Q4 2021 Avadel Pharmaceuticals PLC Earnings Call
Operator: Ladies and gentlemen, thank you for your patience. Today's conference will begin momentarily. Once again, thank you for your patience.
Ladies and gentlemen, thank you for your patience today's conference will begin momentarily. Once again. Thank you for your patience today's conference will begin momentarily.
Operator: Today's conference will begin momentarily. [music] David Amsellem, David Amsellem, David Amsellem, Thomas McHugh, Thomas McHugh, Thomas McHugh, Greetings and welcome to the Avadel Pharmaceuticals fourth quarter and full year 2021 earnings call. At this time, all participants are in a listen-only mode.
[music].
Okay.
Operator: A question and answer session will follow the formal remarks. As a reminder, this call is being recorded. It is now my pleasure to introduce Brandi Robinson. Thank you.
Greetings and welcome to the avid Dow Pharmaceuticals fourth quarter and full year 2021 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal.
Thanks.
A reminder, this call is being recorded it is now my pleasure to introduce brand New Robinson. Thank you you may begin.
Brandi Robinson: You may begin. 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 and full year ended December 31st, 2021. The release can be found on our website, www.avadel.com. As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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.
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 and full year ended December 31st 2021.
The release can be found at our website www dot.
Dot com.
Brandi Robinson: These lists include information regarding products in the development stage that may not achieve scientific objectives or milestones or meet stringent regulatory requirements. Uncertainties also exist regarding market entry and acceptance of products and the impact of competitive products and prices. These and other risks are described more fully in Avadel's public filings under the Exchange Act, including the Form 10-K for the year ended December 31, 2021, which was filed yesterday, as well as any subsequent SEC filing.
As a reminder, before we begin the following presentation includes several matters.
That constitutes forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Forward looking statements are subject to risks and uncertainty that could cause actual results to differ materially from those contemplated in such forward looking statements.
These risks include information regarding products and development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements.
Uncertainties regarding market entry and acceptance of products and the impact of competitive products and pricing.
These and other risks are described more fully in <unk> public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2021, which was filed yesterday as well as any subsequent SEC filings.
Brandi Robinson: Unless required by law, Avadel undertakes no obligation to update or revise any forward-looking statements contained in this presentation, to reflect new information, future events, or otherwise. On the call today are Greg Divis, Chief Executive Officer; Dr. Doug Williamson, Chief Medical Officer; and Tom McHugh, Chief Financial Officer.
That is required by law.
<unk> undertakes no obligation to update or revise any forward looking statements contained in this presentation. It.
It looks like new information future events or otherwise.
On the call today are Greg Davis, Chief Executive Officer.
Doctor, Doug Williamson Chief Medical Officer.
Tom the Hugh.
<unk> financial officer.
Richard Kim cheap.
Commercial officer and Doctor Jennifer Bitterman.
Nice president of medical and clinical affairs will additionally be available for Q&A is probably going to call.
Gregory Divis: Richard Kim, Chief Commercial Officer, and Dr. Jennifer Gudeman, our Vice President of Medical and Clinical Affairs, will additionally be available for Q&A following the call. At this time, I'll turn the call over to Greg. Thank you, Brandy.
At this time I'll turn the call over to Greg.
Gregory Divis: Good morning, everyone, and thank you for joining us for our call. I'll start off by providing an update on our business and highlighting the progress made toward potential FDA approval and commercialization of FC2 and 8, including a brief update on our commercial readiness activities. Dr. Woodinson will then provide a summary of the new data recently presented at World's Fleet 2022. Tom will then review the financial results for the quarter, including an update on our recent convertible maturity extension.
Thank you Brandy and good morning, everyone and thank you for joining us for our call.
I'll start off by providing an update on our business and highlighting the progress made towards potential FDA approval and commercialization of Etsy Q&A <unk>.
<unk> a brief update on our commercial readiness activities.
Dr. Williamson will then provide a summary of the new data recently presented at World Sleep 2022, Tom.
Tom will then review the financial results for the quarter, including an update on our recent convertible note maturity extension, we will conclude with a Q&A session. When we will be joined by Richard and Jennifer.
Gregory Divis: We will conclude with a Q&A session when we will be joined by Richard and Jennifer. As we head toward what we believe will be a full approval and launch for FT2 and 8. There are four priorities for the company that are mission critical to ensure we realize the full potential and value that FT218 can create for patients, for shareholders, and for Avadel at large. Number one, and most importantly, is the FDA taking a formal action on our FT218-NDA and granting full approval.
As we head toward what we believe will be a full approval and launch for ft Q&A.
Gregory Divis: Number two, continuing our deep understanding of the market opportunity and the clear, unmet need for Oxybate-eligible patients that goes well beyond the current Oxybate-treated patient population. Number three, the significant progress we are making in preparing the company and the narcolepsy community for the potential future launch of FT218, including launch readiness and data generation. And finally, number four, the strengthening of our balance sheet to ensure maximum flexibility to achieve our business objectives.
There are four priorities for the company that are mission critical to ensure we realize the full potential and value that S. P. Two one it can create for patients for shareholders and for Abbott I'll, let larch.
One and most importantly, the FDA, taking a formal action on our F. T 208, NDA and granting our full approval.
Number two continuing our deep understanding of the market opportunity and the clear unmet need for oxalate eligible patients that goes well beyond the current oxalate treated patient population.
Three the significant progress, we're making and preparing the company and the narcolepsy community for the potential future launch of Etsy to one eight including launch readiness and data generation.
And finally number four the strengthening of our balance sheet to ensure maximum flexibility to achieve our business objectives.
Gregory Divis: So let's begin our update with priority number one, the one topic on everyone's mind, which is the status of our NBA review for FT2 and A. Earlier this year, we sent in additional edits to the draft label, and we confirmed with the agency at that time that there were no additional questions or information requests pending. We were given no specifics on the timing of the completion of our review and subsequently requested a meeting with more senior officials from the FDA to clarify the timing and any remaining review items.
So lets begin our update with priority number one the one topic on everyone's mind, which is the status of our NDA review for Etsy Q&A.
Earlier this year, we sent an additional edits to the draft label and we confirmed with the agency at that time, there were no additional questions or information request pending.
We were given no specifics on the timing of the completion of our review and subsequently requested a meeting with more senior officials from the FDA to clarify timing and any remaining review items.
Gregory Divis: Based on these and subsequent exchanges, let me share with you what we have been told directly by the FDA. First, we have reconfirmed that there are currently no outstanding questions or information requests and that the last and final remaining matters are, as communicated to us, administrative and internal to the FDA. Furthermore, within the past week, the agency confirmed to us that they are working on the FT-218 label and expect to send it, along with any potential follow-up comments, back to us soon, which is the language used in writing to us by the FDA.
Based on these and subsequent exchanges, let me share with you what we have been told directly by the FDA.
First we have reconfirmed that there are currently no outstanding questions or information request and that the last and final remaining matters are as communicated to us administrative and internal to the F. D. A.
Furthermore, within the past week the agency confirmed to us that they are working on the F. T Q&A label and expect to send it along with any potential follow up comments back to us soon which is the language used in writing to us by the FDA.
Gregory Divis: We share this detail so our stakeholders know we are continuing to take action to move this forward with all means at our disposal, and we have always expected that the next step upon completion of the FDA's internal and administrative process would be for us to receive an updated, proposed, and potentially final label. And now, based on this very recent and direct feedback, we have been informed that it is currently being worked on and is expected to happen soon for the FDA.
We share this detail so our stakeholders know we are continuing to take action to move this forward with all means at our disposal and we have always expected that the next step upon completion of the Fda's internal and administrative process is for us to receive an updated proposed and potentially final label.
And now based on this very recent and direct feedback we have been informed that it is currently being worked on and is expected to happen soon per the F. D. A.
Gregory Divis: Completing this next step on the label is, we believe, an important step forward toward the potential stolen approval of F-D-2-N-A, which takes us to priority number two. [inaudible] As it relates to the market opportunity and unmet need of oxybate eligible patients, we have continued to conduct extensive patient and healthcare professional research, research which continues to inform and confirm that ST208 can command a meaningful share of the narcolepsy treatment market among oxybate eligible patients, including the potential to expand the treated oxybate patient pool.
Completing this next step in our label. We believe is an important step forward to the toward the potential full approval of F. 'twenty.
Which takes us to priority number two.
As it relates to the market opportunity and unmet need a box of beat eligible patients. We have continued to conduct extensive patient and health care professional research research, which continues to inform and confirm that S. T. 218, if approved can command a meaningful share of the narcolepsy treatment market.
Among octavate eligible patients, including the potential to expand the treated oxalate patient pool.
Gregory Divis: We believe this is important to understand because, despite the introduction of an additional twice-nightly oxabate formulation over the last 15-plus months, there has not been a meaningful increase in the number of narcolepsy patients being treated with any form of twice-nightly oxabate. Through our extensive research, we have learned that the introduction of once-at-bedtime ST-2 and ST-8 will be well-received by current, high-volume Oxybate prescribers and can expand the utilization of Oxybates by physicians who currently prescribe at low volumes or even not at all.
We believe this is important to understand because despite the introduction of an additional twice nightly oxo baked formulation over the last 15 plus months there has not been a meaningful increase in the number of narcolepsy patients being treated with any form of it twice nightly occupancies and.
And through our extensive research we have learned that the introduction of once at bedtime FTE tourney will be well received by current high volume ox it'd be prescribers.
And can expand the utilization of box debates with physicians, who currently prescribe at low volumes or even not at all.
Gregory Divis: Positions we have surveyed indicated their intent to switch patients, as well as increase their Oxidate utilization upon the potential approval and launch of F-218, including those who currently do not prescribe any choice that we offer. Furthermore, very recent patient research informs us that the majority of Oxybate-eligible patients Whether naive to therapy, previously treated with Oxybates, or currently on either of the Twice Nightly Formulations, patients self-reported as being interested or significantly interested in learning more about once-at-bedtime FT-218 and, if approved, interested or significantly interested in initiating therapy with FT-218. And this includes those who have recently switched to the Twice Nightly Mixed Salts Formulation as well.
Physicians, we have surveyed indicated their intent to switch patients as well as increased or octavate utilization upon the potential approval and launch of F. T 20, including those who currently do not prescribed any twice nightly octavate.
