Axsome Therapeutics, inc (AXSM) Q3 2021 Earnings Call Transcript

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Axsome Therapeutics, inc (AXSM 1.31%)
Q3 2021 Earnings Call
Nov 8, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Axsome Third Quarter 2021 Financial Results Conference Call. [Operator Instructions]. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions].

I would now like to hand the conference over to your speaker today, Mark Jacobson, Chief Operating Officer. 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 on the Company's financial results for the third 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 and 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; Dr. Kevin Laliberte, Executive Vice President, Product Strategy; Lori Englebert, Senior Vice President of Commercial and Business Development; and Dr. Amanda Jones, Senior Vice President of Clinical Development.

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 are 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' third quarter 2021 financial results and business update conference call. Over the past several months, we have continued to advance our differentiated late-stage CNS product candidates aimed at meaningfully improving the lives of patients. I will provide an update on our development pipeline before turning it to Lori, who will provide a commercial update.

Starting with our first lead product candidate, the AXS-05, which is undergoing an NDA review for the treatment of major depressive disorder. The FDA did not take action on the NDA by the August 22nd PDUFA date as previously disclosed, and review of the application is ongoing. The agency recently informed us of two deficiencies related to analytical methods in the Chemistry, Manufacturing, and Controls section of the NDA, which must be addressed prior to the FDA taking action on the NDA. We believe these deficiencies are addressable and are confirming the details of the request with the FDA.

The AXS-05 is also being developed for the treatment of Alzheimer's disease agitation. Enrollment in the Phase 3 ACCORD trial for the syndication is progressing. And based on current enrollment trends, we anticipate completion of the trial in the first half of 2023. With regards to the development of the AXS-05 in smoking cessation, we received a positive pre-IND meeting written guidance from the FDA on a proposed clinical development plan. Based on this feedback, we plan to proceed to a pivotal Phase 2/3 trial in this indication and expect to provide timing on initiation of that trial next year.

Moving on to our second lead product candidate AXS-07, a multi-mechanistic acute treatment for migraine. The NDA for AXS-07 was accepted for review by the FDA, with a PDUFA target action date of April 30th, 2022. The FDA has also informed us that due to COVID-19 pandemic-related travel restrictions, they may be unable to complete an inspection of one of the AXS-07 manufacturing facilities prior to the PDUFA date. They will continue to monitor the public health situation as well as travel restrictions, and we will keep you informed of any developments on this front.

With two NDAs under active review, Axsome is in a position to potentially commercialize two new treatments in the near to intermediate term for patients living with depression and migraine. Lori will provide details on our commercial launch readiness for AXS-05 and our pre-launch commercial activities for AXS-07. The rest of our rich pipeline continues to advance.

For AXS-12, our product candidate being developed for the treatment of narcolepsy, we initiated a SYMPHONY Phase 3 trial in the third quarter. Enrollment in the trial is progressing, and top-line results are 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. Based on the status of these activities, we now expect to submit the NDA in 2023.

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. Today, I will give you an update on our commercial activity as it relates to launch readiness for AXS-05 and pre-launch activities that are progressing for AXS-07. As Herriot stated, the commercial team has been actively preparing for the potential launch of AXS-05, and we remain incredibly excited about the opportunity to bring this product to market for the millions of patients suffering from depression. We are ready and prepared should we receive approval.

The US remains in the middle of a mental health crisis. Multiple studies have been released recently stating dramatic increases in depression due to the COVID-19 pandemic. Most recently, a global study published in Lancet showed that worldwide, rates of depression climbed by 28% in 2020, showcasing a devastating ripple effect of the COVID-19 pandemic.

Awareness of mental health issues is at an all-time high and people are talking about mental health today more than ever. Given the personal and economic burden associated with mental health conditions, there is an undeniably urgent need to bring support to those affected. If approved, AXS-05 would be an important new treatment option for the many Americans living with depression. We are prepared and ready to bring this meaningful innovation to patients by commercializing the product soon after a potential approval.

Our commercial launch strategy is innovative and purposeful with the intent to bring important new products to market in a meaningful way. We have undertaken great efforts to understand the needs of patients and the healthcare professionals who treat them. This information has informed our strategy.

Our Digital Centric Commercialization or DCC technology-enabled platform designed to increase efficiency and effectiveness of our marketing efforts is fully implemented, tested and ready for execution. As a reminder, we have designed our DCC platform to use streamlined systems and digital enablement tools, combined with sophisticated data and analytics to allow for a more effective, efficient and meaningful engagement with physicians and patients.

Last quarter, I stated that our impressive field leadership team was fully staffed. Over the past several months, they have been working hard on recruiting top talent to staff our field representative positions. At this time, we have offers formally accepted for a complete sales force team. All offers are contingent upon approval. In the event of a potential approval, we anticipate having all field representatives onboard, trained and certified by launch.

