Q3 2025 Axsome Therapeutics Inc Earnings Call

November 3, 2025

At this time all participants are in a listen only mode. Later, there will be a question and answer session and instructions will be given at that time.

Operator: Will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, there will be a question-and-answer session, and instructions will be given at that time. Please note that this call is being recorded. I would now like to hand the call over to Darren Opland, Senior Director of Corporate Communications. Please go ahead.

Ari Maizel: Yeah, thanks so much for the question. Yes, we believe primary care is a really important specialty area for Auvelity and MDD. It's largely because most patients in the US present to a primary care office upon diagnosis, and many stay with primary care throughout the course of their depression episodes. As you mentioned, we are seeing very positive response in the primary care setting. It now represents roughly 1/3 of our prescriber base, and we're seeing strong performance in terms of new patient starts as well as overall prescriptions. In terms of how do we further grow the primary care segment, part of that is just our focused Salesforce effort. Obviously, we've expanded the team several times, and that has enabled us to reach more primary care clinicians on a routine basis.

Please note that this call is being recorded I would now like to hand, the call over to Darin <unk> Senior director of corporate Communications. Please go ahead.

Thank you Carol good morning, everyone. Thank you for joining us for <unk> third quarter 2025 earnings Conference call.

Darren Opland: Thank you, Darryl. Good morning, everyone. Thank you for joining us for Axsome's Q3 2025 Earnings Conference Call. With us today are Dr. Herriot Tabuteau, our Chief Executive Officer, Nick Pizzie, our Chief Financial Officer, and Ari Maizel, our Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdock, our General Counsel, will also be available for Q&A. This morning, we issued our press release providing a business update and detailed financial results for Q3. I encourage everyone to visit the investor section of our website to find the press release and accompanying presentations to today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities.

US today are Dr. Arie <unk>, our Chief Executive Officer, Nick <unk>, Our Chief Financial Officer, and already May sell our Chief commercial officer, who will begin our call with prepared remarks.

Jacobson, our chief operating officer, and Hudson Murdock, Our General Counsel will also be available for Q&A.

This morning, we issued a press release, providing a business update and detailed financial results for the quarter.

I encourage everyone to visit the investors section of our website to find the press release and accompanying presentation for today's call.

Please note that today's discussion includes forward looking statements regarding our financial performance commercial strategy and operational plan, including research development and regulatory activities.

Ari Maizel: We believe the expanded market access that we've been able to accomplish over the past couple of years is also helping to ease the prescribing path for a primary care treater that may not have as many resources to support PA processing. Finally, our direct-to-consumer campaign, which launched in the quarter, we're seeing early positive signals in terms of patient awareness, patient requests for the product, and we expect that to facilitate further growth in the primary care setting along with the psychiatry setting.

These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially.

Darren Opland: These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. Now I'll turn the call over to Aria.

Please refer to our SEC filings, including our quarterly and annual reports.

Description of these and other risks.

You are cautioned not to rely on these forward looking statements, which are made only as of today and the company disclaims any obligations to update such statements.

And now I'll turn the call over to area.

Operator: Thank you. Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Please proceed with your question.

Thank you Darin and good morning, everyone Exome continues to lead in CNS innovation, driven by disciplined execution and a clear focus on sustained growth and value creation.

Operator: Thank you, Darren, and good morning, everyone. Axsome continues to lead in CNS innovation, driven by disciplined execution and a clear focus on sustained growth and value creation. In Q3, we delivered strong revenue growth with total revenue of $171 million across our three marketed products, representing a 63% increase year-over-year. Auvelity continues to gain traction as a differentiated treatment for Major Depressive Disorder, driven by strong underlying demand. We're pleased with the pace of Auvelity's performance, which is tracking well against our long-term expectations and underscores the significant opportunity for continued growth ahead. Sunosi remains on a steady trajectory, with year-to-date sequential growth nearly double that of the same period last year, a testament to the product's durable performance and expanding adoption. Symbravo completed its first full quarter of commercial launch in Q3.

Herriot Tabuteau: Thank you, Darren, and good morning, everyone. Axsome continues to lead in CNS innovation, driven by disciplined execution and a clear focus on sustained growth and value creation. In Q3, we delivered strong revenue growth with total revenue of $171 million across our three marketed products, representing a 63% increase year-over-year. Auvelity continues to gain traction as a differentiated treatment for Major Depressive Disorder, driven by strong underlying demand. We're pleased with the pace of Auvelity's performance, which is tracking well against our long-term expectations and underscores the significant opportunity for continued growth ahead. Sunosi remains on a steady trajectory, with year-to-date sequential growth nearly double that of the same period last year, a testament to the product's durable performance and expanding adoption. Symbravo completed its first full quarter of commercial launch in Q3.

Nick Pizzie: Hello, and congrats on the quarter. Thank you for taking my question. There's a clear distinction in the clinical profile of AXS-05 versus antipsychotics. Given the differences in clinical data for Alzheimer's agitation and the mechanisms, what are your expectations for Auvelity adoption if approved? How do you plan to drive uptake in the various channels? Have you identified key elements from resulting commercialization and marketing strategy you will do differently to ensure greater uptake and success? Thanks.

The third quarter, we delivered strong revenue growth with total revenue of $171 million across our three marketed products, representing a 63% increase year over year.

<unk> continues to gain traction as a differentiated treatment for major depressive disorder.

Driven by strong underlying demand, we're pleased with the pace of abilities performance, which is tracking well against our long term expectations and underscores the significant opportunity for continued growth ahead.

Ari Maizel: Yeah, thanks for the question. Obviously, we're very optimistic about the impact AXS-05 can have on the Alzheimer's agitation market. In terms of our focus area, what we have seen in our early launch preparation is that there are a mix of specialties that are treating agitation. Primary care is the largest. There are also geriatric psychiatrists, neurologists, and then traditional psychiatrists. Long-term care is an important setting of care for Alzheimer's patients. Our anticipation is that we'll cover all of those different specialties and settings of care with our efforts. We see a high degree of overlap between Alzheimer's agitation and major depressive disorder in terms of prescriber base, and so we'll be able to leverage our existing Salesforce. We see high synergies related to promotion there.

The nosy remains on a steady trajectory with year to date sequential growth nearly double that of the same period last year, a testament to the product's durable performance and expanding adoption.

And Bravo completed its first full quarter of commercial launch in Q3.

Our focus now is to continue strengthening the foundation for long term success by broadening patient access and driving awareness with clinicians.

Operator: Our focus now is to continue strengthening the foundation for long-term success by broadening patient access and driving awareness with clinicians. Nick and Ari will speak in more detail about our financial and commercial performance and the strategic execution driving momentum across Axsome's portfolio. Beyond our continued commercial growth, Axsome's R&D engine is advancing a robust pipeline of late-stage programs with the potential to deliver transformative therapies for patients and significant value to our shareholders. Over the coming months, we expect meaningful activity across our late-stage programs, including 2 NDA-stage programs and multiple registrational trials underway or initiating. I'd like to start with our top priority areas in psychiatry and neurology: Alzheimer's disease agitation, narcolepsy, and ADHD. These are areas where we see substantial opportunity to transform patient outcomes, leverage our commercial infrastructure, and unlock significant value.

Herriot Tabuteau: Our focus now is to continue strengthening the foundation for long-term success by broadening patient access and driving awareness with clinicians. Nick and Ari will speak in more detail about our financial and commercial performance and the strategic execution driving momentum across Axsome's portfolio. Beyond our continued commercial growth, Axsome's R&D engine is advancing a robust pipeline of late-stage programs with the potential to deliver transformative therapies for patients and significant value to our shareholders. Over the coming months, we expect meaningful activity across our late-stage programs, including 2 NDA-stage programs and multiple registrational trials underway or initiating. I'd like to start with our top priority areas in psychiatry and neurology: Alzheimer's disease agitation, narcolepsy, and ADHD. These are areas where we see substantial opportunity to transform patient outcomes, leverage our commercial infrastructure, and unlock significant value.

Nick <unk>, who will speak in more detail about our financial and commercial performance and strategic execution driving momentum across <unk> portfolio.

Beyond our continued commercial growth excellence R&D engine is advancing a robust pipeline of late stage programs with the potential to deliver transformative therapies for patients and significant value to our shareholders.

Ari Maizel: Of course, we will need to invest in long-term care promotion, which is something we don't currently have, but do anticipate bringing online if the drug is approved. In terms of Rexulti's promotion, we don't typically comment on other companies and their promotional mix, but we have been following along, and they're having really nice success with Rexulti. There are some learnings that we'll incorporate into our launch strategy if AXS-05 is approved.

Over the coming months, we expect meaningful activity across our late stage programs, including two NDA stage programs and multiple registrational trials underway for initiating.

I'd like to start with our top priority areas in psychiatry, and neurology Alzheimers disease agitation narcolepsy and ADHD.

These are areas, where we see substantial opportunity to transform patient outcomes.

Our commercial infrastructure and unlock significant value.

First we are pleased to share that we have submitted our supplemental NDA for <unk> five in Alzheimers disease agitation.

Operator: Thank you. Our next question comes from the line of Sean Lemon with Morgan Stanley. Please proceed with your question.

Operator: First, we are pleased to share that we have submitted our supplemental NDA for AXS-05 and Alzheimer's disease agitation, and we look forward to announcing the FDA's decision on acceptance of the filing. This submission is an important milestone for AXS-05 and for the millions of patients and caregivers affected by this serious and underserved condition. The addressable market for Alzheimer's disease agitation is substantial, and the unmet need is high, with currently only one product approved. AXS-05 represents a first-in-class mechanism of action that has the potential to set a new standard in the treatment of AD agitation. Work is already underway to efficiently scale our commercial platform to deliver an impactful launch if approved. As a reminder, we are also developing AXS-05 and smoking cessation, and we are on track to initiate a Phase 2/3 trial in this syndication this quarter. Our next pipeline priority area is narcolepsy.

Herriot Tabuteau: First, we are pleased to share that we have submitted our supplemental NDA for AXS-05 and Alzheimer's disease agitation, and we look forward to announcing the FDA's decision on acceptance of the filing. This submission is an important milestone for AXS-05 and for the millions of patients and caregivers affected by this serious and underserved condition. The addressable market for Alzheimer's disease agitation is substantial, and the unmet need is high, with currently only one product approved. AXS-05 represents a first-in-class mechanism of action that has the potential to set a new standard in the treatment of AD agitation. Work is already underway to efficiently scale our commercial platform to deliver an impactful launch if approved. As a reminder, we are also developing AXS-05 and smoking cessation, and we are on track to initiate a Phase 2/3 trial in this syndication this quarter. Our next pipeline priority area is narcolepsy.

[Analyst] (UBS): Good morning, everyone, and hope all is well. Yeah, I'm just wondering on the Salesforce expansion. I think you just mentioned on the call you're up to 46,000 prescribers, added 5,000. Given the bump in SG&A, I'm wondering how much capacity you think you've got in the existing Salesforce, and when you might have to go again, and how that ties into your thinking about the time-to-cash flow positivity. Thanks.

And we look forward to announcing the fda's decision on acceptance of the filing.

The submission is an important milestone for <unk> five and for the millions of patients and caregivers affected by the serious and underserved condition.

The addressable market for Alzheimers disease agitation is substantial and beyond met need is high with currently only one product approved.

The access code five represents a first in class mechanism of action that has the potential to set a new standard in the treatment of agitation.

Ari Maizel: Yeah, I'll take the first part of the question. We are pleased with the size of our Salesforce at the moment. It is driving considerable growth in terms of new prescribers, as well as new patients. We've previously shared that we intend to add some additional representatives in support of the Alzheimer's agitation approval. We have started our efforts in terms of laying the groundwork for future expansions. Although we haven't quite settled on a final number, that is something that we're looking to do early in 2026.

Work is already underway to efficiently scale.

Scale, our commercial platform to deliver an impactful launch if approved.

As a reminder, we are also developing <unk> and smoking cessation and we are on track to initiate a phase two three trial in this indication this quarter.

These statements are based on current expectations and assumptions.

Jack.

Certainty that may cause actual results to differ materially.

Our next pipeline priority areas narcolepsy, we continue to target the submission of our NDA for access 12 for the treatment of cataplexy in narcolepsy in the fourth quarter of this year.

Please refer to our S E filings, including our quarterly and annual reports for a description of these and other risks.

Operator: We continue to target the submission of our NDA for AXS-12 for the treatment of cataplexy in narcolepsy in the Q4 of this year. AXS-12 represents a highly differentiated opportunity to address critical gaps in current treatment. Up to 70% of patients suffer from cataplexy. Many continue to experience inadequate relief or poor tolerability to existing treatment options. We are excited about AXS-12's potential to make a meaningful difference for patients living with narcolepsy. We also like its strategic fit with our existing sleep franchise, which we anticipate will enable a highly efficient and synergistic launch if approved. For ADHD, Solriamfetol has demonstrated positive results in adults in the FOCUS Phase 3 trial completed earlier this year. The next step is a Phase 3 trial in children and adolescents, which we plan to initiate in the Q4 of this year.

Herriot Tabuteau: We continue to target the submission of our NDA for AXS-12 for the treatment of cataplexy in narcolepsy in the Q4 of this year. AXS-12 represents a highly differentiated opportunity to address critical gaps in current treatment. Up to 70% of patients suffer from cataplexy. Many continue to experience inadequate relief or poor tolerability to existing treatment options. We are excited about AXS-12's potential to make a meaningful difference for patients living with narcolepsy. We also like its strategic fit with our existing sleep franchise, which we anticipate will enable a highly efficient and synergistic launch if approved. For ADHD, Solriamfetol has demonstrated positive results in adults in the FOCUS Phase 3 trial completed earlier this year. The next step is a Phase 3 trial in children and adolescents, which we plan to initiate in the Q4 of this year.

You are cautioned not to rely on these forward looking statements, which remains only as of today and the company disclaims any obligations to update such statements.

Marcus Jacobson: Yeah, maybe just a little bit on the SG&A for the quarter. This is Nick. In Q3, the SG&A increased slightly. That was really driven by our launch of the DTC campaign that we launched in September. Additionally, we had a full quarter of commercialization activity for Sembravo. Even with that, if you take a look at our net loss on a cash basis, we continue to improve quarter over quarter, as well as on a GAAP basis, continue to improve on the net loss. No changes as it relates to our outlook for cash flow positivity.

Excess 12 represents a highly differentiated opportunity to address critical gaps in current treatment.

And now I'll turn the call over to Terry.

Up to 70% of patients suffer from cataplexy and many continue to experience inadequate relief.

Thank you Darin and good morning, everyone Exome continues to lead in CNS innovation, driven by disciplined execution and a clear focus on sustained growth and value creation.

For tolerability to existing treatment options.

We're excited about excess <unk> potential to make a meaningful difference for patients living with narcolepsy with.

In the third quarter, we delivered strong revenue growth with total revenue of $171 million across our three marketed products, representing a 63% increase year over year.

We also like its strategic fit with our existing sleep franchise, which we anticipate will enable highly efficient and synergistic launch if approved.

For ADHD. So it ran for toll has demonstrated positive results in adults and the focus phase three trial completed earlier this year.

<unk> continues to gain traction as a differentiated treatment for major depressive disorder, driven by strong underlying demand.

Operator: Thank you. Our next question comes from the line of Ash Verma with UBS. Please proceed with your question.

The next step is a phase III trial in children, and adolescence, which we plan to initiate in the fourth quarter of this year.

Pleased with the pace of abilities performance, which is tracking well against our long term expectations and underscores the significant opportunity for continued growth ahead.

[Analyst] (William Blair): Thanks for taking our question. Just on the AD agitation application, can you comment on how many days past you are after the application filing? Are there some investigation going on whether you're past the 60 days and thus unlikely to get a priority review? Any implications that you can draw from the government shutdown to your filing, application process review, and how this may play out? Thanks.

If successful the syndication could substantially expand the opportunity for <unk> beyond its currently approved indications.

Operator: If successful, the syndication could substantially expand the opportunity for Solriamfetol beyond its currently approved indications. As a reminder, we are also developing Solriamfetol in three additional indications: MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. For MDD, we anticipate the initiation of a Phase 3 trial in adults with MDD with excessive daytime sleepiness this quarter. Next year, we expect top-line results from the ongoing ENGAGE Phase 3 trial in binge eating disorder and the SUSTAIN Phase 3 trial in shift work disorder, we look forward to providing progress updates in the near future. Turning to AXS-14, we are finalizing preparations for our planned Phase 3 trial in fibromyalgia, which we expect to launch before year-end.

Herriot Tabuteau: If successful, the syndication could substantially expand the opportunity for Solriamfetol beyond its currently approved indications. As a reminder, we are also developing Solriamfetol in three additional indications: MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. For MDD, we anticipate the initiation of a Phase 3 trial in adults with MDD with excessive daytime sleepiness this quarter. Next year, we expect top-line results from the ongoing ENGAGE Phase 3 trial in binge eating disorder and the SUSTAIN Phase 3 trial in shift work disorder, we look forward to providing progress updates in the near future. Turning to AXS-14, we are finalizing preparations for our planned Phase 3 trial in fibromyalgia, which we expect to launch before year-end.

