Q2 2022 Avadel Pharmaceuticals PLC Earnings Call

Greetings and welcome to Avadel Pharmaceutical's second quarter 2022 earnings call.

Greetings and welcome to Avenova Pharmaceuticals second quarter, 2022 earnings call.

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It is now my pleasure to introduce Brandi Robinson.

It is now my pleasure to introduce bad News Robinson. Thank you you may begin.

Thank you.

You may begin.

So most of my questions have been answered, but I did want to ask you a couple of questions, on commercialization.

Good morning, and thank you for joining us on our conference call to discuss second quarter 2022 learning as.

Number one, can you talk through where you think early adoption is going to come from?

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 1994.

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.

Let's conclude with the.

In the development stage may not achieve scientific a J.

Or milestones or meet stringent regulatory requirements.

Uncertainties regarding market entry and acceptance of products and the impact of competitive products and pricing.

In other words to describe more fully inhabit those public filings under the Exchange Act included in Form 10-K.

Year ended December 31st 2021, which was filed on March 16, 2022, and subsequent SEC filings.

Sept as required by law I'm, Darren just takes no obligation to update or revise any forward looking statements contained in this presentation.

That's new information future events or otherwise.

And in particular, do you expect that most of your earlier patients will have had exposure, to the Xyrem Authorized Generic before they get on Lumerize?

On the call today are Greg <unk>, Chief Executive Officer, Dr. Jennifer Goodman.

Vice President of medical and Chi.

Excuse me Vice President of medical and clinical Affairs.

Richard Kim Chief Chief Commercial Officer, and Jonathan Excuse me in Tom Kim Chief Financial Officer.

Good morning, and thank you for joining us on our conference call to discuss second quarter 2022 earnings.

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

As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones, or meet stringent regulatory requirements, uncertainties regarding market entry and acceptance of products, and the impact of competitive products and pricing.

So that's number one.

Good morning, everyone and thank you for joining us to discuss our second quarter 2022 results.

These and other risks are described more fully in Avadel's public filings under the Exchange Act, included in the Form 10-K for the year ended December 31st, 2021, which was filed on March 16th, 2022, and subsequent SEC filings.

Number two is, as you look at your IP runway, does it make sense for you to run a registration, quality study in idiopathic hypersomnia?

This was an important quarter for avid held where we continued to make progress in our mission to bring loom right to all once at bedtime eligible patients.

Living with narcolepsy, which included the receipt of a notable and important regulatory milestone for whom rise in the form of a tentative approval.

Active pursuit of additional legal and regulatory strategies to accelerate a final FDA decision for a boom right. Prior to June of 2023 or when the Rems patent we certified on will expire.

And the continued execution of our commercial preparations with a focus on shortening the time between final approval and launch while we took the necessary actions to ensure as required we have the liquidity to carry us through the potential out of date of a final FDA approval decision.

Except as required by law, Avadel undertakes no obligation to update or revise any forward-looking statements, contained in this presentation to reflect new information, future events, or otherwise.

Is that something that's in the cards?

With that I will start by commenting on our most recent company update.

On the call today are Greg Bivis, Chief Executive Officer, Dr. Jennifer Goodman, Vice President of Medical and Clinical Affairs, Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer.

Thank you.

On July 19th we announced that the FDA granted tentative approval of <unk>, formerly known as <unk>, our investigational once at bedtime Oxidate therapy for the treatment of cataplexy or excessive daytime sleepiness in people with narcolepsy.

A.J.

Thanks, David.

Received tentative approval is an important step toward a final approval.

Richard, do you want to take the first one?

Granting tentative approval the FDA has validated the clinical and safety profile of Blue mice and confirms that room rights is approvable as a once at bedtime therapy for eligible patients living with narcolepsy, which we believe is a meaningful derisking regulatory event for the company.

R.S.

Sure.

No, great question, David.

So as far as early adoption is concerned, I mean, first, I sort of think about it from, the prescriber base. And equally, our assumption is we'll have the earliest adoption from the most experienced, oxybate prescribers. We know that there's less than 500 physicians that account for over 50% of the oxybate volume, in the marketplace right now as well.

And actually, what we see in our market research is a great opportunity for patients who are, currently on poissonly oxybates discontinued in de novo.

It reminds us a demonstrably strong clinical profile with an improved dosing regimen that per our extensive research is preferred by patients and sleep specialists.

But if you think about the switch patients themselves, we actually know that current, So, we absolutely do see, you know, a good opportunity for patients there to be attracted to the Lumrise value proposition, as are the current SIREN patients, where, you know, potentially that switch makes the most intuitive sense.

And as far as the AG is concerned, like I said, we still see it having limited impact, in the marketplace.

This along with our comprehensive launch strategy gives us the confidence in the potential significant role moonrise can play in the $3 billion plus market opportunity.

Further and perhaps most importantly, receiving tentative approval confirms that the potential latest date, we could receive a final approval decision for whom rises after expiry of the Rems patents, which is June 17, 2023, or just 10 months and eight days from today.

As previously stated we are and will continue to aggressively pursue legal and regulatory strategies with the clear objective of potentially leading to a final approval decision prior to June 2023, and depending on timing and results of these legal actions, possibly by the end of this year.

In this regard we filed a motion in the U S District Court for the district of Delaware to Delist. The Rems patent from the Fda's Orange book on June 20, <unk> as we do not believe the substance of the Rems patent qualifies as an eligible Orange book listed patents.

A court order requiring the patent holder to delist the rems patents from the Orange book could provide a pathway for a final approval of Bloom right. Prior to June 2023.

As the court previously stated that a claim construction hearing is required before ruling on the motion to the list. The next step in this process is the markman or claim construction hearing which is scheduled for August 31.

Additionally, we recently announced that we filed an administrative procedure act lawsuit against F. D. A alleging that their decision to requiring us to file a patent certification on the Rems patent was arbitrary and capricious and contrary to applicable law.

In this lawsuit we are asking the court to vacate the Fda's patents certification decision and order F. D. A to take final action on the <unk> NDA within 14 days after vacating their decision.

A successful outcome and it's a P. A suit could also lead to a potential final approval of blue mice prior to June of 2023.

Our next celebrate a briefing schedule water has been approved by the court and we currently expect this case to be heard at the end of September 2022.

In addition to these opportunities to accelerate a potential final approval. We are also focusing on launch preparation activities that will shorten the time to launch following final approval.

This includes completion of manufacturing in primary packaging for our commercial supply and operationalized, our Rems program. Both in advance of our final approval and before the end of this calendar year.

Now, clearly, we'll likely have some time to see that.

In summary, we are well positioned to execute on all of these priorities to potentially accelerate bringing loom rise to a final approval prior to June 2023, and subsequent launch as soon as possible thereafter.

But we absolutely do see the switch from existing twice-nightly oxybases being a relatively, large segment in the oxybate-experienced physicians.

As you will hear next Jennifer will provide details on the data we presented this quarter at three 2022 and following Richard will give an update on our launch readiness actions now with a tentative approval in hand.

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

We also see that opportunity with patients who tried twice-nightly, but are no longer, on them for various reasons.

With that I'll turn the call over to Jennifer.

Good morning, everyone, and thank you for joining us to discuss our second quarter 2022 results.

And we also do believe we're going to get a good share of the de novo patients, because, as many physicians have told me, when you offer the chance to not have to wake up during the middle of the night to a de novo patient, it's a pretty clear value proposition as well.

So, we feel fortunate that we know that we have a great opportunity of the switch patients, but we absolutely sort of see the opportunity for growth in all three of those patient segments overall.

Thanks, Greg and good morning, I'd break that this was an important quarter for Abdel tend to get a pretty bolstering. The night is a significant milestone that validates its efficacy and safety profile and also had facility that are starting our wins build out which will shorten our time to launch following final approval.

This was an important quarter for Avadel, where we continue to make progress in our mission to bring LoomRise, to all once-at-bedtime eligible patients living with narcolepsy, which included the receipt of a notable and important regulatory milestone for LoomRise in the form of a tentative approval, the active pursuit of additional legal and regulatory strategies to accelerate a final FDA decision for LoomRise prior to June of 2023, or when the REMS patent we certified on will expire, and the continued execution of our commercial preparations with a focus on shortening the time between final approval and launch while we took the necessary actions to ensure, as required, we have the liquidity to carry us to the potential outer date of a final FDA approval decision.

And Greg, I'll turn the IP question back to you.

With that, I will start by commenting on our most recent company update.

Yeah.

On July 19th, we announced that the FDA granted tentative approval of LoomRise, formerly known as FT218, our investigational once-at-bedtime oxibate therapy for the treatment of cataplexy or excessive daytime sleepiness in people with narcolepsy. Receiving tentative approval is an important step toward a final approval. By granting tentative approval, the FDA has validated the clinical and safety profile, of Lumrise and confirms that Lumrise is approvable as a once-at-bedtime therapy for eligible patients living with narcolepsy, which we believe is a meaningful, de-risking regulatory event for the company. Lumrise has a demonstrably strong clinical profile with an improved dosing regimen that, per our extensive research, is preferred by patients and sleep specialists.

This, along with our comprehensive launch strategy, gives us the confidence in the potential, significant role Lumrise can play in the $3 billion-plus market opportunity.

Thanks, David.

Furthermore, we had a strong presence at sleep 2020 with considerable interest in the body of evidence supporting the life as described in our nine posters.

