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Axsome Therapeutics, Inc. (NASDAQ:AXSM)
Q1 2021 Earnings Call
May 10, 2021, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, and welcome to the Axsome Therapeutics Conference Call. [Operator Instructions]

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 -- Chief Operating Officer

Thank you, operator. Good morning, and thank you all for joining us on today's conference call. Our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2021 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 in the source of future clinical trials, regulatory plans, future research and development plans, commercial plans 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; Lori Englebert, Senior Vice President of Commercial and Business Development; Dr. Amanda Jones, Senior Vice President of Clinical Development; and Dr. Cedric O'Gorman, Senior Vice President of Medical Affairs. Herriot will first provide an overview of the company and then review recent developments and upcoming milestones. Following Herriot, Lori will provide a commercial update and then Nick will review our financial results. We will then open the line for questions. Questions will be taken in the order they're received.

And with that, I will turn the call over to Herriot.

Herriot Tabuteau -- Chief Executive Officer

Thank you, Mark. Good morning, everyone, and thank you all for joining Axsome Therapeutics first quarter 2021 financial results and business update conference call. The timing of this call coincides with the Mental Health Month, and Axsome is proud to observe May as Mental Health Month by partnering with advocacy groups and helping to raise awareness and support for people living with depression and other mental health conditions.

In the first quarter, we continued to make significant strides toward becoming a premier CNS biopharmaceutical company focused on delivering potentially life changing medicines to people living with serious CNS conditions. The dedicated work of the Axsome team resulted into submission of our NDA for AXS-05 for the treatment of major depressive disorder or MDD. The NDA was granted priority review by the FDA, and the FDA has set up a PDUFA target action date for the NDA of August 22, 2021.

The NDA for our second lead product candidate, ASX-07 for the acute treatment of migraine, is on track for submission to the FDA this quarter. And we expect to announce the FDA's decision regarding its acceptance of the filing in the third quarter. With two NDA filings and PDUFA target action date for AXS-05 in late August, Axsome is quickly approaching commercialization stage. Lori, will provide some details on our pre-commercial activities to ensure launch readiness assuming a successful NDA review.

The rest of our differentiated late-stage pipeline continues to advance. AXS-05 is also being developed for the treatment of Alzheimer's disease agitation, and enrollment in the Phase 3 ACCORD trial is progressing. Our AXS-12 product candidate for narcolepsy is progressing toward initiation of the planned Phase 3 trial early in the third quarter. For our AXS-14 product candidate for the treatment of fibromyalgia, we recently met with the FDA to discuss its further clinical development plan, and we are awaiting written feedback from the meeting.

Our portfolio comprises four late stage product candidates under development for six distinct indications, representing unmet medical needs that affect a large percentage of Americans. We are energized by their potential to deliver significant benefit to patients and by our planned commercialization approach.

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

Lori Englebert -- Senior Vice President, Commercial and Business Development

Thank you, Herriot, and good morning, everyone. This is an exciting time at Axsome as we continue to prepare for a successful launch of AXS-05 in major depressive disorder. Today, I will give you an update on our commercial activities as it relates to launch readiness.

The prevalence of depression symptoms in U.S. adults has been steadily on the rise for many years. However, recent studies have shown that in 2020, almost one-third of U.S. adults experienced depressive symptoms. That's a greater than four-fold increase versus 2019. As a result of a rapid increase in mental health conditions and the associated personal and economic burden associated with them, there's an undeniable urgent need to bring awareness and support to those affected.

If approved, AXS-05 would be an important new treatment option for the many Americans living with depression. We are committed to bringing this meaningful innovation to patient by commercializing the product in a timely manner. With an expected PDUFA date of August 22, we anticipate launch in the fourth quarter of this year.

Consistent with Axsome's culture, a commercial launch strategy is innovative and purposeful. I've spoken previously about the plan for our Digital Centric Commercialization or DCC platform to be used as means to optimize engagements across all customer type. Our commitment to and belief in a digital focus has only amplified over the past year as research continues to indicate a strong preference for and trend in this direction with our core customers. Our foundational technology infrastructure is now fully implemented, and we continue to build out our digital capabilities. Using sophisticated data and analytics, streamlined system and digital enablement tools, our DCC platform will allow for a more effective, efficient and meaningful engagement with physicians and consumers.

