Earnings Call Transcript - AXSM Q3 2022

Operator, Operator

Good morning and welcome to the Axsome Therapeutics Conference Call. Currently, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead.

Mark Jacobson, COO

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 a corporate update and details of the company's financial results for the third quarter of 2022. 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; and Lori Englebert, Executive Vice President of Commercial and Business Development. Herriot will first provide an overview of the company and then review recent developments and upcoming milestones. Following Herriot, Nick will review our financial results and Lori will provide a commercial update. We 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.

Herriot Tabuteau, CEO

Thank you, Mark. Good morning everyone and thank you all for joining Axsome Therapeutics third quarter 2022 financial results and business update conference call. The past few months have been pivotal and exciting at Axsome. Our transformation into a commercial stage, fully integrated, research and development driven, CNS focused biopharmaceutical company has accelerated with the commercialization of Sunosi for EDS associated with narcolepsy and obstructive sleep apnea, and now with the launch of Auvelity for the treatment of MDD in adults. In addition, our broad and differentiated CNS pipeline continues to progress. The third quarter was the first full quarter of sales for Sunosi, and the results demonstrate the efficiency of our commercial approach. Current and future initiatives and potential indication expansion for Sunosi bode well for the continued growth of this differentiated product with significant market potential. Nick will provide more details on our financial performance. We are thrilled to have recently launched Auvelity, making this important new treatment available to the millions of adult patients living with MDD in the U.S. Auvelity is now helping to address a major public health concern given the current mental health epidemic. While still very early days with only 12 days on the market, Lori will provide some comments on our initial experience. Complementing our commercial progress, our broad late stage CNS pipeline continues to progress, setting the stage for potentially continued significant value creation over the near, intermediate and long term. This pipeline includes AXS-07 for migraine, AXS-05 for Alzheimer's disease agitation, AXS-12 for narcolepsy, AXS-14 for fibromyalgia as well as ADHD, a potential new indication for solriamfetol or Sunosi. With regards to AXS-07 for the acute treatment of migraine, we completed a Type A meeting with the FDA in the third quarter. Based on the meeting results, we intend to resubmit the AXS-07 NDA in the third quarter of 2023. As a reminder, no additional clinical efficacy or safety trials have been requested by the FDA for resubmission of the NDA. With regards to our Alzheimer's disease agitation program, we recently initiated the ADVANCE-2 study, which is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 for the treatment of Alzheimer's disease agitation. Concurrent with the initiation of the ADVANCE-2 trial, we have concluded the ACCORD randomized withdrawal trial as planned. Top line results from the ACCORD trial are now on track for the fourth quarter of 2022. For AXS-12, our product candidate for the treatment of narcolepsy, enrollment in the SYMPHONY Phase 3 trial is progressing and top line results continue to be anticipated in the first half of 2023. For AXS-14, our product candidate for the treatment of fibromyalgia, manufacturing and other activities related to the planned submission of an NDA are ongoing. And we expect to submit the NDA for this product in 2023. With regards to solriamfetol or Sunosi for the treatment of ADHD, we are preparing to initiate a Phase 2/3 multi-center, randomized, double-blind, placebo-controlled trial in this indication in the fourth quarter of this year. The Axsome team is therefore busy and excited as we prepare to deliver on continued ongoing commercial progress, and near and intermediate term pipeline milestones, which include clinical trial readouts, clinical trial initiations and NDA filings over the remainder of this year and through 2023. I will now turn the call over to Nick who will provide a financial update.

Nick Pizzie, CFO

Thank you, Herriot, and good morning, everyone. Today, we'll discuss our third quarter results and provide some financial guidance. Total revenue in the third quarter of 2022 consisted of net sales of Sunosi. Sunosi generated U.S. net sales of $16.8 million in the third quarter, which was the first full quarter of sales. As a reminder, the acquisition of Sunosi in the U.S. was completed on May 9, so there were no Axsome generated sales in the prior year comparable period. We remain on track to close the ex-U.S. portion in the fourth quarter of 2022. Cost of product sales for the quarter were $1.9 million. R&D expenses were $14.9 million for the third quarter and $13.2 million for the comparable period in 2021. The increase was driven by personnel expense and costs associated with ongoing clinical trials. SG&A expenses were $40.9 million for the third quarter and $20.2 million for the comparable period in 2021. The increase was primarily related to a full quarter of commercial activities for Sunosi, pre-launch activities for Auvelity and personnel expense, along with an increase in non-cash stock compensation expense. Net loss was $44.8 million or $1.07 per share for the third quarter and net loss of $34.9 million or $0.93 per share for the comparable period in 2021. The net loss for the current period included $9.2 million of non-cash stock compensation expense compared to $5.7 million in the comparable period. We ended the quarter with $227.5 million in cash and equivalents compared to $86.5 million at December 31, 2021. During the third quarter, we utilized our ATM facility realizing net proceeds of $175 million. As a reminder, with the FDA approval of Auvelity, up to $100 million is immediately available under our $300 million term loan facility. We believe that our current cash balance along with the remaining committed capital from the $300 million term loan facility with Hercules Capital is sufficient to fund anticipated operations into 2025 based on our current operating plan. I will now turn the call over to Lori for a commercial update.

