Hello, and welcome to the Axsome Therapeutics Second Quarter 2024 Financial Results Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Please go ahead, Darren..

Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing a corporate update and details of the company's financial results for the second quarter of 2024. The release crossed the wire a short time ago and is available on our website at axsome.com.

During today's call, we will be making certain forward-looking statements.

These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding Sunosi, Auvelity, and our pipeline products, revenue projections, and possible intended use of cash and investments.

These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date and the company disclaims any obligation to update such statements.

Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; Mark Jacobson, Chief Operating Officer, and Ari Maizel, Executive Vice President and Head of Commercial. Herriot will comment on the progress we made in the second quarter of 2024 and review key upcoming milestones.

Following Herriot, Nick will review our financial results and then Ari will provide a commercial update. We will then open the line for questions. Questions will be taken in the order that they are received. And with that, I will turn the call over to Herriot..

Thank you, Darren. Good morning everyone and thank you for joining Axsome Therapeutics second quarter 2024 financial results and business update conference call. We had a very productive second quarter with all elements of our business advancing across our singular CNS focused portfolio, as we continue to build a leading neuroscience company.

We delivered strong commercial performance with continued momentum for the launch of Auvelity. In particular, we secured important improvements in both the quality and quantity of payer coverage and we are clearly seeing the impact of our expanded sales representative team.

We remain pleased with Sunosi and remain excited by the opportunities we see in the currently improved indications alone. Nick and Ari will provide additional color on both products shortly. Adjacent to our commercial products, we made important progress on both our NDA stage product candidates.

The NDA for AXS-07 for the acute treatment of migraine has been resubmitted to the FDA, and we look forward to providing updates on the FDA review. We believe that AXS-07, if approved, would be an important new treatment option that could provide differentiated outcomes for patients.

With respect to AXS-14 for the management of fibromyalgia, we made important progress in our NDA package, taking a steady approach to ensure a quality submission, and we expect to complete this NDA submission shortly in the third quarter.

Fibromyalgia is a debilitating chronic CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression and cognitive impairment. With limited treatment options available, AXS-14 has the potential to deliver much-needed innovation to patients and HCPs alike.

Moving on to the rest of our robust late-stage development pipeline, we are making excellent progress in our numerous important clinical programs, a number of which have pivotal trial readouts later this year and next.

AXS-05 is Axsome's novel oral investigational NMDA receptor antagonist and sigma-1 receptor agonist that we are developing for Alzheimer's disease agitation. We continue to anticipate top line results for the pivotal ADVANCE-2 Phase 3 trial in the second half of the year.

Additionally, the enrollment target in the pivotal ACCORD-2 Phase 3 trial has been reached. As a result, we now expect top line results for both of these studies in the second half of 2024. Solriamfetol, our dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist is now in Phase 3 trials in four new indications.

The FOCUS Phase 3 trial in adults with ADHD remains on track for top line results in the second half of the year. In addition, the PARADIGM Phase 3 trial in major depressive disorder and the ENGAGE Phase 3 trial in binge eating disorder are also ongoing with results from both trials anticipated in 2025.

We also recently launched the SUSTAIN Phase 3 trial in shift work disorder, for which we anticipate results in 2026. Each of these programs, if successful, has the potential to represent a significant commercial expansion opportunity for solriamfetol.

Finally, we continue to anticipate results this year from the EMERGE Phase 3 trial of AXS-07 in patients with an inadequate response to oral CGRP therapy as well as results from the Phase 3 open label safety extension trial of AXS-12 in narcolepsy.

In total, we have five product candidates in late-stage development for nine important indications, each of which has key, potentially value-driving milestones on the horizon.

We are incredibly excited by our work and the potential Axsome has to contribute to differentiated patient outcomes and to the advancement of medical practice in neuropsychiatry. Stay tuned for updates on our advancements as we continue to work every day to make a difference in the lives of the millions of people in the U.S.

affected by central nervous system disorders. I will now turn the call to Nick who will provide details of our financial performance..

Thank you, Herriot. And good morning. Today I will discuss our second quarter results and provide some financial guidance. Total net product revenue for the second quarter of 2024 was $87.2 million, representing 87% year-over-year growth. Total net product revenue for the comparable period in 2023 was $46.7 million.

