Q2 2025 Axsome Therapeutics Inc Earnings Call

Operator: Good morning and welcome to the Axsome Therapeutics second quarter 2025 financial results conference call. Currently, 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 this call is being recorded. I will now turn the call over to Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Please go ahead.

Good morning, and welcome to the Axsome Therapeutics Therapeutic Second Quarter 2025 Financial Results Conference Call.

Darren Opland: Thank you and good morning, everyone. Thank you all for joining us for our second quarter 2025 earnings call. With me 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 join us for the Q&A portion of the call. This morning, we issued our earnings press release, providing a business update and details of the company's financial results for the second quarter of 2025. I encourage everyone to visit the investors page of our website to find our press release and the presentation related to today's call.

Thank you and good morning, everyone. Thank you all for joining us for our second quarter 2025 earnings call. With me 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 Murdoch, our General Counsel, will join us for the Q&A portion of the call.

This morning, we issued our earnings press release to provide a business update and details of the company's financial results for the second quarter of 2025.

Darren Opland: Before we begin, please note that today's discussion includes certain forward-looking statements regarding, among other things, the efficacy, safety, and intended utilization of our investable agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, commercial plans, and the possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations of future events that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.

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

Before we begin.

Please note, that today's discussion includes certain forward-looking statements regarding among other things. The efficacy safety and intended utilization of our investable agents.

Our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct in the source of future clinical trials, regulatory plans, future research and development, commercial plans, and the possible intended use of cash and investments.

These forward-looking statements are based on current information, assumptions, and expectations of future events that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward-looking statements.

Darren Opland: You are cautioned not to rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements. I will now turn the call over to Ari.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission. Including our quarterly and annual reports.

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

I'll now turn the call over to Ari Maizel.

Herriot Tabuteau: Thank you, Darren, and thank you all for joining us this morning. Axsome delivered a strong second quarter, reflecting focused execution across our commercial business and development pipeline. Demand for our in-market products saw robust growth, and we continue to advance multiple late-stage development programs targeting several important neuroscience indications with significant unmet needs and substantial market opportunities. We delivered total revenue of $150 million for the quarter, representing substantial double-digit year-over-year and sequential growth driven by our performance for both Auvelity and Sunosi. Nick and Ari will provide additional details on the accelerating dynamics for these important life-changing medicines. We are also excited to have recently launched Symbravo, our third approved product and our second product that has been developed wholly in-house.

Thank you, Darren, and thank you all for joining us this morning.

Axon delivered a strong second quarter, reflecting focused execution across our commercial business and development pipeline.

Demand for our in-market products saw robust growth, and we continue to advance multiple late-stage development programs targeting several important neuroscience indications with significant unmet needs and substantial market opportunities.

We delivered total revenue of $150 million for the quarter, representing substantial double-digit year-over-year and sequential growth, driven by outperformance for both Ovality and Sosi.

The Qunari will provide additional details on the accelerating dynamics for these important life-changing medicines.

Herriot Tabuteau: This launch represents a significant milestone for Axsome and for the millions of patients with migraine who desire new treatment options to manage the burdensome symptoms of this condition. Ari will comment on the early feedback on the product thus far. All in all, we are encouraged by the accelerating trajectory of our commercial portfolio. In parallel with the commercial progress, we continue to advance our innovative late-stage neuroscience pipeline. Last month, we hosted our Frontiers in Brain Health R&D Day with expert clinicians and key opinion leaders. The event showcased the breadth and depth of Axsome's potentially first-in-class or best-in-class pipeline, underscored the strengths of our clinical data, and highlighted our position at the forefront of neuroscience innovation. I will provide a brief update on the pipeline programs and upcoming milestones, starting with AXS-05 and Alzheimer's Disease Agitation.

We are also excited to have recently launched Sim Bravo, our third approved product and our second product that has been developed wholly in-house.

This launch represents a significant milestone for Axon and for the millions of patients with migraine who desire new treatment options to manage the burdensome symptoms of this condition.

Ari will comment on the early feedback on the product thus far.

All in all, we are encouraged by the accelerating trajectory of our commercial portfolio.

In parallel with the commercial progress, we continue to advance our innovative late-stage neuroscience pipeline.

Last month, we hosted our Frontiers in Brain Health R&D Day with expert clinicians and key opinion leaders.

The event showcased the breadth and depth of Axsome's potentially first-in-class or best-in-class pipeline, underscoring the strength of our clinical data and highlighting our position at the forefront of neuroscience innovation.

I will provide a brief update on the pipeline programs and upcoming milestones.

Herriot Tabuteau: We are on track to submit the NDA for AXS-05 and Alzheimer's Disease Agitation this quarter. This is a key priority for the organization, and we look forward to keeping everyone updated on our progress for this program. We also continue to make progress on our development plans for AXS-05 for the treatment of smoking cessation, with a Phase 2/3 trial expected to initiate in the fourth quarter of this year. Moving on to AXS-12, our novel product candidate for the treatment of narcolepsy with cataplexy. Progress continues in our NDA submission to the FDA, which is slated for the fourth quarter. In clinical trials to date, AXS-12 has demonstrated the potential to provide meaningful relief across multiple key symptoms of narcolepsy and to address a critical gap in care for this patient population.

Starting with AXS-05 and Alzheimer's disease agitation.

We are on track to submit the SNDA for AXS and Alzheimer's disease agitation this quarter.

This is a key priority for the organization, and we look forward to keeping everyone updated on our progress for this program.

We also continue to make progress on our development plans for AXS, so far for the treatment of smoking cessation, with a Phase 2/3 trial expected to initiate in the fourth quarter of this year.

Moving on to AXS-12, our novel product candidate for the treatment of narcolepsy with cataplexy,

Progress continues in our NDA submission to the FDA, which is slated for the fourth quarter.

Frustrated, the potential to provide meaningful relief across multiple key symptoms of narcolepsy.

And to address the critical gap in care for this patient population.

Herriot Tabuteau: For AXS-14 and fibromyalgia, we look forward to initiating a Phase 3 trial in the fourth quarter to address the FDA's feedback in the previously disclosed refusal to file letter. With more than 17 million people in the U.S. affected by this condition and with a paucity of approved treatments, we see a substantial opportunity for AXS-14 to transform the standard of care for these patients. Our Sunosi infantile development programs continue to advance across four potentially high-value indications: ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. In ADHD, we previously reported Phase 3 efficacy results in adults, and we plan to initiate a Phase 3 trial in pediatric patients in the fourth quarter. In MDD with excessive daytime sleepiness, we are taking a precision medicine approach based on the clinical presentation and underlying pathophysiology of MDD.

For excess 14 in fibromyalgia, we look forward to initiating a Phase 3 trial in the fourth quarter to address the FDA's feedback in the previously disclosed refusal to file letter.

With more than 17 million people in the U.S. affected by this condition.

And with a paucity of approved treatments, we see a substantial opportunity for AXS 14 to transform the standard of care for these patients.

I was already told that development programs continue to advance across four potentially high-value indications.

ADHD.

MDD with excessive daytime sleepiness.

Binge eating disorder and shift work disorder.

In ADHD, we previously reported Phase 3 efficacy results in adults, and we plan to initiate a Phase 3 trial in pediatric patients in the fourth quarter.

Herriot Tabuteau: This approach is supported by pilot data from our paradigm study, and we expect to initiate a Phase 3 trial in this patient population in the fourth quarter. Our engaged Phase 3 trial of Sunosi infantile and binge eating disorder continues to enroll and remains on track to read out next year. Binge eating disorder is the most common eating disorder, estimated to afflict over 7 million individuals in the U.S. With only one agent approved for this condition, it represents a high unmet medical need. The sustained Phase 3 trial of Sunosi infantile and excessive sleepiness associated with shift work disorder is also progressing, with top-line results also slated for 2026. With three innovative CNS medicines now on the market and multiple late-stage programs advancing toward registration, we continue to build a strong, durable foundation for continued growth and significant long-term value creation.

MDD with excessive daytime sleepiness. We are taking a precision medicine approach based on the clinical presentation and underlying pathophysiology of MDD.

This approach is supported by pilot data from our Paradigm study, and we expect to initiate a Phase 3 trial in this patient population in the fourth quarter.

Our engaged phase 3 trial of Authority amytal in bingeing disorder continues to enroll and remains on track to read out next year.

Engineering disorder is the most common eating disorder.

Estimated to afflict over 7 million individuals in the U.S.

With only one agent approved for this condition, it represents a high unmet medical need.

The sustained Phase 3 trial of Celerion for all and excessive sleepiness associated with shift work disorder is also progressing with topline results. It is also slated for 2026.

