

We've only we've only indicate indicated that.

It's sort of related to that.

Yes.

But there's no if there's no questions for us.

Greg Divis: Just curious there. No, it's complete. It was, you know, again, it was much more procedural in nature than anything.

Any of the any informal request.

And I think.

We should expect updated.

Okay.

Greg Divis: And it, you know, it took us a matter of hours to complete that on our end. Okay, okay, great. Thanks. That's all.

Yes.

Process.

Over the last for the last module of months.

We have we haven't had as Jean Martin April April we've labeled a label.

James: Cool. Thanks, James. Thank you. Our next question will come from Ami Fadia with Needham. Please go ahead. Hey guys, this is Amin for Asking for Ami.

Yeah.

And at this stage.

Ami Fadia: Thank you for taking the question. I wanted to know a little bit more on, building the REMS and how long do you take, it will take from the approval until you build the REMS and get to the commercialization site. Yeah, thanks Amin. Richard, maybe I'll turn that over to you. Sure, great question. So yeah, as far as timing, in terms of timing of building out the REMS, you know, REMS is complicated. It's a very important program to support the launch of Once at Bedtime FT2 and FT8.

And where did the FDA.

Review is ongoing.

And then we've been we've been.

And feedback that we should expect follow up specifically on this within this month.

Hello, Mark you still there.

His line needed to be close because it was causing an echo.

Richard Kim: And for us, as everything we do, it's really important that we get it done right. So because it's going to become the first entry point for physicians and obviously for patients on their journey to be able to get back. So, we have partnered with the leading REMS provider in the industry, and they've been with us on this journey for well over a year at this point. So, once we get the label, it will be clear the final steps that we'll have to take. That will be built into the program. And then beyond just building the program, after that, then we obviously need to go out there and get physicians trained and certified in our program as well.

Oh, okay.

Okay. So let's say we go to the next question is Jason It's Paul Matteis with Stifel. Please go ahead.

Hi, This is James on for Paul Thanks for taking our question.

You mentioned that the office of regulatory policy and Chief Counsel Council are among the stakeholders that still needs to review the application does that suggest that it's related to the <unk> ODT and I guess, what would be the timeline to a resolution there.

Well as it relates to timeline.

As we've just discussed and disclosed that we would expect follow up on this on this matter. This administrative matter within this month. So our expectation is we're going to gain more clarity and advanced the NDA right as it relates to your comment James about orphan drug exclusivity again.

Richard Kim: That will be supported a lot by our field force. Also, we'll have to make sure that the specialty pharmacy is on board as well. So, that will take a few months, at least a couple months to get that going.

<unk>.

There hasn't been a week that hasnt gone by that we havent requested specificity on timing and on on.

Where the administrative review six from that standpoint, what we can say is that we've had numerous interactions with the agency on every section within the NBA, including orphan drug exclusivity and although we can't speculate on what's happening behind the scenes so to speak but this review division in particular has certainly demonstrated.

Richard Kim: And then from that point forward, post the approval, then we can actually go out there, begin this training, and then get people certified in our program. So, overall, it will take us several months to get that going. But at the same time, that gives us a chance to really engage with and interact with. And as I said, as always, it's really important that we get this done right, because this will be the cornerstone to make sure that the safe and effective... Co-host, The Daily Show. This is the Daily Show. I'm your host, Ashwini Verma.

Richard Kim: And I'll see you next week. Thanks for watching. I'm Ashwini Verma.

Richard Kim: And I'll see you next week. Thanks for watching. I'll see you next week.

Greg Divis: Thanks for watching. Thanks, Richard. The only thing I would add to Richard's comment is nobody has more of an incentive to get it done right and get it done as fast as we can, as they can in us.

Traded with OA is the matter in question.

Certainly arent shy to communicate that directly to the sponsor because we've seen that the communicated publicly by at least one other company in this regard they've confirm theres no questions around o'dea from us they confirm theres no data they needed from us regarding orphan drug because we continue to generate data to make their decision. So again I guess until we have the final piece of paper that says here's your <unk>.