Auvelity net product sales were $65 million for the second quarter of 2024, representing 135% year-over-year growth. Auvelity net product sales for the comparable period in 2023 were $27.6 million.

Sunosi net product revenue was $22.1 million for the second quarter of 2024, consisting of $21.5 million in net product sales and $600,000 in royalty revenue associated with sales in out-licensed territories, representing 16% year-over-year growth.

Sunosi net product revenue for the comparable period in 2023 was $19.1 million, consisting of $18.4 million in net product sales and $700,000 in royalty revenue. Total cost of revenue was $8.1 million for the second quarter of 2024 versus $4.6 million for the comparable period in 2023.

Research and development expenses were $49.9 million for the second quarter of 2024, compared to $20.6 million for the comparable period in 2023.

The increase was primarily related to the initiation and continuation of solriamfetol Phase 3 trials in major depressive disorder, ADHD, and binge eating disorder, ongoing trials of AXS-05 and AXS-12, manufacturing costs associated with AXS-07 and AXS-14, post-marketing commitments for Auvelity and Sunosi, and higher personnel costs, including non-cash stock-based compensation due to organizational growth.

Selling, general and administrative expenses were $103.6 million for the second quarter of 2024 compared to 78.9 million for the comparable period in 2023.

The increase was primarily related to commercialization expenses, largely driven by field force expansion and higher personnel costs, including non-cash stock-based compensation due to organizational growth.

Net loss for the second quarter of 2024 was $79.3 million or $1.67 per share compared to a net loss of $67.2 million or $1.54 per share for the comparable period in 2023. The net loss in the second quarter of 2024 reflects $26 million in non-cash charges. Gross to net discount for Q2 was in the low to mid-50s for both Auvelity and Sunosi.

We ended the second quarter of 2024 with $315.7 million in cash and cash equivalents compared to $386.2 million as of December 31, 2023. We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

I will now like to turn the call over to Ari who will provide a commercial update..

Thank you, Nick. Axsome drove significant demand growth for Auvelity and Sunosi in the second quarter of 2024, reflecting strong market acceptance of our sales and marketing efforts and positive experiences with our products.

Our optimization of commercial execution and operations, powered by our digital-centric commercialization platform, combined with improved market access dynamics beginning in Q3 position Axsome well for the second half of the year.

Starting with Auvelity, the second quarter of 2024 saw Auvelity outperform the market and branded competitors with approximately 123,000 prescriptions, representing 29% quarter-over-quarter growth and 131% growth compared to the second quarter of 2023.

By comparison, the antidepressant market grew 1% sequentially and declined 1% compared to the second quarter of 2023.

More than 24,000 new patients were prescribed Auvelity in the quarter and we successfully activated 4,300 new prescribers in Q2, underscoring strong underlying demand for the product as we continue to expand use among depression treaters in both psychiatry and primary care offices.

Our efforts to improve market access for Auvelity recently resulted in a significant commercial coverage decision, which added more than 22 million new covered lives effective August 1st.

This increases the percentage of covered commercial lives from 48% to 60% and the percentage of total covered lives across all payer channels from approximately 70% to 76%. We anticipate continued progress on coverage dynamics as we strive to improve access for the millions of patients living with major depressive disorder.

Turning to Sunosi, total prescriptions were approximately 45,000 in the quarter, representing 8% sequential growth and 15% growth versus Q2 2023. By comparison, the waste promoting agent market grew 4% sequentially and declined 1% compared to the second quarter of 2023.

Of note, Sunosi had strong performance with new patient prescriptions in Q2 with more than 4,200 new patients initiating Sunosi treatment during the quarter. In addition, approximately 400 new writers were activated in Q2, as Sunosi continues to grow adoption across the universe of sleep specialists in the United States.

Payer coverage for Sunosi in Q2 was stable with 83% of lives covered across channels. Efforts to improve patient access for Sunosi are ongoing.

In closing, we are very pleased with our commercial performance in Q2 for both Auvelity and Sunosi, evidenced by key metrics including new patient starts, new writer activation, and improved market access dynamics.

In addition, we continue to receive outstanding real-world feedback on the impact our products are having on the lives of millions of adult patients suffering from major depressive disorder and excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy.

