Good morning, and welcome to the Axsome Therapeutics conference call. Currently, all participants are in a listen-only mode. Later, there will be a question -and -answer session, and instructions will follow at that time. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead.
Thank you, operator. Good morning, and thank you all for joining us on today's conference call. This morning we issued two press releases. Our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2022, and the release relating to the FDA's action on the AXS-07 NDA. These crossed the wire a short time ago and are 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, Lori Englebert, Executive 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. With that, I will turn the call over to Herriot.
Thank you, Mark. Good morning, everyone, and thank you all for joining Axsome Therapeutics' first quarter 2022 financial results and business update conference call. The past few months have been incredibly busy and productive for Axsome. We have made progress in the FDA reviews of both of our NDAs, announced the agreement to acquire SUNOSI, and continue to advance the rest of our rich late-stage pipeline, which includes AXS-05 in Alzheimer's disease agitation, AXS-12 in narcolepsy, and AXS-14 in fibromyalgia. Axsome is poised to transform into a commercial entity potentially as early as this month, a direct result of our team's focused execution. I will provide an update on the status of our NDAs, the pending SUNOSI acquisition, and the rest of our pipeline before turning it over to Lori and Nick, who will provide a commercial and financial update.
With regards to AXS-07, this morning we announced that we have received a complete response letter, or CRL, from the FDA for the AXS-07 NDA for the acute treatment of migraine. Importantly, the CRL did not identify or raise any concerns about the clinical efficacy or safety in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS-07. The principal reason given in the CRL relate to chemistry, manufacturing, and controls or CMC considerations. The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process. We believe that all the issues raised in the CRL are addressable. We are excited by the prospects for AXS-07. This excitement is driven by the strong clinical data and product profile of AXS-07.
The approval of AXS-07 would offer a much needed new multi-mechanistic treatment option for the millions of people living with migraine. It is our goal to work closely with the FDA to provide them with the information they need so that we can make this important new medicine available to patients as quickly as possible. We intend to provide potential timing for a resubmission following consultation with the FDA. With regards to AXS-05, review of the NDA is progressing. Based on feedback from the FDA, we believe that the previously disclosed CMC deficiencies have been resolved. In addition, we recently received and agreed to post-marketing requirements and commitments proposed by the FDA for AXS-05. Based on this interaction, we anticipate potential FDA action on the NDA in the second quarter of 2022.
With regards to our Alzheimer's disease agitation program, enrollment in the phase III ACCORD trial of AXS-05 in this indication continues to progress. As previously disclosed, we are evaluating the design of this study and will provide an update following consultation with the FDA. Moving on to the SUNOSI acquisition. In March 2022, we entered into a definitive agreement to acquire SUNOSI or solriamfetol from Jazz Pharmaceuticals. SUNOSI is a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. The Hart-Scott-Rodino waiting period for the acquisition has now expired, and so we expect the transaction to close this month.
Between the pending FDA action on our NDA for AXS-05 in depression and the expected closing of our acquisition of SUNOSI, Axsome is poised to potentially make two important new medicines available to patients living with serious CNS disorders in the coming months. The rest of our late-stage pipeline continues to advance. For AXS-12, our product candidate being developed for the treatment of narcolepsy, enrollment in the SYMPHONY phase III 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, and we expect to submit the NDA for this product candidate in 2023. I will now turn the call over to Lori, who will provide a commercial update.
Thank you, Herriot, and good morning. The commercial team remains focused on preparations for potential commercial launches and simultaneously have been working hard to ensure a smooth transition of SUNOSI into the Axsome infrastructure. I am extremely proud of the efforts from the entire Axsome team. Immediately upon deal close, we look forward to welcoming the Jazz employees to Axsome. Axsome is on the verge of becoming a commercial entity, and we are excited about the opportunity to bring potentially life-changing therapies to patients. The addressable diseases of focus for our near-term products are highly prevalent and have substantial unmet need. Our products, if approved, will bring a differentiated clinical profile to their respective markets. As a reminder, SUNOSI is the first and only FDA-approved dual-acting DNRI to treat excessive daytime sleepiness in adults with narcolepsy or OSA.
EDS associated with narcolepsy or OSA is a serious condition that is associated with impaired neurocognitive function and can have effects on attention, memory, and executive functioning. Narcolepsy is an orphan condition that affects close to 200,000 people in the U.S., all of whom experience EDS. OSA, on the other hand, is a highly prevalent condition that affects an estimated 22 million U.S. adults. An estimated 75% of OSA patients experience EDS. Many of them continue to experience EDS despite the use of continuous positive airway pressure, or CPAP. Regarding AXS-05 and major depressive disorder, the mental health crisis impacting the U.S. continues, with an estimated 21 million U.S. adults experiencing MDD each year. Recent studies estimate that number has likely increased threefold due to the COVID-19 pandemic.