Along with building out our DCC platform, over the past year, we've constructed a commercial team that combines breadth and depth of commercial experience with a desire to innovate. I am extremely proud of our commercial team, and I am impressed with their thought leadership and passion for helping those affected by CNS condition. Functional senior leadership across marketing, market access, commercial operations and sales are all in place.

Launch activities are focused on a potential Q4 launch of AXS-05 if approved. The preparations also include launch readiness for a potential AXS-07 launch. Our marketing team is focused on disease education and post-PDUFA launch promotional planning. The market access team continues to engage in ongoing permitted discussions with payers, ensuring awareness of Axsome and of ASX-05 product profile along with actively setting up comprehensive patient support services.

The commercial operations team is expertly working to implement and execute our DCC vision. And lastly, our sales team has determined the optimum size, structure and design of our sales force and are now concentrating on sales force preparedness as hiring at both the build leadership and rep level has commenced. And finally, outside of commercial, the medical affairs group is focused on data presentations at upcoming congresses and continuing MSL engagement with KOLs.

I will now turn it over to Nick who will review our financials.

Nick Pizzie -- Chief Financial Officer

Thank you, Lori. Good morning, everyone. Today we'll discuss our first quarter 2021 results and provide some financial guidance.

We ended the first quarter with approximately $165 million in cash compared to roughly $184 million in cash at the end of the fourth quarter, a net decrease of approximately $19 million. R&D expenses were $16.6 million for the quarter ending March 31, 2021 versus $27.5 million for the comparable period in 2020. The decrease in R&D expense was driven by a one-time charge in the prior period of $10.2 million related to the Pfizer license agreement along with several of our clinical trials that were ongoing in comparable period that has subsequently been completed.

The current quarter include a $2.9 million charge related to the PDUFA application fee for the NDA submission for AXS-05. Subsequent to the end of the quarter, we have received confirmation from the FDA that our small business waiver request has been accepted and we will be refunded this PDUFA application fee.

G&A expenses were $11.2 million for the quarter ending March 31, 2021 and $5 million for the comparable period in 2020. The change was primarily due to the increase in pre-commercial activities and stock compensation expense. Net loss was $29.3 million or $0.78 loss per share for the quarter ended March 31, 2021 compared to a net loss of $32.5 million or $0.88 loss per share for the comparable period in 2020.

As a reminder, we currently have a $225 million term loan facility, of which $175 million in funding remains available. This committed non-dilutive capital gives us additional financial flexibility through both anticipated potential commercial launches on AXS-05 and for AXS-07. We believe our current cash position of $165 million along with the remaining committed capital from our $225 million term loan facility is sufficient to fund our anticipated operations based on our current operating plan into at least 2024.

That concludes our first quarter 2021 financial review. I will now turn the call back to Mark to lead the Q&A discussion.

Mark Jacobson -- Chief Operating Officer

Thank you, Nick. Operator, may we please have our first question.

Questions and Answers:

Operator

Thank you. [Operator Instructions] Your first question comes from the line of Charles Duncan from Cantor Fitzgerald. Please go ahead. Your line is now open.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah, fabulous. Good morning, Herriot and team. Congrats on really good progress in the quarter. I had a quick question regarding the PDUFA -- the upcoming PDUFA date for AXS-05 for MDD. Would you anticipate an AdCom in advance of that? Has the FDA communicated anything or even if they haven't, are you prepared to conducting an AdCom?

Herriot Tabuteau -- Chief Executive Officer

Thanks Charles for the question. We have not gotten any communication from the FDA indicating that there will be an AdCom. Now that can change. And if that were to change, we'd be in a position to let the Street know as soon as possible. And with regards to preparations for an AdCom, as you know, when you file the NDA, there's a lot of preparation that goes into that very significant filing. And so based upon that work, we think that we would be prepared for whatever happens during the review cycle. AdComs are the potential expected part of any review cycle. But for the time being, we have not gotten any indication that there would be an AdCom.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. That's helpful. Let me ask a quick question for Lori and then I'll hop back in the queue, and that is regarding the commercial readiness. When you think about AXS-05 versus AXS-07, can you perhaps highlight some of the synergies in the preparations that you're doing? But then also, perhaps, how would you address any differences in the prescriber base? And how does that impact optimal sizing of the field force? And I imagine also, you haven't talked about those numbers, but can you provide any color on that?

