Hello, and welcome to the Axsome Therapeutics Second Quarter 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 Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead, Mark..

Thank you, operator. Good morning. And thank you all for joining us on today's conference call. This morning we issued our earnings press release, providing corporate update and details of the company's financial results for the second quarter of 2023. The release crossed the wire a short time ago 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 nonclinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plan, future research and development plan, our commercial plans regarding the Sunosi, Auvelity, and our other 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 report. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. 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; and Lori Englebert, Executive Vice President of Commercial and Business Development. Herriot will provide an overview of the company and progress made in the second quarter of 2023, as well as key upcoming milestones.

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

Thank you, Mark. Good morning, everyone. And thank you for joining Axsome Therapeutics second quarter 2023 financial results and business update conference call. In the second quarter, we continue to execute across whole areas of our business.

We drove continued success in the commercialization of Auvelity and Sunosi, advanced our late stage product pipeline and further solidified our financial foundation to the public equity offering that provided us significant operational flexibility and strength.

Total net product sales in the quarter were $46.7 million driven by strong performances from both Auvelity and Sunosi. Based on the growing Auvelity prescription trends to date, and positive feedback from clinicians, we are increasing the Auvelity feel force by nearly 100 representatives.

In conjunction with our Digital Centric Commercialization or DCC platform the expansion should nearly double the number of prescribers we are able to reach. Later in the call, Lori will comment further on our commercial performance and Nick will provide additional details on our financials.

In conjunction with the commercial performance, our first in class development pipeline continues to expand and advance. With respect to solriamfetol, our dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist we recently initiated the focused Phase 3 trial in ADHD.

Today, we're pleased to announce the launch of two new high value potential indications for solriamfetol. Binge eating disorder and excessive sleepiness associated with shift work disorder. Binge eating disorder is the most common eating disorder affecting approximately 2.8% of U.S. adults.

There is currently only one FDA approved product for this indication. We recently received positive pre-IND meeting feedback from the FDA for this program and are preparing to initiate a Phase 3 trial in patients with binge eating disorder before the end of this year.

Turning to shift work disorder, an estimated nearly one-third of Americans perform shift work, of whom 10% to 43% are diagnosed with shift work disorder. There are currently only two FDA approved products for the treatment of excessive sleepiness associated with a shiftwork disorder.

We also recently received positive pre-IND meeting feedback from the FDA for this program and are preparing to initiate a Phase 3 trial in shiftwork disorder in the first quarter of 2024.

The target indications of ADHD, binge eating disorder, and shiftwork disorder, have the potential to dramatically increase the number of patients solriamfetol could help successful in clinical testing. Further growing are already first in class CNS pipeline.

Stay tuned for more updates on these programs, and the rest of our leading late stage CNS pipeline. We are excited by the number of value creating opportunities that lie ahead of us. We anticipate completion of the Phase 3 SYMPHONY trial of AXS-12 for the treatment of narcolepsy in the fourth quarter of this year.

We continue to see study enrollment in the Phase 3 ADVANCE-2 trial of AXS-05 for the treatment of Alzheimer's disease agitation and we remain on track to complete ADVANCE-2 in the first half of 2024.

We are making progress towards initiating the plan Phase 2/3 trial of AXS-05 on smoking cessation, which is scheduled to start in the fourth quarter of this year or the first quarter of 2024. Additionally, the team is nearing finalization of the work for the resubmission of the NDA for AXS-07 in migraine.

This work has moved at a slower pace than anticipated. And as a result, we now expect to resubmit the NDA in the first half of 2024. With respect to the plan NDA submission for AXS-14 for the management of fibromyalgia, we are making good progress and are working to finalize the content and datasets that will complete the submission.

We are tracking to an NDA submission in the fourth quarter of this year to the first quarter of next year. Each of these potential milestones, builds value for our stakeholders and we continue to make strategic decisions to maximize the potential for future growth.

Lastly, we recently closed an underwritten public offering of common stock that resulted in $258.8 million in gross proceeds, fortifying our financial foundation, and providing additional flexibility to execute on multiple fronts.

Not only expanding commercial activities by strategically expanding our field force, but also by adding the aforementioned new indications for solriamfetol that may serve to maximize the product's potential. Lori and Nick will each discuss in further detail how the financing amplifies our ability to read value across our portfolio.

All in all, we expect a productive second half of 2023 that sets us up for multiple milestones over the next 12 months. 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 revenue in the second quarter of 2023 was $46.7 million consisting of net sales of our two commercialized products Auvelity and Sunosi and royalty revenue from Sunosi sales and out-licensed territories.