Greg Divis: So we certainly will do it right, but we have every sense, all the necessary sense of urgency as well. Because of what we see is the clear, clear need in the marketplace, and we want to be able to serve that need as soon as we possibly can. Thank you. That was very helpful.

Approval in your orphan drug.

Greg Divis: Thank you. Thank you. Our next question will come from Oren Livnat with AC Wainwright. Please go ahead. Hi, thanks for taking the question. I can hear the frustration in your voice, and it's not lost on me a couple of times in this script that you've mentioned that you will, you are or will use all internal and external resources available to you.

Our orphan drug exclusivity.

We can't rule out in totality, but at this point from our standpoint, given the nature of the exchange we've had to date.

And kind of the history of this review division relative to O D.

We certainly believe that there arent any questions that are pending in this regard.

Oren Livnat: So I'm wondering if you could, maybe you can't, but I'm wondering if you can expand on, you know, what sort of pressures you can or cannot bring to bear on this process, or if it's really just, you know, until you hear something, it's, you know, wait and see. And just to follow up, I think on, you know, what Francois was asking up front regarding, you know, orphan and data. Can you confirm, have there been any information requests, I guess, from Regulatory Affairs or Council, I guess, since you filed that might relate to ORFIN, or have you submitted any, you know, can you make unsolicited submissions of all this, you know, interesting data you've been publishing to support your case regarding, you know, major contribution to patient care or safety advantages? Thanks.

Okay. Thanks, and maybe just one other quick question.

I know I think it was last month.

<unk> got new patents listed in the Orange book around drug drug interactions.

I know you mentioned youre going to plan was to carve them out and just curious has that already happened and carving out in that process.

Dealing with the new patents is already kind of happened and you moved on from that or is that still kind of in place just curious there.

No it's complete it was.

Again, it was much more procedural in nature than anything.

And it took us a matter of hours to complete that on our end.

Okay. Okay, great. Thanks, that's helpful.

Thanks James.

Thank you. Our next question will come from any <unk> with Needham. Please go ahead.

Oren Livnat: Sorry about the multi-part question. No, Oren, thanks, appreciate the question. I think, you know, to your first comment, I think most importantly is, you know, we're directing all of our energy, sparing no effort, and deploying whatever resources we need to to bring 218 to an approval as quickly as we can. We do expect to gain insight and make progress this month. And where we go from here will, in some part, be predicated by what we learn. And, you know, we won't talk specifics about what we will or won't consider doing.

Hey, guys. This is Alan.

Asking for Ami.

Thank you for taking the question I wanted to.

Two knowing a little bit more on.

Building drams, and how long do you take it will take some of the absolute well until you build to filter in and get to the commercialization side.

Yeah, Thanks, Aman, Richard maybe I'll turn that over to you.

Greg Divis: But, you know, rest assured, you know, that whatever options are out there for us, we have done our work and are prepared to, you know, you know, pull those as necessary, recognizing that we're doing everything we think we should be doing right now to continue to move this forward. As it relates to your comment about ODE, we haven't talked specifically about what areas of the NDA we've gotten IRs on or not. We can say we have said we haven't had any questions on orphan drug.

Sure Hey, Great question, Amit So, yes, first timing in terms of timing of filling up the ramp.

It is complicated it's a very important program to support the launch of once at that time for Q&A and for US as everything we do it's really important that we get it done right. So.

So because it's going to become the first entry point for physicians and obviously for patients on their journey to be able to get access to ft. Q&A. So we have partnered with the leading rents provider in the industry and they've been with US on this journey for well over a year at this point so.

Greg Divis: But even more relevant, I think, in that regard is, is we've had an opportunity to ask very specific questions about, to your exact point, there is an opportunity to provide more data if we so choose to. And as we probed about providing more data, it was made clear to us that, you know, we're happy to, you know, to provide more data. We can provide more data. That option exists for us. But we also learned that more data wasn't necessary for a decision to be made.