Our highly capable and experienced market access team continues to engage with payers in ongoing permitted discussions, ensuring awareness of Axsome, our pipeline and the clinical profile of AXS-05. We look forward to engaging with payers immediately after approval. Our marketing and patient support services teams have been working hard to ensure that our comprehensive patient support services and all marketing materials are complete, implemented and ready for execution in anticipation of a potential approval.

Our launch readiness preparations have been heavily focused on AXS-05. However, we are also actively preparing for potential subsequent launch of AXS-07 for the acute treatment of migraine, a debilitating disease that continues to have a tremendous unmet need and impacts an estimated 37 million US adults. Marketing activities are well underway along with DCC integration and initiating AXS-07 permitted payer discussions.

We are enthusiastic about the potential opportunity that AXS-07 could bring to a market that still sees close to 70% dissatisfaction rate with currently available therapies. The differentiated clinical profiles for both AXS-05 and AXS-07 have the potential to bring significant benefit to patients and the physicians who treat them. We are excited about the opportunity to potentially bring these important new products to market in an innovative and meaningful way.

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

Nick Pizzie -- Chief Financial Officer

Thank you, Lori, and good morning everyone. Today, we'll discuss our third quarter 2021 results and provide some financial guidance. We ended the third quarter with approximately $115 million in cash, compared to roughly $141 million at the end of the second quarter, a net decrease of approximately $26 million. R&D expenses were $13.2 million for the quarter ending September 30, 2021, versus $14.8 million for the comparable period in 2020. The decrease in R&D expense was driven by the completion of NDA enabling clinical trials that were ongoing in the prior comparable period.

G&A expenses were $20.2 million for the quarter ending September 30, 2021, and $6.3 million for the comparable period in 2020. The increase was primarily related to pre-commercial activities and personnel expense, along with an increase in non-cash stock compensation expense. Net loss was $34.9 million or $0.93 per share for the quarter ended September 30, 2021, compared to a net loss of $22.9 million or $0.61 per share for the comparable period in 2020.

We recently announced that we have expanded our term loan facility with Hercules Capital to $300 million, with $100 million now available upon FDA approval of AXS-05 and MDD and access to an additional $150 million thereafter. This committed non-dilutive capital gives us additional financial flexibility through both anticipated potential commercial launches for AXS-05 and AXS-07.

We believe our current cash position of $115 million, along with the remaining committed capital from our $300 million term loan facility is sufficient to fund our anticipated operations based on our current operating plan into at least 2024.

That concludes our third 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

[Operator Instructions]. Your first question comes from Charles Duncan of Cantor Fitzgerald.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah. Good morning. Thanks, Herriot and team for the update and for taking our question. Yeah, so regarding AXS-05 and the analytical deficiencies that were mentioned, I guess I'm wondering if you could provide us a little bit more color, if you will, on that in terms of what would be expected to be able to address the deficiencies? Are there any additional clinical or non-clinical experiments that you need to run? Or do you think that you'll be able to address these with the information that you have on hand? And if so, what kind of timing are we looking at, is it months or quarters?

Herriot Tabuteau -- Chief Executive Officer

Thanks, Charles for the question. I'll turn it over to Kevin to answer that question.

Kevin Laliberte -- Executive Vice President, Product Strategy

Great. Thanks for the question. So just to give an update, we are actively working on the update to the analytical methods that the FDA has requested. But we are still in communication with the FDA to fully understand the specifics and the process to resolve the items that they brought to our attention. I will note that they are manufacturing specific that we understand right now. And so, it would be solely resolved from a manufacturing point of view based on what we understand from the agency at this time. And we expect our work to be complete on those method in the near to intermediate term for resolution.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. That's helpful. So you don't anticipate it impacting any ongoing studies with the product candidate?

Kevin Laliberte -- Executive Vice President, Product Strategy

We would not anticipate that, that would have an impact on any ongoing studies.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. Super. And then my second question is maybe for Herriot or someone on the team to wax philosophically about the treatment landscape in MDD. Lori mentioned the challenges of mental health and how awareness has really increased and lots of discussion on them. But I guess I'm wondering, when you think about daily chronic therapy paradigm of historic versus say an intermittent treatment paradigm certainly for the more highly burdened patients, how do you think about that relative to AXS-05 and its role in the future treatment landscape?

Herriot Tabuteau -- Chief Executive Officer

We're excited about the potential role of AXS-05 in the treatment landscape, because as you know that the current treatment landscape leaves the vast majority of patients with inadequate responses that is in terms of not just clinical response, meaning, the reduction of 50% of symptoms but also of remission.

