We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. By pressing "Accept All" or closing out of this banner, you accept our Privacy Policy and Terms of Service, revised from time to time, and you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties. You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Axsome Q4 Loss Wider Than Expected, Auvelity Drives Sales Growth
Read MoreHide Full Article
Axsome Therapeutics (AXSM - Free Report) incurred an adjusted loss of 96 cents per share in the fourth quarter of 2024, wider than the Zacks Consensus Estimate of a loss of 90 cents. The company had incurred a loss of 73 cents per share in the year-ago quarter.
Axsome’s total revenues surged 66% year over year to $118.8 million in the fourth quarter, slightly beating the Zacks Consensus Estimate of $118 million. The year-over-year increase in revenues can be attributed to strong sales of Auvelity (AXS-05).
In the past year, shares of Axsome have rallied 41.3% against the industry’s decline of 8.8%.
Image Source: Zacks Investment Research
More on AXSM's Q4 Results
Total revenues in the fourth quarter consisted of product revenues from Auvelity and Sunosi (solriamfetol) and royalty revenues.
Net product revenues were $117.3 million in the quarter compared with $70.7 million reported in the year-ago period. The figure beat our model estimate of $112.2 million.
Product revenues in the fourth 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 $92.6 million, up 89% year over year. Sales of the drug beat our model estimate of $87.7 million.
Per Axsome, around 158,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 10% and a year-over-year increase of 87%.
Sunosi’s net product sales were $26.2 million, up 16% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 4% sequentially to 49,000.
Axsome acquired U.S. rights to Sunosifrom 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.
Royalty revenues totaled $1.4 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.
Research and development expenses (including stock-based compensation) increased to $55 million, up 78.6% 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 as well as other pipeline candidates like AXS-05, AXS-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $113.3 million, up 30.5% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Dec. 31, 2024, Axsome had cash and cash equivalents worth $315.4 million compared with $327.3 million as of Sept. 30, 2024.
AXSM's Full-Year Results
In 2024, Axsome generated revenues of $385.7 million, which reflected around 42.5% growth year over year.
For the same period, the company reported an adjusted loss of $5.99 per share, wider than a loss of $5.27 in the year-ago period.
Guidance
Management believes that its cash balance of $315.4 million (as of December-end) is enough to fund future operations into cash flow positivity.
AXSM's Pipeline Updates & Recent FDA Nod for New Migraine Drug
Last month, the FDA approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. AXSM expects to launch Symbravo in the United States in about four months.
The FDA nod for Symbravo should diversify Axsome’s commercial drug portfolio and drive growth in future quarters.
Also, the phase III EMERGE study is evaluating the safety and efficacy of Symbravo for the acute treatment of migraine in adults with a prior inadequate response to an oral CGRP inhibitor. Top-line data from the EMERGE study is expected later in the first quarter of 2025.
Meanwhile, Axsome is evaluating Auvelity in several label expansion studies for other central nervous system disorders.
In December 2024, the company announced that the ACCORD-2 study achieved the primary endpoint compared to placebo, while the ADVANCE-2 study did not demonstrate statistical significance for the primary endpoint. Importantly, AXS-05 was safe and well tolerated in both controlled studies. Based on these efficacy and safety results, Axsome plans to submit a new drug application (NDA) for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half 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 central nervous system indications.
AXS-12 is currently being developed in three studies for the treatment of narcolepsy. Treatment with AXS-12 demonstrated statistically significant efficacy versus placebo in all three efficacy studies (CONCERT, SYMPHONY, and ENCORE). Based on the data from these studies 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.
Axsome plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in the first quarter of 2025.
The company is evaluating Sunosi in separate phase III studies for treating attention deficit hyperactivity disorder (ADHD), MDD, binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).
Top-line data from the FOCUS study and the PARADIGM study, evaluating Sunosi for treating ADHD and MDD, respectively, are expected later in the first quarter of 2025.
Meanwhile, top-line data from the ENGAGE study and the SUSTAIN study, evaluating Sunosi 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 Harmony Biosciences’ earnings per share have increased from $2.64 to $3.16 for 2025. In the past year, shares of HRMY have risen 15.3%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for Pacira BioSciences’ earnings per share have increased from $2.79 to $3.46 for 2025. In the past year, shares of PCRX have decreased 12.6%.
PCRX’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 7.13%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report predicting the 7 stocks that will soar highest in the coming month.