Once we get the label it will be clear the final steps that will have to take that will be built into the program and then beyond just building. The program. After that then we obviously need to go out there and get physicians trained and certified in our program as well that will be supported a lot by our field force also will have to make sure that especially pharmacy is important as well.

So that will take a few months at least a couple of months to get that going and then from that point forward post the approval.

Greg Divis: So from that standpoint, you know, we, based on, you know, the time period that has passed and the consistency of engagement we've had with the FDA, and the fact that we continue to be told that there's no, there's no outstanding IRs, that we should expect to get a turn under the label, and that we expect to get, you know, you know, this administrative review, more clarity and insight, you know, within this month, we remain highly confident, based upon all of this exchange we've had on the full approvability of FT218 and the commercial opportunity that it can bring for patients and for the company and our shareholders. Alright, appreciate the help.

And then we can actually go out there begin this training and then get people certified in our program. So overall it will take us several months to get that going but at the same time that gives us a chance to really engage with any interact with <unk>.

And as I said, it's always it's really important that we get this done right. Because this will be the cornerstone to make sure that the safe and effective use of <unk> is done from day, one as well.

Okay. Thanks, Richard the only thing I would add to Richard's comment is nobody has more of an incentive to get it done right and get it done as fast as we can as they jammed enough. So we certainly will do it right, but we have every sense at all necessarily sense of urgency as well.

Oren Livnat: Thank you. Our next question will come from Matt Kaplan with Lattinburg. Please go ahead.

Because of what we see is the clear clear need in the marketplace and we want to be able to serve that need as soon as we possibly can.

Matt Kaplan: I thanks for taking the questions. Um, just a quick follow up, um, from the prior question, um, with your expectation in terms of, uh, you know, follow up expected in May, what, what, what do you think this follow up will be? Will this be the kind of the final turn of the label? Or will this put to rest the, uh, the outstanding administrative issues at this point?

Okay that was very helpful.

Thank you.

Thank you. Our next question will come from Oren <unk> with H C. Wainwright. Please go ahead.

Hi, Thanks for taking the question.

I can.

Hear the frustration in your voice and it's not lost on me a couple of times in this script that you've mentioned that you will you or will use all internal and external resources available to you. So I'm wondering if you could maybe you can't but I'm wondering if you can expand on what sort of pressures you can or cannot bring to bear on there.

Greg Divis: Yeah, I think to speculate or speak on behalf of the FDA, I don't think it's appropriate from that point. We can only base our view of what they've communicated to us. And we have specifically requested clarity on this matter and on timing. And that's what we expect to get. And yes, the short answer is that it could be, it's also been told to us that this is the final matter.

This process or if it's really just.

Tell you hear something.

Wait and see and just to follow up I think on what Francois is asking upfront regarding.

Greg Divis: So we're looking forward to gain more insight and have this follow up to be able to advance to the next stage from that standpoint. And again, they can continue to communicate it to us that we should expect a follow up labeling as well. So again, we're encouraged that we should gain more insight this month, for sure. And we believe that we see it as progress.

Orphan and data.

Can you confirm have there been any information request I guess from regulatory affairs or counsel I guess since you filed that might relate to orphan or have you submitted any can you make unsolicited submissions.

All this interesting data you've been publishing to support your case regarding a major contribution to patient care or safety advantages. Thanks, sorry about the multi part question.

Greg Divis: And we'll certainly update as appropriately as that advances. Perfect. Thank you. And then, um, I guess, uh, a market question. Um, what do you think FT2N8 will take market share?

No Oren. Thanks, John appreciate the question I think to your first comment I think most importantly is we're directing all of our energy sparing no effort and deploying whatever resources, we need to to bring 202 and approval as quickly as we can we.

