Axsome Therapeutics Q2 2026 Earnings Report

Axsome Therapeutics EPS Results

• Actual EPS: -$0.99
• Consensus EPS: -$0.89
• Beat/Miss: Missed by -$0.10
• One Year Ago EPS: N/A

Axsome Therapeutics Revenue Results

• Actual Revenue: $218.38 million
• Expected Revenue: $221.11 million
• Beat/Miss: Missed by -$2.74 million
• YoY Revenue Growth: N/A

Axsome Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 8/10/2026
• Time: Before Market Opens
• Conference Call Date: Monday, August 10, 2026
• Conference Call Time: 8:00AM ET

Axsome Therapeutics (NASDAQ:AXSM) is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.

Axsome’s pipeline includes several late-stage and approved product candidates. AXS-05, a first-in-class oral investigational therapy combining dextromethorphan and bupropion, received U.S. Food and Drug Administration (FDA) approval for the treatment of major depressive disorder in 2021 and for agitation associated with Alzheimer’s disease. AXS-07, a combination of meloxicam and rizatriptan for acute migraine, gained FDA approval in 2023. The company is also advancing AXS-12 for narcolepsy and idiopathic hypersomnia under FDA review, as well as AXS-14, a proprietary formulation of esreboxetine, targeting fibromyalgia and related chronic pain conditions.

Founded in 2012 and headquartered in New York City, Axsome Therapeutics conducts its research and development activities primarily in the United States. The company’s leadership team is led by President and Chief Executive Officer Herriot Tabuteau, M.D., who brings extensive experience in neurologic and psychiatric drug development. Under his guidance, Axsome has advanced multiple clinical programs through crucial regulatory milestones and continues to collaborate with academic institutions and contract research organizations to support its growth strategy.

Axsome Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Second-quarter revenue rose 46% year over year to $218 million, led by AUVELITY sales of $180.3 million, up 51%, and SUNOSI revenue growth of 20%.
• Positive Sentiment: AUVELITY’s launch in Alzheimer’s disease agitation and expanded sales force are showing encouraging early indicators, including a 126% increase in new-to-brand prescriptions among patients aged 65 and older during the first eight weeks and 89% overall payer coverage.
• Positive Sentiment: SYMBRAVO demand increased 30% sequentially to approximately 23,500 prescriptions, while SUNOSI prescriptions grew 14% year over year and 8% sequentially, both outpacing their respective markets.
• Positive Sentiment: The FDA accepted the NDA for AXS-12 in narcolepsy cataplexy with a May 1, 2027 action date; Axsome also plans to begin its AXS-05 smoking-cessation trial and expects binge-eating-disorder data from solriamfetol in the fourth quarter of 2026.
• Negative Sentiment: The company reported a $51.3 million quarterly net loss, while SG&A increased to $208.1 million due to commercialization investments; AUVELITY and SUNOSI gross-to-net discounts remained near 50%, and SYMBRAVO discounts temporarily rose into the high-80% range.

Presentation

[Operator]

Good morning, and welcome to the Axsome Therapeutics second quarter 2026 earnings conference call. My name is Kevin. I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, there'll 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 hand the call over to Ashley Dong, Senior Director of Investor Relations. Please go ahead, Ashley.

[Ashley Dong, Senior Director of Investor Relations at Axsome Therapeutics]

Thank you. Good morning, everyone, and welcome to Axsome's second quarter 2026 earnings conference call. Joining me today to discuss our results for the quarter are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, and Ari Maizel, Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdock, our General Counsel, will also be available for Q&A. Before we begin, I encourage everyone to visit the investors section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially.

[Ashley Dong, Senior Director of Investor Relations at Axsome Therapeutics]

Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. With that, I'll hand it over to Herriot.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Thank you, Ashley, and good morning, everyone. The second quarter was highly productive for Axsome as we grew our commercial business robustly and made important regulatory and clinical progress across our innovative neuroscience pipeline. In the second quarter, our commercial portfolio generated $218 million in net product revenue, a 46% increase year-over-year, driven by strong performance for AUVELITY and SUNOSI. In the quarter, we launched AUVELITY in Alzheimer's disease agitation and completed the expansion of the AUVELITY sales force. Early metrics for the sales force expansion and Alzheimer's disease agitation launch point to growth acceleration for AUVELITY. Underlying demand growth for SYMBRAVO is also accelerating, and we expect SUNOSI growth to continue outpacing the market, positioning us for continued strong growth across the entire commercial portfolio.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Later in the call, Nick will comment further on our financials, and Ari will provide additional detail on our commercial performance, including early observations on the Alzheimer's disease agitation launch. During the quarter, we also advanced our leading neuroscience pipeline of six innovative product candidates, which we are developing for 10 serious conditions. Our broad late-stage neuroscience pipeline positions us to potentially file on average one new NDA each year between now and 2030, delivering potentially significant value to patients and stakeholders. Following Ari's remarks, I'll provide an update on each of these programs. With that, I'll turn the call over to Nick.