Herriot Tabuteau: With that, I will hand the call over to Nick Pizzie, who will provide details of our financial performance.

With three innovative CNS medicines now on the market and multiple late-stage programs advancing toward registration, we continue to build a strong, durable foundation for continued growth and significant long-term value creation.

With that.

I'll hand the call over to Nick, who will provide details of our financial performance.

Nick Pizzie: Thank you, Ari Maizel, and good morning, everyone. Our second quarter performance highlights the growing momentum of Axsome's commercial portfolio and our continued execution in bringing important medicines to patients. Total product revenues for the quarter were $150 million, driving an increase of 72% year-over-year and an increase of 24% quarter-over-quarter. Auvelity continues to demonstrate impressive growth. Net product sales were $119.6 million, up 84% versus last year and up 24% versus the previous quarter. Sunosi net product revenues were $30 million, up 35% versus last year and up 19% versus the previous quarter. Sunosi revenues in the quarter consisted of $28.9 million in net product sales and $1.1 million in royalty revenue associated with Sunosi sales in out-licensed territories. Symbravo was launched on June 10th and for this partial quarter generated net sales of $410,000.

Thank you, Ariel, and good morning, everyone. Our second-quarter performance highlights the growing momentum of Axsome's commercial portfolio and our continued execution in bringing important medicines to patients.

Total product revenues for the quarter were $150 million, driving an increase of 72% year-over-year and an increase of 24% quarter-over-quarter.

A validity continues to demonstrate impressive growth. Net product sales were $119.6 million, an increase of 84% versus last year and up 24% versus the previous quarter.

The nosy net product revenues were $30 million, up 35% versus last year and up 19% versus the previous quarter.

The nosy revenues in the quarter consisted of $28.9 million in product sales and $1.1 million in royalties, revenue associated with Senosi sales in the licensed territories.

Nick Pizzie: Auvelity and Sunosi gross net discounts for the second quarter were both in the mid-50s range. We continue to anticipate Auvelity and Sunosi GTNs will remain in this range for the remainder of the year. Symbravo gross net for the quarter was in the low 80% range. Turning now to expenses, total cost of revenue were $13.4 million compared to $8.1 million for the second quarter of 2024. Research and development expenses were $49.5 million for the second quarter compared to $49.9 million for the second quarter of 2024. The decrease was primarily related to the completion of solar infantile trials in ADHD and MDD, along with the completion of the AXS-05 trials in Alzheimer's Disease Agitation, which was partially offset by higher personnel costs. Selling, general and administrative expenses were $130.3 million compared to $103.6 million for the second quarter of 2024.

Some Bravo was launched on June 10th and, for this partial quarter, generated net sales of $410,000.

A validity and Sosi gross in that discounts for the second quarter were both in the mid-50s range.

We continue to anticipate developing Senosi. GT&S will remain in this range for the remainder of the year.

And, Bravo, gross enough for the quarter was in the low 80% range.

Turning now to expenses, the total cost of revenue was $13.4 million compared to $8.1 million for the second quarter of 2024.

Research and development expenses were $49.5 million for the second quarter compared to $49.9 million for the second quarter of 2024.

The decrease was primarily related to the completion of salary. Ethical trials in ADHD and MDD, along with the completion of the AXSO5 trials in Alzheimer's disease, that rotation was partially offset by higher personnel costs.

Nick Pizzie: The increase was primarily related to commercialization activities for Auvelity, including the expansion of the Auvelity sales force and expenses related to the commercial launch of Symbravo. Net loss for the second quarter was $48 million or $0.97 per share compared to a net loss of $59.4 million or $1.22 per share for the previous quarter and $79.3 million or $1.67 per share for the second quarter of 2024. The $48 million net loss for this quarter includes $24.6 million related to stock-based compensation expenses. We ended the second quarter with $303 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.

Selling, general, and administrative expenses were $130.3 million compared to $103.6 million for the second quarter of 2024.

Launch of Sabra.

Net loss for the second quarter was $48 million, or 97 cents per share, compared to a net loss of $59.4 million, or $1.22 per share, for the previous quarter, and $79.3 million, or $1.67 per share, for the second quarter of 2024.

The $48 million net loss for this quarter includes $24.6 million related to stock-based compensation expenses.

We ended the second quarter with $303 million in cash and cash equivalents compared to $315.4 million.

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

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.

Darren Opland: Thank you, Nick. The second quarter of 2025 marked Axsome's first with three marketed products, highlighted by the mid-June launch of Symbravo into the acute migraine market and continued strong demand growth for Auvelity and Sunosi. Our commercial infrastructure, powered by Axsome's proprietary digital-centric commercialization model, supported robust business performance in Q2 and enabled rapid market entry for Symbravo, with encouraging early signals of the product's potential. Starting with Auvelity, Auvelity delivered another strong quarter of growth, with increased new patient starts and continued expansion in prescriber engagement supported by our expanded sales force. Auvelity led the market in TRX growth, generating approximately 192,000 prescriptions in Q2, representing 15% quarter-over-quarter growth and 56% year-over-year growth. By comparison, the antidepressant market grew 2% sequentially and 1% compared to the second quarter of 2024.

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

Thank you, Nick.

The second quarter of 2025 marked Axsome's first with three markets, highlighted by the mid-June launch of Sim Bravo into the acute migraine market and continued strong demand growth for Ally and Senosi.

Our commercial infrastructure, powered by Axon's proprietary digital-centric commercialization model, supported robust business performance in Q2 and enabled rapid market entry for Sim Bravo, with encouraging early signals of the product's potential.

Starting with ality.

Ality delivered another strong quarter of growth, with increased new patient starts and continued expansion in prescriber engagement, supported by our expanded sales force.

Velleity led the market in TRX, generating approximately 192,000 prescriptions in Q2, representing 15% quarter-over-quarter growth and 56% year-over-year growth.

Darren Opland: Auvelity also led the market in new patient prescription growth, with nearly 30,000 new patients initiating Auvelity in the quarter, increasing the total number of patients treated with Auvelity since launch to nearly 220,000. A key growth driver in the quarter was the activation of approximately 4,800 new prescribers, with about half coming from the primary care setting, another positive index of product adoption. In addition to delivering strong prescription growth, Axsome made significant progress with market access for Auvelity in the quarter, with the addition of approximately 28 million new covered lives in the commercial channel starting July 1st. Auvelity coverage now stands at 83% of lives across all channels, including approximately 73% of commercial lives and 100% of government lives. Turning to Sunosi, total prescriptions in Q2 exceeded 50,000 for the first time, representing 9% sequential growth and approximately 13% growth versus Q2 of last year.

Like in comparison, the antidepressant market grew 2% sequentially and 1% compared to the second quarter of 2024.

A valid also led the market in new patient prescription growth, with nearly 30,000 new patients initiating therapy in the quarter.

Increasing the total number of patients treated with all validity since launch to nearly 220,000.

The key growth driver in the quarter was the activation of approximately 4,800 new prescribers, with about half coming from the primary care setting, another positive index of product adoption.

In addition to delivering strong prescription growth, Axsome made significant progress with market access for Allity in the quarter, with the addition of approximately 28 million new covered lives in the commercial channel starting July 1st.

Elalan coverage now stands at 83% of lives across all channels, including approximately 73% of commercial lives and 100% of government lives.

Turning to senosi.

Darren Opland: By comparison, the wake-promoting agent market grew 5.5% sequentially and increased by 5% compared to the second quarter of 2024. Payer coverage for Sunosi remains at approximately 83% of lives covered across channels. Finally, we are proud to have launched Symbravo in mid-June, offering patients with migraine an important new and novel multi-mechanistic treatment option. While still early, just six weeks into launch, feedback from the migraine community has been very encouraging, with initial patient experiences validating the differentiated profile of Symbravo as an effective, safe, and tolerable acute treatment for migraine. On the access front, we recently executed a commercial contract with one of the three largest group purchasing organizations, or GPOs, for potential formulary coverage of Symbravo. Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for Symbravo based on the contracted terms.

Total prescriptions in Q2 exceeded 50,000 for the first time, representing 9% sequential growth and approximately 13% growth versus Q2 of last year.

By comparison, the weight promoting agent Market, grew 5 and a half percent sequentially and increased by 5% compared to the second quarter of 2024.

Payer coverage for Senosi remains at approximately 83% of lives covered across channels.

Finally, we are proud to have launched Sim Bravo in mid-June, offering patients with migraine important new and novel multi-mechanistic treatment options.

While still early, just six weeks into launch, feedback from the migrant community has been very encouraging.

With initial patient experiences validating, the differentiated profile of sim Bravo as an effective, safe, and tolerable acute treatment for migraine.