Our success in 2024 provides compelling evidence of the promise and potential of Axsome's commercialization capabilities in support of future product launches in the CNS space. I will now turn the call back to Darren for Q&A..

Thank you, Ari.

Operator, may we please have our first question?.

[Operator Instructions] Our first question is coming from Vikram Purohit from Morgan Stanley. Your line is now live..

Hi, good morning. Thanks for taking our question. Our one question is on Auvelity commercialization. So you mentioned that the sales force expansion was having a benefit that you saw in the quarter.

Would just be curious to get some more context on the specific kinds of prescribers and kind of the -- to any extent you could quantify what sort of benefit you saw from the salesforce expansion would be helpful. Thank you..

Yes. Thanks, Vikram. This is Ari. Obviously, we're really pleased with how the quarter ended up, and the impact for the sales force is being seen in a couple different areas. One, we saw a clear inflection in weekly new patient starts that began at the end of March and continued through the quarter.

Secondly, we're seeing a nice growth in the primary care segment. So although psychiatrists, MDDs and MPPAs are still the lion's share of our volume, we are seeing primary care utilization increase and solidly so over the course of the quarter. So those are two things that I would point to in terms of sales force expansion impact..

Thank you. Next question is coming from Leonid Timashev from RBC Capital Markets. Your line is now live..

Hi, guys, thanks for taking my question. Congrats on another quarter. I just want to ask on the progress for ADVANCE-2.

I guess, can you talk about what you're seeing with respect to the dynamics, in particular with the fact that there's now an approved agent there? I guess what's driving your confidence that you can complete recruitment in second half of 2024 and I guess read that trial out? So any kind of color on the recruitment for ADVANCE-2 would be appreciated.

Thank you..

Sure. Thanks for the question. What's driving our confidence is simply the enrollment progress, the study is progressing in terms of enrollment very steadily and it's putting us on track to report results in the second half. So we're pretty confident with regards to that.

And as it relates to the launch of Auvelity, which is an approved agent in this indication, the impact that we anticipated was that it could provide patients with an alternative treatment.

So patients who were considering or are considering to enroll in a clinical trial in Alzheimer's disease agitation, they will now be presented with another approved agent.

So that could have an impact and that's an impact that we had anticipated and built into our modeling and we're very comfortable with the pace of progress of the trial and a readout in the second half..

Thank you. Our next question today is coming from Marc Goodman from Leerink Partners. Your line is now live..

Yes. Good morning. Is the plan still to do a DTC advertising campaign in the second half of this year [technical difficulty] and then also just update us on the marketing plans, the spend, like just give us a sense of what will happen next year considering you may be launching multiple products? Thank you..

Yes. Thanks, Mark. You broke up a little bit, but I believe the first question was plans on direct to consumer. We obviously have direct to consumer in market right now. It's primarily focused on digital media.

We continue to evaluate the potential for a broad-based media campaign, and we'll share updates as things progress, part of the decision criteria, just with the anticipated noise level with the election season is one of the factors that we're evaluating. Secondly, your comments about spend as it relates to ongoing launches.

Maybe Nick, do you want to take that?.

Sure. Yes. So we're currently evaluating -- planning for the spend for those launches, and as we get closer to those launches, we'll be able to share more information with you..

Thank you. Next question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live..

Yes. Good morning, Herriot and team. Congratulations on a good quarter. I had a two-part question on AXS-05 or Auvelity. One is, with regard to Auvelity, are you seeing persistence that perhaps exceeds expectations relative to other antidepressant medicines? And for AXS-05, relative to the two readouts, congrats on finishing ACCORD, that enrollment.

I guess the question is, what is the rate-limiting step to filing an NDA? And when would you anticipate that if those two studies are positive? Thanks..

Sure. So I'll take the second question, and then I'll turn it over to Ari to talk about persistence. With regards to AXS-05, the gating factor, the major gaining factor, is completion of the ongoing studies, including the long-term open-label portion.

So once those studies are completed, then we'll be in a very good position to put together an NDA filing. Typically that takes about six months.

Ari, you want to comment on persistence?.

Yes. Charles, you may remember in the past, we talked about some of the anecdotal feedback we've received that suggested persistency on Auvelity is greater than that observed with SSRIs. We recently conducted a cohort analysis using claims data that did validate there is a numerical advantage for Auvelity relative to the most widely used SSRI.

