Axsome Therapeutics touts AUVELITY $155M quarter, doubles salesforce ahead of April FDA decision

Key Points

• AUVELITY generated $155 million in quarterly revenue and is annualizing north of $600 million just 13 quarters after launch, yet penetration remains small at about 0.2% of the antidepressant market; Axsome plans to double its salesforce from 300 to 600 reps to drive further uptake and support a potential Alzheimer’s agitation launch.
• Axsome’s supplemental NDA for AXS-05 in Alzheimer’s disease agitation is under priority review with a PDUFA date of April 30, and the submission includes long-term safety data (~100 patients at 12 months, ~300 at six months).
• Management reported strong financial traction—revenues outpaced operating expense growth 3-to-1 in 2025—and expects continued operating leverage despite higher DTC spending that raised SG&A from ~$150 million in Q3 to nearly $170 million in Q4, with 2026 spending forecast between those levels.

Axsome Therapeutics NASDAQ: AXSM executives highlighted expanding commercial momentum for AUVELITY and a slate of regulatory and clinical catalysts extending into 2026 during TD Cowen’s 46th Annual Healthcare Conference. COO Mark Jacobson and CFO Nick Pizzie said the company is seeing operating leverage as revenue growth outpaces operating expense growth, while advancing multiple late-stage programs across central nervous system (CNS) indications.

AUVELITY growth and commercial expansion plans

Pizzie said AUVELITY generated $155 million in quarterly revenue, and that 13 quarters from launch the product is “already annualizing north of $600 million.” Management emphasized that despite that run rate, AUVELITY’s penetration remains small relative to the broader antidepressant market. Pizzie described the current footprint as about 0.2% of the total antidepressant market.

Jacobson provided additional detail on prescribing patterns, saying that for the past few months more than 50% of prescriptions have been monotherapy, and about 50% are first-line or first-switch therapy. He broke that down further as roughly 15% first-line and about 35% first-switch. Jacobson also said primary care clinicians account for about 30% (about one-third) of AUVELITY writers.

Both executives pointed to market opportunity and prior return-on-investment analysis as drivers behind a planned sales force expansion. Pizzie said Axsome plans to increase its field force from 300 to 600 representatives, describing the decision as based on learnings from prior expansions and expected ROI, as well as preparation for a potential new indication in Alzheimer’s disease agitation.

On the cost side, Pizzie said the company saw “great operating leverage” in 2025, with revenues outpacing operating expenses 3-to-1. He added that Axsome expects continued operating leverage even with planned commercial expansion and a potential 2026 launch if FDA approval is received.

DTC advertising learnings and spending expectations

Pizzie said Axsome launched its first national direct-to-consumer campaign for AUVELITY in early September and ran it through year-end, using cable TV and connected TV. He said the company expects to continue DTC programming through 2026, but not at the same intensity as in the fourth quarter, when the campaign ran daily and weekly.

He tied that activity to selling, general and administrative expense, noting that SG&A rose from $150 million in Q3 to nearly $170 million in Q4 during heavier DTC spending. Pizzie said the company does not expect Q4’s level to represent a 2026 baseline, and anticipates a level “in between” Q3 and Q4. He also said Axsome expects improved DTC ROI once the field force is expanded, because representatives can “pull through” consumer-driven interest.

Alzheimer’s disease agitation: priority review and April PDUFA

Jacobson reiterated that Axsome’s supplemental NDA for AXS-05 in Alzheimer’s disease agitation is under priority review, with a PDUFA date of April 30. He said the company does not comment on day-to-day FDA review details, but stated that “two months out,” activities are where they would be expected to be for a priority review. He also reviewed typical timing windows for labeling discussions and post-marketing requirements, noting that the company is beyond those rough milestones.

In discussing the clinical package, Jacobson described how Axsome views the contribution of different trial designs:

• Parallel-group studies (including ADVANCE-1 and ADVANCE-2) help evaluate longitudinal change and provide controlled safety data in an elderly, higher-risk population. Jacobson said ADVANCE-1 showed statistically significant separation versus placebo, with separation observed at two weeks and statistical significance at three weeks, and the primary endpoint at five weeks.
• Randomized withdrawal trials support assessment of duration of effect and relapse prevention, and the company pursued them in part because they “tend to be better for signal detection” amid rising placebo and “trial response” in neuropsychiatric studies.

