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Axsome (AXSM) Q2 Loss Widens Y/Y, Revenues Beat Estimates
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Axsome Therapeutics, Inc. (AXSM - Free Report) incurred an adjusted loss of $1.24 per share for the second quarter of 2024 compared with a loss of $1.00 reported in the year-ago period. The Zacks Consensus Estimate was pegged at a loss of $1.30 per share.
The above-adjusted loss excludes the impact of certain non-cash charges, including which the reported loss per share was $1.67 in the second quarter of 2024 compared with a loss of $1.54 per share reported in the year-ago quarter.
Axsome’s total revenues surged 87% year over year to $87.2 million in the reported quarter, which beat the Zacks Consensus Estimate of $85 million. The increase in revenues can be attributed to strong sales of Auvelity.
Shares of Axsome have gained 6.1% year to date against the industry’s decline of 2.1%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues in the second quarter consisted of product revenues from Sunosi and Auvelity, and royalty revenues.
Net product revenues were $86.5 million in the quarter compared with $46 million reported in the year-ago period. The figure beat our model estimate of $80.4 million.
Product revenues in the second quarter benefited from the strong sales uptake of its two marketed products, Auvelity (AXS-05) for major depressive disorder and Sunosi (solriamfetol) for narcolepsy.
Auvelity, launched in 2022, recorded sales of $65 million, up 135% year over year, owing to strong underlying demand. Sales of the drug beat our model estimate of $60.8 million.
Per Axsome, around 123,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 29%.
Axsome acquired U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, 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 received approval for Sunosi as a treatment for narcolepsy in 2019.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Sunosi’s net product sales were $22.1 million, up 16% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 8% sequentially to 45,000.
Royalty revenues totaled $0.6 million in the quarter, reflecting royalties on Sunosi sales in out-licensed territories.
Research and development expenses (including stock-based compensation) amounted to $49.9 million, up 142% from the year-ago quarter’s level. The significant increase was due to higher costs associated with clinical studies, especially the label expansion study of Sunosi, as well as higher costs associated with clinical studies on other pipeline candidates like AXS-05, AXS-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $103.6 million, up 31% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Jun 30, 2024, Axsome had cash and cash equivalents worth $315.7 million compared with $331.4 million as of Mar 31, 2024.
Guidance
Management believes that its cash balance of $315.7 million (as of June-end) is enough to fund future operations into cash flow positivity.
Axsome is evaluating Auvelity in several label expansion studies for other central nervous system disorders. The phase III ADVANCE-2 study is evaluating the safety and efficacy of Auvelity for treating agitation associated with Alzheimer’s disease (AD). Top-line data is expected in the second half of 2024.
AXSM is also conducting a withdrawal phase III ACCORD-2 study to evaluate the efficacy and safety of AXS-05 for the treatment of AD agitation. Top-line data from the ACCORD-2 study is also anticipated in the second half of 2024.
AXSM plans to start a pivotal phase II/III study of Auvelity for smoking cessation later in 2024.
Axsome’s key pipeline candidates include AXS-07, AXS-12 and AXS-14, which target multiple central nervous system indications.
AXS-07 is being developed for the acute treatment of migraine. In 2022, Axsome received a complete response letter for a new drug application (NDA) seeking approval for AXS-07 for the migraine indication.
During the reported quarter, the company resubmitted its AXS-07 NDA to the FDA for the acute treatment of migraine. A decision from the regulatory body is expected within six months.
A late-stage study, EMERGE, is currently evaluating AXS-07 in adults with a prior inadequate response to an oral CGRP inhibitor for the acute treatment of migraine headaches. Top-line results from the EMERGE study are expected in the second half of 2024.
AXS-12 is currently being evaluated in an open-label safety extension study for the treatment of narcolepsy. Top-line data readout is expected in the fourth quarter of 2024.
Axsome plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in the third quarter of 2024.
The company is investigating Sunosi in a label expansion study — the phase III FOCUS study. The study evaluates the efficacy and safety of Sunosi for the treatment of attention deficit hyperactivity disorder. Top-line data from the study is expected by the second half of 2024.
Axsome is also evaluating Sunosi in separate phase III studies for the treatment of major depressive disorder and binge eating disorder. Data from both studies are expected in 2025. Additionally, during the second quarter, the company initiated a separate phase III study evaluating Sunosi for the treatment of excessive sleepiness associated with shift work disorder. Top-line data from this additional study is expected in 2026.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 53.7%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 14.9%.
ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%.
