Avadel Pharmaceuticals Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2024

There are 14 speakers on the call.

Operator

Greetings, and welcome to Avadel Pharmaceuticals First Quarter 24 Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to turn to introduce Austin Mortaugh with Stern Investor Relations.

Operator

Thank you. You may begin.

Speaker 1

Good morning, and thank you for joining us on our conference call to discuss Avadel's Q1 2024 Earnings. 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 and uncertainties are described in Avadel's public filings under the Exchange Act included in the Form 10 ks for the year ended December 31, 2023, which was filed on February 29, 2024 and subsequent SEC filings. Except as required by law, Avadel undertakes no obligation to update or revise any forward looking statement contained in this presentation to reflect new information, future events or otherwise.

Speaker 1

On the call today are Greg Divis, Chief Executive Officer Richard Kim, Chief Commercial Officer and Tom McHugh, Chief Financial Officer. At this time, I'll turn the call over to Greg.

Speaker 2

Thank you, Austin. Good morning, everyone, and thank you for joining us to review our Q1 Following my opening remarks, Richard will provide an update on our launch progress, including our key metrics through March 31. Tom will then review our Q1 financial results and we will conclude with a question and answer session. I'm pleased to report another quarter of strong execution and results of our LumRise launch. We continue to deliver on our ability to reach the narcolepsy community and drive significant quarter over quarter growth across our early launch metrics.

Speaker 2

Metrics we believe are critical to building a strong foundation for LumRise both in the near term and in the long term. While our top business priority and focus remain on the launch of LumRise, during Q1 we also made important progress in our efforts to expand our reach into those living with idiopathic hypersomnia or IH as well as pediatric patients with narcolepsy, both of whom can possibly benefit from LumRise and if approved for those uses offers potentially significant incremental value and future growth opportunities for Loomrise beyond narcolepsy. Since launch last summer, our team has begun to deliver on the promise of Lumerise in our pursuit of becoming the market leader and achieving preferred oxybate status among patients and providers. Our early robust uptake among patients and physicians provides unequivocal evidence of this progress and of the opportunity based on the clear unmet needs of oxybate eligible patients, evidence that has been further solidified by the consistent and compelling patients, caregiver and provider feedback we routinely hear. As we now approach our 1st full year in the market with LumRise, I continue to be impressed by the relentlessness and the results being delivered by the entire Avadel team.

Speaker 2

It is their collective efforts, contributions and achievements that have established the initial foundation for Lumerise, which we believe positions us very well to achieve our future aspiration and expectation of achieving market leadership. Underscoring the results we announced this morning, since the launch of LumRise greater than 2,800 patients have enrolled into Avadel's Rise Up Patient Support Services Program and greater than 1700 cumulative patients have initiated Lumenitis therapy. In addition, in Q1 of this year, we generated $27,200,000 of net revenue. The results we achieved continue to show the strength and the opportunity of LumRise's position in the evolving narcolepsy treatment landscape. And as a team, we are laser focused on the launch of LumRise and ensuring we continue to deliver on the promise of LumRise to the narcolepsy community.

Speaker 2

And we are well positioned to continue advancing the launch and driving growth for LUMRISE in narcolepsy and beyond. In this regard, while our launch focus and priorities are very clear, we are also in parallel beginning to make real progress on specific future growth opportunities we believe can deliver additional long term value for patients, for the company and our shareholders. Our first near term opportunity is our potential expansion into the pediatric narcolepsy population, which represents approximately 5% of all oxybate treated narcolepsy patients. Our supplemental new drug application for LumRise has been accepted by the FDA and a target action data set for September 7. We believe Lumine is approved for this use has the potential to address both patient and caregivers unmet needs, while potentially offering a transformational treatment option for pediatric patients and their families.

Speaker 2

We look forward to hearing the FDA's decision later this year. Next, as we have previously shared, we are evaluating LumRise's use for the treatment of IH. During Q1, we've made significant progress in our readiness to initiate a pivotal Phase 3 trial for IH in the second half of this calendar year. Similar to pediatric narcolepsy, we have heard from many experts in the field that there is a clear and compelling need for once at bedtime Loomrise for those suffering from IH due to the associated deep sleep inertia making it extremely difficult for some patients to even wake up for their second dose of an immediate release oxybate. We are currently on track to dose our first patient in the second half of this year and plan to provide additional details at that time.