The nosy remains on a steady trajectory with year to date sequential growth nearly double that of the same period last year, a testament to the product's durable performance and expanding adoption.

As a reminder, we are also developing sold ran patrol and three additional indications.

MTV with excessive daytime sleepiness.

Some bravo completed its first full quarter of commercial launch in Q3.

Binge eating disorder.

Shift work disorder.

Our focus now is to continue strengthening the foundation for long term success by broadening patient access and driving awareness with clinicians.

A M D D. We anticipate the initiation of a phase III trial in adult with MPD with excessive daytime sleepiness this quarter.

Marcus Jacobson: Sure. Hey, Ash. Good morning. As is our practice, we haven't disclosed the date of the submission, but the FDA typically lets sponsors know up to 74 days following the submission when on a potential acceptance. We don't see any potential impact from the shutdown for the timing. As we said, the next update that we expect to share is a potential acceptance decision.

They can already will speak in more detail about our financial and commercial performance and strategic execution driving momentum across axons portfolio.

Next year, we expect topline results from the ongoing engage phase III trial contingent disorder, and the sustained phase III trial and shift work disorder, and we look forward to providing progress updates in the near future.

Beyond our continued commercial growth axons R&D engine is advancing a robust pipeline of late stage programs, what's the potential to deliver transformative therapies for patients and significant value to our shareholders.

Turning to access <unk>.

Are finalizing preparations for our planned phase three trial in fibromyalgia, which we expect to launch before year end.

Over the coming months, we expect meaningful activity across our late stage programs, including two India state programs and multiple registrational trials underway for initiating.

These milestone highlight the continued expansion of axon, leading neuroscience pipeline spanning multiple psychiatry, and neurology indications with significant unmet medical needs and substantial long term growth potential.

Operator: These milestones highlight the continued expansion of Axsome's leading neuroscience pipeline, spanning multiple psychiatry and neurology indications with significant unmet medical needs and substantial long-term growth potential. All in all, our portfolio of novel medicines is robust and diverse, and our late-stage pipeline is deep and rapidly advancing, uniquely positioning Axsome to deliver substantial near- and long-term value through multiple, highly differentiated paths. With just three years as a fully integrated R&D and commercial organization, Axsome is shaping the frontier of differentiated innovation in brain health. The fundamentals of our business have never been stronger, and we are excited to continue building on this foundation to drive further growth. With that, I'll hand the call over to Nick to review our financial results for the quarter.

Herriot Tabuteau: These milestones highlight the continued expansion of Axsome's leading neuroscience pipeline, spanning multiple psychiatry and neurology indications with significant unmet medical needs and substantial long-term growth potential. All in all, our portfolio of novel medicines is robust and diverse, and our late-stage pipeline is deep and rapidly advancing, uniquely positioning Axsome to deliver substantial near- and long-term value through multiple, highly differentiated paths. With just three years as a fully integrated R&D and commercial organization, Axsome is shaping the frontier of differentiated innovation in brain health. The fundamentals of our business have never been stronger, and we are excited to continue building on this foundation to drive further growth. With that, I'll hand the call over to Nick to review our financial results for the quarter.

Operator: Thank you. Our next question comes from the line of Andrew Tsai with Jefferies. Please proceed with your question.

Operator: Hey, good morning. Great execution this quarter. Thanks for the question. Maybe shifting gears to the pipeline. You've got two phase 3 readouts with Sunosi for binge eating and shift work disorder. Can you talk a little bit about the study designs, what positive data would entail in order for you guys to file two more sNDAs next year or 2027? Thanks.

Yeah.

I'd like to start with our top priority areas in psychiatry and neurology.

All in all.

Our portfolio of novel medicines is robust and diverse and our late stage pipeline is deep and rapidly advancing.

If I Miss disease agitation narcolepsy and ADHD.

These are areas, where we see substantial opportunity to transform patient outcomes.

Uniquely positioning <unk> to deliver substantial near and long term value through multiple highly differentiated paths.

Our commercial infrastructure and unlock significant value.

First we are pleased to share that we have submitted our supplemental NDA for access so five an all time risk disease agitation.

Marcus Jacobson: Sure. As it relates to binge eating disorder, it's a standard parallel group study design. That would be the first study that we would need in order to be able to file an sNDA. Based upon the results of that study, we would intend to initiate another trial. We would need two studies for that. Other indications for solriamfetol include ADHD, and we currently have one positive phase 3 trial for that in adults. We're looking to start our second study, which would be in pediatric subjects or pediatric patients in the fourth quarter.

With just three years as a fully integrated R&D and commercial organization axon is shaping the frontier of differentiated innovation and brain health.

And we look forward to announcing the fda's decision on acceptance of the filing.

The submission is an important milestone for <unk> five and for the millions of patients and caregivers affected by the serious and underserved condition.

The fundamentals of our business have never been stronger.

And we are excited to continue building on this foundation to drive further growth with that.

The addressable market for Alzheimers disease agitation is substantial and beyond met need is high with currently only one product approved.

I'll hand, the call over to Nick to review, our financial results for the quarter.

Thank you Ariel and good morning, everyone. Our third quarter performance underscores the continued momentum of <unk> commercial portfolio and the breadth of our capabilities as an organization.

Yeah. So five represents a first in class mechanism of action that has the potential to set a new standard in the treatment of agitation.

Herriot Tabuteau: Thank you, Ario. Good morning, everyone. Our Q3 performance underscores the continued momentum of Axsome's commercial portfolio and the breadth of our capabilities as an organization. We continue to advance multiple innovative therapies addressing diverse and critical needs in brain health, a foundation that is driving meaningful growth across our entire business. As Ario mentioned, total product revenues for Q3 reached $171 million, representing a 63% increase year-over-year. Auvelity continues to demonstrate impressive growth. Net product sales for Q3 were $136.1 million, up 69% versus last year. Sunosi net product revenues for Q3 were $32.8 million, up 35% versus the prior year. Sunosi revenues consisted of $31.6 million in net product sales and $1.2 million in royalty revenue associated with Sunosi sales in out-licensed territories. Symbravo, in its first full quarter on the market, generated $2.1 million in net sales.

Nick Pizzie: Thank you, Ario. Good morning, everyone. Our Q3 performance underscores the continued momentum of Axsome's commercial portfolio and the breadth of our capabilities as an organization. We continue to advance multiple innovative therapies addressing diverse and critical needs in brain health, a foundation that is driving meaningful growth across our entire business. As Ario mentioned, total product revenues for Q3 reached $171 million, representing a 63% increase year-over-year. Auvelity continues to demonstrate impressive growth. Net product sales for Q3 were $136.1 million, up 69% versus last year. Sunosi net product revenues for Q3 were $32.8 million, up 35% versus the prior year. Sunosi revenues consisted of $31.6 million in net product sales and $1.2 million in royalty revenue associated with Sunosi sales in out-licensed territories. Symbravo, in its first full quarter on the market, generated $2.1 million in net sales.

Work is already underway to efficiently.

We continue to advance multiple innovative therapies addressing diverse and critical needs in brain health a foundation that is driving meaningful growth across our entire business.

Scale, our commercial platform to deliver an impactful launch if approved.

As a reminder, we are also developing an excess of five and smoking cessation.

Operator: Thank you. Our next question comes from the line of Ami Fadia with Needham & Company. Please proceed with your question.

As Eric mentioned total product revenues for the quarter reached $171 million.

Are on track to initiate a phase two three trial in this indication this quarter.

Representing a 63% increase year over year.

[Analyst] (William Blair): Hi, thanks. Good morning. Thanks for taking my question. My question is just sort of broader, stepping back. You've got a couple of products in the market, making your way towards cash flow positivity, and several other late-stage assets. Sort of from a long-term strategic perspective, where are you in terms of your thinking around the portfolio? Are you looking to add additional assets to drive sort of operational efficiencies over the next couple of years, or do you think that you've got enough in late stage that focuses really more on execution on those assets? Thank you.

Our next pipeline priority areas narcolepsy, we continue to target the submission of our NDA for excess 12 for the treatment of cataplexy in narcolepsy in the fourth quarter of this year.

<unk> continues to demonstrate impressive growth net product sales for the quarter were $136 1 million up 69% first last year.

The nursing net product revenues for the quarter were $32 8 million up 35% versus the prior year Sanofi revenues consisted of $31 $6 million and net product sales and $1 $2 million in royalty revenue associated with Sanofi sales in our licensed territories.

Yeah. That's 12 represents a highly differentiated opportunity to address critical gaps in current treatment.

Up to 70% of patients suffer from cataplexy and many continue to experience inadequate relief.

Poor tolerability to existing treatment options.

And Bravo in its first full quarter on the market generated $2 1 million and net sales.

We are excited about excess 12 potential to make a meaningful difference for patients living with narcolepsy. We also like its strategic fit with our existing sleep franchise, which we anticipate will enable highly efficient and synergistic launch if approved.

These results reflect our continued top line growth and focused execution driving increasing operating leverage across the business.

Herriot Tabuteau: These results reflect our continued top-line growth and focused execution, driving increasing operating leverage across the business. Auvelity and Sunosi gross net discounts for Q3 were both in the high 40% range. We anticipate that Auvelity and Sunosi gross net discounts will increase in Q4 to the low 50% range. Symbravo gross net discount for the quarter was in the mid-70% range, which we anticipate will remain elevated during the launch phase. Turning now to expenses, total cost of revenue were $11.9 million compared to $8.4 million for Q3 2024. Our research and development expenses of $40.2 million decreased 11% compared to last year, primarily driven by the completion of our clinical trials for Solriamfetol and ADHD and MDD.

Nick Pizzie: These results reflect our continued top-line growth and focused execution, driving increasing operating leverage across the business. Auvelity and Sunosi gross net discounts for Q3 were both in the high 40% range. We anticipate that Auvelity and Sunosi gross net discounts will increase in Q4 to the low 50% range. Symbravo gross net discount for the quarter was in the mid-70% range, which we anticipate will remain elevated during the launch phase. Turning now to expenses, total cost of revenue were $11.9 million compared to $8.4 million for Q3 2024. Our research and development expenses of $40.2 million decreased 11% compared to last year, primarily driven by the completion of our clinical trials for Solriamfetol and ADHD and MDD.

Marcus Jacobson: Thank you for the question. We're in a very unique position from the perspective of, as you mentioned, we do have three marketed products, which are still in relatively early stages of launch. There's a lot of growth ahead. We're also very fortunate that the period of exclusivity for these products goes out into the next decade or couple of decades. That's a great position to be in. On the back of that, there's the next wave of products and indications which we would expect to be approved over the next couple of years. We talked about the sNDA filing for Alzheimer's disease agitation and the planned NDA filing for AXS-12. Then, of course, there's AXS-14, for which we intend to launch our next phase 3 trial.

<unk> gross to net discounts for the third quarter were both in the high 40% range, we anticipate that ability and Sanofi gross to net discounts will increase in Q4 to the low 50% range.

ADHD Salt, where amphenol has demonstrated positive results in adults and the focus phase three trial completed earlier this year.

The next step is a phase III trial in children, and adolescence, which we plan to initiate in the fourth quarter of this year.

Bravo gross to net discount for the quarter was in the mid 70% range, which we anticipate will remain elevated during the launch phase.

If successful the syndication could substantially expand the opportunity for solid ramp of call beyond its currently approved indications.

Turning now to expenses total cost of revenue were $11 $9 million compared to $8 4 million for the third quarter of 2024.

As a reminder, we are also developing soldiering on patrol and three additional indications.

Our research and development expenses of $42 million decreased 11% compared to last year, primarily driven by the completion of our clinical trials for <unk> and ADHD and N D D.

D D with excessive daytime sleepiness.

Binge eating disorder.

And shift work disorder.

For M. D D. We anticipate the initiation of a phase III trial in adult with M. D D with excessive daytime sleepiness this quarter.

Our selling general and administrative expenses of $152 million increased 57% compared to last year, primarily driven by commercialization activities for ability, including the sales force expansion and our recently launched direct to consumer advertising campaign, along with the commercial launch of <unk>.

Herriot Tabuteau: Our selling, general, and administrative expenses of $150.2 million increased 57% compared to last year, primarily driven by commercialization activities for Auvelity, including the Salesforce expansion and our recently launched direct consumer advertising campaign, along with the commercial launch of Symbravo. Our net loss for Q3 was $47.2 million or $0.94 per share compared to a net loss of $64.6 million or $1.34 per share for the same period last year. The $47.2 million net loss this Q3 includes $23.1 million of non-cash stock-based compensation expense and a $13.2 million non-cash charge related to contingent consideration. We ended Q3 with $325.3 million in cash and cash equivalents compared to $315.4 million at the end of 2024. We continue to believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

Nick Pizzie: Our selling, general, and administrative expenses of $150.2 million increased 57% compared to last year, primarily driven by commercialization activities for Auvelity, including the Salesforce expansion and our recently launched direct consumer advertising campaign, along with the commercial launch of Symbravo. Our net loss for Q3 was $47.2 million or $0.94 per share compared to a net loss of $64.6 million or $1.34 per share for the same period last year. The $47.2 million net loss this Q3 includes $23.1 million of non-cash stock-based compensation expense and a $13.2 million non-cash charge related to contingent consideration. We ended Q3 with $325.3 million in cash and cash equivalents compared to $315.4 million at the end of 2024. We continue to believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

Next year, we expect topline results from the ongoing engage phase III trial, and binge eating disorder, and the sustained phase III trial and shift work disorder, and we look forward to providing progress updates in the near future.

Marcus Jacobson: All of that means that we really do not need to do anything extra as it relates to the pipeline in the near term. That would be, I think, the standard approach. Our approach is always to make sure that we're ahead of the curve. As it relates to that, we are taking the opportunity of the position that we're in to field inbound as it relates to potential additions to the pipeline, which could be complementary. We're not going to quit while we're ahead, and we'll continue to make sure that we make very good strategic decisions as it relates to potentially enhancing the pipeline. We're in a position whereby we can be very choosy about what we bring on board.

Turning to access 14, we are finalizing preparations for our planned phase three trial in fibromyalgia, which we expect to launch before year end.

Bravo.

Our net loss for the quarter was $47 2 million or <unk> 94 per share compared to a net loss of $64 6 million or $1 34 per share for the same period last year.

These milestones highlight the continued expansion of axons, leading neuroscience pipeline spanning multiple psychiatry, and neurology indications with significant unmet medical needs and substantial long term growth potential.

$47 2 million net loss. This quarter includes $23 1 million of noncash stock based compensation expense and a $13 2 million noncash charge related to contingent consideration.

All in all.

Our portfolio of novel medicines is robust and diverse and our late stage pipeline is deep and rapidly advancing.

We ended the third quarter with $325 3 million in cash and cash equivalents compared to $315 4 million at the end of 2024.

Uniquely positioning axon to deliver substantial near and long term value through multiple highly differentiated paths.

We continue to believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on our current operating plan.

With just three years as a fully integrated R&D and commercial organization axon is shaping the frontier of differentiated innovation and brain health.

And with that I'd like to turn the call over to Ari, who will now provide a commercial update.

Operator: Thank you. Our next question comes from the line of David Amsellem with Piper Sandler. Please proceed with your question.

Herriot Tabuteau: With that, I'd like to turn the call over to Ari, who will now provide a commercial update.

Nick Pizzie: With that, I'd like to turn the call over to Ari, who will now provide a commercial update.

Okay.

Thank you Nick Q3 represented <unk> first full quarter with three products and our commercial team advanced efforts across multiple fronts of <unk> commercial business highlighted by strong performance mobility foundational first full quarter for <unk> Bravo and steady growth for Sanofi.

The fundamentals of our business have never been stronger.

Ari Maizel: Thanks. I had a question on reboxetine. Wanted to get your latest thoughts on how you're thinking of the commercial opportunity, particularly given that you'll be entering the market more or less around the same time as orepaxant, the first direction to receptor agonists. How are you thinking about the competitive dynamics here? How are you thinking about sizing this opportunity? Just wanted to get your latest thoughts on the product. Thank you.

Nick Pizzie: Thank you, Nick. Q3 represented Axsome's first full quarter with three products, and our commercial team advanced efforts across multiple fronts of Axsome's commercial business, highlighted by strong performance for Auvelity, a foundational first full quarter for Symbravo, and steady growth for Sunosi. Auvelity's momentum in major depressive disorder continues to build, with strong prescription growth, increased new writer activation, and the initiation of strategic commercial investments. For the quarter, approximately 209,000 prescriptions were written for Auvelity, representing 46% year-over-year growth and 9% sequential growth. By comparison, the antidepressant market grew 1% year-over-year and was flat versus Q2 of 2025. Since our expansion of the psychiatry sales force earlier this year, average weekly new-to-brand prescriptions, or NBRX, have increased by approximately 35%. Our expanded team continues to drive broader and deeper engagement across prescriber segments, and we have made meaningful progress in the primary care setting.