Revenue for the comparable period was $8.8 million comprised of U.S. Sunosi sales beginning May 9 of 2022. Auvelity net sales in the quarter were $27.6 million, representing 76% sequential growth. There were no net sales in comparable 2022 period due to the timing of the launch. Sunosi revenue for the quarter was $19.1 million, U.S.

Sunosi sales were $17.8 million, International Sunosi revenue was $1.3 million, including approximately $700,000 in royalty revenue from Sunosi sales in the out-licensed territories. Sunosi's net sales for the comparable period were $8.8 million consisting of U.S. sales beginning May 9 of 2022.

Cost of revenue was $4.6 million in the second quarter compared to $1 million in the prior year period. The increase reflects the higher product volumes for both Auvelity and Sunosi in the current year. Research and development expenses were $20.6 million in the second quarter versus $50.8 million for the comparable period in 2022.

The increase was primarily related to higher personnel costs associated with supporting ongoing clinical trials, post marketing commitments for Sunosi and Auvelity and noncash stock compensation expense. Selling, general and administrative expenses were $78.9 million for the second quarter versus $31.2 million for the comparable period in 2022.

The increase was primarily related to commercial activities for Auvelity and Sunosi and higher noncash stock compensation expense due to the build out of both commercial teams. Net loss for the second quarter was $67.2 million or $1.54 per share versus a net loss of $41.4 million or $1.06 per share for the comparable period in 2022.

We ended the quarter with $437.1 million in cash and cash equivalents compared to $200.8 million as of the previous year-end. Our second quarter cash balance reflects the net proceeds received from our common stock public offering completed in June.

In connection with this public offering in July of 2023, the underwriters fully exercised their option to purchase an additional 15% of the offering, resulting in additional gross proceeds to Axsome of $33.8 million. Inclusive of this event, the pro forma June 30, 2023, cash balance was $469 million.

I will now turn the call over to Lori, who will provide a commercial update..

Thank you, Nick, and good morning, everyone. In the second quarter, both Auvelity and Sunosi delivered strong growth results. For Auvelity, we are still early in the launch phase and focused on executing our commercial strategy. With that said, early adoption by prescribers is robust and a promising indicator of future success.

For Sunosi, the second quarter of 2023 marked one full year of Sunosi being commercialized by Axsome. We have begun to see the results from the relaunch of Sunosi, which is resulting in healthy growth quarter-over-quarter. We expect a strong performance for both brands to continue in the second half of 2023.

The second quarter represents only the second full quarter for Auvelity, and we are pleased with the progress we are making with the launch. Important key indicators of the success of our launch our script growth, new patient starts and HCP adoption.

In Q2, approximately 53,000 prescriptions were reported to Auvelity, representing a growth of 72% quarter-over-quarter. In the second quarter, HCPs wrote prescriptions for 17,000 new patients, bringing the total number of unique patients on Auvelity to over 38,000 at the end of Q2.

This prescription growth came from both an increased depth of prescribing with our early HCP adopters as well as an increased breadth of new prescribers. In the second quarter, we added approximately 3,700 new first-time prescribers of Auvelity, increasing the cumulative total number of subscribers since launch to over 9,700.

About 40% of our initial target universe has written Auvelity, after only two full quarters. In response to this early success, we are expanding the Auvelity sales force from 162 to 260 specialty account managers.

The expansion is expected to significantly increase our reach from 26,000 prescribers to approximately 44,000 prescribers, who currently write more than 80% of branded antidepressant prescriptions. We believe that the expansion will help build on early success and accelerate launch uptake.

With regard to payer coverage, we currently have coverage established for 68% of all covered lives. In the commercial channel, which is expected to be the primary channel for Auvelity, coverage is now at 46% of covered lives, and we look forward to additional formulary decisions in the coming months.

In the Medicaid and Medicare channels, approximately 100% of lives are covered. Major depressive disorder, or MDD, is highly prevalent and a major public health concerns with the mental health crisis that the U.S. is currently facing.

We are proud that Auvelity is providing an important and clinically differentiated therapeutic options for patients living with this chronic and devastating condition. Turning to Sunosi. As mentioned previously, the second quarter of 2023 marked one full year of Sunosi being commercialized by Axsome.