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hey, Charles, thank you. Thank you for the question. Can you hear me OK?

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes.

Lori Englebert -- Senior Vice President, Commercial and Business Development

I'm a bit under the weather. So I just want to make sure everyone can hear clearly.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Sounds great.

Lori Englebert -- Senior Vice President, Commercial and Business Development

It's a great question. Rest assured, as we've been planning for commercialization, we've always planned for AXS-07 to potentially follow very closely behind AXS-05. And that includes everything from how we setup our DCC platform in terms of being able to enable quick execution from an AXS-05 and an AXS-07 standpoint as well as how we're structuring our sales force. So whereas our sales force will obviously be originally constructed to call upon our depression prescribing physicians, there is quite a bit of overlap with physicians in terms of migraine and depression. And so we do anticipate being able to quickly pivot when AXS-07 is ready to launch.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. Last question for Nick, just kind of housekeeping. Nick, congrats on getting that money back from the agency, but I know we're dealing with the U.S. government here. When would you actually anticipate them? And could we assume that it come back perhaps to hit the balance sheet in this second quarter?

Nick Pizzie -- Chief Financial Officer

Yeah. Hi, Charles. Yeah, that's a good question. So they have accepted the waiver, as you heard in the opening remarks. So now, we are just waiting for reimbursement. So the process has been started to receive the $2.9 million back and we should be receiving it back shortly. I can't give a specific time on when we would be receiving that back.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. Sounds good. Thanks for taking my questions. Congrats on the progress.

Operator

Your next question comes from the line of Joon Lee from Truist Securities. Please go ahead. Your line is now open.

Joon Lee -- Truist -- Analyst

Hi. Thanks for taking our questions, and congrats on the progress. So the first question is the prevalence of depression is more than four-fold pre-pandemic level, as you say, and that's corroborated by many other sources, but does that necessarily imply that there are that many diagnosable MDD patients? I'm just curious if those people who claim to be depressed are actually -- represent pool of patients who could be medically diagnosed and be prescribed ASX-05? And I have a follow-up. Thank you.

Herriot Tabuteau -- Chief Executive Officer

Thanks Joon for the question. If you look at the CDC data, which we referenced, if you look at the percentage of patients or the percentage of U.S. adults with depression symptoms that they've measured which was about 6.9% or roughly 7% in 2019, that actually corresponds to the prevalence of MDD or major depressive disorder. So it's the same CDC numbers and those have gone up to roughly 30% or so and then that level of patients or U.S. adults with the symptoms of depression. So we don't know the answer to the question of whether or not all these individuals would be diagnosed with MDD. But the original starting point did correlate pretty well with the -- it did correlate pretty well with the prevalence of MDD.

Now -- so I'd like to turn it over to Lori to see if she's got anything more to add to that.

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hi, Joon. Thanks for the question. It is something that we are obviously actively watching to watch either diagnose and drug treated. But what we do know through data is that in 2020, the overall prescription market grew about 6% to 7%. So that would indicate that more patients are coming into the funnel.

Joon Lee -- Truist -- Analyst

Okay, great. Looking forward to the numbers and progress there. And then the second question is that it's great that you got the priority review, but that does shorten the time for inspections of the clinical sites, and more importantly, the manufacturing site. So can you tell us a little bit about your CMO? Can you disclose who they are? And if you can't, maybe their capabilities, experience level and whether they've been inspected recently or not? Thank you.

Herriot Tabuteau -- Chief Executive Officer

So our CMO is a blue chip CMO. And so they get regularly inspected. So they had an [Technical Issue] may get inspected at least once a year.

Joon Lee -- Truist -- Analyst

Okay. Thank you.

Operator

Your next question comes from the line of Marc Goodman from SVB Leerink. Please go ahead. Your line is now open.

Roanna Ruiz -- SVB Leerink -- Analyst

Hi. This is Roanna on the line for Mark. Thanks for taking the question. I was curious, a little bit more detail about the launch plan for AXS-05. Could you let us know how the -- what the cadence is of your payer engagement activities and maybe the scope of educational programs that you're doing ahead of the AXS-05 launch?