And if you look at those parameters and studies that we have conducted with AXS-05, those have been multiple studies now, both controlled as well as open-label in various patient populations. The product definitely shows that it could meaningfully impact the treatment landscape and reduce rates of depression and improve rates of remission, as well as a clinical response. So we're really excited about that.

And as a reminder, the breadth of the types of patients that we have studied spans the gamut from the totally naive patients who've never been treated with an antidepressant to patients with treatment resistant depression who have had multiple lines of treatment. And the product so far appears to perform equally well in all those lines of treatment.

So the other aspect to -- which is notable is the new mechanism of action which we think is contributing to the clinical benefit that we're seeing. And so, we're -- as a Company, we're really excited to be developing a product which not only is needed by a large percentage of the population, but which is timely given the impact of the mental health pandemic on the increased incidence of depression.

Lori, do you have anything to add to that?

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

Sure, Charles. I always love waxing poetic, but what I'm about to state is really based on the extensive amount of discussions with HCPs and market research that we performed. There is undeniable -- an undeniable need for a rapid onset of action in these patients. But what I think people should not lose sight of is that only gets you a little bit of the way what physicians are really concerned about is remission and durability. And the durability piece given that our product has shown durability based off several studies, we believe will bode well for us.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Very good. Thanks for the added color. Look forward to the update on the analytical methods. Good day.

Operator

Your next question comes from Joseph Thome with Cowen and Company.

Joseph Thome -- Cowen and Company -- Analyst

Hi, there. Good morning, and thank you for taking our questions. Maybe the first one on the deficiencies. Are these the only deficiencies that spurred the earlier letter or were there other deficiencies that you have since resolved with the FDA that you're aware of?

And then maybe second, just on the MERIT TRD data. Should AXS-05 be approved and launched, how can you best leverage some of these resistant and refractory patient datasets given that the label is going to be for MDD? Thank you.

Herriot Tabuteau -- Chief Executive Officer

Thanks. Thanks for the question, Joseph. With regards to the deficiencies that we disclosed today, these are the only deficiencies that we have been made aware of. So we're working with the FDA obviously as we've stated to get clarity on the exact response. But this does not mean that these are the only deficiencies or only piece of information that the FDA will request during the review. There could be more, or these could be the only ones, just to be clear. So we're not making any predictions.

And, with regards to the TRD data that we've generated, not just in the MERIT study but in other clinical trials that we've conducted, let's be clear, the indication that we have applied for, and that we're currently under review for is MDD. And so that's the indication. The additional data that we've generated we think will inform physicians and other healthcare professionals, because they do see all sorts of patients, all kinds of patients who will come to them, and it will be up to them to make up their mind as to how best to treat their patients. So we're trying to answer practical questions with regards to -- once the product is available, and how it may perform.

But to be clear, the indication that we are focused on is the MDD indication which is nice, it is broad, it does encompass the full breadth of patients with MDD.

Joseph Thome -- Cowen and Company -- Analyst

Great. Thank you.

Operator

Your next question comes from Vamil Divan with Mizuho Securities.

Vamil Divan -- Mizuho Securities -- Analyst

Great. Thanks so much for the call and for taking my questions. Maybe one more just around the deficiencies that the FDA mentioned. Can you clarify just sort of when you found out about these, and I guess, it just seems like an unusual process here that you're going through as opposed to maybe getting a formal CRL and responding to that the way other companies had. Do you have any insights to just sort of -- maybe it's more of a question for the FDA, but I'm wondering if there's anything you can share on why you sort of ended up in this sort of unusual path here?

And then the second question I had was more on the agitation trial. And it looks like you just kind of shifted out the timing for when that's going to be completed by a little bit. I'm just curious if you can give an update on exactly how far you are into enrollment in that trial at this point, and anything that sort of has changed in terms of why the timing -- why is it taking a little bit longer to complete than you had first thought? Thank you.

Herriot Tabuteau -- Chief Executive Officer

Thanks, Vamil for the questions. I'll turn the agitation question over to Amanda who will provide some color on the trial and maybe some of the unique aspects of the trial and how that would impact in permitting [Phonetic] enrollment trends there, but I'll start by first answering your other questions.

In terms of the timing of when we got the communication from the FDA on these deficiencies, we recently got them. So very end of October and since then, we're -- we've been trying to get details on them so that we could specifically respond. So we're still in the process of getting those details.

And in terms of what you characterize as the unusual nature of this process, it is a unique situation, but remember, this is actually not unusual to receive information requests from the FDA during an NDA review where they might ask for additional information, whether that be -- in any discipline and including CMC as we have received. So we don't view -- we don't view this information request from the FDA as unusual in and of itself.

So I hope that, that helps to answer your questions around those points. And then I'll turn it over to Amanda with regards to -- who will answer the question regarding the Alzheimer's disease agitation trial.