Matt Kaplan: I guess that we would be from new patient starts or from heats back to a significant amount of patients switching from the twice nightly form. Maybe I'll, you know, aside from the short answer of yes, I'll turn it over to Richard and, and, and let him weigh in on that. Greg and Matt, I'll confirm that yes as well.

We do expect to gain insight and make progress as months and where we go from here.

Part be predicated by what we learn.

And we won't talk specifics about what we will or won't consider doing but rest assured that whatever options are out there for us we have done our work and are prepared to.

Richard Kim: So no, you know, Matt, I think with us, with FE218, we have a very unique opportunity to clearly grow significant share within the current octupate marketplace. But, you know, clearly there's a lot of patients and physicians who've been sitting on the sidelines because the current octupates haven't met their current needs. So, you know, we're quite fortunate to sort of see the opportunity within the current OxyBate marketplace to grow share within those who discontinued over the last couple of years of the twice monthly formulations, and also potentially to really accelerate the growth of de novo patients who have just not been satisfied with the options available. So we definitely sort of see a three-pronged approach to sort of gain share and grow this market well beyond the current OxyBate market today. All right. Thanks. Thanks for taking the questions. Thanks, Matt.

Pull those thats necessary recognizing that we're doing everything we think we should be doing right now to continue to move this forward.

As it relates to your comment about we haven't talked specifically about what areas of the NDA. We've gotten IR is on or not we can say we have said, we havent had any questions on orphan drug.

But even more relevant I think in that regard is as we've had an opportunity to ask a very specific questions about to your exact point. There is an opportunity to provide more data if we so choose to and as we probe about providing more data. It was made clear to us that we're happy to.

To provide more data we can provide more data that option exists for us, but we also learned that more data wasn't necessary for a decision to be made so from that standpoint.

Matt Kaplan: Thank you. Our next question will come from Robin Garner with Craig Hallam. Please go ahead. Good morning, everyone.

Robin Garner: Just a question on the market opportunity, perhaps as a follow-up to the last question, how do you quantify the Octobate Naive group? And I ask because it seems that your messaging has deviated a little bit from years past where the focus was more on the commercial opportunity and that low-hanging fruit of patients already on Octobate therapy. So it seems that this is really encouraged by recent data, and it seems to be just kind of more comfort by management to expand into some of these new areas, specifically those de novo patients. Thanks. Thanks, Robin. Go ahead, Richard.

Based on.

The time period that has passed and the consistent engagement, we've had with the FDA and the fact that we continue to be told that there is no. There is no outstanding IRS that we should expect to get a turn on the label and that we expect to get.

This administrative review more equipped more clarity and insight within this month, we remain highly confident based upon all of this exchange we've had on the full approval ability of <unk> and the commercial opportunity that it can bring for patients and for the company and our shareholders.

Alright I appreciate it.

Richard Kim: Hey Robin, really insightful. So yeah, you're spot on. So I think, you know, clearly we will be focused really around driving opportunity within the current OxyBate marketplace. We know that there are less than 5,000 prescribers who prescribe all OxyBates on an annual basis here as well.

Thank you. Our next question will come from Matt Kaplan with Ladenburg. Please go ahead.

Hi, yes, thanks for taking the questions.

Just a quick follow up kind of a prior question.

With your expectation in terms of.

Follow up expected in May.

Richard Kim: But as to your point, as we've grown in our market research and just engagement through various forms with HCPs, We definitely sort of see a lot of the physicians, sort of A, who have been lower volume prescribers of Oxibates and who haven't prescribed Oxibates as telling us that the value proposition of FT-2 and A would either get them into the game more or get them into the game to finally prescribe an Oxibate. We also sort of see from our patient research, those patients who are currently not on Oxibates who are narcolepsy patients today, being very intrigued by the FT-2 and A value proposition as well.

What do you think this call it will be let's see the kind of the final turn of a label.

Or will this put to rest.

Outstanding administrative issues at this point.

Yes, I think.

