Q1 2022 Axsome Therapeutics Inc Earnings Call

Good morning, and welcome to the accident Therapeutics Conference call.

Operator: Good morning and welcome to the Axsome Therapeutics Conference Call. Currently, all participants are in a listen-only mode.

Currently all participants are in a listen only mode.

Operator: 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 of Axsom Therapeutics. Please go ahead.

Later, there will be a question and answer session and instructions will follow at that time.

As a reminder, today's conference is today's conference call is being recorded I would now like to turn the conference over to your host Mark Jacobson Chief operating officer of Axon Therapeutics. Please go ahead.

Mark Jacobson: 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 AXS07 NDA. These crossed the wire a short time ago and are available on our website at Axsome.com.

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 in the release relating to the Fda's action on the acres of seven NDA.

These crossed the wire a short time ago and are available on our website at <unk> com.

Mark Jacobson: During today's call, we will be making a certain forward statement. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-curricular plan, our plans to present or report additional data, the anticipated conduct and source of future clinical trials, regulatory plans, future research and development plans, commercial plans, and possible intended use of cash and investment. 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.

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 plan to.

To prevent or report initial data.

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.

Functions 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.

<unk> disclaims any obligation to update such statements joining.

Mark Jacobson: 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. Ernie Amtabuteau, 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.

Joining me on the call today are Dr area to Bluetooth Chief Executive Officer, Nick <unk>, Chief Financial Officer.

Inglebert executive Vice President of commercial and business development.

Dr. Amanda Jones, Senior Vice President of clinical development.

<unk> will first provide an overview of the company and then review recent developments and upcoming milestones.

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.

Mark Jacobson: Ariel will first provide an overview of the company and then review recent developments and upcoming milestones. Following Ariel, 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 Ari. Thank you, Mark. Good morning, everyone.

And with that I will turn the call over to Ariel.

Ari Maizel: 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 Synozy, and continue to advance the rest of our rich, late-stage pipeline, which includes AXS05 in Alzheimer's disease agitation, AXS12 in narcolepsy, and AXS14 in fibromyalgia. Axsome is poised to transform into a commercial entity, potentially as early as this This is a direct result of our team's focused execution.

Thank you Mark good morning, everyone and thank you all for joining excellent therapeutics first quarter 2022 financial results and business update conference call.

The past few months have been incredibly busy and productive for excellence, we have made progress in the FDA reviews of both of our NDA.

Announced the agreement to acquire some nosy.

And continue to advance the rest of our rich late stage pipeline, which includes <unk> five in Alzheimers disease agitation.

<unk> 12 in narcolepsy and the excess 14 fibromyalgia.

Axon is poised.

I'm into a commercial entity potentially as early as this month.

Result of our team's focused execution.

Ari Maizel: I will provide an update on the status of our NDAs, the pending CENOSI acquisition, and the rest of our pipeline before turning it over to Lori and Nick, who will provide a commercial and financial update. With regard to AXS07, this morning we announced that we have received a complete response letter, or CRL, from the FDA for the AXS07 NDA for the acute treatment of migraines. Importantly, the CRL did not identify or raise any concerns about clinical efficacy or safety in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS07.

I will provide an update on the status of our NDA is the pending so that was the acquisition and the rest of our pipeline before turning it over to Lori and Nick who will provide a commercial and financial update.

Ari Maizel: The principal reasons given in the CRL relate to chemistry, manufacturing, and controls, or CNC considerations. For example, a CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process. We believe that all the issues raised through the CRL are addressable. We believe that all issues raised through the CRL are addressable.

With regards to access those services.

Morning, We announced that we have received a complete response letter or CRM from the FDA for the excess of seven NDA for the acute treatment of migraine.

Importantly, the CRM did not identify or raise any concerns about the clinical efficacy or safety.

The NDA and the FDA did not request any new clinical trials to support the approval of the successful seven.

The principal reason given him a C O L relate to chemistry manufacturing and controls or CMC considerations.

But <unk> identified the need for additional CMC data.

Katy to the drug product and manufacturing process.

We believe that all the issues raised in the CRM or addressable.

Ari Maizel: We are excited by the prospects for AXS07. This excitement is driven by the strong clinical data and product profile of XS07. The approval of XF-07 would offer a much-needed, new, multi-mechanistic treatment option for the millions of people living with migraine.

We are excited by the prospects for excess of 7%.

This excitement is driven by the strong clinical data and product profile of access so seven.

The approval of the excess so seven would offer a much needed new multi mechanistic treatment option for the millions of people living with migraine.

Ari Maizel: 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 your resubmission following consultation with the FDA. With regard to Access 05, the review of the NDA is progressing, and based on feedback from the FDA, we believe that the previously disclosed CMC deficiencies have been resolved.

It is our goal to work closely with the FDA to provide them with the information they need so that we can make.

Jordan, New medicine available to patients as quickly as possible.

We intend to provide potential timing for your Resubmission following consultation with the FDA.

With regards to access sulfide.

If you have the NDA is progressing based.

Based on feedback from the FDA, we believe that the previously disclosed CMC deficiencies have been resolved.

Ari Maizel: In addition, we recently received and agreed to post-marketing requirements and commitments proposed by the FDA for AXS05. Based on this interaction, we anticipate potential FDA action on BNDA in the second quarter of 2022. With regard to our Alzheimer's disease agitation program, enrollment in the phase three accord trial of XSO5 in the syndication continues to progress. As previously disclosed, we are evaluating the design of this study and will provide an update following consultation with the FDA.

In addition, we recently received an agreed the post marketing requirements and commitments proposed by the FDA for access so five.

Based on this interaction we anticipate potential FDA action on the NDA in the second quarter of 2022.

With regards to our old timers disease agitation program enrollment in the phase III trial of <unk>.

So five Elisa indications continues to progress.

As previously disclosed we are evaluating the design of this study and will provide an update following consultation with the FDA.

Ari Maizel: Moving on to the Finozzi acquisition, in March 2022, we entered into a definitive agreement to acquire Sinozi, or Saul Riyanfakal, from Gazz. Sinosie 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.

Moving on to the <unk> acquisition.

In March 2022, we entered into a definitive agreement to acquire so nosy or salary amphenol from jazz pharmaceuticals.

So nosy dual acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea.

Ari Maizel: The Hart Scott-Rodino Wigging Period for 40 Acquisitions has now expired, and so, we expect the transaction to close this month, between the pending FDA action on our NDA for AXS05 in depression. With the expected closing of our acquisition of Cynosi, 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 AXS12, 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 AXS14, our product candidate for the treatment of fibromyalgia, manufacturing and other activities related to the planned submission of an NDA are ongoing.

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 access so five in depression.

And the expected closing of our acquisition of some nosy axon is poised to potentially make two important new medicines available to patients living with serious CNS disorders.

The coming months.

The rest of our late stage pipeline continues to advance.

Excess 12 hour product candidate being developed for the treatment of narcolepsy.

Enrollment in the Symphony Phase III trial is progressing and top line results are anticipated to the first half of 2023.

Boy acts at 14, our product candidate for the treatment of fibromyalgia manufacturing and other activities related to the planned submission of an NDA or ongoing.

And we expect to submit the NDA for this product candidate in 2023.

Lori Englebert: 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, Aereo, and good morning. The commercial team remains focused on preparations for potential commercial launches and, simultaneously, has been working hard to ensure a smooth transition of Cynosi into the Axsome infrastructure. I am extremely proud of the efforts of the entire Axsome team.

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

Thank you Ariel and good morning.

The commercial team remains focused on preparations for potential commercial launches.

Simultaneously had been working hard to ensure a smooth transition of some nurses into the axiom infrastructure.

I'm extremely proud of the efforts from the entire axon team and immediately upon deal close we look forward to welcoming the javelin poised to ask them.

Lori Englebert: And immediately upon deal close, we look forward to welcoming the JAV 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 needs. Our products, if approved, will bring a differentiated clinical profile to their respective markets. As a reminder, CENOSI 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.