Lori Englebert, Executive Vice President of Commercial and Business Development

Thank you, Nick, and good morning, everyone. With Sunosi and the very recent launch of Auvelity, we now have two marketed products, both of which address serious conditions. I am excited to provide a commercial update for these two important and differentiated therapies. I'd first like to start with Sunosi. Q3 represents the first full quarter for Sunosi as an Axsome product. 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. In the quarter, total Sunosi prescription growth outpaced the wake promoting or WPA market. U.S. total prescriptions for Sunosi in the third quarter grew 15% year-over-year versus the WPA market growing only 1%. Quarter-over-quarter, sequential total prescription growth was 3% for Sunosi versus 0% growth for the WPA market. Our Digital Centric Commercialization, or DCC, platform is performing well and has contributed to increased sales force productivity for Sunosi that is approximately twice that of prior periods and of the industry average. This contemporary, integrated omni-channel approach to meaningful customer engagements is also being used for the launch of Auvelity and will be leveraged for the commercialization of future products in our pipeline. The growth potential for Sunosi is substantial, and we continue to estimate peak U.S. sales potential in the current indication alone of $300 million to $500 million. OSA affects an estimated 22 million U.S. adults, 87% of whom experience EDS. And narcolepsy affects close to 200,000 people in the U.S., all of whom experience EDS. Sunosi currently enjoys only a 2% share of drug treated OSA patients and a 7% share in drug treated narcolepsy patients. We expect increased and enhanced promotional and disease education efforts to drive market share growth for Sunosi. Payer coverage for Sunosi remains broad, with 96% of commercial lives covered and 83% of total lives covered. Turning to Auvelity. We announced the commercial availability of Auvelity on October 20. It is still very early days. But so far, we are very encouraged by the early interest. Our field force is actively engaging healthcare providers to provide comprehensive education on Auvelity. We are proud of the quality of our sales specialists, the vast majority of whom have prior psychiatric medication experience, including antidepressants. Guided by our DCC platform, our field force has already reached more than 15% of our prescriber target list with only 12 days on the market. With regards to payer coverage, the commercial channel is expected to be the primary channel for Auvelity. As a rule, new therapies are generally blocked by commercial payers for the first six months after launch, while they perform clinical reviews and decide on formulary placement. Interactions with commercial payers have been active and productive, and we expect some formulary decisions over the next six months. In the Medicare and Medicaid channels, antidepressants are a protected class. In order to help ensure that patients have access to, and that physicians have an easy experience prescribing Auvelity, we have enabled a comprehensive suite of tools and services in our patient support program, Auvelity on My Side. Our patient support services include a pay no more than $10 per month savings card for eligible patients, samples, and prior authorization support for HCPs, among other tools. Major depressive disorder, or MDD, is a major public health concern with 21 million U.S. adults diagnosed in 2020 and recent publications have reported significant increases in prevalence as a result of the pandemic. We are proud to make Auvelity available to patients living with MDD and their physicians. I will now turn the call back to Mark to lead the Q&A discussion.

Mark Jacobson, COO

Thank you, Lori. Operator, can we please have our first question? And if folks on the line that are asking questions, could you please be mindful of two to three questions per person? That would be fantastic and that's just based on the size of the queue that we have. Thank you.

Charles Duncan, Analyst

Hi, Herriot and team. Congratulations on a great quarter. Thank you for taking our questions. My first question is about the commercial side. I also have a pipeline question for Lori regarding commercial. When you discuss Auvelity, what do you believe is the most appealing aspect to prescribers in terms of its clinical profile? Is it the distinct mechanism, quick onset, limited side effects, or something else?