Speaker 2

Additionally, we are progressing the preclinical development of a potential no or low sodium once at bedtime oxybate formulation with a target product profile that is bioequivalent to LumRise. For this program, we currently expect to provide updates by the end of 2024. In summary, we have a number of opportunities to continue to build our leadership in the sleep space and most importantly, positively impact even more patients. These opportunities will continue to be supported by our launch execution for LUMINZA narcolepsy, which has created a strong foundation for continued growth. And with that, I'll turn the call over to Richard for details on our commercial progress.

Speaker 2

Richard?

Speaker 3

Thanks, Greg, and good morning, everyone. As Greg commented, our Lumerise launch has been off to a strong start this year. And today, I'm excited to provide some additional context into the encouraging trends we're seeing. We continue to build on the momentum generated since launching LumRise and have made strong progress during the Q1. Our team's commitment to bring our much needed therapy to the narcolepsy community has allowed us to build a strong foundation, and we believe we are well positioned to see continued growth throughout the year.

Speaker 3

Now turning to our key launch KPIs. We had more than 2,800 patients enrolled in our Horizon program at the end of March, which demonstrates a nearly 50% increase since the end of December. Additionally, 1700 patients initiated therapy as of the end of Q1, representing a greater than 70% increase in cumulative patients who initiated therapy since the end of 2023. Since our launch last June, we continue to build strong and steady positive demand for Lumerise. Looking more closely at the patient segment dynamics, we continue to see patients initiating therapy with BloomRise from all three patient segments.

Speaker 3

Now in comparison to last year, where the majority of patients were switch patients, this year we're seeing beginning to see a more balanced ratio with roughly 50% coming from switches and the other 50% from discontinued and naive patients. Another differentiator from last quarter is that we're seeing a growing number of naive patients on therapy, which signals that Lumarize's value proposition is compelling to patients who have not previously been on enoxubate. Moving to HCPs, more than 2,100 HCPs have completed the REMS certification as of March 31, an increase of more than 300 since the end of December, including those who are experienced oxybate prescribers and some who previous to Lumirize had not written for an oxybate. As a reminder, there are more than 4,500 HCPs who make up the entire oxybate prescribing universe, and our field teams have been focusing their initial efforts on the 1600 high volume Oxoate prescribers who represent 80% of the total prescription volume. For the top 500 prescribers who make up 50% of the total Oxbate prescription volume, now 80% of these HCPs have written for Lumerise, up from 64% at the end of December.

Speaker 3

Gaining use in the highest volume oxybate prescribers has been a key part of our launch strategy, and we are pleased with the progress we are making with these HCPs. Additionally, we reached an important milestone last month when we introduced our 1st Lumeriz patient ambassadors to the narcolepsy community. Katie, Tyler and Wendy are amazing people with narcolepsy who want to share their personal journeys and how being treated with BloomRise has changed their lives. Our market research continues to show the importance of the patient voice in the narcolepsy treatment journey as patients often receive the therapy they ask their HCP for. With the Lumeris patient voice now activated, we are unlocking another opportunity to drive the Lumeris conversation in HCP offices.

Speaker 3

Transitioning to product fulfillment, our overall reimbursement process continues to improve with over 700 new starts in the Q1. We have seen through a combination of our strong payer coverage and the growing experience with HCP offices that we are getting more patients initiated on therapy, and we continue to see good early signs of persistency with Lumarize when compared to twice non the oxibates. Lastly, on the payer front, we have payer coverage policies in place with the 3 largest PBM owned GPOs. Additionally, we recently gained coverage with a large PBM group, Prime Therapeutics, taking overall commercially covered lives to about 85%. Overall, we exited Q1 with growing momentum, and we are thrilled to see the results of our team's relentlessness and dedication to the narcolepsy community materialize and grow quarter over quarter.