[Nick Pizzie, CFO at Axsome Therapeutics]

Thanks, Herriot. Good morning, everyone. I'll begin with a review of our financial results for the quarter. Revenue increased to $218 million compared to $150 million in Q2 of 2025, representing a 46% year-over-year growth. Performance was driven by AUVELITY with steady growth from SUNOSI and continued strength in prescription demand for SYMBRAVO. We recorded net product sales for AUVELITY of $180.3 million in the quarter. That's a 51% increase compared to the second quarter of 2025 and an 18% increase quarter-over-quarter. SUNOSI net product revenue for the quarter was $35.8 million, representing a 20% year-over-year growth. SUNOSI revenue consisted of $33.8 million in net product sales, $1.5 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and a half a million dollars in milestone revenue.

[Nick Pizzie, CFO at Axsome Therapeutics]

Net sales for SYMBRAVO were $2.3 million in the quarter. SYMBRAVO was launched in June of 2025 and had net product sales of $400,000 for the second quarter of 2025. The decrease of $1.8 million in net sales from Q1 of 2026 primarily reflects a prior period adjustment and increased utilization of our patient service program driven by underlying demand growth. As such, SYMBRAVO gross and net discount deviated from trend during the quarter into the high 80% range. We anticipate SYMBRAVO GTN to return to prior levels for the remainder of the year. Gross and net discounts for AUVELITY and SUNOSI were each approximately 50% for the second quarter. We continue to anticipate gross and net discounts for both products to improve throughout the year, consistent with prior year trends.

[Nick Pizzie, CFO at Axsome Therapeutics]

Turning to expenses, cost of revenue in the quarter was $13.6 million, representing 6% of total net revenue. Cost of revenue for the second quarter of 2025 was $13.4 million. Research and development expenses decreased to $46.2 million for the second quarter of 2026, compared to $49.5 million in the second quarter of 2025, which primarily reflects lower costs associated with AXS-05 and AXS-14. Selling, general, and administrative expenses in the quarter were $208.1 million compared to $130.3 million for the second quarter of last year. The increase was primarily driven by commercialization activities for AUVELITY and SYMBRAVO. Net loss for the quarter was $51.3 million, or $0.99 per share, compared to a net loss of $48 million, or $0.97 per share for the second quarter of 2025.

[Nick Pizzie, CFO at Axsome Therapeutics]

Net loss in the quarter includes $27.1 million in stock-based compensation expense. We ended the quarter with approximately $320 million in cash and cash equivalents. This compares to $323 million as of end of 2025. We are seeing continued improvement in operating leverage while investing behind our key commercial opportunities and pipeline priorities. We continue to expect that our current cash balance is sufficient to fund anticipated operations into cash flow positivity. I'll turn the call over to Ari with a commercial update.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks, Nick. During the second quarter, we saw strong underlying demand growth across our portfolio of three differentiated medicines. During the quarter, we further strengthened our commercial foundation, positioning us to drive growth across the portfolio over the balance of the year. AUVELITY. In the quarter, we launched AUVELITY in the Alzheimer's disease agitation market and completed the expansion of the AUVELITY sales force. I'm happy to share that early metrics indicate that these two developments are already beginning to have a meaningful impact on demand growth, positioning AUVELITY for continued momentum over the balance of the year. During the first eight weeks following the launch in this indication, new-to-brand prescriptions among patients 65 years of age and older increased 126% compared to the same period in the prior quarter, reflecting expanding adoption in this patient segment.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

New-to-brand prescriptions represent new patients starting on AUVELITY for the first time and are considered a key leading indicator of growth. While it's early days in the commercialization of AUVELITY in Alzheimer's disease agitation, we are excited by the initial feedback that we have received from prescribers, which includes positive anecdotal evidence of AUVELITY's differentiated clinical profile reflected in real-world patient experience. Providers and care partners alike view the reduction in agitation symptoms and safety and tolerability profile favorably. These early experiences have reinforced our belief that AUVELITY has the potential to transform the treatment paradigm for Alzheimer's disease agitation. We look forward to sharing continued progress in the months ahead.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

