Axsome Therapeutics, Inc. Q3 FY2025 earnings call

Commercial Growth

• AUVELITY showed strong prescription growth with ~209,000 prescriptions in Q3, 46% YOY growth, and ~5,000 new prescribers activated. Primary care now accounts for ~1/3 of prescribers.
• SUNOSI had ~53,000 prescriptions in Q3, 12% YOY growth, with payer coverage at ~83% of lives covered.
• SYMBRAVO had over 5,000 prescriptions and over 3,300 new patients started in its first full quarter, with market access coverage at ~52% of all lives as of October 1.

R&D Pipeline

• Submitted supplemental NDA for AXS-05 in Alzheimer's disease agitation and on track to initiate Phase II/III trial in smoking cessation for AXS-05.
• Targeting NDA submission for AXS-12 in cataplexy in narcolepsy by Q4 2025.
• Plan to initiate Phase III trial in children and adolescents for solriamfetol in ADHD in Q4 2025, and Phase III trials in MDD with excessive daytime sleepiness and other indications in the near term.
• Preparations for Phase III trial of AXS-14 in fibromyalgia to launch before year-end.

In the third quarter, Axsome's total revenue was $171 million across 3 marketed products. AUVELITY had net product sales of $136.1 million in Q3 2025, up 69% year-over-year, contributing a significant revenue share. SUNOSI had net product revenues of $32.8 million in Q3 2025, up 35% year-over-year, with $31.6 million in net product sales and $1.2 million in royalty revenue. SYMBRAVO, in its first full quarter of commercial launch, generated $2.1 million in net sales.

Guidance

• Anticipate AUVELITY and SUNOSI gross-to-net discounts to increase to the low 50% range in Q4 2025 from the high 40% range in Q3.
• SYMBRAVO's gross-to-net discount is expected to remain elevated during the launch phase.
• Current cash balance of $325.3 million at the end of Q3 is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

Risks

• Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks detailed in SEC filings.
• Regulatory uncertainties such as potential delays or changes in FDA review timelines for NDAs.
• Impact of government shutdowns on the timing of FDA review of submissions.

Q: Congrats on the quarter. I actually wanted to ask on SYMBRAVO and your ability to extrapolate what you're seeing in the third quarter out to fourth quarter in 2026. I guess maybe can you talk about the increased depth of prescribing you're seeing and maybe what you'd like to see on the ground before you invest more in the launch and potentially in areas of bottleneck that are stopping additional patients from coming on therapy?

A: Ari Maizel: Leon, thanks for the question. This is Ari. Obviously, it's still very early in the SYMBRAVO launch. And our -- what we're seeing so far is very positive in terms of HCP and patient response. The drug is performing as well as we expected in the real-world setting. We are -- as a reminder, we've taken a very targeted and focused approach, focused on the top 150 headache centers as well as large neurology practices around the country. And our intent is to try to penetrate as many of those providers as possible. And as we observe the impact, we'll make further decisions around expansion or incremental investment for SYMBRAVO. But at this time, we're really pleased with the early response. There's still a lot of work to do, and we're in the early days. But we are really focused on increasing prescribing in our targeted clinicians. As we mentioned earlier, we've seen improvements in market access, which is also a key area of focus for us, and we'll share additional updates as the brand progresses.

Q: This is Basma on for Marc. We have a question on AUVELITY regarding the primary care segment, which seems to be contributing more and more to the scripts right now. Do you see this segment as a key growth driver for AUVELITY? And how do you envision growing this segment? Is it mainly through sales force expansion?

A: Ari Maizel: Yes. Thanks so much for the question. Yes, we believe primary care is a really important specialty area for AUVELITY in MDD, is largely because most patients in the U.S. present to primary care office upon diagnosis and many stay with primary care throughout the course of their depression episodes. As you mentioned, we are seeing very positive response in the primary care setting. It now represents roughly 1/3 of our subscriber base, and we're seeing strong performance in terms of new patient starts as well as overall prescriptions. In terms of how do we further grow the primary care segment, part of that is just our focused sales force effort. Obviously, we've expanded the team several times, and that has enabled us to reach more primary care clinicians on a routine basis. We believe the expanded market access that we've been able to accomplish over the past couple of years is also helping to ease the prescribing path for a primary care treater that may not have as many resources to support PA processing. And then finally, our direct-to-consumer campaign, which launched in the quarter, we're seeing early positive signals in terms of patient awareness, patient requests for the product, and we expect that to facilitate further growth in the primary care setting along with the psychiatry setting.