In the second quarter, we launched our Pull an All-Dayer campaign for Sunosi, which was a complete redesigned and updated promotional campaign. We significantly invested in HCP and DTC directed media with the updated campaign and are seeing immediate results from these promotional efforts. Total prescriptions for Sunosi in the U.S.

grew 15% year-over-year and 8% quarter-over-quarter, with net revenues that exceeded expectations. Since Q2 of last year, we have added greater than 13,000 unique new patients, which represents an increase of approximately 30% in cumulative unique patients over the past year.

The field team is working to drive, both depth within the current prescriber base and breadth by adding new prescribers. Since Q2 of last year, we have increased unique new writers of Sunosi by 24%. Payer coverage for Sunosi remains broad, with 95% of commercial lives and 83% of total lives covered.

The growth potential for Sunosi in the currently approved indications remain substantial, as well as its growth in potential new target indications such as ADHD, binge eating disorder and shift work disorder. As a reminder, Sunosi is the first and only DNRI for excessive daytime sleepiness, and obstructive sleep apnea, and narcolepsy.

And the first and only, wake-promoting agent proven to improve wakefulness through nine hours. Sunosi is the only branded therapy available for patients who suffer from EDS and OSA and we expect our increase in enhanced promotional and disease education efforts to drive continued growth for the product in 2023.

Q2 of 2023 saw the continuation of a strong launch of Auvelity and the continued execution of the relaunch efforts of Sunosi. Both products are clinically differentiated and address patient populations with high unmet need.

We remain focused on commercial execution and expect continued commercial success for both products in the second half of the year. I will now turn the call back to Mark to lead the Q&A discussion..

Thank you, Lori. Operator, may we please have our questions..

Thank you. [Operator Instructions] Our first question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live..

Yes, hi. Good morning Herriot and team. Thanks for taking our questions. Wanted to, first of all, start off with a congratulations, and the strong revenue performance as well as a broadening of pipeline progress. So nice quarter. A couple of quick questions.

First of all, with regard to an approval of a product candidate in postpartum depression, but not major depression disorder.

I guess, I'm wondering if that changes your views on the competitive environment for Auvelity? And if you can give us a sense of what most interest prescribers in its clinical profile, Auvelity's clinical profile and why they're really prescribing the drug?.

Thanks, Charles for the question. In terms of what it changes for our business in terms of what we're doing, it does not change our plans at all. As a reminder, major depressive disorder is highly prevalent. There are 22 million patients out there. What we've seen with the launch thus far of Auvelity is that the clinical need is really great.

And while we anticipated that there would be space for multiple players. And as - we've said in the past, we also think that it's good that a lot of different drugs are being developed for these depressive disorder, because we want to make sure that patients get served and the clinicians have options. So that's our passion.

And I know why you're asking the question, and I know that - the sell side, likes to take accompany against each other. Like they'll just say that we hear [indiscernible] folks that other companies and assess colleagues, we commend the safe team for their work to provide a new treatment to patients with postpartum depression.

We know from experience that - so that development of the new drug and getting approved is really cyclical, especially in CNS. It takes the hard work and dedication and passion, a lot of talented individuals. That's what brings us in every day to work.

And to that end, we are going to continue our work to ensure that we provide new treatments to patients, not just with depression, but also with other CNS limitations. So if you look at the expansion of our pipeline thus far that we announced today, it brings the whole number of patients that we can help, 252 million patients in the U.S. .

That's helpful. And if I could ask just one follow-up regarding Axsome-007 or AXS-007 in migraine. I'm just wondering if you could provide any more color on the work streams required to enable the NDA filing? And also just remind us on the target product profile that you envisioned for the candidate that will serve an unmet need in migraine..

Charles, this is Mark. I'll answer the first question about the work streams for the NDA resubmission. So just to be clear, this is just taking us longer than expected, and it's not as though there were some setbacks since the last call that's going on behind the seat. So we're taking our time to get this right.

And what it is that we need to get right or finishing in additional batches that were requested of us by the FDA. As a reminder, the drug substance and drug product are new. The manufacturing it is a [indiscernible] with external ring stabilized with the buffering system. This is an active innovation that it is the mosaic technology.

So that's as FDAs asks for additional data to support the package. So that work is on its way, right. It's just taking longer than expected, and we remain confident that we'll be able to get it done. And then I'll pass on for the product profile..

Right. Yes. So just you start with regards to the product profile question that you asked, Charles, in the second part of your first question.

Lori?.