Speaker 3

We believe LUMIRIS is positioned for long term growth and is on track to becoming the preferred oxybate for the narcolepsy community. And now I'll turn the call over to Tom to discuss our financials.

Speaker 4

Tom? Thank you, Richard. Good morning, everyone. And before I begin, I'll note that full financial results are available in the press release issued this morning and in the 10 Q. We are pleased to report that we generated $27,200,000 net revenue and gross profit of $25,700,000 for the quarter ending March 31, 2024.

Speaker 4

And additionally, as of March 31, there was approximately 1 month of demand in the channel, which is consistent with prior quarters. Turning to operating expenses, we reported a total of $51,700,000 of GAAP operating expenses for the Q1 2024 compared to $28,300,000 in the prior year. The increase in year over year operating expenses is primarily attributable to launch related costs and higher compensation and legal costs. GAAP operating expenses in the Q1 of 2024 includes $6,500,000 of non cash charges comprised based compensation of $5,400,000 and depreciation and amortization of $1,100,000 After adjusting for these items, cash operating expenses were approximately $45,000,000 for the quarter. This is at the upper end of our previously communicated guidance of $40,000,000 to 45,000,000 dollars of quarterly cash operating expenses and is due primarily to higher legal costs related to the patent trial that took place at the end of February.

Speaker 4

For the remainder of 2024, we expect that recurring quarterly cash operating expenses will be in the range of $40,000,000 to $45,000,000 and non cash operating expenses will be in the range of $5,000,000 to $7,000,000 We believe that net cash used for operations will be materially lower after taking into account expected cash receipts from continued Lumerai sales. With respect to the balance sheet, as of March 31, we had approximately $89,000,000 of cash, cash equivalents and marketable securities compared to $105,000,000 as of December 31, 2020 3. With our current trends, plans and assumptions, we maintain that we can achieve breakeven when there are approximately 1300 to 1500 commercially reimbursed patients and that we can achieve this milestone during 2024. In addition to the number of reimbursed patients on therapy, our expectations regarding the timing of achieving breakeven take into account a number of other assumptions, including how quickly patient demand grows, net pricing of Luminarize and operating expenses. Closing out today's financial updates, we pay close attention to the sell side estimates and at this time we are comfortable with current consensus of approximately $162,000,000 for the full year, including the possibility that 2024 revenue could be higher if actual results such as the rate of increase in reimbursed patients, the total number of reimbursed patients who are treated with Lumeriz and net pricing outperformed the assumptions currently used by the sell side.

Speaker 4

With that, I'll turn the call back to Greg for closing remarks.

Speaker 2

Thank you, Tom. With our LUMRISE launch well positioned for continued growth this year and our meaningful expansion opportunities in the sleep space, the value we are creating today is laying a strong foundation for the long term. We thank you as always for your support and look forward to providing future updates on our progress. And with that, we will open the call for questions. I'll turn it over to the operator.

Operator

Thank you. We will now begin the question and answer session. Your first question comes from the line of Andrew Tsai with Jefferies. Your line is open.

Speaker 5

Hey, good morning. Congrats on the progress and the slope of the curve and such. My question is around the patient additions and treated patients this quarter seemingly grew faster than the actual sales number. So can you help us reconcile the reported sales number? Was it driven more by one time headwinds like a higher gross to net or maybe even free drug use?

Speaker 5

Or was it more driven by permanent patient discontinuation rates increasing? Thanks.

Speaker 2

Richard, you want to start with that?

Speaker 3

Yes. Hey, thanks for the question, Andrew. Yes, so I think overall, to your point, we're very pleased with our early launch metrics, having another 900 patient as in to rise up and 700 patient initiations. At this stage of launch, the most important thing we are really focused in on is getting patients on therapy, A, for that patient experience and B, to get ACP offices used to prescribing and hearing those patient experiences as well. So that's really been our focus.

Speaker 3

To your point, there are some headwinds that we experienced as an industry in Q1 with higher deductibles and other things that impact our co pay. So we expect those settle down. And maybe one last comment on your discontinuation rates. We're pleased with our early discontinuation rates that we see. They are numerically lower than what we see historically with the twice night lease.