On the access front, we've recently executed a commercial contract with one of the three largest group purchasing organizations, or GPOs.

For potential formulary coverage of a Sim Bravo.

Darren Opland: Current coverage for Symbravo is at approximately 38% of lives across all channels, including 26% of commercial lives. We anticipate coverage for Symbravo to expand and evolve throughout the rest of the year. In closing, the second quarter reflected significant growth in Axsome's product portfolio, highlighted by solid performance from Auvelity and Sunosi, the recent launch of Symbravo, and expansion of payer coverage to enhance patient access to our medicines. We expect continued strong commercial execution to drive momentum across the portfolio during the second half of the year. I will now turn the call back to Darren Opland for Q&A.

Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for Sim Bravo based on the contracted terms.

Current coverage for Sub Bravo is at approximately 38% of lives across all channels, including 26% of commercial lives.

We anticipate coverage for some Bravo to expand and evolve throughout the rest of the year.

In closing the second quarter, we reflected significant growth in Axsome's product portfolio, highlighted by solid performance from Validity and Senosi, the recent launch of Sim Bravo, and the expansion of payer coverage to enhance patient access to our medicines.

We expect continued strong commercial execution to drive momentum across the portfolio during the second half of the year.

Herriot Tabuteau: Thanks, Ari. We're ready to begin our Q&A now. We kindly ask that you limit yourselves to one question each so we can get through as many questions as possible. Thank you.

Thanks, Ari. We're ready to begin our Q&A now.

We kindly ask that you limit yourselves to one question each so we can get through as many questions as possible.

Thank you.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to be placed into question queue, 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 if you would like to move your question from the queue. Once again, we ask that you please ask one question, then return to the queue so we get through as many questions as possible. Our first question today is coming from Leonid Timashev from RBC Capital Markets. Her line is now live.

Thank you. We will not be conducting a question-and-answer session. If you'd like to be placed into the question queue, 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 if you'd like to move your question from the queue. Once again, we ask you to please ask 1 question, then return to the queue so we can get through as many questions as possible.

Analyst 1: Hey, thanks, guys. Thanks for taking my question. Congrats on the quarter. I wanted to ask a little bit more about the payer coverage expansion for Auvelity. First of all, given the large number of covered lives added, is this that third contracting organization? It sounds like gross to net is not expected to change for the quarter despite all the new covered lives. I am curious how you are thinking about the dynamic and how much volume we should expect to pull forward in the second half of the year. Thanks.

Our first question today is coming from the unit from RBC Capital Markets. Your line is now live.

Hey thanks guys. Thanks for taking my question and congrats on the quarter. Um, I want to ask a little bit more about the pair coverage expansion for a validity. Um, I guess, first of all, like given the large number of cover uh, covered lives added. Is this that third um, Contracting organization and then I guess it sounds like gross. Tonight's not expected to change for the quarter despite all the new covered lives. So I guess I'm curious how you're thinking about the dynamic. Um, and how much volume we should expect to pull forward. Um, in the second half of the year. Thanks.

Ari Maizel: Hey, Leo. Thanks for the question. Regarding the coverage, this actually represents pull-through of previously announced GPO contracts. We were successful at engaging with the pharmacy benefit managers within those previously announced GPOs to secure access for the product. So this is a really good signal of the strong work on our market access team. Too soon to share exactly what the volume expectation or volume growth will be. I think it's fair to sort of look at last year's major access win as perhaps an analog for what to expect in terms of demand for the product.

Hey, thanks for the question. Uh, regarding the coverage. Uh, this actually represents, pull through of previously announced, uh, GPO contracts. Um, and so we were successful at, um, engaging with the, the pharmacy benefits managers within those. Previously announced gpos, um, to secure access for the product.

Um, so this is a really good signal of the strong work on our Market Access team. Um,

Mark Jacobson: Yeah, as it relates to Auvelity GTN, we shared that we are in the mid-50s in Q2. We will see how the new 28 million lives are adjudicated. Obviously, utilization management will be significantly improved. Access to patients will be significantly improved. With that benefit, we are still able to maintain that mid-50s GTN for Auvelity.

You soon to, uh, to share exactly what the volume expectation or volume growth will be. Um, I think it's fair to sort of look at last year's, uh, major access when is perhaps an analog for, uh, what to expect in terms of demand for the product?

Yeah. And as it relates to um as it relates to a LG gtn, we we share that we are um in the mid-50s and in Q2 um and we will see how um these new the new 28 billion lives are adjudicated. Um, you know, obviously we'll uh utilization management. Uh we'll be significantly improved access to patients will be significantly improved. Um and with that benefit, we're still able to maintain that mid-50s, gtn for a validity

Analyst 1: Thanks, really appreciate it.

Thanks, really appreciate it.

Operator: Thank you. Next question is coming from Sean Lemmon from Morgan Stanley. Your line is now live.

Analyst 2: Good morning. Hope everyone's well, and thank you for taking my question. I have a question on AXS-12. If you could just frame out a little bit the market positioning against Oxybates and the potential Orexin 2 agonists coming, and what data might be included in your NDA filing package? Thank you.

Thank you. Next question is coming from Sean Lawman from Morgan Stanley. Your line is now live.

Uh, good morning. I hope everyone’s well, and thank you for taking my question. I have a question on Access 12. If you could just frame out a little bit the market positioning against Oxybate and, you know, the potential reaction to Agonist coming and what data might be included in your NDA filing package. Thank you.

Ari Maizel: Sure. Yeah, I'll start with the question. First of all, we're really optimistic about the potential profile of AXS-12 in narcolepsy. As we've shared previously, over 90% of patients report discontinuing their medication due to inadequate efficacy, side effect profiles, or recommendations from their HCPs to switch treatments. AXS-12 will be positioned as a rapid-acting narcolepsy treatment with significant reductions in cataplexy, improvements on areas such as excessive sleepiness and cognitive function, which we observed in our great placebo-controlled efficacy trials. I think one of the things that we've learned a lot about is that oftentimes sleep specialists are looking at combinations of treatments based on the unique patient presentation and where they're seeing issues as it relates to symptomatology. It's a little early to tell exactly how AXS-12 will be used relative to other products, but it's once daily dosing.

Treatments and so <unk> will be positioned as a rapid acting narcolepsy.

Narcolepsy treatment with significant reductions in cataplexy improvements on areas such as excessive sleepiness in cognitive function, which we observed in our agency book Controled efficacy trials.

One of the things that we've learned a lot about is that often times.

Sleep specialist or looking at combinations of treatment based on the unique patient presentation.

We're seeing.

Issues as it relates to symptomatology and so it's a little early to tell exactly how <unk> will be used relative to other products, but.

It's once daily dosing.

Ari Maizel: We are very optimistic that it will find a place in the treatment paradigm. As it relates to the Orexin, I think obviously a really great signal for patients and providers with the top-line results that were shared recently. There's not a ton of data shared, but some will want to monitor their additional data that's released, particularly as it relates to the side effect profile. Even with the Orexins, we feel confident based on feedback with KOLs that AXS-12 will have a meaningful place in the treatment paradigm.

We are very optimistic that it will find a place in the treatment paradigm and as it relates to the euro and I think obviously really great signal for for patients and providers with the top line results that were share recently.

Not a ton of data shared but.

Some will want to monitor.

Additional data that's release, particularly as it relates to the side effect profile, but even with Eurex and we feel confident based on feedback with kols that isn't as well we will have a meaningful place in the treatment paradigm.

Analyst 2: Thank you. What kind of data might be shared in the NDA package?

Thank you and any data you're able to to what what kind of data might be shared in the NDA package.

Ari Maizel: Hi, Sean. The NDA package is going to be comprised of the three control trials that we conducted. That is the Concert, Symphony, and Encore trials. All of those studies will be going into the NDA submission, including the long-term safety extension.

Hi, Sean so the NDA package is going to be comprised of the three.

Controlled trials that we conducted at the concert Symphony and Encore trial. So all of those all of those studies will be going into the NDA submission, including the long term safety extension.

Analyst 2: Wonderful. Thank you.

Wonderful thank you.

Operator: Thank you. Next question today is coming from Ami Fadia from Needham & Company. Your line is now live.

Thank you. Your next question today is coming from Amit <unk> from Needham <unk> Company. Your line is now live.

Hunter Murdock: Hi, this is Purnam for Ami Fadia. Thank you for taking our question. On Symbravo, could you provide some additional color on a sampling program? What has been the utilization of the drug through sampling and any trends that you are seeing for conversion of patients from the sampling to the prescription drug? Just in terms of the launch, are you seeing any initial barriers to access or launch in general with Symbravo, and what are the next steps in removing these barriers? Thank you.