So we were really pleased to see that and it does support what we're hearing from providers in their practices..

Thank you. Our next question today is coming from Joon Lee from Truist Securities. Your line is now live..

Congrats on the strong quarter and thanks for taking our questions. For ACCORD-2, can you remind us the duration of open label run in period and what the typical time to relapse was in ACCORD-1, using the ACCORD-2 definition? Thank you..

So with regards to the running period, what we've disclosed is that it is long enough to enable patients to respond. So if you think back to the ADVANCE studies, those are five weeks in duration, and we're able to see patients respond fairly quickly. And then you would add on to that period of time to judge whether or not the response is stable.

And as soon as that judgment can be made, then patients will be able to randomize..

Thank you. Next question is -- sorry..

The other -- I'm sorry, I think the other part of your question was how long did it take for patients to relapse. So we definitely have that information based on the results of the ACCORD-1 study, those Kaplan-Meier curves we've shown. So we can definitely get back to you with regards to some qualitative way of looking at that.

The -- in that study, there was no estimable median time to relapse because the patients on ASX-05 had such low relapse rates, but obviously the results were highly statistically significant in ACCORD-1..

Thank you. Next question is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live..

Thanks very much for taking my question. Ari, you mentioned the various indications potentially commercializable for solriamfetol.

And I was wondering if you could provide additional color on which of those you expect to present the most attractive competitive landscape, competitive opportunity for solriamfetol, and what the peak market opportunity might look like on an annualized basis for solriamfetol in that indication of those four that are currently the basis of ongoing clinical investigation.

Thanks..

Thanks for the question. What's nice about the four indications which we are studying for new indications, ADHD, MDD, binge eating disorder and shift work disorder, is that these are all very large patient populations.

And we think that solriamfetol based on the mechanism of action and the efficacy that's been seen in the current indications does potentially provide added benefit which could be superior to what is seen with the current agents in -- certainly in ADHD and also in binge eating disorder.

So it remains to be seen what the full clinical profile is, which is why we are conducting the current studies. We're looking forward to the results of the ADHD study first. That's in the second half of this year, and then we'll be looking forward towards the results for the other indications thereafter.

Shift work disorder is an interesting indication. So as a reminder, the indication there is excessive daytime sleepiness in patients with shift work disorder. That's very akin to the currently approved indications, which is excess daytime sleepiness in OSA and narcolepsy. So that will round out the currently approved indications.

And then ADHD and binge eating disorder, obviously, those are very new indications, and then MDD would be also a new indication, entirely new indication for solriamfetol..

Thank you. Our next question today is coming from Jason Gerberry from Bank of America. Your line is now live..

Hi, good morning, guys. Thanks for taking my question. Mine is just, I wanted to get your latest thinking on AXS-05 for ADA. Assuming you're able to file, your thoughts on like a unique NDA versus supplemental to the Auvelity NDA.

Specifically like given the differences in the payer mix, just what are your kind of thoughts on tactical considerations for approaching like this more highly Medicare/Medicaid indication in lieu of Part D redesign implications for next year? How like a unique pricing strategy may be important for AXS-05 adoption? So anything you can do just at a high level to frame some of these tactical considerations would be helpful as we think about monitoring kind of launch comps.

Thanks..

Yes. So those are great questions that we obviously are giving a lot of thought to. What's nice is we do have optionality. So we want to make sure that we make the right decision and we're not going to make it hastily. And it does require a lot of work. We like to be very quantitative in our assessments.

And as soon as there's something definitive, we will let you know. Typically that would be closer to the time of the filing and then approval. Having said that, maybe Ari could provide you some guardrails around how we're thinking about things..

Yes. Thanks for the question, Jason. So there are a bunch of considerations that we're working through right now. There's obviously marketing elements as it relates to the halo that may be associated with the drug, with single or separate brand names. There are patient safety considerations.

When you look at other drugs that same molecule, different brand names, generally speaking, there may be a difference in route of administration or dosages. So there are a number of different factors that we're still in the process of evaluating.

And as Herriot mentioned, we'll provide further updates as we get a little bit more certainty around our decision..

Thank you. Our next question today is coming from Ami Fadia from Needham & Company. Your line is now live..