Furthermore, very recent patient research informs us that the majority of Octavate eligible patients whether naive to therapy previously treated with ox abates or currently on either of the twice nightly formulations have self reported as being interested or significantly interested in learning more about once at bedtime FTE two one.
And if approved interested or significantly interested in initiating therapy with ft tuning and this includes those who have recently switched to the twice nightly mixed salt formulation as well.
Gregory Divis: All of this only confirms what we have seen in our past research, that there is a clear need for a once-a-bedtime option like FT-2 and FT-8 for Oxybate-eligible patients, whether on therapy currently or not, due to the challenges associated with having to wake up in the middle of the night, thus providing Avadel a significant opportunity to positively expand the Oxybate Treated Pool almost exclusively to our benefit The potential full approval and launch of FT2&A combined with a market opportunity that is meaningfully larger than the current approximately 16,000 patients and nearly $2 billion requires significant market preparation and launch readiness action, for which, over the last year and specifically the last few months, we have made tremendous progress, leading us to priority number three. Under the leadership of Richard and his experienced team, they have significantly progressed our overall launch readiness across all commercial and launch-related functions.
All of this only confirms what we have seen in our past research that there is a clear need for once at bedtime option like F. P. Tierney for oxalate eligible patients whether on therapy currently are not due to the challenges associated with having to wake up in the middle of the night.
Thus, providing avid I will have a significant opportunity to positively expand the oxalate treated pool almost exclusively to our benefit.
The potential full approval and launch of F. P. Tierney combined with a market opportunity that is meaningfully larger than the current auction approximately 16000 patients and nearly $2 billion require significant market preparation and launch readiness actions for which over the last year and specifically the last few months.
We have made tremendous progress and leads us to priority number three.
Under the leadership of Richard and his experienced team they have significantly progressed, our overall launch readiness across all commercial and launch related functions.
Gregory Divis: This includes, but is not limited to, the selection and set-up of our specialty pharmacy distribution partners, the continued development of our patient services center and REMS, which are prepared to advance upon FDA approval, meaningful engagement with payers with a focus on the three large PBMs representing approximately 85% of commercially insured lives, and the identification and selection of nearly 90% of our sales team with offers accepted pending FDA approval. And lastly, customer-facing activity generating significant interest from healthcare providers at live medical congresses, including most recently at the World Sleep Congress in Rome that just finished yesterday.
This includes but is not limited to the selection and set up of our specialty pharmacy distribution partners. The continued development of our patient services Center, and Rems, which we're prepared to advance upon FDA approval.
Meaningful engagement with payers with a focus on the three large pbms, representing approximately 85% of commercially insured lives.
The identification and selection of nearly 90% of our sales team with offers accepted pending FDA approval.
And lastly, customer facing activity generating significant interest from health care providers at live medical Congresses, including most recently at the World Sleep Congress in Rome that just finished yesterday.
Gregory Divis: Another key component of our launch readiness is to highlight the publication of key data to continue to scientifically demonstrate the potential clinical benefits of ones at bedtime FT-2 and A. Before we hand it over to Tom to conclude with our fourth priority, which is our financial performance and balance sheet-related actions, I am pleased to introduce Dr. Doug Williamson, our newly appointed Chief Medical Officer, to review the highlights of the most recently published clinical data from WorldSleep 2022. Doug, the floor is yours.
Another key component of our launch readiness is to highlight the publication of key data to continue to scientifically demonstrate the potential clinical benefits of once at bedtime FTE Q&A.
Before we hand, it over to Tom to conclude with our fourth priority, which is our financial performance and balance sheet related actions I am pleased to introduce to you Dr. Doug Williamson, our newly appointed Chief Medical Officer to review the highlights of the most recently published clinical data from World Sleep 20, twenty-two Doug the floor is yours.
Dr. Doug Williamson: Well, thank you, Greg, and good morning, everyone. I want to spend a few minutes highlighting some of the new data we recently presented at World Sleep 2022, which continue to support the proposition of FT218 as a potential once-of-a-lifetime option to treat the devastating symptoms of narcolepsy. As you saw from our press release issued earlier today, we had a strong presence at World Sleep with a total of eight narcolepsy posters presented.
Well, thank you Greg and good morning, everyone I wanted to spend a few minutes to highlight some of the new data. We recently presented at World Sleep 2022, which continue to support the proposition of F. T 218, as a potential once at bedtime option to treat the devastating symptoms of narcolepsy.
As you saw from our press release issued earlier today, we had a strong presence will sleep when a total of eight narcolepsy posters presented.
Dr. Doug Williamson: To highlight some of our data, we start with a discrete choice experiment, or DCE. DCEs are a widely accepted way to isolate the specific attributes that ultimately drive choice in medication selection. Building upon a prior study, we surveyed 100 OxyBate-experienced clinicians along with 120 OxyBate-experienced patients, and this time we included the attributes of the two times nightly mixed salts oxidate product as well.
To highlight some of our data, let's start with a discrete choice experiment or D. C E D.
D. C ease are widely accepted way to isolate the specific attributes that ultimately drive choice and medications selection.
Building upon our prior study we surveyed 100 oxy baked experienced clinicians along with 120 Oxidate experienced patients and this time included the attributes of the two times nicely mixed salts auction bait product as well.
Dr. Doug Williamson: This second DCE publication confirmed that once nightly dozing, when compared to either of the twice nightly dozing options, and notably regardless of sodium, the most important attribute driving both patient and clinician preference, as well as patient quality of life, and the reduction of patient anxiety and stress. In addition to this DCE publication, our pivotal phase 3 rest on clinical trial of FT208 continues to yield relevant post-op data. About two-thirds of people with narcolepsy experience disrupted nighttime sleep. This is further exacerbated by the vast majority of medications used to treat excessive daytime sleepiness in narcolepsy, which have the common side effect of insomnia.
This second DC confirmed once nightly dosing when compared to either of the twice nightly dosing options and notably regardless of sodium content was the most important attribute driving both patient and clinician preference as well as patient quality of life and the reduction.
Of patient anxiety and stress.
In addition to this D C E publication, our pivotal phase III rest on clinical trial with <unk> T to ornate continues to yield relevant post hoc data.
About two thirds of people with narcolepsy experience disrupted nighttime sleep. This is further exacerbated by the vast majority of medications used to treat excessive daytime sleepiness, and narcolepsy, which share the common side effect of insomnia.
Dr. Doug Williamson: In the RESTON study, 63% of participants received stable doses of concomitant stimulants. Yet the FT218 group had improvements in disrupted nighttime sleep when compared to placebo, not only regardless of narcolepsy but also, importantly, regardless of whether or not they took a stimulant. In other post-hoc analyses from Reston, FT218 demonstrated improvement compared to placebo in subjective measures of daytime sleepiness, sleep quality, and refreshing nature of sleep as early as week 1 with the 4.5g starting dose, with even greater improvement at week two soon after starting the sixth round.
And the rest arms study, 63% of participants received stable doses of concomitant stimulants, yet the F. T 218 group had improvements in disrupted nighttime sleep when compared to placebo not only regardless of narcolepsy.
But also importantly, regardless of whether or not they took a stimulant.
In other post hoc analyses from restaurant F. T 218 demonstrated improvement compared to placebo in subjective measures of daytime sleepiness sleep quality and refreshing nature of sleep as early as week, one with the four and a half gram starting dose with even greater improvement are we too soon after starting this.
Six gram dose.
Dr. Doug Williamson: Finally, WorldSleep 2022 offered the opportunity for our first presentation of interim data from the ongoing RESTORE study, which was designed to evaluate the long-term safety and tolerability of FT218. Among the participants treated in this open-label study, some for more than 18 months, FT218 has been generally well-tolerated with a low rate of discontinuation due to adverse reactions and no unexpected safety symptoms. Upcoming congresses this spring will include additional analyses from Restore on patient preference data for those switching from either of the twice-nightly products, as well as data on dose initiation and titration.
Finally world Sleep 2022 offered the opportunity for our first presentation of interim data from the ongoing restore study, which was designed to evaluate the long term safety and tolerability of ft to one eight.
Along the participants treated in this open label study some for more than 18 months F. T. 218 has been generally well tolerated with a low rate of discontinuation due to adverse reactions are no unexpected safety signals.
Upcoming Congresses. This spring and will include additional analyses from restore on patient preference data for those switching from either of the twice nightly products as well as data on dose initiation and titration.
Dr. Doug Williamson: Based on a growing, growing body of clinical evidence and the feedback we received from patients, we continued to be motivated by the tremendous potential of FT218, if approved, for people with narcoleps. With that, I'll now turn the call over to Tom to detail our balance sheet actions and financial results. Thank you, Doug.
Based on our growing a growing body of clinical evidence and the feedback we received from patients. We continue to be motivated by the tremendous potential of ft to one eight is approved for people with narcolepsy.
With that I'll now turn the call over to Tom to detail on our balance sheet actions and financial results Tom.
Thank you Doug ill.
Tom McHugh: I'll provide a few highlights for the quarter and also note that full financial results are available in the press release and the 10K. We just announced an exchange of 117.4 million of 143.8 million of senior, unsecured, convertible notes that were originally issued in February of 2018 that had a maturity date of February of 2023. Following this exchange, $26.4 million remain outstanding from that original issue.
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-K.
We just announced an exchange of $117 4 million of $143 8 million of senior unsecured convertible notes that were originally issued in February 2018 that had a maturity date of February 2023.
Following this exchange $26 4 million remains outstanding from that original issuance.
Tom McHugh: But most importantly, the $117.4 million of notes that were exchanged have a maturity date of October 2023, or eight months longer with no change to the interest rate of 4.5% or the exchange price of $10.79. Our rationale for sending a maturity date can be summarized as follows: With $157.2 million of cash on the balance sheet at December 31st.
But most importantly.
117.4 million of notes that were exchanged have maturity date of October 2023, or eight months longer with no change to the interest rate of four 5%.
For the exchange price of $10.79.
Our rationale for extended maturity date can be summarized as follows.
With $157 2 million of cash on the balance sheet at December 31.
Tom McHugh: We believe we are in a strong liquidity position and don't need to raise capital at this time. We believe the cash on hand, based on current plans and expectations, is sufficient to prepare for the launch of FT218, if approved. It's in the maturity by eight months, removes a significant near-term cash requirement, and provides much greater flexibility and time to execute, not only the potential launch of FQ-220 but also time to consider financing options that address Avadel's longer-term capital needs.