Hi, this is going on for Amit. Thank you for taking my question.

One can Bravo could you provide some additional color.

Graham.

It's in the utilization of the drug to something any trends that you're seeing for.

Conversion of patients from the sampling for the prescription drug.

And just in terms of the launch are you seeing any initial values to access gunston Gemzar, that's available and what are the next steps in developing decided years. Thank you.

Ari Maizel: Yeah, thanks for the question. Regarding Symbravo, we do have a sampling program alongside a patient savings program for eligible commercially insured patients. In the early days, we are seeing nice utilization of both those programs. It is very common for migraine patients to start with the sample in order to gauge effective treatment prior to filling a prescription. We've been encouraged by what we've seen thus far, which is samples being accompanied by a prescription and then strong utilization of our patient savings program for commercially insured patients. In terms of overall access, as we mentioned on our release, we have secured coverage for the product, although it's still very early in the launch, and we expect that to continue to expand and evolve over the course of the year.

Yes. Thanks for the question so regarding some Bravo, we do have a sampling program alongside our patient savings program for eligible commercially insured patients and in the.

Early days, we are seeing nice utilization of both those programs.

So it is it is very common for migraine patients who start with example in order to gauge.

Second the treatment prior to filling a prescription.

We've been encouraged by what we've seen thus far.

Which is samples being accompanied by a prescription and then strong utilization of our patient savings program for commercially insured patients.

In terms of overall access you know as we mentioned.

On our release.

We have secured coverage for the product, although it's still very early in the launch and we expect that to continue to expand and evolve over the course of the year, but we are seeing covered claims in these early days, which is a positive signal of the access that we do have.

Ari Maizel: We are seeing covered claims in the early days, which is a positive signal of the access that we do have. Providing support through our patient savings program is a good supplement to the existing access that's in the market today.

Then providing support through our patient savings program.

It's a good supplement.

<unk> to the existing assets that's in the market today.

Hunter Murdock: Great. Thank you.

Great. Thank you.

Operator: Thank you. Next question is coming from Jason Gerberry from Bank of America. Your line is now live.

Thank you next question is coming from Jason <unk> from Bank of America. Your line is now live.

Analyst 1: Hey, guys. Thanks for taking my question. I guess mine's just on Symbravo revenue recognition. My sense was that both Q2 and Q3 would be light with the copay card. I guess the assumption that perhaps you wouldn't have the contracting up in place with the update that you're at nearly 40%. I'm just wondering, will the new start script, I presume, flow through with better, I guess, better gross to net assumption? Just wondering if you can walk us through the next couple of quarters, just how to think about revenue recognition and the script data that we're seeing. Thanks.

Hey, guys. Thanks for taking my question.

I guess, Mike just on.

And Bravo revenue recognition my sense was that both <unk> and <unk>.

Would be light with the copay card and I guess.

The assumption that perhaps you wouldn't have the contracting up in place with the update that you're at nearly 40% I'm just wondering will the new start script.

Presume flow through.

With better.

Better gross to net assumption I'm, just wondering if you can walk us through that.

The next couple of quarters, just how to think about revenue recognition and the script data that we're seeing thanks.

Ari Maizel: Thanks, Jason, for your call for the question. I will talk a little bit about RevRec specifically this quarter in Q2. It was a very short quarter with just about two weeks. Wholesalers did place their minimal stocking orders, their initial stocking orders in June. Any of those orders were recognized as revenue along with the GTN that we shared within the. That is around that 80% range. From that perspective, around the first scripts, Ari, do you want to share maybe a little bit about the NVRXs and how we are approaching them?

So thanks, Jason for your call for the question. So maybe I'll talk a little bit about the Rev. Rec specifically this quarter in Q2, obviously is the very short quarter with just about two weeks. So wholesale has been placed there.

We'll stocking orders or initial stocking orders in June.

So any of those orders were very recognized as revenue along with the GTA and as we shared in the ore that's around that 80% range.

From that perspective around the first Scripps argued wanted to share maybe a little bit about the <unk> and how we are approaching yes, Jason.

Mark Jacobson: Jason, as you know, for early launches, nearly all of the prescriptions are new patient starts. In the migraine market, it is a little bit different than the depression market in that refill rates are not quite as substantial because these are episodic episodes of migraine. They may be having anywhere from a few migraine attacks a month to up to a dozen or so. What we are monitoring is what the refill rate will develop over time. That said, we have started to see refills, but we expect that to be at a slightly lower velocity than what we see with Auvelity overall. In terms of the dynamics that you are referring to, we do have coverage today. We are seeing covered claims in the marketplace. That means that not all patients are relying on our copay support in order to fill the script.

No.

In the early launch is nearly all of the prescriptions are new patient starts in the migraine market is a little bit different than the depression market and then refill rates are not quite as substantial because these are episodic.

<unk> of migraine and so they may be having anywhere from few migraine attacks demand too.

Up to a dozen or so and so what we're monitoring is what the refill rate will develop over time.

That said, we are starting to see rebuilds.

But we expect them to be at a slightly lower velocity than what we see with our ability overall so in terms of the dynamics that you're referring to we do have coverage today, we are seeing covered claims in the marketplace.

So that means that they're not all patients are relying on our copay support.

Order to to build the script. It is still very early days and so that's something we'll continue to monitor.

Mark Jacobson: It is still very early days, and that is something we will continue to monitor. One other point that I will make is that we are seeing scripts flow through from across all the channels, so commercial, Medicare, Medicaid, and those dynamics will also evolve. I think we will have more to share on those dynamics as the year progresses.

One other point that I'll make is that we are seeing scripts flow through from across all the channels, So commercial Medicare and Medicaid.

And those dynamics will also evolve so we'll I think we'll have more to share on those dynamics.

The year progresses.

Analyst 1: Okay. Thank you, guys.

Okay. Thank you guys.

Operator: Thank you. Next question is coming from Steve Stavropoulos from Cantor Fitzgerald. Your line is now live.

Thank you next question is coming from Steve step of Polish from Cantor Fitzgerald. Your line is that right.

Hunter Murdock: Hi, good morning, and congrats on the execution, and thanks for taking my question. It is on AXS-05 in Alzheimer's Agitation. There is a clear mechanistic distinction and clinical profile for 05 versus antipsychotics. Rexulti's uptake has been relatively modest in Alzheimer's agitation. Given the differences in data and mechanisms, what are your expectations for adoption? Are you expecting it to mirror Rexulti, and how do you plan to drive uptake in the other various channels, if approved? Thank you.

Hi, good morning, and congrats on the execution and thanks for taking my question.

A <unk> 5 billion.

Agitation.

Theres, a clear mechanistic distinction and clinical profile for zero five persons Ambac psychotic.

<unk> uptake has been relatively modest in Alzheimer's agitation sort of given the differences in data and mechanisms what are your expectations for adoption.

You expect me to mirror.

And how do you plan to drive uptake in the various channels. Thank.

Thank you.

Ari Maizel: Yeah, thanks for the question, Steve. Obviously, we're following the Rexulti launch very closely, and we are seeing really nice demand, particularly in the Medicare channel. I think that bodes well for AXS-05. One of the key elements that you highlighted, the difference in terms of MOA, but what we're hearing from healthcare providers across the Alzheimer market is that the combination of strong efficacy alongside a really great safety and tolerability profile is what sets AXS-05 apart from the currently used, whether it's off-label atypical antipsychotics or Rexulti. We feel really optimistic, if approved, that this will make a tremendous impact on the marketplace. In terms of raising awareness, there will be some benefit to our existing Auvelity sales force in the sense that there's a large overlap in MDD and EDA prescribing, particularly among psychiatrists and primary care clinicians.

Yes, thanks for the question Steve.

We're following the rental fee launch very closely and we are seeing really nice demand, particularly in the Medicare channel. So.

I think that that bodes well for rigs and so by one of the key elements that you highlighted the difference in terms of MAA, but what we're hearing from health care providers across the cyber market is that the combination of strong efficacy.

Alongside a really great safety and Tolerability profile is.

Access those bonds apart from the currently use whether it's off label wondering if Iconix will result, and so we feel really optimistic.

Through that this will make a tremendous impact on the marketplace.

In terms of raising awareness there will be some benefit to our existing mobility sales force in the sense that there's a large overlap in MTBE in EDA prescribing, particularly among psychiatrists and primary care clinicians but.

Ari Maizel: We're also cognizant of the fact that we'll have to expand our promotional efforts to areas like geriatric psychiatry, neurodegenerative specialists, as well as long-term care facilities. That's something that we'll continue to work through as we prepare for a future launch. We feel really good about the potential for AXS-05 and the receptivity that it will have in the marketplace.