It's an important question, you know, because what's next is an important consideration, for us in terms of how do we build a franchise around the innovation that is once-nightly, Lumrise.

And I think the short answer is there's a tremendous amount of interest from the clinician, community to want to study a true once-nightly dose, once-at-bedtime administration for IH patients.

So, yes, I think in short, we're evaluating that very seriously.

We've done a tremendous amount of work in terms of understanding what that trial design, could be like and whether or not we should, you know, should we consider a registration quality study or whatnot.

I think you'll hear more about that as we go forward, but it is an important consideration, as one of the tools in terms of, you know, building out the full value of Lumrise, whether that's in IH or whether that's in the work we're doing with additional formulation work as well on our own low-sodium formulation, no-sodium formulation.

Got it.

Okay.

Poster that we had the most engagement with described new interim data on dosing and titration from the ongoing restore open label extension switch study other Reits drug candidate.

Thank you.

62% your Christmas event switching from twice nightly Octavate formulations had a stable those equal to their starting dose, which will help clinicians understand that switching can be mice is a straightforward process.

Additionally, participants not currently taking octavate formulations or activate naive participants reached a stable dose with tutor for dose titrations within four weeks and this is particularly relevant as we hear anecdotes of patients having to spend money trying to find a stable.

And consistent dosing regimen of twice nightly ox debate.

We also presented updated results from patient preference and the nocturnal adverse event questionnaire with patient switching from twice nightly off debates in the restore study.

These interim data confirmed previous data, we have presented showing that a high proportion of patients switching from twice nightly octavate formulations.

Peering into difficulty in taking the second dose with nearly two thirds reporting accidentally missing their second dose at least once in the past three months.

And more than 80% of those reporting that they experienced worse narcolepsy, sometimes the next day.

Also consistent with that and we have previously presented 92.5% David a preference for the once nightly dosing regimen.

Thanks, David.

As we talk about restore I want to highlight that we have extended this study. So participants can stay in restore through F. D. A to b the ball and up till March simply my Kid been transitioned to commercially available product I have had the opportunity to speak directly with a number of cricket depends in restore.

The next question comes from Adam Everts with Lightside Capital.

Please go ahead.

Thank you.

Good morning.

They expressed their gratitude for this extension specifically because they don't want to go back to waking up in the middle of the night.

So, just on the commercial side, on Jazz's earnings call, they reported that there are, more patients on ZyWave than ZyRem. Of course, part of that is the idiopathic hypersomnia indication for ZyWave.

Just curious if that impacts your commercial strategy, perhaps messaging or otherwise.

After successfully taking abdel investigational once at bedtime sodium acetate.

Yeah, and thanks for the question.

Going back to our posters, we had five post hoc posters from restaurants, which continue to reinforce the strong efficacy demonstrated in this pivotal trial, including subgroups as both in tier one and in GTO.

Yeah, you're right.

I think what they reported is more patients for ZyWave overall, but if we actually look, at the narcolepsy market, it's still slightly tilted towards ZyRem.

The good news for us is we see the opportunity uniquely, you know, favorable for both of, those segments.

You know, as I mentioned before, what our research tells us is, in general, ZyWave patients, with narcolepsy tend to be earlier doctors, younger patients who have been diagnosed with narcolepsy for less years, seeking more new innovative therapies as well.

We believe that bodes very well for the value proposition of Lumrise once it's available, in the market as well.

And then, once again, you know, so it likely will be a bifurcated market between ZyRem, and ZyWave patients as far as OxyBaits are concerned.

For the ZyRem patients, you know, our value proposition is probably the clearest and most, intuitive overall there as well.

So going from twice at night to once at bedtime therapy, that, in essence, is the same sort, of compound.

So we believe we're really well-positioned for both.

And a lot of it is also going to be driven by some of the patient engagement that we, have overall as well.

And those with and without concomitant stimulant on measures of disrupted nighttime sleep.

So despite the fact that there's about a 50-50 split in the marketplace right now, we believe, we're positioned for both of those segments very well in addition to the discontinued patients and the de novo patients.

Fantastic.

Lastly, we published results from our second discrete choice experiment for D. C E. As some may recall, we have published the results of our first D. C E in patient preference and adherence, which clearly showed that the most important driver of patient choice for sodium arc debate is a single bedtime dose.

Appreciate that.

The second DC. He was expanded to include clinicians.

And the mixed salt Octavate and affirmed our first D C patient.

Patients clearly place the highest priority of treatment selection.

Mr. Reed Oxidate profile for once at Bedtime dosing for.

For the 100 clinicians participating in the D. C E. The data also demonstrated that the most important driver of clinician choice is once at bedtime dosing.

And then one quick clarification.

The sleep meeting provided us the opportunity to connect directly with Kols and explain the delay in FDA decision on approval of Bien Ries.

I think I know the answer to this, but will we get any more color on the label, or we'll, need to wait until full approval to see any more details there?

Yeah, it won't be released until final approval, Adam.

We have been communicating extensively with both the medical and patient communities.

Knowing the tentative approval, including a fact sheet available at Avondale Dotcoms about what this means and a letter to the community you reiterating our commitment to bringing <unk> to patients.

We recognize patients with narcolepsy will be critical in shared decision, making with their clinicians to that end, we were thrilled to publish a plain language summary in future neurology, describing the primary results from our pivotal trial. So people with narcolepsy can access these resolved.

Yeah.

The totality of the data we continue to present supports the robust clinical efficacy the well established safety profile ability to switch from twice nightly octavate and patient preference of them right now.

Further, and perhaps most importantly, receiving tentative approval confirms that the potential, latest date we could receive a final approval decision for Lumrise is after expiry of the, REMS patent, which is June 17, 2023, or just 10 months and 8 days from today.

But, you know, our view on it, where it stands today, it's in really good shape, and, you, know, I think gives us something really good to work with in the marketplace.

Now that we have the tentative approval secured the community is even more eager to see this potential treatment option received final FDA approval and made available to patients.

As previously stated, we are and will continue to aggressively pursue legal and regulatory, strategies with a clear objective of potentially leading to a final approval decision prior to June 2023, and depending on timing and results of these legal actions, possibly by the end of this year. In this regard, we filed a motion in the U.S. District Court for the District of Delaware, to delist the REMS patent from the FDA's Orange Book on June 23, as we do not believe the substance of the REMS patent qualifies as an eligible Orange Book listable patent. A court order requiring the patent holder to delist the REMS patent from the Orange, Book could provide a pathway for a final approval of Lumrise prior to June 2023.

We are proud of all of our hard work that continues to drive new mice forward.

As the court previously stated, that a claim construction hearing is required before ruling, on the motion to delist, the next step in this process is the Markman or claim construction hearing, which is scheduled for August 31.

Great.

I will now turn the call over to Richard to provide details on the commercial opportunity and our preparations for launch Richard.

Thank you.

Additionally, we recently announced that we filed an Administrative Procedure Act lawsuit, against FDA, alleging that their decision requiring us to file a patent certification on the REMS patent was arbitrary, capricious, and contrary to applicable law. In this lawsuit, we are asking the court to vacate the FDA's patent certification decision, and order FDA to take final action on the Lumrise NDA within 14 days after vacating their decision.

Great.

Thank you Jennifer with a tentative approval in hand, we are well positioned to continue to advance our launch preparations as you work towards bringing once a bedtime loom rise to adults with narcolepsy.

Thank you.

Thanks.

Despite a longer than anticipated time for the final approval of them rise one thing that has not changed is our fundamental belief in the potential for this drug candidate to help patients manage their excessive daytime sleepiness or cataplexy Wil.

The next question comes from Mark Goodman with SCD Securities.

Please go ahead.

Hi.

While also providing them with an opportunity for more natural cheap wake cycle.

This is Madhu.

It has been an amazing journey spending time within our 50 community seat specialists medical societies and patient organizations.

I'm for Mark.

Throughout the year, we made significant progress in expanding our reach with sleep specialists through major Congresses like we're all sleep in March and the sleep 2022 carpets in June along with a one on one meetings.

Similarly to the previous participant, I think most of my questions have been answered, but, maybe just a follow-up on the last question.

Do you expect any additional edits to the label or RAMs upon the request for final approval?

This year alone we estimate that we have been in front of over 1000 people from the narcolepsy community.

Yes.

I do.

Thank you.

As a reminder, less than 1600 specialists make up 80% of the current overall octavate prescription volume.

As we get ready to transition from the summer to the fall. We are also preparing for a number of meetings and conferences that will give us continued exposure to patient organizations and sleep specialists.

Not at this time, we don't.

We have both at the American Neurological Association and chest meetings to T J to engage with fleet specialists. This October .

Along with key patient advocacy organization meeting in the next couple of months.

We believe that's complete.

We also continued to see strong interest in our disease education campaign narcolepsy disrupts.

In June we began to make a sleep diary available that helps patients chart, how they are managing their narcolepsy.

And we have already shipped more than 3000 to individuals across the country.

After assessing all that we've accomplished to date with narcolepsy disrupts, we anticipate launching additional enhancements in the early fall.

Our actions this year have really put <unk> on the map with our key stakeholders as a patient's first company, who will not relent until we can bring a new treatment option to people with narcolepsy.

For the payers, we've made very good progress in our conversations this year now.

A successful outcome in this APA suit could also lead to a potential final approval of, Lumrise prior to June of 2023.