Good morning. Thanks for taking my question. Can you talk about the pull-through that you've started to see following the expansion of the commercial coverage? And how do you anticipate gross to net to evolve for the remainder of the year? Thank you..

Yes. So thanks, Amy, for the question. The 22 million additional lives, which increased our commercial coverage from 48% to 60% and overall coverage from 70% to 76% just started on August 1st. So it is premature to talk about pull-through at this point, but obviously we will share additional updates as time goes on.

And then in terms of gross to net dynamics, I'll hand it to Nick..

Hi, Amy. Yes. For the GTN, as I said in my opening remarks, GTN for Auvelity was in the low to the mid-50s. We do expect it to remain in this range for the second half of the year as of now..

Great. I guess let me just alter the question. What I meant to ask was how long do you expect that pull-through to come starting August 1st..

We expect it to be dynamic over the coming months. The impact is not felt immediately. It sort of builds over time. So we would expect that to build in the weeks and months ahead..

Thank you. Our next question is coming from Yatin Suneja from Guggenheim Partners. Your line is now live..

Hi guys, thank you for taking my question. Could you maybe help us clarify or maybe set the stage for the ADHD study? What exactly you are looking for on the AISRS endpoint? How should we think about placebo? What would be meaningful here? That's one. The second is on the ADA side.

Could you maybe also help us articulate or maybe re-familiarize us with your filing strategy? So you have ADVANCE-1, which was more of a component contribution study. You have the ACCORD-1, which was a randomized withdrawal study.

Which one is the primary study from an efficacy standpoint? How are you going to utilize the ADVANCE-2 study or the ACCORD-2 in that package? Thank you..

Sure. With regards to the first question around ADHD, this is for solriamfetol, which is being studied in the Phase 3 trial, the FOCUS trial for ADHD. The study is 90% powered to detect a treatment difference. So we're very comfortable with the powering of the study.

As a reminder, it's enrolling well and it's on track for our readout in the second half of this year. With regards to the Alzheimer's disease agitation program, so we now currently have a total of four different Phase 3 trials. And so we really like the way that that positions us. The ADVANCE-1 trial was a parallel group study.

It did also have a bupropion-only arm. So not only did it provide to pivotal evidence of efficacy, but it also did satisfy the component contribution aspect. The ADVANCE-2 trial is designed exactly like the ADVANCE-1 trial for the most part, and except that it's only -- it's a two-arm study, so it's AXS-05 versus placebo.

The ACCORD-1 trial is a randomized withdrawal study, and the ACCORD-2 study is also randomized withdrawal study. So as a reminder, typically for regulatory considerations, one needs two positive trials.

So we really like the way that the development program has been structured, which provides us -- should provide us a very robust data set for the NDA submission..

Thank you. Next question is coming from David Amsellem from Piper Sandler. Your line is now live..

Yes. On AXS-07, appreciate the color earlier in the call, but wondering if you could elaborate more on your go-to-market strategy in acute migraine, just bearing in mind that there have been some product launches that -- in that space that have failed to gain traction, and just given that the payer landscape is not particularly generous.

So how do you think about that? How do you think about pricing and the payer landscape and just overall thoughts there? Thanks..

Yes. Thanks for the question, David. Obviously we're doing a ton of work on our launch readiness for AXS-07. I think the important thing to remember is that the oral CGRP space is crowded and there are many triptans available.

However, there are still 70% of the 6 million or so migraine patients on therapy who are dissatisfied, who are not getting the efficacy or safety results that they're looking for. And so we do think that there is a meaningful opportunity for AXS-07. Obviously, market access and payer dynamics is top of mind.

We're going through the work right now to understand what the pricing strategy should be, but we do feel confident based on the clinical trials that we've designed and the potential impact on patients with or without prior CGRP utilization is very high.

So we'll provide additional updates as we get a bit closer to launch, but we feel that there is a meaningful opportunity for AXS-07..

Thank you. Next question today is coming from Joel Beatty from Baird. Your line is now live..

Hi, thanks for taking the question. For Auvelity, the press release mentions that Axsome expects coverage to continue to expand and evolve. What do you mean by evolve? And then a question on AXS-07 for migraine.

What will you be looking for in the results of the single group Phase 3 EMERGE study reading out in the second half of this year? And could those results make it into the NDA that was just recently resubmitted?.