We believe we're in a strong liquidity position and don't need to raise capital at this time.
We believe the cash on hand based on current plans and expectations is sufficient to prepare for the launch of <unk> T to one eight.
Approved.
Extended maturity by eight months removed a significant near term cash requirement and provides much greater flexibility and time to execute not only a potential launch about Q2 and eight.
But also time to consider financing options that address abdullah longer term capital needs.
Tom McHugh: We are appreciative of the noteholders who participated in the exchange and look forward to their continued support of Avadel. I'll now turn to a brief commentary on operations. Total operating expenses for the quarter-ended December 31, 2021 were approximately 23 million, which is a $9 million increase versus the prior year. The increase is due to a $12 million increase in SG&A offset by a $3 million decrease in R&D.
We are appreciative of the noteholders, who participated in exchange and look forward to their continued support of Avondale.
Tom McHugh: The year-over-year decrease in R&D resulted primarily from lower clinical expenses and purchases of active pharmaceutical ingredients used in the research and development of FT218. The year-over-year increase in SG&A is attributable to a number of factors, including commercial launch planning costs, higher legal and professional fees, and higher compensation costs associated with higher headcount. Net loss for the fourth quarter of 2021 was approximately $22 million, or $0.38 per diluted share, compared to a net loss of approximately $11 million, or $0.19 per diluted share, in the same period in 2020. The year-over-year increase in net loss and loss per share resulted from an increase in operating expenses.
I'll now turn to a brief commentary on operating expenses.
Total operating expenses in the quarter ended December 31st 2021 were approximately 23 million.
The $9 million increase versus the prior year.
The increase is due to a 12 million dollar increase in SG&A offset by a $3 million decrease in R&D.
The year over year decrease in R&D resulted primarily from lower clinical expenses and purchases of active pharmaceutical ingredients used in the research and development of F. T 218.
The year over year increase in SG&A is attributable to a number of factors, including commercial launch planning costs higher legal and professional fees and higher compensation costs associated with higher head count.
Net loss for the fourth quarter 2021 was approximately 22 million or <unk> 38 cents per diluted share compared to net loss of approximately $11 million or <unk> 19 per diluted share in the same period in 2020.
The year over year increase in net loss and loss per share resulted from the increase in operating expenses.
Gregory Divis: And as noted a moment ago, as a review of our NDA for FT218 progresses and our preparations for launch continue, we believe we're in a strong financial position with $157 million of cash on hand, coupled with the eight-month maturity extension on $117 million of convertible notes, to fund the financial investments needed for the potential launch of FT218. I will now turn the call back to Greg for closing comments before we open up the line for Q&A. Thank you, Tom.
And as noted a moment ago.
As a review of our NDA for FTE tunic progresses, and our preparations for launch continue we believe we're in a strong financial position with 157 million of cash on hand.
Coupled with the eight months maturity extension on 117 million of the convertible notes.
To fund the financial investments needed for the potential launch of Etsy to one eight.
I'll now turn the call back to Greg for closing comments before we open up the line for Q&A.
Gregory Divis: And again, thank you all for taking the time to join us today and for your continued support of Avedel. Now, to wrap up briefly before Q&A, we are fully aware of everyone's interest in the status, the timing, and, most importantly, the completion of the FT218 NDA review. Rest assured, we are directing all our energy, sparing no effort, and will continue to deploy all available resources, both internal and external, to successfully bring FT218 to approval as soon as possible. We have not learned anything, including in our most recent exchanges with FDA, that compromises our belief in the potential approvability of FT218.
Thank you Tom and again, thank you all for taking the time to join US today and your continued support of avid out.
To wrap up briefly before Q&A, we are fully aware of everyone's interest in the status and the timing and most importantly, the completion of the ft to one eight NDA review rests.
Rest assured we are directing all our energy sparing no effort and will continue to deploy all available resources, both internal and external to successfully bring ft to 182 and approval as soon as possible.
We have not learned anything including in our most recent exchanges with FDA that compromises our belief in the potential approve ability of F. 'twenty, we look forward to the FDA as they have recently communicated to us completing their work soon bringing us closer to our mission of delivering this important treatment to people living with narcolepsy.
Operator: We look forward to the FDA, as they have recently communicated to us, completing its work soon, bringing us closer to our mission of delivering this important treatment to people living with narcolepsy. The progress we have made to both prepare ourselves and the market for the potential launch has been significant and clearly demonstrates a much larger Oxybate-eligible patient pool that we can potentially serve, given the clearly defined unmet need for, and the importance of, once-at-bedtime dosing for patients, providers, and caregivers. Once approved, we will be ready to accelerate our FT2 and 8 launch activities and fully maximize the value of FT So with that, let's open the lineup for Q&A. As a reminder, to ask a question, you will need to press star 1 on your telephone, and to withdraw your question, just press the pound.
The progress we've made to both prepare ourselves in the market for the potential launch has been significant and clearly demonstrates a much larger oxalate eligible patient pool that we can potentially serve given the clearly defined unmet need for four and the importance of once at bedtime dosing for patients providers and caregivers.
And once approved we will be ready to accelerate our ft to one eight launch activities and fully maximize the value of ft, Q&A for all stakeholders, including patients shareholders and avatar.
So with that lets open the lineup for Q&A.
As a reminder to ask a question.
Star one on your telephone.
We're drilling a question just press the pound key.
One moment for questions.
Chris Howerton: One moment for questions. Our first question will come from a line from Chris Howerton from Jefferies. You may begin. Hi, good morning.
Our first question will come from the line of Chris Howerton from Jefferies. You may begin.
Gregory Divis: I got to say Greg, really exciting news. I can't wait to hear from the FDA really soon, so thanks for the update today and, of course, for everything else. You know, the questions for me, I guess would be with respect to kind of the NDA review and the labeling. If there's any features of the label that you're currently negotiating that you can kind of give us more color on that would be really interesting. The second question that I would have maybe is from just a logistical perspective.
Hi, good morning.
I got to say, Greg really exciting news and I can't wait to hear from the FDA really soon so thanks for the update today and of course for everything else.
You know the questions for me I guess would be.
With respect to kind of the N D. A re review and the labeling if theres any features of the label that Youre.
Currently negotiating that you can kind of give us more color on that would be really interesting.
Second question that I would have maybe is from just a logistical perspective I know when we were closer to the original producer date. There was some discussion around a hearing for a preliminary injunction just curious if there is any updates on the status and timing of that.
Gregory Divis: I know when we were closer to the original PDUFA date there was some discussion around a hearing for a preliminary injunction. Just curious if there was any updates on the status and timing of that as it appears we're getting closer to a full approval as you said. And then if I may if you want to address a third question you can say no thanks Chris you've already asked too many but the third one would be if you've considered strategically you know obviously narcolepsy is the most near-term opportunity but have you considered strategically label expansion opportunities into things like idiopathic hypersomnia where other occibate formulations have been successful. Yeah, Chris, thanks. Maybe I'll take those briefly.
Is it it appears we're getting closer to a full approval as you said.
And then if I may if you want to address the third question you can say no. Thanks, Chris you've already asked too many but the third one would be.
If you've considered strategically.
Obviously narcolepsy is the most near term opportunity, but have you considered strategically label expansion opportunities into things like idiopathic hypersomnia.
Where other auction bait formulations have been successful thank you.
Gregory Divis: You know, from a labeling perspective, the last term, the pen is really in FDA's hands. We provided the last turn of it earlier this year, as we referenced, I would just put those edits as minor, they're data related, making sure all information is accurate per the sources in our NDA submission. And so that sits in their hands.
Yeah, Chris Thanks, maybe I'll take those briefly.
From a from a labeling perspective, the last the pen is really in I would describe it as in Fda's hands. We provided the last turn of it earlier this year as we referenced I would just close at it says miner their data related making sure. All all information is accurate for the for the <unk>.
As in our NDA submission and so so that sits in their hand, we've always known that we would get a label back.
Gregory Divis: We've always known that we would get a label back. It could be the final approved label; it could have edits to it, based on, you know, whatever the agency is proposing. But we think that's an important, we don't believe that it's an important next step for us to head toward full approval. So there's not much more I think we can provide relative to, you know, the specifics around it. Other than that, we've had a number of exchanges on the label previously.
It could be a final approved label it could have edits to it based on whatever the agency is proposing and but we think that's an important that we don't believe that that's an important next step for us to head toward a full approval. So there's not much more I think we can provide relative to you know the specifics around it other than that we've had a number.
Gregory Divis: So, as we've said to many of you, I believe in the past, we felt the label was in really good shape. And if it ends up anywhere remotely where it was in our last turn, we'll be really, really pleased with the construct of our final approved label. Secondly, on the PI, there really is nothing to report on from that front. You know, there isn't a PI file, and there isn't a hearing planned at this stage of the game. I think whether one gets filed or not is not a question we can answer.
Of exchanges on the label previously so as we've said to many of you I believe in the past we felt the label was in really good shape and if it and if it ends up anything remotely where it was in our last turn will be really really pleased with the construct of our final approved label.
Secondly on the P. I, there really is nothing to.
Report on from that front.
There isn't a P. I filed there isn't a hearing planned.
At this stage of the game.
Gregory Divis: But I think our view, based upon how the court was preparing to handle a potential PI should one have been filed back last year, we have no reason to believe that the court isn't going to take the same perspective and the same view that we'll have an approved asset that patients really need, and we'll want to act on that as efficiently as the court schedule will allow it to do so. So that's how I think from where we sit in the PI, there's really no information to report on.
Think whether one gets filed or not is not a question. We can answer but I think our view based upon how the court had was preparing to handle a potential P. I should one had been filed back last year.
Have no reason to believe that the court isn't going to take the same perspective and the same view of will have an approved asset that patients really need and will want to act on that as efficiently as the court and the.
The court schedule will allow us to do that so.
So that's how I think where we sit from a P. I Theres really no winter no information report on in terms of other label expansions. We've done a lot of work in terms of really evaluating different opportunities and but let's be clear, what's most important for us and for patients, we're serving and for our shareholders is to get the approval and launch ft to one eight.
Gregory Divis: In terms of other label expansions, we've done a lot of work in terms of really evaluating different opportunities. But let's be clear, what's most important for us and for the patients we serve and for our shareholders is to get approval for and launch FT218 as the next major catalyst for the company. But we have done a bit of work on looking at other opportunities, and certainly we'll talk more about that in the future. And I would say the most important priority for us from that regard is lifecycle management.