But we're also cognizant of the fact that we'll have to expand our promotional efforts to areas like geriatric psychiatry, neuro degenerative specialists as well as long term care facilities, and so thats something that will.

You need to work through as we as we prepare for our future launch, but we feel really good about the potential for <unk> five in the receptivity that it will have in the marketplace.

Operator: Thank you. Thank you. Next question today is coming from Ash Verma from UBS. Your line is now live.

Thank you.

Thank you next question today is coming from Ashwin <unk> from UBS. Your line is now live.

Hunter Murdock: Hi, thanks for taking your question. So on Auvelity, I am trying to understand if your GTN has stayed stable from Q1 to Q2. Then the 15% sequential growth that you have, what is driving the 24% net sales growth? Is that primarily inventory, or is there any other factor that is contributing to that? Thanks.

Hi, Thanks, Thanks for taking our questions so our mobility.

I'm trying to understand.

<unk> has stayed stable from <unk> to <unk> than the 15% sequential growth.

That you have what is driving the 24% net sales growth is that primarily and modality or is there any other factor thats contributing to that.

Ari Maizel: Sure. Thanks for the question, Nick. GTN did slightly improve. We were in the mid-50s range for both quarters, but did improve within that range from Q1 to Q2. Secondly, as you spoke about inventory, inventory remains around that two-week mark. That being said, with higher demand, there is obviously an inventory impact of an increasing revenue for Q2 versus Q1, again, maintaining at the Q2 two-week level. Tertiary, I would share that there is a small change of estimate from previous quarter as it relates to how we look at potential liabilities as of the end of Q1. We were favorable from that perspective. That also included in the revenue. To be clear, there is no inventory impact at all as it relates to Auvelity. It remains at that two-week level.

Sure. Thanks.

Thanks for the questions Nick.

So GCM did slightly improve we were in the mid <unk> range for both quarters, but did improve within that range from from Q1 to Q2.

I would say secondly, as you spoke about inventory inventory remains around that two week, mark but that being said with higher demand. There is obviously an inventory impact of an increasing revenue for Q2 versus Q1 again maintaining at the.

Q2.

Q2, two week level, and then tertiary I was sure that there is a.

A small change of estimate from previous quarter as it relates to how we look at.

<unk> liabilities as of the end of Q1.

We were.

Favorable from that perspective, so that is also.

Included in the in the in the brand new but to be clear there is no inventory impact.

At all as it relates to two abilities made that that two week level.

Hunter Murdock: Can you clarify potential change of liability for the previous net sales number, or is that?

So can you quantify potential changes liability somewhat tedious like net sales number or is that for sure.

Ari Maizel: Sure. Yeah, I could share that. It is going to be in the Q, which will file after the quarter, but it was less than a half a million dollars. That is related to any type of rebates that we would owe that is in channel within those two weeks. So we estimate that accrued as of the end of the quarter and then true it up the next quarter as typical, as any company would.

Sure that is going to be in the Q, which we'll file after the quarter, but it was less than $5 million.

And thats related to any type of rebates that we would owe that is in channel within those two weeks. So we estimate that accrued as of the end of the quarter and then true it up the next quarter.

That's typical as any company would.

Hunter Murdock: Thank you.

Thank you.

Operator: Thank you. Next question today is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.

Thank you. Your next question today is coming from Rama <unk> from H C. Wainwright. Your line is now live.

Analyst 1: Thanks so much for taking my question. With respect to Symbravo, I was just wondering if you could give us some additional color on how you expect both gross to nets, as well as coverage percentages, to trend over the course of the remainder of this year. Also, if you could comment on any color from physicians, as well as patients, regarding what you see as the main differentiator for this product relative to the other migraine products on the market. In other words, is this the efficacy in those patients who have historically proven intractable to management with other anti-migraine drugs? Is it the onset of action or some other factor? Thank you.

Yes.

Thanks, so much for taking my question.

With respect to some Bravo I was just wondering if you could give us some additional color on how you expect both gross to nets as well as coverage percentages to trend over the course of the remainder of this year and also if you could comment on any color from physicians as well as patients regarding what you see as the main differentiator.

For this product relative to the other migraine products on the market in other words is this the efficacy in those patients who have historically proven intractable to management with other anti migraine drugs.

The onset of action or some other factor. Thank you.

Ari Maizel: Yeah, hey, Ram, it's Nick again. I'll start with Symbravo and then related to the GTN and then hand it over to Ari. As I mentioned, Symbravo GTN was in that low 80 range for Q2. We expect it to remain high for the back half of the year. As Ari shared, Auvelity is out of the gate. We're making sure that patients receive product. So that will be likely a full buy down. As that proportion is still going to be high for the remaining part of the year, Auvelity to TRX, we would expect GTN to also remain high.

Yeah, Hey, Rob it's Nick again.

For I'll start with some rather than related to the gcs and then hand it over to Ari.

As I mentioned and Bravo GTO was in that low 80 range for Q2, we expect it to remain high for the back half of the year.

As already shared <unk>.

The game, we're making sure that patients receive products.

So that would be likely a full buy down.

That proportion is still going to be high for the remaining part of the year and <unk> is we would expect GTS to also re baseline alright.

Mark Jacobson: Yeah, related to some of the color from the clinicians and patients, I think first and foremost, the fact that Symbravo offers a multi-mechanistic approach to acute migraine treatment is very compelling. Most other products are only focusing on one particular pathway. Symbravo is focusing on two or more. Therefore, the idea of being able to attack the migraine attack in multiple ways is very compelling. I will say anecdotally, one of the things that we're hearing from early patient experience is the rapid onset of action and durability of response, which has come through loud and clear from folks who have tried it thus far. In terms of the patient types, what we're hearing early on is partial triptan responders. Folks who are getting some relief but not feeling totally better or lacking in pain freedom is a key patient type that Symbravo has been used for.

And related to some of the color from the clinicians and patients I think first and foremost the fact thats been Bravo offer the multi mechanistic approach to acute migraine treatment is.

He is very compelling.

Most other products are only focusing on one particular pathway.

And Bravo is focusing on two.

Two more in there.

Therefore, the idea of being able to attack the migraine attack in multiple ways is very compelling and I will say anecdotally one of the things that we're hearing from early patient experience is the rapid onset of action and durability of response.

Come through loud and clear from folks who have tried it thus far in terms of the patient types.

What we're hearing early on is.

Partial triptan responders folks who are getting some relief, but not feeling totally better we're lacking in pain freedom.

The key patient type that <unk> has been used for <unk>.

Mark Jacobson: Also, patients that have had a good response to a triptan-NSAID combo but are looking for the utility of a single product to sort of minimize some of the pill burden. That is another area that we've heard very early on. Again, I would just say that it is still very early in the launch. I anticipate that there will be additional patient types to break through. As we know, there's a ton of dissatisfaction amongst patients in this market. Despite the fact that there are multiple options available, there's still a lot of breakthrough symptoms or tolerability issues that really position Symbravo as a great option.

Also patients that have had good response to a triptan <unk> combo.

We are looking for the utility of a single product.

Minimize some of the pill burden that is another area that we've heard very early on.

But again I would just say that is still very early in the launch I anticipate that there will be additional patient types to break through and as we know there is a ton of dissatisfaction amongst patients in this market. Despite the fact that there are multiple options available. There is still a lot of breakthrough symptoms or tolerability issues there.

<unk> really positions in ramp mode.

It's a great option.

Analyst 1: Thank you.

Thank you.

Operator: Thank you. Next question today is coming from Marc Goodman from Leerink Partners. Your line is now live.

Thank you. Your next question today is coming from Marc Goodman from Leerink Partners. Your line is now live.

Analyst 3: Ari, can you talk about your strategy for this precision medicine approach to ADHD? Does that carry over into the adolescents as well as the adults? How do you plan to move forward with this?

Eric can you talk about.

The strategy for this precision medicine approach to ADHD.

That carryover into.

And to that of lessons as well as the adults.

<unk>.

Cause it to move forward with us.

Sure.

Hunter Murdock: Thanks for the question, Mark. The precision medicine approach that we refer to relates to Sunosi for major depressive disorder. We know that there are different patient types in depression. This is a way of targeting the pathophysiology or one of the aspects of the pathophysiology of MDD, which relates to sleep quality. Some patients either experience excessive sleepiness and others might experience insomnia. That is the precision medicine approach. It is based on looking at the clinical presentation as well as the underlying pathophysiology. As it relates to the other part of your question on ADHD, we do know that there is a continuum of the disease from when patients have it as children into adulthood. We have demonstrated efficacy in adult patients. We think that goes obviously really well for demonstrating efficacy in the pediatric population. That would be both children as well as adolescents.