Image: Shutterstock
Axsome Q4 Loss Wider Than Expected, Auvelity Drives Sales Growth
Axsome Therapeutics (AXSM - Free Report) incurred an adjusted loss of 96 cents per share in the fourth quarter of 2024, wider than the Zacks Consensus Estimate of a loss of 90 cents. The company had incurred a loss of 73 cents per share in the year-ago quarter.
See the Zacks Earnings Calendar to stay ahead of market-making news.
Axsome’s total revenues surged 66% year over year to $118.8 million in the fourth quarter, slightly beating the Zacks Consensus Estimate of $118 million. The year-over-year increase in revenues can be attributed to strong sales of Auvelity (AXS-05).
In the past year, shares of Axsome have rallied 41.3% against the industry’s decline of 8.8%.
Image Source: Zacks Investment Research
More on AXSM's Q4 Results
Total revenues in the fourth quarter consisted of product revenues from Auvelity and Sunosi (solriamfetol) and royalty revenues.
Net product revenues were $117.3 million in the quarter compared with $70.7 million reported in the year-ago period. The figure beat our model estimate of $112.2 million.
Product revenues in the fourth 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 $92.6 million, up 89% year over year. Sales of the drug beat our model estimate of $87.7 million.
Per Axsome, around 158,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 10% and a year-over-year increase of 87%.
Sunosi’s net product sales were $26.2 million, up 16% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 4% sequentially to 49,000.
Axsome acquired U.S. rights to Sunosifrom 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.
Royalty revenues totaled $1.4 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.
Research and development expenses (including stock-based compensation) increased to $55 million, up 78.6% 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 as well as other pipeline candidates like AXS-05, AXS-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $113.3 million, up 30.5% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Dec. 31, 2024, Axsome had cash and cash equivalents worth $315.4 million compared with $327.3 million as of Sept. 30, 2024.
AXSM's Full-Year Results
In 2024, Axsome generated revenues of $385.7 million, which reflected around 42.5% growth year over year.
For the same period, the company reported an adjusted loss of $5.99 per share, wider than a loss of $5.27 in the year-ago period.
Guidance
Management believes that its cash balance of $315.4 million (as of December-end) is enough to fund future operations into cash flow positivity.
AXSM's Pipeline Updates & Recent FDA Nod for New Migraine Drug
Last month, the FDA approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. AXSM expects to launch Symbravo in the United States in about four months.
The FDA nod for Symbravo should diversify Axsome’s commercial drug portfolio and drive growth in future quarters.
Also, the phase III EMERGE study is evaluating the safety and efficacy of Symbravo for the acute treatment of migraine in adults with a prior inadequate response to an oral CGRP inhibitor. Top-line data from the EMERGE study is expected later in the first quarter of 2025.
Meanwhile, Axsome is evaluating Auvelity in several label expansion studies for other central nervous system disorders.
In December 2024, the company announced that the ACCORD-2 study achieved the primary endpoint compared to placebo, while the ADVANCE-2 study did not demonstrate statistical significance for the primary endpoint. Importantly, AXS-05 was safe and well tolerated in both controlled studies. Based on these efficacy and safety results, Axsome plans to submit a new drug application (NDA) for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half 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 central nervous system indications.
AXS-12 is currently being developed in three studies for the treatment of narcolepsy. Treatment with AXS-12 demonstrated statistically significant efficacy versus placebo in all three efficacy studies (CONCERT, SYMPHONY, and ENCORE). Based on the data from these studies 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.
Axsome plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in the first quarter of 2025.
The company is evaluating Sunosi in separate phase III studies for treating attention deficit hyperactivity disorder (ADHD), MDD, binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).
Top-line data from the FOCUS study and the PARADIGM study, evaluating Sunosi for treating ADHD and MDD, respectively, are expected later in the first quarter of 2025.
Meanwhile, top-line data from the ENGAGE study and the SUSTAIN study, evaluating Sunosi 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 Harmony Biosciences Holdings, Inc. (HRMY - Free Report) and Pacira BioSciences, Inc. (PCRX - 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 Harmony Biosciences’ earnings per share have increased from $2.64 to $3.16 for 2025. In the past year, shares of HRMY have risen 15.3%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for Pacira BioSciences’ earnings per share have increased from $2.79 to $3.46 for 2025. In the past year, shares of PCRX have decreased 12.6%.
PCRX’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 7.13%.