Axsome's Q2 Earnings Meet Estimates, Auvelity Drives Y/Y Revenues

Axsome Therapeutics AXSM incurred a loss of 99 cents per share in the second quarter of 2026, which was in line with the Zacks Consensus Estimate. The company had reported a loss of 97 cents per share in the year-ago quarter.

Axsome’s total revenues surged 46% year over year to $218.4 million in the second quarter. The increase in revenues was primarily driven by strong sales of lead drug Auvelity (AXS-05) as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million.

Auvelity is approved for the treatment of major depressive disorder (MDD). In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies.

Year to date, shares of Axsome have rallied 21% compared with the industry’s increase of 6.1%.

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AXSM’s Q2 Earnings in Detail

Total revenues in the second 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 $216.4 million in the quarter, reflecting an increase of 45.2% year over year. Royalty and milestone revenues totaled $2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.

Auvelity recorded sales of $180.3 million, up 51% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $175 million.

Per Axsome, around 266,000 total prescriptions were recorded for Auvelity in the second quarter, reflecting a year-over-year increase of 34%.

Sunosi’s net product sales were $35.8 million in the quarter, up 20% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year to 61,000. Sunosi sales beat the Zacks Consensus Estimate of $33.4 million.

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

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 2025 in the United States. Sales of the drug came in at $2.3 million in the second quarter, down from $4.1 million recorded in the prior quarter. Symbravo’s sales missed the Zacks Consensus Estimate of $7.2 million. 

However, total prescriptions for Symbravo grew 30% sequentially to 23,500 in the second quarter of 2026.

Research and development expenses (including stock-based compensation) were $46.2 million, down 6.7% from the year-ago quarter’s level, primarily due to lower costs related to Auvelity and AXS-14.

Selling, general and administrative expenses (including stock-based compensation) totaled $208.1 million, up 59.7% year over year. The increase was due to higher commercial activities for Auvelity, including the ongoing pre-launch activities for the Alzheimer’s disease agitation indication and Symbravo.

As of June 30, 2026, Axsome had cash and cash equivalents worth $319.9 million compared with $305.1 million as of March 31, 2026. Management believes that its cash balance as of June-end is sufficient to fund future operations into cash flow positivity.

AXSM's Recent Pipeline Updates

Axsome plans to initiate a pivotal phase II/III study of AXS-05 for treating smoking cessation later in the third quarter of 2026.

Other pipeline candidates include AXS-12, AXS-14 and AXS-17, which target multiple central nervous system indications.

In July 2026, the FDA accepted Axsome’s new drug application (NDA) seeking approval for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. With the FDA accepting the NDA for review, a decision from the regulatory body is expected on May 1, 2027.

Axsome is evaluating the efficacy and safety of AXS-14 (esreboxetine) under the phase III FORWARD study for the management of fibromyalgia.

AXS-17 is another pipeline asset of Axsome, which is being developed for epilepsy. The phase II study-enabling activities for AXS-17 in epilepsy are underway. The company plans to develop AXS-20 for schizophrenia and Tourette syndrome, with phase III study-enabling activities in schizophrenia currently underway.

Axsome is advancing solriamfetol across multiple phase III studies for treating attention-deficit hyperactivity disorder (ADHD), MDD, binge eating disorder (BED) and shift work disorder (SWD).

The company recently dosed the first patient in the phase III FOCUS-2 study and the phase III FOCUS-3 study evaluating solriamfetol for the treatment of ADHD in children and in adolescents, respectively.

The phase III CLARITY study evaluating solriamfetol for the treatment of MDD patients with excessive daytime sleepiness symptoms began in February 2026.

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

AXSM's Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Repligen RGEN and Liquidia Corporation LQDA, 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 Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 0.4% year to date.

Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 163.9% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.

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This article originally published on Zacks Investment Research (zacks.com).

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