Axsome Therapeutics Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 4, 2025

Key Takeaways

  • Positive Sentiment: Axsome reported $150 million in Q2 product revenues, a 72% year-over-year and 24% sequential increase driven by strong growth of Auvelity and Sunosi.
  • Positive Sentiment: The mid-June launch of Cymbravo for acute migraine generated encouraging early patient feedback, with initial coverage at ~38% of lives and gross-to-net in the low 80% range.
  • Positive Sentiment: Major pipeline milestones remain on track, including an sNDA submission this quarter for AXS-05 in Alzheimer’s agitation, an NDA for AXS-12 in narcolepsy in Q4, and Phase III starts for AXS-14 (fibromyalgia) and solriamfetol in pediatric ADHD and MDD with excessive sleepiness.
  • Neutral Sentiment: Axsome ended Q2 with $300 million in cash and cash equivalents, while narrowing its net loss to $48 million (–\$0.97/share) versus $59 million in Q1, supporting cash runway toward cash-flow positivity.
  • Positive Sentiment: Market access expanded meaningfully, with Auvelity and Sunosi now each covering ~83% of lives, including 73% commercial and 100% government for Auvelity, underpinning future volume growth.
AI Generated. May Contain Errors.
Earnings Conference Call
Axsome Therapeutics Q2 2025
00:00 / 00:00

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Operator

Good morning and welcome to the Axon Therapeutics Second Quarter twenty twenty five Financial Results Conference Call. Currently, 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 would now like to turn the call over to Darren Oplin, Director of Corporate Communications at Axsome Therapeutics. Please go ahead.

Darren Opland
Darren Opland
Director - Corporate Communications at Axsome Therapeutics

Thank you, and good morning, everyone. Thank you all for joining us for our second quarter twenty twenty five earnings call. With me today are Doctor. Herriot Tabuteau, our Chief Executive Officer Nick Tizzi, our Chief Financial Officer and Ari Maisel, our Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobsen, our Chief Operating Officer and Hunter Murdoch, our General Counsel, will join us for the Q and A portion of the call.

Darren Opland
Darren Opland
Director - Corporate Communications at Axsome Therapeutics

This morning, we issued our earnings press release providing a business update and details of the company's financial results for the 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. 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.

Darren Opland
Darren Opland
Director - Corporate Communications at Axsome Therapeutics

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 Arielle.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

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 end market products 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 $150,000,000 for the quarter, representing substantial double digit year over year and sequential growth driven by outperformance for both Ovelity and Sunosi. Nikonari will provide additional details on the accelerating dynamics for these important life changing medicines.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

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

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Last month, we hosted our Frontiers in Brain Health R and 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-five and Alzheimer's disease agitation. We are on track to submit the sNDA for AXS-five and Alzheimer's disease agitation this quarter.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

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-five for the treatment of smoking cessation with a Phase twothree trial expected to initiate in the fourth quarter of this year. Moving on to AXS-twelve, our novel product candidate for the treatment of narcolepsy with cataplexy. Progress continues in our NDA submission to the FDA, is slated for the fourth quarter. In clinical trials to date AXS-twelve 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.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

For AXS-fourteen in fibromyalgia, we look forward to initiating a Phase three trial in the fourth quarter to address the FDA's feedback in the previously disclosed Refusal to File letter. With more than seventeen million people in The U. S. Affected by this condition and with a paucity of approved treatments, we see a substantial opportunity for AXS-fourteen to transform the standard of care for these patients. Our solriamfetol development programs continue to advance across four potentially high value indications: ADHD, MDD with excessive daytime sleepiness, binge eating disorder and shift work disorder.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

In ADHD, we previously reported Phase III efficacy results in adults and we plan to initiate a Phase III 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. This approach is supported by pilot data from our PARADIGME study and we expect to initiate a Phase three trial in this patient population in the fourth quarter. Our ENGAGE Phase three trial of solriamvitol in 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 seven million individuals in The U.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