Speaker 3

So I'll turn this around once again. It's sort of we're really pleased with our early launch KPIs and maybe I'll turn it over to Greg to add some more color.

Speaker 2

Yes, I think that for us most important for us is patient initiations and getting and keeping people on therapy and I think the team has done an excellent job in that regard to the launch and from a persistency standpoint, I think we remain really bullish on how that will translate to revenue over time.

Operator

And your next question comes from the line of Francois Brisebois with Oppenheimer. Your line is open.

Speaker 6

So I was just wondering in terms of RISE UP, that metric, do you ever see I know it's difficult to know exactly how quickly patients move from RISE UP to on therapy, but are there cases where they just they do not they enter RISE UP and they never get the therapy? If so, what would be the reason for that?

Speaker 3

Yes. Hey, Frank. Yes. No. Yes, sure.

Speaker 3

I'll take that, Greg. Yes. So, great question, Frank. So, yes, as far as RyzhUp is concerned, and I would say any new therapy that comes to marketplace, there are patients who abandoned the process along so that they do not ever get to initiate therapy. That's we're not immune to that either.

Speaker 3

That abandonment rate for us is very low and it stayed relatively consistently low throughout our entire launch. So we've seen very good stick to it in this. And Frank, it's the same reasons for almost any product. Sometimes the patients lose interest. It could be insurance.

Speaker 3

It could be something else has come up in their life. We don't really get all of those details. But once again, our abandonment rate has been relatively low for patients entering Rise

Speaker 6

Up. And then in terms of the pediatric importance, you mentioned 5 to going to follow that with time to see if it's better with you guys. It seems like it's trending well. But that 5% pediatric population, do you guys see that as much bigger than 5% kind of as a read through where if these obviously, it takes a lot of time to diagnose, but if the diagnosis gets quicker, you get pediatrics and then they probably don't want to change what they're on when they become adults. Is there any upside to that 5%?

Speaker 2

Well, I think we agree with all of your thoughts, Frank, from that perspective. We think that the actual market opportunity is likely from a pediatric perspective is likely materially larger than what's actually being treated today, predominantly because the condition is really a condition of adolescence, right, where initial symptoms predominantly present earlier in life. Your comment about the time to proper diagnosis is a major challenge and has been for quite some time from that perspective. So we do think the total opportunity is actually larger than what the actual treated pool is today, no different than how we think about adult. So, for us, I think the opportunity to bring something new that doesn't disrupt the entire family, we think offers opportunity both for currently treated and potentially patients who aren't being treated today.

Speaker 6

Okay, great. And in terms of IH, it seems intuitive if these patients need to sleep and are still restless. Are you getting a lot of feedback that the waking up in the middle of night is a problem or is it not a big deal for these patients?

Speaker 2

Richard, you want to comment on that?

Speaker 3

Yes. I think for IH, it really comes down to more of the sleep inertia. A lot of these folks just have sleep inertia where they're just unable to wake up during the middle of the night to take a second dose. So that's really the key area of the feedback from research that we hear about is oxibates are very effective, but if you can't wake up to take that second dose, you're getting a sub therapeutic dose.

Speaker 6

Thank you.

Operator

Your next question comes from the line of Ami Sathiya with Needham and Company.

Speaker 7

Hi, good morning. Congrats on all the progress. I had a couple of questions just around Bloomrise. Can you sort of quantify what are the net number of patients on treatment currently? And with regards to net price, how has that progressed in Q1?

Speaker 7

And as you comment on your confidence in being able to achieve or potentially beat where the consensus stands today, what are the assumptions you're making with regards to net price evolution through the course of the year?

Speaker 2

Rich, do you want to take the first and Tom the second?

Speaker 3

Yes, sure. I mean, yes, thanks. Ami, right now, we're really clearly focused on our early launch metrics. There's a lot of dynamics that are going on here. And at this stage of the time, we really believe that rise up enrollments in patients who have initiated therapy are really the right view to look at things.