I would say that that's our expectation unless new information or new data is learned during, the pendency of the tentative approval period, but at this stage, we would expect that to be in its final form.

Now with the kind of approval in hand, and more importantly, the outer boundary of our final approval decision now just over 10 months away.

An accelerated briefing schedule order has been approved by the court, and we currently, expect this case to be heard at the end of September 2022.

All right, thanks.

We are accelerating our actions with payers, including the three G. P OS and the affiliated Pbms that represent over 85% of commercially insured lives.

Thank you.

In addition to these opportunities to accelerate a potential final approval, we are also focusing, on launch preparation activities that will shorten the time to launch following final approval. This includes completion of manufacturing and primary packaging for our commercial supply, and operationalizing our REMS program, both in advance of a final approval and before the end of this calendar year. In summary, we are well positioned to execute on all of these priorities to potentially, accelerate bringing Lumrise to a final approval prior to June 2023 and subsequent launch as soon as possible thereafter.

The next question comes from Matt Caplan with Lee.

Our team has done excellent work in establishing the clinical value proposition of once at Bedtime room rise and now we look we look to forward look forward to advancing contract discussions.

As you will hear next, Jennifer will provide details on the data we presented this quarter, at SLEEK 2022, and following Richard will give an update on our launch readiness actions now with the tentative approval in hand.

I'm for Matt.

With that, I'll turn the call over to Jennifer.

I'm for Mark.

The reception has been very positive as the Paris looked again post approval access to a new therapy that we believe can go beyond the limitations of the current standards of care.

Thanks, Greg, and good morning.

As Greg said, this was an important quarter for Avadel. Tentative approval for LoomRise is a significant milestone that validates its efficacy and, safety profile and also has facilitated us starting our RIMS buildout, which will shorten our time to launch following final approval. Furthermore, we had a strong presence at SLEEK 2022 with considerable interest in the body, of evidence supporting LoomRise as described in our nine posters. The poster that we had the most engagement with described new interim data on dosing, and titration from the ongoing Restore Open Label Extension Switch Study of our LoomRise drug candidates.

Sixty-two percent of participants switching from twice-nightly OxyBate formulations had, a stable dose equal to their starting dose, which will help clinicians understand that switching to LoomRise is a straightforward process.

Additionally, participants not currently taking OxyBate formulations or OxyBate Naive participants, reached a stable dose with two to four dose titrations within four weeks. This is particularly relevant as we hear anecdotes of patients having to spend months trying, to find a stable and consistent dosing regimen of twice-nightly OxyBates.

I'm for Lee.

We also presented updated results from patient preference and the Nocturnal Adverse Event, Questionnaire with patients switching from twice-nightly OxyBates in the Restore Study. These interim data confirmed previous data we have presented, showing that a high proportion, of patients switching from twice-nightly OxyBate formulations experienced difficulty in taking the second dose, with nearly two-thirds reporting accidentally missing their second dose at least once in the past three months, and more than 80 percent of those reporting that they experienced worse narcolepsy symptoms the next day.

We continue to be nimble and dynamic and our readiness planning to ensure that we are ready to fully launch at the earliest time after receipt of a final approval.

Also consistent with data we have previously presented, 92.5 percent stated a preference, for the once-nightly dosing regimen.

I'm for Mark.

As we talk about Restore, I want to highlight that we have extended this study so participants, can stay in Restore through FDA approval and up till launch of LoomRise to then transition to commercially available product.

The next question comes from Matt Caplan with Lee.

We retain relationships with our key partners, where the work takes the longest to prepare for launch.

I have had the opportunity to speak directly with a number of participants in Restore who, have expressed their gratitude for this extension, specifically because they don't want to go back to waking up in the middle of the night after successfully taking Avidel's investigational once-at-bedtime sodium OxyBate.

Please go ahead.

Hi, this is Raymond.

With a retro fireman's from the ethane and finalize our program Buildout is in full motion.

I'm for Matt.

Thanks for taking our questions.

The same can be said for the work being done by our team and advancing our commercial launch supply.

Just two quick questions.

Yeah, impressive data showing that dosing is a key factor in patient preference.

For product fulfillment, our patient services center will be ready to go live upon final approval and now we will look to finalize our specialty pharmacy distribution agreements as we head towards a potential final approval.

In summary, the collective work that we've done across Rams supply distribution and fulfillment has put us on track to launch as soon as we can once we have final FDA approval for limb rice.

Going back to our posters, we had five post-hoc posters from Reston, which continue to reinforce, the strong efficacy demonstrated in this pivotal trial, including in subgroups of both NT1 and NT2, and those with and without concomitant stimulants on measures of disrupted nighttime sleep.

We know that once at bedtime. The rise has the potential to address significant unmet need with patients and that our market research and data analytics shows the market potential for <unk> to be roughly double that of the current twice nightly octavate market with more than 30000 potential eligible narcolepsy patients.

I was just wondering to ask, just digging deeper, is there alignment between patient, and clinicians on the relative preference for sodium content in making treatment choice?

Is that something maybe a patient education campaign or that might be a good way to go?

Recall the total pop patient population consists of three key segments.

First approximately 16000 actively treated twice nightly patients.

Second an estimated 10 to 15000 potential patients previously treated octavate, who have discontinued therapy.

And third roughly 3000, new Octavate patient starts and in this segment, we expect robust yearly growth of 25% to 50% per year in the future.

All three patient segments have expressed high levels of interest and loom rise and physicians and patient groups. Both have indicated that once at bedtime dosing is the most important attribute in choosing an observation.

Lastly, we published results from our second Discrete Choice Experiment, or DCE. As some may recall, we have published the results of our first DCE in patient preference, and adherence, which clearly showed that the most important driver of patient choice for sodium oxidate is a single bedtime dose. The second DCE was expanded to include clinicians and the mixed salt oxidate and affirmed our, first DCE. Patients clearly placed the highest priority of treatment selection among the three oxidate, profiles for once-at-bedtime dosing.

For the 100 clinicians participating in the DCE, the data also demonstrated that the most, important driver of clinician choice is once-at-bedtime dosing.

We are a forward looking team and now with the outer battery timing for final approval decision just over 10 months away. We are fully focused on executing our plans to deliver <unk> to patients as effectively and as quickly as we can.

The sleep meeting provided us the opportunity to connect directly with KOLs and explain, the delay in FDA decision on approval of Lumerize.

I'm for Lee.

We have been communicating extensively with both the medical and patient communities following, the tentative approval, including a fact sheet available at avadel.com about what this means and a letter to the community reiterating our commitment to bringing Lumerize to patients.

We recognize patients with narcolepsy will be critical in shared decision-making with, their clinicians. To that end, we were thrilled to publish a plain language summary in Future Neurology, describing the primary results from our pivotal trial so people with narcolepsy can access these results.

The totality of the data we continue to present supports the robust clinical efficacy, the, well-established safety profile, ability to switch from twice-nightly oxidates, and patient preference of Lumerize.

I look forward to providing more updates on future calls.

I'm for Mark.

Now, let me turn the call to Tom for an update on the Companys financials.

Tom.

I'm for Lee.

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

I'm for Mark, or that might help in aligning patient with clinicians.

And my second question is do you expect any updates from the restored study later this, year?

I'll start with the balance sheet, where we reported $104 1 million in cash cash equivalents in marketable securities as of June 32022.

Or is that more of a next year?

Also as of June 30, we had approximately $17 million of tax refunds pending of which $10 million was received in July . We currently expect that the remaining $7 million will be received in the second half of 2022.

Thanks.

As a reminder, earlier this year, we completed an exchange in eight months maturity extension of approximately 80% of $143 8 million.

Jen, can you handle those?

Yes, absolutely.

The convertible notes.

Thank you for the question.

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

So the poster that we had presented at SLEAP on the discrete choice experiment showed, that both patients and clinicians do not place the same value on the sodium content as they do on the dosing frequency.

R&D expenses were $4 5 million in the quarter ended June 32022, compared to $6 8 million for the same period in 2021.

The period over period decrease was due primarily to lower purchases of active pharmaceutical ingredients used in the manufacture of numerous.

SG&A expenses were $21 8 million in the quarter ended June 32022, compared to $15 2 million for the same period in 2021.

The period over period increase is primarily the result of fees associated with the exchange of the convertible notes.

Higher legal and compensation costs were mostly offset by the reversal of previously accrued expenses due to the restructuring.

This quarter, we recorded a restructuring charge of $3 6 million, primarily for severance benefits associated the reduction in the company's workforce.

The workforce reduction will be completed during the third quarter 2022, and we expect to reduce quarterly cash operating expenses, excluding inventory purchases to $12 million to $14 million.

Income tax expense was $3 2 million in the quarter ended June 32022, compared to income tax benefit of $3 8 million for the same period in 2021.

Income tax expense this quarter is due primarily to a valuation allowance recorded against deferred tax assets the.

The valuation allowance is noncash and does not impact our ability to utilize nols in the future when the company begins to generate taxable income.

Net loss for the second quarter of 2022 was approximately $63 4 million or $1 seven per diluted share compared to net loss of approximately $19 6 million or 33 cents per diluted share in the same period in 2021.

Finally, with 104 million of cash on hand at June 30th the $10 million of tax refunds received in July and the 7 million of tax refunds still to be received.

Together with the cost reductions we implemented we believe that the cap. These cash runway extends to at least the middle of 2023.

