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AXSM Q1 Loss Narrower Than Expected, Auvelity Drives Revenues Y/Y
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Axsome Therapeutics (AXSM - Free Report) incurred an adjusted loss of $1.22 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.26. The company had incurred a loss of $1.44 per share in the year-ago quarter.
Axsome’s total revenues surged 62% year over year to $121.5 million in the first quarter, beating the Zacks Consensus Estimate of $119 million. The year-over-year increase in revenues can be attributed to strong sales of Auvelity (AXS-05). (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
Year to date, shares of Axsome have rallied 37.7% against the industry’s decline of 2.2%.
Image Source: Zacks Investment Research
AXSM's Q1 Earnings in Detail
Total revenues in the first quarter consisted of product revenues from Auvelity and Sunosi (solriamfetol) and royalty revenues.
Net product revenues were $120.4 million in the quarter compared with $74.1 million reported in the year-ago period. Royalty revenues totaled $1.1 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.
Product revenues in the first quarter benefited from the strong sales uptake of AXSM’s two marketed products, Auvelity for major depressive disorder (MDD) and Sunosi for narcolepsy.
Auvelity recorded sales of $96.2 million, up 80% year over year. Sales of the drug beat our model estimate of $88.3 million.
Per Axsome, around 167,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 5% and a year-over-year increase of 76%.
Sunosi’s net product sales were $25.2 million, up 17% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 12% year over year to 46,000. Sunosi total prescriptions declined 5% on a sequential basis.
Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 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 high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Research and development expenses (including stock-based compensation) increased to $44.8 million, up 21.7% from the year-ago quarter’s level. The increase was due to higher costs associated with clinical studies, especially the label expansion study of Sunosi and the upcoming launch of the newest drug, Symbravo.
The FDA approved Symbravo (meloxicam and rizatriptan) in January 2025 for the acute treatment of migraine with or without aura in adults. The company expects to launch Symbravo in the United States next month.
Selling, general and administrative expenses (including stock-based compensation) totaled $120.8 million, up 22% year over year. The increase was due to higher commercial activities for Auvelity, along with pre-launch activities for Symbravo and other costs.
As of March 31, 2025, Axsome had cash and cash equivalents worth $300.9 million compared with $315.4 million as of Dec. 31, 2024.
AXSM's Key Pipeline Updates
In February, Axsome announced top-line data from the open-label, phase III EMERGE study, which evaluated the efficacy and safety of Symbravo in patients experiencing an inadequate response to oral CGRP inhibitors.
Data from the same showed that treatment with Symbravo demonstrated a statistically significantly greater migraine treatment response compared to oral CGRP inhibitors, as measured by the Migraine Treatment Optimization Questionnaire (mTOQ-4) – the primary endpoint of the EMERGE study.
Meanwhile, Axsome is evaluating Auvelity in several label expansion studies for other central nervous system (CNS) disorders.
In March 2025, Axsome received formal feedback from the FDA about its plans to seek approval for AXS-05 as a treatment for agitation in Alzheimer’s disease (AD) patients.
The written feedback from the FDA confirmed that Axsome’s regulatory data package is sufficient to support the submission of a supplemental new drug application (sNDA) for AXS-05 in agitation associated with AD. Management expects to submit this sNDA in the third quarter of 2025.
The company also plans to start a pivotal phase II/III study of Auvelity for smoking cessation later in 2025.
Other pipeline candidates include AXS-12 and AXS-14, which target multiple CNS indications.
Along with the earnings release, Axsome announced that it has submitted an NDA to the FDA seeking approval of AXS-14 for the treatment of fibromyalgia. A decision from the regulatory body on the acceptance of the filing is expected later in the second quarter of 2025.
AXS-12 is currently being developed in multiple studies for the treatment of narcolepsy. AXSM plans to submit an NDA for AXS-12 for treating cataplexy in patients with narcolepsy to the FDA in the second half of 2025.
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 announced top-line data from the phase III PARADIGM study, which evaluated solriamfetol for the treatment of MDD with and without severe excessive daytime sleepiness (EDS) last month.
In the prespecified subgroup of patients with severe EDS, treatment with solriamfetol led to greater improvements in depressive symptoms versus placebo. In patients without severe EDS, there was no meaningful difference versus placebo on the study endpoints.
Axsome plans to initiate a phase III study on solriamfetol in MDD patients with EDS later in 2025.
Earlier in March, Axsome announced top-line data from the phase III FOCUS study, which evaluated solriamfetol for the treatment of ADHD in adults.
The company plans to initiate a phase III study of solriamfetol for treating ADHD in pediatric patients later in 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
In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 38.3%.
ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.
In the past 60 days, estimates for Immunocore’s loss per share have narrowed from $1.63 to $1.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.83 to $1.68. Year to date, shares of IMCR have gained 3.9%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 31.91%.
