Q3 2021 Avadel Pharmaceuticals PLC Earnings Call
Yeah.
Operator: Greetings and welcome to the Avadel Pharmaceuticals 3rd Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Courtney Turiano. Thank you. You may begin.
Greetings and welcome to the avid all pharmaceuticals third quarter 2021 earnings call. At this time, all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
This conference is being recorded.
It is now my pleasure to introduce Courtney Triano. Thank you you may begin.
Yeah.
Courtney Turiano: Good morning, and thank you for joining us on our conference call. This morning, we issued our press release providing a corporate update and financial results for the quarter ended September 30, 2021. The release can be accessed on our website, www.avadel.com.
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 quarter ended September 32021.
The release can be accessed on our website www dot Abdel dotcom.
Courtney Turiano: 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. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements; uncertainties regarding market entry and acceptance of products and the impact of competitive products and prices.
As a reminder, before we begin the following presentation includes several matters that constitute forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward looking statements.
These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements.
Uncertainties regarding market entry and acceptance of products and the impact of competitive products and pricing.
Courtney Turiano: These and other risks are described more fully in Avadel's public filing under the Exchange Act, included in the Form 10-K for the year ended December 31, 2020, which was filed on March 9, 2021, and subsequent SEC filings. Except as required by law, Avadel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. On the call today are Greg Divis, Chief Executive Officer, and Tom McHugh, Chief Financial Officer. Dr. Jennifer Goodman, our VP of Medical and Clinical Affairs, and Richard Kim, Chief Commercial Officer, will additionally join us for Q&A following the call. At this time, I'll turn the call over to Greg.
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 31, 2020, which was filed on March 19, 2021, and subsequent SEC filings.
Except as required by law Avatar 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 Davis, Chief Executive Officer, and Tom Mchugh, Chief Financial Officer.
Dr. Jennifer Goodman, our V P of medical and clinical Affairs, and Richard Kim Chief Commercial Officer will Additionally, join us for Q&A following our call.
At this time I'll turn the call over to Greg.
Gregory J. Divis: Thank you, Courtney. Good morning, everyone, and thank you for joining us on our third quarter 2021 conference call. I will begin by providing an update on our business, highlighting the progress we continue to make towards the potential approval and commercialization of FT218, a once-at-bedtime treatment for managing cataplexy or excessive daytime sleepiness, or EDS, in adults with narcolepsy. I will then turn the call over to Tom to review the financial results for the quarter, and we will conclude with a Q&A session, where we will be joined by Richard and Jennifer.
Thank you Courtney and good morning, everyone and thank you for joining us on our third quarter 2021 conference call.
I will begin by providing an update on our business highlighting the progress we continue to make towards the potential approval and commercialization of <unk>.
Or what's the best time treatment for managing cataplexy or excessive daytime sleepiness or eds in adults with narcolepsy with narcolepsy.
I will then turn the call over to Tom to review the financial results for the quarter and we will conclude with a Q&A session. We will be joined by Richard and Jennifer.
Gregory J. Divis: I'll start with an update on the status of our FPQ&A NDA, which undoubtedly is top of mind for everyone. As a reminder, in mid-October, we received notice from the FDA that the review of our NDA for FT218 was still ongoing, and they would be unable to complete the review by the previously assigned target action date of October 15. The agency also informed us that there were no information requests at that time.
I'll start with an update on the status of our <unk> NDA, which undoubtedly is top of mind for everyone.
As a reminder, in mid October we received notice from the FDA that the review of our NDA for <unk> was still ongoing and they would be unable to complete the review by the previously assigned target action date of October 15th.
The agency also informed us that there were no information request at that time.
Gregory J. Divis: Over the last three weeks, we have had interactions with the agency which have been confirmatory of what was communicated on October 15th and that the review of our NDA is ongoing and progressing. As an example, we have had exchanges on review matters which are consistent and ordinary in terms of substance and topics for a company like ours in the late stages of regulatory review. Although we don't believe it is appropriate to discuss specifics, we are pleased the review has continued to progress and look forward to continuing to work with the agency throughout the remainder of our review process.
Over the last three weeks, we've had had interactions with the agency, which had been confirmatory with what was communicated in October 15, and Thats a review of our NDA is ongoing and it is progressing.
As an example, we've had exchanges on review matters, which are consistent and ordinary course in terms of substance and topics for a company like ours in the late stages of regulatory review.
Although we don't believe it is appropriate to discuss specifics. We are pleased to review has continued to progress and look forward to continuing to work with the agency throughout the remainder of our review process.
Gregory J. Divis: Furthermore, consistent with what we have said for the past 10 months, to date, we still have not been asked by the agency to certify paragraph 4 against any Orange Book-listed patent. And we continue to believe, based on the data we have generated and our regulatory filing strategy, there is no basis to request such a certification.
Furthermore, consistent with what we've said for the past 10 months to date, we still have not been asked by the agency to certified paragraph four against any Orange book listed patents and we continue to believe based on the data we have generated and our regulatory filing strategy. There is no basis to request such a certification.
<unk>.
Additionally in October we filed an 8-K regarding a U S patent application that published on October 21.
Gregory J. Divis: Additionally, in October, we filed an 8K regarding a U.S. patent application that was published on October 21st. The question of a drug-drug interaction, or DDI, is a question that has often been asked over the past few years. Moreover, the published patent application clearly discloses that there is no material PK drug interaction between FT218 and divulproxodine. In particular, in the disclosed studies, the systemic exposure ratios of sodium oxidate measured after administration of FT-2NA with and without Dalvoprexodium stayed within the 80-125% no-effect boundary. This is not meant to imply what will or will not be included in the label for FTP1A.
The question of a drug drug interaction or DDI is a question that has often been asked over the past few years and that published patent application clearly discloses there is no material PK drug interaction between <unk> and <unk>.
In particular in the disclosed studies the systemic exposure ratios of sodium oxalate measured after administration of <unk> with and without downward pressure sodium stayed within the 80% to 125% no effect boundary.
This is not meant to imply what will or will not be included in the label for ft, Q&A, but simply put our PK studies indicate there is no material drug drug interaction.
We remain confident in the approve ability of up to one eight and look forward to continuing to work with the agency to bring this important therapy to patients as quickly as possible.
We're motivated and excited by the tremendous potential of <unk>, if approved to offer a meaningful treatment option for patients living with narcolepsy, which is supported by a strong and growing body of clinical evidence.
Gregory J. Divis: But simply put, our PK studies indicate there is no material drug-drug interaction. We remain confident in the approvability of SB218 and look forward to continuing to work with the agency to bring this important therapy to patients as quickly as possible. We're motivated and excited by the tremendous potential of FT218, if approved, to offer a meaningful treatment option for patients living with narcolepsy, which is supported by a strong and growing body of clinical evidence.
In this regard under the leadership of Jennifer along with her medical team. We have now published our primary manuscript in the leading peer reviewed journal sleep.
Scrubbing, the unmet need for a single bedtime dose and the data supporting the clinical effectiveness and Tolerability of FTP Q&A.
Additionally, this quarter, we presented new clinical data from our pivotal phase III restaurant clinical trial, just last month at chest 2021.
These data presented further confirm the potential benefits that <unk>. If approved can offer patients and continues to demonstrate that <unk> has a compelling clinical profile.
Specifically when treated with ft, Q&A, a significantly greater proportion of participants experienced a 25%, 50% and 75% reduction in the number of weekly cataplexy episodes with once it by the time that the Q&A at all doses and at all time periods studied compared to placebo.
Gregory J. Divis: In this regard, under Jennifer's leadership, along with her medical team, we have now published our primary manuscript in the leading peer-reviewed journal, Sleep, describing the unmet need for a single bedtime dose and the data supporting the clinical effectiveness and tolerability of FT-2 and 8. Additionally, this quarter, we presented new clinical data from our Pivotal Phase III Reston clinical trial just last month at CHEST 2021. These data presented further confirm the potential benefits that ST-218, if approved, can offer patients and continue to demonstrate that ST-218 has a compelling clinical profile.
We also presented the results of a discrete choice experiment or a D C E.
<unk> are increasingly used in health care decisions, including regulatory submissions to understand the specific attributes that drive a patient's treatment preference.
For this IRB approved study.
75, participants with narcolepsy, including 50 current twice nightly sodium oxalate patients and twenty-five pass users of twice nightly sodium oxalate.
Were evaluated to understand the drivers of patient treatment preference for sodium <unk>.
The results of this study demonstrates that dosing frequency is the single most important attribute of an auction bait treatment with once nightly dosing being significantly more preferred than twice nightly dosing.
Gregory J. Divis: Specifically, when treated with FT2N8, a significantly greater proportion of participants experienced 25%, 50%, and 75% reductions in the number of weekly cataplexy episodes with once-at-bedtime FT2N8 at all doses and at all time periods studied compared to placebo. We also presented the results of a Discrete Choice Experiment, or a DCE, which is increasingly used in health care decisions, including regulatory submissions, to understand the specific attributes that drive a patient's treatment preference in this IRB-approved study.
In addition, the DCE also ask participants to consider the likelihood of taking the medication exactly as directed.
Which regimen could reduce anxiety or stress associated with their oxo bake treatment.
For both questions once nightly dosing was again identified as the most important driver of our preferred sodium osophy treatment.
These data continue to underscore the importance of once at bedtime dosing supported by the proven clinical efficacy of ft, Q&A to improve both cataplexy attacks and measurements of excessive daytime sleepiness.
Our vision at Avondale has always been centered around patients and to improve the treatment of their narcolepsy.
We're confident that Etsy Q&A, if approved will not only be effective but also preferred by patients and healthcare professionals.
As a review of the <unk> NDA continues our launch preparation readiness plans also are progressing to support the commercialization of ft Q&A.