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hi, Roanna. Thank you for the question. So from a payer engagement standpoint, we have been and continue to engage with payers on a permitted fashion, those producing Axsome overall as well as really educating them on the AXS-05 clinical profile. Payers are extremely interested. As we mentioned earlier, there's a mental health crisis happening in America and that causes tremendous personal and economic burden to the system. Payers obviously are very interested in understanding and learning more about products that may help alleviate the efforts.

Herriot Tabuteau -- Chief Executive Officer

And then with regards to the educational programs, depending on the medical conferences that are upcoming, there's an opportunity for sponsored educational programs that raise awareness to disease state. And we recently had a significant presence with the American Psychiatric Association where we had a sponsored product theater based around the unmet need within MDD, the limitations of current treatments and future directions in terms of clinical development. And by all accounts based on metrics we received from the American Psychiatric Association, excellent product theater was among the best attended at that conference. So there's many more conferences where we can have those kinds of educational programs promoted.

Roanna Ruiz -- SVB Leerink -- Analyst

Got it. Thanks. And one more if I can. I wasn't sure if you've disclosed this yet, but curious, how many target accounts do you plan to detail at the initial launch of AXS-05?

Lori Englebert -- Senior Vice President, Commercial and Business Development

Yeah. It's a great question. [Technical Issue] What I can tell you is that the size and structure of our sales force has long been set, it was actually part of the impetus for our DCC platform. The DCC platform was really developed to help maximize our sales forces' efficiency. But rest assured, we will not sacrifice either quality and/or reach with our target position.

Roanna Ruiz -- SVB Leerink -- Analyst

Got it. Thanks.

Operator

Your next question comes from the line of Vamil Divan from Mizuho Securities. Please go ahead. Your line is now open.

Vamil Divan -- Mizuho Securities USA, LLC -- Analyst

Hi, great. Thanks for taking the questions. Maybe two if I could. Just one the AXS-05 filing, obviously great that you got exception -- accepted in priority review. I'm just curious if you've had further discussions at all with the FDA around the ASCEND trial? I think just given some of the surprises we've seen from the regulators recently, there's been some concerns around if that trial sort of big enough, robust enough to be considered pivotal? I assume just maybe you can give any further updates on your conversation would be helpful. And then just on AXS-07, can you maybe just update us. I know, you're saying you're going to file in the second quarter here. I think it's pushed earlier this year and got pushed back a little bit. Again, can you just maybe remind us of what the gating factors are in terms of getting that submission into the FDA? Thanks.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

Thanks for the questions. With regards to AXS-05 and the NDA, what we can tell you is that it's the obvious. The filing was accepted, it was granted priority review. So therefore, the FDA clearly has everything that it needs in order to conduct a substantive review. Of course, we can't comment on the specifics of our communications with the FDA in one way or another. And with regards to the ASCEND trial, we -- I do remind you that this is a very considerably designated product. And we did previously disclose that the ASCEND trial after the breakthrough meeting was declared a pivotal trial. With regards to AXS-07, we're very much on track to file the NDA this quarter, as we've previously stated, and there really isn't any update there. The team is working diligently to make sure that we have a timely, but also a quality filing.

Vamil Divan -- Mizuho Securities USA, LLC -- Analyst

Okay. All right. Thank you.

Operator

Your next question comes from the line of Yatin Suneja from Guggenheim Partners. Please go ahead. Your line is now open.

Yatin Suneja -- Guggenheim -- Analyst

Hey, guys. Thank you for taking my question. Can you maybe help us understand the time -- the enrollment timeframe for the narcolepsy Phase 3 program? It seems like it got pushed a little bit. Any gating factor to initiating that study? So that's number one. The second is, if you can comment a little bit on the pricing war that you might have done for AXS-05. Are there certain price point where you are seeing sensitivity in the market research? And would you keep the price below specialty tiers and what you might do or what you could do with regards to the co-pay and the help you could provide? Thanks.

Herriot Tabuteau -- Chief Executive Officer

So thanks, Yatin for the questions. So I'll turn it over to Lori to answer the pricing question. With regards to the narcolepsy study, so we are on track to start that trial early in the third quarter. So initially, the guidance that we had given was the second quarter to start the Phase 3 trial. And then frankly, that will slip into roughly the first month of the third quarter. So that's well within the normal variability, which you would expect with planning for a complex study as a Phase 3 trial. And Lori with regards to pricing.