Ask them 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, a 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, Sanofi is the first and only FDA approved dual acting DNR eye to treat excessive daytime sleepiness in adults with narcolepsy or OSA.

E D S associated with narcolepsy or OSA is a serious condition that is associated with impaired neuro cognitive function you can have effects on attention memory and executive function Inc.

Lori Englebert: Narcolepsy is an orphaned 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 EBS, and many of them continue to experience EBS despite the use of continuous positive airway pressure or CPAP.

Narcolepsy is an orphan condition that affects close to 200000 people in the U S. All of whom experienced E. D. S.

Oh, let's say on the other hand is a highly prevalent condition that affects an estimated 22 million U S. Adults.

And estimated 75% of OSA patients experience ETS.

Many of them continue to experience a b S. Despite the use of continuous positive airway pressure or CPAP.

Lori Englebert: Regarding AXSO5 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.

Regarding exercise and major depressive disorder, and mental health crisis impact in the U S continues with an estimated 21 million U S. Adults experiencing MTB each year.

And recent studies estimate that number has likely increase threefold due to the COVID-19 pandemic.

N D D is a common and serious medical illness that negatively affects how people feel where they think and how they act.

Lori Englebert: MDD is also the number one cause of disability worldwide. Given the personal and economic burden associated with mental health conditions, there is an urgent need to bring support to those affected. If approved, AXSO5 would be an important new treatment option for the many Americans living with depression. We are prepared and ready to commercialize if approved. Schiffing to register seven.

N D. D is also the number one cause of disability worldwide.

Given the personal and economic burden associated with mental health conditions. There is an urgent need to bring support to those affected.

If approved except besides would be an important new treatment option for the many Americans living with depression.

We got prepared and ready to commercialize.

Great.

Shifting to a seven.

Lori Englebert: Despite recent innovation in the acute migraine market, there continues to be close to a 70% dissatisfaction rate with currently available therapies, demonstrating high unmet need for the 37 million Americans who experience migraine. Regardless of any delay on AXSOS 7 due to the CRL, we have been actively preparing for launch and will be ready to do so if approved. Promotional efforts of Cinecy, combined with our near-term planned potential launch for AXSO-5 in major depressive disorder, allow for a highly complementary sales horse effort. 40% of the current prescriber base for weight-promoting agents is made up of psychiatrists and neurologists, our primary targets for AXS05 and AXS07.

Recent innovation in 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 an excess of seven due to the E. R. L. We have been actively preparing for launch and we'll be ready to do so if a person.

Promotional effort or something else he combined with our near term plans potential launch for <unk>. So five in major depressive disorder.

Allows for a highly complementary salesforce effort.

40% of the current prescriber base for wake promoting agents is made up of psychiatrist and neurologist our primary targets for excess survive in excess of seven.

Lori Englebert: As a reminder, all Salesforce offers are contingent upon approval. Lastly, our first-in-class digital-centric commercialization platform, or DCC, 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 the market in a meaningful way. The differentiated clinical profiles of CINOSI, AXS05, and AXS07 have the potential to bring significant benefits to patients and the physicians who treat them.

As a reminder, all sell force offers are contingent upon approval.

Lastly, our first in class digital centric commercialization or D. C. C platform remains fundamental to our commercialization strategy.

Our D. C. C 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 D. C. C 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 Sanofi.

So far and excess of seven has the potential to bring significant benefit to patients and the physicians who treat them.

Nick Pizzie: I look forward to discussing in greater detail the commercial plans for AXSO5 upon potential approval and for CINOSI 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.

I look forward to discussing in greater detail the commercial plans for excess so five upon potential approval. Unfortunately oc after the close of the transaction.

We remain excited about the opportunity to potentially bringing these important new products to market in the near term.

I will now turn it over to Nick who will.

Where to view our financials.

Nick Pizzie: 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 31, 2022, and $16.6 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. GNA expenses were $25.7 million for the three months ended March 31, 2022, and $11.2 million for the comparable period in 2021.

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 31, 2020 to $16 $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 because the three months ended March 31, 2022, and $11 2 million for the comparable period in 2021 the.

Nick Pizzie: The increase was primarily related to pre-commercial activities and personnel expenses, along with an increase in non-cash stock compensation expenses. The net loss was $39.6 million, or $1.03 per share, for the three months ended March 31, 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.

The increase was primarily related to pre commercial activities and personnel expense along with an increase in noncash stock compensation expense.

Net loss was $39 $6 million or $1 three per share for the three months ended March 31, 2022, compared to a net loss of $29 3 million or 78 cents 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.

Mark Jacobson: Regarding the Synosy 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 AXS05 and MBD and the acquisition and commercialization of Cenosi. 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.

Regarding the Sanofi 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 the excess of five and M. D D and the acquisition and commercialization of <unk>.

Okay.

That concludes our first quarter 2022 financial review I will now turn the call back to Mark to lead the Q&A discussion.

Operator: Operator, may we please have our first question? Thank you. If you would like to ask a question, please press star followed by 1 on your telephone keypad. If, for any reason, you would like to remove that question, please press star followed by 2.

Thank you Nick operator, maybe we can.

Please have the first question.

<unk>.

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.

Operator: 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 so that you can ask questions or register. Our first question is from Charles Duncan of Cantor Fitzgerald. Charles, your line is open. Hey, good morning, Ariel and team.

Again to ask a question at Starwood.

As a reminder, if you are using a speakerphone. Please remember to pick up your handset before asking your question.

We will pause you briefly ask questions are registered.

Our first question is from Charles Duncan of Cantor Fitzgerald, Charles Your line is open.

Charles Duncan: Thanks for taking our questions. I have 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 with any additional color, not only on the subject, but on this CRL in terms of CMC? 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?

Hey, good morning aerial and team thanks for taking our question.

I had a couple of questions primarily on O seven and then Oh five regarding <unk> seven and the C. R. L. I guess I'm you know I know.

You haven't met with the agency, but can you provide us any additional color.

Not only this subject but of of this BRL in terms of CMC, but what gives you confidence in your ability to address it and how how related is it if at all to the C O L or not the CRM all the CMC issues that you've received with Dell.

Oh five.

Yeah.

Ari Maizel: Hi Charles, thanks for the question. I'll make some overarching comments, and then I'll turn it over to Mark, who can maybe provide some more details. With regard to the relationship, the question between 05 and 07, there is no relationship; the issues are distinct. And then also, with regard to 205, we did also announce that the CMT-related deficiencies have and Rizal. Now what? With regard to the 07 CRL. Dr. Edward II reiterates that the CRL did not identify or raise any concerns around the clinical efficacy or safety of the data in the NDA.

Hi, Charles Thanks for the question of what makes it from some overarching comments and then I'll turn it over to Mark maybe you can provide some more details with regards to the relationship a question between five and seven there isn't a relationship to the issues or the snake.

And then also.

With regards to dual five we did also announce that the same few related deficiencies have been addressed.

And and and resolved.

Now.

With regards to 070.

According to.

Ari Maizel: So, we feel very good about that. We think that it's great to get approval from the FDA at the end of a review with regard to our clinical data. So, I think. We love the product.

Reiterate that the CRM did not identify all raised any concerns around the clinical efficacy or safety of the data in the NDA.

So we feel very good about that and think that it's great to get affirmation.

From the FDA at the end of a review with.

With regards to our clinical data so.

We love the product.

It's an incredibly exciting profile and and and it's good to get to the end of a review now with regards to the CMC questions and considerations.

Mark.

Ari Maizel: We think it's an incredibly exciting profile, and it's good to get to the end of a review. Now, with regard to the CMC questions and considerations, I'll turn it on. Hey, Charles. Good morning.

Hey, Charles Good morning.

So and as we mentioned the questions in their request for additional information they principally related drug product in the manufacturing process and so just a reminder, that net acres all seven incorporates our mosaic technology.