Now that we have the tentative approval secured, the community is even more eager to see this, potential treatment option receive final FDA approval and made available to patients.

We are proud of all of our hard work that continues to drive Lumerize forward.

And with a tentative approval now granted and as we progress toward a final approval decision that could occur by June 2023, or earlier, we will seek opportunities to strengthen the balance sheet and ensure we have the capital resources available to prepare for launch of <unk> into what we believe is a greater than $3 billion market opportunity.

I'll now turn the call back to Gregg for closing remarks.

Thanks, Tom to summarize we are pleased but certainly not satisfied with our recent milestone of receiving tentative approval for loom rise, marking a critical step for avatar.

So that came through very clearly for both patients and clinicians that the number one, driver of treatment selection is the dosing frequency in preference of a once at bedtime dose as compared to twice nightly dosing.

With tentative approval in hand, we are committed to keep moving forward to unlock loom rises clear and intuitive value proposition with a once at bedtime treatment that could be transformative for people with narcolepsy by providing the potential of an uninterrupted night's sleep, while also managing daytime symptoms of narcolepsy.

As far as it pertains to restore, yes, we will be presenting more data at the upcoming, Congresses, both the TEST and ANA Congress that are being held mid-October.

We look forward to keeping you up to date on our continued progress with our regulatory and legal actions as well as our ongoing efforts to prepare for and shorten the time to commercial launch upon receipt of final approval.

I will now turn the call over to Richard to provide details on the commercial opportunity, and our preparations for launch.

With that we will open the call for questions and I'll turn it back to the operator.

Richard?

We will have posters that continues to update our open label data from restore.

Okay.

Thank you we will now begin good question and answer session to ask a question you May Press Star then one on your Touchtone phone. If you are using a speakerphone. Please pick up your handset before pressing the keys.

Dan Your question has been addressed and you would like to withdraw your question. Please press Star then two.

Thank you, Jennifer.

Appreciate that.

With the tentative approval in hand, we are well-positioned to continue to advance our, launch preparations as we work towards bringing once-at-bedtime Lumerize to adults with narcolepsy. Despite a longer-than-anticipated time for the final approval of Lumerize, one thing, that has not changed is the fundamental belief in the potential for this drug candidate to help patients manage their excessive daytime sleepiness or cataplexy while also providing them with an opportunity for a more natural sleep-like cycle.

At this time, we will pause momentarily to assemble IRA.

It has been an amazing journey spending time with the narcolepsy community, sleep specialists, medical societies, and patient organizations. Throughout the year, we made significant progress in expanding our reach with sleep specialists, through major congresses like World Sleep in March and the Sleep 2022 Conference in, June, along with one-on-one meetings. This year alone, we estimate that we have been in front of over 1,000 people from the, narcolepsy community.

As a reminder, less than 1,600 sleep specialists make up 80% of the current overall Oxybate, Prescription volume.

Thanks.

As we get ready to transition from the summer to the fall, we are also preparing for a number, of meetings and conferences that will give us continued exposure to patient organizations and sleep specialists.

We have both the American Neurological Association and CHESS meetings to continue to engage with, sleep specialists this October, along with key patient advocacy organization meetings in the next couple of months.

Okay.

We also continue to see strong interest in our disease education campaign, Narcolepsy, Disrupts.

In June, we began to make a sleep diary available that helps patients chart how they are managing, their narcolepsy. And we have already shipped more than 3,000 to individuals across the country.

After assessing all that we have accomplished to date with Narcolepsy Disrupts, we anticipate, launching additional enhancements in the early fall. Our actions this year have really put Avadel on the map with our key stakeholders as a, patient's first company, who will not relent until we can bring a new treatment option to people with narcolepsy.

For the payers, we have made very good progress in our conversations this year.

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

Thanks, Raymond.

Alright, Thanks for taking the question just alright, so the timelines are.

Changed a little bit we've been we've been tracking we've got the potential rems exploration, but you mentioned just between the filing of the lawsuit and the Markman hearing and what can come of that you mentioned, possibly having news by the end of 'twenty. Two I just wanted to make sure I understood what that referred to.

And also may be hearing about I believe it was the lawsuit by the end of September . So maybe if you could just kind of put it all together and just make sure we know what to expect for potentially earlier approve.

Approval decision then.

<unk> 23.

The next question comes from Chase Knickerbocker with Craig Hallam.

Yeah. Thanks, Frank.

So both of them on both of them being the markman hearing leading into the motion to do list on one track.

Please go ahead.

And on the other track the a P. A action against FDA. So taking the first one again in that in that proceeding in that pursuit.

Good morning, everyone.

That case, we have asked the court.

Assuming they agree with our position on on the actual rems patents not being eligible not being listed eligible orange booklet eligible to be lifted we are asking the court to order.

The delisting of that upon receipt of that delisting.

We will then facilitate the process to in essence re file the necessary documents with FDA seeking their approval to move from a tentative approval to a final approval. So.

Obviously, the Markman hearing is on August 31st we certainly are seeking to have the motion to delist herd as quickly thereafter as possible.

And depending on the timing of those those decisions would whenever that occurs that will set the timeframe for us to then file the necessary documentation with the F. D. A to convert the tentative approval to final approval, which again per FDA guidance generally speaking in that situation.

As recommended anywhere from two months to six months, so depending upon when that occurs and how quickly the FDA acts on that setting could create a situation where a final approval decision could be could be had depending on when that final delisting motion occurs on the AP case. What has occurred is a briefing schedule has been agreed to.

<unk>, which is well go through basically the middle of September and currently tentatively that hearing is expected to be heard.

At the end of September .

And again, what we are requesting from the court. There is if they agree with our position that they vacate the requirement that the decision to require certification.

And I ask the FDA to make a final decision within 14 days, so depending upon how long from the hearing to when the judge makes a final decision or ruling on that if they rule in our favor than a final decision could occur as early as 14 days after that point in time, so again both of those.

Tensely provide windows, where if the decisions happen relatively efficiently and they go in our favor a decision could potentially occur prior to the end of the year.

Perfect. Thank you very much.

That's very helpful. And then just maybe more for Richard on the payer side you guys. Obviously doing a lot of work. There I was just wondering any thoughts would you share.

Any thought strategically of maybe giving out samples for free just to make sure that you know based on the fact that you have to titrate. This medication. It can take time in these patients. There is a high discontinuation rates are for these types of medicines.

Any thoughts about from the script being prescribed to getting in the patients' hands to make sure that happens as quickly as possible thoughts about just giving out some samples for free just to make sure that patients get access quickly.

Yeah, Frank Thanks for the question Yeah, It's an interesting thought the one thing we are absolutely focused in on is making sure. We can get patients had great experience with the room rates as fast as possible. Upon final approval. So through our patient services Center, we have we will offer a bevy of services.

Yes.

Quick start programs, where you're waiting for insurance and other things for applicable patients to ensure that patients can get the experience with loon rise with a office. Obviously you once you've been certified as quickly as possible. So we do know those initial experiences are going to be absolutely pivotal for us which is why we have invested so heavily in ensuring that our patient services central will have.

Not only that but other services aimed at both the patients themselves and the offices as well. So it's a good idea frankly, theres, obviously, some legalities, we'd have to work through but we are working on making sure that we have a full suite of services to ensure that patients can get on therapy as fast as possible.

Okay, great. Thank you very much that's it for me.

Yeah.

Our next question comes from Logan Midnight.

<unk>. Please go ahead.

Thanks, I have a couple.

Just can you remind us upon FC to 18 or Aluminized tentative approval did you get or do you expect to receive in due course, an indication regarding potential orphan exclusivity are of your own product for that would apply to any future once nightly sodium oxy event at <unk>.

Thanks.

Yeah, Thanks Oren again.

As we've shared in the past.

This is a topic we've had engagement with during the pendency of the review on with FDA and fundamentally believe that.

The orphan exclusivity review was by and large complete although not decided upon formerly because technically until there is a basis for a timing for a final decision. The FDA just isn't going to make that final decision that formal decision until the time is right and there's a lot of reasons.

That including that things could change in the marketplace or whatnot between now and that point in time that that being said.

What's been communicated to us in our tentative approval letter, which I do believe is online now you'll see what was noted in that approval letter was the rems patents as we previously identified as the issue that we need to climb over so again from our perspective.

Our discussions with FDA, although not a formal decision.

This issue is the same as it was prior to our missing the producer date and whatnot and we believe both in the context of the robustness of our submission on the basis of clinical superiority that we provided.

To be granted orphan drug exclusivity, but as we've also stated based upon the statute, we don't necessarily believe orphan drug exclusivity is required to be granted a full and final approval.

Okay and.

As we think about the launch scenarios and the timing to launch.

So I touched on this.

But what are how long do you think it would take to actually get this product out the door, which includes having to enroll.

Physicians and Rems et cetera.

Post approval and if you were if you were approved in fall or year end, how many months do you think it would take to actually get some scripts are rolling through the system and maybe even revenue producing.

Richard you want to start on that.

Now, with the tentative approval in hand, and more importantly, the outer boundary of, a final approval decision now just over 10 months away, we are accelerating our actions with payers, including the three GPOs and the affiliated PBMs that represent over 85% of commercially insured lives. Our team has done excellent work in establishing the clinical value proposition of once-at-bedtime, loom rise, and now we look forward to advancing contract discussions.

Just first for me, can you speak a bit to how your REMS program and the existing Oxybate's, REMS would have to interact?