Amanda Jones -- Senior Vice President, Clinical Development

Great, thanks. Yeah, so great point about the agitation trial. So as a reminder, this is a randomized-withdrawal study. So it's a two-period study where patients are enrolled and randomized, and then the trial completion is actually -- really contingent upon the number of relapses which occur.

So based upon all of those variables, the way we've been tracking the study, we are anticipating the study to complete in the first half. So it's just a slightly complex study [Phonetic] design which -- which again is the only different metrics that we're tracking related to enrollment.

Vamil Divan -- Mizuho Securities -- Analyst

Okay. Thank you.

Operator

Your next question comes from Ram Selvaraju of H.C. Wainwright.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Thanks very much for taking my questions. So just kind of following on from what others have already asked. I just wanted to clarify whether at this point you have clarity on if the FDA is going to issue a CRL at some point on AXS-05 or if you think the currently outstanding matters can be resolved without a CRL, in fact having to be issued? And if a CRL is going to be issued and I'm not saying that that's going to be the case, I don't know, but if a CRL is going to be issued, then ultimately given what you currently know about the deficiencies that remain outstanding, what would you expect resubmission of the NDA for AXS-05 to be classified as Class 1 or Class 2? Thanks.

Herriot Tabuteau -- Chief Executive Officer

Thank you, Ram for the question. So the first thing is, whether or not -- your question around whether or not a CRL is going to be issued and that is a -- that would be an action -- an FDA action. So -- and we don't determine that, the FDA determines that. Now what we can tell you is that, as we stated in our press release and in the opening comments, the FDA has stated that these deficiencies with regards to analytical methods must be addressed before they can take action. And an action on the NDA would come in two forms. It could be either one an approval or a CRL. So -- and what the FDA has asked us to do is to provide them information to resolve the deficiencies, that must be done prior to them taking one of those actions. I hope that, that is helpful.

Ram Selvaraju -- H.C. Wainwright -- Analyst

So just as a clarification to what you just said Herriot, that means that it still remains possible that when you submit this information to the FDA, the agency will decide not to issue a CRL. That's still possible, right? I don't want you to kind of handicap for us what the odds of that happening are, but just clarify for us whether that is indeed still possible that the FDA may not ultimately issue a CRL on AXS-05 once they see the data that you submit?

Herriot Tabuteau -- Chief Executive Officer

The reason why I'm hesitating in answering your question is the way you've posted which is in the negative as if the presumption is that there would be a CRL and they would not issue a CRL. I guess what we're saying is that -- is, the agency clearly has not taken action on the NDA.

So that's -- which means they have not issued a CRL. They also have not approved the product. Those are the two potential outcomes. And before they make their decisions, they've indicated very clearly to us that they would like the information that they've requested. We are working to make sure that we understand exactly what needs to go into that response and we will do that expeditiously.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Okay. And then just on the CMC information that is being requested. I'm assuming based on the responses you gave to some earlier questions that, in fact, this CMC information pertains to further characterization of the product as opposed to any change in the actual product itself. So this would not affect not only ongoing clinical studies, but would not require any further bridging work down the line in order to ensure not only that the product is approvable in MDD, but in other indications for which you ultimately may seek approval. Is that correct?

Herriot Tabuteau -- Chief Executive Officer

That is correct.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Okay. And then just very quickly on the smoking cessation clinical program. Have you received information yet from the FDA regarding specific design parameters of this program, including in particular, the extent to which the agency wants to see long-term, follow-up long-term evidence of impact on smoking cessation or does that still remain to be determined at this point?

Herriot Tabuteau -- Chief Executive Officer

So the point of the pre-IND meeting guidance was to get the agency's input on an entire clinical development plan to get AXS-05 approved for smoking cessation. So that would include the design of the pivotal trials or subsequent trials and also of -- on the safety database. So coming out of that process, we do have a very clear guidance which is why we've stated that based on that information we can proceed into a pivotal trial. And so, we can do that. We're very excited about that. And I think, you know, we are able to leverage and we have been able to leverage all of the data that has been generated with AXS-05 in other indications and -- in both the long-terms, as well as the short-term setting.

So the answer is yes. I think, we do have a lot of information on the long-term safety of AXS-05, and we believe that we'll be able to leverage that information for the development of AXS-05 in smoking cessation.

Ram Selvaraju -- H.C. Wainwright -- Analyst

And just to clarify, with respect to the smoking cessation program, the FDA has already agreed that if this Phase 2/3 study results in a positive outcome, then you would be able to file on the basis of that foreign approval in smoking cessation. And do you have a sense of whether the smoking cessation Phase 2/3 study could yield data before the end of 2022 or is it more likely to be a 2023 event? Thank you.