Speculate or speak on behalf of the FDA I don't think its appropriate from that point, we can only base share our view of what they've communicated to us and we have specifically requested clarity on this matter and on timing and Thats, what we expect to get and yes. The short answer is that it could be.

Richard Kim: So I think various food observation that we have grown in our confidence that our market opportunity goes well beyond the current Oxibate marketplace. And we absolutely sort of see those other growth opportunities. Now, we're going to balance those to make sure that we don't lose too much focus at the beginning of launch, because we absolutely see our base to grow within the Octobit marketplace and then grow well beyond it for years to come as well.

<unk> been told to US that this is the final matter. So we're looking forward to gain more insight.

This follow up to be able to advance to the next stage.

From that standpoint, and again, they can continue to communicate it to us that we should expect.

A follow up labeling as well so again, we're encouraged that we should gain more insight this months for sure and we believe if we see it as progress and we'll certainly update as appropriately that advances.

Richard Kim: So, thanks. Okay, thank you. And as a quick follow up, should we expect to see new data at the sleep meeting in June? There will be some encoring of some of the data that's been presented earlier this year and one new data set out of the restore data, yes.

Perfect. Thank you and then I guess.

Yes.

A market question.

Thank <unk> will take market share in gas.

<unk>.

Robin Garner: Okay, thank you so much. Thank you. Our next question will come from Adam Everett with Lifesci Capital. Please go ahead. Great. Good morning. Quick one for me.

New patient starts or.

Do you expect to see.

Isn't that a patient switching from twice nightly forms.

Adam Everett: Just a reminder on the approval timeline and how that might impact any hearing procedures, preliminary injunction, and so forth. Yeah, from, you know, I guess the first question in there, Adam, is, will there be a PI? You know, that's a question for the other party than it is for us at this stage, although we clearly have to be prepared for that. You know, I would say as relates to the PI, if there is a PI motion, based on the court's scheduling order, our expectation is that that actual process will occur relatively quickly post-approval, right?

Maybe I'll aside from the short answer of yes, I'll turn it over to Richard.

Let him weigh in.

Gregg and Matt I'll confirm that yes, as well so.

I think with us with Q&A, we have a very unique opportunity to clearly grow significant share within the current occupant marketplace, but.

Clearly theres a lot of patients and physicians who've been sitting on the sidelines because the current octavate haven't met their current needs.

We are quite fortunate to recede opportunity within the <unk> marketplace to grow share within those who discontinued over the last couple of years up twice nightly formulations and also potentially to really accelerate the growth of de novo patients who have just not been satisfied with the options available. So we definitely see a three pronged approach to sort of gain sharing.

Greg Divis: So, we don't think that the timing of the potential PI, if there is one, will be any rate limiting in any way for us relative to coming to market, both from a timing perspective and or, you know, a legal barrier perspective. So, we continue to prepare and, you know, if it's something we have to deal with, we're certainly well prepared to deal with it. Great. Thank you. Thanks, Adam.

Grow this market well beyond the current <unk> market today.

Alright.

Thanks, Thanks for taking my questions.

Thanks Mark.

Thank you. Our next question will come from Robin Garner with Craig Hallum. Please go ahead.

Greg Divis: Thank you. We do have a follow-up from Francois Brisebois with Oppenheimer. Please go ahead.

Good morning, everyone. Just a question on the market opportunities are perhaps a follow up to the last question. How do you quantify the activate naive group and I ask because it seems that your messaging has deviated a little bit from years past, where the focus was more on the commercial opportunity in that low hanging fruit of patients.

Francois Brisebois: Hey, thanks for just taking a follow up here. So I was just wondering, in terms of the patients on the market side, in terms of the patients that are treated and diagnosed, clearly, there's been kind of a flatness in terms of the Oxybate market, at least from a competitor. But is it that, you know, do you ever quantify the amount of patients maybe that are okay and happy with the generic stimulants or weight promoting agents that they currently are on? Or is this just a fear of different products that maybe aren't generic?