We are also beginning to see the early impact of our expanded sales organization, with overall new-to-brand prescriptions in the second quarter of 2026 increasing 26% compared to the first quarter of 2026. This momentum has continued into the third quarter. The expanded sales force activated more than 6,800 new AUVELITY prescribers in the quarter, representing 21% growth versus the previous quarter, bringing the total number of unique prescribers since launch to approximately 69,000. The inflection in new-to-brand prescriptions and increased velocity of new writer activation are strong leading indicators of our expanded sales force investment, resulted in market share gains for both new-to-brand and total prescriptions in the quarter. We expect these trends to continue to build in Q3 and Q4, translating into positive TRx trends, further market share penetration.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Total prescriptions for AUVELITY in the second quarter reached approximately 266,000, an increase of 34% year-over-year and 12% sequentially, substantially outpacing the antidepressant market, which grew 1% and 2% in the same time periods, respectively. In addition, AUVELITY market access continued to improve during the quarter, with coverage now at approximately 89% of total lives across channels, including 82% of commercial lives and approximately 100% of lives in the government channel. Our market access team is working closely with payers in both the commercial and government channels. We expect patient access for AUVELITY in both the MDD and ADA markets to continue to expand and evolve. Taken together, we expect the momentum from the sales force expansion, continued growth in MDD, and uptake in Alzheimer's disease agitation to drive continued growth over the rest of the year.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

For SYMBRAVO, demand was strong, growing 30% quarter-over-quarter to approximately 23,500 total prescriptions. Prescriber and patient feedback continue to be very positive, supporting our commercial strategy to drive prescription volume while improving market access to support sustained growth over time. As mentioned on our prior earnings call, based on the strong demand for SYMBRAVO to date, our previously announced sales force expansion to approximately 150 sales representatives is substantially complete. Following the previously announced addition of approximately 17 million lives in Q2, overall payer coverage is now at approximately 57% of lives covered across channels, including approximately 56% of commercial lives and 57% of government lives. We expect coverage for SYMBRAVO to further improve moving forward. SUNOSI delivered another quarter of durable growth, with approximately 61,000 total prescriptions written during the quarter.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Representing 14% year-over-year growth and 8% sequential growth, compared to a 1% decline and 2% increase for the wake-promoting agent market in the same periods, respectively. More than 17,000 clinicians have now prescribed SUNOSI since launch. We continue to maintain broad payer coverage of approximately 82% of lives covered across all channels. Overall, the underlying commercial performance in Q2 reflects positive momentum for Axsome's portfolio of differentiated CNS products. Acceleration of AUVELITY in MDD and Alzheimer's disease agitation, continued market penetration for SYMBRAVO in migraine, and consistent growth from SUNOSI in EDS associated with narcolepsy and OSA position Axsome for a strong second half of 2026 and robust growth in the years ahead. I will now turn the call back to Herriot.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Thank you, Ari. We are excited by our innovative neuroscience pipeline, which targets high unmet medical needs, novel indications, first-in-class mechanisms of action, and best-in-class profiles. I will now review the recent pipeline progress and discuss key upcoming clinical and regulatory milestones. In the quarter, the FDA accepted our NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy with a PDUFA target action date of May 1st, 2027. Based on its differentiated mechanism of action and resulting clinical profile, AXS-12 has the potential to provide a meaningful addition to the treatment armamentarium for patients living with narcolepsy, if approved. For AXS-05, the next indication under development is smoking cessation. We are on track to initiate our planned phase II/III trial in this indication this quarter.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Exploring the full clinical potential of AXS-05 remains a top priority for us based on its unique pharmacology, which is potentially applicable across multiple neuropsychiatric disorders. With solriamfetol, our clinical programs across four new indications continue to advance. As a reminder, the new indications being explored are ADHD, binge eating disorder, MDD with excessive daytime sleepiness or EDS symptoms, and EDS associated with shift work disorder. All in all, we currently have five phase III trials underway across these indications. In ADHD, we recently initiated the FOCUS-2 and FOCUS-3 studies of solriamfetol in children and adolescents with ADHD. These studies use a parallel group design with a primary endpoint of change from baseline to week six in the ADHD Rating Scale.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

These two studies, if positive, together with the previously completed positive FOCUS phase III trial of solriamfetol in adults, would form the basis of an NDA filing for solriamfetol in the treatment of ADHD. In binge eating disorder, our ENGAGE phase III trial continues to enroll, and we anticipate top-line results from the study in the fourth quarter of this year. Our CLARITY phase III trial of solriamfetol in MDD with EDS, and our SUSTAIN phase III trial of solriamfetol in EDS associated with the shift work disorder are also advancing. For AXS-14, which we are developing for fibromyalgia, enrollment in our FORWARD phase III trial continues to progress. The FORWARD trial, if positive, together with the previously completed positive phase II and phase III trials, would support an NDA filing for AXS-14 for the treatment of fibromyalgia.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

With AXS-20, our first-in-class selective PDE10A inhibitor, we are making good progress in our chemistry, manufacturing, and controls activities with the goal of initiating a phase III trial with this molecule in schizophrenia. We are also advancing phase II-enabling activities for AXS-17, our GABA subtype selective PAM, which we are developing for epilepsy. In summary, we are excited by the programs in our leading neuroscience pipeline. Combined with building momentum in our existing commercial business, these programs, targeting areas of unmet medical need, lay the groundwork for continued growth and value creation for patients and stakeholders. I will now turn the call back to Ashley.