Yeah. So.

So.

And the Great news with the tenant approval in hand under <unk> leadership. The Rems program is in full build out right now as well so.

And, you know, would there have to be some cooperation between the two of you to ensure, Oxybate patients are properly managed between the two programs?

You know, if you could just speak to any challenges here as you are building out your, REMS program sort of around there, that would be helpful here.

PVC that would have been viewed as sort of one of the long pole to attend but now with us having the ta that's going forward. So our belief is our work will be shortly after very shortly after our final approval that will be up and going and obviously wants to rent is up and going we can actually begin to certify both physicians and patients so did.

Yeah, thanks, Chase.

The reception has been very positive as the payers look to gain post-approval access to, a new therapy that we believe can go beyond the limitations of the current standards of care.

I think the first answer to that question is that upon a final approval, both REMS programs are going to have to communicate with each other and cooperate.

So it's not just theirs cooperating with ours or ours cooperating with theirs.

Both companies are going to have the requirement to ensure a patient only has one active Oxybate prescription at a time.

There is a process for which the FDA has approved and how that's going to work on our part.

Pending on timing will either have time to do that a little bit before product is out there or it will be done concurrently. So that one element has really shrunk down a significant part of our prelaunch readiness here.

That's part of our REMS program and our design.

And if you look at our tentative approval letter online, you'll see that components of the REMS document, the REMS program has been provided by FDA.

And inclusive of that is Section 9, which is a section that basically requires us to report how the other party is responding to, you know, and the timeliness of those response, the response in our inquiries to determine if a patient has an active prescription or not.

Our assumption is that will be reciprocal on their side as well, but don't know that for sure.

But clearly, there is a mechanism to report the responsiveness of the other, REMS program to FDA at their request.

Awesome.

Now, we continue to be nimble and dynamic in our readiness planning to ensure that we, are ready to fully launch at the earliest time after receipt of a final approval.

That's helpful, Culler.

So, but it will still take us that potentially a few months from the final approval before the first product is shipped out Greg would you like to add on to that yes. I think that's right I think are in the best way to think about it is in the scenario where good news comes early.

We retain relationships with our key partners where the work takes the longest to prepare, for launch.

Thanks.

And then just last for me, can you provide, some details of, you know, what specific business functions were cut or reduced in the workforce reduction and cost optimization?

With the REMS requirements from the FDA now finalized, our program build-out is in full, motion.

Or, you know, what will needed to be added or added back upon full approval?

The same can be said for the work being done by our team in advancing our commercial launch, supply.

For product fulfillment, our patient services center will be ready to go live upon final, approval, and now we will look to finalize our specialty pharmacy distribution agreements as we head towards a potential final approval.

Yeah, I would say there was, you know, there was no area that was, you know, spared, so, to speak, from that standpoint.

In summary, the collective work that we have done across REMS, supply, distribution, and, fulfillment has put us on track to launch as soon as we can once we have final FDA approval for loom rise.

And I would characterize it in really a couple of ways.

We know that once-at-bedtime loom rise has the potential to address significant unmet, need with patients, and that our market research and data analytics shows the market potential for loom rise to be roughly double that of the current twice-nightly-oxibate market with more than 30,000 potential eligible narcolepsy patients.

Recall, the total patient population consists of three key segments.

The first way is, in part, it was part of the DNA organization that was built to prepare, for an onboarding of a significant expansion of headcount in the organization, more than a doubling of it by far, as we would, as we were heading toward a potential final approval.

First, approximately 16,000 actively treated twice-nightly patients.

And third, roughly 3,000 new Oxybate patients starts.

And clearly, you know, those aren't positions we need in place right now, although the infrastructure, and systems have been built to support that in the future.

Second, an estimated 10,000 to 15,000 potential patients previously treated with Oxybate who, have discontinued therapy.

And in this segment, we expect robust yearly growth of 25% to 50% per year in the future.

And where we.

We have that as a tailwind and we're building toward a launch date on the back of an approval. There are certain things that we will continue to be worked on that that otherwise would have been completed if we go all the way till June of next year. So I think you know in the scenario, where an approval comes by the end of this year, we may be launching.

All three patient segments have expressed high levels of interest in Lumerize, and physicians, and patient groups both have indicated that once-at-bedtime dosing is the most important attribute in choosing an Oxybate.

And then secondly, I would say it's roles where there are certain roles that, you know, we've done a lot of work to get ready for launch, and now it's ready to go.

We are a forward-looking team, and now, with the outer boundary timing for a final approval, decision just over 10 months away, we are fully focused on executing our plans to deliver, Lumerize to patients as effectively and as quickly as we can.

I look forward to providing more updates on future calls.

No.

Now a few months after that into the early part of next year into you know, perhaps even depending on when the approval comes in the early part of May be Q2. Unlike if a launch if it goes all the way till after June 17th then we're likely.

Towards the end of Q2 before a final approval, where we're obviously likely launching in the subsequent quarter.

Okay, and just if I may you talked about.

And there's no really active work that's required from those functions.

So, you know, we've made the decision on those sorts of roles to let them go, but really keep critical roles that we need to continue to execute to shorten the time, you know, from approval, from final approval to launch.

You know your increased optimism for the oxalate market growth potential with several different buckets.

Got it.

That's it for me.

Given all of that work you've done in the interim whats the latest view on the resources necessary to successfully launched the product realized sort of those ambitions what sort of footprint.

Marketing I guess, just you probably wouldn't comment on total costs, but just as he tried understood the magnitude of investment necessary.

Now, let me turn the call to Tom for an update on the company's financials.

Yes.

Go ahead Richard.

Yeah, no. It's a great question I mean, the one thing that's always really key for us to think about further occupancy market is it's relatively compact rate. Once again, we know that as far as the treater base of oxalate prescribers are concerned for narcolepsy Theres only about 5016 hundred make up 80% of the total Oxford volume so for acid.

Ben it's relatively compact.

Our initial plans are still about the same where we'd probably focusing at around 50 representatives that will allow us to cover that entire universe and add some we've really invested very heavily in our data analytics platform. So that we can really effectively target the right physicians at the right time and a lot of the work that we've done up to this point is our foundation going forward, which is a great base.

For us everything from our disease education with narcolepsy disrupts to the engagement that we've had with patients digitally we have is to build upon so the great news for US is I don't think it's like we need a massive bolus, we're just going to keep building upon what we have clearly we're going to have to spend more to hire sales force again and things like that but the fact that this is a compact marketplace and then.

From making good inroads into that was that core there's clearly room to expand in the future, but that's what makes this marketplace from my perspective really.

Attractive to execute on is we don't have to do like multiple things. We can really focus on the physician engagement the patient engagement and the payer engagement and we've got great plans going against all three segments.

Alright, Thanks, good luck.

Thanks Mark.

Our next question comes from Amit <unk> with Needham. Please go ahead.

Tom?

Thanks.

Thank you, Richard.

Thanks, Chase.

Hi, Good morning, this is easily entre army.

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

As a reminder, earlier this year, we completed an exchange and 8-month maturity extension, of approximately 80% of the $143.8 million of convertible notes. As a result, $117.4 million now matures in October of 2023, and $26.4 million will mature, in February of 2023.

The next question comes from Paul Maddow with Steven.

I'll start with the balance sheet, where we reported $104.1 million of cash, cash equivalents, and marketable securities as of June 30, 2022. Also as of June 30, we had approximately $17 million of tax refunds pending, of which, $10 million was received in July. We currently expect that the remaining $7 million will be received in the second half, of 2022.

R&D expenses were $4.5 million in the quarter ending June 30, 2022, compared to $6.8 million, for the same period in 2021. The period-over-period decrease was due primarily to lower purchases of active pharmaceutical, ingredients used in the manufacture of LoomRise.

The workforce reduction will be completed during the third quarter of 2022, and we expect, to reduce quarterly cash operating expenses, excluding inventory purchases, to $12 to $14 million.

Please go ahead.

SG&A expenses were $21.8 million in the quarter ending June 30, 2022, compared to $15.2 million, for the same period in 2021. The period-over-period increase is primarily a result of fees associated with the exchange, of the convertible notes.

Income tax expense was $30.2 million in the quarter ending June 30, 2022, compared to, the income tax benefit of $3.8 million for the same period in 2021. Income tax expense this quarter is due primarily to a valuation allowance recorded against, deferred tax assets. The valuation allowance is non-cash and does not impact our ability to utilize NOLs in the future when the company begins to generate taxable income.

Net loss for the second quarter of 2022 was approximately $63.4 million, or $1.07 per diluted share, compared to net loss of approximately $19.6 million, or $0.33 per diluted share in the same period in 2021. Finally, with $104 million of cash on hand on June 30th, the $10 million of tax refunds received in July, and the $7 million of tax refunds still to be received, together with the cost reductions we implemented, we believe that the cap-to-use cash runway extends to at least the middle of 2023.

Hi, this is James.

Higher legal and compensation costs were mostly offset by the reversal of previously accrued, expenses due to the restructuring. This quarter, we recorded a restructuring charge of $3.6 million, primarily for severance, benefits associated with the reduction in the company's workforce.

And with the tentative approval now granted, and as we progress toward a final approval decision that could occur by June 2023 or earlier, we will seek opportunities to strengthen the balance sheet and ensure we have the capital resources available to prepare for the launch of LoomRise into what we believe is a greater than $3 billion market opportunity.