S. With only one agent approved for this condition, it represents a high unmet medical need. The sustained Phase three trial of solriamfetol in 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. With that, I'll hand the call over to Nick, who will provide details of our financial performance.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Thank you, Herriot, 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 $150,000,000 driving an increase of 72% year over year and an increase of 24% quarter over quarter. AVELITY continues to demonstrate impressive growth. Net product sales were $119,600,000 up 84% versus last year and up 24% versus the previous quarter.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Sunosi net product revenues were $30,000,000 up 35% versus last year and up 19 percent versus the previous quarter. Synosi revenues in the quarter consisted of $28,900,000 in net product sales and $1,100,000 in royalty revenue associated with Synosi sales in out licensed territories. Zimbravo was launched on June 10 and for this partial quarter generated net sales of 4 and $10,000 Avelity and Sunosi gross to net discounts for the second quarter were both in the mid-50s range. We continue to anticipate VELDINE and Sunosi GTNs will remain in this range for the remainder of the year. And Bravo gross to net for the quarter was in the low 80% range.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Turning now to expenses, total cost of revenue were $13,400,000 compared to $8,100,000 for the 2024. Research and development expenses were $49,500,000 for the second quarter compared to $49,900,000 for the 2024. The decrease was primarily related to the completion of solriamfetil trials in ADHD and MDD, along with the completion of the AXS-five trials in Alzheimer's disease agitation, which was partially offset by higher personnel costs. Selling, general and administrative expenses were $130,300,000 compared to $103,600,000 for the 2024. The increase was primarily related to commercialization activities for Evelity, including the expansion of the Evelity sales force and expenses related to the commercial launch of Sobrato.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Net loss for the second quarter was $48,000,000 or $0.97 per share compared to a net loss of $59,400,000 or $1.22 per share for the previous quarter and $79,300,000 or $1.67 per share for the 2024. The $48,000,000 net loss for this quarter includes $24,600,000 related to stock based compensation expenses. We ended the second quarter with $3.00 $3,000,000 in cash and cash equivalents compared to $315,400,000 at the 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. And with that, I'd like to now turn the call over to Ari who will provide a commercial update.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Thank you, Nick. The 2025 marked Axiom's first with three marketed products, highlighted by the mid June launch of Cymbravo into the acute migraine market and continued strong demand growth for AUBELITY 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 Cymbravo with encouraging early signals of the product's potential. Starting with Ovelity. Ovelity delivered another strong quarter of growth with increased new patient starts and continued expansion in prescriber engagement supported by our expanded sales force.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

AVELITY 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 2024. AUVELITY also led the market in new patient prescription growth with nearly 30,000 new patients initiating Ovelity in the quarter, increasing the total number of patients treated with Ovelity since launch to nearly 220,000. A key growth driver in the quarter was the activation of approximately 4,000 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 28,000,000 new covered lives in the commercial channel starting July 1.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Avelity coverage now stands at eighty three percent 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. By comparison, the weight promoting agent market grew 5.5% sequentially and increased by 5% compared to the 2024. Payer coverage for Sunosi remains at approximately eighty three percent of lives covered across channels.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Finally, we are proud to have launched Zimbravo 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 Cymbravo 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 Cimbravo. Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for Cimbravo based on the contracted terms. Current coverage for Cimbravo is at approximately thirty eight percent of lives across all channels, including twenty six percent of commercial lives.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

We anticipate coverage for Cimbravo to expand and evolve throughout the rest of the year. In closing, the second quarter reflected significant growth in Axone's product portfolio, highlighted by solid performance from Mauvelity and Sunosi, the recent launch of Cimbravo 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 for Q and A.

Darren Opland
Darren Opland
Director - Corporate Communications at Axsome Therapeutics

Thanks Ari. We're ready to begin our Q and 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'll now be conducting a question and answer session. Our first question today is coming from Lunat Timmiched from RBC Capital Markets. Your line is now live.