Mark Jacobson: As we mentioned, the questions and the requests for additional information principally relate to the drug product and the manufacturing process. So just a reminder that ASIS-07 incorporates our Mosaic technology, which is a novel technology that Axsome developed. And so that does increase the complexity of the manufacturing process. And so we understand the basis for many of the questions, and we do believe they're addressed. And 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. And one other bit of information that might be helpful just to try and address.

We have a novel technology that the act from developed and so that that does increase the complexity of the manufacturing process the Mosaiq technology.

And so we understand.

The basis for many of the questions and we do believe they are addressable.

To give you just a little bit more detail on the <unk>.

Technology is a molecular inclusion complex buffering system and in many of the questions relate to that.

One other bit of information that.

That may be helpful just to try and address Hum.

Mark Jacobson: The different elements of your question are, our impression is the facility inspection that we had previously shared, that we were informed was required, that that was completed, and that there were no findings as a result of that. So, it sounds like really a distinct set of issues relative to O5, but you feel like they're addressable, and you'll provide us with a timeline after you meet with the agency. Do you have a sense of when that could be? So that's correct that that will be the approach we plan to take and how we will share it with folks. So we want to do that expediently.

The different elements of your question is our impression.

So the inspection that that we had previously shared that we were informed with required that that were completed and that there were no findings.

As a result of that inspection.

Right.

So it sounds like really a distinct set of issues relative to old five but you you feel like it's addressing their addressable aneel provided us timing. After you meet with the agency do you have a sense of when that could be.

So that's correct that we that that will be the approach we plan to take and how we share with folks that we want to do that Expediently, we do want to make sure. We take our time to prepare for the consultations and we will do that expediently and as soon as we have a sense of.

Mark Jacobson: We do want to make sure we take our time to prepare for the consultations, and we will do that expediently. And as soon as we have a sense of granularity for timing, we'll let you all know. And then, related to timing, we would expect this to be a Class 2 resubmission. And so that...

Granularity for tiny, but we'll let you all know.

And then related to timing, we would expect it to be a class two resubmission and so that.

Mark Jacobson: I think, as everyone is aware, that's a six-month, Okay. And then one quick two-part question on O5, 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 provide a lot of detail on that, but I'm wondering if the post-marketing requirements for O5 should be approved? Does that include a REM? And if so, can you provide any color?

I think as everybody was aware that that's a that's a six month review.

Got it and then one quick two part question on O five 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 post marketing requirements for all five should it be approved.

Does that include a rams.

Charles Duncan: And then the second part is, given the kind of changing therapeutic landscape to incorporate perhaps more intermittent treatment, for example, with Seranolone, you know, out of Biogen, and Sage; they're 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, say, Access Holdfast? Thanks.

And if so can you provide any color and then and then the second part is given the kind of changing therapeutic landscape to incorporate perhaps more intermittent treatment. For example, with Saran alone you know out of out of Biogen stage, there they're filing do you.

Hey, there to be the same kind of demand or or opportunity set that you had seen when you initiated a program with a successful first thanks.

Ari Maizel: Sure. Thanks, Charles, for those follow-up questions with regard to questions around the REMS. A REMS was not part of the PMR's agreed to or discussed, and just some overarching comments. On your question around intermittent treatment, before I turn over to Lori, who might be able to provide some additional details there, but some overarching comments are that The Wavehack, major depressive disorder has always been treated with intermittent treatment, so major depressive episodes are treated, of course, and then many patients, once they get better and they've been better for a while, clinicians would take them off their medication. The important aspect of treatment is that not only should patients receive relief from their depressive symptoms, but that that should be maintained. So durability is really important.

Sure.

For those follow up questions.

With regards to.

The question around the Rems.

Rems was not part of <unk> P. M sees that agreed to.

Or discussed.

Yeah.

And.

There's 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, but some overarching comments or that the way that.

Major depressive disorder is treated has always been intermittent treatment. So major depressive episodes are treated.

Of course and then.

Many patients once they get better and they've been better for awhile conditions would take it anymore.

Medications.

Important.

Aspect of treatment is that new.

Not only should patients.

The relief from their depressive symptoms.

That should be maintained so durability is really important and we've shown.

Significant durability with five of them over a long treatment periods, we've treated patients out to one year, so well field.

As good as ever.

Ari Maizel: And, you know, we've shown significant durability with XSO5 over a long treatment period. So we've treated patients out to one year. So we'll feel, as good as ever, isn't better about the prospects for AXS 05 and MDD. Yeah, hi, Charles.

If not better about the prospects are for instance will five and M D.

Lori Englebert: Good morning. You know, there are up to 80 million prevalent NDD patients in the US right now. And as we all know, we're in the middle of a mental health crisis. So any new therapies coming to market, we are excited about for patients and their ability to get treatment. But what we know now with the current available therapies, two-thirds do not achieve remission.

Yeah, Hi, Charles Good morning.

You know, there's estimated up to 80 million prevalent M. D D patients in the U S right now.

We all know we're in the middle of a mental health crisis.

So any new therapies coming to market you know, we we were excited about for patients and their ability to get treatment.

What we know now with current available therapies, you know two thirds do not achieve remission.

Lori Englebert: And given the clinical profile of O5, you know, with the fast onset of action, the really fast achievement of remission, and the durability, as Ariel was mentioning, we do believe it is differentiated and compelling for physicians, and we don't see this as hindering our work. Very good. Thanks for taking my questions. Congratulations on the progress. Our next question is from Joon Lee of True Security. Joon, your line is open.

And given the clinical profile of five you know with the fast onset of action I'm being really fast achievement of our mission and the durability of as Eric was mentioning we do believe it is differentiated and compelling for physicians and we don't see this as a 10.

Our demand at all.

Very good thanks for taking my questions Congrats on the progress.

Yeah.

Our next question is from Joon Lee of Truth Securities.

June your line is open.

Joon Lee: Hi, thanks for taking our questions, and thanks for the updates. So, on 05, have you started labeling discussions yet? Thank you, and 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. And then can you remind us the conditions under which you can draw additional funds from the Hercules loan facility? Does it require approval?

Hi, Thanks for taking my questions and thanks for the update.

So for an O five have you started labeling discussions yet.

Okay.

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 and then can you remind us the conditions under which you can draw additional funds from the Hercules loan.

The facility.

Does it require approval.

Oh, Yeah sure.

Nick Pizzie: Yeah, sure. So, upon approval of AXS05, there is $100 million that is tied to that approval. However, we do have an amendment that we have signed and that becomes executed upon the Synosy Transaction. And that will accelerate the later tranches to fund up to $45 million of the Synosy Transaction. I think it's also important to note that Hercules has also committed $5 to $8 million in a direct equity investment upon the

So.

For upon approval of a excess of five there is a $100 million that is tied to that.

That approval.

We do have a amendment.

That we assigned and becomes executed upon the Sanofi transaction and that will accelerate the the later tranches to fund up to $45 million of the Sanofi transaction I think it's also important to note that.

Hercules is also committed $5 million to $8 million and a direct equity investment upon the close of the transaction.

Nick Pizzie: And the last question quickly, you know, the trial amendment that you're contemplating for the Alzheimer's agitation study for AXS05, is that in any way related to sort of the discussion you're having with the FDA with regard to the depression indication? No, it's not related to that.

Thank you and our last question quickly.

The trial amendment that you're contemplating for the Alzheimers agitation study or access or five is that in any way related to sort of the discussion you're having with the FDA with regards to the depression indication.

Oh, no it's not related to that.

Joon Lee: Great, thanks for the questions. Our next question is from Vikram Purohit of Morgan Stanley. Vikram, your line is open.

Great Thanks for that.

Thanks for the questions.

Yeah.

Our next question is from Vikram Pier a hit of Morgan Stanley .

Your line is open.

Vikram Purohit: Great, thank you for taking my questions. So, two on the pipeline from our side. So first, staying on the topic of the Accord study, you did mention previously that relapse events have been below your initial projection, so I just wanted to see if you could give us an update on how those have been trending since you last provided us with an update. And also, do you have any sense of timing at this point 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.