I'll now turn the call back to Greg for closing remarks.

On for Paul.

For taking our questions just two from us.

Let me first I'm curious ahead of kind of the August 31st Markman hearing is there any read through that we could get from.

Thanks, Tom.

Thanks for taking our question.

To summarize, we are pleased, but certainly not satisfied with our recent milestone of receiving tentative approval for LoomRise, marking a critical step for Avidel. With tentative approval in hand, we are committed to keep moving forward to unlock LoomRise's clear and intuitive value proposition with a once-at-bedtime treatment that could be transformative for people with narcolepsy by providing the potential of an uninterrupted night's sleep while also managing daytime symptoms of narcolepsy.

That.

In terms of.

Potentially getting a favorable ruling regards to the delisting counter claim.

I just wanted to understand, the exact steps behind, you know, getting a full approval.

And then maybe second week.

It sounds like from the press release, you'll receive full approval kind of immediately following the expiry of the REMS patent.

Just love your latest thoughts kind of on pricing of luminaries and kind of in this market in general given.

And I guess, is that the case?

Or is there anything that needs to happen, at the FDA first?

For example, will they need to make a decision on ODE following patent expiry?

And I guess, what's the risk that could cause a further delay?

Thanks.

Given the entry of authorized generics looking like no kind of start off in the beginning of next year. Thank you.

Yes, thanks, as it relates to kind of any read through.

Yeah, James, as previously shared, there is a process. If we're heading toward the situation, where June 17th is the expiry of the patent, and that's the last remaining item for us to move to from a tentative approval to a final approval decision, we would begin the process in notifying FDA and filing all of our related documentation well in advance of that per FDA guidance, such that upon that expiry or shortly thereafter, we would expect a final decision to be made on loom rise.

So, I think the short answer to the question is, you know, not speaking directly for how long after June 17th that will occur, but we will take the necessary steps to file the necessary documentation and request the FDA to begin the process to make whatever final decisions need to be made to convert from a tentative approval to final approval in advance of that, such that when that patent expires, the FDA should be in a position to do so.

From that perspective, it's probably not appropriate for us to speak on any of those specifics relative to this ongoing litigation other than the fact that you know when it comes to this specific 96 three grams pattern.

Great.

Thanks.

That's helpful.

Again, I think what we're what we believe based upon the components of the patent that is a computer system pattern given that describes things such as processors and servers and screen shots and whatnot.

Thank you.

And believe that that is not a list of Bull Orange book listed patents, which really is tied to formulation or method of use of that specific product and therefore again we.

We've asserted just because we believe in our position and we look forward to the first step in this process in just a few weeks from now.

We look forward to keeping you up to date on our continued progress with our regulatory and legal actions, as well as our ongoing efforts to prepare for and shorten the time to commercial launch upon receipt of final approval.

This concludes our question and answer session.

I would like to turn the conference back over to Gregory Divis for any closing remarks.

To advance it as it relates to pricing and the market dynamics I'll turn it over to Richard.

With that, we will open the call for questions, and I'll turn it back to the operator.

Thank you.

Thank you, operator.

Yes. Thanks.

Thanks for the question so.

We will now begin the question-and-answer session.

Thank you, everyone, for joining us today.

To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

Obviously, when it comes to the marketplace first and foremost we've seen at the occupant market would be relatively flat.

If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2.

At this time, we will pause momentarily to assemble our roster.

As far as narcolepsy concerned and all of our plants that we've made in prelaunch and our post.

Our first question comes from Francois Brissonbois with Oppenheimer.

We look forward to keeping, you up to date on our progress on a number of these fronts and these matters and wish you a great rest of the day and look forward to any follow-up necessary.

Take care.

Thank you.

Approval plans have actually been contemplating an AGM in the marketplace now we don't really see the AG significantly impacting the potential for a once at bedtime loom rise at all.

Please go ahead.

Thanks for taking the question.

The timelines have changed a little bit.

We've been tracking.

We've made plans whether or not they make some further in roads are not here as well, but regardless you know when it comes to <unk>. It's always remember important to remember that it's still going to be a twice nightly product as are all of the current ox debates as well and we believe our work that we've done with the payers is really been to establish the clinical value proposition of the ones at bedtime loom rises.

We've got the potential REMS expiration, but you mentioned just between the filing of the lawsuit and the Markman hearing and what can come of that, you mentioned possibly having news by the end of 2022.

I just wanted to make sure I understood what that referred to and also maybe hearing about I believe it was the lawsuit by the end of September.

Maybe if you could just kind of put it all together and just make sure we know what to expect for a potentially earlier approval decision than June of 2023.

Yeah, thanks, Frank.

So both of them being the Markman hearing leading into the motion, to delist on one track and on the other track, the APA action against FDA.

So taking the first one, again, in that proceeding, in that case, we have asked the court, assuming they agree with our position on the actual REMS patent, not being eligible, not being, you know, listed, eligible, Orange Book eligible to be listed, we are asking the court to order the delisting of that.

Upon receipt of that delisting, we would then facilitate the process to, in essence, refile the necessary documents with FDA, seeking their approval to move from a tentative approval to a final approval.

So obviously, the Markman hearing is on August 31st.

We certainly are seeking to have the motion to delist heard as quickly thereafter, as possible.

And depending on the timing of those decisions, whenever that occurs, that will set the timeframe for us to then file the necessary documentation with the FDA to convert the tentative approval to final approval, which again, per FDA guidance, generally speaking in that situation, is recommended anywhere from two months to six months.

So depending upon when that occurs and how quickly the FDA acts, in that setting could create a situation where a final approval decision could be had, you know, depending on when that final delisting motion occurs.

On the APA case, what has occurred is a briefing schedule has been agreed to, which is what will go through basically the middle of September. And currently tentatively, that hearing is expected to be heard at the end of September.

And again, what we're requesting from the court there is if they agree with our position, that they vacate the requirement, the decision to require certification and ask the FDA to make a final decision within 14 days.

So depending upon how long from the hearing to when the judge makes a final decision, or ruling on that, if they rule in our favor, then a final decision could occur as early as 14 days after that point in time.

So again, both of those potentially provide windows where if the decisions happen relatively efficiently and they go in our favor, a decision could potentially occur prior to the end of the year.

So we've definitely take that into account as well, we don't anticipate them really having significant pricing erosion, but we'll adjust our plans with whatever goes on there and also keep in mind. The AG, it's really generally not attractive to payers as far as where the increasing the uptake.

Off of our assumptions today and as far as your question on pricing. We've stated right from the beginning our goal with payers has to be sort of impair at parity access position with the best of the OXXO rates overall, and so our pricing. We've always stated that to be sort of in the zone, where we believe the branded ox debates will be in the future as well.

Perfect.

Okay.

Alright, thank you.

Thank you.

Okay.

Okay.

Our next question comes from Chris Harris.

Please go ahead.

Thank you very much.

That's very helpful.

Yes.

And then just maybe more for Richard on the payer side, you guys obviously are doing a lot of work there.

Yeah.

I was just wondering any thoughts, would you share any thoughts strategically of maybe giving out, you know, samples for free just to make sure that, you know, based on the fact that you have to titrate this medication, it can take time in these patients, there is a high discontinuation rate for these types of medicines.

Frank, thanks for the question.

Hi, this is ajay.

Any thoughts about, you know, from the script being prescribed to getting in the patient's hand to make sure that happens as quickly as possible, thoughts about just giving out some samples for free just to make sure the patients get access quickly?

It's an interesting thought.

At Jefferies.

Yeah.

Quick housekeeping housekeeping question do you have a target budget for API stocking I just see it was the only item excluded from your expenditure guidance.

You know, the one thing we're absolutely, focused in on is making sure we can get patients a great experience with Lumrise as fast as possible upon final approval.

Tom you want to answer that.

So through our patient services center, we will offer a bevy of services.

If it's a quick start programs where you're waiting for insurance and other things for applicable patients, to ensure that patients can get the experience with Lumrise with obviously once they've been certified as quickly as possible.

So we do, know those initial experiences are going to be absolutely pivotal for us, which is why we have invested so heavily in ensuring that our patient services center will have not only that, but other services aimed at both patients themselves and the offices as well.

So it's a good idea.

You broke up a little bit. Your question was do we have guidance on the amount of our API purchases.

Frankly, there's obviously some legalities we'd have to work through, but we're working on making sure that we have a full suite of services to ensure that patients can get on therapy as fast as possible.

Okay, great.

Thank you very much.

That's it for me.

Our next question comes from Lauren Livnat with HC Bengrise.

Please go ahead.

Yeah.

Thanks.

Yes, we're not providing specific yes, we're not providing a specific guidance around that you know the API API purchases are included in our R&D costs at this point.

I have a couple.

Just can you remind us upon FC218 or Lumrise tentative approval, did you get, or do you expect to receive in due course, an indication regarding potential orphan exclusivity of your own product for, you know, that would apply to any future once nightly sodium oxybate?

Okay got you and a quick follow up question on the <unk>.

I have follow up.

Thanks.

Let's see disrupts program do you have an update on what kind of engagement you are seeing with patients.

Yeah, thanks Lauren.

Yeah, no we've seen a really great enrollment so far were clothing in about 6000.

Individuals who have registered into our program and I think you know as you mentioned during prepared remarks, what's been really cool to sort of see as we offered what we deem as a very simple very very essential tool around a sleep diary and in the first sort of months and a bit we had over 3000 individuals' request getting it.