Leonid Timashev
Leonid Timashev
Biotechnology Analyst at RBC Capital Markets

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 Avelity. I guess first of all, given the large number of covered lives added, is this that third contracting organization? And then it sounds like gross to net is not expected to change for the quarter despite all the new covered lives.

Leonid Timashev
Leonid Timashev
Biotechnology Analyst at RBC Capital Markets

So I guess I'm curious how you're thinking about the dynamic and how much volume we should expect to pull forward in the second half of the year? Thanks.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Helio, thanks for the question. Regarding the coverage, this actually represents pull through of previously announced GPO contracts. And so 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. Obviously, we expect there to be some acceleration in volume, particularly related to these plans.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

But in terms of overall impact, I think it's a little 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.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Yes. And as it relates to Availity GTN, we shared that we are in the mid-50s in Q2. And we will see how these new twenty eight million lives are adjudicated. Obviously, we'll the utilization management will be significantly improved, access to patients will be significantly improved. And with that benefit, we're still able to maintain that mid-50s GTN for Avelity.

Leonid Timashev
Leonid Timashev
Biotechnology Analyst at RBC Capital Markets

Thanks. Really appreciate it.

Operator

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

Sean Laaman
Sean Laaman
Executive Director at Morgan Stanley

Good morning. Hope everyone is well and thank you for taking my question. I have a question on AXS-twelve. If you could just frame out a little bit the market positioning against oxybates and the potential orexin-two agonist coming and what data might be included in your NDA filing package? Thank you.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Sure. Yes, I'll start with the question. So first of all, we are really optimistic about the potential profile of ASS12 in narcolepsy. As we've shared previously, over ninety percent of patients report discontinuing their medication due to inadequate efficacy, the side effect profiles or recommendations from their HCPs to switch treatments. And so AXS-twelve 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 three placebo controlled efficacy trials.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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. And so it's a little early to tell exactly how AXS-twelve will be used relative to other products, but it is it's once daily dosing. We are very optimistic that it will find a place in the treatment paradigm. And as it relates to the orexins, I think obviously really great signal for patients and providers with the top line results that were shared recently. There was not a ton of data shared, but so we'll want to monitor their additional data that's released, particularly as it relates to the side effect profile.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

But even with the orexins, we feel confident based on feedback with KOLs that AXS-twelve will have a meaningful place in the treatment paradigm.

Sean Laaman
Sean Laaman
Executive Director at Morgan Stanley

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

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Hi, Sean. So the the NDA package is gonna be comprised of the three trial controlled trials that we conducted. That's the concert, symphony, and encore trials. So all of those all of those studies will be going into the NDA submission, including the long term safety extension.

Sean Laaman
Sean Laaman
Executive Director at Morgan Stanley

Wonderful. Thank you.

Operator

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

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

Hi, this is Puna on for Ami. Thank you for taking our question. On CINBRAVO, could you provide some additional color on your sampling program? What has been the utilization of the drug through sampling? And any trends that you're seeing for conversion of patients from the sampling to the prescription drug?

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

And just in terms of the launch, are you seeing any initial barriers to access or launch in general with Cimbravo? And what are the next steps in removing these barriers? Thank you.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes, thanks for the question. So regarding Cimbravo, we do have a sampling program alongside a 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 very common for migraine patients to start with the sample in order to gauge effect of the treatment prior to filling a prescription. But we've been encouraged by what we've seen thus far, which is samples being accompanied by a prescription and then a strong utilization of our patient savings program for commercially insured patients.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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. But we are seeing covered claims in the early days, which is a positive signal of the access that we do have. And then providing support through our patient savings program is a good supplement to the existing access that's in the market today.

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

Great. Thank you.

Operator

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

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

Hey, guys. Thanks for taking my question. I guess mine is just on Cimbravo revenue recognition. My sense was that both 2Q and 3Q would be light with the co pay 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, I presume, flow through with better, I guess, gross to net assumption?

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

And just wondering if you can walk us through the next couple of quarters, just how to think about revenue recognition in the script data that we're seeing?