Lori Englebert -- Senior Vice President, Commercial and Business Development

Sure. Hi, Yatin. Thanks for the question. It's a bit premature for us to disclose any details around pricing, but you can use -- we plan to do that closer to launch. But what I can tell you is that we are working really hard to make sure that we ensure fair and timely [Technical Issue] while adequately capturing the value of the product. And along with that is obviously engaging and educating payers with the clinical profile of AXS-05. But as Cedric mentioned earlier, we are continuing to present additional data at congresses that are upcoming that we will use as supportive information for the payers. In terms of...

Yatin Suneja -- Guggenheim -- Analyst

Lori, one more question -- sorry, go ahead.

Lori Englebert -- Senior Vice President, Commercial and Business Development

No, I was just going to answer your patient support and co-pay questions. Just wanted to assure you that we -- as I mentioned in the prepared remarks, we are preparing patient support services to make sure that patients receive that product in an easy fashion.

Yatin Suneja -- Guggenheim -- Analyst

Got it. The question I have is on the Veeva -- your partnership with Veeva Systems. If you can just maybe talk a little bit how are you going to leverage it? What does this system exactly do? Are there other companies that have successfully used the Veeva platform in launching the product? Just trying to understand the edge it gives you and what the -- what others successful launches that have been done using this platform. Thank you.

Lori Englebert -- Senior Vice President, Commercial and Business Development

Yeah. Thanks for that question. So it's important to keep in mind that Veeva is a critical foundational component of our DCC platform, it's not the only component. Companies all over the world are leveraging Veeva right now, and we have been extremely pleased with the partnership that we have with them in setting the foundation for DCC. We are also working to add systems and to complement the Veeva Systems with a digital capability that does enable real-time data to be fed and sophisticated analytics to be fed back out to sales reps so they make an efficient and effective promotional call.

Yatin Suneja -- Guggenheim -- Analyst

Got it. Thank you.

Operator

Your next question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead. Your line is now open. Ram Selvaraju from H.C. Wainwright, please go ahead. Your line is now open. And caller you may be muted.

Mark Jacobson -- Chief Operating Officer

So why don't we move on to the next question, and we'll get back to Ram.

Operator

Certainly. Your next question here comes from Joe Thome from Cowen and Company. Please go ahead. Your line is now open.

Joseph Thome -- Cowen -- Analyst

Hi, there. Good morning, and thank you for taking my questions. The first one, I know you touched a little bit on the difference between the increase in depressive symptoms that have been seen over the past year versus a formal MDD or TRD diagnosis. Do you expect that this impacted the enrollment of the MERIT trial or how are you thinking about that? And then my second one is on AXS-14. Can you just remind us what the base case expectations are here and the patients or the FDA have a certain symptom that they are looking at kind of most carefully? Thank you.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

Sure. So with regards to MERIT enrollment, as a reminder, that study -- just to remind folks, the MERIT trial is the Phase 2 trial in treatment resistant depression. So that study uses a randomized approach design. And so that's pretty heavily enrolled. Currently, we are waiting for our relapses to occur in that trial and that determines the timing of the rehab. And then you asked the question about AXS-14. So this is our product candidate for fibromyalgia. Could you just be more specific in terms of what you'd like to know about AXS-14?

Joseph Thome -- Cowen -- Analyst

Yeah. I guess, in terms of next steps, what are your base case expectations? Is sort of another Phase 3 expected? Can you file on the current package? And then I guess, in your conversations with the FDA, was there a certain symptom that appeared that they were most concerned about whether it's pain or fatigue? Kind of what do you think will drive benefiting update to you? Thank you.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

We met with the FDA in the second quarter as we had planned around AXS-14. And currently, we are anticipating and waiting for the final meeting minutes. And we'll have more to say once we get those final meeting minutes. But we'd like to get the written feedback prior to providing any details. And with regards to symptoms in general for fibromyalgia, you accurately pointed out, fibromyalgia, it does incorporate pain, but not just pain, but other symptoms such as [Technical Issue] In the current regulatory endpoints for fibromyalgia studies, they do incorporate those other symptoms. So there is pain obviously, that is one regulatory endpoint, but another regulatory endpoint, for example, is a functional endpoint, which incorporates many other symptoms of fibromyalgia.