Again, you know, as we've shared in the past, this is a topic we've had, engagement with during the pendency of the review on the FDA and fundamentally believe that the orphan exclusivity review was by and large complete, although not decided upon formally, because technically until there's a basis for a timing for a final decision, the FDA just isn't going to make that final decision, that formal decision until the time is right.

And there's a lot of reasons for that, including that things could change in the marketplace or whatnot between now and that point in time.

That being said, what's been communicated to us in our tentative approval letter, which I do believe is online now, you'll see what was noted in that approval letter was the REMS patent as we previously identified as the issue that we need to climb over.

So again, from our perspective in our discussions with FDA, although not a formal decision, you know, this issue is the same as it was prior to missing the PDUFA date and whatnot.

So our discussions with our patients our engagement has been very good and as I mentioned as well, we're sort of looking to sort of having a larger revamp to sort of take that next wave of engagement as we go into the early part of fall, but so far we're super pleased with the impact that the campaign has really had and the continued engagement and dialogue that we're having with patients online.

And we believe both in the context of the robustness of our submission on the basis of, clinical superiority that we provided to be granted orphan drug exclusivity, but as we've also stated based upon the statute, we don't necessarily believe orphan drug exclusivity is required to be granted a full and final approval.

Okay.

Okay.

Got it thank you.

Our next question comes from David <unk> with Piper Sandler. Please go ahead.

So most of my questions have been answered, but I did want to ask a couple of questions on commercialization.

And as we think about the launch scenarios and the timing to launch, you know, Francois touched on this, but what, you know, how long do you think it would take to actually get this product out the door, you know, which includes having to enroll physicians and REMS, et cetera, post-approval?

And if you were approved in fall or year end, you know, how many months do you think it would take to actually get some scripts rolling through the system and maybe even revenue produced?

We're one.

Can you talk through.

Where you think early adoption is going to come from and in particular.

Do you expect that most of the earlier patients will have had exposure to the xyrem authorized generic or.

So that's number one.

<unk> two.

As you look at your IP runway.

Sure It makes sense for you too.

Iran.

Registration quality study in idiopathic hypersomnia is that something that's in the cards. Thank you.

Yeah. Thanks, David Richard do you want to take the first one.

Richard, do you want to start on that?

Sure No great question, David So as far as really a doctor is concerned I mean first I sort of thinking about it from the prescriber base.

Yeah.

You know, so in the great news with the tentative approval in hand under Jen's leadership, the, REMS program is in full buildup right now as well.

So previously that would have been viewed as sort of one of the long pulls in a tent, but now with us having the TA, that's going forward.

So our belief is our work will be shortly after, very shortly after our final approval.

That will be up and going and obviously once the REMS is up and going, we can actually, begin to certify both physicians and patients.

So depending on timing, we'll either have time to do that a little bit before a product, is out there or it will be done concurrently.

Greg, would you like to add onto that?

So that one element has really shrunk down a significant part of our pre-launch readiness, here.

And clearly you know our assumption is we'll have the earliest adoption from the most experienced octavate prescribers. We know that there is less than 500 physicians that account for over 50 per script per cent of the oxalate volume in the marketplace right now as well and actually what we see in our market research is a great opportunity for patients who are currently on twice nightly ox debates.

So, but it will still take us potentially a few months from the final approval before, the first product is shipped out.

Yeah, I think that's right.

I think, Oren, the best way to think about it is in the scenario where good news comes, early and we're, you know, we have that as tailwind and we're building toward a launch date on the back of an approval, there are certain things that will continue to be worked on that otherwise would have been completed if we go all the way until June of next year. So I think, you know, in the scenario where an approval comes by the end of this year, we may be launching, you know, a few months after that into, you know, the early part of next year into, you know, perhaps even depending on when the approval comes in the early part of maybe Q2.

Unlike if a launch, if it goes all the way until after June 17th, then we're likely, you know, towards the end of Q2 before final approval, we're obviously likely launching in the subsequent quarter.

Okay.

And just if I may, you know, you've talked about, you know, your increased optimism for, the oxidative market growth potential, you know, with several different buckets, you know, given all that work you've done in the interim, what's the latest view on the resources necessary to successfully launch the product, realize, you know, sort of those ambitions, what sort of footprint, you know, marketing, I guess just you probably wouldn't comment on total cost, but just as we try to understand the magnitude of an investment necessary.

Go ahead, Richard.

Yeah.

Discontinued in de Novo, but if you think about the switch patients themselves. We actually know that current design wave patients tend to be <unk>.

No, Oren, it's a great question.

I mean, the one thing that's always really key for us to think about for the narcolepsy, market is it's relatively compact, right?

You know, once again, we know that as far as the treater base of oxidative prescribers, are concerned for narcolepsy, there's only about 5,000 and 1,600 make up 80% of the total oxidative volume.

<unk> adopters of innovative new therapies, so we absolutely do see a.

Good operative for patients there to be attracted to the <unk> value proposition as are the current xyrem patients where potentially that that which makes the most intuitive sense.

And as far as the AG is concerned like I said, we still see it having limited impact.

Impacting the marketplace and that clearly will have likely it hasnt time to see that but we actually.

So, for us, it's been, it's relatively compact.

You know, our initial plans are still about the same where we'd probably be focusing, on around 50 representatives that will allow us to cover that entire universe and add some.

<unk> do you see the switch from existing twice nightly oxy basis as being a relatively large segment in the Oxford experienced physicians. We also see that opportunity with patients who tried twice at least but are no longer on them for various reasons and we also do believe we're going to get a good share of the de novo patients because as many physicians have told me when you offer the chance to not have to wake up.

We've really invested very heavily in our data analytics platform so that we can really, effectively target the right physicians at the right time.

Middle of the night with de Novo patients, it's a pretty clear value proposition as well. So we feel fortunate that we know that we have a great opportunity of the switch patients, but we absolutely sort of see the opportunity for growth in all three of those patient segments overall and break I'll turn the IP question back to you.

And you know, a lot of the work that we've done up to this point is our foundation going, forward, which is a great base for us, everything from our disease education with narcolepsy disrupts to the engagement that we've had with patients digitally. We have this to build upon.

Yeah.

Thanks, David.

It's an important question because what's next is an important consideration for us in terms of how do we build a franchise around the innovation that is once nightly loom rise and I think the short answer is there's a tremendous amount of interest from the clinician community to want to study a true once nightly dose.

Once at Bedtime administration for IH patients. So, yes, I think in short we're evaluating that very seriously we've done a tremendous amount of work in terms of understanding what that trial design could be like and whether or not we see.

We should we consider.

A registration quality study or whatnot, I think you'll hear more about that as we go forward, but it is an important consideration as one of the tools in terms of building out the full value of the of our Bloom.

Bloom rise, whether that's in IH or whether that's in the work we're doing with the additional formulation work as well on our own low sodium formulation no sodium formulation.

Got it okay. Thank you.

Thanks, David.

The next question comes from Adam <unk> with lifestyle Catherine. Please go ahead.

Thank you good morning, a question on the commercial side on Jazzes earnings call. They reported that there are more patients on <unk> of course part of that is the idiopathic hypersomnia indication for <unk> I was just curious if that impacts your.

Our commercial strategy, perhaps messaging or otherwise.

Yeah, Hey, Thanks for the question, Yes, you are right I think what they reported is more patients for XI wave overall, but if we actually look at the narcolepsy market, it's still slightly tilts towards xyrem.

So, you know, the great news for us is I don't think it's like we need a massive bolus.

The good news for US is we see the opportunity uniquely favor.

Favorable for both of those segments as I mentioned before what we our research tells US is in General XI OA patients with narcolepsy tend to be early adopters younger patients who've been diagnosed with narcolepsy for last years seeking more new innovative therapies as well. So we believe that bodes very well for the value proposition.

We're just going to keep building upon what we have.

Clearly, we're going to have to spend more to hire a sales force again and things like that.

But the fact that this is a compact marketplace and then from making good inroads into that, core, there's clearly room to expand in the future.

Memorize once it's available in the market as well and then once again, so it likely will be bifurcated market between Xyrem is iwate patients as far as ox debates are concerned for the Xyrem patients you know our value proposition is probably the clearest and most intuitive overall there as well.

But that's what makes this marketplace, you know, from my perspective, really attractive, to execute on is we don't have to do like multiple things.

We can really focus on the physician engagement, the patient engagement, and the payer engagement.

Unknown Attendee Our next question comes from Ami Fadia with, Needham.

Please go ahead.

Eason Leon Hi.

Good morning.

This is Eason Leon for AMI.

So going from twice at night too once at Bedtime therapy that in essence is the same sort of compound. So we believe we're really well positioned for both and a whole lot of it is also going to be driven by some of the patient engagement that we have overall as well. So despite the fact that there's about a 50 50 split in the marketplace right. Now we believe we are positioned for both.

Thanks for taking our questions.

Just two from us.

Maybe first, I'm curious, ahead of the August 31st Markman hearing, is there any read-through, that we could get from that in terms of, you know, y'all potentially getting a favorable ruling regards to the delisting counterclaim?

Both of those segments very well in addition to the discontinue to patients and to de novo patients as well.

And then maybe second, we just love your latest thoughts kind of on, you know, pricing of, Loomer Eyes and kind of in this market in general, given, you know, given the entry of authorized generics looking like they'll kind of start off in the beginning of next year.