Gregory J. Divis: 75 participants with narcolepsy, including 50 current twice-nightly sodium oxidate patients and 25 past users of twice-nightly sodium oxidate, were evaluated to understand the drivers of patient treatment preference for sodium oxidate. The results of this study demonstrate that dosing frequency is the single most important attribute of an Oxabate treatment, with once-nightly dosing being significantly more preferred than twice-nightly dosing. In addition, the DCE also asked participants to consider the likelihood of taking the medication exactly as directed and which regimen could reduce anxiety or stress associated with their Oxybate treatment.
Over the past six plus months the progress Richard and his team have made is both significant and exceptional.
They continue to build a strong team of highly experienced orphan drug launch leaders and key operational team members, who in short order have really accelerated our launch readiness across all critical commercial functions.
And as we've stated previously the largest addition to our growing commercial team will be our field sales team, which we are prepared to complete following potential FDA approval of Etsy Q&A.
We also continue to advance work with our external partners to build out our distribution strategy. As we are now finalizing our specialty pharmacy network. Following the selection of our Rems and patient services partners respectively.
We recently launched our disease education website, narcolepsy disrupts dotcom and continue to build out other patient provider and payer engagement tools and programs to support our launch and launch readiness.
Gregory J. Divis: For both questions, once nightly dosing was, again, identified as the most important driver of a preferred sodium ostobate treatment. These data continue to underscore the importance of once-at-bedtime dosing supported by the proven clinical efficacy of FT208 to improve both cataplexy attacks and measurements of excessive daytime sleepiness. Our vision at Avadel has always been centered around patients and improving the treatment of their narcolepsy, and we are confident that FP218, if approved, will not only be effective but also preferred by patients and health care professionals.
On the payer front, we continue to make strong progress and are pleased with the level of engagement payers have had with our team to date.
Our market access team was well represented at the PCM a annual meeting for the Pbms and their G. P OS as well as at the recent assembly a meeting for specialty pharmacy.
I personally was able to join our team at P. CMA and saw firsthand the high level high level of interest and potential future collaborations with us to help serve the narcolepsy patient community.
Our launch strategy and preparations are supported by our ongoing market research customer insights and data analytics, all of which continue to demonstrate that the <unk> value proposition is clearly understood and is highly valued across patients prescribers and payers.
We believe that once at bedtime that <unk>, if approved has the potential to not only help patients manage their eds and cataplexy, but also potentially enable patients to do this while enjoying a more natural sleep wake cycle, which includes the possibility of a desperate desperately needed uninterrupted night's sleep.
Gregory J. Divis: As the review of the FT-218 NDA continues, our launch preparation readiness plans also are progressing to support the commercialization of FT-218. Over the past six-plus months, the progress Richard and his team have made is both significant and exceptional.
Current twice nightly oxalate simply cannot offer.
Overall from a launch readiness perspective, we continued to make great progress and plan to provide more details of our launch plans, including our views on the market and the subsequent commercial opportunity following the potential approval of <unk>.
Gregory J. Divis: They continue to build a strong team of highly experienced orphan drug launch leaders and key operational team members who, in short order, have really accelerated our launch readiness across all critical commercial functions. As we have stated previously, the largest addition to our growing commercial team will be our field sales team, which we are prepared to complete following potential FDA approval of FT2 and A. We also continue to work with our external partners to build out our distribution strategy as we are now finalizing our specialty pharmacy network following the selection of our REMS and patient services partners, respectively.
I'm extremely proud of the dedication of our team getting us to where we are today.
And we're excited about the future for avid L. The future for our shareholders and as importantly, the future for patients living with narcolepsy as we continued to advance our vision of bringing once at bedtime FTE Q&A to market.
With that I will turn the call over to Tom to review, our financials for the quarter Tom.
Thank you Greg 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.
From a balance sheet perspective, we ended the quarter in a strong cash position with $181 1 million of cash cash equivalents and marketable securities and as a reminder, we have $143 8 million of convertible debt that matures in February of 2023.
Gregory J. Divis: We recently launched our disease education website, narcolepsydisrupts.com, and continue to build out other patient, provider, and payer engagement tools and programs to support our launch and launch readiness. On the payer front, we continue to make strong progress and are pleased with the level of engagement payers have had with our team to date. Our market access team was well-represented at the PCMA annual meeting for the PBMs and their GPOs, as well as at the recent Assembly meeting for specialty pharmacists. I personally was able to join our team at PCMA and saw firsthand the high level of interest in potential future collaboration with us to help serve the narcolepsy patient community.
Total operating expenses in the quarter ended September 32021, or $25 7 million, which is a $12 million increase versus the prior year.
The increase was primarily due to a $12 9 million dollar increase in SG&A costs, they were offset by a $1 $2 million decrease in R&D costs.
R&D expenses were $4 4 million in the quarter ended September 32021.
Compared to $5 6 million for the same period in 2020.
The $1 $2 million year over year decrease resulted primarily from fewer purchases of raw materials.
As well as a decrease in clinical study costs versus the prior year.
SG&A expenses were $21 three.
<unk> 3 million in the quarter ended September 32021, compared to eight 4 million for the same period in 2020.
Gregory J. Divis: Our launch strategy and preparations are supported by ongoing market research, customer insights, and data analytics, all of which continue to demonstrate that the FT218 value proposition is clearly understood and is highly valued across patients, prescribers, and payers. We believe that One-Set Bedtime FT218, if approved, has the potential to not only help patients manage their EDS and their cataplexy but also potentially enable patients to do this while enjoying a more natural sleep-wake cycle, which includes the possibility of a desperately needed uninterrupted night's sleep that current twice-nightly oxibates simply cannot offset.
The $12 $9 million year over year increase is attributable to a number of factors, including market research costs medical education costs <unk>.
Implementation costs associated with preparations for a launch of that T 218, and compensation related costs associated with increased head count.
In total the number of people that Abigail has doubled from 30 at September 32020 to a little over 60 people as of September 32021.
Income tax benefit was $5 1 million in the quarter ended.
In the third quarter of 2021 compared to been in a benefit of 5 million in the prior year.
Net loss for the third quarter of 2021 was $22 million or <unk> 38 cents per diluted share compared to net loss of $11 7 million or <unk> 20 per diluted share in the same period in 2020.
Gregory J. Divis: Overall, from a launch readiness perspective, we continue to make great progress and plan to provide more details of our launch plans, including our views on the market and the subsequent commercial opportunity following the potential approval of FT218. I'm extremely proud of the dedication of our team in getting us to where we are today.
The year over year increase in net loss and loss per share was a result of the increase in operating expenses.
Finally.
As a review of our NDA for F. T 218 is ongoing and our preparations for launch continue we believe we are in a strong financial position with over 180 million of cash on hand to fund the financial investments needed to prepare for the potential launch of <unk>.
Thomas S. McHugh: And we're excited about the future for Avadel, the future for our shareholders, and, as importantly, the future for patients living with narcolepsy as we continue to advance our vision of bringing once-at-bedtime FT-2NA to market. With that, I will turn the call over to Tom to review our financials for the quarter.
I will now turn the call back to the operator to open the line for Q&A.
If you would like to ask a question. Please press Star then one if your question has been answered and you'd like to remove yourself from the queue press the pound key.
First question comes from Chris Howerton with Jefferies. Your line is open.
Thomas S. McHugh: Thank you, Greg. 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. From a balance sheet perspective, we ended the quarter in a strong cash position with $181.1 million of cash, cash equivalents, and marketable securities. And as a reminder, we have $143.8 million of convertible debt that matures in February of 2023. Total operating expenses for the quarter ended September 30, 2021 were $25.7 million, which is a $12 million increase versus the prior year.
Hi, good morning, Thanks, so much for taking the questions.
Look forward to the exciting times for F T to an ATM so.
To that end, Greg and team maybe the two questions for me would be how could you just.
Describe any communication that you've had with the FDA between kind of the initial notification and now and.
Just any kind of information you can provide to us around.
What might be.
Holding things up and you know some timelines moving forward to the extent that you can obviously I know that information.
Information likely is limited.
But for the second question, maybe you could provide a little more meat here.
Thomas S. McHugh: The increase is primarily due to a $12.9 million increase in SG&A costs that were offset by a $1.2 million decrease in R&D costs. R&D expenses were $4.4 million in the quarter ending September 30, 2021, compared to $5.6 million for the same period in 2020. The $1.2 million year-over-year decrease resulted primarily from fewer purchases of raw materials, as well as a decrease in clinical study costs compared to the prior year. SG&A expenses were $21.3 million in the quarter ended September 30, 2021, compared to $8.4 million for the same period in 2020.
In the absence of an official approval or F D. A.
Decision what pre commercial activities can you do ahead of time like what things can you do to implement.
The rems or things of that nature. Thank you very much.
Thanks, Chris and thanks for the questions.
Guarding the communication to date.
Since our disclosures and our communication in mid October I think we would characterize them.
Fairly ordinary course relative to a company like ours in the late stages of a regulatory review.
The work has continued the agency as we stated back in October requested they needed more time and Thats exactly what <unk>.
What has occurred and again I would I think the way we would characterize it as as you know our.
Our back and forth with them are things that are typical at this stage of an NDA review.
As it relates to the timelines again.
No theres nothing we have to share at this stage with regards to the timing. We're very pleased that the the activity has continued on the NDA and our.
Excited about the prospects of bringing it to a successful conclusion here hopefully sooner.
Thomas S. McHugh: The $12.9 million year-over-year increase is attributable to a number of factors, including market research costs, Medical Education Costs, implementation costs associated with preparations for a launch of FT218 and compensation related costs associated with increased headcount. In total, the number of people at Avadel has doubled from 30 at September 30th of 2020 to a little over 60 people as of September 30th of 2021.
As it relates to the pre commercial activities, maybe I'll ask Richard to comment on that initially and then I'll add some additional color as necessary Richard Yeah. Thanks, Craig and thanks, Chris for the question. So first you know for US our launch and commercial preparations really remain on track and we're.