[Ashley Dong, Senior Director of Investor Relations at Axsome Therapeutics]

Thanks, Herriot. This concludes our prepared remarks and we'll now begin the Q&A session. To allow enough time for as many questions as possible, we kindly ask that you limit yourself to one question. Operator, please open the line.

[Operator]

Certainly. We'll now be conducting a question and answer session. If you'd like to be placed in the 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'd like to remove your question from the queue. As a reminder, please ask one question, then return to the queue. Our first question today is coming from Leonid Timashev from RBC Capital Markets. Your line is now live.

[Leonid Timashev, Director of Equity Research at RBC Capital Markets]

Hey, guys. Thanks for taking my question. Just one maybe on the Alzheimer's agitation launch, specifically as it relates to long-term care. Can you talk about the trends that you're seeing in the long-term care? The enthusiasm there given that it's a new area that you're launching into, sort of any successes or challenges that you're seeing there?

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks, Leo, for the question. As we stated earlier on the call, we're just eight weeks into the launch. We're really encouraged by some of the early data we're seeing. The early patient experience has been very promising. We're seeing strong growth in new-to-brand prescriptions in patients aged 65 and older. That feedback is consistent from both the community and long-term care settings.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Obviously, as we get further into the launch, we'll be able to share some additional details around specific settings of care. We've been really encouraged by what we're seeing across both LTC and community.

[Operator]

Thank you. Our next question is coming from Malcolm Hoffman from BMO Capital Markets. Your line is now live.

[Malcolm Hoffman, VP of Equity Research at BMO Capital Markets]

Hi. Thanks for taking our question. You highlighted some pretty strong growth in NBRX for AUVELITY in the 65-plus patient group there. Can you maybe break this out further to indicate how much of this may be driven by agitation versus MDD expansion as well? Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah, thanks so much for the question. As we mentioned on the call, NBRX growth was very positive, 26% versus Q1. We are seeing meaningful increases in both MDD and Alzheimer's disease agitation, which we would expect to continue moving forward.

[Operator]

Thank you. Our next question is coming from [crosstalk] I'm sorry.

[Malcolm Hoffman, VP of Equity Research at BMO Capital Markets]

Go ahead.

[Operator]

Our next question is coming from Ash Verma from UBS. Your line is now live.

[Ash Verma, Executive Director at UBS]

Hey, guys. Thanks for taking my questions. Congrats on the progress here. Maybe just on Alzheimer's agitation, can you talk about the level of sampling that you need to do early in the launch? As the time progresses, would that gradually be lower? Is this sampling going to be more or less than the MDD launch that you did? Just help us understand so that we can correlate to data that we are seeing at our end at the third-party sources. Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. As it relates to sampling, particularly in a community setting, sampling is important to gain trial with patients. We've been committed as an organization to ensure that patients are appropriately titrated based on the approved dosage and administration. I think it's a little too early for us to indicate how sampling will change over time, but right now we're very pleased with the strong demand for samples. It's been applauded by the clinical community in order to get patients started effectively and to give them the best chance for the clinical profile that we saw in our phase III clinical trials.

[Operator]

Thank you. Next question is coming from Rudy Li from Wolfe Research. Your line is now live.

[Rudy Li, Director of Equity Research at Wolfe Research]

Hey, thanks for taking my question. For ADA, can you provide more color on the capture rates of like IQVIA of the prescription data for the titration package, what additional key commercial metric you'll be monitoring to track the progress? Thank you.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah, I would say on the capture rate for the titration pack specifically, there's really limited data, we'll learn more as we get further into the launch. In terms of ongoing performance data, I think obviously sharing information about adoption or utilization with patients who are 65 years and older was an important signal for this particular call. As we get more data into the launch, I think we'll update based on the most relevant trends related to the launch.

[Operator]

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

[Marc Goodman, Analyst at Leerink Partners]

Nick, can you talk about where you think AUVELITY gross nets will settle out in, let's say, two years after both of these indications are kind of going. Just for depression alone, first line, second line, what % are we up to now? Thanks.

[Nick Pizzie, CFO at Axsome Therapeutics]

Sure. Hey, Marc. Maybe first, where we were for AUVELITY and GTN for this quarter, we were around 50%, as I shared in the opening remarks. That's obviously with the increase in covered lives and also with improving the quality of coverage to first line or first switch. As you allude to, in a couple of years, we anticipate Medicare scripts to become as a higher proportion of scripts compared to commercial. What we've shared longer term is that we would anticipate GTN to remain in the 50s. We'll be able to give better guidance probably towards the end of the year as we see this launch grow in ADA.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

As it relates to first, second line use, in this quarter, we saw about more than half of patients, 56% were treated in a first or second line setting. As we've shared previously, we don't have a particular % in mind. We know that AUVELITY has been effective in patients as early as treatment naive and as late as treatment experienced. We're very comfortable with what we've seen over the past few years, and it's certainly supporting continued growth in both MDD and Alzheimer's agitation.