Great. Thank you for taking my questions.

Two on the pipeline from our side the first staying on the topic of the accord study. So you did mention previously that relapse events have been looked below your initial projections. So I just wanted to see if you could give us an update on how those have been trending since you last provided an update and 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.

Yes.

Okay sure.

But I'll, let I'll, let him answer that question.

Amanda Jones: Sure, thank you. Regarding the rate of relapse currently, we have not disclosed any numbers, and we will disclose it when we provide top-line data for this study. And in regards to the timing of the discussions with the NDA, you know, we haven't provided any granularity, but we do intend to do so as soon as possible. Okay, and as a follow-up, for AXS14 and fibromyalgia, I know you've got it to an NDA submission in 2023. What needs to happen between now and then? for that NDA submission. And 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.

Sure. Thank you regarding the rate.

Right of Relapses currently so we have not disclosed any numbers and we will disclose it when we provide top line data or just studying and in regards to the timing of it especially with the N V. A we haven't provided any granularity, but we do intend to do so it seems possible.

Okay and as a follow up.

For extra 14th in fibromyalgia.

I know you've got it to an NDA submission in 2023, what needs to happen between now and then.

Or for that NDA submission and do you know specifically one in 2023 that might be expected is it more like a first type of event or a second half event.

Mark Jacobson: So we haven't given granularity on the timing yet for 2023. As we get closer, we'll narrow that guidance for you all. And right now, the rate-limiting step continues to be manufacturing and stability; we do have to recapitulate in our manufacturing process from the prior process, and that work is ongoing. Okay, understood. Thanks. Our next question is from Mark Goodman of SVB Learing. Mark, your line is open. Yes, good morning, Ari. I think I heard you say that with respect to 07, you have confirmation that there is nothing else related to efficacy or safety. Can you make that same comment when it comes to 05?

Hey, Brett it's mark.

We haven't given granularity on the timing yet for 2023 is as we get closer we'll narrow that guidance for 40, well right now the rate limiting step is continues to be the manufacturing and stability. We do have to recapitulate in R. B the manufacturing from from the prior processing and that work is ongoing.

Okay.

Okay understood. Thanks.

Hum.

Our next question is from Marc Goodman of SBB Leerink.

Mark Your line is open.

Yes, good morning.

Oh, Yeah, I think I heard you say that you have affirmation with respect to Oh, seven that there is nothing else related to efficacy or safety.

Can you make that same comment when it comes to O five.

Yeah.

Mark Goodman: It's impossible for us to make any comment like that with regard to 05 prior to an NDA action, but we're able to make comments with regard to 07 because the review is efficiently completed, and the FDA has formally provided us with the determination that the NDA is completed and what the outstanding issues are. So with regard to 05, while we are very positive about 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, we... As you can understand, it's not over until we get FDA action, and we're very much looking forward to FDA action, hopefully.

It's impossible for us to make any comment like that with regards to five prior to an NDA action now so we're able to make a comment with regards to seven because you can.

Now the review is efficiently completed and Emt has formally.

Formally provided us.

With the determination that the NDA was completed and what the outstanding issues are so so with regards to why while we are.

Very positive.

On on the efficacy profile and on our package and while we are encouraged by the latest developments in in the review process with the Pmiers and the Pmc's we.

As you can understand you know its not over until we get the FDA action and we're very much looking forward to the FDA action hopefully soon.

Mark Goodman: Yeah. And, you know, just on O5, 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 component.

Yeah.

You know just on O five there seems to be 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 component you.

You mentioned, specifically that there will be no rems. So that's that's great news so are there any other issues.

Mark Goodman: 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, do you think that's going to end up being a labeling issue at all?

Seem to be out there with the FDA regarding dextromethorphan or you don't think that's going to end up being a labeling issue at all.

Yeah.

Ari Maizel: Well, all we can speak about is our product. And just as a reminder, the technology with AXS05 is, you know, we're using metabolic inhibition to inhibit the metabolism of dexamethorphan. So 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 expansion study and also to have exposure in you know, thousands of patients. So we've done that, which is fantastic.

Well all we can speak to is our product and just as a reminder, with the technology is.

The excess of <unk> five is that you know, we're using metabolic inhibition to inhibit the metabolism of Dextromethorphan.

So therefore, the pharmacology he's gonna be different which is why you have to you know didn't require us to conduct a very large job.

Ari Maizel: We're confident in the data. We've released those data. And, you know, we're looking forward to the conclusion of the review under the Indy Act. And then lastly, just on the big picture of manufacturing, obviously, it seems to be a discussion here on just about every product. Can you just remind us, are you using the same?

Open label Safety extension study and also to have exposure in.

Thousands of patients. So we've done that which is fantastic we're confident in the data.

We released that.

The those data.

And you know we're looking forward to the to the conclusion of the review on the India action.

And then 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.

Mark Goodman: Manufacturing companies with respect to all of these products of seven or five fourteen, you know. I mean, are we going to have the same kind of issues, you know, or not? There is some natural overlap, as you can imagine, amongst vendors. However, we do not think that the issues related to one NDA versus the other are related at all in any way.

Manufacturing companies with respect to all of these products are seven or 514, you know I mean are we going to have the same kind of issues.

Or what.

Yeah.

There are some natural overlap as you can imagine amongst vendors.

However, we do not think that the issues are related to one NDA versus the other are related at all in any way.

Mark Jacobson: And then the other thing that I would mention, I'm sorry, the other thing that I would mention to you is, you know, while this is, While it is disappointing to get to the end of a review and have a CRL, there does seem to be, more globally, if you look at the industry, an increase in the percentage of... In the first half of this year, compared to around 15.5% historically, and most of those are related to So, you know, we fully understand the reasons why the agency would want to make sure that, you know, any new technology, any new manufacturing process is fully that. Well, you're working on manufacturing right now for 14.

And then the other thing that I already mentioned.

I'm sorry, the other thing that I would mention too is you know while this is.

While it is disappointing obviously to get to the end of a review and happens to your L.

But there does seem to be just more globally. If you look at the industry and.

An increase in the percentage of.

N D A's that receives urls, especially for manufacturing that may be.

An indication of the climate of the F D a.

For example, you know the.

The rate of of fewer else who's been roughly 50% at least.

In the first half of so far this year appear to around 15, one 5% historically.

Most of those are related to CMC. So.

We fully understand the reasons why.

Why agency would want to make sure that you don't.

Any new technology, new manufacturing processes is fully vetted.

Mark Jacobson: So it just kind of lends the question of, you know, are you learning some things from the issues before? Is this the same manufacturing people who will learn from what the FDA needs with these other products? That's, that's really the question.

What are you working on manufacturing right now for 14, so it just kind of length of the question that you know are you learning some things from you know the issues before is this the same manufacturing people, who you know well learn from what the FDA needs with these other products. So that's that's really the question.

Okay.

Mark Jacobson: Hey Mark, so each program, we've selected CMOs that we think are best suited to commercialize the product candidates. And so AXS14, that's an entirely different animal, that has its own facility, its own company, API, and drug products with 807. There are multiple facilities involved there. As we mentioned, one of them had a required infection, and our understanding is there were no findings.

Hey, Mark so so each program we have selected CMO that we think are our best suited to to commercialize the product candidates.

For 2014, that's an entirely different.

That has its own facility its own company's API and drug product.

So seven there are multiple facilities involved there as.

As we mentioned one one of them had a required infection and our understanding was there were no findings. So there's this question about Oh is there an underlying issue with the CMO. We're not we're not aware that that's the case and.

Mark Jacobson: So 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 between the programs, but generally, each is different. Yeah, and another way of answering your question, Mark, is, Yes, there are learnings from every interaction with the FDA, from every NDA, and you know by the time that we filed the NDF for fibromyalgia, you know we would have gone through at least two, you know, maybe three NDA filings. And we will take every lesson that is possible.

There is some overlap with the programs, but generally aegis aegis.