Really pleased with the progress that we've made over the last several months and to reach and we're really using a time very well. Our teams are very busy and first and foremost we're doing a lot to focus on disease education, and really connecting with our customers as Greg mentioned, we just rolled out our first disease asset called narcolepsy disrupts dot com.
Operator: Income Tax Benefit was $5.1 million and the quarter ended in the third quarter of 2021 compared to a benefit of $5 million in the prior year. Net loss for the third quarter of 2021 was $22 million, or $0.38 per diluted share, compared to a net loss of $11.7 million, or $0.20 per diluted share, in the same period in 2020. The year-over-year increase in net loss and loss per share was a result of an increase in operating expenses.
We continue to be engaged with patient advocacy groups could we continue to learn about the marketplace. In addition to having like meetings with sleep specialists and clearly with the payers across the country as well.
Operationally, we are using this time as Greg mentioned, we are now in the final stages of choosing our farmers, especially pharmacy network. In addition to the fact that we have already chosen our rems and especially how providers as well.
We're getting as much work as we can get them. Some work will depend on getting that final approval, but to work. Besides that is really progressing very nice manner over the last few months.
Operator: Finally, as a review of our NDA for FQ218 is ongoing, and our preparations for launch continue, we believe we're in a strong financial position with over $180 million of cash on hand to fund the financial investments needed to prepare for the potential launch of FT218. I will now turn the call back to the operator to open the line for Q&A.
Yes, Thanks, Richard I think to your question specifically on brands. There's only so much that we can do at this stage until we have a final label so.
Describe the heavy lifting if you will of the Buildout of our Rems and its interconnectivity with our entire distribution and patient services model really begins predominantly post an approval with a final label and of course aside from building it from kind of you know.
Scratch so to speak we will also need to go out and train and certify physicians on it as well once that's complete so thanks, Chris.
Oh, yeah absolutely.
Operator: If you would like to ask a question, please press star, then one. If your question hasn't been answered and you'd like to remove yourself from the queue, press the pound key. Our first question comes from Chris Howerton on Jeffrey's. Your line is open.
Absolutely in and Greg If I may maybe just another just slight clarification to that as well.
What about like drug supply, sometimes theres things like labeling that's.
Chris Howerton: Hi, good morning. Thanks so much for taking the questions. I look forward to
Printing and all that kind of stuff is there additional gating materials on that side of the equation as well.
Gregory J. Divis: The exciting times for FT218 will soon arrive. So to that end, Greg and team, maybe the two questions for me would be, you know, how could you describe any communication that you've had with the FDA between kind of the initial notification and now and, you know, just any kind of information you can provide to us around what might be holding things up and, you know, some timelines moving forward to the extent that you can.
Yeah. Thanks, Chris there is to a certain extent.
Our product is configured and package we have daily doses that have approved labeling on them that will be subject to our final an approved label. So some of that work that supports our configure our dosing configuration.
The way our product is packaged is dependent upon a final approval as well.
Any point in time, if you will the exchanges with the agency on these sorts of matters that are at the latter stages of your regulatory review, we believe we're far enough along to begin to do some of those things. If you will at risk. We certainly would do that recognizing that we will still be subject to whatever the final approved label and information is.
That will be required to represent our product from a packaging and labeling standpoint so.
Gregory J. Divis: Obviously, I know that information likely is limited. But for the second question, maybe you could provide a little more meat here. You know, in the absence of official approval or FDA decision, what pre-commercial activities can you do ahead of time? Like, what things can you do to implement the REMS or things of that nature?
That's perfect Okay, well. Thank you so much Greg I appreciate it.
Our next question comes from Francois for Spa with Oppenheimer. Your line is open.
Hi, This is Dan on behalf of Frank Please blah, thanks for taking the questions. Thank you for adding some color.
<unk> launch readiness activities.
Just one from my end.
Gregory J. Divis: Thank you very much. Thanks, Chris, and thanks for the questions. Regarding the communication to date, since, you know, our disclosures and our communication in mid-October, I think we would characterize them as, you know, a fairly ordinary course relative to a company like ours in the late stages of a regulatory review. The work has continued. The agency, as we stated back in October, requested they needed more time, and that's exactly what has occurred. And, again, I think the way we would characterize it as, you know, our back and forth with them are things that are typical at this stage of an NDA review. As it relates to timelines, again, there's nothing we have to share at this stage with regard to timing.
On the restore studying.
If youre sharing anything on that what are you hoping.
You see on the cloud besides besides safety any color you can add on the upcoming data.
Yes, Thanks, Dan maybe Jen alternative yes, absolutely. Thank you for the question so.
The deadline for screen Congress data on just submit abstracts are on us and we are submitting information beyond simply the safety. That's been generated and is this sharing kind of restore study one of the most important aspect of the restore study is understanding for switch patients. After they have been on <unk>.
Three months of <unk>, one eight week dosing regimen may pressure, our once nightly or twice nightly.
Very pleased with the responses that were receiving and those data will debut in the spring time. We're also seeking to understand patient experience from taking twice nightly immediate release, oxidate and that data as well will be presented in the springtime.
Thanks and just.
Just as a follow up to that is that similar to the discrete choice experiment or is there are you sharing anything on that.
So with the discrete to wait to see on it.
While it is an IRB approved study is hypothetical with restore this provides the actual real life experience both from patients describing their experiencing taking twice nightly immediately when you talk to date as well as the all important question. Once the patient has received both a once nightly.
Richard Kim: We're very pleased that the activity has continued on the NDA and are excited about the prospects of bringing it to a successful conclusion here, hopefully sooner. As it relates to the pre-commercial activities, maybe I'll ask Richard to comment on that initially, and then I'll add some additional color as necessary.
And has prior experience with twice nightly, which do they prefer so this is going to be more.
The actual real life evidence.
Great. Thank you for taking the questions. Thanks.
Richard Kim: Yeah, thanks, Greg, and thanks, Chris, for the question. So first, you know, for us, our launch and commercial preparations really remain on track. We're really pleased with the progress that we've made over the last... And if I can, we're really using the time very well. Our teams are very busy.
Our next question comes from Amit <unk> with Needham Your line is open.
Hi, good morning, Thanks for taking my questions.
Yeah.
Just with regards to your meeting with DSP following the October 15th.
Richard Kim: And first and foremost, we're doing a lot to focus on disease education and really connecting with our customers. As Greg mentioned, we just rolled out our first disease asset called Narcolepsy Disrupts.gov. And, you know, we continue to be engaged with patient advocacy. How can we continue to learn about the market? In addition to having live meetings with sleep specialists and clearly with payers across the country.
<unk>.
And can you give us any color on why the FTE was unable to meet that could do for date.
And if at all if there's going to be any more or any new producer date it sounds like.
This view is continuing and at some point they will complete this deal without necessarily you're signing up for Duke Realty.
And I have one more question, but if people to answer this question.
Thanks Tommy.
Richard Kim: Operationally, we're using this time, as Greg mentioned, we are now in the final stages of choosing our pharmacy, especially pharmacy, In addition to the fact that we've already chosen our REMS and HUP providers, especially HUP providers as well. And, you know, we're getting as much work as we can get done. Some work will depend on getting that final approval, but the work besides that has really progressed very nicely. Yeah, thanks, Richard.
I think what we've shared with everybody is what we've shared with US which was that they werent finished then they needed more time to complete the review.
Didn't offer.
A lot of specificity other than that they needed more time.
And in our subsequent discussions and exchanges. If you will we've seen the review continue and progress.
In many ways from where reward back in mid October they did tell us that it was unlikely they would be completed in October and that certainly has been the case and we've certainly seen activity.
And exchanges with the agency continue entered into in November as well for sure over the last number of days.
So in terms of what other color. We got we've tried we've tried to share everything that that's been communicated with us and I think again, our context around what we've been.
Richard Kim: I think, you know, to your question specifically on REMS, there's only so much that we can do at this stage until we have a final label. So, I would describe the heavy lifting, if you will, of the build out of our REMS and its interconnectivity with our entire distribution and patient services model really begins predominantly post approval with a final label. And of course, aside from building it from kind of, you know, scratch, so to speak, we'll also need to go out and train and certify physicians on it as well.
Changing on is really matters that we would describe based upon our experience.
Much more ordinary course for things late stage in the review process.
As it relates to.
An official target action date, or a new <unk> date. The agency has not yet at this stage given us a new target action date.
And based on where we sit today.
We don't see any basis for any sort of formal action that would actually result in a new <unk> date for instance, a major amendment that would kick it out 90 days or whatever from that standpoint. So at this stage. The review progresses, it's continuing to go on and.
And we're happy about that and believe we're hopefully and based upon the matters that were reviewing with the agency now we're in the later stages of this review.
Richard Kim: Once that's complete, so thanks, Chris. Absolutely. And Greg, if I may, maybe just another slight clarification to that as well. What about, like, the drug supply? You know, sometimes there's things like labeling that's printing and all that.
Great that was helpful.
Just a follow up question to the launch preparations.
Perhaps can you give us a sense of you know whenever the approval come.
How many weeks both.
That approval or do you think you would be ready with.
Chris Howerton: printing and all that kind of stuff. Are there additional gating materials on that side of the equation as well?
Packaged product that's ready for launch of course Oh.
Gregory J. Divis: Yeah, thanks, Chris. There is, to a certain extent, the way our product is configured and packaged; we have daily doses that have approved labeling on them that will be subject to our final and approved label. So some of that work that supports our dosing configuration and the way our product is packaged is dependent upon a final approval as well. If at any point in time, and if you will, the exchanges with the agency on these sorts of matters that are at the latter stages of your regulatory review, we believe we're far enough along to begin to do some of those things.
If you could help us understand the DEA approval timeline is Brandon how badly.
Drive.
You know a launch date for the approval.