[Operator]

Thank you. Our next question is coming from Ami Fadia from Needham & Company. Your line is now live.

[Ami Fadia, Managing Director at Needham & Company]

Hi, good morning. Thanks for taking my question. Maybe if you can talk about some of the market dynamics with SYMBRAVO and talk about the evolution of the adoption rate there and how you see that progressing over the coming months. Thank you.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah, thanks for the question. I mean, we're very pleased with the underlying demand for SYMBRAVO. As we stated earlier, it grew 30% versus Q1. We're receiving very positive feedback from both patients and providers around SYMBRAVO's clinical profile and impact on patients. We expect that to continue. We mentioned that our sales force is expanding to approximately 150 sales representatives. That will enable us not only to call on higher decile headache specialists with more frequency, but also continue to expand and penetrate the primary care setting, which has been a key source of growth over the past several quarters.

[Operator]

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

[Matt Barcus, VP of Equity Research at Jefferies]

Hey. Good morning and congrats on the quarter. This is Matt Barcus on for Andrew Tsai. I just want to ask, can you confirm what the exact percentage of your Alzheimer's agitation scripts or samples right now? Since samples tend to run out in two to three weeks, any patient in June, July, a sample should be converting to an actual patient by now, you think? Is the total AUVELITY weekly script growth in the last couple of weeks representative of the weekly growth profile that could be going forward? Would you absolutely expect a faster cadence in August and September compared to June and July?

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. Thanks for the question. We don't share specific details regarding sampling as a proportion of overall demand, but we've been very pleased with the overall demand for samples in the community setting. Again, think that that's a very important aspect of the launch to support effective titration for elderly patients. In terms of weekly growth, as we mentioned, we've got eight weeks of data that we're sharing today. We expect to learn much more in the coming months related to the launch, but we've been very pleased with the early indicators.

[Operator]

Thank you. Our next question is coming from Pete Stavropoulos from Cantor Fitzgerald. Your line is now live.

[Pete Stavropoulos, Director of Equity Research at Cantor Fitzgerald]

Good morning and congrats on the quarter. Thank you for taking my question. For AXS-12, reboxetine. There was the first approval of an orexin-2 receptor agonist last week. How do you think about the underlying commercial opportunity for reboxetine in the narcolepsy market that has this new class of drug approved? Also, have you had discussions with payers around the profile of AXS-12 and possible pricing?

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Great. Thanks for the question. I'll take the first part of that question, and Ari can take the second part. If you look at the narcolepsy market, we know that it is characterized by a lot of heterogeneity in the narcolepsy patient population. More treatment options are better for patients. We're excited by the potential for AXS-12 to provide a new and differentiated treatment option for patients living with narcolepsy. If you think about it mechanistically, it works on the orexin pathway. Orexin stimulates the locus coeruleus to produce norepinephrine, and AXS-12 also stimulates norepinephrine production. What we like about AXS-12 clinically are a few things. One, it works very quickly. We have onset of action, which is demonstrated at one week. Secondly, the efficacy is durable. We have data out to six months. If you look at the side effect profile, it is very favorable.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

You combine that with a first-in-class mechanism of action for narcolepsy. Also, you look at the clinical data, which shows that there is the potential to affect EDS as well as cognition. We're very excited by the potential to provide a new treatment option for patients, and we think that that will be welcome in the marketplace.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. Regarding your question about market access, we've had very productive conversations with payers as they're learning more about AXS-12, and obviously there's a lot of interest in narcolepsy. We won't comment on pricing until closer to the launch, but we feel very optimistic about the potential for patient access for AXS-12.

[Operator]

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

[Ram Selvaraju, Managing Director at H.C. Wainwright]

Thanks so much for taking our question. Congrats on the quarter. Just wanted to see how you're thinking about the relative positioning of balipodect in schizophrenia, and if you are thinking about specific treatment combinations positioning as adjunct treatment versus standalone, and what the prospects are for applicability of this drug in neuropsych indications beyond schizophrenia down the road. Thank you.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Sure. Thanks, Ram, for the question. We're really excited by the prospects for balipodect in schizophrenia. Right now, what we're doing is we are conducting chemistry manufacturing and controlled activities to enable the start of a phase III trial in schizophrenia. Stay tuned. That work is well underway, and that is a priority for that program. Other indications that we're looking at are Tourette syndrome. We've stated that we do intend to initiate a phase II trial in that indication also. That molecule and the clinical programs are progressing. As it relates to how it would be used, either as monotherapy or with other products, it's too early. We want to do the experiment, and that is the phase III trial. We are encouraged by the results of the phase II trial, which was conducted in this patient population, which showed a very significant treatment effect.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

If you look at the product as well as a favorable side effect profile, which dovetails very nicely with the unique mechanism of action of the product.