Joseph Thome -- Cowen -- Analyst

Great. Thank you.

Operator

Your next question comes from the line of Chris Howerton from Jefferies. Please go ahead. Your line is now open.

Chris Howerton -- Jefferies -- Analyst

Wonderful. Thanks so much for taking the questions. I think a lot of them have been asked at this point, but I guess, as we move toward commercialization, is the plan -- does the team have a plan to give us more color and solid information around kind of how it is that they've devised the commercial infrastructure in team kind of what will be the key metrics moving forward? So just trying to get an understanding of when might we learn more about the commercial efforts and the structure and all that? The second question that I would have is with respect to the MERIT trial and the readout. Obviously, we're expecting the PDUFA for AXS-05 soon in August. So how might that information alter your activities in the commercial setting if it is approved at that time? Thanks.

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hi, Chris. Thanks. Thanks for the question. So in terms of when we'll disclose size and structure, you can expect that at around launch. That's typically when we would be prepared to reveal that information. I think what I can tell you is that we recently, within the past three weeks, have started our hiring efforts for the sales force at the field leadership level as well as the rep level. The response has been overwhelming in terms of the amount of applicants as well as the quality of the applicants. So we're quite pleased at the response that we've received as well as it gives us great insight that we'll be able to meet our timelines that we've set out to meet. And then also make sure that we have the right type of people in the positions given our unique approach and vision. In terms of metrics around how we're going to measure success at launch, we will -- you can expect us to start thinking about revealing that closer to the launch.

Chris Howerton -- Jefferies -- Analyst

Okay. Thank you.

Herriot Tabuteau -- Chief Executive Officer

And with regards to your question on the MERIT trial.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

So the MERIT trial, this is a Phase 2 trial, which is -- which we launched at the same time that we had launched our other studies, the COMET studies, for example, the COMET sub-studies, with a goal of generating data to provide to clinicians across a wide spectrum of patients with MDD. So that was the reason for launching that trial. And so once it reads out in terms of its potential impact on the launch that impact will be that it will be -- it will allow us to publish and provide additional data to clinicians on how AXS-05 performs in a variety of different types of patients with MDD.

Chris Howerton -- Jefferies -- Analyst

Okay. That's wonderful. Thank you very much for taking the questions.

Operator

Your next question comes from the line of Matt Kaplan from Ladenburg Thalmann. Please go ahead. Your line is now open.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Hi. Good morning, guys. Just wanted to follow-up a little bit more on the -- your interaction with payers. Specifically, Lori, maybe can you give us a sense in terms of how we should think about the rollout of coverage over time, maybe initially and then the first six to 12 months with respect to commercial and other coverage for AXS-05? And then also, I guess, with AXS-07 kind of close on the heels, potentially filing approval. But what are your thoughts and interaction with payers on AXS-07 as well?

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hey, Matt. Thanks. So in terms of coverage, it's -- I know, I've said it a lot on this call, but it is really too premature for us to really disclose that, but it's also premature because our discussions are ongoing. And so we're thinking through that in terms of a patient support services offerings so that we make sure that patients are covered. But we do anticipate that the product will be covered. We have high confidence that the product will be covered. And we do believe that payers are extremely interested in the product profile. In terms of AXS-07 that -- those discussions have -- we've performed market research, but we have not discussed ASX-07 with payers specifically outside of just an overall Axsome portfolio introduction.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Very good. Thanks. And then maybe Herriot. In terms of next indications for AXS-05, can you talk a little bit about where you are and how it's -- how the AD agitation Phase 3 program is progressing? And then kind of next steps for smoking cessation as well?

Herriot Tabuteau -- Chief Executive Officer

Sure. Thanks, Matt, for those questions. And I think I'm going to turn it over to Amanda Jones to provide color on those two programs.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Great. Thank you.

Amanda Jones -- Senior Vice President, Clinical Development

Hi. So in regards to the AD agitation program, it is progressing nicely. It's still a little bit early for us to give any formal guidance on the overall status just based on the nature of the study design, which involves patients responding and then being randomized and going on to relapse. And then the second question was around smoking cessation?

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Yes.