Speaker 3

We're going to continue to look at these metrics. And in the future, we will be transitioning to other metrics like patients who are actually on therapy at this time as well. There's a lot of dynamics at this stage of a launch, but we do tend to shift to that in the future.

Speaker 4

Yes. Hi, Ami. It's Tom. So with respect to the second part of your question on net pricing, we've consistently pointed to an expectation that on average, patients will generate about $120,000 of net revenue per year. I will share with you we're at that point now.

Speaker 4

The expectation has always been that when we have more patients continuing on therapy, as Richard just noted, the new patients coming in would represent the tipping point, as I've called in the past. The other things that can affect net pricing, one of them is certainly compliance. Listen, if every patient took every the dose every day of the year, net revenue goes up, of course. But that's certainly one of the variables. And the other is the gross to nets themselves, which as we commented earlier, there were some we're not unique in that regard.

Speaker 4

Gross to nets as a percentage of revenue go up during Q1, but that tends to settle down over the course of the rest

Speaker 3

of the year.

Speaker 2

Yes. The only comment I'll add, Ami if I may, the only comment I'll add generally on metrics and KPIs, I think we've got our eyes set that as the launch continues to mature a little bit and some of these variables get a little bit more mature that really drive and ultimately result in kind of net average patients or net exit patients on therapy that we will transition to that during the course of this year. What our intention is, is to do that and have an overlapping quarter where we continue with the same metrics and add in patients on therapy and then ultimately I think where we'll net out over time is just patients on therapy.

Speaker 7

Got it. And if I may ask one more question. As I think about the total number of patient adds to rise up over the last couple of quarters, it seems that you're continuing to see growth in average monthly patient adds per quarter over the last three quarters for which we have the data. Can you just talk about sort of the momentum as you see progressing through the course of the year? I'm sort of seeing kind of an increase by 100 new patient adds per quarter in addition to sort of the previous quarter.

Speaker 7

And I'm just sort of trying to understand how should we be modeling that trend as we go through 2024?

Speaker 2

Richard, do you want to comment?

Speaker 3

Yes. No, it's a great observation. I think, Ami, first, we're just very pleased with the strong and steady positive growth we see with Lumerise and really just the feedback that we've heard from offices. Over the last couple of quarters, we sort of been commenting sort of on this sort of net sort of over 900 patient adds into price up. It's hard to predict exactly where this is going forward, But we're only reporting on our Q3 of full launch.

Speaker 3

And we think steady positive growth is a good and positive thing. So that trend of those 900 ish ads every quarter, we'd like to continue that trend at a minimum going forward.

Operator

Your next question comes from the line of David Amsellem with Piper Sandler.

Speaker 8

Just have a couple of questions. So and I apologize if I missed these, if you mentioned these details. Can you talk to the percentage of LumRise patients who have actually been on Zywave? That's number 1. Number 2, can you talk to the lag time between enrollment in RISE UP and initiation of therapy and how that lag time differs between patients who have access and patients who don't have access or don't have good access?

Speaker 8

So that's the second question. And then last question is on idiopathic hypersomnia. Is it fair to assume that that's going to be a randomized withdrawal design similar to the registration study that Jazz ran for Zywave?

Speaker 2

Thank you. Thanks, David. Richard, maybe you take the first two.

Speaker 3

Yes, sure. No problem. Thanks, David. So as far as the percentage of the XYOST patients, so the majority of our up to launch to date right now, the majority of our enrollments and patients initiated are patients, who have switched from twice only oxibates and the majority of those are XY Wave patients. So if you take more than 50% of overall enrollments and more than 50% of those, it's somewhere north of 25% to 30% of the patients who have switched from Zywave.

Speaker 3

And if you look overall as far as the lag time or the timing to get that initiation through RYZUp or the enrollment into a patient started. To your point, it is very different for the 2 groups, those who are covered, in essence, meet all the prior authorization criteria. Those are averaging still right about 30 days, about a month for us to get those initiated. And those without coverage are much longer, are being measured in months. Several weeks can still get through in shorter period of time, the range is quite large.