Lori Englebert, Executive Vice President of Commercial and Business Development

Hi, Charles. Thanks for the question. It encompasses everything mentioned. Our field team has been incredibly active since we announced the product's availability. In just 12 days in the market, they have conducted full clinical reviews of Auvelity with 15% of our target list, engaging directly with healthcare professionals. It’s been exciting to see their level of activity and the engagement from physicians. It's challenging to identify just one factor, as it varies by physician, but all the aspects mentioned are being prioritized.

Charles Duncan, Analyst

Okay. We'll look for more color in later quarters. On the pipeline, I guess on AXS-05, Herriot you mentioned the randomized withdrawal study has been concluded, but double-blind study is advancing or ADVANCE-2 has started. I guess I'm wondering what kind of feedback have you gotten from the agency with regard to being able to interpret randomized withdrawal. And then just a quick one on AXS-07. What is really the gating factors to give you visibility on one year from now being able to resubmit that NDA for AXS-07 in migraine? Thanks.

Herriot Tabuteau, CEO

Thanks for the question, Charles. With regards to the feedback from the FDA on randomized withdrawal studies, if you look at that design, what that design does is it provides evidence of whether or not a drug is working relative to control. That's very clear. And products have been approved, not just overall but also in psychiatry, specifically, with the randomized withdrawal study design. Randomized withdrawal studies though they do not provide you the same information that parallel group studies provide, and that information would include a treatment effect. And with regards to your question on AXS-07, I'll turn that over to Mark.

Mark Jacobson, COO

Hi, Charles. Good morning. So just the recap there why approximately one year or the third quarter of next year? The FDA asked for a number of things from us with respect to CMC, including stability data on new batches that had already been made or are being made. And so just a brief background on stability data, right. That data is used to assess and inform the shelf life of an approved product. And there are various stability protocols that can be run, but typical ICH guidelines or at room temperature and accelerated conditions, and those cannot be sped up. And so typical times are zero, one month, six months, 12 months, et cetera. So it's just going through that process and generating that data.

Charles Duncan, Analyst

Got it. So it's really Gantt chart. Appreciate you taking the questions. Nice quarter. Thanks.

Marc Goodman, Analyst

Yes. So we talked about Sunosi a little bit. Just give us a sense of just what's going on behind the scenes with gross to net inventory changes. I know this is your first full quarter, but maybe you can talk about the product, just how the gross to net have been throughout the year, and just your payer coverage and just physician feedback on the product. Thanks.

Herriot Tabuteau, CEO

Yes. Great. Thanks for the question. I think Nick will take the gross to net question and Lori will comment on what's going on behind the scenes, inventory changes, et cetera.

Nick Pizzie, CFO

Sure. Hi, Marc. Good morning. Regarding your question on gross to net, as mentioned during the investor call, we anticipated the gross to net ratio to be around 50%, and that aligns with what we are currently observing. It has remained relatively stable. Concerning inventory, the sales for the quarter were not influenced by any inventory buildup or channel inventory. In Q2, we had to stock the channel initially, but for Q3, I believe we are in a steady state. Therefore, there was no inventory impact during the quarter.

Herriot Tabuteau, CEO

Lori?

Lori Englebert, Executive Vice President of Commercial and Business Development

Yes. Hi, Marc. And I'll just add on payer coverage. Our payer coverage has maintained exactly what it was when we acquired the product back in May. There's been no payer coverage changes.

Joon Lee, Analyst

Hi. Thanks for taking our questions. In addition to Veeva Systems, are you supplementing your efforts with services from IQVIA? Our understanding is that due to the ongoing litigation between Veeva and IQVIA, Veeva clients are blocked from certain services provided by IQVIA. Just wanted to understand the flexibility of your DCC efforts? And on the pipeline, what can we expect in terms of the kinds of data you will share for ACCORD by year end? And are there any material differences between the designs of ADVANCE-1 and 2? Thank you.

Lori Englebert, Executive Vice President of Commercial and Business Development

Hi, Joon. Thanks for the question. Yes, so let me just recap from DCC how our infrastructure is built and then I can answer your question around IQVIA. So as we've stated in the past, our DCC platform is really built off of Veeva as foundational and it is supplemented by several different additional tools and analytical machine learning AI offerings. The limitation with Veeva and IQVIA, we're not impacted by that at all. We actually use SYMPHONY data. And so they're very interchangeable. And that is what feeds through the Veeva system. So there's really no impact to us in terms of what our offerings look like.