Ari Maizel: Thank you, Nick. Q3 represented Axsome's first full quarter with three products, and our commercial team advanced efforts across multiple fronts of Axsome's commercial business, highlighted by strong performance for Auvelity, a foundational first full quarter for Symbravo, and steady growth for Sunosi. Auvelity's momentum in major depressive disorder continues to build, with strong prescription growth, increased new writer activation, and the initiation of strategic commercial investments. For the quarter, approximately 209,000 prescriptions were written for Auvelity, representing 46% year-over-year growth and 9% sequential growth. By comparison, the antidepressant market grew 1% year-over-year and was flat versus Q2 of 2025. Since our expansion of the psychiatry sales force earlier this year, average weekly new-to-brand prescriptions, or NBRX, have increased by approximately 35%. Our expanded team continues to drive broader and deeper engagement across prescriber segments, and we have made meaningful progress in the primary care setting.

And we are excited to continue building on this foundation to drive further growth with that.

I'll hand, the call over to Nick to review, our financial results for the quarter.

Thank you Ariel and good morning, everyone. Our third quarter performance underscores the continued momentum of access commercial portfolio and the breadth of our capabilities as an organization.

<unk> momentum in major depressive disorder continues to build with strong prescription growth and increased new rider activations and the initiation of strategic commercial investment.

We continue to advance multiple innovative therapies addressing diverse and critical needs in brain health a foundation that is driving meaningful growth across our entire business.

For the quarter approximately 209000 prescriptions are written for <unk>, representing 46% year over year growth and 9% sequential growth.

Marcus Jacobson: Yeah. I think we'll all tackle that. One thing which is really interesting about roboxetine is its focus on norepinephrine reuptake inhibition. That is a common pathway for the erection. The physiology of the disease is erection neuron loss, which then decreases the production of norepinephrine. This is how roboxetine works, in a very logical, rational way in terms of the pathophysiology of the disease. We're very excited about the product profile because we know from our experience in the sleep space with Sunosi that there's still a very high unmet medical need.

As Eric mentioned total product revenues for the quarter reached $171 million.

By comparison, the antidepressant market grew 1% year over year and was flat versus the second quarter of 2025.

Representing a 63% increase year over year.

Since our expansion of the psychiatry sales force earlier this year average weekly new to brand prescriptions for <unk> have increased by approximately 35%.

The LD continues to demonstrate impressive growth net product sales for the quarter were $136 $1 million up 69% first last year.

Our expanded team continues to drive broader and deeper engagement across prescribers sector, and we have made meaningful progress in the primary care setting.

It's been noticing net product revenues for the quarter were $32 8 million up 35% versus the prior year. Sanofi revenues consisted of 31 6 million in net product sales and $1 2 million in royalty revenue associated with Sanofi sales in our licensed territories.

Approximately one third of <unk> prescribers are primary care clinicians.

Nick Pizzie: Approximately 1/3 of Auvelity prescribers are primary care clinicians. NBRXs from the primary care setting have increased by approximately 50% since the expansion. Approximately 5,000 new prescribers were activated this quarter, bringing the total number of unique prescribers to 46,000 since launch. In addition to strong demand growth, we continue to make progress with market access for Auvelity. Commercial coverage increased from 73% to 75% this quarter, bringing total coverage to 85% of all lives across channels. Importantly, we have also contracted with a third large commercial group purchasing organization, or GPO, effective 1 August, which will support continued coverage efforts moving forward. Turning now to Symbravo. The Q3 marks Symbravo's first full quarter on the market, with early progress that is helping to establish a strong foundation for long-term growth. More than 5,000 prescriptions were written. Over 3,300 new patients started Symbravo in the quarter.

Ari Maizel: Approximately 1/3 of Auvelity prescribers are primary care clinicians. NBRXs from the primary care setting have increased by approximately 50% since the expansion. Approximately 5,000 new prescribers were activated this quarter, bringing the total number of unique prescribers to 46,000 since launch. In addition to strong demand growth, we continue to make progress with market access for Auvelity. Commercial coverage increased from 73% to 75% this quarter, bringing total coverage to 85% of all lives across channels. Importantly, we have also contracted with a third large commercial group purchasing organization, or GPO, effective 1 August, which will support continued coverage efforts moving forward. Turning now to Symbravo. The Q3 marks Symbravo's first full quarter on the market, with early progress that is helping to establish a strong foundation for long-term growth. More than 5,000 prescriptions were written. Over 3,300 new patients started Symbravo in the quarter.

<unk> from the primary care setting have increased by approximately 50% since the expansion.

And Bravo in its first full quarter on the market generated $2 $1 billion of net sales.

Ultimately 5000, new prescribers were activated this quarter, bringing the total number of unique prescribers to 46000 since launch.

These results reflect our continued top line growth and focused execution driving increasing operating leverage across the business.

In addition to strong demand growth, we continue to make progress with market access for <unk> <unk>.

Ari Maizel: Yeah. I'll just add, when you look at the clinical profile that was observed in the phase 3 trials, great efficacy in cataplexy, non-stimulant, daytime treatment, favorable tolerability profile, there's a lot to like about it. What we hear from KOLs and sleep experts is that many patients require polypharmacy. There's a lot of trial and error. Even with the entry of a new mechanistic approach, we believe that there will still be significant unmet need, which creates opportunity for AXS-12 in those patients.

<unk> gross to net discounts for the third quarter were both in the high 40% range, we anticipate that ability and Sanofi gross to net discounts will increase in Q4 to the low 50% range.

<unk> coverage increased from 73% to 75% this quarter, bringing total coverage to 85% of all lives across channels.

Fortunately, we have also contracted with a third large commercial group purchasing organization or GPO effective August one, which will support continued coverage efforts moving forward.

Bravo gross to net discount for the quarter was in the mid 70% range, which we anticipate will remain elevated during the launch phase.

Turning now to some Bravo.

Turning now to expenses total cost of revenue were 11 $9 million compared to $8 4 million for the third quarter of 2024.

Third quarter marks <unk> first full quarter on the market with early progress that is helping to establish a strong foundation for long term growth.

More than 5000 prescriptions were written and over 3300, new patient starting to Bravo in the quarter.

Our research and development expenses of $42 million decreased 11% compared to last year, primarily driven by the completion of our clinical trials for <unk> in ADHD and N D D.

Our targeted approach, including focused sales and marketing activity among headache specialists to drive the majority of branded migraine prescription is effectively building awareness and driving trial.

Nick Pizzie: Our targeted approach, including FOCUS sales and marketing activity among headache specialists who drive the majority of branded migraine prescriptions, is effectively building awareness and driving trials. Feedback from patients continues to reinforce Symbravo's robust clinical profile. Symbravo's MoSEIC technology, which enables rapid absorption while maintaining a long half-life, resulting in strong efficacy, is resonating with HCPs. In a recent survey of migraine treaters, key drivers of prescribing include Symbravo's multi-mechanistic targeting of the CGRP and prostaglandin pathways, fast migraine symptom relief, improvements in patient functioning, and SUSTAIN freedom from migraine pain. We continue to make progress with Symbravo market access and coverage, with overall payer coverage at approximately 52% of all lives as of 1 October. The proportion of covered lives in the commercial and government channels is 48% and 56%, respectively. We have also contracted with a second large GPO effective 1 August for potential coverage of Symbravo.

Ari Maizel: Our targeted approach, including FOCUS sales and marketing activity among headache specialists who drive the majority of branded migraine prescriptions, is effectively building awareness and driving trials. Feedback from patients continues to reinforce Symbravo's robust clinical profile. Symbravo's MoSEIC technology, which enables rapid absorption while maintaining a long half-life, resulting in strong efficacy, is resonating with HCPs. In a recent survey of migraine treaters, key drivers of prescribing include Symbravo's multi-mechanistic targeting of the CGRP and prostaglandin pathways, fast migraine symptom relief, improvements in patient functioning, and SUSTAIN freedom from migraine pain. We continue to make progress with Symbravo market access and coverage, with overall payer coverage at approximately 52% of all lives as of 1 October. The proportion of covered lives in the commercial and government channels is 48% and 56%, respectively. We have also contracted with a second large GPO effective 1 August for potential coverage of Symbravo.

Marcus Jacobson: Maybe just one other add is, with respect to sizing. We see incredibly high synergy, almost near-perfect synergy, with the current sales and marketing infrastructure that we have in place for Sunosi right now. Very, very complementary to what's already in place. We're excited about that.

Our selling general and administrative expenses of $152 million increased 57% compared to last year, primarily driven by commercialization activities for <unk>, including the sales force expansion and our recently launched direct to consumer advertising campaign, along with the commercial launch of <unk>.

Feedback from patients continues to reinforce and Bravos robust clinical profile.

Bravos Mosaiq technology, which enables rapid absorption, while maintaining a long half life, resulting in strong efficacy is resonating with HCP.

In a recent survey of migraine Treaters key drivers of prescribing include and Bravos multi mechanistic targeting of the <unk> and prostaglandin pathways. That's migraine symptom relief improvements in patient functioning and sustained freedom from migraine pain.

Bravo.

Our net loss for the quarter was $47 2 million or <unk> 94 per share compared to a net loss of $64 6 million or $1 34 per share for the same period last year.

Operator: Thank you. Our next question comes from the line of Joon Lee with Truist Securities. Please proceed with your question.

Operator: Hey, congrats on the strong quarter, and thanks for taking our questions. Your commercial execution on Sunosi is quite impressive. Any idea where the demand for Sunosi is coming from? Is it NT1, NT2, IH, or something else? Given your strength in combining products, any thoughts on combining Sunosi with AXS-12 to address both EDS and cataplexy, or do you think it's just better to keep them à la carte? Thank you.

The $47 $2 million net loss. This quarter includes $23 1 million of noncash stock based compensation expense and a $13 2 million noncash charge related to contingent consideration.

We continue to make progress with <unk> Bravo market access and coverage with overall payer coverage at approximately 52% all lives as of October one.

The proportion of covered lives in the commercial and government channels is 48% and 56% respectively.

We ended the third quarter with $325 $3 million in cash and cash equivalents compared to $315 $4 million at the end of 2024.

We are also contracted with a second large GPO effective August one for potential coverage and Bravo.

We anticipate coverage for some bravo to expand and evolve throughout the balance of the year and into 2026.

We continue to believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on our current operating plan.

Ari Maizel: Yeah, I'll take the first part of that question. We're seeing sort of a. The predominant growth is coming from the OSA segment. There's significant unmet need in terms of excessive sleepiness with OSA patients. It represents roughly two-thirds or so of the overall prescribing for Sunosi. We are seeing very strong demand for Sunosi with those patients. Narcolepsy, of course, is an important component of the Sunosi sales mix. What we've seen, particularly over the past couple of years, is a greater awareness of excessive sleepiness among OSA patients. As a consequence, we're seeing increased utilization there.

Nick Pizzie: We anticipate coverage for Symbravo to expand and evolve throughout the balance of the year and into 2026. Finally, Sunosi delivered another quarter of strong and steady performance, with approximately 53,000 prescriptions representing 12% year-over-year and 5% sequential growth. By comparison, the weight-promoting agent market grew 4% year-over-year and 3% quarter-over-quarter. More than 460 new clinicians prescribed Sunosi in the quarter, bringing the total cumulative prescriber base to approximately 15,100 since launch. Payer coverage for Sunosi remains at approximately 83% of lives covered across channels. Overall, Q3 represented another period of strong commercial performance across Axsome's growing portfolio of differentiated CNS products. With continued execution on Auvelity and Sunosi and the establishment of a growth foundation for Symbravo, Axsome is driving increased demand, growing prescriber and patient engagement, and expanding access to our products.

Ari Maizel: We anticipate coverage for Symbravo to expand and evolve throughout the balance of the year and into 2026. Finally, Sunosi delivered another quarter of strong and steady performance, with approximately 53,000 prescriptions representing 12% year-over-year and 5% sequential growth. By comparison, the weight-promoting agent market grew 4% year-over-year and 3% quarter-over-quarter. More than 460 new clinicians prescribed Sunosi in the quarter, bringing the total cumulative prescriber base to approximately 15,100 since launch. Payer coverage for Sunosi remains at approximately 83% of lives covered across channels. Overall, Q3 represented another period of strong commercial performance across Axsome's growing portfolio of differentiated CNS products. With continued execution on Auvelity and Sunosi and the establishment of a growth foundation for Symbravo, Axsome is driving increased demand, growing prescriber and patient engagement, and expanding access to our products.

And finally, the nosy delivered another quarter of strong and steady performance with approximately 53000 prescriptions, representing 12% year over year and 5% sequential growth.

With that I'd like to turn the call over to Ari, who will now provide a commercial update.

Yeah.

Thank you Nick Q3 represented <unk> first full quarter with three products and our commercial team advanced efforts across multiple fronts. The backstops commercial business highlighted by strong performance in mobility, a foundational first full quarter first at Bravo and steady growth for Sidoti.

By comparison, the weight promoting agent market grew 4% year over year and 3% quarter over quarter.

More than 460, new clinician prescribers to note in the quarter, bringing the total accumulated through scriber basis to approximately 50100 since launch.

Payer coverage for <unk> remains at approximately 83% of lives covered across channels.

Mobility is momentum in major depressive disorder continues to deal with strong prescription growth increased new rider activations and the initiation of strategic commercial investment.

Overall, the third quarter represented another period of strong commercial performance across <unk> growing portfolio of differentiated CNS product.

For the quarter approximately 209000 prescriptions are written for mobility, representing 46% year over year growth and 9% sequential growth.

Marcus Jacobson: Yeah. As it relates to your question about whether it should be an à la carte approach for AXS-12 and Sunosi, given how complementary the planned indications are, our priority is to make sure that we get the product approved. That's first and foremost. Let's start with that. That's going to accomplish our main goal, which is to provide clinicians extra treatment options. Clearly, given how the patients are treated with narcolepsy, given the varied symptomatology, probably undoubtedly, there would be patients who would receive both Sunosi and AXS-12. Our goal is to provide clinicians the data such that they can treat the patients in the best way that they see fit.

With continued execution on our ability and Sanofi and the establishment of a growth Foundation first and Bravo axon is driving increased demand growing prescriber and patient engagement and expanding access to our products.

By comparison, the antidepressant market grew 1% year over year and was flat versus the second quarter of 2025.

We remain confident in <unk> continued growth potential and look forward to sharing future updates on our commercial progress.

It is our expansion of the psychiatry sales force earlier this year average weekly new to brand prescriptions for <unk> have increased by approximately 35%.

Nick Pizzie: We remain confident in Axsome's continued growth potential and look forward to sharing future updates on our commercial progress. I will now turn the call back to Darren for Q&A. Thanks, Ari. That concludes our prepared remarks. Darryl, please open the line for Q&A.

Ari Maizel: We remain confident in Axsome's continued growth potential and look forward to sharing future updates on our commercial progress. I will now turn the call back to Darren for Q&A. Thanks, Ari. That concludes our prepared remarks. Darryl, please open the line for Q&A.

I will now turn the call back to Darren for Q&A.

Our expanded team continues to drive broader and deeper engagement across prescribers.

Thanks, all right that concludes our prepared remarks.

Now please open the line for Q&A.

And we have made meaningful progress in the primary care setting.

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two to remove yourself from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing.

Approximately one third of <unk> prescribers are primary care clinic.

Operator: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, for your first questions. Our first questions come from the line of Leonid Timashev with RBC Capital Markets. Please proceed with your questions.

And N b, our exits from the primary care setting have increased by approximately 50% since the expansion.

Approximately 5000, new prescribers were activated this quarter, bringing the total number of unique prescribers to 46000 since launch.

On the Star Keys.

One moment please for your first questions.

In addition to strong demand growth, we continue to make progress with market access for <unk> <unk>.

Our first questions come from the line of Liana <unk> with RBC capital markets. Please proceed with your questions.

Coverage increased from 73% to 75% this quarter, bringing total coverage to 85% of all lives across channels.

Operator: Thank you. Our next question comes from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your question.

Hey, congrats on the quarter and thanks for taking my question actually I wanted to ask on some Bravo and.

Leonid Timashev: Hey, congrats on the quarter, and thanks for taking my question. I actually wanted to ask on Symbravo and your ability to extrapolate what you're seeing in Q3 out to Q4 in 2026. I guess maybe can you talk about the increased depth of prescribing you're seeing and maybe what you'd like to see on the ground before you invest more in the launch and potentially any areas of bottleneck that are stopping additional patients from coming on therapy? Thanks.

Importantly, we have also contracted with a third large commercial group purchasing organization or GPO effective August one.

Operator: Thanks so much for taking my questions, and congratulations on all the progress. With respect to Sembravo, I was wondering if you could elaborate on the number of centers that you expect to target in the next wave after the initial 150 headache centers. Also, if you could tell us a little bit about the timing with which you expect the DTC campaign for Sembravo to be engaged, if we should be thinking about the timeline as being similar to the timeline with which you initiated the DTC promotional activity in support of Auvelity. Thank you.

Now your ability to extrapolate what youre seeing in the third quarter out to fourth quarter. In 2026, I guess, maybe can you talk about the increased depth of prescribing youre seeing and maybe what you'd like to see on the ground.

Will support continued coverage efforts moving forward.

Turning now to some problem.