Speaker 3

But if you don't have a coverage policy, those ones definitely take us those timelines are measured in months and definitely not in weeks. Greg, I guess I'll turn it over back to you for IH.

Speaker 2

Yes, I think David, we haven't said explicitly what the trial design is yet. That will become public certainly over the summer as it gets posted on clinicaltrials.gov and whatnot. But what I will say is that there's been a handful of companies who have done studies in this area with full support of FDA. We obviously engage with FDA on this process, and I think it's fair to say that those proxies are good proxies for how our trial will what our trial design will look like as we go forward.

Speaker 8

Okay. That's very helpful. Thank you.

Speaker 2

Thanks.

Operator

Your next question comes from the line of Mark Goodman with Leerink Partners.

Speaker 9

Hi, good morning. Two questions. First, what's your sense of how many patients are actually on oxybate this past quarter, just in total between all the companies involved? And second of all, can you just give us an update on the litigation that's still outstanding? Thank you.

Speaker 2

Yes. Richard, you want to answer the first one to the best of our ability?

Speaker 3

Sure. Yes. It's a great question, Mark. The data is becoming a little more fragmented across the different oxibates as we go forward right now. So can't say we have a perfect answer for you today.

Speaker 3

But what we can say is we definitely see growth in segments Lumeris coming in the marketplace. A couple of notable ones are in patients who had previously discontinued twice the oxybates who are now on Lumerise and also that we have people HCPs writing for Lumerise who had never written for an oxybate previously as well. So we are definitely piecing those numbers together to our claims and reports from other oxybate companies. And our overall view is the market is growing. It's just hard for us to give you an exact number at this stage, but we're definitely working on that.

Speaker 2

Yes. And regarding the litigation, I'll just describe it this way kind of generally, right? There's a couple of near term hearings upcoming. The APA hearing in terms of the suit against FDA is scheduled for this Friday at 2 p. M.

Speaker 2

In the DC Federal Court. As noted previously, we intervened alongside FDA and the Department of Justice and we'll make our own arguments in support of the government this Friday. So that's the APA status. In terms of the Delaware litigation, obviously we had the ruling a couple of months back on from the jury and the royalties and whatnot. The next stop there is a hearing on June 4 and that's along this process in Delaware.

Speaker 2

So we'll be glad to get those 2 hearings behind us and continue to move forward with our launch and outside of those comments there probably isn't much else to say right now in terms of what's near term on the litigation.

Speaker 9

Thanks. Thanks, Mark.

Operator

Your next question comes from the line of Ash Verma with UBS.

Speaker 10

Hi. Thanks for taking our questions. Hi, Sai, I'm joining a little bit late, so maybe if something is repeated, let me know. Like on this first question, like can you clarify like on this 1Q pricing or inventory dynamics of what you saw with Lumiere? It seems the patient adds were pretty encouraging, but the revenue came in a little bit lighter versus how the patient numbers are?

Speaker 10

Then secondly, so Jazz noted on their Q1 call that there are some of these patients that came off the item because it's not in formularies. And for those patients who are in transition, do you think LumRise can be an attractive option? And how much of these patients do you think you stand to benefit from during this year? Thanks.

Speaker 2

Thanks, Ash. Tom, can you take pricing and inventory and maybe Richard, you can take the other comment.

Speaker 4

Yes. Hi, Ash. Listen, I'd say that pricing inventory came in as we expected it to. I commented on an earlier question that average net revenue per patient, we're currently annualized into about $120,000 per year. The inventory in the channel has consistently been at about a month and that's going back to when we first launched.

Speaker 4

So really no surprises there relative to

Speaker 3

revenue. Yes. And as far as the changes in formulary, yes, there clearly were several changes in formulary in many cases where the branded twice nightly sodium oxalate and or the AG were no longer being covered. So, yes, those patients have definitely been a focal point for us and they've been going on for a while. So, we definitely see that as a unique opportunity going forward here with some of the payers as well for Lumeris.

Operator

Your next question comes from the line of Arun Leifnath with H. C. Wainwright.