As the next major catalyst for the company, but we have done a bit of work in looking at other opportunities and certainly we'll talk more about that in the future and I would say the most important priority for us from that regard is lifecycle management, So clearly, there's which studies being done in idiopathic idiopathic hypersomnia.
Gregory Divis: So clearly, there are studies being done in idiopathic hypersomnia, and we'll see how that data and those launches progress over the coming months. And it's obviously something we're very interested in and something that we hear from a lot of KOLs, including just this past week at the World Sleep Congress in Rome, a tremendous amount of interest in wanting to study FT218 in idiopathic hypersomnia. So we'll have more to talk about that in the future.
We'll see how that data and those launches progress over the coming months.
And its obviously something were very interested in and something that we hear from a lot of kols, including just this past week at the World Sleep Congress in Rome.
Tremendous amount of interest in wanting to study F T. Two and eight in idiopathic hypersomnia. So we'll have more to talk about that on the future. In addition, what we've what we've also done is we've begun some early work on some ultimate formulation work for that subset of patient population that may need something different formulation with a different salt.
Gregory Divis: In addition, what we've also done is we've begun some early work on some alternate formulation work for that subset of the patient population that may need something, a different formulation with a different salt content. Given that we have a technology platform that allows us to do that once a night, so that work is ongoing, and there'll be more to talk about that in the future, but it's still early at this point in time. So, thanks, Chris.
Content, we given that we have a technology platform that allows us to do that in a once nightly. So that work is ongoing and there'll be more to talk about that in the future, but it's still it's still early at this point in time, so thanks, Chris.
David Amsellem: Awesome. Interesting little tidbit there at the end, Greg. So thank you for that, and I appreciate all the progress. Our next question will come from David Amsellem from Piper Center. You may begin. Thanks.
Awesome.
Interesting little Tidbit, there did Greg so thank you for that and I appreciate all the progress.
Our next question comes from the line of David insulin from Piper Sandler you may begin.
David Amsellem: So maybe I'll turn the discussion over to the commercial landscape, and what I wanted to get your thoughts on is how you think the Xyrem generic market will develop. Obviously, we know that there is an authorized generic coming, and there are significant royalties attached to that. So I guess the question here, Greg, is how do you think about 218's place in the market to the extent that we see significant uptake of an AG? So that's my first question.
Thanks, So maybe I'll turn the discussion over to the commercial landscape and you know what I'm, what I wanted to to get your thoughts on is how you think the.
The xyrem generic market will develop obviously, we know that there's an authorized generic coming.
And there are significant royalties attached to that.
So I guess the question here Greg is.
How do you think about you know.
No.
Two a teens place.
In the market to the extent that we see significant uptake of of an E. G.
So that's my first question and then I have a follow up.
Richard Kim: Then I have a follow-up question. Sure. Thanks, David. Maybe I'll ask Richard, our Chief Commercial Officer, to answer this one. Yeah, hey, thanks, Greg. And thanks, David, for the question. So yeah, you know, obviously, we did all hear from Jez about the anticipation of the AG for the second half of this year.
Sure. Thanks, David maybe I'll I'll ask Richard our Chief commercial officer to to answer this one.
Richard Kim: And, you know, I can sort of say that's pretty consistent with where we view this marketplace. If, if by chance, the AG happens to grow this marketplace, I think we view that as positive for more potential oxidate utilization that goes on overall. But I also think at the end of the day, you know, the AG and the existing two branded compounds in this marketplace, and even one day when you get the multisource generics, they're all twice-nightly oxidates. And that's, you know, a very consistent value proposition.
Yeah, Hey, Thanks, Craig and thanks, David for the question. So yeah, obviously, we did I'll hear from jazz sort of anticipation of the AG for the second half of this year and you know I can sort of say, that's pretty consistent with where we view this marketplace.
If by chance the EG happened sports marketplace, I think we view that as positive for more potential octavate utilization that goes on overall.
But I also think at the end of the day, the EG and the existing two branded compounds this marketplace and even one day when you get the multi source generics, they're all twice nightly oxo base and that's a very very.
Very consistent value proposition, we think the proposition of ft Q&A.
Richard Kim: We think the proposition of FT218 as the only once-at-bedtime treatment option is a very differentiated treatment option that's going to be well needed, as you've heard Greg saying earlier. And I think our value proposition is very well understood by not only patients and physicians but also by the payers that we engage with as well. So our view on the AG and the multisource generic... We believe we are well positioned in this marketplace with or without them.
Only once at bedtime or treatment options is a very differentiated.
Treatment option thats going to be well needed as you've heard from Greg, saying earlier and I think our value proposition is very well understood by not only patients and physicians, but also by the payers that we engage with as well so our view on the EG and multi source generics potentially future hasnt changed at all and we believe.
We're well positioned in this marketplace with or without them coming to market. So.
Richard Kim: I think I would only add that, you know, we have no expectation at this stage, given your commentary on royalties, that there's going to be a substantial reduction in the pricing in the marketplace for the AG. And if that is the case, if it's more typically priced or even higher than more typically priced, given what the AG providers have to give back to the reference list of drug holders, you know, our view from and our research with payers would tell us that it's going to be treated like an extension to the brand. So we don't believe it.
Okay.
Yeah, sorry, yeah.
I would only add that you know.
We have no expectation at this stage given that your commentary on royalties that theres going to be a substantial reduction in the in the pricing in the marketplace of the E. G and if that is the case, if it's more typically priced or even higher than more typically price given what the AG providers have to give back to the.
A reference listed drug holder.
<unk>.
Argue from an all research with payers would tell us that it's going to be treated like an extension to the brand. So we don't believe it we don't expect it to be a step at it we don't expect it to be preferential and candidly as Richard noted every twice nightly product patient is a candidate for us right, whether they're on therapy or or not quite frankly.
David Amsellem: We don't expect it to be a step toward it. We don't expect it to be preferential. And candidly, as Richard noted, every twice-nightly product patient is a candidate for us, right, whether they're on therapy or not, quite frankly. So again, I don't think we see it as a material shake-up to the marketplace or that it mitigates the opportunity one bit for FT2. Okay, that's helpful. And maybe I'll ask sort of the commercialization of the commercial landscape question a little differently, which is that you've talked about whether it's an AG or the brand, it still looks like a twice-nightly product.
So.
Again.
We don't see it being a material shake up to the marketplace, nor mitigates the opportunity one bit four ft Q&A.
David Amsellem: But as the pie for the low sodium product increases, do you look at that as... You know, a landscape where your pie could be shrinking, or do you have confidence that, you know, potentially you can get some low sodium patients moved over to 218, obviously once nightly, but it is going back to high sodium. So how do you think about that? Yeah, thanks, David. Richard, do you want to go?
Okay. That's helpful. And then maybe I'll ask sort of the you know.
The commercialization of commercial landscape question, a little differently, which is that you don't you've talked about.
Whether it's in AG or the brand, it's still a twice nightly product, but as the pie for the low sodium product increases do you look at that as.
You know a landscape, where you know your pie could be shrinking or do you have confidence that potentially you can get some low sodium patients moved over to 218, obviously once nightly but it is going back to high sodium so how do you think about that.
Yeah. Thanks, David Richard do you want to go yes sure Greg.
Richard Kim: Yeah, sure. No, it's a great question again, David. So, you know, a great comment earlier on the growing body of market research that we continue to do. And what we do know is when we show our product profile to patients who are either on, you know, the sodium oxidate version right now, there's a very high interest in learning about FE2 and 8. We also know that there is also interest in potentially switching to this agent.
Question again, David So you know.
Great comment earlier on.
The growing body of market research that we continue to do and what we do know is when we show our product profile to patients who are either on the sodium ox to beat or the mixed Salt version right. Now is there's a very high interest in learning about Etsy chewing eight. We also know that there is also an interest in potentially switching to this agent and in fact.
Richard Kim: And in fact, David, patients who are on the mixed salt version tend to be patients who have changed therapy quicker over their treatment duration than on sodium, the twice nightly sodium oxidate. So we actually view the opportunity if patients are switched on to the mixed salt version as still a very robust opportunity for us. They tend to be more early adopters of treatment change as well.
David and patients who are on the mixed halt version they tend to be patients who have changed therapy quicker over their treatment duration, then on sodium twice nightly sodium ox abate. So we actually view the opportunity if patients are switched onto the mixed salt version as still a very robust opportunity for us they tend to be more early.
Richard Kim: So we view both the pool of currently stable sodium oxidative twice on these and those who are on the MIPS help version as both being very viable candidates to be considered upon approval for FT-2NA. So we don't see the mixed operation shrinking our ability to grow the product, penetrate the marketplace, or grow it at all in the Yeah, I think in addition to that, I think where your commentary and, from our perspective, doesn't represent is that we believe the pie of oxibate-treated patients can grow, and we don't believe that that certainly hasn't been demonstrated with the introduction of the mixed salts product.
Adopters of treatment change as well so we view both the at the pool of currently stable sodium octavate twice that mutations and those who are on the mix operation as both being very viable candidates to be considered upon an approval for FTE Q&A. So we don't see a mixed operation shrinking our ability to grow that.
The marketplace or to grow it at all in the future either.
Gregory Divis: So, based on our research, we think there are more patients out there that don't require a switch. But yet, we hear from patients on therapy today who have switched from both the twice nightly original formulation and the more recent mix all formulation. We have those patients in our restore study now, and we hear how they're doing. And we think, as you know, that body of experience grows from being in an open-label extension study to being in the market. I think that will be a major catalyst for us, accordingly. But as Richard noted, there are still twice nightly and clearly have expressed an interest to want to learn about FT21. That's a helpful color.
Yeah I think in addition to that I think where your commentary.
From our perspective.
Doesn't represent is that we believe the pie a box of bait treated patients can grow and we don't believe that certainly hasn't been demonstrated with the introduction of the mixed salts product so but based on our research we think theres more patients out there that don't require a switch, but yet we hear from patients on therapy today, who have who.
Have switched from both the twice nightly original formulation and the more recent mixed all formulation we have those patients in our restore study now we hear how they're doing and we think as you know that that body of experience grows from being in a in an open label extension study to being in the market. We think that will be a major catalyst for.
Us.