Yeah.

Another way of answering your question.

Mark is is.

Yes, there are learnings from every interaction with the FDA from every and debate and you know by the time that we file the NDA for fibromyalgia.

We would have gone through.

At least two maybe three NDA filings.

And and and and we will take every lesson then it's possible we'll mine those experiences to make sure that we increase our probabilities of success in the future.

Ari Maizel: We'll mine those experiences to make sure that we increase our probability of success in the future. Our next question is from Vamil Devon of Miseho Security. Vamil, your line is open.

Gotcha.

Right.

Yeah.

Our next question is from the meal Divan of Mizuho Securities.

Your line is open.

Vamil Devon: Great, thanks for taking my questions and for all the info today. So maybe just a couple separate questions. So one on O5, I think we've still got a lot of questions from investors on sort of the payer dynamics here since this is sort of a two-holder product. Obviously, we're still waiting for full approval here, but I'm wondering if you can give any sort of updated thoughts on kind of how you think payers will respond and other indications of the onward authority. Thanks, Donald, for the questions. Actually, there were two.

Great. Thanks for taking my questions and for all the info today. So maybe just a couple a separate question for one on one five I think we still got a lot of questions from investors on sort of the payer dynamics years in prison or to hold your products.

Honestly, we're still waiting for approval here, but I'm wondering if you can give any sort of updated thoughts on kind of how do you think payers will.

Bond in this product and sort of what sort of hurdles my patients have to go through before they can get onto the product.

And then for <unk> just had a question there on I know you probably somewhat limited in what you can say what the deal officially closes but.

And your expectations for sort of $1 billion product here quite a bit above what the street is generally thought of as probably I assume that's because of 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 open expand this product out into into other indications beyond what is already a proof point.

Thank you.

Lori Englebert: I'll take the Sunosi question before turning it over to Lori to take the payer dynamics question on 105. Yeah, we're really excited about the Sunosi acquisition. We did put out an 8K this morning announcing that the HSR waiting period has now expired. So we do expect the transaction to close very shortly, and we do anticipate having some kind of investor forum to discuss. What the new indications are and what we, the timing of that, the timing of.

Well, thanks for going forward for the question.

Questions I mean, there were two.

I'll I'll take this and only question before turning it over to Lori to take the payer dynamics question on 25.

Yeah.

Really excited about the <unk> acquisition, we did.

Put out an 8-K this morning announcing the HSR waiting period has now expired. So we do expect the transaction to close very shortly and and we do.

We anticipate.

Having.

Some kind of Investor Forum.

To discuss.

What the new indications are and what we.

The timing of that the timing of us.

Lori Englebert: Making sure that we take the steps that we need to take to get to that one billion dollar plus market potential, which we outlined when we first announced the signing of the acquisition. So we're really excited about CINOZI, and I'll turn it over to Lori to talk about the pay-a-dynamics and to add anything more that she may want to add about CINOZI. Sure. And Hi, thanks for the question. So, you know, we started permitted payer discussions back in 05, about a year ago, and nothing's changed.

Making sure that we take the steps that we need to take.

Do you want to get to that.

1 billion dollar plus market potential, which we outlined when we first announced the signing of the acquisition. So we're really excited about that's nosy and I'll turn it over to Lori to talk about the payer dynamics in to add anything more that you may want to add about some movie.

Sure.

Thanks for the question. So so you know we started payor permitted payer discussions back Oh, five about a year ago.

And nothing has changed payers continue to recognize the unmet need and M. D D and they you know continually express there.

Lori Englebert: Payers, you know, continue to recognize the unmet need in MDD, and they, you know, continually express their understanding of the fact that AXSO5 will bring a novel mechanism of action to market. They recognize that there is a need for fast and rapid onset of action, but also durability for those patients. I look forward to telling you more once the... Charles Prima, Convin, We engage more with In terms of the NOSI, you know, we are excited about the current indication as well.

You know their understanding of the fact that access of five will bring a novel mechanism of action to market them you know they they recognize that there's a need for fast and rapid onset of action, but also durability for.

For those patients and Oh, we look forward to telling you more once the lumpy potential.

Potential approval comes in and we re engagement with theirs.

In terms of Sanofi.

We are excited about the current indication as well, we do believe that there's incredible untapped potential and the current indication.

Lori Englebert: 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 JAST team that will come over to Axsome has been working during this transition period. Last week, in fact, NBRX was new to brand.

For Etfs.

Especially with narcolepsy or OSA.

We're also really excited about how the jazz team has that will that will come over time to ask them having been working during this transition period last week in fact, mdx MBR access or new to brand.

Lori Englebert: Prescriptions were the second highest of the year, and that came during, you know, a time. So we are really excited about the caliber of Jazz employees that have come over to Axsome and look forward to welcoming them upon their discharge. 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. The next question is from Joseph Thorn of Cohen and Company. Joseph, your line is open.

<unk> prescriptions were the second highest of the year and that came during a time of.

Transition.

So we are really excited about the caliber of jazz employees.

And look forward to welcoming them.

One of them.

Yeah.

Okay. Thank you.

Yeah.

Yeah.

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 Thorn of Cowen and company.

Joseph Your line is open.

Joseph John: Hi there, good morning, and thank you for taking our questions. Maybe just on the AXSO5 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?

Hi, there good morning, and thank you for taking my question, maybe just on the excess of five review it's been a couple of weeks now almost I think since 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 what's sort of the cadence of interactions around this and I guess during that discussion.

Ari Maizel: And 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? Thanks for the question. As you can imagine, during this phase of the NDA review, there are multiple interactions, so those continue. And with regard to the initial deficiencies, all we are aware of are what the deficiencies are that have been communicated to us. Those deficiencies were CMC, and as we've stated, we have addressed those deficiencies, and they are now resolved. We have not been made aware of any other deficiencies.

And.

Able to kind of find out maybe what the initial deficiencies noted in the July letter last year happened to be thank you.

Yeah.

Thanks for the question.

As you can imagine a dream.

During this phase of the NDA review.

There are multiple interactions so those continue.

And with regards to the initial deficiencies.

All we all we all wear them or what the deficiencies or that had been communicated to us.

Those deficiencies were CMC and as we've.

As stated we have addressed the deficiencies and they are now resolved and you might be made aware of any other deficiencies.

Ari Maizel: Great, thank you. Maybe just one follow-up. How are you thinking about Europe?

Great. Thank you maybe just one follow up how are you thinking about Europe .

You'll you'll get synergy here hopefully.

Joseph John: And obviously, you'll get to this. But, marketing, how are you thinking about that? The way that Synozy factors into our European strategy is that it gives us an additional product in Europe, a product which is currently approved and marketed in Europe and which has also been rolled out in multiple new European markets on the roster.

Hopefully in the third quarter or is that something that you want to launch yourself and when you think about the excess of five in excess of seven.

How far do you want to keep those in discussions in Europe before.

Our marketing how do you think about that overall.

The women. That's you know the factors into our European strategy is now it gives us an additional product in Europe .

<unk>, which is approved and marketed currently in Europe , and which has also a rollout in multiple new European markets.

On the roster.

<unk>.

Ari Maizel: So, as it relates to our overall corporate strategy prior to the CMLZ acquisition announcement, which was to out-license our product candidates outside of the U.S., this only puts us in a much stronger position. And as you can imagine, you know, that might lead to greater interest from potential partners. Thank you very much. Our next question is from Ram Selvaraju from HC Wainwright. Ram, your line is open.

As it relates to our overall corporate strategy prior to the some Nosy Act.

Acquisition announcement, which was to out license our product candidates outside of the U S. Its only puts us in a much stronger position as you can imagine.

That might lead to greater interest from potential partners.

Great. Thank you very much.

Yes.

Okay.

Our next question is from Ram <unk> from H C Wainwright.

Graham Your line is open.

Raghuram Selvaraju: Thanks very much for taking my questions. Firstly, I just wanted clarification regarding the timeline for potential approval of AXS07. 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 AXS07 could be approved in the US would be in 2023?