Speaker 11

Thanks for taking the question. I just want to build on others. We've heard from piecing together Jazz and your commentary today, it does seem clear that you are seeing market growth now that you're driving some market growth from where the market was before you entered. And I'm just wondering, going forward, now you're at a fifty-fifty mix, where do you see that playing out in mix as you go forward? Because I'm seeing Xyrem is highly eroded now, right?

Speaker 11

And a lot of those patients have moved to both the AG and Ziwave and your product. Do you need to take patients away from Ziwave to meet your targets? Or are you feeling like through this year your comfort versus estimates rests on your opportunities in other buckets?

Speaker 2

Richard, do you have any maybe opening comments on it?

Speaker 3

Yes. It's a great perspective. So first, we're just very pleased to sort of see continued demand for all three patient segments, the switches, the previously discontinued and naive. Going forward, we anticipate to still have robust representation from all three segments. And as we talked before, so yes, there was a little bit of an increase in naive patients, but the proposition for switch patients is as strong as it's ever been, if they've been on a twice nightly sodium oxybate or twice nightly mixed cell version.

Speaker 3

So we do anticipate demand coming from all three patient segments going forward. The composition may switch a little bit over time here, but we do definitely anticipate all three segments being well represented for the rest

Speaker 9

of this year.

Speaker 11

Okay. And I was hopping on and off the call, so I apologize if I misheard. But I thought I heard you say 700 patient starts in the quarter. I wasn't sure if I heard correctly, I don't believe that's a metric you've given us in the past. Is that does that mean new patients initiated on paid therapy?

Speaker 11

And do we know what that 700 on top of what before? I'm trying to see if we can piece together a patient's on therapy number if that's wishful thinking.

Speaker 2

Richard, do you want to clarify?

Speaker 3

Yes, Oren. So just to be very clear, we had announced that we had over 1700 patients initiated cumulatively through the end of the Q1. We were at about 1,000 at the end of Q4. So that's in Q1 an additional over 700 patient initiations that occurred in Q1. So just to clarify, so that's the same metric that we've given before.

Speaker 3

So it's just sort of taking the 1700 and subtracting out how we ended up in 2023.

Operator

Your next question comes from the line of Chase Knickerbocker with Craig Hallum.

Speaker 5

Good morning, guys. A lot has been asked, maybe just a couple around the edges here. Now that we have more patients from the naive and previously discontinued groups on drug, if we think about persistency specifically in these groups on LumRise or trends in the larger population of people patients on drug now that they're a bigger portion of your patients Have trends and discontinuations at the 1 kind of 2 month timeframe ticked up at all from these patients as they become a larger part of the mix? Basically, is there a higher level of discontinuation with these 2 patient populations?

Speaker 3

Yes, Chase? Yes. Thanks for the question, Chase. Yes. No, overall, our discontinuation rate across all three segments is very strong.

Speaker 3

And if we look at our overall composition, it is lower than what we saw traditionally for twice on the oxibates. For the naive and the discontinued like it was really just this quarter where they sort of stepped up in the representation. We are seeing slightly lower rates compared to the switch patients, but not meaningfully lower. So it's still relatively early on. So we're going to definitely watch those trends.

Speaker 3

So as I mentioned, it's lower, but what we had sort of articulated is not meaningfully lower at this stage.

Speaker 5

Helpful color. And then maybe another one for you, Richard. As we think about the pediatric opportunity, obviously, Medicaid is a very important payer there. Can you update us on how coverage looks for LumRise with Medicaid generally today? I know it's likely to be different state to state, but just general color there.

Speaker 3

Yes. We are going through the process, Chase, and Medicaid, as you know, takes a very, very, very long time. So we haven't really had a significant amount of Medicaid usage come through at this stage and we'll provide more updates as we make more progress there. We also do have other assistance programs if patients aren't covered through our patient assistance. But at this stage right now, we've got we're still early in the process as far as getting our Medicaid coverage.