Yes, I think from a launch timing perspective.
I would measure the work that has to be done that will really kicks off after a final approval and a label.
I would measure that.
More so in the form of months than I would in weeks, we've always talked that the analog one of the base kind of analogs here is.
The recent mixed salt product, which was a little over four months, we believe from approval to launch which was.
Our view was probably DEA centric and probably a little bit of rems as well, but it needed to be updated without having all of the color I think the difference here is we have the same DEA matters at hand for sure, but we also have to really build the rents from the from the from the start and then once that's completed we need to go out and train.
Gregory J. Divis: If you will, at risk, we certainly would do that, recognizing that we'll still be subject to whatever the final approved label and information is that will be required to represent our product from a packaging and labeling standpoint. That's perfect.
And certified physicians accordingly for them to be able to prescribe our product. So I think when you layer in that with kind of the other if you will matter that likely would take a little bit more time as well around commercial supply.
Some of that that we can start now based upon what we can do in 2021, but some of that also will have to carryover into 2022 as well to ensure we have adequate supply. So I think from a launch timing perspective, no one wants to launch sooner than we do for sure.
Chris Howerton: That's perfect. Okay. Well, thank you so much, Greg. I appreciate it.
Operator: Our next question comes from Francois Brisebois with Oppenheimer. Your line is open.
And I think the two kind of drivers of timing center around when do we have an approval. So we have the kind of the jumping off the starting point and then the execution of all the things that we need to deliver on to be ready to launch fully.
Operator: Hi, this is Dan on behalf of Frank Brisebois. Thanks for taking the questions. Thank you for adding some color on the Launch Readiness Act.
In 2022, and that's something we will certainly communicate.
More specifically as we get past the approval and are executing all of our launch readiness activities and again from our standpoint, no one wants to come to the market faster than we do however, we need to make sure we do it right with obviously right and fast really being the goal.
Dan: Just one from my end. On the RESTORE study,
Gregory J. Divis: If you're sharing anything on that, what are you hoping to see in the trial besides safety? Any color you can add to the upcoming data?
Understood. Thank you.
Thanks, Tom.
Our next question comes from Marc Goodman with SPV Leerink. Your line is open.
Jennifer Goodman: Yeah, thanks, Dan. Maybe, Jen, I'll turn it to you. Yes, absolutely. Thank you.
Alright, Thanks for taking my question.
Jennifer Goodman: Yes, absolutely. Thank you for the question.
Judy underlying hallmark.
I have two questions first kind of walk us through the litigation process with Chad and the expected timeline.
Jennifer Goodman: The deadline for spring Congresses to submit abstracts is on us, and we're submitting information beyond simply the safety that's been generated and is reassuring from the RESTORE study. One of the most important aspects of the RESTORE study is understanding for switch patients after they have been on 3 months of FT218, which dosing regimen they prefer, once nightly or twice nightly. We're very pleased with the responses that we're receiving, and those data will debut in the springtime. We're also seeking to understand patient experience from taking twice nightly immediate release Oxibates, and that data, as well, will be presented in the springtime.
Any additional color would be helpful. Here.
And secondly can you talk about your view of the market dynamics for narcolepsy.
For the past several months since the launch of <unk>.
Did you notice any changes that may impact your commercial strategy here. Thanks.
Yes, thanks Rudy.
Take the litigation question, and then I will ask Richard to answer our comments around the market dynamics post the launch of the mix of product.
With regards to the litigation, it's really I would say.
Status quo from what's been communicated to date right. We have a full trial hearing scheduled for towards the end of 2023 to hear the full patent case. The court had a range preliminarily timing for a potential pie or preliminary injunction should one have been filed at this stage one has not been filed.
So there is nothing scheduled currently from a Pi perspective, our expectation continues to be that based at least on the prior schedule that was put in place that.
Dan: Thanks. And is this, just as a follow-up to that, is this similar to the discrete choice experiment, or are you sharing anything on that?
Hearings should actually one be filed we would expect to occur in a timely enough manner to not be a deterrent to our to our launch timing and again I think the when there's something more specific to provide we certainly will but in the meantime, I think our only commentary around the litigation as we remain highly confident in our innovation of wants it.
Jennifer Goodman: So with the Discrete Choice Experiment, that, while it is an IRB-approved study, is hypothetical. With Restore, this provides the actual real-life experience, both from patients describing their experience with taking twice-nightly immediate-release oxybates, as well as the all-important question, once a patient has received both a once-nightly and had prior experience with twice-nightly, which do they prefer? So this is going to be more aligned to actual real-life evidence. Great.
Bedtime Etsy Q&A, we don't see this litigation as a barrier for us coming to market.
Richard do you want to answer market dynamics. Please sure. Thanks.
Thanks for the question. So I would say first and foremost we don't really comment on the specifics of other companies watches. However, maybe a couple of observations from US one with the introduction of the mixed salt formulation. It does not appear at this stage that there has been a large influx of new patients coming into the marketplace.
Obviously, we're all waiting on more data to sort of check into those dynamics, but additionally, it doesn't appear like the market is growing all towards the sodium oxidate or all towards the mixed salt version as well it looks like there will likely be a good mix of both types of patients by the time, we go into 2022 as well so I think for US, we just sort of will understand that.
Dan: Great. Thank you for taking the questions.
Operator: Our next question comes from Ami Fadia on Needham. Your line is open.
Ami Fadia: Hi, good morning. Thanks for taking my questions. Just with regard to your meeting with the FDA following the October 15th date, can you give us any color on why the FDA was unable to meet that GDUFA date? And if at all there's going to be any more, any new PDUFA data, it sounds like... The review is continuing, and at some point, they will complete the review without necessarily assigning approval. And I have one more question, but if you could answer this first, please. Thanks.
There are patients who have been motivated to switch to the mixed hopped version, but there are also patients who have been staying on the sodium ought to be twice nightly version as well. So I think those are really the underlying dynamics that we see so far.
Got it that's very helpful. Thank you.
Gregory J. Divis: Yeah, thanks, Ami. Again, what we've shared with everybody is what was shared with us, which was that they weren't finished and they needed more time to complete the review. They didn't offer a lot of specificity other than that they needed more time. And in our subsequent discussions and exchanges, if you will, we've seen the review continue and progress in many ways from where we were back in mid-October.
Our next question comes from David <unk> with Piper Sandler Your line is open.
Thanks, So just a couple so first.
On the review process I wanted to touch on the orphan drug exclusivity for <unk> and wanted to ask if it is at all possible that the.
The reason, we haven't gotten any decision has anything to do with the ODP for XI wave or is that a a parallel process.
Gregory J. Divis: They did tell us that it was unlikely they would be completed in October, and that certainly has been the case. And we've certainly seen activity, you know, and exchanges with the agency continue into November as well, for sure, over the last number of days. So in terms of what other information we have, we've tried to share everything that's been communicated with us.
That doesn't have any bearing on the review can you just talk to that.
And then also just your general level of confidence that there won't be an issue.
Regarding design Weibo D. So that's number one and number two just a clarification question. So to the extent that you do gain a full approval.
Gregory J. Divis: And I think, again, our context around what we've been exchanging is really matters that we would describe, based upon our experience, as a much more ordinary course for things at late stages in the review process. As it relates to an official target action date or a new PDUFA date, the agency has not yet, at this stage, given us a new target action date. And based on where we sit today, really, we don't see any basis for any sort of formal action that would actually result in a new PDUFA date.
In the near term.
What is your sense in terms of.
Timing of launch in other words, how many months do you think you'll need to implement.
The rems.
And this is sort of bearing in mind that when.
They've got approved there was a several month lag time between its approval.
Gregory J. Divis: For instance, a major amendment that would kick it out for 90 days or whatever, you know, from that standpoint. So at this stage, you know, the review progresses. It's continuing to go on. And we're happy about that and believe we're, you know, hopefully, and based upon the matters that we're reviewing with the agency now, we're in the later stages of this review.
And its launch so should we think about a several month timeline.
Between approval and launch for <unk>.
<unk> that would be helpful. Thanks.
Yes, Thanks, David.
Another question I would say that your characterization is how we would describe it I think that.
Recognizing that what the mix salt product had to go through is a certain level of work that we have we just quite frankly have more to do given we don't have an existing program in place that has to be built based upon our final label and that and then we have to go out and train and certify position. So I think your care.
<unk> is correct in terms of.
Of months and again I think we certainly have every interest and desire to when they come as quickly as we can recognizing we need to do it right.
And we will certainly want to update that as we go along.
And as we've said always.
We certainly have always expected it to be a 2022 weekends.
With regards to your question about.
Orphan drug exclusivity is this a <unk>.
Tangible reason for the review issue is it running parallel paths again, we've tried to be as transparent as we can be based upon what's been communicated with us to date. We are currently unaware at this stage.
<unk> is a topic that.
Issue here or not.
We can say that we certainly have no current information requests or outstanding data requirements asked of us relating to this topic, specifically and I think what we would say relative to our our exclusivity requests and the robustness of our data. There is a number of things I think it's important to shares one we are.
And is that a single bedtime dose of sodium <unk> provides both a greater safety and a major contribution to patient care.
Because we all know for nearly 20 years patients with sleep disorder have been required to forcefully awaken in the middle of the night to take a second dose of immediate release medications and we believe by eliminating that.
We will substantially improve patient care so what.
What I will say is that when you think about our designation that was granted it was granted on that plausible hypothesis that FTC when it could be can clinically superior from a safety perspective right.
And the basis for this goes goes back early or quite frankly that our submission in 2018. It goes back to as early as 2013, when when when the FDA met with key stakeholders from the narcolepsy community and they actually identified that the awakening of patients due to the middle of the night dosing as a potentially significant issue.