Herriot Tabuteau, CEO

Certainly. Here’s the rewritten Earnings Call remark: Regarding your other two questions, we expect to have the top line results from the ACCORD trial by year end. We're eager to unblind the study and share the results, as they will give us more insight into the product's effectiveness in this patient population. It's worth noting that the ADVANCE-1 trial yielded very positive results. Although we reduced the power of the ACCORD trial since we halted it to start the events trial, we still believe the results may provide us with directionally useful information that could affirm the product's activity. As for the ADVANCE-1 and ADVANCE-2 studies, there are no significant differences in their designs; they are essentially identical.

Joon Lee, Analyst

Thank you.

Jason Gerberry, Analyst

Hi. Good morning. Thanks for taking my questions. Wondering if you can just talk a little bit about Auvelity’s insurance mix and how that impacts gross to net in say the first six to nine months? I know you guys have been out talking about sort of the challenge with commercial coverage in the early days. So just kind of wondering how you anticipate sort of revenue capture per script basis? And maybe Lori, if you can comment on sort of effectively the Amgen kind of free script model with CGRP antibodies out of the gate, if that's something that you can kind of leverage to get early awareness and utilization of Auvelity in the marketplace? And then also just on the DCC program with Sunosi, like what's the right amount of time to assess the effectiveness of DCC as it pertains to Sunosi? Thanks.

Lori Englebert, Executive Vice President of Commercial and Business Development

Hi, Jason. Thank you for your questions. Let me start from the beginning. The commercial channel is expected to be our main channel for Auvelity. Typically, new therapies face temporary coverage restrictions from commercial payers after approval while these payers conduct their clinical reviews and determine formulary placement. However, this doesn’t prevent coverage for patients if healthcare providers complete the necessary paperwork. That's why we have a strong prior authorization support system and our Auvelity on My Side co-pay card program in place to ensure patients have affordable access to the therapy. We have been actively communicating with commercial payers, and these conversations have been productive since our launch announcement. We expect some formulary decisions to come in the next six months. Additionally, we will see some volume through the Medicare and Medicaid channels, which are classified as protected classes. In response to your question about the Amgen approach of providing free scripts, that's not our strategy. We are offering a co-pay card and assistance to patients so they can access the drug at an affordable rate, while their physicians complete the necessary paperwork to request coverage from payers. You also inquired about the DCC program with Sunosi and its potential impacts. As I mentioned earlier, we are already witnessing the effects of DCC with the Sunosi sales team. Our field force is about half the size of previous quarters, yet we are maintaining the same level of productivity. This is encouraging as we continue to relaunch Sunosi. We are focused on ensuring we target the right healthcare providers who can reach enough suitable patients to drive growth. Our sales representatives are highly experienced, supported by an outstanding leadership team, and we believe that coupled with increased emphasis on disease education and promotional spending, this will be our path to growth.

Jason Gerberry, Analyst

Got it. Great, thanks.

Joseph Thome, Analyst

Hi, there. Good morning and thank you for taking our questions. I have a first question regarding the initial demand. Where is it coming from and where are these patients in their treatment journey? Do you anticipate any changes over time? Now that Auvelity is approved in the U.S., what are your updated thoughts on international approvals or licensing? Thank you.

Lori Englebert, Executive Vice President of Commercial and Business Development

Yes. Hi, Joseph. Thanks for the question. So as you would expect, again, it's only 12 days on market. But what we're seeing in these very early days is exactly what you would expect. So the scripts are coming primarily from psychiatrists with a nice handful from PCPs. Where patients are in terms of their treatment journey, it's all over the place. And that is likely supported by the fact that the clinical profile of Auvelity has data in a very robust and broad subsets of patient groups. So physicians are really finding patients across the board, if they are a candidate for Auvelity. Right now, it's a little bit too early to tell which lines of therapy we're concentrating on. And I'll turn it over to Nick for the ex-U.S.

Nick Pizzie, CFO

Hi, Joe. So for Auvelity right now as we've always stated, we're always looking for ex-U.S. partners. That's how we've consistently stated. And then for Sunosi will be from an ex-U.S. standpoint, as we stated in our opening comments. We are expecting to close on the ex-U.S. portion of Sunosi this quarter.

Mark Jacobson, COO

It's Mark. Joe, for AXS-12, work is ongoing for CMC. Just a reminder, the API is a custom synthesis process that we oversee along with the drug product. All the work to support registration batches is in progress.