Speaker 5

Got it. And then 85 percent commercially covered lives plus there is an impressive number. Maybe anywhere else that you're hearing from physicians as far as kind of key sticking points as far as coverage goes, as far as making this where you can kind of block and tackle from here to make this an easy the easiest as possible kind of writing experience for them? And then just lastly, as far as any impact from change the change in disruption, cyber attack on the quarter, did we see any change in fill rates there? Was that kind of part of what it might have affected the quarter?

Speaker 3

Yes, sure. So as far as the to your point, Chase, we're really pleased with our commercial coverage. The team has done an excellent job in securing those nearly 85% commercial cover lives. And I would say, in general, we're sort of in the same situation now with other established products where there's just always going to be some bumps and roads for some patients going through. Now it's how the patients met all the PA criteria and those sorts of things even though that they're covered.

Speaker 3

So we have an outstanding field reimbursement team that's there to actually help walk offices through every step. And our goal is to really help sort of guide every new patient initiation through with our field reimbursement team to make it as easy as possible for the offices. And as far as your change health comment is concerned, thus far, we have not seen any meaningful impact to any of our fill rates being impacted by them.

Speaker 5

Got it. Thank you, guys.

Operator

Your next question comes from the line of Miriam Bugatti with LifeSci Capital.

Speaker 12

Thanks for taking my question and congrats on the quarter. I was just wondering if you could provide a little more detail in terms of the distribution of patients initiating therapy? I understand 50% is both discontinued and naive, but can you provide a further breakdown of those two segments?

Speaker 3

Yes, sure, Miriam. Thanks for the question. So yes, as we said, sort of we've seen if we look at the overall response of all of our patients thus far, the majority of our switch patients, Q1 was where we sort of saw more of a balance between the switches and the discontinued naive. And of those discontinued and naive, they're moderately balanced, but there definitely has been growth almost quarter over quarter for the naive segment within that other bucket. So, it's a little bit more balanced in Q1 and we'll sort see where the trend is going forward.

Speaker 3

But it's been nice to see the naive segment start to tick

Speaker 6

up here over time.

Speaker 12

Okay. And in terms of the IH opportunity, are there any important differences between IH and narcolepsy patients when it comes to cardiovascular risk or any relevant comorbidities when it comes to SOGEN intake?

Speaker 2

Richard, do you have

Speaker 3

any thoughts on that? Sure. Sorry about that, Greg. Yes, in general, no. These are still generally younger patients, less of a Medicare population overall.

Speaker 3

So a general statement would be not really that we see from our data.

Speaker 12

Okay, got it. Thanks for taking my question.

Operator

Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Mr. Kaplan, your line is open.

Speaker 6

Good morning,

Speaker 13

and congrats on the quarterly results. Given your success in terms of adding prior XY Wave patients to NURAISE, how important is it to have a low sodium offering in the market? And I guess second part of that question is how difficult will it be to create a low sodium bioequivalembryze?

Speaker 2

Yes. I think our view has been very consistent on this topic from the beginning, which is that we think all patients should have the opportunity to have an uninterrupted night sleep. And for the subset of patients who are at risk for sodium, if we have the ability to formulate and develop and bring that opportunity to the marketplace, then we're certainly going to do the work to try to accomplish that. So from our perspective, it isn't a requirement to have a successful once nightly Loomrise franchise because we do believe the data on sodium speaks for itself. That being said, we certainly know there's patients out there who could benefit from both a lower sodium version and a once at bedtime Lumerai.

Speaker 2

So, therefore, we're doing the work. In terms of the difficulty of it, it's a formulation challenge in and of itself given how the active moiety performs in this sort of situation, but we certainly have our best and brightest working with our 3rd party partners on this and we look forward to giving an update later this year.

Speaker 13

All right. Thanks for taking the question.

Speaker 2

Thanks, Matt.

Operator

That concludes our Q and A session. I will now turn the conference back over to Greg Davis for closing remarks.

Speaker 2

Thank you. And most importantly, thank you everyone for joining us today. Thank you for your time and we wish you a great day and we look forward to future updates and any follow-up during the course of today and over the next couple of weeks. Have a great day. Thank you.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Powered by Quartr
Earnings Conference Call
Avadel Pharmaceuticals Q1 2024
00:00 / 00:00