Herriot Tabuteau -- Chief Executive Officer

So the guidance that we've given is that we will provide further guidance on the exact timing of the initiation of the Phase 2/3 trial next year. And part of that is for planning purposes. We have a lot going on, two NDAs, which are currently filed, an incredibly rich pipeline. And looking at 2023, we could be filing three more NDAs then potentially depending on the outcome of a lot of these studies. So there's a lot going on. We are scaling up in terms of our capabilities to -- just to make sure that we can take advantage of all of these opportunities. And so -- so that's why we would like to take our time and make sure that we can provide you with very precise guidance around when we start that trial -- you know guidance that we can have confidence in and we'll do that next year.

And with regards to the pivotal nature of the studies -- the Phase 2/3 trial would be a pivotal trial. And we believe that based on the guidance that we would need two studies in the indication. So the Phase 2/3 trial will be one of those two studies.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Thank you.

Operator

Your next question comes from Joon Lee of Truist Securities.

Joon Lee -- Truist Securities -- Analyst

Thanks for the updates. You mentioned that deficiencies could be resolved near to mid-term. Can you define what that means, is that weeks, months or quarters? And then, you stated that, all the offers have been made for the sales force, but that they're contingent upon approval. Is your next probation date on those offers? Thank you.

Herriot Tabuteau -- Chief Executive Officer

Sure. I'll let Lori take the second question first.

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

Sure. So the current contract as it states and we're thinking through June. So depending upon additional clarity from the FDA, how we leverage the offers that are already outstanding. There -- the field force that -- that we've been able to -- have offers extended to -- you know, their caliber is incredibly impressive. And so, we would like to be able to leverage keeping them, but we really need additional clarity in terms of timing from the FDA before we can make that decision.

Joon Lee -- Truist Securities -- Analyst

Right.

Herriot Tabuteau -- Chief Executive Officer

And then with regards to what the near to mid-term means, it's weeks to months. And that really depends on the -- a further feedback that we get from the FDA, and we're weighing [Phonetic] on that feedback.

Joon Lee -- Truist Securities -- Analyst

Great. And then will you press release once you have submitted those responses to deficiencies?

Herriot Tabuteau -- Chief Executive Officer

So we want to provide as much information as we can to you, to investors, to stakeholders, given the unique situation that we are in with regards to the NDA for AXS-05, but we also want to balance that with the fact that we are still undergoing review. And historically, we have not provided details of the back and forth with the agency during the review, because as you can imagine, it is a fluid situation and it remains a fluid situation.

So would you want to balance disclosures and also expectations, so do not expect that we will be giving a play by play. We don't think that, that would benefit the process, the NDA review process with the agency. However, we do intend to update The Street on any definitive developments.

Joon Lee -- Truist Securities -- Analyst

Great. Thank you.

Operator

Your next question comes from Marc Goodman of SVB Leerink.

Marc Goodman -- SVB Leerink -- Analyst

Hi, Herriot. I have a couple of questions. First of all, if you just simplistically think about an NDA with three sections CMC, safety and efficacy. Has the FDA signed off on the safety and the efficacy portions? Or you don't even have those signed off on yet?

Herriot Tabuteau -- Chief Executive Officer

So if you think about it simplistically, I agree that those would be the main sections. But the process unfortunately is not necessarily simple process. What the FDA does is, as it reviews the NDA, it does ask sponsors for information which it needs for its reviews.

So -- and right now, the information which has been requested and we've discussed, which is around CMC, and that's what we are responding to. We have not gotten any notice from the FDA on other deficiencies and other disciplines. So we've not gotten... [Speech Overlap].

Marc Goodman -- SVB Leerink -- Analyst

So you have got no [Technical Issues] but your feedback from the FDA, you don't know whether they need something with respect to efficacy, whether you've got two placebo controlled studies that are good enough, like, you don't know that yet or you do know that that you're good on that second [Phonetic] part of it?

Herriot Tabuteau -- Chief Executive Officer

I think that when sponsors know that the FDA is fully satisfied is, once they have approved the product. And before that -- before that, they are doing their jobs, which is to review the NDA, and our job is to -- to respond to them.

Marc Goodman -- SVB Leerink -- Analyst

Oh, I understand. I'm just trying to understand whether there has been a discussion about the studies, yeah, and you're -- and the safety of that aspect, the other stuff besides the CMC. You've had that -- any discussions there yet?

Herriot Tabuteau -- Chief Executive Officer

Well, the FDA has been reviewing the application. So they have certainly been reviewing the efficacy as well as the safety portions of the NDA. And I think your question was whether or not they had signed off? And we don't know of any specific process whereby they sign off on any specific aspects of the application until they have approved it.

Operator

Right. Of course. And maybe the better question is, have there been interactions back and forth with FDA on the safety data and the efficacy data?

Herriot Tabuteau -- Chief Executive Officer

Well, there has been interaction with the agency on all the disciplines [Phonetic] of the NDA as one would expect given the stage of the review.