MDD is a common and serious medical illness that negatively affects how people feel, the way they think, and how they act. MDD is also the number one cause of disability worldwide. Given the personal and economic burden associated with mental health conditions, there's an 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 commercialize if approved. Shifting to AXS-07. Despite recent innovation in the acute migraine market, there continues to be close to 70% dissatisfaction rate with currently available therapies, demonstrating high unmet need for the 37 million Americans who experience migraine. Regardless of any delay on AXS-07 due to the CRL, we have been actively preparing for launch and will be ready to do so if approved.
Promotional efforts on SUNOSI, combined with our near-term planned potential launch for AXS-05 in major depressive disorder, allows for a highly complementary sales force effort. 40% of the current prescriber base for wake-promoting agent is made up of psychiatrists and neurologists, our primary targets for AXS-05 and AXS-07. As a reminder, all salesforce offers are contingent upon approval. Lastly, our first-in-class digital-centric commercialization, or DCC platform, remains fundamental to our commercialization strategy. Our DCC platform was designed to augment our promotional efforts to allow for highly effective, efficient, and more meaningful engagement with physicians and patients. The goal of DCC is to meet customers where and how they want to be engaged, with the right content at the right time.
Our commercial launch strategy is innovative and purposeful, with the intent to bring important new products to market in a meaningful way. The differentiated clinical profiles of SUNOSI, AXS-05 and AXS-07 have the potential to bring significant benefit to patients and the physicians who treat them. I look forward to discussing in greater detail the commercial plans for AXS-05 upon potential approval and for SUNOSI after the close of the transaction. We remain excited about the opportunity to potentially bring these important new products to market in the near term. I will now turn it over to Nick, who will review our financials.
Thank you, Lori, and good morning, everyone. Today, I will discuss our first quarter results and provide some financial guidance. We ended the quarter with approximately $85 million in cash compared to roughly $86 million at the end of the year, a net decrease of approximately $1 million. During the first quarter, we accessed our ATM facility, receiving net proceeds of approximately $31 million. R&D expenses were $12.6 million for the three months ended March 31st, 2022, and $15.6 million for the comparable period in 2021. The decrease was driven by expenses related to the NDA filing, which occurred in the prior comparable period. G&A expenses were $25.7 million for the three months ended March 31st, 2022, and $11.2 million for the comparable period in 2021.
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 $39.6 million, or $1.03 per share for the three months ended March 31st, 2022, compared to a net loss of $29.3 million or $0.78 per share for the comparable period in 2021. The net loss for the current period included $7.6 million of non-cash stock compensation expense, compared to $3.7 million in the comparable period. Regarding the SUNOSI acquisition, the acquisition is being funded through our existing $300 million facility with Hercules Capital, plus an additional equity investment from Hercules Capital.
We believe that our current cash balance, along with the remaining committed capital from the $300 million term loan facility, is sufficient to fund anticipated operations into 2024 based on our current operating plan, which includes the potential launch of AXS-05 and MDD and the acquisition and commercialization of SUNOSI. That concludes our first quarter 2022 financial review. I will now turn the call back to Mark to lead the Q&A discussion.
Thank you, Nick. Operator, may we please have our first question?
Thank you. If you'd like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by two. Again, to ask a question, it is star one. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question. We will pause here briefly as questions are registered. Our first question is from Charles Duncan of Cantor Fitzgerald. Charles, your line is open.
Hey, good morning, Herriot and team. Thanks for taking our question. I had a couple of questions, primarily on 07 and then on 05. Regarding 07 and the CRL, I guess, you know, I know you haven't met with the agency, but can you provide us any additional color on not only the subject but of this CRL in terms of CMC, but what gives you confidence in your ability to address it? And how related is it, if at all, to the CRL or not the CRL, the CMC issues that you received with 05?
Hi, Charles. Thanks for the question. I'll make some overarching comments, and then I'll turn over to Mark, who maybe can provide some more details. With regards to the relationship question between 05 and 07, there is no relationship. The issues are distinct. Also with regards to 05, we did also announce that the CMC-related deficiencies have been addressed and resolved. Now, with regards to the 07 CRL, it's important to reiterate that the CRL did not identify or raise any concerns around the clinical efficacy or safety of the data in the NDA. So we feel very good about that.