[Operator]

Thank you. Our next question today is coming from David Amsellem from Piper Sandler. Your line is now live.

[David Amsellem, Managing Director at Piper Sandler]

Thanks. On ADA, and I know these are early days, but do you have a good read regarding how the drug is being used relative to reuptake inhibitors? Are you seeing usage in frontline or downstream of reuptake inhibitors that historically have been used off-label in ADA, or maybe a mix of both? Just wondering if you have a sense of where the usage mix is falling again in these early days. Thank you.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks for the question, David. I think the data is limited at this point regarding where patients are coming from, if they're switching from SSRIs, SNRIs, atypical antipsychotics. The line of treatment, we'll learn more as the launch progresses. I would say in general, the anecdotal feedback we're getting is that the drug is working per the label, meaning that we're seeing a rapid onset of action, a reduction in both the severity and frequency of symptoms, and the safety tolerability profile has been viewed favorably by both HCPs and care partners alike. I think we'll learn more in the coming weeks and months about line of usage and where the patients are coming from. We're very pleased with the early response we're hearing.

[Operator]

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

[Jason Gerberry, Managing Director at Bank of America]

Hey, guys. Thanks for taking my question. It sounds like some impressive physician or prescriber expansion metrics, I think plus 6,500, I think I heard. That, I guess, breadth of prescriber expansion, how much of that is just neurologists, someone who's maybe more of a unique prescriber to ADA versus, say, primary care, a type of prescriber that might be prescribing AUVELITY across both indications? I don't know if you have a sense of, as you're seeing that prescriber base expand, if it's more just breaking into the newer prescribers unique for ADA, or if you're getting prescribers who could potentially drive growth in both indications. Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks, Jason. I think for the Q2 data, it's largely related to our sales force expansion, and we're very pleased with those early signals as it relates to new writer activation and obviously NBRX or new-to-brand prescription growth, which largely is coming from the sales force expansion and predominantly from growth within the MDD indication. For this particular quarter, I would say neuros may not be representative necessarily. Primary care is the predominant growth driver within Q2 data specifically. Obviously, as the launch progresses in Alzheimer's agitation, we would expect to see more specialists adopt. For this particular quarter, I would say that really nice growth in the psych specialties, but faster growth within primary care.

[Operator]

Thank you. Our next question is coming from Sean Laaman from Morgan Stanley. Your line is now live.

[Sean Laaman, Analyst at Morgan Stanley]

Good morning. Thanks for taking my question. Hope everyone's well. Just thinking to your peak revenue assumptions for AUVELITY. Which of these would have the greatest impact among prescriber activation, long-term care penetration, treatment duration, payer access, and market expansion into previously untreated patients? Which has the greatest sensitivity?

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks for the question. I think all of those things are important. Obviously, we'll be focused on all aspects in accelerating new writer activation. I think new-to-brand prescriptions are a really important leading indicator of long-term growth potential, that's a key area of focus. As we've demonstrated our ability to expand market access and payer coverage for our brands has also been very positive. I would say it's difficult to pick just one of the elements that you're describing. From a commercial perspective, we're focused on improving execution across the board.

[Operator]

Thank you. Next question today is coming from Brian Skorney from Baird. Your line is now live.

[Brian Skorney, Managing Director at Baird]

Hey, good morning, everyone. Thanks for taking my question. I was hoping you could help us think through a little more on the sampling impact in the early days of the Alzheimer's agitation launch. Are these free samples at point of care? Is this primarily a coupon card that's issued at point of care or online and turned in at the pharmacy that covers the full cost of treatment? Just trying to think, would it be reasonable to assume most of the NBRXs in Alzheimer's agitation right now are free samples? For a Medicare patient, would the goal be to have them on commercial at the first refill? Do you see sampling as a bridge to securing best coverage for the patient, or is it to getting over initial abandonment of the new prescription over the copay? Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. Thanks for the question, Brian. When we refer to sampling, we're primarily talking about free samples, a trial offer that is provided to community-based settings where the clinicians are able to give a sample to a patient or care partner during an office visit. It's an important aspect of any launch in order to encourage trial and to really give early patient experience with the product. As you can imagine, in the Alzheimer's population, there's a heightened sensitivity just to the patients and safety tolerability aspects. This gives them a chance to see how the drug performs in advance of a first prescription. We expect to continue to sample as appropriate.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

It's been applauded by the clinician community primarily because it allows the patient to go home with the titration doses in order to get up to steady state on the maintenance dose when they're home. I think we'll have more to share down the road as we see more data related to sample conversion. I would just say that samples are not prescriptions, they're not showing up in the IQVIA data. That's an important factor as you think about it.