Accordingly, but as Richard noted Theres still twice nightly and clearly have expressed an interest to want to learn about FY 'twenty.
David Amsellem: Thanks, guys. Thanks, David. Burnett's question will come from the line of Ami Fadia from Needham. You may begin. Good morning.
Okay. That's helpful color. Thanks, guys. Thanks.
Thanks, David.
Our next question will come from the line of.
<unk> idea from Needham you may begin.
Ami Fadia: Thanks for taking my question. Greg and team, congratulations on the update. I had one clarification on that. So it sounds like you got an update from the FDA that they will send you their comments on the label soon. Was this after a reasonably long gap since the last time in January that you communicated on the label? If you could clarify that and if there was any other back and forth in the meantime, that would be helpful to know, and then I have to come up with all the rest. Yeah, Ami, thank you.
Hi, good morning, Thanks for taking my question.
Greg and team congratulations on the update.
I had one clarification on that so it sounds like.
You got an update some of the actual bad.
They will send you the comments on the neighbor.
One was this after all.
Ah recently non-GAAP since the last time in January that you communicated on the neighbor. If you could clarify on that and if there was any other back and forth in the meantime, our that would be helpful to know.
And then I have follow ups, yeah Ami. Thank you, there's definitely been back and forth.
Gregory Divis: There's definitely been back and forth, you know, over the period of time. But I will say that, you know, the last turn of the label was ours back in January; we haven't seen a label come back to us yet. But again, our edits at that point in time were fairly minor in nature, relative to just, you know, correcting some data tables and ensuring that everything was, was, you know, tied to the data in the NDA.
Over the period of time.
And but I will say that the last turn of the label was ours back in January we haven't seen a label come back to us yet.
But again, our edits at that point in time work.
Nearly minor in nature.
Relative to just correcting some data tables and ensuring that everything was was.
Gregory Divis: So, but there's definitely been an exchange going on. And, again, this recent communication has occurred within the last week. Okay, excellent, and... Um... In your meeting with the FDA and some senior management at the FDA earlier this year, they'd given you some color on timelines. Are we still within that timeline?
Tied to the data in the NDA so.
So, but theres definitely been exchange going on and.
This recent communication has occurred within the last week.
Okay.
Yeah.
And they are meeting with DFT them from senior management of <unk>.
Yeah, they've given you some color on timeline.
I mean still within that timeline.
Gregory Divis: Yeah, they gave us some guidance in terms of how long they thought it may take them to complete the work that was remaining from that standpoint. And, you know, with us recognizing that there's nothing binding around that because we're not heading toward a specific action date. But at this stage, we haven't surpassed that guidance we received. Okay.
Yeah. They gave us some some some guidance in terms of how long they thought it may take them to complete.
The work that was remaining from that standpoint and.
With us recognizing that theres nothing binding around that because we're not heading toward a specific action date, but at this stage, we havent surpassed that.
That guidance we received.
Ami Fadia: You talked about the REMS program. Can you give us some color around, you know, once everything is approved and you're ready to go, how long would it take you to enroll physicians into your REMS program? And tactically, how would you target patients that are already on a Zyrum or Zybe product?
Got it okay.
Let me ask about just.
The launch.
You talked about the rents program can you give us some color around you know one.
The proved and you're ready to go.
A long would it take you to.
Physician into Yoga EMS program.
And tactically how would you target patients that are already on <unk>.
Xyrem or xyrem product.
Richard Kim: To Think Conversion David Amsellem, Franois Brisebois, Yeah, thanks, Ami. Maybe, Richard, if you want to start. Yeah, Ami, great question. So the good news is under Jen's leadership, the REMS program build and also our overall distribution commercially have continued to progress. Obviously, we need the final components from the FDA to sort of get to that next sort of near-finalization stage, but we've made really great progress to where we are, so we feel once we actually have the final details from the FDA, we will enter that next phase of building those programs.
Just think conversion.
Yeah. Thanks, Amit maybe Richard if you want to start.
Yeah, Great question. So the good news is under John's leadership, the Rems program build.
And also our overall distribution commercially has continued to progress obviously, we need the final components from the F. D. A to sort of get to that next sort of near Finalization stage, but we've made really great progress to where we are so we feel once we actually have to morph. The final details from the FDA, we will enter that next phase of building those programs.
Richard Kim: Now when you think about towering the patient, [inaudible] So the good news is that this marketplace is very concentrated, both from a patient's stance, but also from a physician's. We know that there are less than 6,000 overall octubate prescribers.
Now when you think about turning the patients. So the good news is we know that this marketplace is very concentrated both from a patient but also from a physician standpoint, we know that there is less than 6000 overall ought to be prescribers, we know that theres less than 1800 physicians, who account for over 80% of the script volume. So we know who.
Richard Kim: We know that there are less than 1,800 physicians who account for over 80% of the script volume, so we know who we have to go see as far as where those patients reside right now. So we think we have a very good targeted plan and, obviously... We will be building our resources to make sure that we can support that network. But the other thing I would also add is, as we see in the patient organizations, we think there is pretty good anticipation for having the potential option of once-daily therapy to be available.
We have to go see as far as where those patients reside right. Now. So we think we have a very good targeted plan and obviously.
We built will be building our resources to make sure that we can support that network, but the other thing I would also add is as we see is within.
Within the patient organizations and we think there is pretty good anticipation of having.
The potential option of a once at night time at once at bedtime therapeutic to be available. So we will be approaching this both from our physician engagement that we have and also.
Richard Kim: So we will be approaching this both from the physician engagement that we have and also many of our targeted patient initiatives as well. So we feel really good about where we are right now, but clearly, we need that approval so we can get to that next stage of our rollout as well.
Many of our targeted patient initiatives as well. So so we felt really good about where we are right now, but clearly we need that approval take you to get to that next stage of our rollout as well.
Ami Fadia: Maybe a last question for me, if I may, just with regards to switching patients from a low-sodium to a once-nightly product, The feedback that we've heard from JAS and some of the other physicians is that patients that have a cardiovascular underlying disease or patients who are renally impaired, were the ones that they see as most ideal for a low-sodium product, in your work and the feedback that you've received. Would these patients also be interested in switching to a more convenient monthly dose?
Got it maybe a last question for me if I'm wrong.
Just with regard to switching patients from Oh, no sodium too old one Nike product.
The feedback that we've heard from jazz.
Jazz and Barbara portion of that.
<unk>.
Have you.
You know a cardiovascular underlying disease or push until I lean the lean pad.
Well the ones that they see us most ideal for indoor sodium product.
In your work and the feedback that you've received.
Would these patients to also be interested in speaking to a more convenient months blanket.
Thank you.
Ami Fadia: Thank you. Well, I think, you know, go ahead. Go ahead, Richard. No, a great question. And, you know, first and foremost, there are some patients that may benefit from a lower sodium version. You know, our perspective of that is it's a relatively small share, less than 10 percent of the overall potential marketplace with potentially more severe hypertension or on renal dialysis. The question fundamentally for a lot of those patients will still come down to the benefit of the thought versus the benefit of having a therapy that they only need to take once at bedtime.
Well, yes.
No go ahead go ahead Richard.
Great question, So first and foremost there are some patients that may benefit from a lower sodium version our perspective of that is it's a relatively low less than 10% of the overall potential marketplace with potentially more severe hypertension or on renal dialysis.
The question fundamentally for a lot of those patients will still come down to the benefit of the salt versus the benefit of having a therapy that they only need to take once at bed time, its really the fundamental issue of treating the narcolepsy versus either conditions that the patient goes through as well. So you know we will not necessarily be the perfect option for everyone, but I think that's the fundamental.
Ami Fadia: It's really the fundamental issue of treating the narcolepsy versus other conditions that the patient goes through as well. So, you know, we will not necessarily be the perfect option for everyone, but I think that's the fundamental choice in those more severe hypertensive and renal dialysis patients that may need therapy. Got it.
Joyce in those more severe hypertensive and renal dialysis patients that may need to be considered.
Got it thank you.
Richard Kim: Thank you. Thanks Ami. Our next question will come flying out of Marc Goodman from S.R.B. Theorying.
Thanks Tommy.
Marc Goodman: You may begin. Thanks for taking my question. It's really an ally for Mark.
Our next question will come from the line of Marc Goodman from <unk> theory, you may begin.
Marc Goodman: So do you think payer pushback will be a hurdle for switching to 1s 90 dosing after generic entry for Xyrem? And can you remind us what percent of patients who tried and discontinued Xyrem or Zywave and how you would target these patients? Thanks. Yeah, go ahead, Richard.
Thanks for taking my question is really on a life of Mark.
So do you think payer pushback will be a hurdle for switching to 190 <unk> dosing of the generic entry of Xyrem and can remind us what percent.
Patient, who tried and discontinued xyrem or <unk> and how would you target these patients. Thanks.
Yes go ahead Richard.
Richard Kim: Yeah, great, great question again. So, as far as you know, first and foremost, I'm really proud of the work that we've had our pair team doing engaging with pairs across the country as well. And I think the first thing that I would say is that the clinical value proposition of Once at Bedtime FT218 has become very clear to all of our key stakeholders. Right now, as far as the pushback is concerned, I mean, obviously, the label will enable us to initiate the next wave of deeper conversations, but I think they're ready for another option to come into this overall class.
Yeah, Great Great question again, so as far as first and foremost I'm really proud of the work that we had of our payer team engaging with payers across the country as well and I think the first thing that I would say is the clinical value proposition once.
Once at Bedtime Effie Q&A is become very clear to all of our key stakeholders right.
Right now as far as the pushback I mean, obviously the label.
Able to initiate the next wave of deeper conversations, but I think they're ready for another option to come into this overall class.
Richard Kim: There clearly haven't been a lot of options as far as they negotiate with industry within the OxyBase space. So I think that, along with our clear value proposition, puts us in quite a good position overall with the partners across the board. So what I would say is they've been very engaged. We've been able to speak with all the major PBMs and GPOs that will cover the vast majority of patients that we look at.
We haven't been a lot of options as far as they negotiate with industry within the oxalate space. So I think that along with our clear value proposition puts us in quite a good position overall with the with the payers across the board so.
What I would say is deepening very engaged we've been able to speak with all of the major pbms in G. P. O S. A that will cover the vast majority of patients that we're looking to.