We think that it's great to get affirmation from the FDA at the end of a review with regards to our clinical data. We love the product. We think it's an incredibly exciting profile. It's good to get to the end of a review. Now, with regards to the CMC questions and considerations, I'll turn it over to Mark.
Hey, Charles. Good morning. As we mentioned, the questions and the requests for additional information, they principally relate to drug product and the manufacturing process. Just a reminder that AXS-07 incorporates our MoSEIC technology, which is a novel technology that Axsome developed. That does increase the complexity of the manufacturing process, the MoSEIC technology.
We understand the basis for many of the questions and we do believe they're addressable. To give you just a little bit more detail, the technology is a molecular inclusion complex buffering system, and many of the questions relate to that. One other bit of information that may be helpful just to try and address, you know, the different elements of your question is our impression the facility inspection that we had previously shared that we were informed was required, that was completed and that there were no findings as a result of that inspection.
It sounds like really a distinct set of issues relative to 05, but you feel like they're addressable, and you'll provide us timing after you meet with the agency. Do you have a sense of when that could be?
That's correct that that will be the approach we plan to take and how we share with folks. We wanna do that expediently. We do wanna make sure we take our time to prepare for the consultations, and we will do that expediently. As soon as we have a sense of granularity for timing, we'll let you all know. Then related to timing, we would expect this to be a Class 2 resubmission. So that, I think as everyone was aware that that's a six-month review.
Got it. Then one quick two-part question on 05, and that is, great to hear that you've received some communication from the agency on post-marketing requirements. I'm sure that you can't provide a lot of detail on that, but I'm wondering if the post-marketing requirements for 05, should it be approved, does that include a REMS? And, if so, can you provide any color? Then the second part is, given the kind of changing therapeutic landscape to incorporate perhaps more intermittent treatment, for example, with zuranolone, you know, out of Biogen/Sage , their filing. Do you anticipate there to be the same kind of demand or opportunity set that you had seen when you initiated the program with AXS-05? Thanks.
Sure. Thanks, Charles, for those follow-up questions. With regards to the question around the REMS, a REMS was not part of the PMRs or PMCs that were agreed to or discussed with the FDA. Just some overarching comments on your question around intermittent treatment before I turn it over to Lori, who might be able to provide some additional details there. Some overarching comments are that the way that major depressive disorder is treated has always been intermittent treatment. Major depressive episodes are treated, of course. Then, many patients once they get better and they've been better for a while, clinicians would taper them off their medications.
The important aspect of treatment here is that not only should patients receive relief from their depressive symptoms, but that should be maintained. Durability is really important. You know, we've shown significant durability with AXS-05 over a long treatment period. We've treated patients out to one year. We feel as good as ever, if not better, about the prospects for AXS-05 in MDD. Lori?
Yeah. Hi, Charles. Good morning. You know, there's estimated up to 80 million prevalent MDD patients in the U.S. right now. As we all know, you know, we're in the middle of a mental health crisis. Any new therapies coming to market, you know, we're excited about for patients and their ability to get treatment. What we know now with the current available therapies, you know, two-thirds do not achieve remission. Given the clinical profile of 05, you know, with a fast onset of action, the really fast achievement of remission and the durability, as Herriot Tabuteau was mentioning, we do believe it is differentiated and compelling for physicians, and we don't see this as hindering our demand at all.
Very good. Thanks for taking my questions. Congrats on the progress.
Our next question is from Joon Lee of Truist Securities. Joon, your line is open.
Hi. Thanks for taking our questions, and thanks for the updates. For 05, have you started labeling discussions yet?
Joon, thanks for the question. What we've said is that, as soon as we enter into labeling discussions, we will let the street know.
Great. Can you remind us the conditions under which you can draw some funds from the Hercules loan facility? Does it require approval of AXS-05?
Upon approval of AXS-05, there is $100 million that is tied to that approval. However, we do have an amendment that we had signed and becomes executed upon the SUNOSI transaction. That will accelerate
the later tranches to fund up to $45 million of the SUNOSI transaction. I think it's also important to note that Hercules has also committed $5 million-$8 million in a direct equity investment upon the close of the transaction.
Thank you. The last question quickly, you know, the trial amendment that you're contemplating for the Alzheimer's agitation study for AXS-05, is that in any way related to sort of the discussion you're having with the FDA, with regards to the depression indication?
No, it's not related to that.
Great. Thank you. Thanks for the questions.
Our next question is from Vikram Purohit of Morgan Stanley. Vikram, your line is open.