Marc Goodman -- SVB Leerink -- Analyst

And just to flip to the CMC for a second. I had thought that CMC was OK. I thought we were OK there, and I presume that you did too. So what kind of came out of the woodwork here to surprise us?

And then secondly, I forgot I think it might have been in the Q&A in the first question, but the response was, we're working to update the analytical methods, we're still trying to figure out exactly what the FDA needs. So how can you feel comfortable that it's weeks to months when you're still not exactly comfortable with what the FDA needs?

Herriot Tabuteau -- Chief Executive Officer

So the -- so we stated weeks to months for us to complete the work that we need to complete. And then the reason why it is weeks to months or actually we said near term to medium term, that is meant to reflect the fact that that we need to get more specifics from the FDA in terms of what would go into the response.

And then, with regards to your other question around CMC, the review is ongoing. And as part of the ongoing review, it is typical for sponsors to get information requests along the way, and it really depends on the rhythm of the review. It depends on the particular reviewer and it depends. So -- and our job is, we can't predict when those requests will occur or what they are, and our job is just to make sure that, as the sponsor, we adequately respond to them which is what we're doing.

Marc Goodman -- SVB Leerink -- Analyst

And Herriot, are you willing to help characterize what these two deficiencies are a little better? It's an analytical method in demonstrating that the manufacturing is as good as it needs to be. What exactly are you talking about here?

Herriot Tabuteau -- Chief Executive Officer

So analytical methods relates to testing of the finished drug product. So meaning, our tablets. This does not relate to the manufacturing process at all. And so you can make analytical methods more sensitive or less sensitive. You can broaden the range or narrow the range. And we have what we believe to be a pretty robust process and you can make it more robust or less robust, more sensitive or less sensitive. And we are responding to the FDA's request and we think that those are totally addressable and those are things that we can do.

Marc Goodman -- SVB Leerink -- Analyst

Thank you. Just one quick question on the migraine. Can you just help us understand, did you say that one of the two manufacturing sites might not be able to be signed off on by the PDUFA date? So you're implying that one could be and is one enough? Do both have to be filed? I was a little bit confused by your comment. Thank you.

Herriot Tabuteau -- Chief Executive Officer

Yeah. So it's -- I'll turn it over to Kevin who will respond to that, but I think it's pretty straightforward in terms of what the FDA is trying to give sense [Phonetic] up on there.

Kevin Laliberte -- Executive Vice President, Product Strategy

Thanks for that question. So there are obviously multiple manufacturing sites involved in the process for AXS-07. The FDA notified us that one specific manufacturing location that is based in the United States is required to have an inspection prior to them as part of the review process. And then they did notify us that, you know that -- because of COVID-related restrictions that maybe in jeopardy of happening before the PDUFA date. So it's just this one manufacturer based in the United States that they specifically noted by us in their communication.

Marc Goodman -- SVB Leerink -- Analyst

Thank you.

Operator

Your next question comes from Vikram Purohit of Morgan Stanley.

Vikram Purohit -- Morgan Stanley -- Analyst

Great. Good morning. Thanks for taking our questions. So two from our side. First, going back to again 05 for MDD. So I just wanted to clarify one basic question around next steps. So here the situation basically that you've now submitted questions for clarification to the agency and you're waiting to hear back or are you preparing a submission in response to the initial feedback you got which could take weeks to months and then after that submission you will get some clarification on some more specifics around what the agency might be looking for?

And then secondly beyond 05, set of question on AXS-14 and fibromyalgia. So your release mentions that NDA submission is expected in 2023, and I was just wondering if you could kind of walk us through what needs to happen between now and then to enable the filing? Thank you.

Herriot Tabuteau -- Chief Executive Officer

Sure. So with regards to the first question, we -- that is correct. We have submitted clarification questions to the agency. And the reason for that is, we want to make sure that when we respond that the response is adequate, and that it is exactly what they need to continue their assessment of the NDA with regards to CMC. So we don't want to rush to submit a response or to do an experiment and submit it and have it not be exactly what it looked before. So that -- so you're correct.

And with regards to AXS-14 for fibromyalgia, what needs to happen right now is primarily CMC manufacturing. As a reminder, AXS-14 is the new chemical entity. So we do have to sympathize the material which we are working to do and then also generate the stability data. So most of the work -- and certainly the rate determining steps in filing the NDA has to do with our manufacturing.

Vikram Purohit -- Morgan Stanley -- Analyst

Okay. Got it. Thank you.

Operator

Your next question comes from Ashwani Verma of Bank of America.

Ashwani Verma -- Bank of America -- Analyst

Hi there. Thanks for taking our questions. So I wanted to understand, like, I think there is a lot of discussion on these deficiencies which seem pretty complex to me. I mean, can you give us some confidence that your team or any external partners that you have will be able to navigate through this? Has your team or any regulatory consultant that you have has hired such -- has handled such a specific situation before? That's my first question.