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

So thanks, Jason, your call for the question. So maybe I'll talk a little bit about rev rec specifically this quarter in Q2. Obviously, it was a very short quarter with just about two weeks. So wholesalers did place their minimal stocking orders, their initial stocking orders in June. So any of those orders were very recognized as revenue along with the GTN that we shared in the or that's around that 80% range from that perspective. Around the first scripts, Ari, do you want to share maybe a little bit about the NBRxs and how we're approaching them?

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. Jason, as you know, in the for early launches, nearly all of the prescriptions are new patient starts. And the migraine market is a little bit different than the depression market in that you know, refill rates are not quite as substantial because these are episodic episodes of migraine. And so they may be having, you know, anywhere from a few migraine attacks a month to, you know, up to a dozen or so. And so what we're monitoring is what the refill rate will develop over time.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

That said, we have started to see refills, but we expect that to be at a slightly lower velocity than what we've seen with Albany 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. And so that means that they're not all patients are relying on our co pay support in order to fill the script. It is still very early days.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And so that's something we'll continue to monitor. One other point that I'll make is that we are seeing scripts flow through from across all the channels. So commercial, Medicare, Medicaid and those dynamics will also evolve. So I think we'll have more to share on those dynamics as the year progresses.

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

Thank you, guys.

Operator

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

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

Hi, good morning and congrats on the execution and thanks for taking my question. It's on AXS-five in Alzheimer's agitation. There's a clear mechanistic distinction and clinical profile for five versus antipsychotics. Rexulti's uptake has been relatively modest in Alzheimer's agitation. Sort of given the differences in data and mechanisms, what are your expectations for adoption?

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

Are you expecting to mirror Rexulti? And how do you plan to drive uptake in the other various channels, if approved? Yes.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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. So I think that bodes well for AXS-five. 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-five apart from the currently used, whether it's off label atypical antipsychotics or Rexulti.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And so 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 Ability sales force in the sense that there's a large overlap in MDD and EDA prescribing, particularly among psychiatrists and primary care clinicians. But 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. And so that's something that we'll continue to work through as prepare for a future launch. But we feel really good about the potential for AXS-five and the receptivity that it will have in the marketplace.

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

Thank you.

Operator

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

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Hi. Thanks. Thanks for taking the question. So on Avelity, I'm trying to understand if your GTN has stayed stable from 1Q to 2Q, then the 15% sequential growth that you have, what is driving the 24% net sales growth? Is that primarily inventory?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Or is there any other factor that's contributing to that? Thanks.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Sure, Ash. Yes, thanks for the question. This is Nick. So GTN did slightly improve. We were in the mid-50s range for both quarters, but did improve within that range from Q1 to Q2.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

I would say secondly, as you spoke about inventory, inventory remains around that two week mark. But that being said, with higher demand, there's obviously an inventory impact of an increasing revenue for Q2 versus Q1, again, maintaining at the Q2 two week level. And then 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. So that also included in the revenue.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

But to be clear, there's no inventory impact at all as it relates to Avelity's made at that two week level.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Sorry, can you clarify potential change of liability from the previous like net sales number or is that

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Sure. Something can share that. It's going be in the Q, which we'll file after the quarter, but it was less than $05,000,000 that's 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 sure would up the next quarter as typical as any company would.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Thank you.

Operator

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

Raghuram Selvaraju
MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC

Thanks so much for taking my question. With respect to Cimbravo, 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? Is it the onset of action or some other factor? Thank you.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Hey, Ram, it's Nick again. For I'll start with Zimbravo and then related to the GTN and then hand it over to Ari. As I mentioned, SENBRAVO GTN was in the low 80 range for Q2. We expect it to remain high for the back half of the year. As Ari shared, NBRx

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

We're making sure that patients receive product. So that will be likely a full buy down. And as that proportion is still going be high for the remaining part of the year NBRxs to TRxs, would expect GTN to also remain high. Ari?