Great. Thank you for taking my questions. Two on the pipeline from our side. The first, staying on the topic of the ACCORD study. You did mention previously that relapse events have been below your initial projections. I just wanted to see if you could give us an update on how those have been trending since you last provided us an update. Then also, do you have any sense of timing at this point on when you might be able to speak with the FDA about, amendments to the study design that you might have in mind?
Sure. I'll let Amanda take that question.
Sure. Thank you. Regarding the, you know, rate of relapses currently, so we have not disclosed any numbers, and we will disclose it when we provide top-line data for the study. In regards to the timing of discussion with the NDA, you know, we haven't provided any granularity, but we do intend to do so as soon as possible.
Okay. As a follow-up, for AXS-14 and fibromyalgia, I know you've guided to an NDA submission in 2023. What needs to happen between now and then, for that NDA submission? Do you know specifically when in 2023 that might be expected? Is it more like a first half event or a second half event?
Hey, Vikram, it's Mark. We haven't given granularity on the timing yet for 2023. As we get closer, we'll narrow that guidance for you all. Right now the rate limiting step continues to be the manufacturing and stability. We do have to recapitulate and redo the manufacturing from the prior process, and that work is ongoing.
Okay. Understood. Thanks.
Our next question is from Marc Goodman of SVB Leerink. Marc, your line is open.
Yes, good morning. Herriot, I think I heard you say that you have affirmation with respect to 07, that there is nothing else related to efficacy or safety. Can you make that same comment when it comes to 05?
It's impossible for us to make any comment like that with regards to 05 prior to an NDA action. We're able to make comments with regards to 07 because now the review is officially completed, and the FDA has formally provided us with the determination that the NDA is completed and what the outstanding issues are. With regards to 05, while we are very positive with on the efficacy profile and on our package, and while we are encouraged by the latest developments in the review process with the PMRs and the PMCs, as you can understand, you know, it's not over until we get the FDA action, and we're very much looking forward to the FDA action hopefully soon.
Yeah, you know, just on 05, there seems to be, you know, just a concern out there that there could be a problem with how this thing gets labeled? I assume it's because of the dextromethorphan, you know, component. You mentioned specifically that there will be no REMS, so that's great news. Are there any other issues that seem to be out there with the FDA regarding dextromethorphan? Or, you know, you don't think that's going to end up being a labeling issue at all?
Well, all we can speak to is our product. Just as a reminder, the technology with AXS-05 is, you know, we're using metabolic inhibition to inhibit the metabolism of dextromethorphan. Therefore the pharmacology is gonna be different, which is why the FDA, you know, did require us to conduct a very large open label safety extension study and also to have exposure in, you know, in thousands of patients. We've done that, which is fantastic. We're confident in the data. We've released those data, and, you know, we're looking forward to the conclusion of the review and the NDA action.
Lastly, just on a big picture manufacturing, you know, obviously it seems to be a discussion here on just about every product. Can you just remind us, are you using the same manufacturing companies with respect to all of these products, 07, 05, 14? You know, I mean, are we gonna have the same kind of issues?
You know, or what? Thanks.
Yeah. There is some natural overlap, as you can imagine, among vendors. However, we do not think that the issues related to one NDA versus the other are related at all in any way. Then the other thing that I would mention.
Are you-
Oh, I'm sorry. The other thing that I would mention, too, is, you know, while this is while it is disappointing, you know, obviously to get to the end of a review and have a CRL, there does seem to be just more globally, if you look at the industry, an increase in the percentage of NDAs that receive CRLs, especially for manufacturing, that may be an indication of the climate at the FDA. For example, you know, the rate of CRLs has been roughly, you know, 50% at least in the first half or so far this year, compared to around 15% historically, and most of those are related to CMC.
You know, we fully understand the reasons why the agency would wanna make sure that you know, any new technology, any new manufacturing process is fully vetted.
Well, you're working on manufacturing right now for 14, so it just kinda lends the question of, you know, are you learning some things from, you know, the issues before? Is this the same manufacturing people who, you know, will learn from what the FDA needs with these other products? That's really the question.
Hey, Mark. We've selected CMOs that we think are best suited to commercialize the product candidates. AXS-14, that's an entirely different. That has its own facility, its own company, the API and drug product. With AXS-07, there are multiple facilities involved there. As we mentioned, one of them had a required inspection, and our understanding is there were no findings. This question about, oh, is there an underlying issue with the CMO, we're not aware that that's the case. There is some overlap with the programs, but generally each is distinct in their input.