Amanda Jones -- Senior Vice President, Clinical Development

So we are planning to meet with the FDA in the third quarter. And then based on our interactions with them, we'll provide an update on that program.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

And if I just may add to Amanda's comments regarding Alzheimer's disease agitations. So the -- in addition to the progress that's being made in the trial, while it is still early, the metrics that we're seeing internally corroborate our initial guidance of data read out in the second half of 2022.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay. Thanks for the added detail.

Operator

Your next question comes from a line of Myles Minter from William Blair. Please go ahead. Your line is now open.

Myles Minter -- William Blair -- Analyst

Thanks for taking the questions. Just one on the payer landscape and for AXS-05. It seems reasonable that the payer is probably going to set through a few therapies. And by the time a clinician is trying to prescribe this product, it's technically to [Indecipherable] population. So I'm wondering, have you got any pushback from clinicians that [Indecipherable] missed endpoint so we haven't necessarily seen controlled positive data there? And I guess if that's the case, what's your current message that you're educating to those clinicians to get them over the line to prescribe this upon potential launch?

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hey, Myles. So I'll certainly answer some of your questions, but I'd like to turn it over to Cedric in terms of what the MSLs are hearing on those lines.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

Yeah. And I'm happy to share Myles that the nature of clinical trials, people who actually enroll in clinical trials for MDD center and typically in responding to existing treatments. So in essence, patients are coming into MDD are already patients who are somewhat resistant. There hasn't been a great degree of pushback because people realize that new [Technical Issue] coming after the brand new treatments tend to [Technical Issue] market. And I think that the data that we've generated to fit in MDD versus Bupropion [Phonetic] sense study versus placebo, shows a differentiated clinical profile, both in terms of rapidity onset of action, but also in the early improvements in quality of life and functioning. So I think overall, the clinical profile and differentiation of AXS-05 is from what we're hearing in the field is a compelling argument as to why they use this drug, they see a difference from authority out there.

Herriot Tabuteau -- Chief Executive Officer

Right. And if I may add too. One of the things that we're hearing from KOLs and from the MSLs in the field based upon our recent data presentation on the COMET sub-studies, for example, our COMET sub-studies is in TRD is that there's a very compelling profile that is emerging with a lot of evidence showing that the drug works actually just as well in those patients who have TRD and who failed multiple lines of treatment as in the patients who are treated frontline.

And then the other thing too that we are hearing from experts in the field who are familiar with TRD and just depression in general is that it is actually rather impressive that we have had now essentially four Phase 3 trials, all of which have been positive. So even if you look at the STRIDE-1 trial in TRD, the drug clearly separated from an active control using a higher dose. And the effect that was seen with regards to depressive symptoms was evident at week one and at week two. So it's important to remember that in the TRD trial, resistible significance was achieved at week one and at week two in a TRD patient population. And not only that, improvements in quality of life and also in disability were much higher than have been seen with other agents. So overall, it's been -- it's a very positive, and actually, the MSLs have been getting a lot of questions around STRIDE because of its positivity [Technical Issue] what happens into variability, which is expected in this patient population.

Lori Englebert -- Senior Vice President, Commercial and Business Development

Hey, Myles. I'll just pile on here as your third comment -- question to comment on your question. What was just stated by both Cedric and Herriot is very consistent for what we're hearing with payers as well. They are taking the entire patient population in the study that we conducted and this population into account.

Myles Minter -- William Blair -- Analyst

Yeah. I think all of that's along with what I've been hearing as well. Maybe just another quick one. I know you're not commenting on the minutes because you're waiting for them, but in the cash guidance that you've provided today, does that actually include provisions for a potential additional clinical trial for AXS-14 in fibromyalgia? Thanks.

Nick Pizzie -- Chief Financial Officer

So our cash guidance certainly includes spend for AXS-14. So as you know, as was previously stated, we are incentivizing API, which is a new chemical entity. And we do want to make sure that we have a clinical supply ready since that would be necessary for registration. So it's -- so that spend is necessary for any potential next step. With regards to the specifics of a clinical development plan, we will await getting a written feedback from the agency before making any pronouncements.

Myles Minter -- William Blair -- Analyst

Fair enough. Thanks for the questions.

Operator

Your next question comes from the line of David Hoang from SMBC. Please go ahead. Your line is now open.