Yes. So Charles, I'm going to switch back to Auvelity and answer the question on the most - on interest positions, but then I'll also answer the competitive piece on 07. Sorry about that. What most interesting - what we're seeing out in the real world is, I would say, three things.

One, obviously, the rapid onset of action is really impressive to HCPs, and we are seeing results very similar to what we saw in the clinical trials. The second piece is, we are getting to a point now where we have enough patients on therapy, where the durability is really starting to come through the sustained effect of the product.

And so that's really encouraging out there to physicians. We are able to have a very large number of patients achieve remission, and that is something that physicians are commenting on quite a bit on how fast not only does symptoms improve, but we are able to achieve remission.

Again, everything is very similar to what we're seeing in the clinical trials or what we saw in the clinical trials with remission as early as two weeks. But then the last thing is the side effect profile. So the side effect profile is obviously favorable versus some of the competitors out there and physicians and patients are both commenting on them.

In terms of AXS-07, the - as Mark was mentioning, the Mosaic technology really does allow for that very early onset of action for patients to reduce pain.

That is despite the fact that there are multiple entrants in the category right now and a lot of activity and a lot of promotional dollars, even now more than 70% of patients still are dissatisfied with their current therapies. We know they cycle through therapy is looking for something that's efficacious.

And so we hope to bring us up to market as an option for them..

Regarding Auvelity, you point out three key differentiations from [indiscernible]. So thank you for the added color and congrats on the quarter..

Thanks Charles..

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

Thanks so much for taking my questions and congrats again on the quarter.

I just wanted to ask a little bit about the kinetics of the sales force expansion for Auvelity within what time frame you expect that to be concluded if you expect that new expanded size to effectively be the steady state for the sales force for the foreseeable future? Or if any further expansion might be on the cards? And also, if you could perhaps comment on the sales force composition and what you see as the facility with which you're going to be able to execute those new hires from a pool of candidates who have prior CNS or antidepressant sales experience.

Thank you..

Ram thanks. Sorry, if don't get all of them. I just try to write down every question that you asked. So if I miss something, please remind me. So, we are intending to have the expansion rolled out and completed and ready to perform in Q4. We are very much underway in building that expansion right now and have been for a little bit.

Part of the reason why we think and believe so strongly that the expansion is needed right now is we are seeing such early success. We have 10,000 HCP writers, 40,000 new patients or patients on therapy right now. We're adding about 1,000 HCPs or more than 1,000 HCPs every month.

And what we're seeing and why we're so encouraged is, obviously, field forces at this stage of launch, typically struggle between depth and breadth. We are trying to achieve both. And right now, greater than 40% of our target list has already written. And remember, our target list is a very substantial target list with a very small sales force.

But also of those 40% that have already written, 60% of those writers have found more than two patients already to write. And so that's really encouraged from both a depth and a breadth standpoint, and we think that expanding the sales force will further accelerate the launch uptake.

In terms of composition and pull of candidates, our first recruit, I think we had greater than 90% with CNS experience, more than that with psych experience. We are obviously going to - that is our goal for this expansion piece as well..

Thank you..

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

Hi. Congrats on the strong quarter. And thanks for taking our questions. Any particular reason why the SYMPHONY trial in narcolepsy got pushed out to fourth quarter? And if by trial completion, you're also referring to completion and data readout or just a trial completion stuff.

And also similar to Alzheimer's agitation if by completion of trial in the first half of next year, we can also expect data in the first half of next year? Thank you. And I have a quick follow-up..

Thanks for the questions. So with regards to SYMPHONY, we're on track to complete the study and report results out in the fourth quarter. And this is not a change from our last update. And the reason for the - for granularity around the timing of the AXS-12 trial is that this is an orphan medication and orphan indications they - could not be.

So let me try and provide granularity as we get closer. And so, we're on track there. With regards to - yes, I think the nuance is that it's - the prior guidance of completion of the enrollment, this is completion of the study..

Got it. That's really helpful.

And similarly, with Alzheimer's agitation, we can also expect top line data first half of this year [ph] or is that just to check?.

Yes. And then - similarly, with the Alzheimer's disease agitation - the guidance of trial completion also incorporates - data read out..

Perfect. And based on your experience with digital-centric commercial strategy in partnership with Veeva, is this something that you may also consider down the road for migraine, narcolepsy or ADHD or even Alzheimer's? Thank you..

The rationale behind putting together the platform is, I think, we could leverage it for our entire pipeline. So, we're very glad that we made that investment, and we're looking forward to leveraging it for - really vast pipeline that we haven't raised a product candidate..