Gregory J. Divis: Great, that was helpful. Just a follow-up question about the launch preparations. Perhaps, can you give us a sense of whenever the approval comes, how many weeks post that approval do you think you would be ready with a packaged product that's ready for launch? Of course, also if you could help us understand the DEA approval timeline as well and how that would affect Dr. Ashwani Verma. Thank you; you know a launch date post approval. Thank you.
And a potential safety issue. So again, we feel like the robustness of our of our submission certainly supports its own orphan drug exclusivity based upon demonstrating clinical superiority over the middle of the night dosing both from a safety perspective, and a major contribution to patient care.
Okay. That's helpful. Thank you.
Thanks, David.
Our next question comes from Paul Matisse with Stifel. Your line is open.
Great. Thanks, so much I just had two follow ups one on orphan drug exclusivity I thought that was a good question because I guess from our seat. It feels like ahead of filing and since you've really had direct engagement with the FDA as it relates to certification CMC the strength.
Gregory J. Divis: Yeah, I think from a launch timing perspective, you know, I would measure the work that has to be done that really kicks off after a final approval and a label. I would measure that, you know, more so in the form of months than I would in weeks.
Of your data and have confidence that there is no outstanding questions there.
But have you talked in the past with FDA about what it would take and whether or not your package is sufficient not just to get in a vacuum, but also to break XI waves orphan drug exclusivity.
Gregory J. Divis: You know, we've always talked that one of the basic kinds of analogs here is, you know, the recent Mixed Salt product, which was, you know, a little over four months, we believe, from approval to launch, which was DEA-centric and probably a little bit of REMS as well that needed to be updated without having all the color. I think the difference here is that we have the same DEA matters at hand, for sure, but we also have to really build the REMS from the start, and then once that's completed, we need to go out and train and certify physicians accordingly for them to be able to prescribe our product.
And then separately I was wondering if you could just kind of clarify a little bit more specifically you said that your engagement with the FDA is consistent with the late stage of a regulatory review given that Theres no questions. What exactly does that mean are you spending back and forth draft labels like maybe a little bit more detail there would be helpful. Thank you.
Yes, Thanks Paul.
Again on the latter topic.
And then there is without getting into any specifics because we don't necessarily believe that that's necessarily prudent to talk specifically, but it could be things that you can imagine from exchanges on draft language is relating to partner containers relating to your <unk> or your instruction for use or your medication guide for that matter.
And of course your label are prescribing information, so again I would characterize those as matters that are late stage.
Gregory J. Divis: So I think when you layer in that with, you know, kind of the other, if you will, matter that likely will take a little bit more time as well around commercial supply, there's some of that that we can start now based upon what we can do in 2021, but some of that also will have to carry over into 2022 as well to ensure we have an adequate supply. So I think from a launch timing perspective, no one wants to launch sooner than we do, for sure, and I think the two, you know, kind of drivers of timing center around when do we have an approval so we have the kind of jumping off point and then the execution of all the things that we need to deliver on to be ready to launch fully up, you know, in 2022.
The agency doesn't ever exactly tell you where you are in any one area. So those exchanges can go on for a period of time you May think you're finished with an area and then get more more questions at a later date, but but again I think based upon our experience in our history.
That's a topic that we've been engaged with since October 15th have been consistent with these sorts of later stages of the review.
With regards to your question on <unk>.
Again, the basis for our submission centers around.
Twice nightly dose that hasnt changed relative to the introduction of the mixed salt product and again that product got approved shortly before we actually filed our NDA. So.
Given that context, I think it's safe to assume that where we could.
Provide information our relevancy to all formulations of twice nightly sodium ox debate in our in our submission.
Gregory J. Divis: And that's something we'll certainly communicate more specifically as we get past the approval and are executing all of our launch readiness activities. And again, from our standpoint, no one wants to come to the market faster than we do. However, you know, we need to make sure we do it right, with obviously right and fast really being the goal.
Did I would also say that in our in our leading up to that and then in terms of crafting our orphan drug exclusivity strategy. In total yes, there are opportunities to ask the agency questions about your approach, which I think is fair to say you should assume we've done that and that again it all centers around.
The middle of the night dosing and the complications that implications associated with that.
And the data that we've generated to support that which hasnt changed relative to any other sort of remarks of beta octavate related formulation in the marketplace.
Ami Fadia: I understand. Thank you. Thanks, Tom.
Operator: Our next question comes from Mark Goodman with SVB Larynx. Your line is open.
And Greg. Thank you for that does now just as it relates to breaking o'dea or I guess not breaking it.
Operator: Thanks for taking my question. This is really on the line for Mark.
Rudy: I have two questions. First, can you walk us through the litigation process with Jazz and the expected timeline? Any additional color will be helpful here. And secondly, can you talk about your view of the market dynamics for narcolepsy, especially for the past several months since the launch of Zywave? And did you notice any changes that may impact your commercial strategy here? Thanks.
More of it you get my sense right transcending someone else's already is that the division that determines that or do they need to get input from.
A separate orphan office at the agency.
Yes, the orphan.
The office of orphan products would be.
The part of the agency that is acting on that on that part of the review.
Okay. Thanks for clarifying.
Thanks, Paul.
And our next question comes from Oren <unk> with H C. Wainwright Your line is open.
Gregory J. Divis: Yeah, thanks, Rudy. I'll take the litigation question, and then I will ask Richard to answer or comment about the market dynamics post the launch of the Mixol product. With regard to the litigation, it's really, I would say, you know, the status quo from what's been communicated to date, right? We have a full trial hearing scheduled for towards the end of 2023 to hear the full patent case. The court had arranged preliminarily timing for a potential PI or preliminary injunction should one have been filed. However, at this stage, one has not been filed, so there is nothing scheduled currently from a PI perspective.
Thanks, I have a few questions I'm going to keep beating the drum here I apologize answer what you can on the orphan situation, but just to clarify you've mentioned a few times.
<unk> was approved before you filed your NDA so of course.
That was taken into consideration with whatever materials filed in the orphan front, but they didn't actually get their exclusivity until almost nine months after their own approval. So well into your review so are you in a position.
Confirm.
Whether you had.
Any post XI wave orphan exclusivity granting.
Richard Kim: Our expectation continues to be that, based at least on the prior schedule that was put in place, that a PI hearing should actually be filed, we would expect it to occur in a timely enough manner to not be a deterrent to our launch timing. And again, I think when there's something more specific to provide, we certainly will. But in the meantime, I think our only commentary around the litigation is that we remain highly confident in our innovation of once-at-bedtime FD2 and FD8, and we don't see this litigation as a barrier for us coming to market. Richard, do you want to answer questions on market dynamics, please? Sure. Thanks for the question.
Interactions on yearend with OLED or your reviewer to address any potential issues that may or may not have come up then.
And also on the orphan front can you just confirm you know obviously you've got your OE.
On the plausible hypothesis I think that's what they call it that youre safer.
I think both about the agree intuitively that they there are safety and material contribution.
And just for your product.
But is there a hurdle to actually prove it is mentioned data what data do you have to generate to satisfy that theoretically and what have you submitted.
Richard Kim: So, you know, first and foremost, we don't really comment on the specifics of other companies' launches. However, maybe a couple observations. One, with the introduction of the mixed salt formulation, it does not appear at this stage that there's been a large. Obviously, we're all waiting on more data to sort of... But additionally, it doesn't appear like the market is going all towards sodium oxidate or all towards... It looks like there will likely be a good mix of both types.
All of those.
Yeah.
Yes again.
Regarding our submission the basis of our submission is centered around the challenges associated with the middle of the night dosing.
If we will have generated additional data during the during post our submission in December through the point in time of which.
The NDA is acted on we uncover or learn of additional information that we felt was relevant to share with the agency.
Certainly would have done so as part and parcel to ensure our submission is as robust and complete as possible if new insights we are gaining.
From that standpoint, so whether we did or didn't is not something we're going to comment on but I would say that that is.
Richard Kim: So I think for us, we just sort of will understand that there are patients who have been motivated to switch to the mixed treatment, but there are also patients who have clearly been staying on the sodium oxalate. I think those are really the underlying dynamics.
Work, that's always ongoing with us in terms of assessing whats happening in the marketplace and the challenges patients may or may not be experiencing our insights that we've learned based upon trying to understand those challenges specifically with regards to.
Rudy: Thank God, that's very helpful. Thank you.
Your second question in terms of what data could you generate right I would say that.
Operator: Our next question comes from David Amsellem with Piper Sandler. Your line is open.
The way, we would look at it the way we've looked at it as a couple is a couple fold, but it's not necessarily when it comes to orphan drug about head to head data.
David A. Amsellem: Thanks, so just a couple.
David A. Amsellem: So first, in the review process, I wanted to touch on the orphan drug exclusivity for Zywave and wanted to ask if it is at all possible that the reason we haven't gotten a decision has anything to do with the ODE for Zywave, or is that a parallel process that doesn't have any bearing on the review? Can you just talk about that and then also just your general level of confidence that there won't be an issue regarding the Zywave ODE? So that's number one.
Parroted studies right.
Really two components here one is to really ensure that we've done the work to identify the issues that manifest itself in patients from an adverse event or risk perspective, or safety perspective, as a result of the middle of the night dosing.
No other company has any incentive or motivation to disclose that data, but we've done the work to try to uncover what for the last number of years.
Adverse events or risks are associated with that middle of the night dosing.
Gregory J. Divis: And then number two, just a clarification question, so to the extent that you do gain full approval in the near term, what is your sense in terms of timing for launch? In other words, how many months do you think you'll need to implement the REMS? And this is sort of bearing in mind that when Zywave got approved, there was a several-month lag time between its approval and its launch, so should we think about a several-month timeline between approval and launch for FP2 and 8? That would be helpful.
And that would be information that we use as part of our submission to highlight specifically the challenges there and that are associated with the forcible weakening in the middle of the night.
And then again what data we can provide relative to once at bedtime FTE Q&A that potentially could be.