Jacobson also outlined the standalone safety database FDA requested for the sNDA, saying the submission includes long-term exposure data of approximately 100 patients at 12 months and about 300 patients at six months.

When asked about ADVANCE-2 missing statistical significance, Jacobson said the trial separated numerically and noted the impact of “trial response” in this population, where improved medical attention during a study can benefit patients regardless of treatment arm. He also pointed to increasing placebo response across neuropsychiatric indications as a factor Axsome considered in its broader development strategy.

On market size, Jacobson said there are about 7 million Alzheimer’s patients in the U.S., and Axsome estimates 70%+ have agitation. Pizzie added that there are roughly 20 million+ scripts currently written, “majority off label,” for Alzheimer’s disease agitation.

Commercial approach for a potential Alzheimer’s launch and market access

Management said the planned AUVELITY sales force could also support Alzheimer’s disease agitation due to overlap in prescribers. Jacobson said the same team would call on both depression and agitation targets, with mix varying by geography. He also said Axsome is building a smaller, separate team to target long-term care (LTC) settings, which the company does not currently call on.

On market access, Pizzie contrasted AUVELITY’s earlier access hurdles with expectations for an Alzheimer’s agitation indication. He said AUVELITY currently has 86% total covered lives in MDD and 100% commercial coverage because MDD is a protected class. For Alzheimer’s agitation, he said the company expects 100% coverage in the government channel and that more than 70% of scripts would be written in Medicare Part D, which he characterized as providing favorable access.

Discussing Rexulti as the only approved product for Alzheimer’s agitation, Pizzie said he believes 15%–20% of Rexulti scripts are coming from that indication in Part D, potentially up to 25%, and that most of the product’s growth is now coming from the Alzheimer’s agitation indication. Jacobson cautioned that while Rexulti is a relevant analog, comparisons may be imperfect due to differences in mechanism, profile, and the fact that some products were already used off-label in the space.

Pipeline updates: Simbravo, AXS-12, Sunosi expansions, and AXS-14

Jacobson said the company’s pipeline includes five product candidates across nine indications. For Simbravo, he described a targeted launch with about 100 representatives focused on headache centers and high prescribers of branded acute migraine treatments. He said payer management makes access a key factor, and noted that Axsome recently signed with a third GPO, covering the three major GPOs, with work underway to convert those agreements into plan coverage and placement.

For AXS-12 in narcolepsy type 1 (cataplexy), Jacobson said a pre-NDA meeting at the end of the year provided a “green light” to submit, and that the NDA is expected imminently. He emphasized fit with Axsome’s existing sleep commercial infrastructure detailing Sunosi, describing AXS-12 as “plug and play” with limited incremental investment needed if approved. Pizzie provided an estimate for peak sales potential of $500 million to $1 billion.

On Sunosi expansion opportunities, Jacobson cited “very compelling” phase III adult ADHD results and said Axsome aligned with FDA on pediatric development. He said the company will run two parallel studies—one in children and one in adolescents—starting in the first half of this year, and described the change as not impacting overall timeline and not materially changing program investment. Pizzie said Axsome views ADHD as the largest opportunity, estimating $1 billion to $3 billion in peak sales potential.

Jacobson also discussed a “precision approach” study in major depressive disorder patients with symptoms of excessive daytime sleepiness, saying the trial is enrolling now following proof-of-concept data from the PARADIGM trial.

Finally, Jacobson addressed AXS-14 for fibromyalgia, stating that Axsome previously submitted an NDA that was refused to file because the phase II study, while highly statistically significant, was a fixed-dose study that was not 12 weeks long. He said Axsome has started the additional trial, the FORWARD study, which management expects to be the only new study needed based on subsequent alignment with FDA. The company has not yet provided timing guidance, Jacobson said, because it is Axsome’s first fibromyalgia study conducted internally and management wants more enrollment experience before forecasting timelines.

About Axsome Therapeutics NASDAQ: AXSM

Axsome Therapeutics, Inc 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.

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