Thanks.

The question Mark So the precision medicine approach that we've referred to relates to <unk> for major depressive disorder, and we know that they have.

Or different patient types in depression.

So this is.

Way of targeting the pathophysiology or one of the aspects of the pathophysiology of Mds.

Which relates to the quality and.

Either some patients either experience excessive sleepiness and others.

My experience.

So that's the precision medicine approach.

Based on looking at the clinical presentation as well as the underlying pathophysiology.

As it relates to your question on the other point of your question with ADHD.

So.

There, we do know that there were.

As a continuum of of of.

Of the disease from when patients have it.

As children into adulthood, so we've demonstrated efficacy in adult patients.

And we think that that bodes obviously really well for demonstrating efficacy in the pediatric population that would be both children as well as adolescence.

Okay.

Operator: Thank you. Next question is coming from David Amsellem from Piper Sandler. Your line is now live.

Thank you next question is coming from David <unk> from Piper Sandler. Your line is is that a lot.

Ari Maizel: Thanks. On Auvelity and MDD, can you talk to the mix between second and third-line usage and even the extent to which you are getting flat-line usage? Also, with your comments on greater utilization among general practitioners, it sort of begs the question, do you think you need to expand the sales force to better target a broader audience of general practitioners? How are you thinking about that? Thank you.

Thanks Valerie.

And can you talk to the mix between second and third line use.

And even the extent to which you are getting frontline usage and also with your comments on greater utilization among general practitioners.

Sort of begs the question do you think you need to expand the sales force to.

Better target a broader audience of general practitioners, how are you thinking about that thank you.

Mark Jacobson: Yeah, thanks for the questions. We saw continued stability in terms of early-line usage for Auvelity at approximately 50%, really no change. It's sort of the second-third-line dynamic. We are comfortable with that. I think we've shared previously that one of the benefits of Auvelity is that it has strong effectiveness regardless of prior treatment experience. That said, as access improves and utilization management evolves, we expect early-line usage to continue to grow, particularly as we are able to penetrate the primary care market. We've seen nice growth in the primary care market. I think we are very comfortable with the size of our sales force right now. This quarter really underscored the impact of that sales force expansion earlier this year. We started seeing an inflection in new patient starts late Q1 that continued throughout Q2, which will impact the TRXs over the course of the year.

Yes, thanks, thanks for the questions.

We saw continued stability in terms of early line usage for our ability at approximately 50%.

Really no change, it's sort of the second third line dynamic.

We're comfortable with that and I think we've shared previously that one of the benefits of mobility is that it has strong effectiveness regardless of prior treatment experience.

That said as access improves and utilization management.

We expect early line usage to continue to grow particularly.

As we're able to penetrate the primary care market.

We've seen nice growth in primary care market and I think we're very comfortable with the size of the sales force right now this quarter really underscored the impact of that sales force expansion earlier this year.

<unk> seeing an inflection in new patient starts late Q1 that continued throughout Q2.

Which will impact the Trs is over the course of the year. So I think we're comfortable where we are right now and we will continue to monitor the market dynamics to evaluate for the future.

Mark Jacobson: So I think we are comfortable with where we are right now. We will continue to monitor the market dynamics to evaluate for the future.

Ari Maizel: Thanks.

Thanks.

Operator: Thank you. Next question today is coming from Cerena Chen from Wells Fargo. Your line is now live.

Thank you. Your next question today is coming from Serena Chen from Wells Fargo. Your line is now live.

Analyst 4: Great. Thanks for taking my question. I had a question on AXS-05 for AD agitation. Just wanted to know when was the last time you heard from the current FDA administration that the data package for AD agitation is sufficient? Thank you.

Great. Thanks for taking my question.

I had a question on <unk> 480 application just wanted to know when was the last time you heard from the current administration that the data package for.

Application sufficient thank you.

Ari Maizel: Hi, Cerena Chen. Good morning. We had announced earlier this spring our pre-NDA meeting minutes where we aligned with the FDA on the submission. Since then, we've been completing the build of the submission, which is on track for this quarter.

Thanks, Ryan and good morning, we had announced a few earlier in the spring our pre NDA meeting minutes.

Where are we aligned with the FDA on on the submission and since then we've been completing the build of the submission which is on track.

For this quarter.

Analyst 4: Okay. Thanks.

Okay. Thanks.

Operator: Thank you. Next question is coming from Andrew Tsai from Jefferies. Your line is now live.

Thank you. The next question is coming from Andrew Tsai from Jefferies. Your line is now live.

Analyst 1: Hey, guys. This is John on for Andrew. Thanks for taking the question. If we fast forward in 9 to 12 months or so, how are you thinking about the commercial strategy for AXS-05 in terms of penetrating community centers or long-term care? Is there any low-hanging fruit from the very beginning? Also, thinking about if there was a potential add-com based on your prior FDA discussions, what would be the key talking points that the FDA would want to discuss in your view?

Hey, guys. This is John on for Andrew Thanks for taking the question.

So if we fast forward in nine to 12 months or so how are you thinking about the commercial strategy for <unk>.

In terms of penetrating like community centers or long term care is there any low hanging fruit.

From the very beginning and then also thinking about if there was a potential AD com based on your prior to FCA discussion. So what would be the key talking points that the FDA would want to discuss in your view.

Mark Jacobson: Yeah, I'll start with the commercial strategy question. It's a little early to share too many details, but obviously, we track the utilization of Alzheimer's Disease Agitation prescriptions across both outpatient and long-term care facilities. We have a really good idea of where the majority of these patients are being treated and which providers are most active in the space. Part of our commercial strategy will be to be really focused, like we've done with all of our products, and highly targeted on the highest SI or highest value prescribers within a particular space. I expect that that would be maintained for an ADA launch.

Yes, I'll start with the commercial strategy question, Yes, it's a little early to share too many details, but obviously, we track utilization of Alzheimer's disease agitation prescriptions across both alopecia and long term care facilities until we have a really good idea of where.

Sure.

The majority of these patients are being treated in which providers are most active in the space and so.

Part of our commercial strategy will be to be really focused like we've done with all of our products and highly targeted on the highest desai, our highest value prescribers within a particular space.

Then.

<unk> maintained for a <unk> launch.

Ari Maizel: With respect to a potential advisory committee, we have not received any indication that the FDA is looking to hold one. However, that is always something they notify you upon potential acceptance of a filing. As a reminder, there was not one held for Auvelity in MDD. The psychiatry division did hold one for the product Rexulti in the indication where they talked about a number of things, endpoints, the scale used, which is the same scale that we use, etc. It is really hard to speculate. Again, we are not aware of one at this time and have not received communication of such. If there were one to occur, we would be ready for it.

And then with respect to a potential advisory committee, we've not received any indication.

But the FDA is looking to all one however that that's always.

Something they notify you upon potential acceptance of a filing.

Yeah.

As a reminder, there was not one held for mobility and MDT.

And the.

The Psychiatry division did hold one for the product that they.

For <unk> indication, where they talked about a number of things endpoints. The scale used which is the same scale that we use et cetera. So it's really hard to speculate but again, we're not aware of one at this time.

Haven't received communication of such and.

But if there were wanted to occur we'd be ready for it.

Analyst 1: Great. Thank you so much.

Great. Thank you so much.

Operator: Thank you. Next question today is coming from Joon Lee from Truist Securities. Your line is now live.

Thank you. Our next question today is coming from Joon Lee from <unk> Securities. Your line is now live.

Analyst 4: Congrats on the quarter, and thanks for taking the question. This is Asim Rana on for Joon Lee. On smoking cessation, bupropion is already approved for smoking cessation. Are there any plans to conduct a head-to-head study of AXS-05 against Wellbutrin? Thank you.

Congrats on the quarter and thanks for taking the questions. This is awesome run on for June.

Smoking cessation.

The propane is already approved for smoking cessation are there any plans to conduct a head to head study of <unk> against <unk>. Thank you.

Okay.

Hunter Murdock: Thanks for the question. AXS-05 does combine two axes. Therefore, in order for the product to be approved, there does need to be demonstration of component contribution. By definition, a registration study would involve a bupropion arm.

Thanks for the question.

So <unk> five.

Those combined to access and therefore.

In order to put the product to be approved there does need to be demonstration of component contribution. So by destination a registration study would involve the bupropion arm.

Analyst 4: Thank you. Can you just remind us when the sales force split across the three commercialized products?

Thank you and then can you just remind us on the sales force split across the three commercialized products.