Yes. I'll take the first question, which is around expand and evolve. So obviously we're very focused on our negotiations with payers. The expand is what you just saw, which was the addition of 22 million lives. So increasing the percent of covered lives is the expand part.

The evolve is we -- our strategy is to secure access, that is first line or first switch. And in instances where we have existing coverage where that first line, first switch is not accessible, we work with payers to try to improve the access over time. And so that's sort of a two pronged approach to our market access engagement..

Great. And with regards to the question on the migraine study with AXS-07, this is the study in patients, the EMERGE trial in patients with a history of inadequate response to oral CGRPs.

The way that that study is designed is it is enrolling patients who are not responding to oral CGRPs and we monitor their treatment once they've been switched over to AXS-07, and what we'd be looking for there is what the response rates are with patients who are taking AXS-07 versus what the response rates were prior to when they were on AXS-07; in other words, response rates on all CGRPs versus the response rates on AXS-07.

And in terms of whether or not that would make it into the NDA filing, by definition, that will not be the case, right? Because that study has not yet read out. However, we do think that it will provide very good information, should it be positive from a marketing perspective and certainly from an HCP education perspective..

Thank you. Next question is coming from Joseph Thome from TD Cowen. Your line is now live..

Hi there. Good morning and thank you for taking our question. Maybe on the commercial side for Sunosi, you are seeing growth obviously, but maybe a little bit slowly.

So can you talk a little bit about maybe what you can do or your plans to increase prescribing in the narcolepsy and OSA market? Is there still more room here or are you getting to a place where you might be a little bit tapped out? And then second, can you just remind us on the AXS-12 in narcolepsy, what are sort of the next steps there? Do you have to meet with the FDA for a pre-NDA meeting? Are you waiting for the safety database? Just sort of some timeline updates would be helpful..

Yes. So I'll take the first question. Obviously we're very pleased with how Sunosi has performed. It was a good quarter and we saw a really nice uptake in terms of new patients started on treatment. This is overall a smaller market opportunity relative to major depression.

That said, we do look at the entire commercial mix of activities and investments, everything from our marketing plans, our sales force effort, market access dynamics as well as our marketing to consumers.

And so all those things are levers that we're evaluating to try to support the brand growth, but we're really pleased with how it's performed since we acquired the product from Jazz..

Sure. Great. And as it relates to AXS-12 and the next steps there, so the next steps are completion of the long-term open label safety extension trial and that's -- and then it is typical to meet with the FDA and have a pre-NDA meeting. So we would love to do that..

Thank you. Next question is coming from David Hoang from Citigroup. Your line is now live..

Hi there. Good morning. Thanks for taking my questions. So I just wanted to ask about first or second-line usage of AXS-05 in MDD. Have you seen any increased early line usage this quarter? And then also want to ask about AXS-05 versus solriamfetol in MDD. Obviously you have a trial for solriamfetol now going on there.

How do you think about these two products fitting into the MDD competitive landscape? Thank you..

Yes. Thanks, David. So we have seen continued progress in terms of first and second-line use. It's roughly 50% of all utilization for Auvelity now as first or second line, and we've seen that progress over the past year or so. So we're really pleased with the direction that it's heading..

And as it relates to the profile in MDD for AXS-05 of Auvelity and solriamfetol, what we want to do is wait to see what the profile is of solriamfetol in MDD. We're currently conducting that study. So once we see that profile, we'll know more.

There are some things though that we can say right now, which is that if you look at patients who have MDD, a very large percentage of them also have excessive daytime sleeplessness. So remember, that is an indication which is currently approved for solriamfetol.

So there is a tremendous amount of overlap in terms of symptomatology between MDD and EDS associated with OSA. So you can imagine that if solriamfetol were to be positive in major depressive disorder, that might be helpful for clinicians who are trying to treat a patient who is both depressed and who also has excessive daytime sleepiness.

So this is a recurring theme if you look at our entire portfolio, the overlap in terms of symptomatology and disease states for various products and indications..

Thank you. Next question today is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live..

Good morning. Thanks so much and congrats on the quarter. Just a clarification, just around your big Phase 3 data readouts, FOCUS and also your ADVANCE-2 studies. I know the guidance is the second half of this year.