Yes. Joon I can just add one piece of commentary there. We are leveraging it for Sunosi now as well, so it is across both products that we are leveraging..

Thank you..

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

Good morning, guys. Thanks for taking my question. Just wanted to come back to the sales force the announcement.

So, I guess will these new reps just be covering physicians or providers that were not being called on prior? I'm just trying to get a sense of - and I think in the past, the digital strategy was sort of like I thought, meant to improve breadth and productivity of each prescriber, but there's also maybe a rep that's calling on that provider.

So just kind of wondering like what's changed in terms of how you'll leverage kind of the digital component and where the new reps will specifically be adding value?.

Yes. Thanks, Jason. So I'll answer that question kind of the reverse. So our DCC platform was and part of our DCC platform is how our field of size as well as structured.

It was intentionally structured so that we could maintain a share of voice reach through omni-channel measures as well as face-to-face and/or round remote engagement with HCPs by reps at the same rate, as sales forces 2 times our size. So that's why we - the DCC platform is so instrumental in how we reach HCP.

In terms of the expansion of targets, we originally were calling on about 26,000 HCP prescribers, and we are now taking that up to 44,000 prescribers. And I want to make - the reason that magnitude is so important going up to 44,000 is they cover 90% of the branded therapies.

But not only do they cover 90% of prescribing of antidepressant, they cover almost 90% of new branded therapies. So, they are the ones that are writing. These are the HCPs, the 44,000 are the HCPs that are writing and finding new patients to put branded therapies on - this is a very large expansion of the target list.

So it will be current targets and then in addition to going up to 44,000..

If I can just ask a follow-up.

So under the order, I guess, approach with fewer reps suite just those added 20,000 providers, you would have just not caught on those physicians or just sort of try to utilize digital means to get to those providers?.

That's right. It doesn't mean that we're being touched or engaged with. They were just been touched or engaged with through digital or media efforts or non-personal promotion efforts. Now, we are having reps individually calling them to detail the product..

Got it. Got it. Thank you..

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

Hi. Thanks. So just a couple. So first, on Sunosi, so you have a P4 filing, no surprise there.

But I guess the question here is, with all the label expansion opportunities that you're pursuing, how are you thinking about exclusivity runway for the product? I know there's a lot of patents in the orange book, but what have you been assuming, I guess, internally on what kind of exclusivity runway you think you'll have for the underlying molecule.

So that's number one.

And then just going back to the sales force as you're thinking about solriamfetol and ADHD in particular, what's the extent to which you're going to need further headcount, say, in the ped and adolescent psychiatry setting in the pediatrician setting? And I guess the broader question is, how do you think about leveraging the headcount you're going to have in place with respect to solriamfetol? Thanks..

So a lot of questions there. With regards to the label expansion and how we think about the exclusivity runway, so even with the current issue patents, we have on exclusivity running out to at least - 2040.

And then in addition to that - we also have recently issued - recently allowed claims, which go out to December 2022, and those cover all of the new indications..

That'd be December 2042 [ph]..

I'm sorry, December 2042, so that's even longer exclusivity runway, and so that covers all of the additional indications. And then with regards to the additional headcount, one of the things that we like, and I'll turn it over to Lori to maybe provide a little bit more color. But one of the things that we do like is the overlap.

And in the operational leverage with regards to our current neuropsychiatry sales force. ADHD is treated primarily by psychiatrist so that fits in very nicely with our current sales force and sales force expansion..

Yes, perfect, I don't know if I can add much more other than - it's a bit early to talk about size and what that looks like with other lot of factors obviously come into play when you're thinking about what that overlap looks like at the time.

And that is how entrenched we are with Auvelity, what that current sales force efficiency looks like and whatnot. So, we definitely like the overlap. Obviously, it's a very strategic thought from our standpoint in terms of how we structure the sales force. We always seek to be efficient and effective.

So it will be a consideration when it comes time to fit the size of that sales force..

Okay. Thank you..

Thank you. Your next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live..

Hi. Good morning. Thanks for taking our questions. So just two for us on Auvelity.

First, could you provide some additional color on the profile of patients receiving the drug in terms of prior treatment status and prior line of therapy and how this has been evolving over the past couple of months? And then secondly, could you remind us your latest thinking on ex U.S.

plans for commercialization? I believe in the past, you might have mentioned this is something you could evaluate a partnership for. So, I just wanted to see if that's still your current thinking? And if so, how those internal discussions are going? Thanks..