The third quarter marks <unk> first full quarter on the market with early progress that is helping to establish a strong foundation for long term growth.

Before you invest more in the launch and potentially in areas of bottlenecks that are.

Stopping additional patients from coming on therapy.

More than 5000 prescriptions were written and over 3300, new patient starting to Bravo in the quarter.

And then thanks for the question as Ari.

Ari Maizel: Hi, Leo. Thanks for the question, Ms. Ari. Obviously, it's still very early in the Symbravo launch. What we're seeing so far is very positive in terms of HCP and patient response. The drug is performing as well as we expected in the real-world setting. As a reminder, we've taken a very targeted and focus approach, focus on the top 150 headache centers as well as large neurology practices around the country. Our intent is to try to penetrate as many of those providers as possible. As we observe the impact, we'll make further decisions around expansion or incremental investment for Symbravo. At this time, we're really pleased with the early response. There's still a lot of work to do. We're in the early days. We are really focus on increasing prescribing in our targeted clinicians.

It's still very early in the <unk> launch.

Our targeted approach, including focused sales and marketing activity among headache specialists to drive the majority of branded migraine prescriptions is effectively building awareness and driving trial.

And what we're seeing so far is very positive in terms of HCP and patient response, the drug is performing as well as we expected in the real world setting.

Ari Maizel: Thanks, Ram. Regarding the, I guess, increase in number of centers, the way to think about it is right now we are really focused on the predominant headache centers and headache specialists in the country. A future expansion would enable us to actually expand out more into the primary care market, where you might have a heavy proportion of migraine treaters. Right now, we feel very good about our coverage of headache centers and headache specialists. That next wave would really be more about primary care expansion. As it relates to DTC, I think it's a little premature to talk about potential timing.

Feedback from patients continues to reinforce and Bravos robust clinical profile.

As a reminder, we've taken a very targeted and focused approach.

And Bravo is mosaiq technology, which enables rapid absorption, while maintaining a long half life, resulting in strong efficacy is resonating with HCP.

Focus on the top 150, headache centers as well as large neurology practices around the country and our intent is to try to penetrate as many of those providers as possible.

In a recent survey of migraine Treaters key drivers of prescribing include Bravos multi mechanistic targeting of the <unk> and prostaglandin pathways, that's migraine symptom relief.

And as we observe the impact we'll make further decisions around expansion or incremental investment for Sim Bravo, but at this time, we're really pleased with the early response Theres still a lot of work to do and we're in the early days.

<unk> patient functioning and sustained freedom from migraine pain.

We continue to make progress with some bravo market access and coverage with overall payer coverage at approximately 52% all lives as of October one.

But we are.

Really still gift on increasing prescribing.

Our targeted clinicians as we mentioned earlier, we've seen improvements in market access, which is also a key area of focus for us.

The proportion of covered lives in the commercial and government channels is 48% and 56% respectively.

Ari Maizel: If you look at Auvelity and our timing related to our DTC launch, it really was a function of ensuring we had a strong foundation of HCP prescribers, support from a prescriber perspective, we had reached a critical mass in terms of market access, and we had a sales force size that was big enough to support the increase in patient requests coming from a DTC campaign. When that might happen, obviously, we're focused on execution across all fronts, and we'll evaluate as the brand progresses.

Ari Maizel: As we mentioned earlier, we've seen improvements in market access, which is also a key area of focus for us. We'll share additional updates as the brand progresses.

We are also contracted with a second large GTO effective August one for potential coverage and Bob.

We'll share additional updates as the brand progresses.

We anticipate coverage for some bravo to expand and evolve throughout the balance of the year and into 2020.

Thank you our next questions come from the line of Marc Goodman with Leerink Partners. Please proceed with your questions.

Operator: Thank you. Our next questions come from the line of Marc Goodman with Leerink Partners. Please proceed with your questions.

And finally, Sanofi delivered another quarter of strong and steady performance with approximately 53000 prescriptions, representing 12% year over year and 5% sequential growth.

Good morning. This is Bob mantra Mark. Thank you for taking our question. We have a question from <unk> regarding the primary care segment, which seems to be contributing more end market right now.

Basma Radwan Ibrahim: Good morning. This is Basma from Marc. Thank you for taking our question. We have a question on Auvelity regarding the primary care segment, which seems to be contributing more and more to the scripts right now. Do you see this segment as the key growth driver for Auvelity, and how do you envision growing this segment? Is it mainly through Salesforce expansion? Thank you. That's it for us.

In comparison, the weight promoting agent market grew 4% year over year and 3% quarter over quarter.

Do you see this segment as a key growth driver for <unk> and how do you envision growing this segment is it mainly through sales force expansion. Thank you. This is Frank.

More than 460, new clinician prescribers to notice in the quarter, bringing the total accumulated to prescribers base to approximately 15100 since launch.

Yes. Thanks, so much for the question, Yes, we believe primary care.

Operator: Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Ari Maizel: Thanks so much for the question. We believe primary care is a really important specialty area for Auvelity and MDD. It's largely because most patients in the US present to a primary care office upon diagnosis, and many stay with primary care throughout the course of their depression episodes. As you mentioned, we are seeing very positive response in the primary care setting. It now represents roughly a third of our prescriber base, and we're seeing strong performance in terms of new patient starts as well as overall prescriptions. In terms of how do we further grow the primary care segment, part of that is just our focused Salesforce effort. Obviously, we've expanded the team several times, and that has enabled us to reach more primary care clinicians on a routine basis.

Really important specialty area for ability and MPD is largely because most patients in the U S present, two primary care office.

Your coverage first to notice the remains at approximately 83% of lives covered across channels.

Ari Maizel: Hi, good morning. It's Dina An for Jason. Congrats on the quarter, and thank you so much for taking our question. Just on AXS-05 for Alzheimer's disease agitation, could you maybe share your understanding of the clinical profile bar that's necessary for priority review under breakthrough designation? Is there a requirement that AXS-05 shows efficacy benefit relative to Rexulti? Maybe how do you think investors should think about that scenario and the read-through to the core trials? Just a quick follow-up on your comment on AXS-05's ADA long-term care promotion. Could you maybe detail what those efforts look like? Are there docs that are affiliated with long-term care facilities? Appreciate any additional color there. Thank you.

Overall, the third quarter represented another period of strong commercial performance across axons growing portfolio differentiated CNS products.

Upon diagnosis and many stay with primary care throughout the course of.

With continued execution on our ability and Sanofi and the establishment of a growth Foundation person Bravo axon is driving increased demand growing prescriber and patient engagement and expanding access to our products.

Depression.

<unk>.

As you mentioned, we are seeing very positive response in the primary care setting and now represents roughly a third of our prescriber base and we're seeing strong performance in terms of new patient starts as well as overall prescriptions.

We remain confident in <unk> continued growth potential and look forward to sharing future updates on our commercial progress.

In terms of how do we further grow the primary care segment part of that is just our.

I will now turn the call back to Darrin for Q&A.

Thanks, all right that concludes our prepared remarks.

Our focused sales force effort, obviously, we've expanded the team several times and that has enabled us to.

Please open the line for Q&A.

Reach more primary care clinicians on a routine basis.

Believe the expanded market access that we've been able to accomplish over the past couple of years is also helping to ease the prescribing path for our primary care treater than may.

Marcus Jacobson: Sure. Hi. Just one thing to share. Our base case here is always a standard review for the application. We are eligible for potential priority review. Our understanding is that currently, the default position for the FDA for any application is standard review. With respect to quantitative efficacy bars, that's not how it works, right? It's not a specific or, again, quantitative analysis that the agency does. It's hard to give you anything there for what may or may not go into an analysis like that. Again, our base case has always been standard review. I think, as we said, we'll keep people posted on a potential acceptance decision, as I think the next thing that we'd expect for the course of review.

It may not have as many resources to support P. A processing and then finally, our direct to consumer campaign, which launched.

The Starkey.

One moment please for your first questions.

Our first questions come from the line of Liana <unk> with RBC capital markets. Please proceed with your questions.

In the quarter.

We're seeing early positive signals in terms of patient awareness patient requests for the product and we expect that to facilitate further growth in the primary care setting along with the psychiatry Senate.

Hey, congrats on a quarter and thanks for taking my question I actually wanted to ask on some Bravo and now your ability to extrapolate what youre seeing in the third quarter out to fourth quarter. In 2026, I guess, maybe can you talk about the increased depth of prescribing youre seeing and maybe what you'd like to see on the ground before you invest more in the.

Thank you. Our next question comes from the line of Pete several uplifts with Cantor Fitzgerald. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Please proceed with your question.

Hello, Congrats on the quarter now thank you for taking my question.

Launched in potentially in areas of bottleneck that or.

Pete Stavropoulos: Hello. Congrats on the quarter. Thank you for taking my question. There's a clear distinction in the clinical profile of AXS-05 versus antipsychotics. Given the differences in clinical data for Alzheimer's agitation and the mechanisms, what are your expectations for Auvelity adoption if approved? How do you plan to drive uptake in the various channels? Have you identified key elements from resulting commercialization and marketing strategy you would do differently to ensure greater uptake and success? Thanks.

There is a clear distinction in the clinical profile of <unk>.

Stopping additional patient from coming on therapy.

Five versus anti psychotic given the differences in clinical data for Alzheimer's agitation and the mechanisms what are your expectations for <unk> adoption, if approved and how do you plan to drive uptake in the various channels and have you identified key elements from resort to commercialization.

And then thanks for the question as Ari.

Obviously, it's still very early in the <unk> launch.

And our what we're seeing so far is very positive in terms of HCP and patient response, the drug is performing as well as we'd expected in the real world setting.

Ari Maizel: Yeah. Dina, in terms of your long-term care question, it's a little different than traditional outpatient facilities where you may be calling on MDs, NPs, PAs, along with office staff. In long-term care facilities, there's a significant nursing staff, pharmacy directors, and medical directors. Of course, there are physicians, NPs, and PAs that will make rounds in long-term care. They also are treating patients in the community, and so there's a synergistic effect of the community-based promotion for those clinicians that go into long-term care. It is a little bit of a different approach, which is why we feel it's necessary to have a dedicated team focused on long-term care facilities if the drug's approved.

And marketing strategy, you would do differently to ensure greater uptake and success.

As a reminder, heavy we've taken a very targeted and focused approach.

Yes. Thanks for the question, obviously, we're very optimistic about the impact access if I can have on the Alzheimers agitation market.

Focus on the top hundred 50, headache centers as well as large neurology practices around the country and our intent is to try to penetrate as many of those providers as possible.

Ari Maizel: Yeah. Thanks for the question. Obviously, we're very optimistic about the impact AXS-05 can have on the Alzheimer's agitation market. In terms of our focus area, what we have seen in our early launch preparation is that there are a mix of specialties that are treating agitation. Primary care is the largest. There are also geriatric psychiatrists, neurologists, and traditional psychiatrists. Of course, long-term care is an important setting of care for Alzheimer's patients, and our anticipation is that we'll cover all of those different specialties and settings of care with our efforts. We see a high degree of overlap between Alzheimer's agitation and major depressive disorder in terms of prescriber base, and so we'll be able to leverage our existing sales force. We see high synergies related to promotion there.

In terms of our focus area.

We have seen in our early launch preparation is that there are mix of specialties that are treating agitation primary care is the largest that are also geriatric psychiatrist and neurologist and then traditional psychiatrist of course long term care is an important.

But we are really.

Setting of care for Alzheimer's patients and our anticipation is that we'll cover all of those different specialties in settings of care with our with our efforts.

It really still just on <unk>.

Creasing prescribing.

Our targeted clinicians as we mentioned earlier, we've seen improvements in market access, which is also a key area of focus for us and we will share additional updated says as the brand progress it is.

Operator: Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim Partners. Please proceed with your question.

We see a high degree of overlap between Alzheimers agitation and major depressive disorder in terms of prescriber base and so we'll be able to.

[Analyst] (Leerink Partners): Guys, one more question on the ADA. How do you think about the AdCom? Is that going to be required, given that we already had one for the space with Rexulti? Just curious to hear your thought and how you are thinking about it.

Leverage our existing sales force.

Thank you our next questions come from the line of Marc Goodman with Leerink Partners. Please proceed with your questions.

We see high synergies related to.

Promotion there.

Good morning. This is Bob mantra Mark. Thank you for taking our question. We have a question of Alex regarding the primary care segment, which seems to be contributing more than most of the scripts right now.

Of course, we will need to invest in long term care promotion, which is something we don't currently have but do anticipate bringing online.

Ari Maizel: Of course, we will need to invest in long-term care promotion, which is something we don't currently have but do anticipate bringing online if the drug is approved. In terms of Rexulti's promotion, we don't typically comment on other companies and their promotional mix, but we have been following along, and they're having really nice success with Rexulti. There are some learnings that we'll incorporate into our launch strategy if AXS-05 is approved.

Marcus Jacobson: In AdCom, that's something companies find out on potential acceptance decisions for FDA. Stay tuned on that.

If the if the drug is approved.

Do you see the segment as a key growth driver for mobility and how do you envision growing this segment is it mainly through sales force expansion. Thank you. This is Larry.

In terms of <unk> promotion.

We don't typically comment on other other companies in their promotional mix, but we have been.

Operator: Thank you. Our next question comes from the line of Graig Suvannavejh with Mizuho Securities. Please proceed with your question.

Yeah. Thanks, so much for the question, Yes, we believe primary care is a is a really important specialty area for ability and M. D. D is largely because most patients in the U S present, two primary care office upon diagnosis and many are staying with primary care.

Following along in.

Operator: Hey, good morning. Thanks for taking my question. Congrats on the continued success across the board, both commercially and on the pipeline. Just wanted to talk about Auvelity commercially. Just wanted to revisit the gross-to-net and its evolution. I think you mentioned that the gross-to-net was in the high 40% in the third quarter. I'm wondering what led to that happening and whether there were any unique one-time events or items that contributed to that. Also, just looking forward on the progress you've made with contracting, are there any other significant gains that you're looking forward to? I mean, it seems like you're at a pretty good place, but just wondering, just in the future, how we should think about that dynamic. Thanks.

They're having really nice success with <unk> and so there are some learnings that will incorporate into our launch strategy.

So if <unk> is approved.

Thank you. Our next question comes from the line of Sean <unk> with Morgan Stanley. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Sean Egan with Morgan Stanley. Please proceed with your question.

Throughout the course of their <unk>.

Good morning, everyone and hope all is well.

<unk> episodes.

Sean Egan: Good morning, everyone. Hope all is well. Yeah, I'm just wondering on the Salesforce expansion. I think you just mentioned on the call you're up to 46,000 prescribers, added 5,000. Given the bump in SG&A, I'm wondering how much capacity you think you've got in the existing Salesforce and when you might have to go again and how that ties into your thinking about the time-to-cash flow positivity. Thanks.

Just wondering on the sales force expansion I think you just mentioned on the call you up to 46000 prescribers added 5000.

Given the bump in SG&A I'm I'm wondering how much capacity you think you've got an existing sales force.

When you might have to go again, and how that ties into your thinking about the time to cash flow positivity. Thanks.

Ari Maizel: Sure, Greg. Hey, this is Nick. Thanks for the question. You're correct. Auvelity discount for the quarter improved from the mid-50s to the high 40s in Q3. Pleased with the net price improvement around Auvelity. Something that did change during the quarter is that we received additional 28 million lives in Q3. We were able to see those lives covered in an improved fashion in first line or first switch. Improved access, improved amount of patients covered, along with improved net price from a GTN perspective.

Our focused sales force effort, obviously, we've expanded the team.

Yes, I'll take the first part of the question.

We are pleased with the size of our sales force at the moment it is driving.

Ari Maizel: Yeah. I'll take the first part of the question. We are pleased with the size of our Salesforce at the moment. It is driving considerable growth in terms of new prescribers as well as new patients. We've previously shared that we intend to add some additional representatives in support of the Alzheimer's agitation approval, and we have started our efforts in terms of laying the groundwork for future expansions. Although we haven't quite settled on a final number, that is something that we're looking to do early in 2026.

Several times and that has enabled us to.

Reach more primary care clinicians on a on a routine basis.

<unk> growth in terms of new prescribers as well as new patients.

We believe the expanded market access that we've been able to accomplish over the past couple of years is also helping to ease the prescribing path for our primary care Treater then may.

Previously as he previously shared that we intend to add some additional representatives in support of the Alzheimers agitation.

Approval and.

It may not have as many resources to support P. A processing and then finally, our direct to consumer campaign, which launched.

We have started our.

Our efforts in terms of laying the groundwork for future expansions, although we haven't quite settled on a final number.

In the quarter.

Operator: All right. You want to take that second question?

We're seeing early positive signals in terms of eastern awareness patient requests for the product and we expect that to facilitate further growth in the primary care setting along with the psychiatry aesthetic.

Ari Maizel: Yeah. I think, first and foremost, we're at 85% total lives covered, which we're really pleased with. We shared in the opening remarks that we signed the third large GPO. Our expectation is to continue to add additional covered lives. Our goal is to try to get as close to 100% as we can. Obviously, with the third GPO signed, that will enable additional covered lives moving forward. As you know, it's very difficult to predict exactly when those new PBM contracts will come online. We do feel optimistic that there's great interest, and the team is continuing to focus on driving additional covered lives moving forward.