Reduce or mitigate some of those potential issues that have been identified based upon the data that we've generated so again, that's I think how we would describe it generally I don't know Jan if theres anything you want to add to that completely agree nothing else to add at this time, okay. Thank you.
Okay, and if all else equal you are filing with get to go in the orphan was the only issue if they had already decided that you were blocked.
Gregory J. Divis: Yeah, thanks, David. On the latter question, I would say that your characterization is how we would describe it. I think that recognizing that what the mixed salt product had to go through is a certain level of work that we have, we just, quite frankly, have more to do, given we don't have an existing program in place that has to be built, you know, based upon our final label, and that, and then we have to go out and train and certify physicians. So I think your characterization is correct.
But otherwise, yes, an approvable product should you have received a tentative approval.
You know when you go back to October 15, there is a number of decisions that could have been taken on that day by the agency. If they were in the place that you've described dorm, yes. They could have granted us a tentative approval subject to the orphan exclusivity. They could have granted us a CRM if there was something wrong with our <unk>.
An issue at this point in time so.
And yes, it could have granted us a full approval, which they did it but.
Again, what we told them what we said is what they've told us.
But the short answer to your question is yes, we could have gotten a ta.
At this point in time and we haven't.
Okay, and just quickly and maybe a bit of a modeling question SG&A.
Gregory J. Divis: In terms of months, and again, I think we certainly have every interest and desire to want to come as quickly as we can, recognizing we need to do it right. And we'll certainly want to update that as we go along. And as we've always said, it's, you know, we certainly have always expected it to be a 2022 event. With regard to your question about, you know, orphan drug exclusivity, is this a, you know, a potential reason for the review issue? Is it running parallel paths?
Even ahead of the <unk> data <unk> ramping pretty substantially I think it's already at almost a run rate where most of us were for 2022.
Actual launch year. So can you just talk about why.
How much litigation cost is maybe already baked into this SG&A number and.
Does this keep going up in <unk> and how fully baked as this number I know there's different pieces. Some things go away some things come in but with only a $50 to 60 person sales force like most of US anticipate how close to a fully baked commercial quarterly spend might be already be at at this level.
Gregory J. Divis: Again, we try to be as transparent as we can be based upon what's been communicated to us to date. We are currently unaware, at this stage, if ODE is a topic that's, you know, of issue here or not. We can say that we certainly have no current information requests or outstanding data requirements asked of us relating to this topic specifically. And I think what we would say relative to our exclusivity request and the robustness of our data, there's a number of things I think it's important to share.
Correct.
Yes, yes. Thanks, Thanks, Laurent so without going to specifics of what's in or out of the SG&A number certainly includes legal costs associated with <unk>.
With respect to how close to fully baked.
I think theres puts and takes in any of our quarterly numbers at this point, we are implementation costs associated with preparing for preparing for launch.
Things like building the Rems program, putting a patient hub program and then the last major component of spend that we haven't committed to yet and we will certainly be dependent upon approval of the NDA is the addition of the sales force.
Gregory J. Divis: One, we are confident that a single bedtime dose of sodium oxalate provides both greater safety and a major contribution to patient care. Because we all know, for nearly 20 years, patients with a sleep disorder have been required to forcefully awaken in the middle of the night to take a second dose of an immediate release medication. And we believe eliminating that will substantially improve patients' care. So, you know, what I will say is that when you think about our designation that was granted, it was granted on that plausible hypothesis that FD-218 could be clinically superior from a safety perspective, right?
That will certainly ramp up our costs, but from our perspective I think our costs are in line with what we would expected. We've commented previously that our cost will increase quarter over quarter, particularly as we approach approval.
Again, the last major spending to firm has to bring onboard the bring on board the sales force.
Alright, thanks, guys.
Chuck.
Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open.
Hi, good morning, and thanks for taking the question just wanted to make sure there's clarity on kind of the next steps in the process with FDA given I guess the late stage nature of the game.
Which is still ongoing in terms of can you give us a sense in terms of timing and next steps on your end in terms of getting information to the FDA or will kind of.
Gregory J. Divis: And the basis for this goes back earlier, quite frankly, than our submission in 2018. It goes back to as early as 2013, when the FDA met with key stakeholders from the narcolepsy community, and they actually identified the awakening of patients due to the middle of the night dose as a potentially significant issue and a potential safety issue. So, again, we feel like the robustness of our submission certainly supports its own orphan drug exclusivity based upon demonstrating clinical superiority over middle-of-the-night dosing, both from a safety perspective and a major contribution to patient care.
Addressing what items are outstanding to two.
To facilitate a pool.
Yes.
Yeah, Thanks, Matt I would say that we're quite timely in our response back to the FDA and any question or any exchange we have on any of the matters.
We're under discussion with them.
At this stage of the game so.
We certainly.
Respond quite quickly from that perspective.
Again, our expectation is to review will continue to progress.
It will progress at the rate that the FDA decides.
Size is going to progress.
I have always said is that as we go forward. If we learned something that we believe should be disclosed to shareholders.
Investors, we certainly will for sure.
And we're just pleased with that.
The review has continued during this period of time and the fact that they needed more time certainly.
Certainly appears to be the case, so if we learn something that we think warrants.
Public disclosure around timing, we certainly believe me, we certainly will.
Otherwise, we'll continue to execute and proceed.
As efficiently as we can in responding to whatever.
Information or exchanges of documents, we have with the agency that with what we're going through right now.
Okay. That's helpful and just a quick follow up on that in terms of.
David A. Amsellem: Okay, that's helpful. Thank you.
How should we think about this.
Operator: Our next question comes from Paul Matisse with Stiefel. Your line is open.
That's something that's that should take weeks or in your experience is it.
Paul Matisse: Great, thanks so much.
Paul Matisse: One, on orphan drug exclusivity, I thought that was a good question because, from our seat, it feels like, ahead of filing and since, you've really had direct engagement with the FDA as it relates to certification, CMC, the strength of your data, and have confidence that there are no outstanding questions there. But have you talked in the past with FDA about what it would take and whether or not your package is sufficient, not just to get ODE in a vacuum but also to break Zywave's orphan drug exclusivity?
Is it months.
We're thinking of them in terms of reaching.
<unk>.
Yes, Matt I, just think it's really it's impossible for us to answer that question at this stage.
Only because the agency hasnt cumulative communicated to us an official timeline.
Formally in that state.
<unk> been taking an action that really gives us a <unk> date that would be something we would disclose if the agency came back to us or if they have already come back to us and said to us we intend to be done by this date.
It's really if you will not have formal artificial deadline. It would be an internal target just something thats not likely we would disclose just because it's not it wouldn't be something that.
They would be held they can be really be held accountable to and certainly don't think it's in our best interest.
Paul Matisse: And then separately, I was wondering if you could just kind of clarify a little bit more specifically that you said that your engagement with the FDA is consistent with the late stage of a regulatory review. Given that there are no questions, what exactly does that mean? Are you sending back and forth draft labels? Maybe a little bit more detail there would be helpful. Thank you. Yeah, thanks, Paul.
Put that kind of information out into the public that being said, we're pleased that the activities continued.
And on the topics that we're engaging on end.
We stand ready to respond as quickly as we can if they have any more questions for us.
Okay.
Great. Thanks, Lee added color.
Thanks, Matt. Our next question comes from Robin Garner with Craig Hallum. Your line is open.
Good morning, and thank you you mentioned a doubling in your head count has any of that sales force has been hired at this point other than the sales force do you anticipate substantially more hiring in general.
Gregory J. Divis: Again, on the latter topic, again, without getting into any specifics, because, you know, we don't necessarily believe that it's necessarily prudent to talk specifically, but it could be things that you can imagine from exchanges on draft languages relating to partner containers, relating to your IFU or your instruction for use, or your medication guide, for that matter, and, of course, your label or your prescribing information. So, again, I would characterize those as matters that are late in the stage.
Yeah.
Havent hired any of our of our sales representatives, who would be those customer facing we've begun to build out the sales leadership team as they are required to do all the screening and the profiling and identification of candidates that we can hire post an approval. So some of that the leadership and management of that organization is.
Place.
Describe the additional head count that would likely come on board.
In addition to the sales force would be other.
Either customer facing roles that would support access.
Gregory J. Divis: You know, the agency doesn't ever exactly tell you where you are in any one area, so those exchanges can go on for a period of time. You may think you're finished with an area and then get more questions at a later date, but, again, based upon our experience and our history, the topics that we've been engaged with, you know, since October 15th have been consistent with these sorts of later stages of the review.
And.
And coverage related and reimbursement related activities.
And then beyond that it's primarily really kind of internal head count to just two.
Continue to.
Manage the infrastructure of the organization that has gotten margin right. So more support functions to ensure that we can keep up with the pace and the size of the organization as we go forward, but not materially incremental over and above the.
Gregory J. Divis: With regard to your question on ODE, again, the basis for our submission centers around twice nightly dosing. That hasn't changed relative to the introduction of the Mixalt product, and again, that product got approved shortly before we actually filed our NDA. So, you know, given that context, I think it's safe to assume that where we could provide information or relevancy to all formulations of twice nightly sodium oxidate in our submission, we
The large number of reps that we would additionally at.
At around 50 comment.
Tom maybe you won't answer that covers.
Okay. Thank you and maybe this is a question for Tom but.
With the convertible debt coming due what is your cash management plan for early.
That time.
Yes. Thank you for the question.
We were contemplating mode. If you will and we look at a lot of different scenarios Robin in terms of future cash needs.
Potential capital raises.
Gregory J. Divis: I would also say that in our leading up to that and in terms of crafting our orphan drug exclusivity strategy in total, yes, there are opportunities to ask the agency questions about your approach, which I think is fair to say you should assume we've done that, and that, again, it all centers around the middle of the night dosing and the complications and implications associated with that and the data that we've generated to support that, which hasn't changed relative to any other sodium oxidate or oxidate-related formulation in the marketplace. And Greg, thank you for that. Does now just as it relates to breaking ODE or I guess not breaking it, that's, you know, more of a, you get my sense, right? Transcending someone else's ODE.
