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AXSM Q1 Loss Widens, Revenues Jump on Higher Auvelity Sales

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Key Takeaways

  • AXSM reported wider Q1 loss, but delivers 57% revenue growth, beating estimates.
  • Auvelity sales surged 59% to $153 million, driven by strong prescription gains.
  • Sunosi grew steadily, while Symbravo misses estimates despite rising prescriptions.

Axsome Therapeutics (AXSM - Free Report) incurred a loss of $1.26 per share in the first quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 85 cents. The company had reported a loss of $1.22 per share in the year-ago quarter.

Axsome’s total revenues surged 57.4% year over year to $191.2 million in the first quarter, beating the Zacks Consensus Estimate of $189 million. The year-over-year increase in revenues was primarily driven by strong sales of Auvelity (AXS-05), which is approved for the treatment of major depressive disorder (MDD) as well as other marketed drugs.

AXSM’s Q1 Earnings in Detail

Total revenues in the first 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 $189.4 million in the quarter, reflecting an increase of 57.4% year over year. Royalty and milestone revenues totaled $1.8 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.

Auvelity recorded sales of $153.2 million, up 59% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $144 million.

Per Axsome, around 223,000 prescriptions were recorded for Auvelity in the first quarter, reflecting a year-over-year increase of 35%.

In April 2026, the FDA approved Axsome’s supplemental new drug application (“sNDA”) seeking approval of Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease (AD). The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies. The company remains on track to commercially launch Auvelity for this indication in June 2026.

Sunosi’s net product sales were $33.9 million in the quarter, up 34% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 16% year over year to 54,000.

Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) 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 $4.1 million in the first quarter and were in line with the prior quarter. However, Symbravo’s sales missed the Zacks Consensus Estimate of $6.7 million.  

Total prescriptions for Symbravo grew 36% sequentially to 17,000 in the first quarter of 2026.

Despite the earnings miss, shares of AXSM rose 8% on Monday, likely due to the better-than-expected sales performance of its marketed products and the newest approval for Auvelity in AD.

Year to date, shares of Axsome have soared 22.5% against the industry’s 3.2% decline.

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Image Source: Zacks Investment Research

Research and development expenses (including stock-based compensation) were $52.7 million, up 17.6% from the year-ago quarter’s level, primarily due to a one-time acquisition-related expense.

Selling, general and administrative expenses (including stock-based compensation) totaled $185 million, up 53.1% year over year. The increase was due to higher commercial activities for Auvelity and Symbravo, and also the ongoing pre-launch activities for Auvelity for the Alzheimer’s disease agitation indication.

As of March 31, 2026, Axsome had cash and cash equivalents worth $305.1 million compared with $322.9 million as of Dec. 31, 2025. Management believes that its cash balance as of March-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 in the second quarter of 2026.

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

AXS-12 is currently being evaluated in late-stage studies for the treatment of narcolepsy. Axsome has submitted an NDA to the FDA seeking approval for the treatment of cataplexy in narcolepsy and expects to announce the FDA’s decision soon.

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 company has initiated phase II trial-enabling activities for the candidate.

In April 2026, Axsome entered into an asset purchase agreement with Takeda to obtain exclusive global rights to TAK-063 (balipodect), a novel oral PDE10A inhibitor, now designated AXS-20.The company plans to develop AXS-20 for schizophrenia and Tourette syndrome, with phase III trial-enabling activities in schizophrenia expected to begin in 2026.

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

The company plans to begin phase III studies in pediatric ADHD in the second quarter of 2026. The CLARITY study in MDD with excessive daytime sleepiness began in February 2026. Results from the ENGAGE (BED) study are expected in the second half of 2026, while data from the SUSTAIN (SWD) study is anticipated in 2027.

Axsome Therapeutics, Inc. Price, Consensus and EPS Surprise

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 Castle Biosciences (CSTL - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , 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 Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 34.4% year to date.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.26. Over the same period, EPS estimates for 2027 have risen from $3.40 to $3.57. INDV shares have risen 8.6% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.

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