David Hoang -- SMBC -- Analyst

Hi. Thanks for the update and taking my questions. A lot of great questions asked already, so I just have a couple of quick ones. So first, on AXS-05 for MDD, how much of the target prescriber population would you say is primary care physicians versus like hydrous? And do you expect that there would be a lot of prescribing from the primary care side of the prescriber base?

Lori Englebert -- Senior Vice President, Commercial and Business Development

Yeah. Hi, David. Thanks for the question. It's a really good one. So we tend to not look at it as site versus PCT. We tend to look at it as hydrous first and/or the highest propensity to prescribe. I'm not either categorizing sites or PCT. There are many PCTs out there who are mental health focused and are actually prescribed at the same level as some of the sites. So our targeting will encompass high prescribers along with the ones that we consider to be the most -- the best potential for prescribing.

David Hoang -- SMBC -- Analyst

Got it. Thanks. That's really helpful. And then just in terms of both AXS-05 and AXS-07, are there any plans to eventually commercialize those products outside of the U.S., in ex-U.S. geographies either on your own or through a partner?

Lori Englebert -- Senior Vice President, Commercial and Business Development

So I can answer that question as well. Yes, there is. We've publicly disclosed that we are looking for partners outside of the U.S., and those discussions are ongoing.

David Hoang -- SMBC -- Analyst

Okay, thanks. That's all for me.

Operator

Your next question comes from the line of Robert Hazlett from BTIG. Please go ahead. Your line is now open.

Steve Terry -- BTIG -- Analyst

Hi. This is Terry on the line for Bert. Thanks for taking the question. Just a brief question on the AXS-05 on Alzheimer's disease agitation trial. Should we expect an interim analysis at some point? And if so, what can we expect in terms of efficacy data at that point? And any color on in terms of timing for a potential interim analysis? Thanks.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

There currently is -- there is not currently a plan for an interim analysis of this trial. However, the study is designed so that based upon what we see in terms of event rates that one could be incorporated. So randomized withdrawal studies are driven by the number of events and that is typically how they are powered. So right now, as we mentioned in the earlier remarks, it's too early to know what the cadence will be of relapses. No one has done a study like this before in Alzheimer's disease agitation. So we're very much looking forward to seeing how this thing plays out, but right now, we are not -- we have not planned an interim analysis.

Steve Terry -- BTIG -- Analyst

Okay, thanks. Thanks for that. And then just one more on AXS-12. Could you just talk a bit about potential thoughts on endpoints in the trial, including timing? Any color will be helpful.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

So for AXS-12, the primary endpoint of the study will be the change in the frequency of cataplexy attacks. So that is the same primary endpoint that we will use in the completed Phase 2 trial [Technical Issue]

Steve Terry -- BTIG -- Analyst

Okay, perfect. Thanks for taking the questions, and congratulations on the progress.

Cedric O'Gorman -- Senior Vice President, Medical Affairs

Thank you.

Operator

And your last question here comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead. Your line is now open. Once again, Ram Selvaraju from H.C. Wainwright, please go ahead with your question. Okay. And there are no further questions in the queue. I will turn the call back over to management for closing comments.

Herriot Tabuteau -- Chief Executive Officer

Well, thank you all again for joining our call this morning. We are excited as we move potentially toward commercialization and as we advance the rest of our pipeline for the benefit of the many people living with serious CNS conditions. We look forward to keeping you updated on our progress in the months ahead.

Operator

[Operator Closing Remarks]

Duration: 50 minutes

Call participants:

Mark Jacobson -- Chief Operating Officer

Herriot Tabuteau -- Chief Executive Officer

Lori Englebert -- Senior Vice President, Commercial and Business Development

Nick Pizzie -- Chief Financial Officer

Cedric O'Gorman -- Senior Vice President, Medical Affairs

Amanda Jones -- Senior Vice President, Clinical Development

Charles Duncan -- Cantor Fitzgerald -- Analyst

Joon Lee -- Truist -- Analyst

Roanna Ruiz -- SVB Leerink -- Analyst

Vamil Divan -- Mizuho Securities USA, LLC -- Analyst

Yatin Suneja -- Guggenheim -- Analyst

Joseph Thome -- Cowen -- Analyst

Chris Howerton -- Jefferies -- Analyst

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Myles Minter -- William Blair -- Analyst

David Hoang -- SMBC -- Analyst

Steve Terry -- BTIG -- Analyst

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