Thanks, very much for taking my questions. Firstly I just wanted clarification regarding the timeline for potential approval of access those seven since you mentioned that this is likely to be considered a class II resubmission is it.

Appropriate for us to assume at this juncture that the earliest access those seven could be approved in the U S would be in 2023.

Ari Maizel: So, Ron, 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.

So rob Thanks for the question.

When 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.

Ari Maizel: 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, the resubmission would likely be treated as a class to resubmission, leading to a six-month review. And then just two very quick additional ones from me.

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 the resubmission.

Would likely be treated as a class two resubmission, leading to a six month review.

Yeah.

Raghuram Selvaraju: Can you comment on how you anticipate deploying the Sanofi sales force that is coming over in the Jazz acquisition transaction? And if you anticipate a meaningful role for those sales representatives in the ultimate promotion of drugs like AXS05 and AXS07? And then also, if you could comment on any plans that you may have with respect to the deployment of either AXS05 or AXS12 in the area specifically of idiopathic hypersomni

Great and then just two very quick additional ones for me.

Can you comment on how you anticipate deploying the Sanofi sales force that is coming over and the jazz acquisition transaction and if you anticipate a meaningful role for those sales representatives in the ultimate promotion of drugs like excess Oh, five a day exit so seven and then also.

If you could comment on any plans that you may have.

With respect to deployment of either the nosy or excess 12 can be area specifically of idiopathic hypersomnia. Thank you.

Yeah.

Ari Maizel: Thank you. So taking those backwards, with regard to the additional indications that you mentioned, we're always thinking about additional indications with regard to specificity. We don't have any specifics to share with you right now. And I'll turn it to Lori to comment on the Salesforce question. Lori Englebert Hey, Rob.

So taking those backwards.

With regards to the additional indications that 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.

And alternative Morita comment on the sales force question, Hey, Rob. Thanks, Thanks for the question so.

Lori Englebert: Thanks for the question. I think it's very important for Salesforce, especially during launch periods, and in this case, for Sanosi. They need to stay focused on their priority targets, and so they will be deployed to high prescribing, high potential prescribers in the market.

It's very important for sales forces, especially during launch periods.

In this case, you know first Tennessee, honey actually viewing this as somewhat of a relaunch coming over to us.

You know they need to stay focused on their priority targets.

So they will be deployed to high prescribing high potential high.

High value prescribers.

And in the markets.

Lori Englebert: You know, respective markets, except for five sales, primarily focused on those targets related to IXSR5, well, we believe we will have the highest potential, and the same for the. 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. The next question is from Jason Gerberry from Bank of America. Jason, your line is open. Well, hey guys, thanks for taking my questions.

Respected markets, except for five sales force well.

Primarily focus on on those targets.

Related to excess of five where we believe we will.

<unk> has the highest potential hussein for different nursing. However, we do know that there is a very high overlap between prescribers and as appropriate we will leverage those synergies.

Thank you.

Our next question is from Jason <unk>.

From Bank of America, Jason Your line is open.

Lori Englebert: 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? And then there's been some recent narrow-set launches that have exceeded investor expectations. So just curious if there's read across. Are there any, you know, structural challenges at all? Contracting Cycles.

Oh, Hey, guys. Thanks for taking my questions one clarification.

In terms of rooms is that something that you learn about the label discussion or is it more something that you learn about what the post market study.

Requirements.

And then there's been some recent.

Like what you don't have exceeded investor expectations. So I'm just curious if you think there's read across.

Actively.

Is there any structural.

Structural challenges at all.

In fact in cycles.

Yeah.

Sure.

Jason Gerberry: Thanks. Yeah, just with regard to the question on the REMS, this is a... if this is one of the first... NDAs.

Yeah.

Just with regards to the question on the Rems.

This is.

Yeah.

This is one of one of the first NBA likely these are first to join the east that we are going through a ramp is not anything that.

Ari Maizel: Actually, these are our first two NDAs that we are going through. Around it, not anything, We're thinking... Martin Breslin back in manufacturer, thank you all so much, until the review is over. We can't really assure you of the FDA's findings or decisions or requirements.

Ah we're thinking.

Would be needed with regards to these product candidates.

You never know, though and and.

Until the review is over.

We can't really assure you of the Ftes findings, where decisions were more requirements. We can communicate to you or the pmiers and the PMC, which we have agreed to and which had been communicated to us and they have not included our rems.

Ari Maizel: 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 do not include a wrap. Bory, Jason, sorry, your second question kind of faded in and out. Would you mind repeating that question?

I'm sorry, your second question kind of faded in and out but do you mind repeating that question.

Yeah.

Yeah.

Jason Gerberry: Yes. I'm curious if you think there's read across the AXS 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.

Expectations so.

Curious if you think there's read across to access so five how much you're seeing it seems like maybe payer coverage is coming online a little faster unexpected I mean, you guys will have effectively a midyear launch I don't know if that will be like a 2020 do challenge in terms of where you're at in the contracting cycle or a non issue.

Lori Englebert: I don't know if that will be like a 2022 challenge in terms of where you're at in the contracting cycle or non-issue. Yeah, great, great question. Thank you. We will. All we have are the permitted player discussions that we've had thus far and that we are highly encouraged by how the players are reacting to them. There's a product profile for AXSO5, so 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 our player coverage. Yeah, if I may add to that, Lori, I think...

Yeah, Great Great question. Thank you Yeah, we will.

All we have are the permitted player discussions that we you know we've had thus far and that we are highly encouraged by how the payers are reacting to.

I think it's probably high profile of access of five so you know.

Once we get approval and we know the timing of that approval.

We are happy to discuss more around what we expect from a payer coverage standpoint.

And if I may have done to get to that morry.

Ari Maizel: So, 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, and 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. Goodman, David Amsellem, Vikram Purohit, Charles Duncan, Joel Beatty, Mark Jacobson, An increase, a significant increase, in neuropsych disorders.

Just don't part of.

Jason's question related to the broader environment.

<unk> like as it relates to.

Recent launches.

Recent neuropsychological, which have exceeded expectations and is there something broader going on.

It's hard to know if Bob.

The performance of individual product launches, even though they coincide in time.

Reflecting anything that's on the line there is one underlying trend.

It is worth repeating which is we are in the middle of a mental health prices. So.

There has been.

An increase a significant increase in nurse like disorders.

Ari Maizel: Thank you for listening. Scientists think that it's related to the COVID pandemic. So 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.

We think more and more.

Scientists and things like that it's related to the Covid pandemic.

So that is one backdrop that had 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.

Patients who have.

Experienced.

Ari Maizel: So there is that aspect to it, and I think what it speaks to more broadly is the high level of medical need for neuropsychiatric indications in general. You know, that's why Axsome is a CNS-focused company, and that's why we're really excited about what we're doing. Thank you. Our next question is from Yatin Suneja from Guggenheim. Yatin, your line is open. Thank you. A few clarification questions from me. The first is on AXS-05.

COVID-19, so so so there is there is that aspect to it and I think what it speaks to more broadly is the high unmet medical need in neuro psychiatry indications.

In general.

Why no exome is a CNS focused company and that's why we're really excited about what we're doing.

Oh.

Got it thank you guys.

Our next question is from Jaap <unk> from Guggenheim.

Your line is open.

Thank you.

Clarification questions for me.

Yatin Suneja: What are your expectations for labeling? Do you expect a box warning similar to what we see with Valdutrin or other anti-doping drugs? So we, since Buproprion is a component of AXS05, we would expect that aspects of the Buproprion label would be reflected in the 05 label. And then when you say that this, this is again related to 05.

So first is on access or five what are your expectations for labeling.

Do you expect the box warning similar to what we see with Lal D train or other anti depressant.

Yes.

So we are since bupropion as a component of an excess of five we would expect that.

The aspects of.

Corporate on label.

Would be.

To be reflected in five label.