Richard Kim: And they've been really good conversations. So we feel like we're in a really good spot there overall with our discussion. And then if you look at discontinuation rates, some of our data tells us that after 30 days, after the first. About 30% of patients have dyspnea.
And they've been really good conversations so we feel like we're in a really good spot there overall with our discussions and then if you look at discontinuation rates. So some of our data tells us that after 30 days after the first month.
About 30% of patients package.
Richard Kim: They're twice nightly oxidation, so some of that may be for reasons that even a once-at-bedtime therapy may not be able to address. But for many of those, it may be an option. Some of the main reasons why people discontinue treatment are lack of efficacy, or they can't take their therapy. Now, we don't know if the lack of efficacy also ties into the fact that I couldn't take my second dose of treatment as well, but we do see those people who have recently discontinued as a potential pool of patients.
There are twice nightly ox debates. So some of that may be for reasons that even once at bedtime therapy may not be able to dress, but for many of those it may be an option. Some of the main reasons why people just continuous lack of efficacy or they couldn't take their therapy now we don't know if the lack of efficacy efficacy also ties into I could.
Take my my my second dose of treatment as well, so, but we do see that those people who have recently discontinued as a potential pool of patients.
Richard Kim: Once again, maybe not all of them will consider that, but the fact that they took the steps to try to initiate an oxybate, we see as a very good step. And the fact that there may be an option upon approval that there's a new once-at-bedtime opportunity, we think that bodes well for an opportunity for those patients who would potentially benefit from an Octobit. Thanks to the caller. It's very helpful.
Once again, maybe not all of them well, we'll consider that but the fact that he took the steps to try to initiate an oxalate, we see as a very good step and the fact that there may be an option upon approval that there are some new ones at that time opportunity, we think that bodes well for an opportunity for those patients to potentially benefit from an octavate treatment as well.
Okay. Thanks for the color that's very helpful.
Richard Kim: Our next question will come from Paul Mateus from CFO. You may begin. Thank you for taking my questions.
Our next question will come from the line of Paul Matteis from Stifel. You may begin.
Paul Mateus: I had a few related to orphan drug exclusivity. I know you've gotten this question from analysts and investors a bunch of times, but as, hopefully, the review process winds up here, do you think that some of the delay has been driven by vetting the implications of XyWave's orphan drug exclusivity and what that means for FT218 freedom to operate? And second, I was wondering if you could clarify the different scenarios.
Thank you for taking my questions I had a few related to orphan drug exclusivity I know you've gotten this question from analysts and investors a bunch of times, but as hopefully the review process winds down here.
Do you think that some of the delay has been driven by vetting the implications of <unk> orphan drug exclusivity and what that means for FTE Q&A freedom to operate and then second I was wondering if you could clarify the different scenarios here. So I guess for you to attain full approval does.
Paul Mateus: So I guess for you to attain full approval, does that mean that FDA needs to essentially determine that once nightly provides a major contribution to patient care, thereby, I guess, breaking or transcending XyWave's ODE? Or is that not the right way to think about it?
That mean that FTA needs to essentially determine that once nightly provides a major contribution to patient care, thereby I guess breaking your transcending zywiec zody or is that is that not the right way to think about it is there a tentative approval scenario, maybe just expanding upon how this could play out and how we should be thinking about.
Gregory Divis: Is there a tentative approval scenario? Maybe just expounding upon how this could kind of play out and how we should be thinking about it would be really helpful. Thank you. Yeah, thanks, Paul.
It would be really helpful. Thank you.
Gregory Divis: I won't speculate in terms of, you know, what all is kind of behind the scenes and has been described generally as administrative and internal to us by the FDA directly. But what I can say is we've had the opportunity, during this recent period of time, as we met with the FDA, to go through every aspect of the NDA with them, every component, every section within the review, within the NDA, including orphan drugs, seeking to clarify, is there anything else needed, any additional information required, anything we can do to, you know, help get to the decision more quickly that we believe we have, that we believe is coming And the answer to us was, there are no questions, there's no information needed, there's no data needed.
Yes, Thanks, Paul I won't speculate in terms of you know what always kind of behind the scenes and as had been described generally is administrative and internal to us by the FDA directly but what I can say is we've had the opportunity.
During this recent period of time as we've met with the FDA.
We went through every aspect of the NDA with them every component every section.
Within the review.
Within the NDA, including orphan drug seeking to clarify is there any anything else needed anything additional information required anything we can do to help.
Get to the decision more quickly that we believe we have that we believe is coming and the answer is to us Theres no questions. There is no information needed Theres no data needed.
Gregory Divis: And from that standpoint, so we don't, we feel, again, we didn't learn anything in those conversations that compromised our belief in the full approvability of FT2NA, which is really the question. The second question is, what do we think has to happen? We've always said, and we firmly believe that, and we've communicated this directly to the FDA, that we believe we can have full approval without an orphan drug exclusivity being granted.
From that standpoint, so we don't we feel again, we didn't learn anything in those conversations that compromised our belief in the full approve ability of F. T. Q&A, which is really the question. The second question is what do we think has to happen. We've always said and we firmly believe that and we've communicated this directly to the F D.
That we believe we can have a full approval without an orphan drug exclusivity being granted that being said we believe we have provided.
Gregory Divis: That being said, we believe we have provided a robust submission of data that clearly demonstrates, based on evidence, that once-at bedtime dosing of FT2NA is clinically superior to the current twice nightly options, based upon both safety and a major contribution to patient care. We believe that will be arbitrated and decided upon at the time of their final decision. That's our current expectation. But again, we don't imagine at this stage a scenario that wouldn't be other than full approval. All right, thank you. Thanks.
A robust submission of data that clearly demonstrates based on evidence that once at bedtime dosing of Etsy to an eight is clinically superior to the current twice nightly options based upon both safety and a major contribution to patient care we.
That will be arbitrated and decided upon our expectation is in or around at the time of their final decision. That's our current expectation, but again.
We don't envision at this stage a scenario that wouldn't be other than a full approval.
Alright, thank you.
Thanks.
Oren Livnat: Our next question will come from Oren Livnat of H.C. Wainwright. You may begin. First of all, could you comment on whether you've hit pause on some of that as you wait, but I guess more importantly, given all the progress you've highlighted in the script, is there potentially any shortening of the window post-approval to launch from, I think we've all been assuming, about six months, given all the progress you've made on setting up that REMS and also PBM interactions?
Our next question will come from Orin.
<unk> <unk> from H C. Wainwright you may begin.
Thank you.
A couple.
You've clearly been investing heavily in the prelaunch activities at least through Q4 I guess.
Oren Livnat: And I guess just to make that a quintuple part question, on the PBM issue, how substantive have those conversations been? Should we hope for coverage right out the gate? So on that last question, maybe I'll let Richard chime in. Yeah, great question. But, you know, I've never been one to try to precisely predict a pair decision.
First of all could you comment on whether you know you've hit pause on on some of that as you wait, but I guess more importantly, given all the private as you highlighted in the script.
Is there potentially any shortening of the window post approval to launch from I think we've all been assuming about six months.
Given all the progress you've made on setting up that rents and.
Also PVM interactions and I guess, just make that a quintuple part question on the P. B M.
Issue, how substitute have those conversations been should we hope for you know coverage right out the gate.
So on that last question, maybe I'll, let Richard.
Yeah, Great question so.
I've never been one to try to precisely predict appear decision, but what I can say is you know obviously the time between <unk> and.
Richard Kim: But what I can say is, obviously, the time between an approval and the full launch; we intend to utilize every one of those days to our fullest. The conversation has gone very well, but until we actually have that full approval, it's hard to get the conversation to that really deep level. What I can say is we're definitely going to be working to have as much coverage as we can around the time of approval or shortly thereafter as well. And with where we are in the conversations right now, I feel like we've made good progress.
Approval and the full launch we intend to utilize every one of those days to a full extent.
The conversation has gone very well, but you know until we actually have that full approval, it's hard to get the conversation to that that really deep level. What I can say is we're definitely gonna be working to have as much coverage as we can around the time of approval or shortly thereafter, as well and with where we are with conversations right now I feel like we've made good progress I think in next page post triggered by.
Richard Kim: I think the next stage, post-triggered by the potential approval, will really be the telltale sign around how quickly we can move forward. So potentially, at our upcoming calls, we can provide an update on sort of where we are with the payer engagement. And Greg, I'll turn it over to other questions. Yeah, again, we have a very disciplined approach to how we've built our pre-launch activities, recognizing that the approval is an important catalyst for us to really go to the next level.
A potential approval will really be the tell tale sign around how quickly we can move things so potentially at our upcoming calls we can provide an update on sort of where we are with the payer engagement and Greg I'll turn it over other questions over to you.
Yeah again.
We have a very disciplined approach to how we built our prelaunch activities recognizing that the approval is an important catalyst for us to really go to the next level. So I wouldn't say, we've hit pause, but we've made progress in the areas, where we can and need to make progress where we're the lead times are even longer than what it may be relative to.
Richard Kim: So I wouldn't say we've hit pause, but we've made progress in the areas where we can and need to make progress, where the lead times are even longer than what they may be relative to post-approval to a full launch. We certainly have made progress in certain areas and have made a decision to go forward, i.e., in building commercial supply and those sorts of things.
To post.
Post approval to up to a full launch.
We certainly have made progress in certain areas and have made a decision to go forward I E. In building commercial supply and those sorts of things and so we've been able to potentially drawback. Some time from that standpoint, I think the big you know kind of swing in that decision when we get our full approval will be what is our what is our.
Gregory Divis: And so we've been able to potentially, you know, draw back some time from that standpoint. I think the big, you know, kind of swing in that decision when we get our full approval will be what our primary packaging will look like. We don't believe, and we don't expect there's going to be any changes to that artwork at this stage.
Primary packaging look.
Look like we don't believe and we don't expect there's going to be any changes to that art work at this stage, but if there is and we're going to have to re prints out or after reprint some of that primary packaging foil which.
Which certainly doesn't allow the opportunity to shorten the timeframe.
Gregory Divis: But if there is, then we're going to have to reprint some of that primary packaging foil, which certainly doesn't allow the opportunity to shorten the time. Okay. And then specifically just on the sales force, I think you mentioned you have in that 90%, you know, identified maybe, uh, I don't know if that's, if all of those have accepted offers, but just, um, is that potential crew still ready to roll post approval, uh, with conditional offers, or given the delay should, you know, is there churn there, you know, they, they need to work So, um, I guess. Post-approval, do you need to go back and re-initiate some of that recruiting process?