The organization might need to support the launch of <unk>.
Well as other growth opportunities for <unk>, so without getting into specifics about what we may be doing in the future of particular strategies from the convertible notes that we do view that the approval of FY 2008.
As a catalyst forces if you will.
And the convertible notes.
And.
Addressing those prior to maturity is certainly in our planning horizon.
Okay. Thank you and if I may my last question is.
It's just around the SBA and whether.
You're aware of any other companies that have had a similar delay with no further questions.
Our data are being required by them.
Well.
I would say that I guess, if you look hard enough you can probably find an example of every situation within the FDA from that perspective.
We've been more focused on what's happening more real time relative to the timing of our NDA and we certainly know that that on the day of October 15th there were there were at least four other decisions that occurred that day with two <unk> and two of Us Scott.
Paul Matisse: Is that the division that determines that? Or do they need to get input from, you know, a separate orphanage at the age? Yeah, the Orphan, you know, the Office of Orphan Products would be the part of the agency that is acting on that part of the review. Okay, okay. Thanks for clarifying.
Basically no action taken with one being driven by now.
Not happening and us, saying, they just need more time for the review.
From that standpoint, and as we sit here today I mean thats the context that we've been trying to understand where we sit from that perspective and again the agency. It picked up and continue to do the work so from our perspective, they needed more time, and that's where we're and it continues to progress and advance accordingly.
Operator: Our next question comes from Oren Livnat with HC Wainwright. Your line is open.
Oren Gabriel Livnat: Thanks, I have a few questions. I'm going to keep beating the drum.
Oren Gabriel Livnat: I'm going to keep beating the drum here, I apologize, answer what you can on the orphan situation. But just to clarify, you know, you've mentioned a few times that obviously Zywave was approved before you filed your NDA, so of course, that was taken into consideration with whatever materials you filed on the orphan front, but they didn't actually get their exclusivity until almost nine months after their own approval.
Yes.
We know of no outstanding questions, we know of no outstanding requirements from a CMC perspective at this stage and again like we said you never know exactly where they are in the review because I never tell you when they kind of check a box and move on to the next one so we stand ready to react to anything.
With immediately to be able to advance to a full approval.
Okay. Thank you thanks, Rob.
Our next question comes from Jason Go Barry.
Bank of America. Your line is open.
Hey, good morning, guys. Thanks for taking my questions.
Oren Gabriel Livnat: So, you know, well into your review. So are you in a position to confirm or not whether you had any post-ZiWave orphan exclusivity granting interactions on your end with OOPD or your reviewer to address any potential issues that may or may not have come up then?
I guess first just for me.
Thinking about payer contracting and how that evolves next year mindful. It's a it's a very fluid situation, but I would assume.
At a minimum that rems finalization for <unk> would sort of be needed before you can enter into subsequent discussions and having contracts struck.
Oren Gabriel Livnat: And also on the orphan front, can you just confirm, you know, obviously, you've got your ODE on the plausible hypothesis, I think that's what they call it, that you're safer. I think most of us agree intuitively that there is safety and material contribution, you know, advantages to your product. But is there a hurdle to actually prove it?
And I guess it would seem logical to me.
Potentially payers may want to slow play things to pit Avondale against the Hikma generic from a pricing competition perspective. So my question really is do you think there is an opportunity if you can get out in front of generic approvals.
Oren Gabriel Livnat: You've mentioned data. What data do you have to generate to satisfy that theoretically? And what have you... and I have a follow-up.
Gregory J. Divis: Yeah, again, you know, regarding our submission, the basis of our submission is centered around the challenges associated with middle-of-the-night dosing. If we generated additional data during and after our submission in December, through the point in time of which, you know, the NDA has acted on, if we uncover or learn of additional information that we thought was relevant to share with the agency, we certainly would have done so as part and parcel to ensure our submission is as robust and complete as possible if new insights were gained from that standpoint.
It makes strong offers to payers if that can drive better access for <unk> and then my second question is just I would love to get your thoughts on Jazzes Rems patent as a gating factor I think in the past you've talked about a two pronged strategy with the courts in SBA and Youre not infringing rems.
So I guess, how important I think there was a recent court ruling that the courts decline to sort of address this issue and pathway. So I'm just curious how important you think that is and if you can put any context around that that'd be great. Thanks.
Gregory J. Divis: So whether we did or didn't is not something we're going to comment on, but I would say that, you know, that's work that's always ongoing with us in terms of assessing what's happening in the marketplace and the challenges patients may or may not be experiencing or insights that we've learned based on trying to understand those challenges specifically. With regard to your second question in terms of what data you could generate, right?
Yes, So Richard do you want to start with the payer.
Comments are absolutely yes, thanks for the question Jason.
For us our plans with the Payors has been made with or without an authorized generic coming to this marketplace. So we're fully aware that the event could occur in the not too distant future, but we would also argue it's still it twice nightly sodium ox debate in the marketplace and we've really been focused with our payers are really describing especially with jennifer's teams help.
Gregory J. Divis: I would say that, you know, the way you look at it, the way we've looked at it is a couple of things. It's not necessarily, when it comes to orphan drugs, about head-to-head data or comparative studies, right? There's really two components here.
Really the clinical value proposition that we have with once at that time at the Q&A.
Gregory J. Divis: One is to really ensure that we've done the work to identify, you know, the issues that manifest themselves in patients from an adverse event or risk perspective or a safety perspective as a result of the middle-of-the-night dosing. No other company has any incentive or motivation to disclose that data, you know, but we've done the work to try to uncover what, for the last number of years, what adverse events or risks are associated with that middle-of-the-night dosing.
As far as the timing for contracts are concerned to your point, we'd prefer to have as many dentists earliest possible. The rems is not really technically a gating factor for us in those conversations.
Really getting through the approval first.
We've been really pleased with the fact that as a small company we've had a seat at the table with the largest payers with the key decision makers, so really focused on making sure that our value proposition from a clinical perspective is really understood and then we will work with the payers to ensure that our goal is to make sure that people with narcolepsy, who are in need of ft Q&A have opt.
Gregory J. Divis: And that would be information that we use as part of our submission to highlight specifically the challenges therein that are associated with forcible waking in the middle of the night. And then, again, what data we can provide relative to once-at-bedtime FT2 and 8 that potentially could reduce or mitigate some of those potential issues that have been identified based upon the data that we've generated. So, again, that's how we would describe it generally. I don't know, Jen, if there's anything you want to add to that.
Turning to really access it so Greg I guess I'll turn the next question back to you.
Yeah, Thanks, Richard Jason regarding the Rems patents, if you will and the one remaining rems patent with a handful of claims.
That are remaining we're obviously very aware of that intellectual property it's matters.
The matters that we have to deal with.
Jennifer Goodman: I completely agree. There is nothing else to add at this time. Okay, thank you.
Relative to our regulatory submission and relative to our build out from a from a how.
<unk> will operate and I'll, just remind everyone that again there has been a prior approved Rems program designed.
By the FDA to effectively meet their meet the FDA standards and be an alternative in the marketplace from an FDA perspective.
Gregory J. Divis: Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host. You know, when you go back to October 15th, there were a number of decisions that could have been taken on that day by the agency. If they were in the place that you've described, Oren, yes, they could have granted us a tentative approval subject to orphan exclusivity. They could have granted us a CRL if there was something wrong with ours; they had an issue at this point in time.
And although no one is using it it certainly provides a roadmap for for parties like us as a means to.
And the development in crafting of our Rems program were keenly aware of their intellectual property and believe we have effectively developed a rems program.
That will become obvious and clear through the matter of the courts that we're not infringing it.
From that standpoint, and that will play out in due course relative to the.
Gregory J. Divis: So, you know, and yes, they could have granted us full approval, which they didn't. But, again, what we told them is what they told us. But the short answer to your question is yes, we could have gotten a TA at this point in time.
The patent case, that's pending currently.
So we don't view it as again.
Patent or any of the other patents as a deterrent or a blocker to us coming to market.
And.
And relative to the court's recent decision to not.
Oren Gabriel Livnat: Okay, and just quickly, it may be a bit of a modeling question, SG&A, you know, it's like most of us anticipate, how close to a fully baked commercial quarterly spend might we already be at this level?
Cannot hear our motion to deal with that from the Orange book, We don't think it's relevant to the merits of the case whatsoever.
Okay. Thanks.
Thank you.
Thank you at this time I would like to turn the call back over to Greg Davis for any closing remarks.
Thomas S. McHugh: Thanks, Oren. Without specifics of what's in or out of the SG&A number, it certainly includes legal costs associated with FT218. You know, with respect to how close to fully baked we are, I think there are puts and takes in any of our quarterly numbers. At this point, we have implementation costs associated with preparing for launch, things like building the REMS program and building a patient health program. And then the last major component of spend that we haven't committed to yet, and will certainly be dependent upon approval of the NDA, is the addition of the sales force.
Thank you operator, and thank you all for taking the time to join US today and your continued support of avid though I want to provide my assurance, who said narcolepsy community to our shareholders to key stakeholders and our employees, but there is nothing more important to Abbott all they're doing whatever is required to get <unk> approved as soon as possible and <unk>.
<unk> launch in 2022.
As our NDA review continues and given the recent interaction with the agency on the NDA, we remain confident in our regulatory filing strategy and the robustness of our complete NDA package.
We're continuing all launch and commercial preparation to ensure to ensure we are fully ready to offer once at that time. After 2008, if approved to all eligible patients living with narcolepsy.
We look forward to providing you more updates as we continue to make progress and we thank you for your time and wish you all a great day. Thank you.
Oren Gabriel Livnat: Alright, thanks guys. Good luck.