Yeah. Another way of answering your question, Mark, is yes, there are learnings from every interaction with the FDA, from every NDA. By the time that we file the NDA for fibromyalgia, you know, we would have gone through, you know, at least two, you know, maybe three NDA filings. And we will take every lesson that is possible. We'll mine those experiences to make sure that we increase our probabilities of success in the future.
Thanks, guys.
Our next question is from Vamil Divan of Mizuho Securities. Vamil, your line is open.
Great. Thanks for taking my questions and for all the info today. Maybe just a couple separate questions. One on 05, I think there's still been a lot of questions from investors on sort of the payer dynamics here since this is sort of two whole new products. Obviously, we're still waiting for full approval here, but I'm wondering if you could give any sort of updated thoughts on kinda how you think payers will respond to this product and sort of what sort of hurdles might payers have to go through before they can get onto the produc?
For SUNOSI, just had a question there on. I know you're probably somewhat limited in what you can say before the deal officially closes, but I think your expectations for sort of a billion-dollar product here are quite a bit above what the street has generally thought of for this product. I assume it's because the sort of newer indications that you're looking to move this product into. I'm just wondering if there's any more you could share at this point in terms of how you're hoping to expand this product out into other indications beyond what it's already approved for? Thank you.
Well, thanks, Vamil, for the questions, actually. I'll take the SUNOSI question and before turning it over to Lori to take the payer dynamics question on 05. Yeah, we're really excited about the SUNOSI acquisition. We did put out an 8-K this morning announcing that the HSR waiting period has now expired. We do expect the transaction to close, you know, very shortly.
We do anticipate, you know, having some kind of investor forum to discuss what the new indications are and what we the timing of that, the timing of making sure that we take the steps that we need to take to get to that, you know, $1 billion plus market potential, which we outlined when we first announced the signing of the acquisition. We're really excited about SUNOSI. I'll turn it over to Lori to talk about the payer dynamics and to add anything more that she may wanna add about SUNOSI.
Sure. Hi, thanks for the question. You know, we started payer-permitted payer discussions back on 05 about a year ago, and nothing's changed. Payers, you know, continue to recognize the unmet need in MDD, and they continually express their
You know, their understanding of the fact that AXS-05 will bring a novel mechanism of action to market. You know, they recognize that there's a need for fast and rapid onset of action, but also durability for those patients. We look forward to telling you more once the potential approval comes and we engage more with payers. In terms of SUNOSI, you know, we are excited about the current indication as well. We do believe that there's incredible untapped potential in the current indication for EDS associated with narcolepsy or OSA. We're also really excited about how you know, the Jazz team that will come over to Axsome have been working during this transition period.
Last week, in fact, you know, NBRx's are new to brand prescriptions were the second highest of the year, and that came during, you know, a time of transition. We are really excited about the caliber of Jazz employees that will come over to Axsome and look forward to welcoming them upon the deal close.
Okay, thank you.
Before we turn to our next question, I would like to remind everyone to limit their questions to two to three questions due to the high number of people in the question queue. Our next question is from Joseph Thome of Cowen and Co. Joseph, your line is open.
Hi there. Good morning, and thank you for taking our questions. Maybe just on the AXS-05 review. It's been a couple weeks now, almost I think, since you announced that you agreed to the post-marketing commitments. I guess in the interim, do you continue to interact with the FDA? What's sort of the cadence of interactions around this? I guess during that discussion, were you able to kind of find out maybe what the initial deficiencies noted in the July letter last year happened to be? Thank you.
Thanks for the question. As you can imagine, during this phase of the NDA review, there are multiple interactions, so those continue. With regards to the initial deficiencies, all we are aware of are what the deficiencies are that have been communicated to us. Those deficiencies were CMC. As we've stated, we have addressed those deficiencies and they are now resolved, and we have not been made aware of any other deficiencies.
Great. Thank you. Maybe just one follow-up. How are you thinking about Europe? And obviously you'll get SUNOSI here, hopefully in the third quarter. Is that something that you wanna launch yourself? When you think about AXS-05 and AXS-07, how far do you wanna take those in discussions with Europe before making a decision on marketing? How are you thinking about that overall?
The way that SUNOSI factors into our European strategy is now it gives us an additional product in Europe. A product which is approved and marketed currently in Europe, and which has also a rollout in multiple new European markets on the roster. As it relates to our overall corporate strategy prior to the SUNOSI acquisition announcement, which was to out-license our product candidates outside of the U.S., this only puts us in a much stronger position. As you can imagine, you know, that might lead to greater interest from potential partners.
Great. Thank you very much.