Yatin Suneja, Analyst

Hi, guys. Thank you for taking my question. Just a couple from me. First one is on the sampling. Can you just comment on whether you are doing sampling? How are the sampling setup? Is it like a weekly pack, two-week pack? And then maybe also comment on if somebody starts on a sample, how the reimbursement work? So that's first part. Second is around how are you recognizing revenues? If you can just tell us what does that entail? And then finally, the Rx data or the TRx data that's available to third party, how accurate that is? Should we use that to help model the launch? Thanks.

Herriot Tabuteau, CEO

Thanks, Yatin, for the question. So I think Lori will handle the sampling question and also the data reporting and Nick will handle the revenue recognition.

Lori Englebert, Executive Vice President of Commercial and Business Development

Hi, Yatin. Good morning. Regarding samples, we are currently distributing them in a way that healthcare professionals can order them online or receive them when their representative visits the office, so they are electronic samples and shipped immediately. Typically, the process varies by healthcare professional, but generally, physicians will provide samples to patients and then give them the prescription or file the EMR prescription simultaneously through the EMR system. As for size, it is a two-week supply bottle.

Nick Pizzie, CFO

Great. And then as it relates to the revenue, so we are in a title model. So, as such, once inventory transfers from our warehouse to the distributor, sale is recorded, risk of losses is passed at that point, title is transferred. And then we are booking associated gross to net accruals against those gross sales.

Lori Englebert, Executive Vice President of Commercial and Business Development

I'll address the data reporting aspect. In the beginning, both SYMPHONY and IQVIA found it challenging to accurately predict their capture rates for national scripts. There's always a variable in play. However, we have observed that their performance is closely aligning with our expectations. We anticipate that their capture rates will improve over the coming weeks as data is reconciled, and the trend is moving in a positive direction.

Yatin Suneja, Analyst

Got it. Just one quick, if I may. What about the inventory? How are you managing that? Is there a target, like you need to be in the two-week range, just if you can comment? And I'll get back in the queue. Thank you.

Nick Pizzie, CFO

Yes, that's correct. So with the title model, it's pretty easy to ensure that supply is in the channel. So there's roughly basically two weeks at any given time that's in the channel. And that's currently how we're seeing it.

Vikram Purohit, Analyst

Hi. Good morning. Thanks for taking my questions. We have two, both related to what you've learned about duration of use for Auvelity in the early phase of the launch. So question one, how many bottles of treatment do you think one prescription currently represents? And how do you think this could evolve once the launch is in more of a steady state? And then secondly, more broadly, what are your current thoughts on how many bottles of Auvelity per year you think the average patient would use, again, once the launch in kind of a full blown steady state? Thanks.

Herriot Tabuteau, CEO

Hi, Vikram. Thanks for the question. We've been on the market 12 days, so it's a little bit early to be able to provide you with any credible answer to the duration of use and also to the duration of use. With regards to what the scripts represent, I think it's pretty clear. But Lori, could you maybe clarify?

Lori Englebert, Executive Vice President of Commercial and Business Development

Yes, I would say it's a bit too early to provide a definitive answer. However, the prescribing information is very clear about the dosing, and we fully expect that a 30-day prescription will amount to two bottles. Again, it's still too early for us to have any data at this point.

Herriot Tabuteau, CEO

Lori, that's what we're seeing.

Lori Englebert, Executive Vice President of Commercial and Business Development

That's exactly what we're seeing.

Chris Howerton, Analyst

Great. Thank you so much. I just had two quick questions. One was with respect to the Sunosi commercial launch. Could you give us a sense of the split between OSA and narcolepsy? And I guess the follow up to that, what would be the strategy to maximize revenues in narcolepsy, assuming success in AXS-12? And then the second question I had is just a curiosity with respect to the new mechanism that was discovered for Sunosi. Any plans to capitalize on the TAAR1 agonism in any way, or just an interesting finding that you found about the molecule? Thank you.

Herriot Tabuteau, CEO

Great. So Lori, maybe you could comment on the split between OSA and narcolepsy in terms of scripts, and then I'll take the other question.

Lori Englebert, Executive Vice President of Commercial and Business Development

Sure. Hi, Chris. So right now, the current scripts split is about 70% OSA, 30% narcolepsy. The OSA market is a massive market, right, 22 million patients suffer from OSA versus 200,000 in narcolepsy. There's definitely room to grow in both. And it's a bit premature to talk about how we'll work with AXS-12. But Sunosi is indicated for EDS in narcolepsy only. And so we will make sure that the early treatment for narcolepsy is capitalized on since that is usually one of the first symptoms that is present in diagnosis.