That is something that we're looking to to do early in 2026.

Yes, maybe just a little bit on the SG&A for the quarter. This is Nick so.

Nick Pizzie: Yeah. Maybe just a little bit on the SG&A for the quarter. This is Nick. In Q3, the SG&A increased slightly. That was really driven by our launch of the DTC campaign that we launched in September. Additionally, we had a full quarter of commercialization activity for Symbravo. Even with that, if you take a look at our net loss on a cash basis, we continue to improve quarter-over-quarter, as well as on a GAAP basis, continue to improve on the net loss. No changes as it relates to our outlook for cash flow positivity.

Q3, the SG&A increase slightly that was really driven by our launch of the DTC campaign that we launched in September. Additionally, we had a full quarter of commercialization activity first and Bravo. So even with that if you take a look at our net loss on a on a cash basis.

Thank you. Our next question comes from the line of Pete Stavros Uplifts with Cantor Fitzgerald. Please proceed with your question.

Hello, Congrats on the quarter and I. Thank you for taking my question.

There's a clear distinction in the clinical profile of M. A X.

Five versus anti psychotic you know given the differences in clinical data for Alzheimer's agitation and the mechanisms what are your expectations for our ability adoption if approved and you know how do you plan to drive uptake in the various channels and have you identified key elements from resort to commercialization.

We continue to improve quarter over quarter as well as on a GAAP basis continue to improve on the net loss. So no changes as it relates to our outlook for cash flow positivity.

And marketing strategy, you would do differently. If you went to a greater uptake and success. Thanks.

Thank you. Our next question will come from the line of Ash Verma with UBS. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of David Hoang with Deutsche Bank. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Ashwani Verma with UBS. Please proceed with your question.

Yeah. Thanks for the question, obviously, we're very optimistic about the impact takes us if I can have on the alzheimers agitation market.

Hi, Thanks for taking our question just on the agitation application can you comment on how many in the past.

[Analyst] (UBS): Hi. Congrats on the quarter. Thanks for taking my questions. Just wanted to go back to the planned sales force expansion for ADA. Recognize that it's early days, but could you maybe bookend or at least point us towards maybe a minimum number of reps that you think would be sufficient to execute a successful launch in that indication? Are those numbers already contemplated in your guidance for reaching cash flow positivity? Thank you.

Ashwani Verma: Thanks for taking our question. Just on the AD agitation application, can you comment on how many days past you are after the application filing? Are there some discussion going on whether you're past the 60 days, and that's unlikely to get a priority review? Any implications that you can draw from the government shutdown to your filing application process review and how this may play out? Thanks.

In terms of our focus area.

After the application filing.

A discussion going on there.

You passed the 60 days and that's unlikely to get a priority review.

And then.

Any indications that you can draw from the government shutdown.

Fighting.

Litigation process review and how this may play out thanks.

Setting of care for all timer stations and our anticipation is that we'll cover all of those different specialties in settings of care with our with our efforts.

Sure Hey, guys good morning.

So.

Ari Maizel: Sure. Hey, Ash. Good morning. As is our practice, we haven't disclosed the date of the submission, but the FDA typically lets sponsors know, say, up to 74 days following the submission on a potential acceptance. We don't see any potential impact from the shutdown for the timing. As we said, the next update that we expect to share is a potential acceptance decision.

As is our practice, we havent disclosed the date of the submission.

Ari Maizel: Yeah. Thanks, David. The plan would be to expand the team if the drug is approved. In terms of the overall number, we're still working through that. There's obviously two pieces to it. One is, are there clinicians we would like to cover that we don't currently cover with the current team, and what sort of incremental headcount numbers do we need to reach them? The long-term care area is something that we'll need to think through in terms of overall headcount needed to appropriately educate and engage with long-term care settings. A little early to share a specific number, but the goal is to expand the team if AXS-05 is approved, and we'll share additional updates in the future. David, would you mind just repeating? I think you had a question about cash flow positivity.

The FDA typically lead sponsors know.

We see a high degree of overlap between Alzheimers agitation and major depressive disorder in terms of prescriber base and so we'll be able to.

Say up to 74 days following submission win.

On a potential exempt it we don't.

Don't see any potential impact from.

Rich our existing sales force.

We see high synergies related to the promotion there.

The shutdown for the timing so well.

As we said the next update that we expect to Sharon's potential acceptance decision.

And of course, we will need to invest in long term care promotion, which is something we don't currently have but do anticipate bringing online.

Thank you. Our next question comes from the line of Andrew Tsai with Jefferies. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Andrew Tsai with Jefferies. Please proceed with your question.

If the if the drug is approved.

Hey, good morning, great execution this quarter. Thanks for the question.

In terms of <unk> promotion.

We don't typically comment on other other companies in their promotional mix, but we have been.

David Amsellem: Hey. Good morning. Great execution this quarter. Thanks for the question. Maybe shifting gears to the pipeline. You've got two Phase 3 readouts with Sunosi for binge eating and shift work disorder. Can you talk a little bit about the study designs, what positive data would entail in order for you guys to file two more SNDAs next year or 2027? Thanks.

Andrew Tsai: Hey. Good morning. Great execution this quarter. Thanks for the question. Maybe shifting gears to the pipeline. You've got two Phase 3 readouts with Sunosi for binge eating and shift work disorder. Can you talk a little bit about the study designs, what positive data would entail in order for you guys to file two more SNDAs next year or 2027? Thanks.

Maybe shifting gears to the pipeline you've got two phase III readouts with Sanofi for binge eating and shift work disorder. So can you talk a little bit about the study designs with positive data would entail for in order for you guys to file two more <unk> next year or 2027.

Following along in.

They're having really nice success with rich salty and so there are some learnings that will incorporate into our launch strategy.

So if <unk> is approved.

Sure.

Thank you. Our next question comes from the line of Sean Lehmann with Morgan Stanley. Please proceed with your question.

<unk> two <unk> disorder.

Nick Pizzie: Sure. As it relates to binge eating disorder, it's your standard parallel group study design. That would be the first study that we would need in order to be able to file an SNDA. Based upon the results of that study, we would intend to initiate another trial. We would need two studies for that. Other indications for Solriamfetol include ADHD, we currently have one positive phase 3 trial for that in adults. We're looking to start our second study, which would be in pediatric subjects or pediatric patients in the Q4.

Standard parallel group study design.

[Analyst] (UBS): Yeah. Whether the anticipated ADA sales force expansion is already contemplated within the existing guidance for cash flow positivity?

Good morning, everyone and hope all is well.

And.

That would be the first study that.

I'm just wondering on the sales force expansion I think you just mentioned on the call you up to 46000 prescribers added 5000, you know given the bump in S. G and I am I'm wondering how much capacity you think you've got an existing sales force and when you might have to go again and how that ties into your thinking about the time to cash flow positivity.

Would need in order to be able to file an NDA. So then based upon the results of that study we would.

Ari Maizel: Yeah. David, Nick, absolutely. It's contemplated. The way that we forecast our cash is assuming that everything is positive as it relates to clinical and regulatory outlooks, and then the additional associated costs with that. Obviously, upon a launch, you would have the capital-intensive period in the first few quarters, and then ultimately seeing an ROI. Yes, the answer is we have already included that in our cash flow.

Tend to initiate another trials, where we would need two studies for that.

Other indications for <unk> include.

ADHD and we currently have one positive phase III trial for that in adults and we're looking to see.

Thanks.

Yeah I'll take the first part of the question.

We are pleased with the size of our sales force at the moment. It is driving considerable growth in terms of new prescribers as well as new patients.

Start our second study to be in.

In pediatric subjects.

Pediatric patients in the fourth quarter.

We've previously as he previously shared that we intend to add some additional representatives in support of the Alzheimer's agitation.

Operator: Thank you. Our next question comes from the line of Troy Langford with TD Cowen. Please proceed with your question.

Thank you. Our next question comes from the line of Amit <unk> with Needham <unk> Company. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Ami Fadia with Needham & Company. Please proceed with your question.

Fruitful and we.

Operator: Hi. Thanks for taking our question, and congrats on all the progress in the quarter. Just with respect to Auvelity, approximately how many quarters do you think it will take to see an impact from the recently launched DTC campaign on prescriptions? Do you think we'll see any sort of inflection in the current trajectory of prescriptions, or do you think we'll see just more of a continued gradual upward trend?

We have started our efforts in terms of laying the groundwork for future expansions, although we haven't quite settled on a final number that.

Hi, Thanks. Good morning. Thanks for taking my question. My question is just sort of broader stepping back you Scott.

Basma Radwan Ibrahim: Hi. Thanks. Good morning. Thanks for taking my question. My question is just sort of broader, stepping back. You've got a couple of products in the market making your way towards cash flow positivity and several other late-stage assets. Sort of from a long-term strategic perspective, where are you in terms of your thinking around the portfolio? Are you looking to add additional assets to drive sort of operational efficiencies over the next couple of years, or do you think that you've got enough in late-stage that focuses really more on execution on those assets? Thank you.

Ami Fadia: Hi. Thanks. Good morning. Thanks for taking my question. My question is just sort of broader, stepping back. You've got a couple of products in the market making your way towards cash flow positivity and several other late-stage assets. Sort of from a long-term strategic perspective, where are you in terms of your thinking around the portfolio? Are you looking to add additional assets to drive sort of operational efficiencies over the next couple of years, or do you think that you've got enough in late-stage that focuses really more on execution on those assets? Thank you.

A couple of products in the market.

That is something that we're looking to to do early in 2026.

The heatwave towards cash flow positivity in several other late stage assets.

From a long term strategic perspective, where are you in terms of your thinking around the portfolio.

Yes, maybe just a little bit on the SG&A for the quarter. This is Nick so.

Ari Maizel: Yeah. Thanks, Troy, for the question. In terms of number of quarters, it's hard to predict exactly when the most significant impact from DTC will hit. One of the things that we're looking at is changes in our weekly new patient starts. We have begun to see an increase in new patient starts in general. It's sort of eight to 12 weeks is when we'd be looking for anything significant in terms of DTC impact. Right now, we feel like it's still early days, but we're pleased with some of the trends that we've observed. We'll continue to provide updates.

In Q3, the SG&A increased slightly that was really driven by our launch of the DTC campaign that we launched in September. Additionally, we had a full quarter of commercialization activity first and Bravo. So.

Are you looking to add additional assets to drive set of operational efficiencies over the next couple of years or do you think that he has got enough in late stage.

Even with that if you take a look at our net loss on a on a cash basis, we continue to improve quarter over quarter as well as on a GAAP basis continue to improve on the net loss. So no changes as it relates to our outlook for cash flow positivity.

That focus is really more on execution on those assets. Thank you.

Thank you for the question.

Mary.

Nick Pizzie: Thank you for the question. We're in a unique position from the perspective of, as you mentioned, we do have 3 marketed products, which are still in relatively early stages of launch. There's a lot of growth ahead. We're also very fortunate that the period of exclusivity for these products goes out into the next decade or a couple of decades. That's a great position to be in. On the back of that, there's the next wave of products and indications which we would expect to be approved over the next couple of years. We talked about the SNDA filing for Alzheimer's disease agitation and the planned NDA filing for AXS-12. Of course, there's AXS-14 for which we intend to launch our next Phase 3 trial.

We're in a unique position from the perspective of.

As you mentioned, we do have.

Three marketed products, which are still in relatively early stages of launch so theres a lot of growth ahead and welcome very fortunate that.

Thank you. Our next question comes from the line of Ash Verma with UBS. Please proceed with your question.

Hi, Thanks for taking our question just on the agitation application can you comment on how many in the past.

The period of exclusivity for these products.

Operator: Thank you. Our next question comes from the line of Myles Minter with William Blair. Please proceed with your question.

It goes out.

Into the next decade or a couple of decades, so that's a great position to be in.

[Analyst] (UBS): Hi. Thanks for the question. Just the first on the third JPI contract, and there's Pay and T maintenance coming online. Would you expect that commercial covered lives moving from 75% somewhere in the mid-90% to have a similar favorable gross-to-net impact as you saw with the 28 million lives coming online in the third quarter there? Secondly, just given the FDA news this morning with Unicure and then George Tidmarsh, obviously resigning, just anything you can say about the confidence of the FDA as you work through the regulatory process on the CETA side. Thank you very much.

You are after the application filing.

Thats a discussion going on better yeah.

And on the back of that there is the next wave of products.

Over the past 60 days and that's unlikely to get a priority review.

And then any implications that you can draw from the government shutdown D filing.

Which we.

Wood products and indications, which we would expect to be approved over the next couple of years.

We talked about.

Application process review and how this may play out thanks.

The SMB E filing falls under disease agitation in the plan.

Sure Hey, guys good morning.

Finally, <unk> 12.

So Oh, you know as is our practice, we havent disclose the date of the submission.

And then of course Theres excess 14.

For which we intend to launch our next phase III trial. So.

The FTAA typically lead sponsors know.

Say up to 74 and eight following submission win on a potential exempt it we don't see any potential impact from the shutdown for the timing so well well you know as we said the next update that we expect to share his potential acceptance decision.

All of that means that we really do not need to do anything extra as it relates to the pipeline in the near term.

Nick Pizzie: All of that means that we really do not need to do anything extra as it relates to the pipeline in the near term. That would be, I think, the standard approach. Our approach is always to make sure that we're ahead of the curve. As it relates to that, we are taking the opportunity of the position that we're in to field inbound as it relates to potential additions to the pipeline, which could be complementary. We're not going to quit while we're ahead. We'll continue to make sure that we make very good strategic decisions as it relates to potentially enhancing the pipeline. We're in a position whereby we can be very choosy about what we bring on board.

Ari Maizel: Hey, Myles, I'll take the first one on GTN. I think it's too early to say where GTN will land with an additional contract now at hand. We are pleased, as we shared, with where we are with the improvement in GTN, as well as the improvement in the amount of lives covered and the formulary access. Stay tuned for where we'll land. We will continue to negotiate in a similar fashion as we have previously, ensuring that we maintain long-term value, and try to have as many patients covered as possible.

But that would be I think the standard approach and our approach is always to make sure that we're ahead of the curve and so as it relates to that.

We are taking the opportunity.

Thank you. Our next question comes from the line of Andrew Tsai with Jefferies. Please proceed with your question.

The position that we're in to field.

Inbound as it relates to potential additions to the pipeline, which could be complementary so we're not going to quit.

Hey, good morning, great execution this quarter. Thanks for the question.

<unk>.

We're ahead and we will continue to make sure that we make.

Very good strategic decisions as it relates to potentially enhancing the pipeline and we're in.

Marcus Jacobson: On the FDA side, right now, things are status quo for us in terms of our dialogue and interactions across the various divisions that we engage with.

Position, whereby we can be very choosy.

Sure.

Rates to binge eating disorder.

<unk>.

What we bring on board.

Standard parallel group study design.

Thank you. Our next question comes from the line of David <unk> with Piper Sandler. Please proceed with your question.

<unk>.

That would be the first study that a bit.

Operator: Thank you. Our next question comes from the line of David Amsellem with Piper Sandler. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Madison Alsotti with B. Riley Securities. Please proceed with your question.

Would need in order to be able to file an S. N D. A.

Thanks, I had a question on <unk>.

Based upon the results of that study, we would intend to initiate a trial. So we would need two studies for that.

David Amsellem: Thanks. I had a question on esreboxetine. Wanted to get your latest thoughts on how you're thinking of the commercial opportunity, particularly given that you'll be entering the market more or less around the same time as oveporexton, the first direction to receptor agonist. How are you thinking about the competitive dynamics here? How are you thinking about sizing this opportunity? Just wanted to get your latest thoughts on the product. Thank you.

Wanted to get your latest thoughts on how youre thinking of the commercial opportunity, particularly given that you'll be entering the market.

[Analyst] (William Blair): Hey, good morning. Thanks for taking our question. Congrats on the quarter. On Auvelity and Sunosi as well, but more so Auvelity, are you seeing per-prescriber activity trending upward? Just trying to kind of get a sense of how much growth here is sensitivity to promotion versus more organic growth. Obviously, the sensitivity to promotions is great. My sense is that there's also some organic growth here as well. If you could just comment, and then maybe a follow-up.

Other indications for solar ramp calls include.

More or less around the same time as <unk> and the first orexin two receptor agonist. So how are you thinking about.

ADHD and we currently have one positive phase III trial for that in adults and we're looking to.

On the competitive dynamics here, how are you thinking about.

Start our second study B.

Sizing this opportunity just wanted to get your latest thoughts on the product. Thank you.

In pediatric subjects, Oh pediatric patients in the fourth quarter.

Yeah.

Yes.

Thank you. Our next question comes from the line of Amit <unk> with Needham <unk> Company. Please proceed with your question.

Well I'll tackle that.

