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Axsome (AXSM) Q1 Loss Widens Y/Y, Revenues Beat Estimates
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Axsome Therapeutics, Inc. (AXSM - Free Report) reported an adjusted loss of $1.00 per share for the first quarter of 2024, compared with a loss of 22 cents per share reported in the year-ago period. The Zacks Consensus Estimate was pegged at a loss of $1.20 per share.
The above-adjusted loss excludes the impact of certain non-cash charges, including which the reported loss per share was $1.44 in the first quarter of 2024 compared with a loss of 26 cents per share reported in the year-ago quarter.
The company reported total revenues of $75 million for the first quarter, which beat the Zacks Consensus Estimate of $70 million. AXSM had recorded revenues of $94.6 million in the year-ago period. The year-over-year decline in revenues can be attributed to a one-time upfront payment received for the out-licensing of Sunosi in certain ex-U.S. markets in the year-ago quarter.
Shares of Axsome have decreased 4.6% so far this year compared with the industry’s decline of 5.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues in the first quarter consisted of product revenues from Sunosi and Auvelity, and royalty revenues.
Net product revenues were $74.1 million in the quarter compared with $28.6 million reported in the year-ago period. The figure beat our model estimate of $68.6 million.
Product revenues in the first 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 $53.4 million, up 240% year over year, owing to strong underlying demand. Sales of the drug beat our model estimate of $44.8 million.
Per the company, around 95,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 12%.
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 $21.6 million, up 63.6% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year but declined 1.6% sequentially, as demand in the first quarter was adversely impacted by typical seasonality.
Royalty revenues totaled $0.9 million in the quarter, reflecting royalties on Sunosi sales in out-licensed territories.
Research and development expenses (including stock-based compensation) amounted to $36.8 million, up 106.7% 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-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $99.0 million, up almost 33.4% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Mar 31, 2024, Axsome had cash and cash equivalents worth $331.4 million compared with $386.2 million as of Dec 31, 2023.
Guidance
Management believes that its cash balance of $331.4 million (as of March-end) is enough to fund future operations into cash flow positivity.
Pipeline Updates
Axsome is evaluating Auvelity in several label expansion studies that are underway for the treatment of 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.
AXSM has also initiated a placebo-controlled, randomized, withdrawal phase III ACCORD-2 study to evaluate the efficacy and safety of AXS-05 for the treatment of AD agitation. Enrollment in the study is expected to be completed in mid-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 April 2022, Axsome received a complete response letter for a new drug application (NDA) seeking approval for AXS-07 for the acute treatment of the disease.
Axsome plans to resubmit its NDA later in the second quarter of 2024. The FDA has not requested any additional safety or efficacy data for the candidate in light of the NDA resubmission.
AXS-12 is being evaluated in the phase III SYMPHONY study for the treatment of narcolepsy. In March 2024, AXSM announced that the SYMPHONY study achieved its primary endpoint of a rapid and significant reduction in weekly cataplexy events.
AXSM plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in the second 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 recently initiated separate phase III studies evaluating Sunosi for the treatment of major depressive disorder and binge eating disorder. Data from both studies are expected in 2025. The company plans to initiate a separate phase III study evaluating Sunosi for the treatment of excessive sleepiness associated with shift work disorder later in the second quarter of 2024.
Axsome Therapeutics, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for Cytek Biosciences’ 2024 earnings per share have improved from 3 cents to 8 cents. Year to date, shares of CTKB have decreased 29.6%.
CTKB’s earnings beat estimates in one of the trailing four quarters and missed the same on the remaining three occasions, the negative average surprise being 20.84%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have risen 2%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
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Axsome (AXSM) Q1 Loss Widens Y/Y, Revenues Beat Estimates
Axsome Therapeutics, Inc. (AXSM - Free Report) reported an adjusted loss of $1.00 per share for the first quarter of 2024, compared with a loss of 22 cents per share reported in the year-ago period. The Zacks Consensus Estimate was pegged at a loss of $1.20 per share.
The above-adjusted loss excludes the impact of certain non-cash charges, including which the reported loss per share was $1.44 in the first quarter of 2024 compared with a loss of 26 cents per share reported in the year-ago quarter.
The company reported total revenues of $75 million for the first quarter, which beat the Zacks Consensus Estimate of $70 million. AXSM had recorded revenues of $94.6 million in the year-ago period. The year-over-year decline in revenues can be attributed to a one-time upfront payment received for the out-licensing of Sunosi in certain ex-U.S. markets in the year-ago quarter.
Shares of Axsome have decreased 4.6% so far this year compared with the industry’s decline of 5.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues in the first quarter consisted of product revenues from Sunosi and Auvelity, and royalty revenues.
Net product revenues were $74.1 million in the quarter compared with $28.6 million reported in the year-ago period. The figure beat our model estimate of $68.6 million.
Product revenues in the first 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 $53.4 million, up 240% year over year, owing to strong underlying demand. Sales of the drug beat our model estimate of $44.8 million.
Per the company, around 95,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 12%.
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 $21.6 million, up 63.6% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year but declined 1.6% sequentially, as demand in the first quarter was adversely impacted by typical seasonality.
Royalty revenues totaled $0.9 million in the quarter, reflecting royalties on Sunosi sales in out-licensed territories.
Research and development expenses (including stock-based compensation) amounted to $36.8 million, up 106.7% 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-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $99.0 million, up almost 33.4% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Mar 31, 2024, Axsome had cash and cash equivalents worth $331.4 million compared with $386.2 million as of Dec 31, 2023.
Guidance
Management believes that its cash balance of $331.4 million (as of March-end) is enough to fund future operations into cash flow positivity.
Pipeline Updates
Axsome is evaluating Auvelity in several label expansion studies that are underway for the treatment of 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.
AXSM has also initiated a placebo-controlled, randomized, withdrawal phase III ACCORD-2 study to evaluate the efficacy and safety of AXS-05 for the treatment of AD agitation. Enrollment in the study is expected to be completed in mid-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 April 2022, Axsome received a complete response letter for a new drug application (NDA) seeking approval for AXS-07 for the acute treatment of the disease.
Axsome plans to resubmit its NDA later in the second quarter of 2024. The FDA has not requested any additional safety or efficacy data for the candidate in light of the NDA resubmission.
AXS-12 is being evaluated in the phase III SYMPHONY study for the treatment of narcolepsy. In March 2024, AXSM announced that the SYMPHONY study achieved its primary endpoint of a rapid and significant reduction in weekly cataplexy events.
AXSM plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in the second 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 recently initiated separate phase III studies evaluating Sunosi for the treatment of major depressive disorder and binge eating disorder. Data from both studies are expected in 2025. The company plans to initiate a separate phase III study evaluating Sunosi for the treatment of excessive sleepiness associated with shift work disorder later in the second quarter of 2024.
Axsome Therapeutics, Inc. Price, Consensus and EPS Surprise
Axsome Therapeutics, Inc. price-consensus-eps-surprise-chart | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Axsome currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Cytek Biosciences, Inc. (CTKB - Free Report) and Ligand Pharmaceuticals Incorporated (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Cytek Biosciences’ 2024 earnings per share have improved from 3 cents to 8 cents. Year to date, shares of CTKB have decreased 29.6%.
CTKB’s earnings beat estimates in one of the trailing four quarters and missed the same on the remaining three occasions, the negative average surprise being 20.84%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have risen 2%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.