Herriot Tabuteau, CEO

Regarding your question about Sunosi in narcolepsy versus AXS-12, it's important to note that AXS-12 is being developed for cataplexy in narcolepsy, while Sunosi is indicated for excessive daytime sleepiness in narcolepsy, without activity observed for cataplexy. Thus, the products are complementary. The new mechanism of action for Sunosi, which involves TAAR1 agonism, is significant because it differentiates solriamfetol. This TAAR1 mechanism has also demonstrated pro-cognitive effects, which relates to the potential impact of the drug on cognition. We recently shared the results from the SHARP study, which included cognitively impaired patients with obstructive sleep apnea and excessive daytime sleepiness. The study revealed a statistically significant and strong effect on cognition with Sunosi compared to placebo. We find this mechanism of action particularly interesting for the ADHD indication and plan to initiate a Phase 2/3 trial for Sunosi or solriamfetol in ADHD in this quarter.

David Hoang, Analyst

Hi. Thanks so much for taking the questions, and congrats on the quarter. I just had a couple. So with the ADA indication for AXS-05, can you just remind us again, walk us through the different scenarios that are possible there? So if the ACCORD randomized withdrawal study is positive, do you still intend to file for approval based on that data? And then if it's not, then is the plan that you would need the ADVANCE-2 data to support the filing? Are there any other alternatives besides those pathways?

Herriot Tabuteau, CEO

So the way that we are approaching it is that we intend to have ADVANCE-2 readout before we file an NDA. We want to ensure that we have a robust package. As you are implying there are a lot of different factors. And we'll know a lot more once we read out the ACCORD trial. But right now, our working assumption is that ADVANCE-2 would serve as the second positive trial for an NDA.

Joseph Thome, Analyst

Great. And maybe if I can just do one on the pipeline. In terms of AXS-12, is all you need for regulatory submission this upcoming Phase 3 data, is there any additional CMC work that would need to be completed for this therapy ahead of an NDA submission? Thanks.

Mark Jacobson, COO

It's Mark. Joe, for AXS-12, there is ongoing work for CMC. Just a reminder, the API is a custom synthesis process that we oversee along with the drug product. All the work to support registration batches is underway.

Myles Minter, Analyst

Hi, everyone. Thanks for taking the questions. Just the first one, are you aware of any major payers since the Auvelity launch that have progressed through their pay and say meetings, or at least have them scheduled? And I guess what proportion of covered lives those payers would represent? Thanks.

Lori Englebert, Executive Vice President of Commercial and Business Development

Hi, Myles. Thanks for the question. So as we mentioned earlier, those discussions are active and progressing. But general rule, they're usually blocked for some period of time right after launch so that they can complete their process. Right now, only the Medicare, Medicaid channel, given that it's a protected class, is covered. But as we mentioned previously, the commercial channel will be the primary channel for Auvelity.

Myles Minter, Analyst

Okay, cool. And then quick follow up just on the free sampling program, if you give those to patients, do those end patients have to have a clear path to reimbursement after their two-week script is finished? Thanks.

Lori Englebert, Executive Vice President of Commercial and Business Development

No. So the samples are up to the physician to provide to the patient. So the physician is well within his right to provide samples to his patient and decide when and how to write a script.

Bert Hazlett, Analyst

Thank you for taking the question. One is very straightforward. Is there upside to the ADVANCE-2 trial timing or is 2025 conservative? Thank you and congratulations on all the progress.

Herriot Tabuteau, CEO

So the timing reflects what is on clinicaltrials.gov. And I think it's too early to decide how much leeway there could be in that timing. We think that it is overall conservative, but it is a placeholder. And as the study gets underway further and as we have more information in terms of initial enrollment, then that will allow us to provide more granularity on the timing of study readout.

Operator, Operator

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

Herriot Tabuteau, CEO

Thank you again for joining us on the call today. At Axsome, we are committed to bringing potentially life-changing medicines to people living with serious CNS conditions. With the commercialization of Sunosi, the launch of Auvelity, and our broad late stage pipeline, the hard work of the Axsome team is translating into tangible and meaningful benefits to patients and their healthcare providers. We look forward to updating you over the coming months on our continued commercial and development pipeline progress. Have a great day.

Operator, Operator

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.