Nick Pizzie: Yeah. I think we'll all tackle that. One thing which is really interesting about esreboxetine is its focus on norepinephrine reuptake inhibition. That is a common pathway for the orexin. The physiology of the disease is orexin neuron loss, then decreases the production of norepinephrine. This is the esreboxetine works in a very logical, rational way in terms of the pathophysiology of the disease. We're very excited about the product profile because we know from our experience in the sleep space with Sunosi that there's still a very high unmet medical need.

One thing, which is really interesting about.

Reboxetine as its focus on.

Hi, Thanks. Good morning. Thanks for taking my question. My question is just sort of broader stepping back.

Northern African reuptake inhibition and.

Ari Maizel: Yeah. Thanks for the question, Madison. I guess the way that I would recommend sort of thinking about the growth is it's a function of two things: productivity among existing writers, so the number of prescriptions per existing writer, and then our ability to add additional new writers into the prescriber mix. For both brands, we're seeing those things come to fruition, which I think is a testament to the impact that these medicines are having on patients' lives, the positive reinforcement that these clinicians are hearing from their patients, and our team's ability to engage with them and educate them on a routine basis. Those are things that we'll continue to look to drive moving forward.

That is a common pathway for the Orexin so.

Got it.

A couple of products in the market are making our way towards cash flow positivity and several other late stage assets.

The physiology of the disease is orexin neuron loss.

Yes.

Then decreases.

So that's from a long term strategic perspective, where are you in terms of your thinking around the portfolio.

The production of Northern Africa, and so then.

So we.

The <unk> team works.

Uh huh.

And very logical rational.

Are you looking to add additional assets to drive set of operational efficiencies over the next couple of years or do you think that he has got enough in late stage. Our focus is really more on execution on those assets. Thank you.

Wait in terms of the past ideology of the disease. So we're very excited about the product profile, because we know from our experience in listings space.

With that.

There is still a very high unmet medical need.

Thank you for the question you know we're in a very hum.

Yeah, and I'll just add when you look at the clinical profile that was observed in the phase three trials.

We're in a unique position from the perspective of as you mentioned, we do have three marketed products, which are still in relatively early stages of launch. So theres a lot of growth ahead, and we're also very fortunate that the.

Ari Maizel: Yeah. I'll just add, when you look at the clinical profile that was observed in the Phase 3 trials, great efficacy in cataplexy, non-stimulant, daytime treatment, favorable tolerability profile. There's a lot to like about it. What we hear from KOLs and sleep experts is that many patients require polypharmacy. There's a lot of trial and error. Even with the entry of a new mechanistic approach, we believe that there will still be significant unmet need, which creates opportunity for AXS-12 in those patients.

Great efficacy in cataplexy, non stimulant daytime <unk> been favorable tolerability profile.

[Analyst] (William Blair): Got it. Understood. We have four phase 3 trials planned to initiate this quarter. Just wondering on the cadence of those, should we think of these as almost parallel launches, or will these kind of come in a sequence throughout the remaining quarter? Thank you.

A lot to like about it and what we hear from Kols and sleep experts is that many patients.

The period of exclusivity for these products are goes out.

Into the next.

Required polypharmacy, there is a lot of trial and error.

A couple of decades, so that's a great position to be in.

And even with the entry of a new mechanistic approach, we believe that there will still be significant unmet need which creates opportunity for access 12 in those patients.

And on the back of that you know there is the next wave of products.

Which we wood products and indications, which we would expect to be approved over the next couple of years.

Ari Maizel: Yeah. Four phase 3 trials launching. There are a lot of moving parts from an operational perspective to make sure that that happens. It's very unlikely that they're all going to happen on the very same day. Do expect a natural cadence. It's nothing that we're pre-planning. However, we are working towards and are on track for the initiation of those studies in the fourth quarter.

We talked about.

And maybe just one other at is with respect to sizing.

The Essent E filing for Congress disease agitation in the plan.

Nick Pizzie: Maybe just one other add is with respect to sizing. We see incredibly high synergy, almost near-perfect synergy with the current sales and marketing infrastructure that we have in place for Sunosi right now. Very, very complementary to what's already in place. We're excited about that.

Ari Maizel: Maybe just one other add is with respect to sizing. We see incredibly high synergy, almost near-perfect synergy with the current sales and marketing infrastructure that we have in place for Sunosi right now. Very, very complementary to what's already in place. We're excited about that.

<unk>.

We see incredibly high.

NDA filing for <unk> 12.

Synergy almost almost near perfect synergy with the current sales and marketing infrastructure that we have in place for us to note right now so very very.

And then of course Theres excess 14.

For which we intend to launch our next phase III trial. So.

All of that means that we.

We really do not need to do anything extra as it relates to the pipeline in the near term.

Very complimentary to what's already in place. So so we're excited about that.

Operator: Thank you. Our last questions will come from the line of Benjamin Brett with Wells Fargo. Please proceed with your question.

But that would be I think the standard approach.

Thank you. Our next question comes from the line of Joon Lee with true Securities. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Joon Lee with Truist Securities. Please proceed with your question.

Our approach is always to make.

Make sure that we're ahead of the curve and so as it relates to that.

Operator: Hey, guys. This is Graig on for Ben. Just a couple from us here. Given your successful track record of getting products through the finish line, I'm curious, can you provide a little bit of color on how your regulatory interactions in regards to the sNDA for AXS and NDA has maybe differed from some of those past programs? I guess second question, in regards to narcolepsy, I feel like we're seeing a lot of estimates of the epidemiology of those indications kind of expanding and expanding further. Out of curiosity, what do you guys think is driving that? Are you seeing growth in IH, NP1, NP2, any one particular area? Yeah, any color there would be helpful. Thank you.

Hey, congrats on the strong quarter and thanks for taking our questions.

David Amsellem: Hey. Congrats on the strong quarter, thanks for taking our questions. Your commercial execution on Sunosi is quite impressive. Any idea where the demand for Sunosi is coming from? Is it NT1, NT2, IH, or something else? Given your strength in combining products, any thoughts on combining Sunosi with AXS-12 to address both EDS and cataplexy, or do you think it's just better to keep them à la carte? Thank you.

Joon Lee: Hey. Congrats on the strong quarter, thanks for taking our questions. Your commercial execution on Sunosi is quite impressive. Any idea where the demand for Sunosi is coming from? Is it NT1, NT2, IH, or something else? Given your strength in combining products, any thoughts on combining Sunosi with AXS-12 to address both EDS and cataplexy, or do you think it's just better to keep them à la carte? Thank you.

Your commercial execution on Sanofi is quite impressive any idea where does demand for us is coming from is it anti one and two IH or something else.

We are taking the opportunity of the position that we're in to field.

Inbound as it relates to potential additions to the pipeline, which could be complementary so while we're not going to quit while we're.

And given your strength in combining products any thoughts on combining.

We're ahead and we will continue to make sure that we make are.

Sanofi with excess 12 to address both eds, and cataplexy or you think it's just better to keep them Ala carte. Thank you.

Very good strategic decisions as it relates to potentially enhancing the pipeline and were in a position whereby we can be very choosy.

Yes, I'll take the first part of that question.

Ari Maizel: Yeah. I'll take the first part of that question. We're seeing sort of the predominant growth is coming from the OSA segment. There's significant unmet need in terms of excessive sleepiness with OSA patients. It represents roughly two-thirds or so of the overall prescribing for Sunosi. We are seeing very strong demand for Sunosi with those patients. Narcolepsy, of course, is an important component of the Sunosi sales mix. What we've seen, particularly over the past couple of years, is a greater awareness of excessive sleepiness among OSA patients. As a consequence, we're seeing increased utilization there.

We're seeing sort of.

About what we bring on board.

The predominant growth is coming from the OSA segments. There is significant unmet need in terms of excessive sleepiness with OSA patients.

Thank you. Our next question comes from the line of David <unk> with Piper Sandler. Please proceed with your question.

Ari Maizel: I'll take the first part. It's ordinary course at the moment based on where we are in the cycle. In terms of the submission for AXS-05 and ADA education.

Thanks, I had a question on Reboxetine.

It represents roughly two thirds or so of the overall prescribing <unk> and we are seeing very strong demand for Sanofi with those patients narcolepsy of course is an important component of the.

Wanted to get your latest thoughts on how you're thinking of.

Commercial opportunity, particularly given that you'll be entering the market.

[Analyst] (William Blair): Yeah. From an epidemiological perspective, for narcolepsy, you've got to look at the surveys that are done and the quality of those surveys. However, one aspect of the market that we've always pointed to is the fact that in this orphan indication, there is still a large percentage of patients who, one, have remained undiagnosed in the past, and secondly, were treated. Certainly, as there is more interest in the space, as more products are being developed and coming to market, one would expect that there would be an increase in awareness, and maybe that's what you're seeing. Anything that you would add, Ari?

More or less around the same time as over per accident.

<unk> sales mix, but what we've seen particularly over the past couple of years is.

The first Orexin two receptor agonist. So how are you thinking about.

A greater awareness of.

Excessive sleepiness, among OSA patients and.

The competitive dynamics here, how are you thinking about.

And as a consequence, we're seeing increased utilization there.

This opportunity just wanted to get your latest thoughts on the product. Thank you.

Yes.

Rates too.

<unk> about.

Nick Pizzie: Yeah. As it relates to your question about whether it should be an à la carte approach for AXS-12 and Sunosi, given how complementary the planned indications are, our priority is to make sure that we get the product approved. That's first and foremost. Let's start with that. That's going to accomplish our main goal, which is to provide clinicians extra treatment options. Clearly, given how the patients are treated with narcolepsy, given the varied symptomatology, probably, undoubtedly, there would be patients who would receive both Sunosi and AXS-12. Our goal is to provide clinicians the data such that they can treat the patients in the best way that they see fit.

Weather.

Yes.

Well I'll tackle that.

Whether it should be.

One thing, which is really interesting about reboxetine as it's a focus on.

And our current approach.

For TX 12, <unk> Z given how complementary the planned indications are.

Northern African reuptake inhibition and that.

That is a common pathway for the Orexin so are the.

All right.

Our priority is to make sure that we can get the product approved.

The pathophysiology of the disease is orexin neuron loss.

First and foremost so let's start with that.

Then decreases.

And that is going to accomplish.

Production of norepinephrine and so then.

<unk>, which is to provide solutions on extra treatment options and clearly given how the patients were treated with narcolepsy.

Ari Maizel: No. I think you mentioned NP1, NP2, IH. I think that there's a lot of symptomatology overlap in different formalized diagnoses, which may muddy the waters a little bit. From our perspective, we feel good about our current estimates, which is around 185,000 people in the US suffering from narcolepsy. That's what we're building our plans around.

So we this is the.

With box team works and very logical rational.

Given the varied symptomatology.

Way in terms of the past physiology of the disease. So we're very excited about the product profile, because we know from our experience in this space.

Probably you undoubtedly you would be.

Okay.

Those who had received both Sanofi and <unk> 12.

And our goal is to provide clinicians with data such that.

With <unk> that there is still a very high unmet medical needs.

They can treat the patients and the best way that they see fit.

Yeah, I'll just add when you look at the clinical profile that was observed in the phase three trials.

Operator: Thank you. There are no further questions at this time. I now would like to hand the call back over to management for any closing comments.

Thank you. Our next question comes from the line of Ram <unk> with H C. Wainwright. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Ram Savaraju with H.C. Wainwright. Please proceed with your question.

Great efficacy in cataplexy, non stimulant daytime <unk> been favorable tolerability profile.

Thanks, so much for taking my questions and congratulations on all the progress just with respect to <unk> I was wondering if you could elaborate on the number of centers that you expect to target in the next wave. After the initial 50 headache centers and also if you could tell us a little bit about the timing with which you expect.

[Analyst] (William Blair): Thank you. Thank you to everyone for joining us this morning. As we've highlighted today, Axsome delivered another strong quarter. We continue to drive robust growth across our commercial portfolio, and we are well-positioned to deliver significant long-term value through our advancing pipeline. We look forward to sharing our continued progress over the coming months. Thank you.

Graig Suvannavejh: Thanks so much for taking my questions. Congratulations on all the progress. Just with respect to Symbravo, I was wondering if you could elaborate on the number of centers that you expect to target in the next wave after the initial 150 headache centers, and also if you could tell us a little bit about the timing with which you expect the DTC campaign for Symbravo to be engaged if we should be thinking about the timeline as being similar to the timeline with which you initiated the DTC promotional activity in support of Auvelity. Thank you.

Ram Selvaraju: Thanks so much for taking my questions. Congratulations on all the progress. Just with respect to Symbravo, I was wondering if you could elaborate on the number of centers that you expect to target in the next wave after the initial 150 headache centers, and also if you could tell us a little bit about the timing with which you expect the DTC campaign for Symbravo to be engaged if we should be thinking about the timeline as being similar to the timeline with which you initiated the DTC promotional activity in support of Auvelity. Thank you.

There's a lot to like about it and what we hear from Kols and sleep experts is that many patients require polypharmacy theres a lot of trial and error.

And even with the entry of a new mechanistic approach, we believe that there will still be significant unmet need which creates opportunity for access 12 in those patients.

The DTC campaign for some Bravo to be engaged if we should be thinking about the timeline as being similar to the timeline with which you initiated the DTC promotional activity in support of our ability. Thank you.

Operator: Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

And maybe just one other at is is with respect of sizing.

Yes, thanks, Ron so regarding.

We see incredibly high.

Ari Maizel: Thanks, Ram. Regarding the, I guess, increase in number of centers, the way to think about it is right now, we are really focus on the predominant headache centers and headache specialists in the country. A future expansion would enable us to actually expand out more into the primary care market where you might have a heavy proportion of migraine treaters. Right now, we feel very good about our coverage of headache centers and headache specialists. That next wave would really be more about primary care expansion. As it relates to DTC, I think it's a little premature to talk about potential timing. If you look at Auvelity and our timing related to our DTC launch, it really was a function of ensuring we had a strong foundation of HCP prescribers support from a prescriber perspective.

The increase in number of centers the way to think about it is right now we are.

Synergy almost almost near perfect synergy with the current sales and marketing infrastructure that we have in place force unknowns right now so very very.

Really focused on the predominant headache centers and headache specialists in the country.

Very complimentary to what's already in place. So so we're excited about that.

Future expansion would enable us to actually expand out more into primary care market, where you might have a heavy.

Thank you. Our next question comes from the line of Joon Lee with Truest Securities. Please proceed with your question.

Proportion of migraine treaters, and so right now.

Hey, congrats on the strong quarter and thanks for taking our questions. Your commercial execution honestly now he is quite impressive any idea where does demand for Sanofi is coming from is it empty one andy to IH or something else and given your strength in combining product any thoughts on combining.

We feel very good about our coverage of headache centers and headache specialists.

That next wave would really be more about primary care expansion.

As it relates to DTC I think it's a little premature to talk about potential timing.

If you look at <unk> and our timing related to our DTC launch it really was a function of ensuring we had a strong foundation of HCP prescribers.

Now see with excess 12 to address both eds and cataplexy or.

It's just better to keep them Ala carte. Thank you.

Yeah, I'll take the first part of that question.

Support from a from a prescriber perspective, we.

We have reached a critical mass in terms of market access and we had.

We're seeing sort of a.

Ari Maizel: We had reached a critical mass in terms of market access, and we had a sales force size that was big enough to support the increase in patient requests coming from a DTC campaign. When that might happen, obviously, we're FOCUS on execution across all fronts, and we'll evaluate as the brand progresses.

The predominant growth is coming from the OSA segments. There is significant unmet need in terms of excessive sleepiness with OSA patients in.

Our sales force size that was big enough to support the increase in patient requests coming from a DTC campaign. So when that might happen. Obviously, we're focused on execution across all fronts and we will evaluate.

It represents roughly two thirds or so of the overall prescribing <unk>. We are seeing very strong demand for Sanofi went those patients narcolepsy of course is an important component of the Sanofi sales mix, but what we've seen particularly over the past couple of years is.

The brand progresses.

Thank you. Our next question comes from the line of Jason <unk> with Bank of America. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Hi, Good morning, it's Dana on for Jason Congrats on the quarter and thank you so much for taking our question.

A greater awareness.

Dina: Hi. Good morning. It's Dina for Jason. Congrats on the quarter, and thank you so much for taking our question. Just on AXS-05 for Alzheimer's disease agitation, could you maybe share your understanding of the clinical profile bar that's necessary for priority review under breakthrough designation? Is there a requirement that AXS-05 shows efficacy benefit relative to Rexulti? Maybe how do you think investors should think about that scenario and the read-through to the ACCORD trials? Just a quick follow-up on your comment on AXS-05's ADA long-term care promotion. Could you just maybe detail what those efforts look like? Are there docs that are affiliated with long-term care facilities? I appreciate any additional color there. Thank you.

Dina Ramadane: Hi. Good morning. It's Dina for Jason. Congrats on the quarter, and thank you so much for taking our question. Just on AXS-05 for Alzheimer's disease agitation, could you maybe share your understanding of the clinical profile bar that's necessary for priority review under breakthrough designation? Is there a requirement that AXS-05 shows efficacy benefit relative to Rexulti? Maybe how do you think investors should think about that scenario and the read-through to the ACCORD trials? Just a quick follow-up on your comment on AXS-05's ADA long-term care promotion. Could you just maybe detail what those efforts look like? Are there docs that are affiliated with long-term care facilities? I appreciate any additional color there. Thank you.