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. And related to some of the color from the clinicians and patients, I think first and foremost, the fact that CINBRAVO offers a multi mechanistic approach to acute migraine treatment is very compelling. Most other products are only focusing on one particular pathway. Cymbravo is focusing on two or more. And therefore, the idea of being able to attack the migraine attack in multiple ways is very compelling.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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 are getting some relief, but not feeling totally better or lacking in pain freedom is a key patient type that Cymbalvo has been used for. And also patients that have had 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. But 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.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And as we know, there's a ton of dissatisfaction amongst patients in this market. And despite the fact that there are multiple options available, there's still a lot of breakthrough symptoms or tolerability issues that really positions Cymravo as a great option.

Raghuram Selvaraju
MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC

Thank you.

Operator

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

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

Can you talk about your strategy for this precision medicine approach to ADHD? And does that carry over into the adolescents as well as the adults? And how you plan to move forward with this?

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Thanks for the question, Mark. So the precision medicine approach that we referred to relates to solriamtol for major depressive disorder. And we know that there are different patient types in depression. And so this is a way of targeting the pathophysiology or one of the aspects of the pathophysiology of MDD, which relates to sleep quality and either some patients either experience excessive sleepiness and others might experience insomnia. So that's the precision medicine approach.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

So it's based on looking at the clinical presentation as well as the underlying pathophysiology. As it relates to your question on the other part of your question on ADHD, so there we do know that there is a continuum of the disease from when patients have it as children into adulthood. So we 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 adolescents.

Operator

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

David Amsellem
David Amsellem
Senior Research Analyst at Piper Sandler Companies

Thanks. On OVELADEE and MDD, can you talk to the mix between second and third line usage and even the extent to which you're 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.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. 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.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And we're comfortable with that. I think we've shared previously that one of the benefits of Velvety is that it is 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're able to penetrate the primary care market. We've seen nice growth in primary care market. I think we're very comfortable with the size of sales force right now.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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. So I think we're comfortable with where we are right now and we'll continue to monitor the market dynamics to evaluate for the future.

David Amsellem
David Amsellem
Senior Research Analyst at Piper Sandler Companies

Thanks.

Operator

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

Cerena Chen
Cerena Chen
VP - Biotech and Pharma Equity Research at Wells Fargo

Great. Thanks for taking my question. I had a question on AXS-five for AD agitation. Just want 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.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Hi Serena. Good morning. We had, announced a few, earlier this spring, our pre NDA meeting minutes, where we align 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.

Cerena Chen
Cerena Chen
VP - Biotech and Pharma Equity Research at Wells Fargo

Thanks.

Operator

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

Analyst

Hey guys, this is John on for Andrew. Thanks for taking the question. So if we fast forward in nine to twelve months or so, how are you thinking about the commercial strategy for, AXS-five, 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 AdCom based on your prior FDA discussions, what would be the key talking points that the FDA would want to discuss in your view?

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yeah, start with the commercial strategy question. Yeah, it's a little early to share too many details, but obviously we track utilization of Alzheimer's disease education prescriptions across both outpatient and long term care facilities. And so 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. 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 decile or highest value prescribers within a particular space.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And I expect that, that would be maintained for an ADA launch.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And then with respect to a potential advisory committee, we've not received any indication that the FDA is looking to hold one. However, that's always something they notify you upon potential acceptance of a filing. And, you know, as a reminder, there was not one held for Ovality and MDD, and the psychiatry division did hold one for the product that they for Rexulti in the indication where they talked about a number of things, endpoints, the scale used, which is the same scale that we use, etcetera. So it's it's really hard to speculate. But again, we're we're not aware of one at this time and haven't received communication of such.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

And but if there were one to occur, we we'd be ready for it.

Analyst

Great. Thank you so much.

Operator

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

Asim Rana
Asim Rana
Equity Analyst at Truist Securities

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

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Thanks for the question. So AXS-five does combine two axes. And therefore, in order to for the product to be approved, there does need to be demonstration of component contribution. So by definition, a registration study would involve a bupropion arm.