Our next question is from Ram Selvaraju from H.C. Wainwright. Ram, your line is open.
Thanks so much for taking my questions. Firstly, I just wanted clarification regarding the timeline for potential approval of AXS-07. Since you mentioned that this is likely to be considered a Class 2 resubmission, is it appropriate for us to assume at this juncture that the earliest AXS-07 could be approved in the U.S. would be in 2023?
Ram, thanks for the question. What we're looking to do is to meet with the FDA as expeditiously as possible. That's a Type A meeting. We want to make sure that we get our ducks in a row prior to requesting that meeting and getting a date. Once we have that meeting and we get feedback from the agency, in other words, we confirm exactly what it is that should go into the resubmission so that we can have success, then we'll be in a position to provide you with updated guidance on timing. Apart from what we've already said, which is that we do expect that once we resubmit, that the resubmission would likely be treated as a Class 2 resubmission, leading to a six-month review.
Great. Just two very quick additional ones from me. Can you comment on how you anticipate deploying the SUNOSI sales force that is coming over from the Jazz acquisition transaction? If you anticipate a meaningful role for those sales representatives in the ultimate promotion of drugs like AXS-05 and AXS-07. If you could comment on any plans that you may have with respect to deployment of either SUNOSI or AXS-12 in the area, specifically of idiopathic hypersomnia. Thank you.
Taking those backwards, with regards to the additional indications that you mentioned, we're always thinking about additional indications. With regards to the specificity, we don't have any specifics to share with you right now. I'll turn it to Lori to comment on the sales force question.
Hey, Ram. Thanks for the question. You know, I think it's very important for sales forces, especially during launch periods, and in this case, you know, for SUNOSI, essentially viewing this as somewhat of a relaunch coming over to us. You know, they need to stay focused on their priority targets. They will be deployed to high prescribing, high potential, high value prescribers in the markets, you know, respective markets. The AXS-05 sales force will primarily focus on those targets related to AXS-05, where we believe we will, you know, have the highest potential, and the same for SUNOSI. However, we do know that there is a very high overlap between prescribers and, you know, as appropriate, we will leverage those synergies.
Thank you.
Our next question is from Jason Gerberry from Bank of America. Jason, your line is open.
Hey, guys. Thanks for taking my question. One clarification, just in terms of REMS, is that something that you learn about via label discussion or is it more something that you learn about with the post-market study requirements? There's been some recent neuropsych launches that have exceeded investor expectations. Just curious if you think there's read across effectively. Is there any, you know, structural challenges at all contracting cycles? Thanks.
Sure. Yeah. Just with regards to the question on the REMS. This is one of the first NDAs. Actually, these are our first two NDAs that we are going through. A REMS is not anything that we were thinking would be needed with regards to these product candidates. You never know, though. Until the review is over, we can't really assure you of the FDA's findings or decisions or requirements. What we can communicate to you are the PMRs and the PMCs, which we have agreed to and which have been communicated to us, and they have not included a REMS. Lori?
Jason, sorry, your second question kind of faded in and out. Would you mind repeating that question?
Yeah. Expectations. Curious if you think there's read across the 05 from what you're seeing, it seems like maybe payer coverage is coming online a little faster than expected? I mean, you guys will have effectively a mid-year launch. I don't know if that will be like a 2023 challenge in terms of where you're at in the contracting cycle or a non-issue?
Yeah, great. Great question. Thank you. You know, we will, you know, all we have are the permitted payer discussions that we, you know, we've had thus far, and that we are highly encouraged by how the payers are reacting to, you know, product profile of AXS-05. You know, once we get approval and we know the timing of that approval, we'll be happy to discuss more around what we expect from a payer coverage standpoint then.
Yeah. If I may add to that, Lori, I think just part of Jason's question related to the broader environment in neuropsych as it relates to recent launches, recent neuropsych launches which have exceeded expectations. Is there something broader going on? It's hard to know if the performance of individual product launches, even though they coincide in time, reflect anything that's underlying. There is one underlying trend which is worth repeating, which is that we are in the middle of a mental health crisis. There has been an increase, a significant increase in neuropsych disorders. We think or scientists think that it's related to the COVID pandemic. That is one backdrop that has been occurring.
We know that that's the case, for example, in depression, certainly, but not just in depression, but even across, for example, migraine. The incidence of migraine has gone up in patients who have experienced COVID-19. There is that aspect to it. I think what it speaks to more broadly is the high unmet medical need in neuropsychiatry indications in general. You know, that's why, you know, Axsome is a CNS-focused company, and that's why we're really excited about what we're doing.