Thanks for the questions. So I'll answer the last - the second question, and then I'll turn it over to Lori to answer the question on the patient profile. So ex U.S. plans. So, we've always - we've always said that we would look to out-license the product ex U.S.

And so that - those plans and that strategic direction has not changed, Lori?.

Yes, thanks. In the very early days of launch, we were, of course, getting that later-line patient just based on -- mostly due to the unmet need and new therapy coming to market, especially with a novel mechanism of action.

But as subscribers have gained experience with the product and seeing early success in that patient population, they are starting to move the use up into earlier line.

Right now, there is about 10% to 12% usage in first-line therapy, which is really encouraging because that typically means that physicians have seen success in patients that they feel warrants using the product profile benefits patients is always first line.

But the majority that we're seeing right now is that it's roughly around 60% of patients that we're getting have failed either one or two prior therapies. As clinicians get more experience with Auvelity. And again, we are only two full quarters into launch.

But as clinicians get more experience with Auvelity and our access to that [ph], we do expect it to be prescribed to people earlier in the treatment algorithm..

Got it. Thank you..

Thank you. Next question today is coming from Yatin Suneja from Guggenheim Partners. Your line is now live..

Herriot, thank you for taking my question. Just real quick ones. With regard to the narcolepsy, can you maybe just talk about hitting on the cognition endpoint there? Like what do you need to show? Is that even important, maybe the benefit of showing cataplexy in? Just trying to understand what the exact expectation would be.

And then quickly, if you can just let us know what the gross to net. I missed it if you said it, what the gross to net was and maybe what the inventory is in the channel for Auvelity? Thanks..

Thanks for the questions. With regards to AXS-12 cataplexy is the primary endpoint of the trial. So, we are also looking at other endpoints and specifically the endpoints that we looked at in the Phase 2 CONCERT study. One of those was cognition, as you mentioned.

So, we do demonstrate a reduction or an improvement in Auvelity to concentrate in that trial. So that's exploratory, obviously, but it's something that we're definitely looking at. Because the cognition, cognitive difficulty, it is one of the key symptoms or one of the symptoms that that's experienced by the majority of patients some with narcolepsy..

Hi Yatin, it's Nick. As it relates to the gross net for Auvelity for the quarter, it was in the low to mid-50s. This was an improvement from the high upper 50s in Q1, mostly due to higher proportion of refills of the scripts, which had a more favorable if you can [ph] versus new scripts. And I think your second question related to inventory.

I want to be clear that the performance for Auvelity was not impacted by changes in the inventory level. As we stated previously, normal inventory levels will be and remain around two weeks. So, no impact specifically as it relates to inventory levels..

Okay. Just one quick one on gross to net. Do you expect that to - I mean just curious how do, you expect it to change over time. And once you have sort of full reimbursement, I'm just trying to understand where it should sort of shake out? Thanks..

Thank you. Thanks, Yatin. We expect the GTN for Auvelity to remain in that mid-50% range for the foreseeable future. It's obviously volatile depending on when payer access comes in and then that offsets the co-pay reimbursement. So for the foreseeable future, we expect in that mid-50% range for GTN..

Thanks..

Thank you. Next question is coming from Marc Goodman from Leerink Partners. Your line is now live..

This is [Rudy] on line for Mark. Can you provide more color on the duration of effect and persistency for Auvelity? I know you're still in the early stage of launch, but any color will be helpful. And also painful one like the gross line for Sunosi and inventory changes in the quarter? Thanks..

Yes, good. Thanks for the question.

Could you repeat the second part of the question, we had problem hearing?.

The second part, I'm just wondering the gross line our inventory changes for Sunosi in the quarter?.

Okay. Thanks. So with regards to the duration of effect for Auvelity, what we saw in the CONCERT trials, as you know, our clinical trials were six weeks. And the primary endpoint was at six weeks. So we showed early onset of action at one week, at two weeks and wait for every time point and including at six weeks.

And then subsequently in very large as follow-on studies. We looked at the duration of effect, patients were treated out to at least one year. And what we saw was that the improvement either increased or was maintained out to at least one year.

And what we're seeing from - the actual use of the product in the field as we got now, we have what how many patients on that..

40,000..

Yes, 40,000 patients who've been treated with the product. It's still early, but the experience and the prescription trying to support this, we're seeing that the patients are being on therapy at the rate that we would have expected..