Asim Rana
Asim Rana
Equity Analyst at Truist Securities

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

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Yes, sir. Simon?

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. So we have three distinct sales forces for each product and approximately 300 representatives on Auvelity and approximately 100 each for Sunosi and Sunbravo.

Asim Rana
Asim Rana
Equity Analyst at Truist Securities

Thank you.

Operator

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

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

Hey guys, thank you for taking my questions. Very nice quarter. Just a question on OVELITY and the MDD dynamic. I mean, obviously, you have DTC ongoing, there is sales for expansion. So I'm just curious to understand from you, how should we think about the inflection that we should get?

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

When exactly we should anticipate the inflection? And what level of step changes we should be expecting during these two dynamics? And if you can also comment on the duration that you're seeing in the marketplace? I missed the last part, but Duration. Duration. Yeah, last one duration.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Okay. Thanks so much.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. So in terms of Auvaldi MED, obviously, we're very pleased with the performance so far this year. One correction I'll make is although we have we have not launched a national DTC campaign, we are expecting to later this year. But that is not currently reflected in our demand trends. So just want to make sure you're aware of that.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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 TRx demand growth or increase in trajectory. And so we'll be paying close attention to performance in the back half of the year. But we would expect there to be continued growth progress over the course of the year. And then once we launch DTC, we expect that to be incremental growth to the current trends.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

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 sales force expansion, improved access and then DTC later this year will provide incremental growth rate for the brand. And in terms of duration, we're 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. But on average, it's somewhere around six or seven.

Operator

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

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

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. And maybe to 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 solriamfetol will be active in pediatric patients? And then tangentially, trial seems to have taken a little bit of time to get off the ground.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

I guess how confident are you in that Q4 guidance? And 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.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Great. Thanks for the question. As it relates to the pediatric study, we anticipate 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. So we'd be using a pediatric scale as opposed to the adult study, which adult scale.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

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 have been active in patients, they've been active in both adults as well as pediatric patients. And, you know, biologically that would make sense since adult patients must have been diagnosed with ADHD as children, that's part of a diagnostic criteria. And as it relates to the timing of the start of the study, it's there is a 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 any trial in a pediatric population.

Operator

Thank you. Next question is coming from Matthew Hirschenhorne from Oppenheimer. Your line is now live.

Matthew Hershenhorn
Equity Research Associate at Oppenheimer & Co. Inc.

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

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. Thanks so much for the question. There's near perfect overlap in terms of the targets for AXS-twelve and Sunosi. And so we'll be able to leverage our current Sunosi team fully for an AXS-twelve launch. So it's a real synergistic opportunity for us as a company. As it relates to physician, 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-twelve and Sunosi will have distinct indications, you may see some combination use, but I think it's a little too soon to tell clinicians are going to want to sort of weigh in based on final label, etcetera. But we feel very optimistic and we've heard a lot of enthusiasm for the potential benefit of both products in patients. And so unlike the other treatments that exist, we expect there'd be a whole variety of combinations used of the currently approved treatments.

Matthew Hershenhorn
Equity Research Associate at Oppenheimer & Co. Inc.

That's helpful. Thanks so much.

Operator

Thank you. Next question is coming from Greg Suvannavejes from Mizuho Securities. Your line is now live.

Graig Suvannavejh
Graig Suvannavejh
Managing Director at Mizuho Financial Group

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 IRA pricing, especially for Avelity and kind of what your current thinking is around timing of when Avelity might be for such negotiations or discussions? Thanks.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes, I'll start with the seasonality question. So there is summer seasonality really across all three of the markets that we're currently in. I think in some ways depression is perhaps the most pronounced. Obviously, we expect with Cin 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, cross migraine, EDS and depression.

Nick Pizzie
Nick Pizzie
CFO at Axsome Therapeutics

Yes. And then as for AVELD, and you mentioned IRA pricing, it's presumably related to ADA. Again, ADA will be priced at the same WAC price as Avelity. So it is Avelity, so $11.77 dollars of the current WAC price. And as a reminder, I think we would be up for negotiations somewhere around 2029, 2030 with a potential implementation in that $31.32 range.