Got it. Thank you.
Our next question is from Yatin Suneja from Guggenheim. Yatin, your line is open.
Thank you. A few clarification questions from me. First is on AXS-05. What are your expectations for labeling? Do you expect a box warning similar to what we see with Wellbutrin or other antidepressant?
Since bupropion is a component of the AXS-05, we would expect that aspects of the bupropion label would be reflected in the 05 label.
Okay. When you say that this is again related to 05. When you say that the CMC issues have been resolved, did you get an acknowledgement from the FDA that they are satisfied with your response or it has been resolved just that you have submitted the response? I'm just trying to get a little bit clarity here. What does a resolution mean here?
It's pretty clear to us that it's been resolved based on the communications and also the PMRs and the PMCs.
Okay. Finally, how quickly you might be able to launch once approved for 05? Thank you.
Yeah. Yeah, we expect to launch within a quarter of approval.
Any comment on the pricing? How should we think about pricing? What work you've done? Any sort of recent comp for us to look at, in terms of the price?
Yeah. We haven't communicated price yet and, you know, we will do that upon approval, when we announce price. You know, we expect to price this product, you know, to recognize the clinical differentiation of the product. But we also, you know, have an eye towards providing patients with the approach of appropriate access.
Okay. Thanks.
Our next question is from Chris Howerton of Jefferies. Chris, your line is open.
Great. Really appreciate you taking all the questions this morning and all the extra info. I think for me, I was just curious if you could provide any comments or color on how the 05 approval and launch plays into your current stated cash runway. As a sequelae to that, if there was a delay or non-approval for 05, how might that affect your cash runway guidance? Thank you.
Yeah, sure. Thanks. Thanks, Chris, for the question. Again, upon 05 approval, there is $100 million tied to that approval with our Hercules facility. We feel that we are in, you know, a very good position to launch the product. You know, we are planning that for, you know, this quarter. We do have sufficient cash for over a 12-month period. As I stated on the opening remarks, we did tap our ATM facility in Q1 for upwards of $31 million to bridge the delay in the approval of 05.
Okay. Maybe just as a quick clarification, if there was a further delay to 05, how might that affect your current kind of cash runway guidance?
If there's a further delay, you know, we'll reassess it at that time. As I said earlier, we do have north of 12 months of cash on hand to fund our current operating plan.
Okay. All right. Thanks so much. Appreciate it.
Our next question is from Matt Kaplan of Ladenburg Thalmann. Matt, your line is open.
Thank you. Good morning. Just wanted to have a little more detail perhaps on the AXS-07 CRL. Beyond CMC questions, was there anything else detailed in the CRL that needs to be addressed?
Matt, so principally it was all CMC. There was one item related to non-clinical, which was just a request for additional information which we believe we can provide. So for us, the real focus is CMC.
Okay. Very good. Thank you. I guess a question for Lori. Can you give us some more metrics in terms of how you're thinking about the sales organization as you go into launch several products here?
In terms of some of the metrics around the size of the SUNOSI and dedicated sales force and 05 and 07 dedicated sales forces. How they'll
Yeah. I got you.
How they'll kind of interact? Yeah.
Yeah, sure. A couple of things to keep in mind as you think through how we plan to structure. You know, we haven't revealed the size of the sales forces yet, but what I can tell you is that we plan to target for AXS-05 at least 85% of high-value prescribers, which is more than 25,000 HCPs. You know, we will not only have a sales force in place, but we will also intend to leverage our DCC platform to help ensure that we have optimal reach to those high-value prescribers.
For AXS-07, you know, it will be a very similar approach in terms of how we structure the sales force. You know, highly targeted, highly strategic, highly focused. You know, we plan to have coverage of 50%-60% of the high value prescribers with 07. Then on SUNOSI, you know, the. You know, virtually all the offers that we extended to the Jazz employees were accepted, and that sales force size, you know, we look forward to talking to you more about on the deal close. But it will be an exact the same kind of structure and decision making, highly focused on the those high value prescribers.
To make sure that we hit our reach, we will augment with DCC.
Okay, great. Thanks for that detail.
Our next question is from Bert Hazlett of BTIG. Bert, your line is open.
Yes, thank you for taking the question. Quick follow-up to Matt. And what is the additional ask for information regarding CRL for 07, is that related to MoSEIC technology, or can you be any more specific with regard to the additional ask? Thank you. I've got one or two other.
Hey, Bert. You know, I think we characterize it. I mean, much of it does relate to MoSEIC and the process around that and drug product.