And the second one just on this analytical methods. So would you need to redo some experiment here or anything downstream of that or the deficiency in the methods specifically, what does that mean in terms of resolving it? Would that need to be redone or that just needs to be characterized better the findings that you had from that experiment?

Herriot Tabuteau -- Chief Executive Officer

So to answer those questions, this is the reason why we are making sure that we get as much clarification from the FDA as possible. And so -- and that's what we're doing. So we want to get clarity from the FDA.

And then, with regards to the actual deficiencies themselves, and just -- if you kind of step back, so first of all, we did say that we believe that they are addressable. So -- and we're very confident in that. But if you step back, a lot of these requests or this type of request is not unusual during an NDA review. The only reason why we're discussing it right now is because you know we're past PDUFA and given the unique situation. So we want to provide you guys as much information as possible that is relevant to this unique situation.

But the nature of the requests themselves are probably not unusual. These are the types of requests which normally we think would come up during the review of other sponsors NDAs during a normal NDA review cycle.

Ashwani Verma -- Bank of America -- Analyst

Just a quick follow-up that I had like, so the field force build is complete you said. How many reps are we talking? I mean -- and this is a big market, a lot of different types of prescribers. What's your approach going to be? Are you focused on prior dextromethorphan prescribers or branded prescribers or any other ways to cut the market?

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

Yeah, thanks, Ash. So, you know, I'll speak more to the size of the sales force when we get prepared to launch. I don't want to disclose that right now, but I will tell you that we will personally promote to what we believe will be 85% of the high volume prescribers in the marketplace. And that's a very complex algorithm of determining what high value prescribers are, but they will cover greater than 25,000 HCPs on a personal promotion basis.

From a non-personal promotion basis, we will also be targeting additional HCPs.

Ashwani Verma -- Bank of America -- Analyst

Thank you.

Operator

Your next question comes from Matt Kaplan, Ladenburg Thalmann.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Hi. Thanks for taking the question. I guess, going into the deficiencies a little bit more on this unusual process. You mentioned that kind of the action of the FDA could be either to approve the product or potentially issue a CRL. I guess, beyond that, given the unusual situation, could your answers to the CMC questions be deemed a major amendment? And would they issue you a new PDUFA date or there is -- we're just going -- you are just going to be running through this process with the FDA without a new specific action date?

Herriot Tabuteau -- Chief Executive Officer

Thanks, Matt, for the question. The -- so when the FDA misses a PDUFA date, there is no new PDUFA date, which is issued.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay. Okay, thanks. That's helpful. And I guess a question with respect to commercial preparation. Given the unique profile of 05, what's the -- what's your sense or what's your feedback from potential payers at this point in terms of potential coverage and thinking about the pricing?

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

Yeah. Thanks, Matt. So I've previously mentioned, we've had our national account directors in the field having permitted payer discussions since about the April time frame. And all discussions have been highly encouraging. But we will not engage in discussions, you know formal discussions with payers until after approval and once we have a final label.

In terms of pricing, we will be prepared to reveal that at launch, but our goal is to make sure that patients receive access, but that we capture the value that those product brings to market.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Thanks for taking the questions.

Operator

Your next question comes from Yatin Suneja of Guggenheim.

Yatin Suneja -- Guggenheim -- Analyst

Hey, guys. Thank you. Just maybe a couple of questions from me. Could you enter into labeling discussion prior to addressing these deficiencies or when the -- if the FDA is OK with the clinical section, could you enter or once you submit the CMC, once they are satisfied only then you can enter? So that's the first question.

And I understand the CMC deficiencies, you know more are analytical -- more related to analytical method, but are we sure that there is no physical visit or any inspection anything required by the FDA at this point?

Herriot Tabuteau -- Chief Executive Officer

Sure. Thanks for your questions, Yatin. The deficiencies with regards to CMC have not been characterized to us by the agency as once that would preclude labeling discussions. And you know just to be clear, we will not be commenting on when we enter into labeling discussions, but to answer your question, these are not deficiencies we've characterized as once that would preclude labeling discussions.

And in terms of inspections, we have not been made aware that there are inspections which need to be done prior to the approval of AXS-05. I don't know if Kevin has any information in terms of the pace or rhythm of inspections -- the regular rhythm of inspections at the manufacturers that we use for AXS-05.

Yatin Suneja -- Guggenheim -- Analyst

Got it. I think Kevin, I have a question, one more question. So I mean, obviously you're making progress in terms of the commercial launch. Can you give some color in terms of the payer discussions? How should we think about price? Any consideration in terms of maybe good comp for us to see in this -- in the field in terms of how we should be modeling the price once you get approved and its launched?