Graig Suvannavejh
Graig Suvannavejh
Managing Director at Mizuho Financial Group

Thank you.

Operator

Thank you. Next question is coming from David Holm from Deutsche Bank. Your line is now live.

Sam Beck
Sam Beck
Biotech Equity Research Associate at Deutsche Bank

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? And as a follow on to a prior question on AVELITY, do you feel the need to further increase covered commercial lives from here? Thanks.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

Yes. Thanks, Dan, for the questions. Regarding Sunosi, nothing noteworthy regarding the mix of patients, narcolepsy versus OSA. But we did see very strong growth in prescribers this quarter and then 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 more they were prescribing more Sunosi than in previous quarters.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

So I think this really reinforces our strategy to drive depth of prescribing within the existing EDS marketplace for ACTs. I apologize, you're sorry. For the commercial lives. Yes. On the commercial lives, obviously, we're very pleased with the announcement for today.

Ari Maizel
Ari Maizel
CCO at Axsome Therapeutics

But we're at 83% covered lives in total. And our goal is to get to as much of the insurance market as possible. So we believe we still have work to do, and our expectation is that we continue to add additional coverage as time goes on.

Sam Beck
Sam Beck
Biotech Equity Research Associate at Deutsche Bank

Great. Thank you.

Operator

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

Myles Minter
Research Analyst - Healthcare at William Blair

Hi guys. Thanks for squeezing me in. Just one on Sunosi and ADHD and the comment to receive perfect alignment with the regulators. I'm 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 the two positive pediatric studies, one of which could be done in adolescence would be required for approval here. Just wondering whether you've received alignment with the agency based on that. Thanks very much.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Sure. We'll have more to say, but there are strategies to include both children as well as adolescents in one study. So 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. So there is a 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 and so stay tuned, but our goal as always has been to develop products in a streamlined fashion as possible.

Myles Minter
Research Analyst - Healthcare at William Blair

Thank you.

Operator

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

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

Thank you all for joining us today. As you've 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 one hundred and fifty million patients in The U. S. Alone.

Herriot Tabuteau
Herriot Tabuteau
Founder, Chairman & CEO at Axsome Therapeutics

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.

Executives
    • Darren Opland
      Darren Opland
      Director - Corporate Communications
    • Herriot Tabuteau
      Herriot Tabuteau
      Founder, Chairman & CEO
    • Nick Pizzie
      Nick Pizzie
      CFO
    • Ari Maizel
      Ari Maizel
      CCO
Analysts
    • Leonid Timashev
      Biotechnology Analyst at RBC Capital Markets
    • Sean Laaman
      Executive Director at Morgan Stanley
    • Poorna Kannan
      Biotech Equity Research Associate at Needham & Company
    • Jason Gerberry
      MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch
    • Pete Stavropoulos
      Director - Biotech Equity Research at Cantor Fitzgerald
    • Ashwani Verma
      Executive Director - SMID Biotech & Biopharma at UBS Group
    • Raghuram Selvaraju
      MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC
    • Marc Goodman
      Senior MD - Neuroscience at Leerink Partners
    • David Amsellem
      Senior Research Analyst at Piper Sandler Companies
    • Cerena Chen
      VP - Biotech and Pharma Equity Research at Wells Fargo
    • Analyst
    • Asim Rana
      Equity Analyst at Truist Securities
    • Yatin Suneja
      Biotechnology Research Analyst at Guggenheim Partners
    • Joseph Thome
      Managing Director, Senior Biotechnology Analyst at TD Cowen
    • Matthew Hershenhorn
      Equity Research Associate at Oppenheimer & Co. Inc.
    • Graig Suvannavejh
      Managing Director at Mizuho Financial Group
    • Sam Beck
      Biotech Equity Research Associate at Deutsche Bank
    • Myles Minter
      Research Analyst - Healthcare at William Blair
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