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AXSM Q1 Loss Narrower Than Expected, Auvelity Drives Revenues Y/Y
Axsome Therapeutics (AXSM - Free Report) incurred an adjusted loss of $1.22 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.26. The company had incurred a loss of $1.44 per share in the year-ago quarter.
Axsome’s total revenues surged 62% year over year to $121.5 million in the first quarter, beating the Zacks Consensus Estimate of $119 million. The year-over-year increase in revenues can be attributed to strong sales of Auvelity (AXS-05). (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
Year to date, shares of Axsome have rallied 37.7% against the industry’s decline of 2.2%.
Image Source: Zacks Investment Research
AXSM's Q1 Earnings in Detail
Total revenues in the first quarter consisted of product revenues from Auvelity and Sunosi (solriamfetol) and royalty revenues.
Net product revenues were $120.4 million in the quarter compared with $74.1 million reported in the year-ago period. Royalty revenues totaled $1.1 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.
Product revenues in the first quarter benefited from the strong sales uptake of AXSM’s two marketed products, Auvelity for major depressive disorder (MDD) and Sunosi for narcolepsy.
Auvelity recorded sales of $96.2 million, up 80% year over year. Sales of the drug beat our model estimate of $88.3 million.
Per Axsome, around 167,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 5% and a year-over-year increase of 76%.
Sunosi’s net product sales were $25.2 million, up 17% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 12% year over year to 46,000. Sunosi total prescriptions declined 5% on a sequential basis.
Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 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 high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Research and development expenses (including stock-based compensation) increased to $44.8 million, up 21.7% from the year-ago quarter’s level. The increase was due to higher costs associated with clinical studies, especially the label expansion study of Sunosi and the upcoming launch of the newest drug, Symbravo.
The FDA approved Symbravo (meloxicam and rizatriptan) in January 2025 for the acute treatment of migraine with or without aura in adults. The company expects to launch Symbravo in the United States next month.
Selling, general and administrative expenses (including stock-based compensation) totaled $120.8 million, up 22% year over year. The increase was due to higher commercial activities for Auvelity, along with pre-launch activities for Symbravo and other costs.
As of March 31, 2025, Axsome had cash and cash equivalents worth $300.9 million compared with $315.4 million as of Dec. 31, 2024.
AXSM's Key Pipeline Updates
In February, Axsome announced top-line data from the open-label, phase III EMERGE study, which evaluated the efficacy and safety of Symbravo in patients experiencing an inadequate response to oral CGRP inhibitors.
Data from the same showed that treatment with Symbravo demonstrated a statistically significantly greater migraine treatment response compared to oral CGRP inhibitors, as measured by the Migraine Treatment Optimization Questionnaire (mTOQ-4) – the primary endpoint of the EMERGE study.
Meanwhile, Axsome is evaluating Auvelity in several label expansion studies for other central nervous system (CNS) disorders.
In March 2025, Axsome received formal feedback from the FDA about its plans to seek approval for AXS-05 as a treatment for agitation in Alzheimer’s disease (AD) patients.
The written feedback from the FDA confirmed that Axsome’s regulatory data package is sufficient to support the submission of a supplemental new drug application (sNDA) for AXS-05 in agitation associated with AD. Management expects to submit this sNDA in the third quarter of 2025.
The company also plans to start a pivotal phase II/III study of Auvelity for smoking cessation later in 2025.
Other pipeline candidates include AXS-12 and AXS-14, which target multiple CNS indications.
Along with the earnings release, Axsome announced that it has submitted an NDA to the FDA seeking approval of AXS-14 for the treatment of fibromyalgia. A decision from the regulatory body on the acceptance of the filing is expected later in the second quarter of 2025.
AXS-12 is currently being developed in multiple studies for the treatment of narcolepsy. AXSM plans to submit an NDA for AXS-12 for treating cataplexy in patients with narcolepsy to the FDA in the second half of 2025.
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 announced top-line data from the phase III PARADIGM study, which evaluated solriamfetol for the treatment of MDD with and without severe excessive daytime sleepiness (EDS) last month.
In the prespecified subgroup of patients with severe EDS, treatment with solriamfetol led to greater improvements in depressive symptoms versus placebo. In patients without severe EDS, there was no meaningful difference versus placebo on the study endpoints.
Axsome plans to initiate a phase III study on solriamfetol in MDD patients with EDS later in 2025.
Earlier in March, Axsome announced top-line data from the phase III FOCUS study, which evaluated solriamfetol for the treatment of ADHD in adults.
The company plans to initiate a phase III study of solriamfetol for treating ADHD in pediatric patients later in 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 ADMA Biologics Inc. (ADMA - Free Report) and Immunocore Holdings PLC (IMCR - Free Report) , 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 ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 38.3%.
ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.
In the past 60 days, estimates for Immunocore’s loss per share have narrowed from $1.63 to $1.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.83 to $1.68. Year to date, shares of IMCR have gained 3.9%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 31.91%.