Ari Maizel: Yeah. Yeah. So we have three distinct sales forces for each product and approximately 300 representatives on Auvelity and approximately 100 each for Sunosi and Symbravo.

Yes.

Yes, so we have three.

Three distinct sales forces for each product.

And approximately 300 representatives on our ability.

100, each for Sanofi and some Bravo.

Analyst 4: Thank you.

Thank you.

Operator: Thank you. Our next question today is coming from Yatin Suneja from Guggenheim Partners. Your line is now live.

Thank you. Our next question today is coming from Jaap <unk> from Guggenheim Partners. Your line is now live.

Analyst 2: Hey, guys. Thank you for taking my question. Very nice quarter. Just a question on Auvelity and the MDD dynamic. Obviously, you have DTC ongoing. There is a sales force expansion. I am just curious to understand from you, how should we think about the inflection that we should get, when exactly we should anticipate the inflection, and what level of step changes we should be expecting during these two dynamics? If you can also comment on the duration that you are seeing in the marketplace, thank you.

Hey, guys. Thank you for taking my question very nice quarter, just a question on.

On <unk> and the <unk> dynamic coming out of this thing.

DTC ongoing sales force expansion. So I'm just curious to understand from you.

Should we think about the inflection that we should get.

When exactly we should anticipate the infection and what level of step changes, we should be expecting given those two dynamics.

Can also comment on good duration that youre seeing in the marketplace.

Ari Maizel: I missed the last part, but duration.

I missed the last part but duration.

Analyst 2: The last is on the duration. Yeah, last on duration.

Last year, when the duration, yes lots of growth.

Ari Maizel: Okay. Thanks so much. Yes. In terms of Auvelity and MDD, obviously, we are very pleased with the performance so far this year. One correction I will make is, you know, although we have not launched a national DTC campaign, we are expecting to later this year. That is not currently reflected in our demand trends. I just want to make sure you are aware of that. In terms of the inflection regarding sales force expansion, as I mentioned, we began to see an inflection in new patient starts towards the end of Q1 that continued in Q2. Generally speaking, that is the leading indicator for TRX demand growth or increase in trajectory. We will be paying close attention to performance in the back half of the year. We would expect there to be continued growth progress over the course of the year.

Okay. Thanks, so much yeah. So in terms of <unk>, obviously, we're very pleased with the performance so far this year.

One correctional naked.

Although we have we have not launched the national DTC campaign, we are expecting to later this year.

But that is not currently reflected in your demand trends. So just want to make sure you are aware of that.

In terms of the inflection regarding sales force expansion as I mentioned, we began to see an inflection in new patient starts.

Towards the end of Q1 and that continued in Q2 generally speaking that is the sort of leading indicator for hearings demand growth or increase in trajectory and so we'll be paying close attention to your performance in the back half of the year.

But we would expect there to be continued growth progress over the course of the year.

Ari Maizel: Once we launch DTC, we expect that to be incremental growth to the current trends. In terms of giving you a specific estimate in terms of step change, I think it is a little too premature, particularly because we are announcing this access when starting in July. You can imagine that the totality of sales force expansion, improved access, and then DTC later this year will provide incremental growth rate for the brand. In terms of duration, we are seeing somewhere around six to seven prescriptions over the course of the year on average. Obviously, some patients respond well to the treatment and refill every month. Others that may have inadequate response or drop out of treatment based on achieving remission. On average, it is somewhere around six or seven.

And then once we launched GTC, we expect that to be incremental growth.

Is that occurring trends.

But in terms of giving you a specific estimate in terms of step change I think it's a little too premature.

Particularly because we're announcing this access win starting in July you can imagine that the totality of Salesforce expansion improved access and then DTC later this year and will provide incremental growth rate for brands.

And in terms of duration, we're seeing somewhere around six 6% to seven prescriptions over the course of the year on average obviously some patients.

Respond well to the treatment and refill every months others that may have inadequate response.

Hopped out of treatment based on achieving remission, but on average it's somewhere around six or seven.

Operator: Thank you. Next question today is coming from Joseph Tomi from TD Cowen. Your line is now live.

Thank you. Your next question today is coming from Joseph told me from TD Cowen. Your line is now live.

Analyst 1: Hi there. Good morning. Thank you for taking my question and congrats on the progress. Maybe on the pediatric ADHD study, can you go into a little bit more detail about what that trial will look like? It seemed like the presenting KOL at your analyst day had some opinions on that. Maybe go into a little bit more detail on a prior response. What specifically gives you confidence from the adult data we saw earlier this year that Symbravo will be active in pediatric patients? Tangentially, this trial seems to have taken a little bit of time to get off the ground. I guess, how confident are you in that Q4 guidance? Is there anything specific about the pediatric population versus adults in terms of IRB timing or anything like that that makes this a little bit more challenging? Thank you.

Hi, there good morning. Thank you for taking my question and congrats on the progress maybe on the pediatric ADHD study can you go into a little bit more detail about what that trial will look like two months presenting <unk> at your analyst day had excellent opinions on that.

Maybe go into little bit more detail on our prior response, what specifically gives you confidence from the adult data. We saw earlier this year that's oriented toll will be active in pediatric patients.

And then potentially this trial seems to have taken a little bit of time to get off the ground. It gets how confident are you in that Q4 guidance and is there anything specific about the pediatric population versus adult in terms of timing or anything like that that makes us a little bit more challenging. Thank you.

Hunter Murdock: Great. Thanks for the question. As it relates to the pediatric study, we anticipated that that would be a standard parallel group design. One of the differences between the adult and pediatric studies is a difference in the scale. We would be using a pediatric scale as opposed to the adult study, which is an adult scale. In terms of what gives us confidence that the adult data will translate into the pediatric data, nothing is guaranteed. We are conducting clinical trials in order to test hypotheses. If you look at other drugs for ADHD, which have been active in patients, they have been active in both adults as well as pediatric patients. Biologically, that would make sense since adult patients must have been diagnosed with ADHD as children. That is part of the diagnostic criteria.

Great. Thanks, Thanks for the question.

As it relates to the pediatric study, we anticipated that would be a standard parallel group design.

One of the differences between the adult and pediatric studies as a difference in the scale. So we'd be using a pediatric scale as opposed to the adult study, which you know.

<unk> scale and in terms of what gives us confidence that the adult data will translate into pediatric data well, we're conducting clinical trials in order to test hypotheses. So.

Nothing is guaranteed but.

If you look at other drugs for ADHD, which had been active.

Inpatients.

<unk> been active in both adults as well as pediatric patients and biologically that would make sense since adult patients.

Must have been diagnosed with ADHD.

As children.

The diagnostic criteria.

Hunter Murdock: As it relates to the timing of the start of the study, there is a layer of complexity when dealing with pediatric patients. We want to make sure that we have perfect alignment with the agency as it relates to the design of any trial in a pediatric population.

And as it relates to one.

The timing of the start of the study.

<unk>.

There is.

The layer of complexity when dealing with pediatric patients. So we want to make sure that we have perfect alignment with the agency as it relates to the design of each any trial in pediatric population.

Operator: Thank you. Next question is coming from Matthew Hirschenhorn from Oppenheimer. Your line is now live.

Thank you next question is coming from Matthew Herszenhorn from Oppenheimer. Your line is now live.

Analyst 3: Hey, guys. Thanks so much for taking the question. Ahead of the potential launch for AXS-12 next year, could you just talk about how you could leverage your current commercial capabilities in narcolepsy with Sunosi? How do you think about your overall strategy in narcolepsy with both Sunosi and AXS-12, especially as you think about competitive dynamics in polypharmacy? Really appreciate it.

Oh, Hey, guys. Thanks, so much for taking the question.

Ahead of the potential launch for excess 12 next year could you just talk about how you could leverage your current commercial capabilities in narcolepsy with Sanofi and how do you think about your overall strategy in narcolepsy with both Sanofi and excess 12, especially as you think about competitive dynamics and polypharmacy really appreciate it.

Mark Jacobson: Yeah, thanks so much for the question. There is near perfect overlap in terms of the targets for AXS-12 and Sunosi. We will be able to leverage our current Sunosi team fully for an AXS-12 launch. So it is a real synergistic opportunity for us as a company. As it relates to positioning, as I mentioned in my earlier comments, we see a lot of polypharmacy in the space as clinicians seek to optimize treatment based on the unique symptomatology that patients present with. I think, in some ways, the fact that AXS-12 and Sunosi will have distinct indications, you may see some combination use. But I think it is a little too soon to tell. Clinicians are going to want to sort of weigh in based on final label, etc.

Yes, thanks, so much for the question.

