AXSM Q4 Loss Wider Than Expected, Revenues Surge Y/Y on Auvelity Sales

Axsome Therapeutics AXSM incurred a loss of 71 cents per share in the fourth quarter of 2025, wider than the Zacks Consensus Estimate of a loss of 70 cents. The company had incurred a loss of 96 cents per share in the year-ago quarter.

Axsome’s total revenues surged 65% year over year to $196 million in the fourth quarter, beating the Zacks Consensus Estimate of $193 million. The year-over-year increase in revenues can be primarily attributed to strong sales of Auvelity, which is approved for treating major depressive disorder (MDD) as well as other marketed drugs.

In the past six months, shares of Axsome have soared 50.3% compared with the industry’s rise of 22.8%.

AXSM’s Q4 Earnings in Detail

Total revenues in the fourth quarter consisted of product revenues from Auvelity, Sunosi (solriamfetol) and Axsome’s newest drug, Symbravo (meloxicam and rizatriptan), as well as royalty and milestone revenues.

Net product revenues were $194.7 million in the quarter, reflecting an increase of 66% year over year. Royalty revenues totaled $1.3 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.

Product revenues in the fourth quarter benefited from the strong sales uptake of lead marketed product, Auvelity and Sunosi, the latter being approved for treating narcolepsy.

Auvelity recorded sales of $155.1 million, up 68% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $151 million.

Per Axsome, around 225,000 prescriptions were recorded for Auvelity in the fourth quarter, reflecting a sequential increase of 8% and a year-over-year increase of 42%.

Sunosi’s net product sales were $36.7 million in the fourth quarter, up 40% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 11% year over year to 54,000. Sunosi's total prescriptions increased 3% on a sequential basis.

Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in 2022.

Jazz had received approval for Sunosi as a treatment for narcolepsy in 2019.

Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States.

Axsome’s newest drug, Symbravo, was launched in June in the United States. The drug recorded sales worth $4.1 million in the fourth quarter, up from $2.1 million recorded in the third quarter of 2025. The FDA approved Symbravo in January 2025 for the acute treatment of migraine with or without aura in adults.

Research and development expenses (including stock-based compensation) were $48.8 million, down 11.3% from the year-ago quarter’s level. The decrease was due to the completion of the label expansion studies of Sunosi and AXS-05 in Alzheimer’s disease agitation.

Selling, general and administrative expenses (including stock-based compensation) totaled $169.3 million, up 49.4% year over year. The increase was due to higher commercial activities for Auvelity and the ongoing launch activities for Symbravo and other costs.

As of Dec. 31, 2025, Axsome had cash and cash equivalents worth $322.9 million compared with $325.3 million as of Sept. 30, 2025. Management believes that its cash balance as of December-end is enough to fund future operations into cash flow positivity.

AXSM's Full-Year Results

In 2025, Axsome generated revenues of $638.5 million, which reflected 66% growth year over year.

For the same period, the company reported an adjusted loss of $3.68 per share, narrower than a loss of $5.99 in the year-ago period.

AXSM's Recent Pipeline Updates

Axsome is evaluating Auvelity in several label expansion studies for other central nervous system (CNS) disorders.

The FDA recently accepted Axsome’s supplemental new drug application (“sNDA”) seeking approval for AXS-05 for the treatment of patients with Alzheimer’s disease agitation. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on April 30, 2026.

Axsome also plans to start a pivotal phase II/III study of AXS-05 for treating smoking cessation in the second quarter of 2026.

Other pipeline candidates include AXS-12 and AXS-14, which target multiple CNS indications.

AXS-12 is currently being evaluated in late-stage studies for the treatment of narcolepsy. Axsome recently announced that it has received formal pre-NDA meeting minutes from the FDA supporting a potential NDA submission for AXS-12 in narcolepsy. The company remains on track to submit the application later in the first quarter.

Last month, Axsome announced the initiation of the phase III FORWARD study with the dosing of the first patient, evaluating AXS-14 (esreboxetine) for the management of fibromyalgia.

AXSM's Label Expansion Studies on Solriamfetol

Axsome is evaluating solriamfetol in separate phase III studies for treating attention-deficit hyperactivity disorder (ADHD) and MDD.

The company plans to initiate separate phase III studies on solriamfetol for treating ADHD in children and adolescents in the first half of 2026.

In a separate press release, Axsome announced that it has initiated the phase III CLARITY study evaluating solriamfetol for the treatment of MDD patients with EDS symptoms.

The company is also evaluating solriamfetol in separate phase III studies for treating binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).

Top-line data from the ENGAGE study evaluating solriamfetol for treating BED is expected in the second half of 2026. Top-line data from the SUSTAIN study evaluating solriamfetol for treating SWD in adults is expected in 2027.

Axsome Therapeutics, Inc. Price, Consensus and EPS Surprise

Axsome Therapeutics, Inc. price-consensus-eps-surprise-chart | Axsome Therapeutics, Inc. Quote

AXSM's Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Castle Biosciences CSTL, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have increased from $3.72 to $4.00. HRMY shares have fallen 28.5% in the past six months.

Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average earnings surprise being 7.20%.

Over the past 60 days, Castle Biosciences’ 2026 loss per share estimates have narrowed from $1.06 to 96 cents. CSTL shares have rallied 40.8% over the past six months.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.

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