Hum excessive sleepiness among OSA patients.

Just on an excess of five for Alzheimers disease agitation could you maybe share your understanding of the clinical profile bar that's necessary for priority review under breakthrough designation is there.

The consequence, we're seeing increased utilization there.

Yeah, and as it relates to <unk>.

Your question about.

Whether.

Whether it should be.

Wireman that eight five shows efficacy benefit relative to <unk>.

And on the current approach.

For excess 12, and so nosy given how complementary the planned indications are.

And how do you think investors should think about that scenario and the read through to the core trial and then just a quick follow up on your comment on excess of I 80, a long term care promotion could you maybe detail what those efforts look like are they are docs that are affiliated with long term care facilities.

Yeah.

Our priority is to make sure that we get the product approved.

That's first and foremost so let's start with that.

And that is going to accomplish.

Our main goal, which is to provide solutions on extra treatment options.

And clearly given how the patients were treated with narcolepsy given the varied symptomatology.

Any additional color there. Thank you.

Sure.

So just one thing just to share our base case, there was always a standard review.

Probably you undoubtedly.

Mark Jacobson: Sure. Hi. Just one thing just to share. Our base case here is always a standard review for the application. We are eligible for potential priority review. Our understanding is that currently, the position for the FDA for any application is standard review. With respect to quantitative efficacy bars, that's not how it works, right? It's not a specific or, again, quantitative analysis that the agency does. It's hard to give you anything there for what may or may not go into an analysis like that. Again, our base case has always been standard review. I think we will, as we said, we'll keep people posted on a potential acceptance decision as I think the next thing that we'd expect for the course of review.

Would be Ah.

Patients, who received both Sanofi and <unk> 12.

For the application.

We are eligible and.

And our goal is to provide clinicians with data.

Such that.

For for potential priority review, but our understanding is that.

They can treat the patients and the best way that they see fit.

Currently the <unk> position for the FDA for any application is standard.

Yeah.

Thank you. Our next question comes from the line of Ron <unk> with H C. Wainwright. Please proceed with your question.

And.

With respect to like quantitative efficacy bars.

That's not how it works right.

Thanks, so much for taking my questions and congratulations on all the progress just with respect to some Bravo I was wondering if you could elaborate on the number of centers that you expect it to target in the next wave. After the initial 50 headache centers and also if you could tell us a little bit about the timing with which you expect.

Yes.

So it's not a specific.

Again quantitative analysis that the agency does so it's hard to give you anything there for.

What may or may not.

Go into an analysis like that but again our base case has always been standard.

The DTC campaign for Sim Bravo to be engage if we should be thinking about the timeline as being similar to the timeline with which you initiated the DTC promotional activity and support of all of that ready. Thank you.

<unk>.

I think we are as we said we will keep people posted on a potential acceptance decision is I think the next the next thing that we would expect for the course of the review.

And then in terms of your long term care question.

Ari Maizel: Yeah. Dina, in terms of your long-term care question, it's a little different than traditional outpatient facilities where you may be calling on MDs, NPs, and PAs, along with office staff. In long-term care facilities, there's a significant nursing staff, pharmacy directors, and medical directors. Of course, there are physicians, NPs, and PAs that will make rounds in long-term care, but they also are treating patients in the community. There's a synergistic effect of the community-based promotion for those clinicians that go into long-term care. It is a little bit of a different approach, which is why we feel it's necessary to have a dedicated team FOCUS on long-term care facilities if the drug's approved.

Yeah, Thanks, Ron so regarding I.

It's a little different than traditional outpatient facilities, where you may be calling on Mds NPS.

I guess increase in number of centers the way that to think about it is right now we are.

Along with office staff in long term care facilities theirs.

Really focused on the predominant headache centers and headache specialists in the country.

As significant nursing staff pharmacy directors medical directors of course, there are physicians NPS and PGA event, we'll make rounds in long term care, but they also are treating patients in the community and so there is a synergistic effect of the community based promotion for those clinicians that go into.

Our future expansion would enable us to actually expand out more into primary care market, where you might have a heavy.

Proportion of migraine treaters, and so right now.

A long term care. So it is a little bit of a different approach.

We feel very good about our coverage of headache centers and headache specialists.

Which is why we feel it's necessary to have a dedicated team focused on long term care facilities, if the drugs approved.

That next wave would really be more about primary care expansion.

As it relates to the D. T C. I think it's a little premature to talk about potential timing.

Thank you. Our next question comes from the line of yet and soon Asia with Guggenheim Partners. Please proceed with your question.

If you look at <unk>, and our timing related to our DTC launch it really was a function of.

Operator: Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim Partners. Please proceed with your question.

Okay. One more question on the idea.

Ensuring we had a strong foundation of HCP prescribers, a support from a from a prescriber perspective.

Yatin Suneja: Guys, one more question on the ADA. How do you think about the Adcom? Is that going to be required given that we already had one for the space with Rexulti? Just curious to hear your thought and how you are thinking about it.

How do you think about the outcome is that going to be required given that we already had one for the space with <unk> just curious to hear your thoughts on how youre thinking about it.

We have reached a critical mass in terms of market access and we had a.

Sales force size that was big enough to support the increase in patient requests coming from a DTC campaign. So when that might happen. Obviously, we're focused on execution across all fronts, and we will evaluate as the.

An ad com thats.

Thats something companies find out.

Hunter Murdock: An Adcom, that's something companies find out on potential acceptance decisions for FDA. Stay tuned on that.

Potential acceptance decisions for for FDA.

Stay tuned on that.

Thank you. Our next question comes from the line of Greg <unk> with Mizuho Securities. Please proceed with your question.

The brand progresses.

Operator: Thank you. Our next question comes from the line of Graig Suvannavejh with Mizuho Securities. Please proceed with your question.

Thank you. Our next question comes from the line of Jason <unk> with Bank of America. Please proceed with your question.

Hey, good morning, Thanks for taking my question and congrats on the continued success across the board both commercially and on the pipeline just wanted to talk about <unk> commercially.

Graig Suvannavejh: Hey. Good morning. Thanks for taking my question. Congrats on the continued success across the board, both commercially and on the pipeline. Just wanted to talk about Auvelity commercially. Just wanted to revisit the gross to net and its evolution. I think you mentioned that the gross to net was in the high 40s in Q3. I'm wondering what led to that happening and whether there were any unique one-time events or items that contributed to that. Also just looking forward on the progress you've made with contracting, are there any other significant gains that you're looking forward to? I mean, it seems like you're at a pretty good place, but just wondering just in the future how we should think about that dynamic. Thanks.

Hi, Good morning, it's Dana on for Jason Congrats on the quarter. Thank you so much for taking our question.

I just wanted to revisit the gross to net in its evolution I think you mentioned that the gross to net was in the high four days in the third quarter I'm wondering what led to that happening and whether there are any unique one time events or items that contributed to that and also just looking forward on our progress you've made with contracting are there any other significant gains that you are looking forward to I mean it seems.

Just on an excess of five for Alzheimers disease agitation could you maybe share your understanding of the clinical profile of bar that's necessary for priority review under breakthrough designation is there.

Firemen that eight five shows efficacy benefit relative to like salty and you know maybe how do you think investors should think about that scenario and the read through to the court trial and then just a quick follow up on your comment on excess of I 80, a long term care promotion could you.

You are at a pretty good place, but just wondering.

Just in the future how we should think about that dynamic. Thanks.

Sure. Greg This is Nick Thanks for the question you are correct ability.

Madison El-Saadi: Hello, Graig. Hey. This is Nick Pizzie. Thanks for the question. You're correct. Auvelity discount for the quarter improved from the mid-50s to the high 40s in Q3. Pleased with the net price improvement around Auvelity. Something that did change during the quarter is that we received additional $28 million lives in Q3. We were able to see those lives covered in an improved fashion in first line or first switch. Improved access, improved amount of patients covered, along with improved net price from a GTN perspective. You want to take that second question?

Nick Pizzie: Hello, Graig. Hey. This is Nick Pizzie. Thanks for the question. You're correct. Auvelity discount for the quarter improved from the mid-50s to the high 40s in Q3. Pleased with the net price improvement around Auvelity. Something that did change during the quarter is that we received additional $28 million lives in Q3. We were able to see those lives covered in an improved fashion in first line or first switch. Improved access, improved amount of patients covered, along with improved net price from a GTN perspective. You want to take that second question?

Discount for the quarter improved from the mid <unk> to the high <unk> in Q3, so pleased with the net price improvement around the ability and.

Just maybe detail what those efforts look like are there docks that are affiliated with long term care facilities.

I appreciate any additional color there. Thank you.

Something that did change during the quarter is that.

Yeah.

We received additional 28 million lives in <unk>.

Hello, Hi.

Q3.

So just just one thing just to share our base case, there was always a standard review.

And so we were able to see those lives covered in a <unk>.

Or the application and.

Fashion in first line or first switch so improved access improved amount of patients covered.

We are eligible and.

Or for a potential priority review, but our understanding is that <unk>.

Along with improved net price from a TTM perspective are you going to take the second question, Yes. So I think first and foremost we're at 85% total lives covered.

Currently the default position for the FDA for any application is standard and.

With respect to like quantitative efficacy bars.

Ari Maizel: Yeah. I think first and foremost, we're at 85% total lives covered, which we're really pleased with. We shared on the opening remarks that we signed the third large GPO. Our expectation is to continue to add additional covered lives. Our goal is to try to get to as close as 100% as we can. Obviously, with the third GPO signed, that will enable additional covered lives moving forward. As you know, it's very difficult to predict exactly when those new PBM contracts will come online, but we do feel optimistic that there's great interest, and the team is continuing to focus on driving additional covered lives moving forward.

We're really pleased with we shared on the opening remarks that we signed the third large GPO.

That's not how it works right it is.

So it's not a specific.

Again quantitative analysis that the agency does so it's it's hard to give you anything there for.

Our expectation is to continue to add additional covered lives. Our goal is to try to get to as close as 100% as we can obviously was the third GPO signed that will enable additional covered lives moving forward as you know, it's very difficult to predict exactly when.

What may or may not.

Go into an analysis like that but again our base case has always been standard and I think we will as we said we will keep people posted on a potential acceptance decision is I think the next the next thing that we would expect for the course of the review.

Those new <unk> contracts will come online, but we do feel optimistic that.

There is great interest and.

Yes, and yes.

Terms of your long term care question.

The team is continuing to focus on <unk>.

It's a little different than traditional outpatient facilities, where you may be calling on Mds NPS P. As you know along with office staff in long term care facilities. There is a significant nursing staff pharmacy directors medical directors of course, there are physicians and peace in P. A event.

Driving additional covered lives moving forward.

Thank you. Our next question comes from the line of David Ho with Deutsche Bank. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of David Hoang with Deutsche Bank. Please proceed with your question.

Hi, congrats on the quarter. Thanks for taking my questions. Just wanted to go back to the planned sales force expansion for Ada recognize that it's early days, but could you maybe bookend or at least.

Myles Minter: Hi. Congrats on the quarter. Thanks for taking my questions. Just wanted to go back to the planned sales force expansion for ADA. Recognize that it's early days, but could you maybe bookend or at least point us towards maybe a minimum number of reps that you think would be sufficient to execute a successful launch in that indication? Are those numbers already contemplated in your guidance for reaching cash flow positivity? Thank you.

David Hoang: Hi. Congrats on the quarter. Thanks for taking my questions. Just wanted to go back to the planned sales force expansion for ADA. Recognize that it's early days, but could you maybe bookend or at least point us towards maybe a minimum number of reps that you think would be sufficient to execute a successful launch in that indication? Are those numbers already contemplated in your guidance for reaching cash flow positivity? Thank you.

We'll make rounds in long term care, but they also.

Our treating patients in the community and so there is a synergistic effect of the community based promotion for those clinicians that go into long term care. So it is a little bit of a different approach.

<unk> tours.

Maybe a minimum number of reps that you think would be sufficient to execute a successful launch in that indication and are those numbers already contemplated in your guidance for reaching cash flow positivity. Thank you.

Which is why we feel it's necessary to have a dedicated team focused on long term care facilities.

The drugs approved.

Yes, Thanks, David.

Hi.

Thank you. Our next question comes from the line of getting soon Asia with Guggenheim Partners. Please proceed with your question.

The plan would be to expand the team.

If the drug is approved in terms of the overall number and we're still working through that Theres, obviously two pieces to it one is.

Okay. One more question on the a D a.

How do you think about the outcome is that going to be required given that we already had one for the space with <unk> just curious to hear your thoughts on how youre thinking about it.

Are there are clinicians we don't we would like to cover that we don't currently cover would be the current team and what sort of incremental head count numbers, we need to reach them and then the long term care area.

Yeah.

An AD com that that's something companies find out.

Something that we will need to think through in terms of overall head count needed to appropriately educate.

Potential acceptance decisions for for F D a.

Stay tuned on that.

Thank you. Our next question comes from the line of Greg Savannah, <unk> with Mizuho Securities. Please proceed with your question.

And engage with long term care setting so lynn.

Little early to share a specific number but.

Hey, good morning, Thanks for taking my question.

The goal is to.

Expand the team.

That's on the continued success across the board both commercially and on the pipeline I just wanted to talk about a valid commercially.

<unk> is approved and we will share additional updates in the future.

Nick Pizzie: . David, would you mind just repeating? I think you had a question about cash flow positivity.

Just wanted to revisit the gross to net in its evolution I think you mentioned that the gross to net was in the high forties in the third quarter I'm wondering what led to that happening and whether there are any unique one time events or items that contributed to that and also just looking forward on the progress you've made with contracting are there any other significant gains that you are looking forward to I mean it seems.

And David Mind, just repeat I think you had a question about cash flow positivity.

Yes, whether the AA.

Myles Minter: Yeah. Whether the anticipated ADA sales force expansion is already contemplated within the existing guidance for cash flow positivity.

David Hoang: Yeah. Whether the anticipated ADA sales force expansion is already contemplated within the existing guidance for cash flow positivity.

<unk> sales force expansion is already contemplated within the existing guidance where cash flow positivity.

Yes, David I think absolutely it's contemplated we the way that we forecast our cash is assuming that everything is positive.

Ari Maizel: David's Nick. Absolutely. It's contemplated. The way that we forecast our cash is assuming that everything is positive as it relates to clinical and regulatory outlooks and then the additional associated costs with that. Obviously, upon a launch, it would be capital-intensive in the first few quarters and then ultimately seeing an ROI. Yes, the answer is we have already included that in our cash flow.

You are at a pretty good place, but just wondering.

Just in the future how we should think about that dynamic. Thanks.

Sure. Greg This is Nick Thanks for the question you are correct of LD.

As it relates to clinical and regulatory outlooks and then the additional associated costs with that so obviously you upon our launch it would have.

Discount for the quarter improved from the mid fifties to the high forties in Q3, so pleased with the net price improvement around ability and.

It would be capital intensive further in the first few quarters and then ultimately seeing an ROI.

Something that did change during the quarter is that.

So yes. The answer is we have already included that in our cash flow.

<unk> received additional 28 million lives in <unk>.

Q3.

And so we were able to see those lives covered in a.

Thank you. Our next question comes from the line of Troy Lankford with TV Cowen. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Troy Langford with TD Cowen. Please proceed with your question.

Fashion in first line or first switch so improved access improved amount of patients covered.

Hi, Thanks for taking my question and congrats on all the progress in the quarter just with respect although the approximately how many quarters do you think it will take to see an impact from the recently launched DTC campaign on prescriptions and do you think we'll see them sort of inflection in the current trajectory of prescriptions or do you think we'll see just more of a continued gradual upward trend.

Troy Langford: Hi. Thanks for taking our question, congrats on all the progress in the quarter. Just with respect to Auvelity, approximately how many quarters do you think it will take to see an impact from the recently launched DTC campaign on prescriptions? Do you think we'll see any sort of inflection in the current trajectory of prescriptions, or do you think we'll see just more of a continued gradual upward trend?

Along with improved net price from a TTM perspective are you going to take that second question. Yeah. So I think first and foremost we're at 85% total lives covered.

We're really pleased with we shared on the opening remarks that we signed the third large GPO.

Okay.

Yes, Thanks, Troy for the question.

In terms of number of quarters, it's hard to predict exactly when.

Ari Maizel: Yeah. Thanks, Troy, for the question. In terms of number of quarters, it's hard to predict exactly when the most significant impact from DTC will hit. One of the things that we're looking at is changes in our weekly new patient starts. We have begun to see an increase in new patient starts in general. It's sort of 8 to 12 weeks is when we'd be looking for anything significant in terms of DTC impact. Right now, we feel like it's still early days, but we're pleased with some of the trends that we've observed, and we'll continue to provide updates.

The most significant impact from DTC will will hit but one of the things that we're looking at is <unk>.

Changes in our weekly new patient starts we have begun to see an increase in new patient starts in general.

Very difficult to predict exactly when.

It's sort of eight to 12 weeks is when we'd be looking for anything significant in terms of DTC impact right now we feel like it's still early days, but we're pleased with some of the trends that we've observed.