Any comment on when or if you plan on providing more refined guidance around those timelines? And then just a follow-up question, a commercial question just on Auvelity's performance in the second quarter. Congrats there, but any comments on stocking, destocking in the quarter that might have impacted the performance? Thanks..

Yes. As it relates to the first question, in terms of providing more granularity as it relates to clinical trial readouts, so we've said the second half for these studies, we're very comfortable with that and we definitely will consider providing additional guidance. Typically we do that around the time that we announce our quarterly results.

So stay tuned..

Yes, Graig, it's Nick. As it relates to stocking or destocking, there was no impact specifically around stocking or destocking in channel, remaining two weeks as we have -- pretty much since launch for Auvelity and Sunosi..

Thank you. Next question today is coming from Ash Verma from UBS. Your line is now live..

Hi, thanks for taking our questions. I had questions on AD agitation. So I'm trying to figure out when you can file this. So if you definitely need the OLE to file, wouldn't that mean that you also need ADVANCE-2 to complete first? Because the OLE is drawing in patients from ACCORD-1 and ADVANCE-2.

And then on ADVANCE-2, are there any specific hurdles that you're facing in terms of getting Rexulti-naive patients? Thanks..

Sure. So with regards to the timing for ADVANCE-2 and the open-label safety extension trial, so you are correct that there is a relationship because the open-label safety extension trial is enrolling patients who are coming out of the ADVANCE-2 trial.

However, the guiding factor for the open-label safety extension trial is the number of patients who are exposed. So we need 300 patients who have been treated with AXS-05 in this patient population for six months, and 100 who have been treated for one year.

So we are very much on track to hit those numbers and so that will put us on track for potentially completing not only the ADVANCE-2 trial and the ACCORD-2 trial, but also the open-label safety extension trial all in the second half of this year and then that will put us on the glide path towards submitting an NDA or sNDA filing..

Thank you. Next question is coming from Myles Minter from William Blair. Your line is now live..

Hi, thanks for taking the question. Just on the ACCORD-2 readout, I know that that trial has the opportunity for patients to have up to 26 weeks of treatment post randomization, and you are guiding that the second half of the year here for top line data. Wondering why that guidance is there.

Like are you seeing on a blinded basis similar to what you saw in ACCORD-1, which was the majority of relapse events are happening by 12 weeks and that's what's giving you the confidence you can read it out as early as the second half here rather than pushing year-end if you do require that full 26 weeks of treatment for these patients? Thanks..

So the way that the study is designed, so once the patients have been randomized, then they're treated for -- they're treated until two things occur; either one, they relapse, or two, they've been treated for six months.

So given the timing of completion of randomization, of target randomization, then it just flows that the study should be able to read out in the second half of the year..

Thank you. Next question today is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live..

Hi, good morning, guys. Congrats on the quarterly results.

Just with the near-term filing for AXS-14, can you give us a little bit more sense in terms of the opportunity there in fibromyalgia and how you're thinking about it?.

Yes. Thanks for the question, Matt. So I'll just give maybe just some epidemiological data and then I'll turn it over to Ari to talk about the opportunity. The best, highest quality epidemiological studies that have been conducted in the U.S. show that the prevalence is -- of fibromyalgia is 6.4% U.S. adults.

So if you do the math, that equates to a very large patient population, about 17 million.

Ari?.

Yes. We're really excited about AXS-14. As you may know, there are only three treatments that are approved in fibromyalgia and there have been no new treatments in the last 15 years.

So we believe that AXS-14 has a real potential to become a new standard of care based on the robust clinical profile, and we're looking forward to bringing it to market sometime in the future..

Thank you. We reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further closing comments..

Thank you for taking the time to join us for today's quarterly update. We delivered another robust quarter, driven by focused commercial execution and continued pipeline advancement.

In the second half of the year, we expect similar progress, including top line results from the Phase 3 ADVANCE-2 and Phase 3 ACCORD-2 trials of AXS-05 in AD agitation, and the Phase 3 FOCUS trial of AXS -- of solriamfetol in ADHD.

All told, we expect to make substantial progress across our unparalleled CNS portfolio this year, and we look forward to continuing to deliver innovation and value to patients, healthcare professionals, and investors alike. Thank you and have a great rest of your day..

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today..