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Axsome (AXSM) Q2 Loss Widens Y/Y, Revenues Beat Estimates
Axsome Therapeutics, Inc. (AXSM - Free Report) incurred an adjusted loss of $1.24 per share for the second quarter of 2024 compared with a loss of $1.00 reported in the year-ago period. The Zacks Consensus Estimate was pegged at a loss of $1.30 per share.
The above-adjusted loss excludes the impact of certain non-cash charges, including which the reported loss per share was $1.67 in the second quarter of 2024 compared with a loss of $1.54 per share reported in the year-ago quarter.
Axsome’s total revenues surged 87% year over year to $87.2 million in the reported quarter, which beat the Zacks Consensus Estimate of $85 million. The increase in revenues can be attributed to strong sales of Auvelity.
Shares of Axsome have gained 6.1% year to date against the industry’s decline of 2.1%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues in the second quarter consisted of product revenues from Sunosi and Auvelity, and royalty revenues.
Net product revenues were $86.5 million in the quarter compared with $46 million reported in the year-ago period. The figure beat our model estimate of $80.4 million.
Product revenues in the second quarter benefited from the strong sales uptake of its two marketed products, Auvelity (AXS-05) for major depressive disorder and Sunosi (solriamfetol) for narcolepsy.
Auvelity, launched in 2022, recorded sales of $65 million, up 135% year over year, owing to strong underlying demand. Sales of the drug beat our model estimate of $60.8 million.
Per Axsome, around 123,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 29%.
Axsome acquired U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, 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 received approval for Sunosi as a treatment for narcolepsy in 2019.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Sunosi’s net product sales were $22.1 million, up 16% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 8% sequentially to 45,000.
Royalty revenues totaled $0.6 million in the quarter, reflecting royalties on Sunosi sales in out-licensed territories.
Research and development expenses (including stock-based compensation) amounted to $49.9 million, up 142% from the year-ago quarter’s level. The significant increase was due to higher costs associated with clinical studies, especially the label expansion study of Sunosi, as well as higher costs associated with clinical studies on other pipeline candidates like AXS-05, AXS-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $103.6 million, up 31% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Jun 30, 2024, Axsome had cash and cash equivalents worth $315.7 million compared with $331.4 million as of Mar 31, 2024.
Guidance
Management believes that its cash balance of $315.7 million (as of June-end) is enough to fund future operations into cash flow positivity.
Axsome Therapeutics, Inc. Price and Consensus
Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote
Pipeline Updates
Axsome is evaluating Auvelity in several label expansion studies for other central nervous system disorders. The phase III ADVANCE-2 study is evaluating the safety and efficacy of Auvelity for treating agitation associated with Alzheimer’s disease (AD). Top-line data is expected in the second half of 2024.
AXSM is also conducting a withdrawal phase III ACCORD-2 study to evaluate the efficacy and safety of AXS-05 for the treatment of AD agitation. Top-line data from the ACCORD-2 study is also anticipated in the second half of 2024.
AXSM plans to start a pivotal phase II/III study of Auvelity for smoking cessation later in 2024.
Axsome’s key pipeline candidates include AXS-07, AXS-12 and AXS-14, which target multiple central nervous system indications.
AXS-07 is being developed for the acute treatment of migraine. In 2022, Axsome received a complete response letter for a new drug application (NDA) seeking approval for AXS-07 for the migraine indication.
During the reported quarter, the company resubmitted its AXS-07 NDA to the FDA for the acute treatment of migraine. A decision from the regulatory body is expected within six months.
A late-stage study, EMERGE, is currently evaluating AXS-07 in adults with a prior inadequate response to an oral CGRP inhibitor for the acute treatment of migraine headaches. Top-line results from the EMERGE study are expected in the second half of 2024.
AXS-12 is currently being evaluated in an open-label safety extension study for the treatment of narcolepsy. Top-line data readout is expected in the fourth quarter of 2024.
Axsome plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in the third quarter of 2024.
The company is investigating Sunosi in a label expansion study — the phase III FOCUS study. The study evaluates the efficacy and safety of Sunosi for the treatment of attention deficit hyperactivity disorder. Top-line data from the study is expected by the second half of 2024.
Axsome is also evaluating Sunosi in separate phase III studies for the treatment of major depressive disorder and binge eating disorder. Data from both studies are expected in 2025. Additionally, during the second quarter, the company initiated a separate phase III study evaluating Sunosi for the treatment of excessive sleepiness associated with shift work disorder. Top-line data from this additional study is expected in 2026.
Zacks Rank & Other Stocks to Consider
Axsome currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Annovis Bio (ANVS - Free Report) and Anixa Biosciences (ANIX - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 53.7%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 14.9%.
ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%.