Thank you.

And <unk> I appreciate that and then one quick clarification I think I know the answer to this but will we get any more color on the label or will need to wait until full approval to see any more details there.

Yeah, thanks.

Yes, it won't be released until a final approval Adam.

But our view on it where it stands today, it's in really good shape.

I think gives us something really good to work with in the marketplace.

Great. Thank you.

Thanks.

As it relates to kind of any read-through from that perspective, it's probably not appropriate, for us to speak on any of those specifics relative to this ongoing litigation, other than the fact that, you know, when it comes to this specific 963-BRIMS patent, again, I think what we're, what we believe based upon the components of the patent that it, is a computer system patent, given it describes things such as processors and servers and screenshots and whatnot, and believe that that is not a listable, an Orange Book listable patent, which really is tied to formulation or method of use of that specific product.

And therefore, again, we've asserted this because we believe in our position and we, look forward to the first step in this process in just a few weeks from now to advance it.

As it relates to pricing and the market dynamics, I'll turn it over to Richard.

Yeah, Ethan, thanks for the question.

The next question comes from Mark Mcmahon.

So, you know, obviously when it comes to the marketplace, first and foremost, we've seen, that the occupant market be relatively flat as far as narcolepsy is concerned.

And you know, all of our plans that we've made in pre-launch and our post-approval plans, have absolutely been contemplating an AGE in the marketplace.

Now we don't really see the AGE significantly impacting the potential for once-at-bedtime, lumaries at all.

So we definitely take that into account as well.

You know, we've made plans whether or not they make some further inroads or not here, as well.

And then with SBB Securities. Please go ahead.

But regardless, you know, when it comes to AGE, it's always important to remember that, it's still going to be a twice-monthly product, as are all the current Oxibates as well.

And we believe, you know, our work that we've done with the pairs has really been to establish, the clinical value proposition of the once-at-bedtime lumaries as well.

Hi, This is Matthew on for Mike and similarly to the Pvs.

Previous participant I think most of my questions have been answered, but maybe just a follow up on the last question do you expect any additional edits to the label around of ton the requests for final approval.

We don't anticipate them really having significant pricing erosion, but we'll adjust our plans, with whatever goes on there.

And also keep in mind, the AGE is really generally not attractive to payers as far as really, increasing the uptake off of our assumptions today.

And as far as your question on pricing, we've stated right from the beginning, our goal, with pairs is to be sort of in a parity access position with the best of the Oxibates overall.

And so our pricing, we've always stated to be sort of in the zone of where we believe, the brand of Oxibates will be in the future.

Not at this time, we don't we believe that complete.

I would say that that's our expectation of us new information of our new data has learned during the pendency of the tentative approval period, but at this stage, we would expect that to be and its in its final form.

Unknown Attendee Our next question comes from Chris Howerson, with Avadel.

Okay. Thanks.

Thank you.

The next question comes from Matt Kaplan with Ladenburg Thalmann. Please go ahead.

Please go ahead.

A.J.

Howerson Hi.

This is A.J, for Chris at Jefferies.

Yes.

A quick housekeeping question.

Oh, Hi, this is Raymond interim Matt Thanks for taking our questions. Just two quick questions on your impressive data has shown that dosing is a key factor in.

Patient preference I was wanting to ask just digging deeper alignment between patient and questions on the relative preference for sodium content and making teen choice and is that something maybe a patient education campaign or.

That might be helped in Hawaii patients that clinicians and my second question.

Do you expect any update from their stores study later this year or is that more of a next year.

Thanks.

Dan can you handle those.

Yeah, absolutely. Thank you for the question. So the poster that we had presented at sleep on the discrete choice experiment shows that both patients and clinicians do not place the same value on the sodium content as they do on the dosing frequency. So that came through very clearly for those patients.

And clinicians that the number one driver of treatment selection is the dosing frequency in preference about Wednesday, bedtime dose as compared to twice nightly dosing as far as it pertains to restore yes, we will be presenting more data at the upcoming Congresses.

And Congress that are being held in mid October we will have chemistries that continues to update our open label data from our store.

Appreciate that thanks.

Raymond.

The next question from Chase Knickerbocker with Craig Hallum. Please go ahead.

Do you have a target budget for API stocking?

I just see it was the only item excluded from your expenditure guidance.

Good morning, everyone.

Just first for me can you speak a bit to how your Rems program and the existing oxalate trends would have to interact and would there have to be some cooperation between the two of you to ensure activate patients properly managed between the two programs. If you could just speak to any challenges here as you're building out your Rems program sort of around there that would be helpful.

A.J.

Here.

Yeah, Thanks, Jason I think the first.

The answer to that question is that upon the final approval.

Howerson Tom, do you want to answer that?

Both rems programs are going to have to communicate with each other and cooperate. So it's not just there's cooperating with ours are ours cooperating with theirs. Both companies are going to have the requirement to ensure patient only has one active Oxford <unk> prescription at a time.

There is a process for which the FDA has approved and how that's going to work on our part that's part of our Rems program and our design.

<unk>.

And if you if you look at our tentative approval letter online Youll see that components of the Rems document. The Rems program has been provided by FDA and inclusive of that as well as his section nine.

Which is a section that basically requires us to report how the other party is responding to and the timeliness of those response, the response and our inquiries too.

Determine if a patient has enacted prescription or not our assumption is that we'll be reciprocal on their side as well, but don't know that for sure, but but clearly there is a mechanism to report the responsiveness of the other Rems program to FDA at their request.

That's helpful color. Thanks.

Just last for me can you provide some details of what specific business functions were cut or reducing the workforce reduction and cost optimization or what will needed to be added or added back upon full approval.

Yes, I would say there was there was no area that was was spared so to speak from that standpoint, and I would characterize it and really a couple of ways. The first way is in part it was part of it G&A organization that was built to prepare for an on boarding of our Av.

A significant expansion of head count in the organization more than a doubling of it.

By far as.

As we would as we were heading toward a potential final approval.

Clearly.

Those aren't physicians, we need in place right now, although the infrastructure and systems have been built to support that in the future.

And then secondly, I would say its roles where there are certain roles that that we've done a lot of work to get ready for launch and now it's ready to go and there is no really active.

Work that's required from those functions. So we've made the decision on those sorts of roles to let them go but really keep critical roles that we need to continue to execute to shorten the time from approval from final approval to launch.

Got it that's it for me thanks.

Thank you chase.

The next question comes from Paul <unk>.

Stifel. Please go ahead.

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

Just wanted to understand the exact steps behind getting a fault per of all it sounds like from the press release, you'll receive full approval kind of immediately following the expiry of the Rems patent and I guess is that the case or or is there anything that needs to happen at the FDA first for example.

Well they need to make a decision on an O to O.

D E. Following patent expiry and I guess, what's the risk that could cause a further delay.

Yeah James.

As previously shared there is a a process if we're if we're heading toward.

The situation where.

June 17th is the expiry of the patent and that's the last remaining item for us to move to from a tentative approval to a final approval decision. We would begin the process and notifying the FDA and file a filing all of our related documentation well in advance of that.

Per FDA guidance, such that upon that expiry or shortly thereafter, we would expect a final decision to be made.

On on on <unk>. So I think the short answer to that question is.

Not speaking directly for how long after June 17th that will occur, but we will take the necessary steps to file the necessary.

Documentation and request the F D. A to begin the process to make whatever final decision need to be made to convert from a tentative approval to final approval in advance of that such that when that patent expires. The FDA should be in a position to do so.

Great. Thanks, that's helpful. Thank.

Thank you.

This concludes our question and answer session I would like to turn the conference back over to Greg Davis for any closing remarks.

Thank you operator, thank you everyone for joining us today, we look forward to keeping you up to date on our progress on a number of these fronts in these matters and wish you a great rest of the day and look forward to any follow up necessary take care. Thank you.

A.J.

Howerson Sorry.

You broke up a little bit.

Your question was, do we have guidance on the amount of our API purchases?

A.J.

Howerson Yeah.

A.J.

Howerson Yeah.

We're not providing a specific guidance around that.

You know, the API purchases are included in the, budget.

A.J.

Howerson Yeah.

Thank you.

A.J.

Operator Our next question comes from David Ancelin, the Tiger Sandler, please go ahead.

Howerson Yeah.

D.A.

A.J.

Howerson Yeah.

A.J.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Howerson Yeah.

A.J.

Howerson Yeah.

A.J.

Howerson Yeah.

A.J.

Howerson Yeah, around that, you know, the API purchases are included in our R&D.

Costs at this point.

A.J.

Howerson Okay.

Got you.

And quick follow-up question on the narcolepsy disrupts program.

Do you have an update on what kind of engagement you're seeing with patients?

A.J.

Howerson Yeah.

No.

We've seen really great enrollment so far.

We're closing in about 6,000 individuals who have registered into our program.

And I think, you know, as I mentioned during prepared remarks, what's been really cool, to sort of see is we offer what we deem as a very simple but a very essential tool around a sleep diary. And in the first sort of month and a bit, we had over 3,000 individuals request getting, it.

So, you know, our discussions with the patients, our engagement has been very good.

And as I mentioned as well, we're sort of looking to sort of have a larger revamp to, sort of take that next wave of engagement as we go into the early part of fall.

So far, we're super pleased with the impact that the campaign has really had and the continued, engagement and dialogue that we're having with patients online.

A.J.