[Operator]

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

[Joseph Thome, Managing Director at TD Cowen]

Hi there. Good morning, and thank you for taking my question. Maybe on binge eating disorder, can you comment on the clinically meaningful result that you're looking for later this year on reduction in episodes? Is it just that sig and placebo response in binge eating disorder studies can sometimes be reasonably high, especially if the patient population maybe isn't severe enough. Can you comment on your overall level of comfort with the patient population that you did enroll in this trial? Thank you.

[Herriot Tabuteau, CEO at Axsome Therapeutics]

We're very comfortable with the patient population. We think that we designed a study, and we were enrolling patients that are appropriate to be studied in a clinical trial in binge eating disorder. As it relates to bogies, we don't have any. We designed the study, we've powered it for statistical significance, and that's what we're looking for.

[Operator]

Thank you. Next question is coming from Ben Burnett from Wells Fargo. Your line is now live.

[Ben Burnett, Analyst at Wells Fargo]

Hi, good morning. I also wanted to ask about AUVELITY and the new-to-brand growth rate that you mentioned, the 26% quarter-over-quarter. Just wanted to see if we could get maybe a little bit more context for this number. How does this number compare to the prior period in Q1? Just based on what you're seeing, what kind of growth should we be thinking about in Q3? Thank you.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks for the question. Regarding the new-to-brand growth rate, I think one thing that could be helpful, in the first quarter, we saw essentially equivalent growth from both a total prescriptions and a new-to-brand prescriptions perspective. In Q2, we saw a step-up in growth, 26% with new-to-brand prescriptions and 12% for total prescriptions. I think that's a strong signal of the impact of our sales force expansion in the quarter, we would expect that to continue to build into the second half of the year.

[Operator]

Thank you. Our next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.

[Graig Suvannavejh, Managing Director at Mizuho Securities]

Hey, good morning. Thanks for taking my questions. It's really related to how we should all think about Alzheimer's disease agitation and uptake there. Trying to get a sense of if you could provide some color on how we should think about the smoothness of the uptake, do you anticipate that whether it's due to the sales force expansion or just greater awareness, that there will be a sharp inflection, whether there are formulary approval dynamics, anything that could give us a better sense of how we should think about the uptake over the next several quarters or year for that matter? Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. Thanks, Graig. I think a couple points I'd point to. Number one, we expanded the sales force, and in the quarter, we saw meaningful acceleration in new-to-brand prescriptions and new writer activation. As you know, with eight weeks of launch data in Alzheimer's agitation, the majority of that growth came from MDD. We expect MDD to grow as Alzheimer's agitation launch is ramping up. I think we'll have more to say, obviously, with more data on the Alzheimer's launch. The early indicators are very promising. I think it's premature to say exactly what the inflection will look like, but the early signals that we shared earlier, including the NBRX growth, the positive clinical experience we've received, the growth in patients 65 and older, all point to very strong leading indicators that we expect to build throughout the rest of the year.

[Operator]

Okay. The next question is coming from David Hoang from Deutsche Bank. Your line is now live.

[David Hoang, Director of Equity Research at Deutsche Bank]

Hi there. Thanks for taking my questions. I want to ask a little bit about any, let's say, qualitative commentary you may be getting from your field force about how docs are thinking about the decision for a branded product in Alzheimer's agitation. Obviously, there is the Rexulti is the other approved product out there. Any color commentary on how docs are approaching AUVELITY versus Rexulti would be helpful. Are you hearing anything in terms of step edits or prior authorization that payers are asking for ADA? Thank you.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. Thanks, David. I think, first of all, there's still significant need for provider education in the Alzheimer's disease agitation market. This is a market that did not have any approved products just a couple of years ago. There's still some education required, which we've been really proud to be a part of. Treatment intervention has often been reserved for more severe forms of agitation, particularly in primary care, and so that's been a point of education regarding the benefits and rationale for earlier innovation. As it relates to branded products, I think ultimately, providers want to help patients, and there has not been anything approved with this type of profile historically, and so there's a lot of interest in learning more about the clinical profile, both from an efficacy, safety tolerability standpoint.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

The leading indicators, I think, are very promising in that regard. From an access standpoint, we're really pleased with the coverage that we had at launch, a 100% coverage in the Medicare channel. More than 75% of patients do not require a PA. Of course, PAs can still pop up depending on the patient's coverage. In terms of step edits, by and large, we're very pleased that patients will gain access to AUVELITY based on their prior treatment experience or based on the coverage that they have. All of those things really point to continued progress in the launch moving forward, and we'll obviously share more updates as we get more data moving forward.

[Operator]

Thank you. The next question is coming from Yatin Suneja from Guggenheim. Your line is now live.

