AXSM Q3 Loss Wider Than Expected, Revenues Surge Y/Y on Auvelity Sales

Axsome Therapeutics AXSM incurred a loss of 94 cents per share in the third quarter of 2025, wider than the Zacks Consensus Estimate of a loss of 82 cents. The company had incurred a loss of $1.34 per share in the year-ago quarter.

Axsome’s total revenues surged 63% year over year to $171 million in the third quarter, beating the Zacks Consensus Estimate of $164 million. The year-over-year increase in revenues can be attributed to strong sales of Auvelity (which is approved for treating major depressive disorder (MDD).

Year to date, shares of Axsome have soared 60.5% compared with the industry’s rise of 12.1%.

AXSM’s Q3 Earnings in Detail

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

Net product revenues were $169.8 million in the quarter, reflecting an increase of 63.7% year over year. Royalty revenues totaled $1.2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.

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

Auvelity recorded sales of $136.1 million, up 69% year over year and 14% sequentially. Sales of the drug beat our model estimate of $127.7 million.

Per Axsome, around 209,000 prescriptions were recorded for Auvelity in the third quarter, reflecting a sequential increase of 9% and a year-over-year increase of 46%.

Sunosi’s net product sales were $32.8 million in the third quarter, up 35% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 12% year over year to 53,000. Sunosi's total prescriptions increased 5% 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 $2.1 million in the first full quarter since its launch. 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 $40.2 million, down 11.5% from the year-ago quarter’s level. The decrease was due to the completion of the label expansion studies of Sunosi.

Selling, general and administrative expenses (including stock-based compensation) totaled $150.2 million, up 57.1% 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 Sept. 30, 2025, Axsome had cash and cash equivalents worth $325.3 million compared with $303 million as of June 30, 2025.

AXSM's Recent Pipeline Updates

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

Along with the earnings release, the company announced that it has filed a supplemental new drug application (sNDA) for AXS-05 to the FDA as a treatment for agitation in Alzheimer’s disease (AD).

Axsome also plans to start a pivotal phase II/III study of AXS-05 for treating smoking cessation later in the fourth quarter of 2025.

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

AXS-12 is currently being developed in multiple studies for the treatment of narcolepsy. AXSM plans to submit a new drug application (NDA) for AXS-12 for treating cataplexy in patients with narcolepsy to the FDA later in the fourth quarter of 2025.

Axsome plans to initiate a fixed-dose, phase III, 12-week study on AXS-14 for treating fibromyalgia later in the fourth quarter of 2025. In June, Axsome received a Refusal to File (RTF) letter from the FDA related to its NDA for AXS-14 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 a phase III study on solriamfetol for treating ADHD in pediatric patients later in the fourth quarter of 2025.

Axsome plans to initiate a phase III study on solriamfetol in MDD patients with excessive daytime sleepiness later in the fourth quarter of 2025.

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 and the SUSTAIN study, evaluating solriamfetol for treating BED and SWD in adults, respectively, are expected in 2026.

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 ANI Pharmaceuticals ANIP and Intellia Therapeutics NTLA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 70.2%.

ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.

In the past 60 days, estimates for Intellia’s loss per share have narrowed from $4.15 to $4.11 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.12 to $4.07. Year to date, shares of NTLA have gained 12.1%.

Intellia’s earnings beat estimates in each of the trailing four quarters, the average surprise being 6.21%.

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