Okay.
And then specifically just on the sales force I think you mentioned you are in that 90% identified maybe I don't know if thats. If all of those are accepted offers but just.
Is that potential crews still ready to roll post approval with conditional offers or given the delay should.
Is there a churn there you know they they need to work right. So I guess post approval do you need to go back to Reinitiate some of that recruiting process.
Richard Kim: Yeah, go ahead, Richard. Yeah, so the good thing we're in that we've been doing is we've been trying to keep both our internal, our external and our contingent sort of based upon approval, potential candidates, just engaged in the process, you know, it may sound cliche, but last year we ruled out new core values for the organization and one of them is togetherness and we've really tried to keep our candidates who are sort of triggered by the approval sort of up to date on where we are with things, showing them what we're doing, and so we probably lose a couple people, but we've built backup plans as well.
Yes go ahead Richard.
Yes.
The good thing that we've been doing is we've been trying to keep both our internal or external and our contingent sort of based upon approval potential candidates just engaged in the process.
It may sound cliche, but last year, we rolled out new core values for the organization and one of them is togetherness and we've really tried to keep our our candidates who are sort of triggered by the approval sort of up to date on where we are with things showing them, what we're doing and so it's a very candid, we probably lose a couple of people, but we've built backup plant as well.
Richard Kim: It's been really impressive to really see the engagement of all these folks. I think wholeheartedly they see the opportunity that we have with one set bit time FC2 and FC2 in potentially changing a lot of patients' lives in a positive way. So my belief is we'll lose a couple, but we have backups, but overall, people realize the opportunity that we have to make in the field of narcolepsy. And what I can say from my conversations is that a lot of people want to be part of this, so we think we have a special opportunity here, and it's been really great to see that reinforced by the people who want to join us on this journey. Great. I appreciate it.
It's been really impressive to really see the engagement of all of these folks I think wholeheartedly DC the opportunity that we have with once at bedtime Effie Q&A potentially change a lot of patients lives in a positive way. So my belief is we'll lose a couple but we have backups.
Holistically people realize the opportunity that we have to make in the field of narcolepsy and what I can say from my conversations with a lot of people want to be part of this so we think we have a special opportunity here and it's been really great to see that reinforced by the people who want to join US on this journey at Avondale.
Great I appreciate it.
Thanks Arne.
Richard Kim: Thanks, Oren. Our next question comes from Matt Kaplan from Rottenburg, Germany. All right. Good morning, guys. Thanks for taking the questions and congratulations on the recent feedback from the FDA. That's great.
The next question.
Katherine you may begin.
Hi, Good morning, guys. Thanks for taking the questions and congrats on the recent feedback from the FDA that that's great.
Matt Kaplan: Just wanted to, most of my questions have been answered, but with respect to your comments earlier on the different formulations of a lower sodium content product, what's your sense in terms of the development path of a product like that? Is that just a simple PK, PD type of development, or will that entail a larger, more rigorous, Leave a comment anytime. I would love to see more. Thank you for watching. 09 Yeah, man. It's probably a bit premature to answer that question at this stage.
Just wanted to most of my questions have been answered but just.
Yes.
With respect to your comments earlier on the different formulation of a lower sodium content product, what's what's what's your sense in terms of what.
The development path of.
Product like that.
Is that just a simple PK.
PK PD type of development or without and.
And talent are larger more more.
Rigorous huh.
Clinical trial.
Yeah, Matt, it's probably a bit premature to answer that question at this stage, we're still in the in the in the early stages of doing our work here and that will be discussion, we clearly have with the FDA at the appropriate time in terms of what's the right development path forward and.
Gregory Divis: We're still in the early stages of doing our work here, and that will be a discussion we clearly have with the FDA at the appropriate time in terms of what's the right development path forward. And that will be predicated on, you know, how our formulation advances and its relative bioequivalence to the current once nightly formulation of FT218. So I think ultimately that that feedback or that data and that insight will help inform that recommendation and strategy that we'll go forward with. But I think it's a bit early.
And that will be predicated on how our how our formulation advances and its relative bio equivalents to the current once nightly formulation of FTE Q&A. So I think ultimately that that will be.
That that that feedback of that data and that in fact will help inform that recommendation and strategy that will go forward with but I think it's a bit early at this stage okay.
Gregory Divis: Okay, fair enough. And then in terms of where you are in preparation for the launch, can you talk a little bit about your drug supply and your manufacturing and where you have that in place ready for launch? Yeah, on the drug supply, we've initiated, you know, all of that, all of that effort and activity going back to, towards, the end of last year, from bulk API production and, and, and the beginning of manufacturing of what we'll just call our bulk beads, right?
Okay Fair enough and then in terms of where you are.
In preparation for for the launch can you talk a little bit about your drug supply and manufacturing.
And where you have that in place ready ready for launch.
Yeah on the drug supply we've initiated all of that all of that effort and activity going back to the torque towards the end of last year from bulk.
Bulk API production.
And the beginning of manufacturing of or will what will just called bulk.
Gregory Divis: So barring the bulk supply of our immediate release microparticles and our control release microparticles, we'll go as far as making as much of that as we can in that bulk state through our primary match CMOs. But what we won't do at this stage is actually blend that product and put it inside of our daily stick pack until we have the final approved daily packaging labeling and artwork, right? We don't expect that to change.
Our bulk beads right. So bar bulk supply of our immediate release micro particles and our controlled release micro particles will go as far as making as.
As much of that as we can in that bulk state through our primary mines Cmos, but what we won't do at this stage is actually when that product and put it inside of our daily stick pack until we have the final approved.
Daily packaging labeling and artwork right, we don't expect that to change, but the minute, we put that product into a and into our packaging and our primary packaging and if that labeling would change then that product. We couldn't use. So we continue to make progress in building bulk book active ingredient and.
Gregory Divis: But the minute we put that product into a packaging and our primary packaging, and if that labeling changes, then that product we couldn't use. So we're continuing to make progress in building bulk, both active ingredient, and immediate release and control release microparticles. Post an approval, those actions will, will, will expand to blending those two by strength and the proprietary ratio and then daily stick packing it, picking, stick packing it, which is what will occur post the approval.
Immediate release and controlled release micro particles post an approval that those actions will will.
We will expand to blending those two by strength in the proprietary ratio and then daily stick packing yet picky stick packing it which is what will occur post the approval.
Gregory Divis: Thanks for the added details. Our next question will come from Robin Gardner from Craighalem. You may begin. Thank you for the additional information about your communications with the FDA and congratulations on that update. Some great questions already. Just one final question regarding your life cycle management. So, in this case where you have an idiopathic hyperformulation with a different salt content, would this eventually overtake FT-2 and 8 for use by narcolepsy patients, not just for idiopathic hypersomnia?
Okay, great thanks for that detail.
Thanks.
Our next question comes from the line of Robin Gardner.
Craig Hallum may begin.
Thank you for any additional information about your communications with the FDA and congratulations on that update.
Great questions already just one final question regarding your.
Your lifecycle management. So in this case, where you have an idiopathic hyper.
With a different salt content would you would this eventually overtake FTE Q&A for use by narcolepsy patients not just for idiopathic hypersomnia.
Robin Gardner: Well, again, I think as it relates to lifecycle management, it's a bit early to really speculate on anything specific, but we do, listen, let's be clear, we've demonstrated we have a technology that can deliver Oxybate-related products in a once-at-bedtime dose, and we certainly want to make sure all patients have the opportunity to be treated with a once-at-nightly bedtime option. As it relates to indication, the most likely approach for us, I would say, based upon our thinking, is that we certainly would pursue this formulation in narcolepsy, and what we do beyond that in terms of indication is work we're still evaluating, whether that's idiopathic hypersomnia or some other rare sleep disorder that could be a potential lifecycle extension. But clearly, you know, there's a lot Okay, thank you.
Well again, I think as it relates to lifecycle management, it's a bit early.
To really speculate on anything specific but we do listen let's be clear. We've demonstrated we have a technology that can deliver ox.
<unk> related products and a once at bedtime dosing and we certainly want to make sure all patients have the opportunity to be treated.
Once that nightly bedtime option.
As it relates to indications the most likely approach for us.
I would say based upon our thinking.
Is that we certainly would pursue this indication in this formulation in narcolepsy.
And what we do beyond that in terms of indication is work we're still evaluating.
Whether that's idiopathic hypersomnia or some other rare sleep disorder that could be a potential lifecycle extension, but clearly you know theres a lot of interest and work being done and IH today, and that's again something we're evaluating closely.
Okay. Thank you looking forward to featuring problem.
Gregory Divis: Looking forward to the future. The next question is on the line from Adam Everts from Lifesci Capital. You may begin. Great. Good morning. Thanks for the update. I know it's getting late here.
Our next question comes from the line of Adam.
Ever its firm Lifesize capital you may begin.
Great. Good morning, Thanks for the update I know, it's getting late here.
Adam Everts: On the topic of market expansion, I was hoping for clarification on the types of patients who might not be in the Oxabate market today. You know, these patients who are unwilling to take a twice-nightly product, patients whose physicians haven't been receptive to Oxabate products thus far, something else, a combination, just a little more info there. Yeah, thanks Adam, Richard, do you want to take that? [inaudible] Yeah, hey Adam, great question. So I think it's all of the above from what you've mentioned there.
On the topic of market expansion I was hoping for a clarification on the types of patients who might not be in the oxalate market. Today are these patients who are unwilling to take the twice nightly product patients, whose physician hasnt been receptive to oxalate products, thus far something else a combination just a little more info.
Richard Kim: You know, even within the existing Oxybate prescribers today, there are patients that are just not getting an Oxybate prescription. Some of that may be coming from the physicians themselves, but oftentimes, it's coming from the patients not wanting to. Ashwani Verma, Lin Tsai, Guofang Li, Jennifer Gudeman, Myriam Belghiti, Austin Murtagh, Richard, and others may want to do this as well. Subsequently, on the patient side, it's very similar where there are people, you know, who have been exposed, they've been offered, we have research that says, you know, up to around 40% of patients who have been offered aid twice at night, Oxibate, just didn't want to take it.
There.
Richard Kim: So, you know, we have a little bit more to learn there, but we definitely sort of see both the potential growth opportunity within the physician offices and clearly directly within the patient base. Unknown Attendee Fantastic. Appreciate that. And one more very quick one.