Already on oxygen therapy. So it seems that this is really encouraged by recent data and it seems to be just kind of more comfort by management to expand into some of these new areas specifically at the spin of our patients.

Thanks Robin go ahead Richard.

Hey, Robyn really insightful, so yeah, you're spot on so I think.

Richard Kim: Richard, do you want to start there? Yeah, Francois, it's a great question. I think we're continuing to grow and learn about the marketplace. What we can sort of say is, you know, if you look right now, there is an opportunity for pretty much any, you know, a lot more, who are not on OxyBase but being treated with stimulants, weight-promoting agents. Unknown Attendee, Ashwani Verma, Lin Tsai, Guofang Li, Jennifer Gudeman, Myriam Belghiti, So, you know, I think right now we're still in the midst of starting to quantify some of those opportunities, but what we do see is physicians managing those patients showing an interest in considering using Oxybate where in the past they hadn't on a twice-nightly Oxybate.

We will be focused.

Around driving the opportunity within the current occupant marketplace. We know that there are less than 5000, prescribers, who prescribe <unk>.

Oxo base on an annual basis here as well, but to your point as we've grown in our market research and just engagement through various.

<unk> forms with Acp's.

We definitely see a lot of the physicians sort of a who had been lower volume prescribers of ox base and who haven't prescribed box base is telling us that the value proposition of ft, Q&A would either get them into the game more or get them into the game. Finally prescribing Oxidate. We also sort of see from our patient research those patients who are.

Currently not on ox debates, who R&R 50 patients today being very intrigued by the Effie Q&A value proposition as well. So I think very astute observation that we have grown and our confidence that our market opportunity goes well beyond the current auction marketplace in narcolepsy, and we'd absolutely sort of see those other growth opportunities that we're going to balance.

Richard Kim: Yeah, I think the only thing I would add to that is to just, you know, in the simplest terms, is that there's really three opportunities for us to grow FT218 in the market. One is obviously those, you know, little under 16,000 patients who are on the twice nightly products. Two is those who have been previously treated, which is measured in the thousands and thousands of patients, some of which you've discontinued because of dosing related issues, or compliance related issues, or perhaps adverse event related issues, all potentially are opportunities maybe we can help with.

Those to make sure that we don't lose too much focus at the beginning of launch because we actually see our base to grow within the marketplace and then grow well beyond it for years to come as well. So thanks for the question.

Okay. Thank you and as a quick follow up should we expect to see new data at the sleep meeting in June .

Richard Kim: And then there's the de novo patient population, right? And clearly our research has told us there is a subset of patients sitting on the sideline due to dosing related issues. And as Richard noted, the opportunity to bring more patients and prescribers into the mix by, you know, bringing to market a once at bedtime FT218. So all three of those combined create a much larger opportunity than just, you know, having to convert existing treated patients. Yet we hear in our research and in our switch study that those who have switched over 90% said they prefer the once at bedtime.

There will be there will be some on coring of of some of the data that's been presented earlier this year and one new dataset out of the restore data yes.

Okay. Thank you so much.

Thank you. Our next question will come from Adam Edwards with lifestyle capital. Please go ahead.

Great. Good morning quick one for me just a reminder, on the approval timeline and how that might impact and the sharing procedures preliminary injunction.

Greg Divis: So again, we feel really good about the opportunity and to make a tremendous difference in the lives of a lot of patients, people living with narcolepsy and as a platform to drive significant, you know, market penetration and associated revenue and financial performance of the company. Great. All right. Thank you. Thank you. And ladies and gentlemen, thank you for participating in today's question and answer session. I would now like to turn the call back over to Mr. Greg Divis for any closing remarks. Yeah, thank you.

So forth.

Yes.

I guess the first question in there Adam is whether it be a pie. That's a question for the other party.

It is for us at this stage, although we clearly have to be prepared for that.