Yes. And as it relates to Sunosi GTN, it did improve slightly from Q1, typically due to the seasonality impact for Q2, we were in the low 50s for GTN. And I believe you asked also on inventory, as I stated on the previous question, inventory remains for Sunosi around that two-week level in general..

Got it. That's very helpful. Thank you..

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

Hi, there. Good morning. Thank you for taking my questions. Maybe the first one. I think you mentioned a little over 40% of the target writers were - have already written AM prescription for Auvelity.

Maybe great to see the progress, the remaining that had not written maybe why are they waiting? Is it really just the lack of kind of in-person touch points? Or is there something else that maybe this new sales force can emphasize with the product profile? And then maybe second, is essentially everyone that wants the drug getting the drug, where do we say what kind of prior authorizations and should that ease over the next couple of quarters? Thank you..

Yes. Hi Joseph. Thanks for the question. So I'll comment when a launch happens, what you typically see is that you have some very early adopters. And those early adopters will write coming to Auvelity are usually our most informed physicians.

Given that Auvelity has a novel mechanism of action, those writers who have it written, it certainly isn't due to lack of touch. It is what it is you're now moving into a different physician type. They're typically call it as followers or they wait and see how the early adopters use the product, and then they start to adopt.

That can be achieved through a lot of different means, that either field force, that's peer-to-peer speaker programs, which we are investing pretty heavily in for media. So they are being touched.

Now we're just - we're working through and into that natural phase of a launch where you have to educate the fast followers or the followers that come after your very early adopters. And obviously, as we continue to add HCP, that's more than 1,000 new writers per month, we are seeing that adoption happen in that group as well.

In terms of pages that what the product, we do have a very robust patient support services program, including savings cards, samples, NPA support for physicians' offices. So, we feel very confident that patients who want the product can get the product..

Perfect. And then maybe one quick follow-up. I guess, what are you seeing in terms of response rate based on prior line of therapy? Obviously, we saw the open-label data and present on responsive patients in TRD patients, but you did have that Phase 3 that didn't meet the mark in the TRD patient population.

Are you seeing strong responses in TRD patients? Or is there an ideal place to focus? Thank you..

Yes. So we look at this pretty closely. In other words, we studied the product in patients with various lines of treatment. So of course, the entire spectrum from treatment-naive patients to patients with who meet the criteria for TRD. And what we saw and we announced this in the past, is that the product performs equally well.

So you're seeing just as strong responses in patients with or naive we receive one line of treatment, and then we receive multiple lines of treatment. So that's really encouraging. As a reminder, is open-label data, what we saw the response rate was into the 80% plus range in terms of patients who are responding..

Great. Thank you..

Your next question is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live..

Hi. Good morning, guys. And congrats on the strong quarter. I just wanted to focus a little bit more on the Sunosi and solriamfetol expansion into additional indications. Can you give us some more detail in terms of the positive feedback that you received from the FDA with respect to binge eating disorder and shiftwork disorder.

Specifically, how many studies will you need to complete to file for these indications, NDAs?.

Thank a lot for the questions, Matt. So with regards to the FDA feedback that we received, we received feedback on the entire clinical development plan. In other words, our plan studies to get the products approved. So for binge disorder, with only two stays and for shiftwork we'll need one stay..

And in terms of endpoints and for these studies, what will you be - can you give us more detail on that.

Yes. So typically, we provide the details on the trial design and the endpoint of the trial once we started the trial. So we intend to - so stay tuned and we'll be providing more details on both of those studies because we do intend to launch some in very short order.

So continue this order in the fourth quarter and shiftwork disorder in the first quarter..

Great.

And then with respect to the initiation that you - for the Phase 3 study in ADHD, can you give us a little bit more detail in terms of the opportunity that you see, Sunosi or solriamfetol selling in that indication?.

Yes. So it's a very large patient population, as you know, close to or maybe even rivaling or [MDU]. So just extending the only patients who have ADHD. And right now, if you think about the therapies that are available, they fall into roughly two categories.

You have the stimulus with work, which had very large effect sizes, but which have the issues with tolerability and then scheduling. And then you have the nonstimulants which have lower effect sizes. So it remains to be seen, obviously, what we'll see with solriamfetol. That's why we're conducting the trial.

But the indications from what we see with regards to the currently approved indication. So except at any times spins is that there's a very large effect size and that the growth does - in fact translates to ADHD, and we think that it could provide to [indiscernible] patients.

And then we'll still a need right now, which is not addressed by the current treatments..