Okay. Just shifting to ACCORD for just a second. What are the goals of the interaction with the agency? What can you do with the study? Is it an issue where you might change the design of the study, might change powering? What are the goals of the discussions with FDA with regard to evaluating the study design?
Bert , the reason why it's prudent to have as much feedback as possible is. This is a registration trial and so we wanna make sure that we take the right steps and avail ourselves of the fact that this is a Breakthrough Therapy-designated product to get that feedback.
Okay, thank you. Just one other for me. Smoking cessation, you talk about a pivotal in phase II/III later this year. Do you think you can get away with one or is that something you're gonna do sequentially with regard to two pivotals for smoking cessation for 05? Thanks.
We expect that we would need two pivotal studies and currently the plan would be to do those sequentially.
Okay. Thank you. Thank you for taking the question.
The next question is from Myles Minter of William Blair. Myles, your line is open.
Hey, thanks for taking the questions. Just on the 05, timing guidance that you put out when the PMRs and the PMCs were agreed upon, you said this quarter. I'm gathering that was based on precedent of some sort, but was that directly communicated to you by the agency that timing, or was that from your regulatory consultants? Was that from work that you've done? You know, obviously the Street's used to seeing labeling discussions triggering that one-month clock, but just wondering how you got that clarity from the PMR/PMC stage. Thanks.
Myles, thank you for that question. Just to be clear, there is no remaining PDUFA date. The FDA is not beholden to any particular date. What we try to do is to provide the Street with actionable information, so any change in terms of our internal estimates as quickly as possible. What drove our statement are the PMRs and the PMCs. With regards to those discussions, sometimes there are timing elements tied to those. So that has allowed us to focus our estimate. Again, this is our estimate and it's not tied to any formal PDUFA date.
Okay, thanks. Just on the PMRs and the PMCs, obviously not disclosing the nature of them, but if we were to look at the guideline, the FDA guidance documents for antidepressant drug development, are they 100% encapsulated in the language in there? Like maintenance, dosing studies that might be required post-marketing or safety in certain populations, or are there certain PMRs and PMCs within those that are, you know, would be unique to the product that might not be talked about in those guidance documents? Thank you.
Yeah. As you can imagine, the PMRs and the PMCs would necessarily incorporate both items that are normally required for an indication, which might be included in guidance, as well as items that are specific to the individual product. What we can say is that the PMRs and the PMCs that were discussed and that have been agreed to are consistent, excuse me, they're consistent with our expectations and there was nothing surprising. You know, we're.
We're happy with them and do not expect them to, in any way, impede commercialization of AXS-05 for MDD.
Yeah, beautiful. Thanks for the questions.
Two final questions. Our next questioner is David Hoang from SMBC. David, your line is open.
Yeah, thanks for taking the questions. Just had one on commercialization and the sales force. In terms of your, you know, your digital component there, what's your level of confidence that that, you know, that's gonna be able to supplement the sales force at the current size that you know, that you plan to bring on board? And is this something that, you know, you would have a high level of confidence in, or would you consider potentially expanding the, you know, the number of reps down the line?
Hey, David. Thanks for the question. Our DCC platform, the way that we designed it was really to ensure that engagement with HCPs and patients are optimized. Meaning we have the ability to have efficient promotional efforts, but also effective promotional efforts. What I can tell you is that we're not gonna sacrifice to not have those effective promotional efforts. We believe based on not only research, physician preference data, historical data of how physicians are engaging, how physicians continue to engage, how patients are showing up at physicians' offices or not, meaning you know the level of virtual engagement in our target therapeutic areas still remains extremely high. We feel very confident in the augmentation that DCC will provide our sales force.
Okay. Thanks a lot.
Our final question is from Esther Hong of Berenberg. Esther, your line is open.
Hi. Good morning. On AXS-07 and the CMC issues, was wondering, number one, did the FDA find this issue? Then number two, did this occur after the facility inspection? Thanks.
Hey, Esther. Good morning. I don't know that it's a finding from the inspection. As we mentioned that there were no findings that we're aware of. Our sense is this is the result of their review during the course of the review cycle. That's our impression, but they didn't give us feedback when you know they identified these needs for additional information.
Okay. Got it. Understood. Thanks so much.
Thank you.
That ends our question and answer session. I'd now like to pass the conference back to the management team for any closing remarks.
Well, thank you again for joining us on the call today. We are committed to bringing potentially life-changing medicines to people living with serious CNS conditions. We look forward to updating you over the coming months on our continued pipeline and commercial progress. Have a great day.
That concludes the conference call. Thank you for your participation. You may now disconnect your line.