Yeah. Thanks, Adam Richard do you want to take that.
Richard Kim: You know, as we speak with physicians about high sodium versus low sodium, there's certainly a minority of patients who might need a low salt version due to comorbidities, but it seems like perhaps a more common reason to switch is taste, high sodium obviously being salty, and then low sodium actually being sweet because there's some sweetener added there. Maybe, can you comment on the taste of FT-2NA and how it might fit regarding... Richard, you want to, you've tried a placebo, you want to give your personal experience? Well, Adam, I'm more of a pizza guy than a chocolate guy myself.
Yeah, Hey, Adam Great question. So I think it's all of the above from what you've mentioned there.
Richard Kim: So that's just me personally. But, you know, also, from the mixed salt version, it does have sucralose, and it has a different taste. Whether or not that's perceived to be better or worse, it's probably more of an individual judgment. So we think the taste itself, hopefully, doesn't become a deterrent. I think of a lot of the previous Oxabat experiences. The Saltiness shouldn't be anything new. But we also have heard from patients who have tried the low-salt, mixed-salt version as well that the taste was different. And for some, that was okay, and for some, that was different; I didn't like that either.
Even within the existing Octavate prescribers today, there are patients that are just not getting an oxford treatment. Some of that may be coming from the physician themselves, but oftentimes, it's coming from the patients not wanting to take.
Therapy twice twice at night, So you know what.
And those sort of 6000 current prescribers, there's we do see room to expand the utilization there, but as Greg had mentioned earlier.
With the product profile once at Bedtime Matthew Q&A, we are definitely seeing the feedback from people, who just physicians, who just didn't want to prescribe. The current formulations that are our clinical profile may attract them to want to do this as well and subsequently on the patient side, it's very similar where there was people.
Who had been exposed they've been offered we have research that says up to around 40% of patients who have been offered a twice a night.
Ox abate just didn't want to take it so we have a little bit more to learn there, but we definitely start to see both the potential growth opportunity within the physician offices and clearly directly within the patient base directly as well.
Fantastic.
I appreciate that and one more very quick one.
We speak with physicians about high sodium versus low sodium theres, certainly a minority of patients who might need a low salt version due to comorbidities, but it seems like perhaps some more common reason to switch as taste.
Hi, sodium obviously being salty and then low sodium actually being suite.
Because theres some sweetener added there maybe can you comment on the taste of FTE Q&A and how it might fit regarding this.
Richard do you want to.
You've tried to placebo you want to give you a personal experience.
Thanks, Rich, while Adam I'm more of a pizza guy than a chocolate guy myself. So that's just me personally but also we do know from the mix off version. It does have sucralose it had a different taste whether.
Whether or not that is perceived to be better or worse, it's probably more of an individual judgment.
So we think the case itself.
Hopefully it doesn't become a return I think for a lot of the previous oxiclean experienced patients the saltiness shouldn't be anything new.
But we also have heard from patients who have tried to mixed as well.
The low salt mix-up version as well that the case was different and for some that was different okay and for something that was different I didn't like that either so I think if you were going to continue to grow, but we don't necessarily see taste as a major deterrent.
Gregory Divis: So I think the field's gonna continue to grow, but we don't necessarily see taste as a major deterrent, or, potentially, at this stage, a major opportunity. We think it's really gonna come down to, much more of our overall clinical profile, but once at bed. Yeah, I'll just add to that, Adam, that, you know, we've had over, you know, hundreds of patients on our therapy, we've got a large number on, in, in our open label extension now, and, and, and taste hasn't been a reason for discontinuation.
At this stage a major opportunity, we think it's really kind of come down to much more of our over our overall clinical profile, but once at bed time therapy.
Gregory Divis: And, and, and, let's remember that our formulation is a proprietary ratio of IR and CR, and those CR beads are coded. So we're not releasing sodium in the mouth or in the taste buds for a portion of our formulation, depending upon the strength and the dose that's being administered. So our, our, our product, FD208, has a different texture because we do have, you know, micro particles in there, but I also, as someone who's also taken the placebo, it's certainly not as felt as I expected it to be, and I, too, am a piece of man over, chop.
Yeah, I'll just add to that Adam that we've had over you know we've had hundreds of patients on our therapy. We have got a large number on on and our open label extension now.
And taste hasn't been a reason for discontinuation.
And let's remember that our formulation is a proprietary ratio of IR and CR and they'll see our beads are coded. So we're not releasing sodium in the mouse and the taste buds for a portion of our formulation depending upon the strength in the dose.
That's being administered so are our product FTE Q&A has a different texture.
Because we do have micro particles in there, but I also as someone who has also taken the placebo.
It certainly.
It's certainly not a salt as I expected it to be an item at pizza men over chocolate.
Dr. Doug Williamson: Hey, Greg, just one comment. This is Doug. If you look at the poster for the discrete choice experiment, which there's a link to in the press release, taste was included as one of the attributes that people were asked about. And as well as, you know, once nightly dozing being a stronger preference than, Unknown Attendee. Being the strongest preference, you know, a stronger preference than low sodium in an overall product choice, taste came very, very low on that list as a driver of preference.
Hey, Greg.
This is Doug I just want to comment.
If you look at if you look at the post falls a discrete choice experiment with Krishna is linked to in the press release taste was included as one of the attributes that picked when people were asked about.
And as well as once nightly dosing being a stronger preference then.
And then.
Being the strongest reference Shaun represent low sodium and overall product choice taste came very very low down on that list of that as a driver and preference.
Gregory Divis: Yeah, thanks, Doug. Great, great comment, and our next question will come from the line of Jason Gerberry from Bank of America. You may begin. Hey guys, thanks for squeezing me in.
Yes, Thanks, Doug Great Great comment.
And our next question comes from the line of Jason debris from Bank of America, you may begin.
Jason Gerberry: I wanted to come back to the payer discussion. So I guess it's fair to say what underpins your confidence regarding Outlook for access is that payers do understand the nuances of this Jazz HICMA settlement agreement and that there won't really be a truly multi-source generic price point offered in the marketplace. And as we fast forward to, say, next year, HICMA has some options, presumably, to launch its own true generic, although I think that's debatable.
Oh, Hey, guys. Thanks for squeezing me in.
Just I wanted to come back to the payer discussion. So I guess is it fair to say what underpins your confidence.
Regarding outlook for access is that payers do understand the nuances of this jazz hikma.
The settlement agreement and that there wont really be.
Truly multi source generic price points offered in the marketplace.
And as we fast forward to say next year it might have some options presumably to launch its own true generic although I think that that's debatable, but nonetheless.
Jason Gerberry: But nonetheless, is that really, in your minds, the critical negotiation point with payers? Are they still maybe hoping that there's going to be a true kind of generic pricing in the market? Or do you think that this settlement dynamic is pretty under-appreciated on their end when you talk to them then? Richard, do you want to answer? Yeah. You know, Jason, as Greg said earlier, I think from what the payers have heard, what we've heard from the payers, what they understand of the agreement is, once again, this is being viewed as a little bit more like a line extension as opposed to a quote-unquote new generic coming into this marketplace.
Is that really in your mind, the critical negotiation point with Payors are.
Are they still maybe holding out hope that there's going to be true kind of generic pricing in the market or do you think that this settlement dynamic is pretty under a pretty appreciated on there and when.
When you talk to them. Thanks.
Richard you want to answer.
Yes.
Yeah.
Jason I think you know as Greg said earlier I think.
From what the Payors have heard what we've heard from the payers what they understand that the agreement is once again.
This is being viewed as a little bit more like a line extension as opposed to a quote unquote, new generic coming into the marketplace. So we havent really heard.
Jason Gerberry: So we haven't really heard, you know, obviously it's not in the marketplace yet, but we really haven't heard of anything that would substantially change the way step edits are actually processed as far as the Hikma product is concerned. Although we are aware that they would likely be using the same sort of infrastructure for the REM, we don't really sort of see that as sort of the main driver.
Obviously, you find in the marketplace, yet, but we really haven't heard of anything that would substantially you sort of changed the way.
Step edits are actually process as far as.
The hikma product is concerned.
We are aware that they would likely be using the same sort of infrastructure for the Rams and everything from a jazz is set up so far as well. So we don't really sort of see that as sort of the main driver for us upon approval and upon full launch our goal is to get as many of the appropriate patients onto once at bedtime ft. Q&A. So we.
Richard Kim: Clearly, for us, upon approval and upon full launch, our goal is to get as many of the appropriate patients on to it once at bedtime after Q&A. So you know, we believe that will probably be a good defense in regards to any other generic community marketing. But also, at the end of the day, we'll keep coming back to our fundamental dive pop, that for patients and clinicians, this value proposition is quite different.
Believe that will probably be a good defense in regards to any other generics coming to the marketplace, but also let them that he will keep coming back to our fundamental value proposition that for patients and clinicians. This value proposition is quite different and we believe that the payers will have to acknowledge the fact that at least for those patients who are doing well on points at that time.
Richard Kim: And we believe that payers will have to acknowledge the fact that, at least for those patients who are doing well on once-bedtime therapy, it would be very difficult to disrupt those patients going forward as well.
Therapy that would it would be very difficult to disrupt those patients going forward as well, so and <unk> dynamics will change, but fundamentally our clinical value proposition is what we believe will continue to differentiate us with the payers as well.
Richard Kim: So, clearly dynamics will change, but fundamentally our clinical value proposition is what we believe will continue to differentiate us. Okay, thank you. Jason Gerberry, David Amsellem, Jason Gerberry, David Amsellem, And I'm not showing any further questions in the queue. I'll turn it over to Greg Divis for any closing remarks. Yeah, thank you everybody. Just a quick comment to thank you again for joining us today and appreciate all the time spending an over an hour with us and have a great day and we'll look forward to any follow up as necessary. Take care. Thank you. And this concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day. David Amsellem, David Amsellem, David Amsellem
Alright, thank you.
Thanks, Jason.
And I'm not showing any further questions in the queue I will turn it over to Greg Davis for any closing remarks.
Yes, thank you everybody.
Quick comment to thank you again for joining us today and appreciate all the time and spending and over an hour with us and have a great day, and we'll look forward to any follow up as necessary take care. Thank you.
And this concludes today's conference call. Thank you for participating you may now disconnect.
Great.
Sure.
[music].