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

Yeah. Thanks Yatin. So consistent with what was just mentioned, we have had some very encouraging payer discussions to date, but those have been in a permitted fashion where we specifically introduce Axsome, the clinical profile with AXS-05. We will not engage in discussions -- formal discussions with them until after approval and once we have the final label.

In terms of price, I think payers do recognize an unmet need in the marketplace. They also recognize that AXS-05 does have a novel mechanism of action, and that the clinical benefits that the product can bring to market could be great. So in terms of price, as I mentioned earlier, the way that we will approach it and we will be in a position to announce price at approval is that, you know, our goal really is to make sure that patients have easy access to the product, but we as a Company capture the value that the product brings.

Yatin Suneja -- Guggenheim -- Analyst

Got it. Thank you.

Operator

We do have time for two more questioners. Your next question comes from Myles Minter of William Blair.

Myles Minter -- William Blair -- Analyst

Hi, everyone. Thanks for the questions. I might have missed it, but did you just say that the deficiencies that we're discussing today did not preclude labeling discussions?

Herriot Tabuteau -- Chief Executive Officer

That is correct. So that is right.

Myles Minter -- William Blair -- Analyst

Right. And so it begs the question that the letter that you received that stated deficiencies that did preclude labeling discussions, either they still exist or you're currently in labeling discussions. Sorry for the difficult question, but I'd love clarification around that.

Herriot Tabuteau -- Chief Executive Officer

Yeah. So -- no, thank you for the question and we do appreciate you trying to parse through the situation. And what we've done and what we're trying to do is to provide you the information that we get as soon as possible after we get it. And so that's the information that we have received. So we did disclose the prior letter and we've also disclosed now the fact that we have gotten some information on deficiencies. So we don't know if these deficiencies are the ones which were previously referred to or if those deficiencies are now a thing of the past. But this is the information that we have. And so, we're actually encouraged that we have gotten this information, because that's all we've ever wanted as the sponsor is the ability to address whatever questions that there are that will help the FDA in their NDA review process.

Myles Minter -- William Blair -- Analyst

Okay. Cool. Final one from me is just the NDA filing for 07. Does that carry the same analytical measures on the manufacturing level as 05 in the current filing?

Herriot Tabuteau -- Chief Executive Officer

Kevin?

Kevin Laliberte -- Executive Vice President, Product Strategy

Because the products are distinct molecules with different active components, they would not carry over necessarily into the 07 application specifically.

Myles Minter -- William Blair -- Analyst

Cool. Thanks guys.

Operator

Your next question comes from Joon Lee of Truist Securities.

Joon Lee -- Truist Securities -- Analyst

Well, thanks for taking our follow-up. I just wanted to clarify some questions that I've been getting from investors which is that the analytical method relates to further characterization of the product, but not the product itself, I think that's what you said. Can you clarify what you mean by not the product itself? How you can be confident that this is not related to the product itself or whatever that means?

And the second question is, you got the letter from the FDA or FDA let you know about the deficiencies at August, but the nature of the deficiencies were not disclosed until late October. Is that correct or what -- did that happened earlier? Thank you.

Operator

So the comment around the analytical methods. So we were making a distinction between the manufacturing process and the analytical methods to which test the finished goods. And so, the analytical process that's what it tests -- the analytical methods that's what they test, the finished goods. And so -- so that was the distinction. So these -- the deficiencies do not relate to the manufacturing process itself, you know, in other words, how the tablets are made.

And then, with regards to the timing that you laid out, that is correct.

Joon Lee -- Truist Securities -- Analyst

Thank you.

Operator

Thank you. I will now turn the conference back over to the CEO.

Herriot Tabuteau -- Chief Executive Officer

Well, thank you again everyone for joining us on the call today. With four pipeline candidates being developed in six indications which are either under FDA review or in late-stage development, we believe that we have build the leading CNS focused pipeline in the industry.

We're working hard to bring these potentially life-changing medicines to people who live with serious CNS conditions. And we look forward to keeping you updated on our continued progress. Have a great day.

Operator

[Operator Closing Remarks].

Duration: 60 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

Kevin Laliberte -- Executive Vice President, Product Strategy

Amanda Jones -- Senior Vice President, Clinical Development

Charles Duncan -- Cantor Fitzgerald -- Analyst

Joseph Thome -- Cowen and Company -- Analyst

Vamil Divan -- Mizuho Securities -- Analyst

Ram Selvaraju -- H.C. Wainwright -- Analyst

Joon Lee -- Truist Securities -- Analyst

Marc Goodman -- SVB Leerink -- Analyst

Vikram Purohit -- Morgan Stanley -- Analyst

Ashwani Verma -- Bank of America -- Analyst

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Yatin Suneja -- Guggenheim -- Analyst

Myles Minter -- William Blair -- Analyst

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