Thanks. Thanks Herriot..

Thank you. At this time we have time for two more questions. Our next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live..

Okay. Thanks for taking my questions. Congrats on the quarter. Just my first one on the sales force expansion, I was curious, we've seen a flattening of NRx growth on a four-week rolling basis.

So I'm just wondering if the sales force expansion was somewhat related to seeing that? And - or does that sales force expansion, is there a contemplation of perhaps down the line additional sales force adds? And then just my second question, just on the pipeline updates.

There were a number of shifts in the timing, and I'm just trying to get a sense of what your current confidence in the new time lines that were laid out? Or are there potential uncertainties or swing factors that still exist that could trigger additional delays? Thanks..

So I'll take the second question and then Lori will take the first. With regards to pipeline update, what we're trying to do is make decisions that will generate the most long-term value. So we're fortunate to have so many different potential clinical programs, which are high value and which are late stage.

So a lot of this has to do with one prioritization and two, the natural uncertainties that occur with enrolling trials, so that's what we're seeing. So we're very happy with where we are, what the pipeline expansion. We think that that's the right thing to do. And also we're very well resourced to execute and create value. So that's where we are.

And I think in the grand scene of things there will be shift within the standard decision that you might expect with regards to running any kind of business that involves B2B? Lori?.

Yes. Thanks, Graig. So the very short answer is no what we're seeing in terms of the trend has nothing to do with the need to expand the sales force, the sales force is purely driven by the fact that we're seeing great adoption and that update by physicians.

What we're seeing and what we believe we're seeing in terms of the flatness is a trend that's pretty - that we've seen basically just launches where we'll go through about four weeks and then they pop. And right now, I think what we're feeling a little bit is the seasonality effect.

Antidepressants, typically go through a seasonality effect in the summer particularly in Q3, they can sometimes drop as much as 10% Q3 versus Q2. So that is likely what we're seeing right now. And we're very confident in the fact that sale force will add to that. But again, the sales force should be up and running in Q4..

Thanks Lori..

Thank you. Our final question today is coming from Myles Minter from William Blair. Your line is now live..

Thanks. I'll just keep it to one. I think you added 6% of commercial covered lives in the second quarter here, but you mentioned that pre-IND meetings are ongoing or will occur in the next few months.

Do you have one of sight as to what proportion of covered lives in the commercial channel that those meetings would be from plans that represents? And is your ultimate goal still that 90% of couple plugs in the commercial channel that are similar to your peers?.

Myles, could you maybe repeat the last part of that question, we had - you break out a little bit..

Yes.

It was just that is your goal still to aim to achieve about 90% of covered lives in the commercial channel that would be similar to the - ?.

Yes. So I'll chime in and start. Nick might want to add some color around how we're thinking about it from a growth to net standpoint.

But from our standpoint, our goal has always been in discussions with payers to make sure that we ensure that we are capturing the value of the novelness, the innovation that we bring to the market as well as the clinical benefit of ability But also, we want to make sure that we ensure a path to access for patients.

There are 6.8 million patients who fell prior therapy, and all of those patients are typically taking 6 to 8 weeks to see any kind of response with another therapy. So the delayed onset of action current therapies, low remission rates, we believe Auvelity's clinical profile can really bring value to both payers and into patients.

So we want to make sure that we're very careful to capture that value.

Nick, you want to add anything on that?.

Yes. I think you pretty much said it, Lori - abilities - I mean it's a truly differentiated product, and we just really want to secure meaningful access while maintaining long-term value. So pretty much you said every time..

Yes. The only thing I'll add list the access that we have contracted with and the coverage that we have, it is very favorable. So payers are seeing the value of the products, and we want to make sure we're being very cognizant of protecting that long-term value of the product..

Yes. And then just the last thing that I would add, we're reporting the percentage of covered lives, which is 68%, which is great - it's a great place to be right now. But also while we can report a real time what the percentage of covered lives is, that does not reflect ongoing products. So stay tuned..

Thanks..

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

Well, thank you again for taking the time out of your busy schedule for joining us for today's update. We are excited to continue building our industry-leading CNS franchise in the back half of 2023. We anticipate a milestone billed next few months with potential clinical trial readouts, new trial initiations and new submissions.

We are committed to ensuring continued success for the launch of Auvelity and commercial growth for Sunosi and our fast on our way to achieving our goal of potentially having at least five marketed products by 2025. We look forward to updating you on our progress and milestones throughout the rest of the year. 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..