Okay, and then when you say that this this is again related to O. Five so when you said that the CMC issues have been resolved did you get an acknowledgment from the FDA that they are satisfied with your response or it has been resolved just that you have submitted their response I'm just trying to get.

Ari Maizel: So when you say that the CMC issues have been resolved, did you get an acknowledgment from the FDA that they are satisfied with your response, or has it been resolved just that you have submitted the, trying to get a little bit flattered, as a resolution? It's pretty clear to us that it's been resolved based on the communication and also the, All right. The PMRs and the PMJs. And then finally, a how you might be able to launch it. Hi Yatin, we expect to launch within a quarter. Any comment on the pricing? How should we think about pricing? What work have you done? Any sort of recent comp for us to look at?

That was a little bit Saturday here.

What does the reservation mean here.

It's pretty clear to us that it's been resolved from a communications.

And also the.

<unk> P M sees.

Okay, and then finally, how quickly you might be able to launch once approved four or five thank you.

We expect to launch with them within a quarter of a hurdle.

Okay.

But any comment on the pricing how should we think about pricing what work you've done any sort of recent calm for us to look at it in terms of the price.

Yatin Suneja: Yeah, we haven't communicated price yet. And you know, we will do that upon approval when we announce price. We expect to price this product, you know, to recognize the clinical differentiation of the product, but we also have an eye towards providing patients with the appropriate. Our next question is from Chris Howerton of Jeffrey. Chris, your line is open.

Yeah, we haven't communicated price yet.

Do that upon approval when we announce price we expect to price.

To.

We recognize that the.

The clinical differentiation of the product.

Also.

We have an eye towards providing patients with your personal appropriate access.

Yeah.

Thanks.

Yeah.

Our next question is from Chris Howerton of Jefferies. Chris Your line is open.

Chris Howerton: Great, I really appreciate you taking all the questions this morning and all the extra info. So I think for me, I was just curious if you could provide any comments or color on how the O5 approval and launch plays out. Current Stated Cash Runway.

Great really appreciate you taking all the questions. This morning, and all the extra info. So I think for for me I was just curious if you could provide.

Any comments or color on how the O five approval and launch plays into your current stated cash runway.

And does this equate to that if there was a delay or non approval four O five how might that affect your cash runway guidance. Thank you.

Nick Pizzie: And as a sequel to that, if there was a delay or non-approval for O5, how might that affect your cash runway guidance? Yeah, sure. Thanks, thanks, Chris, for the question. So, so again, upon 05 approval, there is $100 million tied to that approval with our Hercules facility. So we feel that we are in, you know, a very good position. We do have sufficient cash for over a 12-month period, and as I stated in my opening remarks, we did tap our ATM facility in Q1 for upwards of $31 million to bridge.

Yeah sure. Thanks, Thanks, Chris for the question.

So so again upon Oh five approval there was $100 million tied.

To that approval with our.

Hercules facility.

So we feel that we are in a very good position to to launch the product.

And we are planning that for you now.

This quarter.

We are we do have sufficient cash for over 12 month period and as I stated on the opening remarks, we did tap our ATM facility in Q1.

For upwards of $31 million to bridge.

Chris Howerton: The delay in the approval of... And maybe just as a quick clarification, if there was a further delay to 05, how might that affect your current cash runway guidance? So, if there's a further delay, we'll reassess it at that time, but as I said earlier, we do have north of 12 months of cash on hand to fund our current operations. Okay. All right. Thanks so much.

The delay in the approval of robust.

Okay, and maybe just as a quick clarification. If if there was a further delay to O five how might that affect your current kind of cash runway guidance.

Yeah.

So.

If there's a further delay.

We'll reassess it at that time, but 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.

Chris Howerton: Our next question is from Matt Kaplan of Landenburg-Solomon. Matt, your line is open. Thank you. Good morning. I just wanted to have a little more detail, perhaps, on the AXS 07 CRL.

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 access.

Seven C R L b.

Matt Kaplan: Beyond CMC questions, was there anything else detailed in the CRL that needs to be addressed? Matt, principally it was all CNC. 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 deal, this is Bandit Focus. Okay, very good. Thank you. And then 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 in to launch several products here, in terms of some of the metrics around the size of the CINOSI and dedicated force and 05 and 07 dedicated sales?

Beyond and see questions were there.

All detailed in the CRM that needs to be addressed.

Yeah.

Matt.

So principally it was all P&C there was one item.

Related to non clinical which.

It was just a request for additional information, which we believe we can provide so for us the real focus is.

This is a standard focuses at CMT.

Okay very good thank you.

Then I guess a question for Laurie.

Can you give us some more metrics in terms of how you're thinking about the sales organization as you as you go into launched several products here.

Well in terms of.

Some of the metrics around the size of the <unk>.

T and and a dedicated force and a five and seven dedicated sales forces.

Lori Englebert: How they'll kind of interact, yeah. Yeah, sure. So a couple of things to keep in mind as you think through how we plan to structure this. We haven't revealed the size of the self-forces yet, but what I can tell you is that we plan to... We plan to target at least 85% of high-value prescribers, which is more than 25,000 prescribers. We will not only have a self-sourced in place, but we will also intend to leverage our DCC platform to help us share that we have optimal reach to those high-byes. For AXS 07, you know, it will be a very similar approach in terms of how we structure the Salesforce.

How about how about kind of interact.

Yeah sure. So a couple a couple of things to keep in mind as you think through how we plan to structure them. You know we haven't we haven't revealed the size of the sales forces yet, but what I can tell you is that we plan to target.

For access of five we plan to target at least 85% of high value prescribers, which is more than 25000 HCP.

Yeah, we will not only have a sales force in place, but we will also intent and also intend to leverage our DTC platform.

To help ensure that we have optimal reach them to those high value prescribers.

For access and seven are you know it will be a very similar approach in terms of how we are.

How we structure the sales force them.

Lori Englebert: High targeted, highly strategic, highly focused, and we plan to have, you know, coverage of 50% to 50% of the high value for [inaudible] and then also Nosey. Then, you know, virtually all the offers that we extended to the jazz employees were accepted, and that sells for size. We look forward to talking to you more about on a deal close, but it will be in exactly the same kind of structure and decision-making, highly focused on those high-value prescribers. To make sure that we hit our reach, we will augment... Thanks for your attention. Our next question is from Bert Hasla of BTIG. Bert, your line is open.

Highly targeted highly strategic high focus and we plan we plan to to have.

Coverage of 50% to 60% of the high volume prescribers.

Anybody else Adam.

And then on Sanofi and you know.

The virtually all of the offers that we extended to the jazz employees were accepted and that sales force size. Yeah. We will look forward to talking to you more about them on a deal close them, but it will be exactly the same kind of structure and decision, making them highly focused on those high volume prescribers.

To make sure that we get our reach we will augment with DCC.

Okay.

Okay great.

Thanks for that detail.

Our next question is from Bert Hazlett of BT I G. Burke Your line is open.

Bert Hasla: Yes, thank you for taking the question. A quick follow-up to Matt. Is the additional request for information regarding the CRL-407 related to Mosaic technology, or can you be any more specific with regard to the additional request? Thank you. Then I've got one or two others.

Yes. Thank you for taking the question a quick follow up to matts.

And what is the additional what ask for information regarding the CRF rose seven is that related to the Mosaiq technology or can you be any more specific with regard to the additional ask thank you and then I've got one or two others.

Mark Jacobson: Hey Bert, you know, I think we can characterize it. I mean, much of it does relate to Mosaic and the process around that and drug products. Okay. I'm just shifting to Accord for just a second.

Hey, Bert.

I think we characterize it I mean much of it does relate to to mosaic and the process around that and drug product.

Bert Hasla: What are the goals of the interaction with the agent? What can you do with the study? Is it an issue where you might change the design of the study, or might change the powering? What are the goals of the discussions with FDA with regard to evaluating the study design? So Bert, the reason why it's prudent to have as much feedback as possible. This is a registration trial, and so we want to 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 more for me. Smoking cessation, you talk about a pivotal moment in phase two, three later this year. Do you think you can get away with one?