Operator: Our next question comes from Matt Kaplan with Ladenburg-Bauman. Your line is open.
This does conclude the program you may all disconnect everyone have a great day.
Matthew Lee Kaplan: Hi, good morning, and thanks for taking the question. I just wanted to make sure there's clarity on kind of the next steps in the process with FDA, given, I guess, the late-stage nature of the
Yeah.
[music].
Operator: [inaudible]
Gregory J. Divis: And next steps on your end in terms of getting information to the FDA or kind of addressing what items are outstanding to facilitate approval.
Gregory J. Divis: Yeah, thanks, Matt. I would say that we're quite timely in our response to the FDA. And any question or any exchange we have on any of the matters, we're in discussion with them at this stage of the game. So, you know, we certainly respond quite quickly from that perspective. Again, you know, our expectation is that the review will continue to progress. It will progress at the rate that the FDA decides it is going to progress.
Yes.
[music].
Gregory J. Divis: What we have always said is that as we go forward, if we learn something that we believe should be disclosed to shareholders and investors, we certainly will. And we're just pleased that the review has continued during this period of time. And the fact that they needed more time certainly appears to be the case. So if we learn something that we think warrants public disclosure around timing, believe me, we certainly will.
Gregory J. Divis: And otherwise, we'll continue to execute and proceed, you know, as efficiently as we can in responding to whatever information or, you know, exchanges of documents we have with the agency in light of what we're going through right now.
Matthew Lee Kaplan: Okay, that's helpful. And just a quick follow-up on that in terms of how we think about this. Is this something that should take weeks or, in your experience, are months that you're thinking of in terms of reaching conclusions?
Gregory J. Divis: Yeah, man. I just think it's really, you know, it's impossible for us to answer that question at this stage only because the agency hasn't communicated to us an official timeline, you know, formally, and if they, you know, absent them taking an action that really gives us a PDUFA date, that would be something we would disclose. If the agency comes back to us, or if they have already come back to us and said to us, we intend to be done by this date, it's really, if you will, not a formal or an official deadline.
Gregory J. Divis: It would be an internal target, just something that it's not likely we would disclose, just because it's not, it wouldn't be something that, you know, that they would be held accountable for, and certainly don't think it's in our best interest to put that kind of information out in the public. So, that being said, we're pleased that, you know, the activities continued on the topics that we're engaging in, and we stand ready to respond as quickly as we can if they have any more questions.
Matthew Lee Kaplan: Great. Thanks for having me, Colin.
Operator: Our next question comes from Robin Garner with Craig Hallam. Your line is open.
Robin Garner: Good morning and thank you. You mentioned a doubling in your headcount. Has any of the sales force been hired at this point? And other than the sales force, do you anticipate substantially more hiring in general?
Gregory J. Divis: Yeah, you know, we haven't hired any of our sales representatives who would be customer-facing yet. We've begun to build out the sales leadership team as they are required to do all the screening, the profiling, and identification of candidates that we can hire post-sign approval. So some of that, you know, the leadership and management of that organization is in place. I would describe the additional headcount that would likely come on board in addition to the sales force would be other, you know, customer-facing roles that would support, you know, access and coverage-related and reimbursement-related activities.
Gregory J. Divis: And then beyond that, it's primarily really kind of internal headcount to just continue to manage the infrastructure of the organization that has gotten larger, right? So more support functions to ensure that we can keep up with the pace and the size of the organization as we go forward. But not materially incremental over and above the large number of reps that we would additionally add at around 50. Tom, did anyone answer that? No, I wasn't.
Robin Garner: Okay, thank you. And maybe this is a question for Tom, but with the convertible debt coming due, what is your cash management plan for early, for that time?
Thomas S. McHugh: Yeah, thank you for the question. We're in a constant planning mode, if you will, and we look at a lot of different scenarios, Robin, in terms of future cash needs, potential capital raises, and whatever the organization might need to both support the launch of FT218 and other growth opportunities for Avadel. So without, you know, getting into specifics about what we may be doing in the future or particular strategies for the convertible notes, you know, we do view the approval of FT218 as a catalyst for us, if you will, and, you know, the convertible notes and, you know, addressing those prior to maturity are certainly in our planning horizon.
Robin Garner: Okay, thank you. And if I may, my last question is about the FDA and whether you're aware of any other companies that have had a similar delay with no further questions or data being required by them. Well, you know...
Gregory J. Divis: Well, you know, I would say that, you know, I guess if you look hard enough, you can probably find an example of every situation within the FDA. From that perspective, we've been more focused on what's happening in real time, relative to the timing of our NDA. And we certainly know that, you know, on the day of October 15, there were at least four other decisions that occurred that day with two, two CRLs, and two of us got, you know, basically no action taken with one being driven by a PAI not happening, and us saying they just needed more time for the review from that standpoint.
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Gregory J. Divis: And as we sit here today, I mean, that's the context that we're in. We've been trying to understand where we sit from that perspective. And, and again, the agency has picked up and continued to do the work. So from our perspective, they needed more time. And, and, and that's where we are, and it continues to progress and advance accordingly. We know of no outstanding questions; we know of no outstanding requirements from a CMC perspective at this stage.
Gregory J. Divis: And again, like we said, you never know exactly where they are in the review process because they never tell you when they kind of check a box and move on to the next one. So we stand ready to react to anything with, you know, immediately to be able to advance this to full approval.
Operator: Our next question comes from Jason Gerberry with Bank of America. Your line is open. Good morning, guys. Thanks for taking my questions.
Jason Gerberry: Hey morning guys, thanks for taking my questions. I guess the first question for me is just about payer contracting and how that evolves next year. Mindful that it's a very fluid situation, but I would guess at a minimum that REMS finalization for FT218 would sort of be needed before you can enter into substantive discussions and have contracts struck. And it would seem logical to me that, potentially, payers may want to slow play things to pit Avadel against the HICMA generic from a pricing competition perspective.
Jason Gerberry: So my question really is, do you think there's an opportunity if you can get out in front of generic approvals and make strong offers to payers if that can drive better access for FT218? And then my second question is just, I'd love to get your thoughts on Jazz's REMS patent as a gating factor. I think in the past you've talked about a two-pronged strategy with the courts and FDA and your non-infringing REMS.
Jason Gerberry: So I guess how important you think that is. I think there was a recent court ruling that the courts declined to sort of address this issue and pathway, so just curious how important you think that is and if you can put any context around that, that'd be great.
Gregory J. Divis: Thank you. Yeah, so Richard, do you want to start with the payer or comment?
Richard Kim: Sure. Absolutely. Yeah. No. Thanks for the question, Jason.
Richard Kim: So, you know, for us, our plans with the pairs have been made with or without an authorized generic... We're fully aware that the event could occur in the not too distant future. But we would also argue, you know, there is still a twice nightly sodium oxidate in the market. And we've really been focused on our payers and really describing, especially with Jennifer's team's help, the clinical value proposition that we have with once-at-bedtime.
Richard Kim: As far as the timing for contracts is concerned, to your point, we'd prefer to have as many done as early as possible. The REMS is not really a gain factor for us in this conversation. It's really getting through the approval process first. And we've been really pleased with the fact that, as a small company, we've had a seat at the table with the largest payers, with the key decision makers. So, no, we're really focused on making sure that our values, [inaudible] Greg, I guess I'll turn to the next question. Yeah, thanks, Richard.
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Gregory J. Divis: Jason, regarding, you know, the REMS patents, if you will, and the one remaining REMS patent with a handful of claims that are remaining, we're obviously very aware of that intellectual property. It's matters that we have to deal with, you know, relative to our regulatory submission and relative to our build-out of how our own REMS will operate. And I'll just remind everyone that, again, there has been an earlier approved REMS program designed by the FDA to effectively meet the FDA standards and be an alternative in the marketplace from an FDA perspective.
Gregory J. Divis: And although no one's using it, it certainly provides a roadmap for parties like us as a means to, you know, in the development and crafting of our REMS program. We're keenly aware of their intellectual property and believe we have effectively developed a REMS program that, you know, will become obvious and clear through the matter of the courts that we're not infringing on it from that standpoint. And that will play out in due course relative to the patent case that's currently pending.
Gregory J. Divis: So we don't view it as, again, that patent or any of the other patents as a deterrent or a blocker to us coming to market. And relative to the court's recent decision not to, you know, hear our motion to delist that from the orange book, we don't think it's relevant to the merits of the case whatsoever.
Operator: Thank you. At this time, I'd like to turn the call back over to Greg Divis for any closing remarks. Thank you, operators.
Gregory J. Divis: Thank you, Operator, and thank you all for taking the time to join us today and your continued support of Avadel. I want to provide my assurances to the narcolepsy community, to our shareholders, to key stakeholders, and our employees that there is nothing more important to Avadel than doing whatever is required to get FT218 approved as soon as possible and progress to a launch in 2022. As our NDA review continues, and given the recent interaction with the agency on the NDA, we remain confident in our regulatory filing strategy and the robustness of our complete NDA package.
Gregory J. Divis: We are continuing all launch and commercial preparations to ensure we are fully ready to offer Once at Bedtime FT218 if approved to all eligible patients living with narcolepsy. We look forward to providing you with more updates as we continue to make progress. Thank you. This does conclude the program. You may all disconnect. Everyone, have a great day.
Operator: Ashwani Verma, David Amsellem, Franois Brisebois, Ami Fadia, Austin Murtagh, Anne Morse, Gregory Divis, Ashwani Verma, Guofang Li, Richard Kim, Myriam Belghiti, Austin Murtagh, Ami Fadia, Ashwani Verma, Gregory Davis, Ashwani Verma, Guofang Li, Richard Kim, Ashwani Verma, Gregory Davis, Ashwani Verma, Gregory Davis, ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Ashwani Verma, Myriam Belghiti, Austin Murtagh, Ami Fadia, Ashwani Verma, Gregory Divis, ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?