There is near perfect overlap.

In terms of the targets for excess <unk> 12, and <unk> and so we will be able to leverage our current <unk> team.

Fully four exits bulb launch so.

A real synergistic opportunity for us as a company as it relates to position you as I mentioned in my earlier comments.

We see a lot of polypharmacy in the spaces.

Clinicians.

<unk> optimized treatment based on the unique symptomatology that patients present with.

I think in some ways. The fact that there's 12 and Sanofi will have distinct indications.

You may see some combination use.

I think it's a little too soon to tell clinicians are going to want to sort of weigh in based on final label et cetera, but we feel very optimistic.

Mark Jacobson: But we feel very optimistic, and we have heard a lot of enthusiasm for the potential benefit of both products in patients. So like the other treatments that exist, we expect there to be a whole variety of combinations used of the currently approved treatments.

We've heard a lot of enthusiasm for the potential benefit of both products in patients and so like the other treatments that exist, we expect there'd be a whole variety of combination use.

Currently approved treatments.

Operator: That's helpful. Thanks so much. Thank you. Next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.

That's helpful. Thanks, so much.

Thank you next question is coming from Greg So, but I was just from Mizuho Securities. Your line is now live.

Analyst 1: Hey, good morning. Thank you for taking my questions. Across your three products that are now commercial stage, what should we expect with respect to summer seasonality as we think about Q3 sales? Secondly, if I could ask, could you just remind us again your assumptions or expectations around the potential for IRA pricing, especially for Auvelity, and what your current thinking is around timing of when Auvelity might be for such negotiations or discussions? Thanks.

Hey, good morning, Thank you for taking my questions.

Just across your three products that are now commercial stage, what should we expect with respect to summer.

Seasonality as we think about third quarter sales and then secondly, if I could ask could you just remind us again.

Your.

Assumptions or expectations around the potential for IRR pricing, especially for our ability and kind of what your current thinking is around timing of when ability might be.

Such negotiations or discussions thanks.

Mark Jacobson: I will start with the seasonality question. There is summer seasonality across all three of the markets that we are currently in. I think in some ways, depression is perhaps the most pronounced. Obviously, we expect with Symbravo, because it is early in launch, that you may not observe true seasonality effect as the brand is growing from a relatively low base. But there is some seasonality effect in the summer months across migraine, EDS, and depression.

Yes, I'll start with the seasonality question.

There is summer seasonality.

Really across all three of the markets that we're currently in.

Think in some ways depression is perhaps the most pronounced.

Obviously, we expect Woodson Bravo because it's early in launch that you may not observe true seasonality effect as the brand is growing from a relatively low base.

But there is some seasonality effect in the summer months across migraine.

<unk> in depression.

Analyst 3: As for Auvelity, and you mentioned IRA pricing, it's presumably related to ADA. Again, ADA will be priced at the same WAC price as Auvelity. It is Auvelity. It's only $1,177 at the current WAC price. As a reminder, I think we would be up for negotiation somewhere around 2029, 2030 with a potential implementation in that 2031, 2032 range.

Yes, and as for the LD and Mr IRA pricing presumably related to.

Again, <unk> will be priced the same WAC price as ability.

So the $177 in the current WAC price and as a reminder, we will be up for negotiations somewhere around 42009 2030 with the potential implementation of $31 32 range.

Mark Jacobson: Thank you.

Thank you.

Operator: Thank you. The next question is coming from David Hoang from Deutsche Bank. Your line is now live.

Thank you next question is coming from David Ho from Deutsche Bank. Your line is now live.

Analyst 3: Hey, this is Sam on for David. Thanks for taking the question. On Sunosi, anything you all would highlight on what drove the strong quarter and specifically as it relates to the patient mix between narcolepsy and OSA? As a follow-on to a prior question on Auvelity, do you feel the need to further increase covered commercial lives from here? Thanks.

Hey, this is Sam on for David Thanks for taking the question.

<unk> anything you would highlight what drove the strong quarter and.

Specifically as it relates to the patient mix between narcolepsy and OSA.

And as a follow on to a prior question on them.

Do you feel the need to further increase covered commercial lives from here. Thanks.

Thanks.

Mark Jacobson: Yeah, thanks, Sam, for the question. Regarding Sunosi, nothing noteworthy regarding the mix of patients, narcolepsy versus OSA. We did see very strong growth in prescribers this quarter and active writers in the quarter. Not only did we have a higher number than previous quarter, but they were also more productive, meaning they were prescribing more Sunosi than in previous quarters. I think this really reinforces our strategy to drive depth of prescribing within the existing EDS marketplace for HCPs. I apologize.

Yes, thanks to answer the questions regarding Sanofi nothing noteworthy regarding the mix of patients narcolepsy versus the OSA.

We did see very strong growth in prescribers this quarter and then active riders in the quarter.

Not only did we have a higher number than previous quarter, but they were also more productive meeting they were more they were prescribing.

Prescribing more Sanofi.

And then in previous quarters, So I think thats really reinforces our strategy to drive depth of prescribing then.

Listing eds.

Marketplace for <unk>.

<unk>.

And then I apologize youre sort of the commercial lives.

Analyst 3: As far as the commercial lives.

Mark Jacobson: Yeah. So on the commercial lives, obviously, we are very pleased with the announcement for today. We are at 83% covered lives in total. Our goal is to get to as much of the insurance market as possible. We believe we still have work to do, and our expectation is that we continue to add additional coverage as time goes on.

So on the commercial lives obviously, we're very pleased with.

<unk> for today.

We're at 83% covered lives in total and our goal is to get to as much of the bill.

The insurance market as possible. So we believe we still have work to do in orientation is that we continue to add additional coverage.

As time goes on.

Analyst 3: Great. Thank you.

Great. Thank you.

Operator: Thank you. Our final question today is coming from Myles Minter from William Blair. Your line is now live.

Thank you. Our final question today is coming from Myles Minter from Blair. Your line is now live.

Analyst 2: Hi, guys. Thanks for squeezing me in. Just one on Sunosi and ADHD and the comment to receive perfect alignment with the regulators. I am curious as to why you think that a single trial in pediatric and adolescent population would be sufficient for potential approval here, as opposed to the guidance which keeps kind of bringing up that two positive pediatric studies, one of which could be done in adolescents, would be required for approval here. Just wondering whether you have received alignment with the agency based on that. Thanks very much.

Hi, guys. Thanks for squeezing me in just one on <unk> and the comment service a perfect alignment with the regulators.

I'm curious as to why you think that a single trial in pediatric and adolescent population.

They are sufficient for potential approval here as opposed to the guidance, which keeps kind of bringing up the positive pediatric studies, one of which could be done in adolescence with favorite quad for approval here just wondering whether you for safe to alignment with the agency based on that thanks very much.

Hunter Murdock: Sure. We will have more to say, but there are strategies to include both children as well as adolescents in one study. The reason for the guidance is to make sure that one can adequately determine what dose will be effective in both of those patient subpopulations. There are strategies to be able to do that in one study and in conjunction with having demonstrated efficacy in the adult population. Age is a continuum. Stay tuned. Our goal, as always, has been to develop products in as streamlined a fashion as possible.

Sure.

We will have more to say, but there are strategies to include.

Both.

Children as well as Anil lessons in one study.

The reason for the guidance is to make sure that.

One can adequately.

Adequately determine what dose will be effective in both of those.

Patient subpopulations. So there is there are strategies.

To be able to do that in one study and in conjunction with having demonstrated efficacy in the adult population ages a continuum.

And so stay tuned but.

Our goal is always has been to develop products in a streamlined fashion as possible.

Analyst 2: Thank you.

Thank you.

Yeah.

Operator: Thank you. We reached the end of our question and answer session. I would like to turn the floor back over for any further closing comments.

Thank you we reached end of our question and answer session I like to turn the floor back over for any further or closing comments.

Hunter Murdock: Thank you all for joining us today. As you have heard on today's call, Axsome delivered a strong second quarter marked by commercial growth, clinical advancement, and disciplined execution across the business. With a growing portfolio of innovative commercial and development neuroscience products, we are well positioned to potentially address serious conditions that affect more than 150 million patients in the U.S. alone. We look forward to keeping you updated on our continued progress over the balance of the year. Thank you.

Thank you all for joining us today.

<unk> heard on todays call axon delivered strong second quarter marked by commercial growth clinical advancement and disciplined execution across the business.

Our growing portfolio of innovative commercial and development neuroscience products, we are well positioned to potentially address serious conditions that affect more than 150 million patients in the U S alone. We look forward to keeping you updated on our continued progress over the balance of the year. Thank you.

Operator: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.

Okay.

Yeah.