I would say as it relates to the pie. If there is a motion based on the court's scheduling order our expectation is that that actual process will occur relatively quickly post approval right. So we don't think that the timing of the potential. If there is one will be any rate limiting in any way for us relative to coming to market both.

Greg Divis: And again, thank you, everybody, for joining us, and the opportunity for us to provide this update. Well, certainly, in the spirit, we've always been continuing to be as transparent as we can be on where things fit in the progress we're making. We certainly will do so as appropriate in that regard. And again, you know, we remain highly confident in the full approvability of FT218 and on the opportunity, you know, to serve, you know, a lot of patients and make a difference in their lives and obviously create a tremendous amount of value for our shareholders. So with that, we will certainly look forward to future updates, and we thank you for your time today. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

From a timing perspective <unk>.

Illegal barrier perspective, so we continue to prepare and.

If it's something we have to deal with and we're certainly well prepared to deal with it.

Great. Thank you.

Thanks, Ed.

Thank you and we do have a follow up from Francois <unk> voice with Oppenheimer. Please go ahead.

Hey, Thanks for taking the follow up here. So I was just wondering in terms of the patients on the market side in terms of the patients that are.

Treated and diagnosed.

Clearly theres been kind of a flatness in terms of the oxalate market at least from a competitor but is it do you ever quantify the amount of patients may be that are okay, and happy with the generic stimulants or wake promoting agents that they currently are on or is this just a fear of different products that.

Maybe arent generic here.

Richard you want to start there yes.

Yes first of all it's a great question I think we are continuing to grow.

Turn it both the marketplace, what we can sort of say is.

If you look right now there is an opportunity for pretty much any a lot more patients who are not on ox abates, but being treated with stimulants wake promoting agents to potentially consider the benefit of an ox debate. So we actually sort of see all those patients who are on either branded or generics as good growth opportunities for us in the future we know that from <unk>.

First on that patients, who either with or without <unk> had about the same sort of effectiveness from the clinical study across all three endpoints. So I think right now we're still in the midst of trying to quantify some of those opportunities, but what we do see is physicians mentioned with patients showing an interest in considering using oxidate, where in the past they hadn't on a twice.

Nightly octavate before.

Yes, I think the only thing I would add to that is to just.

The simplest terms is that theres really three opportunities for us too.

To grow <unk> in the market one is obviously those.

Little under 16000 patients who are on the twice nightly products to as those who have been previously treated which is measured in the thousands and thousands of patients some of which you've discontinued because the dosing related issues or compliance related issues or perhaps adverse event related issues. All potentially are opportunities. Maybe we can help with and then there is the de novo.

Patient population right and clearly our research has told US there is a subset of patients sitting on the sidelines due to dosing related issues.

And as Richard noted the opportunity to bring more patients and prescribers into the mixed by bringing to market a once at bedtime ft. Q&A. So all three of those combined create a much larger opportunity than just having.

Having to convert existing existing treated patients, yes, we hear in our research and in our switch study that those who have switched over 90% said they prefer their once at bedtime. So again, we feel really good about the opportunity and to make a tremendous difference in the lives of a lot of patients people living with narcolepsy and thats. It.

Platform to drive significant.

Market penetration and associated revenue and financial performance of the company.

Great Alright, thank you.

Thank you and ladies and gentlemen, thank you for participating in today's question and answer session I would now like to turn the call back over to Mr. Greg Davis for any closing remarks.

Yes, Thank you and again, thank you everybody for joining us and the opportunity for us to provide this update will certainly in the spirit, we have always been continuing to be as transparent as we can be on where things sit in the <unk> and the progress we're making we certainly will do so as appropriate in that regard and again.

We remain highly confident in the full approve ability of ft, Q&A and on the opportunity to serve a lot of patients and make a difference in their lives and obviously create a tremendous amount of value for our shareholders. So with that we will certainly look forward to future updates and we thank you for your time today.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.