Okay and.

And then just shifting to accord for for just a second.

What are the goals of the interaction with what can you do with the study is it is it an issue where you might change the design and study powering what are the goals of the discussions.

Discussions with FDA with regard to.

Evaluating study design.

So Bert.

The reason why it's prudent to.

Have as much feedback as possible as this is the registration trial and and so we want to make sure that we take the right steps then.

Ill ourselves on the fact that this is a breakthrough therapy designation product to to get that feedback.

Ari Maizel: Or is that something you're going to do sequentially with regard to the pivotals for smoking cessation profile? Thanks. We expect that we would need two pivotal studies and currently, the plan would be to do those. Okay, thank you. Thank you for taking the question. My next question is from Myles Minter of William Blair. Myles, your line is open.

Okay. Thank you just one other for me smoking cessation, you talked about a pivotal.

In phase two three later this year.

Do you think you can get away with one or is that something youre going to do sequentially with regard to pivotal for smoking cessation profile. 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.

Okay.

Okay.

Our next question is from Myles Minter of William Blair Myles Your line is open.

Myles Minter: 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, or from work that you've done? You know, obviously, the streets are used to saying labeling discussions trigger that one month clock, but just wondering how you've got that clarity from the PMR and PMC stages. So Myles, thank you for that question. Just to be clear, there is no new PDUFA date, so the FDA is not beholden to any particular date.

Hi, Thanks for taking the questions just on the zero to five.

Timing guidance that.

You put out when they pay them off in the payment space, where a greater part and you said this quarter.

Gathering that was based on precedence of some sort, but was that directly communicated to you by the agency that that timing or was that from your regulatory consultants that from work that you've done obviously the strike should sustain labeling discussions triggering not one month clock, but just wondering how you got that clarity from the pay them off paying them safe.

Page <unk>.

So myles thank you for that question.

Just to be clear.

There is no need to do for date, so the FDA is not.

Behold into any particular date, what we tried to do is to provide the street with actionable information so any change in COVID-19, our internal estimates as quickly as possible.

Ari Maizel: 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. So what drove our statement? are the PMRs and the PMCs. So with regard to those discussions, sometimes there are timing elements tied to them. And so that has allowed us to focus our estimate. But again. It's our estimate, and it's not tied to any formal producer. Okay, thanks.

So what.

So would grow our statement.

Are the Pmiers and the Pmt's too.

Regards to those discussions sometimes there are timing elements tied to those.

And so that has allowed us to focus our estimate but again this is our estimate and.

It's not.

It is not tied to any formal <unk> date.

Ari Maizel: And then just on the PMRs and PMCs, obviously not disclosing the nature of them, but if we were to look at the guidelines, the FDA guidance documents for antidepressant drug development, are they 100% encapsulated in the language in there? So, 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 would be unique to the product that might not be talked about in those guidance documents?

Okay. Thanks, and then just on that Pam Allison and Pam Sage, obviously, not disclosing the nature of them, but if we were to look at the guidelines. The FDA guidance documents for antidepressant drug development at 100% encapsulated in the language in that sort of like <unk>.

<unk>.

Dosing studies that might be required post marketing all 16, certain populations or are there certain paying miles and pay them saves within noise that.

It would be unique to the product that Michael talked about it and I saw this document. Thank you.

Yeah. So.

Myles Minter: Thank you. So As you can imagine, the PMR, then the PMC, 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. What we can say is that the PMRs and PMCs that were discussed and that have been agreed to are consistent... They meet our expectations, and there was nothing surprising. And, thank you. We're happy with them, and we do not expect them to be different in any way.

As you can imagine.

<unk> again looking at fees 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, but we can say is that the pmiers.

And those fees that will discuss the net debt that had been agreed to.

Consistent.

Excuse me they are consistent with our expectations and there was nothing surprising.

Sure.

We're happy with them.

To Amy.

In any way.

Ari Maizel: Impeach Commercialization of the Excessive Five-Frame, Beautiful. Thanks for the question. Two final questions. Our next questioner is David Hoang from SMBC. David, your line is open. Yeah, thanks for taking the question. I just had one on commercialization. Salesforce. In terms of your, you know, your digital component there, what's your level of confidence that that, you know, that's going to be able to supplement Salesforce at the current size? Is this something you would have a high level of confidence in, or would you consider potentially expanding the number of reps down the line?

MP commercialization of in excess of 500 D D.

Beautiful thanks for the questions.

Okay.

Two final questions.

And our next questioner is David Hong from S. M D C.

David Your line is open.

Yeah, Thanks for taking the questions.

Just had one on.

Commercialization in the sales force.

In terms of your.

It all component there what's your level of confidence that that that's going to be able to supplement the.

The sales force at the current size that you that you plan to bring on board and is there something that you would have a high level of confidence in or would you consider potentially expanding.

The number of reps down the line.

David Hoang: Hey, David, thanks. Thanks for the question. So, you know, our DCC platform. The way that we designed it was really to ensure that engagement with HCPs and patients is optimized, meaning we have the ability to have efficient promotional efforts but also effective promotional efforts. So what I can tell you is that we're not going to sacrifice having those effective promotional efforts.

Hey, David Thanks, Thanks for the question so.

You know our DCP platform.

The way that we designed it was really to ensure that engagement with ACP and patients are optimized meaning we have the ability.

To have efficient.

Promotional efforts, but also effective promotional efforts. So what I can tell you is that we're not going to sacrifice.

To to not have those effective promotional efforts. So we believe based on not only research.

Lori Englebert: So we believe, based not only on research, physician preference data, but historical data of how physicians are engaging, how they continue to engage, how patients are showing up at their offices, or not, meaning the level of virtual engagement in our target therapeutic areas still remains extremely high, so we feel very confident in the augmentation that BCC will provide. Okay, thanks a lot. Our final question is from Esther Hong of Berenberg. Esther, your line is open. Hi, good morning.

<unk> preference data.

Historical data of how physicians are engaging how physicians continue to engage how patients are showing up at physician offices or not meaning the level of virtual engagement.

And our target on therapeutic areas still remains extremely high and so we feel very confident and the orientation of that D. C will provide our our field force.

Okay.

Okay. Thanks, a lot.

Yeah.

Our final question is from Esther Hong of Bahrenburg.

Esther Hong: So on AXS07 and the CMC issues, I was wondering, number one, did the FDA find this issue? And then, number two, did this occur after the facility? Hey Esther, so 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. But our sense is This is the result of their review during the course of the review cycle, and So that's our impression, but they didn't give us feedback when they identified these, these, Leeds for additional.

Your line is open.

Hi, good morning, so an excess of seven in the CMC issues with one.

Number one did the FDA sign this issue and then number two did this occur after at the east facility inspection. Thanks.

Okay.

Mark Jacobson: Okay. That ends our question and answer session, so I would 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 projects.

Hey.

Good morning.

I don't know.

That is a finding from the inspection as we'd mentioned that there were no findings that were aware of it.

And.

Our senses.

This is the result of.

Their review during the course of of the review cycle.

Hum.

And so that's that's our impression, but they didn't give us feedback when.

They identified these these.

Needs for additional information.

Okay got it understood. Thanks, so much.

Thank you.

Okay.

Okay.

That ends our question and answer session I would now like to pass the conference back to the management team for any closing remarks.

Yeah.

Okay.

Well. Thank you again for joining us on our call today, we are committed to bringing potentially life changing medicines to people living with serious CNS conditions.

Look forward to updating you over the coming months on a continued pipeline and commercial progress.

Ari Maizel: Have a great day. That concludes the conference call. Thank you for your participation. You may now disconnect your line. [music]

Have a great day.

Yes.

That concludes the conference call. Thank you for your participation you may now disconnect your lines.

Uh huh.

Uh huh.

[music].

Yeah.

Uh huh.

Okay.

Yeah.

Yes.

Yeah.

Yeah.

Right.

Yeah.