[Analyst at Guggenheim]

Hi, this is Eddie on for Yatin. Thanks for taking our question. Acknowledging it's still very early, what are prescribers telling you about early patient response and continuation on AUVELITY in ADA? Are you picking up any differences by prescriber setting, just in terms of how they're monitoring or plan to monitor and follow up with patients as they get treated? Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Thanks for the question, Eddie. The response has been really consistent regardless of setting of care or specialty. That is that AUVELITY has been effective at reducing both the frequency and severity of agitation symptoms with a favorable safety tolerability profile. We'll obviously learn more as the launch progresses, but so far it's been very consistent, both in terms of specialists as well as setting of care.

[Operator]

Thank you. Next question is coming from Madison Elsaadi from B. Riley Securities. Your line is now live.

[Madison Elsaadi, Analyst at B. Riley Securities]

Good morning, guys. Thanks for taking our question. Maybe on the 2Q revenue, how much of that reflects any channel stocking versus dispense demand? Sorry if I missed it. If you could just help clarify the underlying operating cash burn, if you strip working capital and everything away, just asking in the context of your path to breakeven. Thanks.

[Nick Pizzie, CFO at Axsome Therapeutics]

Sure, Madison. First off, the full revenue this quarter was related to demand. There was no stocking at the end of the quarter. We continue to be roughly at two weeks of inventory on hand, no change as it relates to that. If you take a look at our cash burn for the quarter, it was somewhere in the neighborhood of $24 million, $25 million, taking the net loss and backing out the majority of the non-cash loss is related to stock-based comp, more than half of that. You're in the neighborhood of the low to mid-20s from a cash burn.

[Nick Pizzie, CFO at Axsome Therapeutics]

What we've shared is that our SG&A for the remainder of the year is we would anticipate it to essentially plateau to where we are this quarter in Q2 of $208 million as we're fully staffed and built a foundation for AUVELITY as well as SYMBRAVO. R&D will continue to tick up as we've commenced the ADHD trials. Importantly, we should see operating leverage continue in the back half of the year. We saw that this quarter with revenues growing at 14% and OPEX growing at 7%.

[Operator]

Thank you. Our next question is coming from Myles Minter from William Blair. Your line is now live.

[Analyst at William Blair]

Hey, team, this is John on for Myles. Thanks so much for taking our question. I was wondering if you can give us any updated plans for the DTC campaign for AUVELITY with the ongoing launch in AD agitation. Thanks.

[Ari Maizel, Chief Commercial Officer at Axsome Therapeutics]

Yeah. Thanks, John. Obviously, DTC is an important part of our marketing mix, and we've been pleased with the impact of our direct-to-consumer investments across really all of our brands, but AUVELITY specifically over the past year or so. Given that it's still only eight weeks into the launch, we're assessing the potential for a more substantial DTC effort. Right now, we are investing in consumer marketing, primarily focused on care partners. The potential for something more broad reaching, like TV or video advertising, is something that we'll continue to evaluate as the launch progresses.

[Operator]

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

[Herriot Tabuteau, CEO at Axsome Therapeutics]

Well, thank you. Our Axsome business advanced significantly in the second quarter. Our commercial strategy is translating into growing adoption of our medicines. Our pipeline continues to progress towards multiple milestones with substantial value creation potential. Our strong financial position allows us to continue investing behind our strategic priorities to maximize the long-term potential of our portfolio of medicines. We are excited for the remainder of the year and look forward to sharing updates on our progress. Thank you all for joining us, and have a great day.

[Operator]

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

Participants

Executives

• Ashley Dong, Senior Director of Investor Relations
• Herriot Tabuteau, CEO
• Nick Pizzie, CFO

Analysts

• Ari Maizel, Chief Commercial Officer at Axsome Therapeutics
• Leonid Timashev, Director of Equity Research at RBC Capital Markets
• Malcolm Hoffman, VP of Equity Research at BMO Capital Markets
• Ash Verma, Executive Director at UBS
• Rudy Li, Director of Equity Research at Wolfe Research
• Marc Goodman, Analyst at Leerink Partners
• Ami Fadia, Managing Director at Needham & Company
• Matt Barcus, VP of Equity Research at Jefferies
• Pete Stavropoulos, Director of Equity Research at Cantor Fitzgerald
• Ram Selvaraju, Managing Director at H.C. Wainwright
• David Amsellem, Managing Director at Piper Sandler
• Jason Gerberry, Managing Director at Bank of America
• Sean Laaman, Analyst at Morgan Stanley
• Brian Skorney, Managing Director at Baird
• Joseph Thome, Managing Director at TD Cowen
• Ben Burnett, Analyst at Wells Fargo
• Graig Suvannavejh, Managing Director at Mizuho Securities
• David Hoang, Director of Equity Research at Deutsche Bank
• Analyst at Guggenheim
• Madison Elsaadi, Analyst at B. Riley Securities
• Analyst at William Blair