Those new P. B M contracts will come online, but we do feel optimistic that.

There is great interest and.

The team is continuing to focus on draw.

Driving additional covered lives moving forward.

And we will continue to provide updates.

Thank you. Our next question comes from the line of David Ho with Deutsche Bank. Please proceed with your question.

Thank you. Our next question comes from the line of Myles Minter with William Blair. Please proceed with your question.

Hi, congrats on the quarter. Thanks for taking my questions. Just wanted to go back to the planned sales force expansion for <unk> recognize that it's early days, but could you maybe bookend or at least.

Operator: Thank you. Our next question comes from the line of Myles Minter with William Blair. Please proceed with your question.

Hi, Thanks for the questions just the first on the search API contract in ISR Pan <unk> coming online.

Myles Minter: Hey. Thanks for the question. Just the first on the third JPO contract, and those P&T meetings coming online, would you expect that commercial covered lives moving from 75% somewhere in the mid-90% to have a similar favorable gross to net impact as you saw with the 28 million lives coming online in Q3 there? Secondly, just given the FDA news this morning with uniQure and then George Tudmarsh obviously resigning, just anything you can say about the confidence of the FDA as you work through the regulatory process on the CDA side. Thank you very much.

Would you expect that commercial covered lives measures from 75% somewhere in the mid 90% to have a similar favorable gross to net impact as you saw with the 28 million lives coming on online in the third quarter that and then secondly, just given the FDA in here this morning with the.

As tors.

Yes, Thanks, David.

Unit Cure and then George Tim Marsh obviously.

The plan would be to expand the team.

Resigning.

Anything you can say around the confidence of the FDIC work through the regulatory process on the state side. Thank you very much.

If the drug is approved in terms of the overall number and we're still working through that Theres, obviously two pieces to it one is.

Hey, Myles I'll take the first one on GTR and I think it's too early to say, where <unk> will land with additional with additional contracts.

Are there are clinicians we don't we would like to cover that we don't currently cover with the current team and what sort of incremental head count numbers, we need to reach them.

Ari Maizel: Hey, Myles. I'll take the first one on GTN. I think it's too early to say where GTN will land with an additional contract now at hand. We are pleased, as we shared, with where we are with the improvement in GTN as well as the improvement in the amount of lives covered and the formulary access. Stay tuned for where we'll land, but we will continue to negotiate in a similar fashion as we have previously, ensuring that we maintain long-term value and try to have as many patients covered as possible.

And so but we are pleased as we shared with with where we are with the improvement in GTS as well as the improvement in <unk>.

And then the long term care.

It's something that we'll need to think through in terms of overall head count needed to appropriately educate.

The amount of lives covered in the formulary access so stay tuned for where that where we will land, but we will continue to look.

And engage with long term care setting so.

<unk> in a similar fashion as we have previously and ensuring that we maintain long term value.

Little early to share a specific number but.

The goal is to.

Expand the team with the <unk>.

Right.

That's a five is approved and we will share additional updates in the future.

It made patients covered as possible.

And.

On the FDA side right now things are status quo for us in terms of our our dialog.

Hunter Murdock: On the FDA side, right now, things are status quo for us in terms of our dialogue and interactions across the various divisions that we engage with.

And David My mind, just repeat I think you had a question about cash flow positivity.

Hunter Murdock: On the FDA side, right now, things are status quo for us in terms of our dialogue and interactions across the various divisions that we engage with.

Dialog and interactions across the various divisions that we engage with.

Yeah, whether the 80, a anticipated salesforce expansion is already contemplated within the existing guidance for cash flow positivity.

Thank you. Our next question comes from the line of Madison, Our Saudi with B Riley's Securities. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Madison El-Saadi with B. Riley Securities. Please proceed with your question.

Yes, David it's Nick absolutely, it's contemplated we the way that we forecast our cash is assuming that everything is positive.

Hey, good morning, Thanks for taking my question and congrats on the quarter.

Madison El-Saadi: Hey. Good morning. Thanks for taking our question. Congrats on the quarter. On Auvelity and Sunosi as well, but more so Auvelity, are you seeing per-prescriber activity trending upward? Just trying to kind of get a sense of how much growth here is sensitivity to promotion versus more organic growth. Obviously, the sensitivity to promotions is great, but my sense is that there's also some organic growth here as well. If you could just comment, and then maybe a follow-up.

On mobility, and Sanofi as well, but more so ability.

As it relates to clinical and regulatory.

Are you seeing per prescriber activity trending upward.

It looks and then the additional associated costs with that's obviously on a launch you would had.

I'm, just trying to kind of get a sense of how much growth here is sensitivity to promotions versus.

It would be capital intensive for the first few quarters and then ultimately seeing an ROI.

More organic growth, obviously sensitivity to promotions is great.

So yes. The answer is we have already included that in our cash flow.

But my sense is that there's also some organic growth here as well.

Thank you. Our next question comes from the line of Troy Lankford with TD Cowen. Please proceed with your question.

If you could just comment and then maybe I'll follow up.

Hi, Thanks for taking my question and congrats on all the progress in the quarter just with respect ability approximately how many quarters do you think it will take to see an impact from the recently launched DTC campaign on prescriptions and do you think we're seeing sort of inflection in the current trajectory of prescriptions or do you think we'll see just more of a continued gradual upward trend.

Okay.

Yes, thanks for the question Matt.

Ari Maizel: Yeah. Thanks for the question, Madison. I guess the way that I would recommend sort of thinking about the growth is it's a function of two things: productivity amongst existing writers, so the number of prescriptions per existing writer, and then our ability to add additional new writers into the prescriber mix. For both brands, we're seeing those things come to fruition, which I think is a testament to the impact that these medicines are having on patients' lives, the positive reinforcement that these clinicians are hearing from their patients, and our team's ability to engage with them and educate them on a routine basis. Those are things that we'll continue to look to drive moving forward.

I guess the way the way that I would recommend and sort of thinking about the growth is.

<unk> two things productivity amongst existing riders.

Number of prescriptions per existing rider and then our ability to add additional new riders into the prescriber mix and for both brands we're seeing.

Okay.

Yes, Thanks, Troy for the question in terms of number of quarters, it's hard to predict exactly when.

The most significant impact from DTC will hit but one of the things that we're looking at is <unk>.

Things come to fruition, which I think is a testament to the impact that these medicines are having on patients' lives. The positive reinforcement that these clinicians are hearing from their patients and our teams ability to engage with them and educate them on a routine basis. So those are things that will continue.

Changes in our weekly new patient starts we have begun to see an increase in new patient starts in general.

To look to drive moving.

Moving forward.

Got it understood.

And then.

Madison El-Saadi: Got it. Understood. Secondly, we have four phase 3 trials planned to initiate this quarter. Just wondering on the cadence of those, should we think of these as almost parallel launches, or will these kind of come in a sequence throughout the remaining quarter? Thank you.

And we will continue to provide updates.

Secondly, so.

We have four phase III trials planned to initiate this quarter.

Thank you. Our next question comes from the line of Myles Minter with William Blair. Please proceed with your question.

Just wondering on the cadence of those should we think of these as almost parallel launches overall these kind of come and I think once throughout the remaining.

Oh, Hey, thanks for the questions just the first on the search API contract in ISR Pan <unk> coming online.

Quarter. Thank you.

Yes so.

With four phase III trials launching there are a lot of.

Myles Minter: Yeah. With four Phase 3 trials launching, there are a lot of moving parts from an operational perspective to make sure that that happens. It's very unlikely that they're all going to happen on the very same day. Do expect a natural cadence. It's nothing that we're preplanning. However, we are working towards and are on track for the initiation of those studies in Q4.

Herriot Tabuteau: Yeah. With four Phase 3 trials launching, there are a lot of moving parts from an operational perspective to make sure that that happens. It's very unlikely that they're all going to happen on the very same day. Do expect a natural cadence. It's nothing that we're preplanning. However, we are working towards and are on track for the initiation of those studies in Q4.

Moving parts from an operational perspective to make sure that that happens. So it's very unlikely that they are all going to happen.

Same day, so do you expect.

A natural cadence its nothing that were preplanning. However.

Marsh obviously.

Resigning.

Anything you can say about the confidence of the FDA as you work through the regulatory process on the state side. Thank you very much.

We are working towards and are on track for the initiation of those studies in the fourth quarter.

Hey, Myles I'll take the first one on GTR and I think it's too early to say where G. T N will land.

Thank you our last question will come from the line of Benjamin Brett with Wells Fargo. Please proceed with your question.

Operator: Thank you. Our last questions will come from the line of Benjamin Burnett with Wells Fargo. Please proceed with your question.

With additional with additional contracts no at hand, so, but we are pleased as we shared with with where we are with the improvement in GTS as well as the improvement in.

Hey, guys. This is Craig on for Ben So just a couple from us here.

Troy Langford: Hey, guys. This is Craig on for Ben. Just a couple from us here. Given your successful track record of getting products through the finish line, I'm curious, can you provide a little bit of color of how your regulatory interactions in regards to the SNDA for AXS and ADA have maybe differed from some of those past programs? I guess second question, in regards to narcolepsy, I feel like we're seeing a lot of estimates of the epidemiology of those indications kind of expanding and expanding further. Out of curiosity, what do you guys think is driving that? Are you seeing growth in IH, NT1, and NT2, any one particular area? Yeah. Any color there would be helpful. Thank you.

[Analyst] (Well Fargo): Hey, guys. This is Craig on for Ben. Just a couple from us here. Given your successful track record of getting products through the finish line, I'm curious, can you provide a little bit of color of how your regulatory interactions in regards to the SNDA for AXS and ADA have maybe differed from some of those past programs? I guess second question, in regards to narcolepsy, I feel like we're seeing a lot of estimates of the epidemiology of those indications kind of expanding and expanding further. Out of curiosity, what do you guys think is driving that? Are you seeing growth in IH, NT1, and NT2, any one particular area? Yeah. Any color there would be helpful. Thank you.

So given your successful track record of getting products through the finish line I'm curious can you provide a little bit of color of how your regulatory interactions in regards.

And the amount of lives covered in the formulary access so stay tuned for I don't know where that where we will land, but we will continue to.

S NDA for access.

Negotiate it in a similar fashion as we have previously ensuring that we maintain long term value.

Ada has maybe different from some of those past programs and I guess second question.

Guards to narcolepsy I feel like we're seeing a lot of estimates of the epidemiology of those indications kind of expanding and expanding further.

Right.

And many patients covered as possible.

And.

On the FDA side right right now things are status quo for us in terms of our.

<unk>.

Out of curiosity, what do you guys think is driving that and are you seeing growth and IH in tier one and two to any one particular area, yes any color there would be helpful. Thank you.

Dialog and interactions with was you know across the various divisions that we engage with.

Thank you. Our next question comes from the line of Madison, Our Saudi with B Riley Securities. Please proceed with your question.

I'll take the first part so it's ordinary course at the moment based on where we are in.

[Company Representative] (Axsome Therapeutics): I'll take the first part. It's ordinary course at the moment based on where we are in the cycle in terms of the submission for AXS-05 and AD agitation, so.

Herriot Tabuteau: I'll take the first part. It's ordinary course at the moment based on where we are in the cycle in terms of the submission for AXS-05 and AD agitation, so.

Hey, good morning, Thanks for taking my question and congrats on the quarter.

In the cycle.

In terms of the submission for eggs and providing education.

On <unk> and Sanofi as well, but more so ability or are you seeing a per prescriber activity trending upward.

Yes.

From an epidemiological perspective.

Ari Maizel: Yeah. From an epidemiological perspective for narcolepsy, you've got to look at the surveys that are done and the quality of those surveys. However, one aspect of the market that we've always pointed to is the fact that in this orphan indication, there is still a large percentage of patients who, one, have remained undiagnosed in the past, and secondly, who are treated. Certainly, as there is more interest in the space, as more products are being developed and coming to market, one would expect that there would be an increase in awareness, and maybe that's what you're seeing. Anything that you would add, Ari? No. I think you mentioned NT1, NT2, IH. I think that there's a lot of symptomatology overlap in different formalized diagnoses, which may muddy the waters a little bit.

For narcolepsy, you've got to look at the <unk>.

<unk> that are done.

I'm, just trying to kind of get a sense of how much growth here is sensitivity to promotions versus <unk>.

And in the.

The quality of the surveys.

However, one aspect of the market that we've always pointed to is the fact that in this orphan indication there is still a large percentage of patients who.

Organic growth, obviously, the sensitivity to promotions is great.

But my sense is that there's also some organic growth here as well.

If you could just comment and then maybe a follow up.

<unk> have remained on diagnosed in the past.

And secondly.

<unk> treated so certainly as there is more interest in this space.

Okay.

Yeah. Thanks for the question Medicine.

I guess the way the way that I would recommend and sort of thinking about the growth is you know it's a function of two things productivity amongst existing writers are sort of the number of prescriptions per existing rider and then our ability to add additional new riders into the prescriber mix and.

As more products are being developed.

And coming to market.

One would expect that there would be an increase in awareness and maybe thats what youre seeing.

Things that you would add.

No I think you mentioned you wanted to age I think that there is a lot of symptomatology overlap in different formalized diagnoses, which muddied the waters, a little bit but from our perspective, we feel good about our current estimates which is around 185000 people in the U S.

For both brands, we're seeing those things come to fruition, which I think is a testament to the impact that these medicines are having on patients' lives. The positive reinforcement that these clinicians are hearing from their patients and our teams ability to engage with them and educate them.

Ari Maizel: From our perspective, we feel good about our current estimates, which is around 185,000 people in the US suffering from narcolepsy, and that's what we're building our plans around.

<unk> from narcolepsy.

That's what we're building our plans around.

On a routine basis. So those are things that we'll continue to look to drive.

Thank you there are no further questions at this time I would now like to hand, the call back over to management for any closing comments.

Operator: Thank you. There are no further questions at this time. I would now like to hand the call back over to management for any closing comments.

Moving forward.

Got it understood.

Thank you.

And then.

And thanks, everyone. Thank you. Thank you to everyone for joining us this morning.

Secondly.

Ari Maizel: Thank you. Thanks, everyone. Thank you to everyone for joining us this morning. As we've highlighted today, Axsome delivered another strong quarter. We continue to drive robust growth across our commercial portfolio, and we are well-positioned to deliver significant long-term value through our advancing pipeline. We look forward to sharing our continued progress over the coming months. Thank you.

So we have four phase III trials planned to initiate this quarter.

As we've highlighted today axon delivered another strong quarter, we continue to drive robust growth across our commercial portfolio and we are well positioned to deliver significant long term value through our advancing pipeline. We look forward to sharing our continued progress over the coming months. Thank you.

Just wondering on the cadence of those should we think of these as almost parallel launches.

These kind of come and I think once throughout the remaining.

Quarter. Thank you.

Yeah. So.

Thank you. This does conclude today's teleconference. We appreciate your participation you may disconnect. Your lines at this time enjoy the rest of your day.

Four phase III trials launching there are a lot of moving parts from an operational perspective to make sure that that happens. So it's very unlikely that they're all going to happen on very same day. So do you expect.

Operator: Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

A natural cadence its nothing that were preplanning. However, we are working towards and on track for the initiation of those studies in the fourth quarter.

Thank you our last question will come from the line of Benjamin Brett with Wells Fargo. Please proceed with your question.

Hey, guys. This is Craig on for Ben So just a couple from us here.

So given your successful track record of getting products through the finish line I'm curious can you provide a little bit of color of how your regulatory interactions in regards.

S NDA for access.

<unk> has maybe different from some of those past programs and I guess a second question.

Guards to narcolepsy I feel like we're seeing a lot of estimates of the epidemiology of those indications kind of expanding and expanding further.

<unk>.

Out of curiosity, what what do you guys think is driving that and are you seeing growth and IH and Tijuana to any one particular area, yes any color there would be helpful. Thank you.

I'll take the first part so it's ordinary course at the moment based on where we are in.

In the cycle.

In terms of the submission for axis.

The excitation.

Yes.

From an epidemiological perspective.

For narcolepsy, you've got to look at the surveys that are done and <unk>.

Quality of the surveys.

However, one aspect of the market that we've always pointed to is the fact that in this orphan indication there is still a large percentage of patients.

One have remained on diagnosed in the past.

And secondly.

War treated so certainly as there is more interest in the space as more products are being developed and coming to market.

We would expect that there would be an increase in awareness and maybe that's what you're seeing anything that you would add.

No I think you mentioned and you wanted to I age I think that there is a lot of symptomatology overlap in different formalized diagnoses, which muddied the waters, a little bit but from our perspective, we feel good about our current estimates which is around 185000 people in the U S.

Suffering from narcolepsy and.

That's what we're building our plans around.

Thank you there are no further questions at this time I would now like to hand, the call back over to management for any closing comments.

Thank you and thanks, everyone. Thank you. Thank you to everyone for joining us this morning.

Thank you. This does conclude today's teleconference. We appreciate your participation you may disconnect your lines at this time.

For the rest of your day.

Yeah.

[music].

Q3 2025 Axsome Therapeutics Inc Earnings Call

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