Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue
January 13 2025 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company leading a new era in the treatment of central nervous
system (CNS) disorders, today announced preliminary net product
revenue for the fourth quarter and full year ended December 31,
2024.
“We delivered strong revenue growth in 2024 and
significantly advanced our industry leading neuroscience pipeline,
including achievement of positive Phase 3 results for AXS-05 in
Alzheimer’s disease agitation and for AXS-12 in narcolepsy,
supporting planned regulatory filings for these indications and
products in 2025,” said Herriot Tabuteau, MD, Chief Executive
Officer of Axsome. “We also look to carry our commercial momentum
into 2025 with continued growth for Auvelity and Sunosi, and are
making active launch preparations for AXS-07 for the acute
treatment of migraine, if approved.”
Preliminary Fourth Quarter and Full Year
2024 Net Product Revenue (Unaudited)
Based on preliminary unaudited financial
information, Axsome expects total product revenue to be
approximately $118.3 million and $385.2 million for the fourth
quarter and full year of 2024, respectively.
- Auvelity® net
product sales are expected to be approximately $92.6 million and
$291.4 million for the fourth quarter and full year of 2024,
respectively.
- Sunosi® net
product revenue is expected to be approximately $25.7 million
and $93.8 million for the fourth quarter and full year of 2024,
respectively.
The foregoing information reflects the Company's
estimate with respect to net product revenue for Auvelity and
Sunosi based on currently available unaudited information. This
announcement is not a comprehensive statement of Axsome’s financial
results and is subject to completion of Axsome’s financial closing
procedures. Axsome’s final financial results will be issued upon
completion of its closing procedures and may vary from these
preliminary estimates.
About Axsome Therapeutics, Inc.
Axsome Therapeutics is a biopharmaceutical
company leading a new era in the treatment of central nervous
system (CNS) conditions. We deliver scientific breakthroughs by
identifying critical gaps in care and develop differentiated
products with a focus on novel mechanisms of action that enable
meaningful advancements in patient outcomes. Our industry-leading
neuroscience portfolio includes FDA-approved treatments for major
depressive disorder and excessive daytime sleepiness associated
with narcolepsy and obstructive sleep apnea and multiple late-stage
development programs addressing a broad range of serious
neurological and psychiatric conditions that impact over 150
million people in the United States. Together, we are on a mission
to solve some of the brain’s biggest problems so patients and their
loved ones can flourish.
Forward Looking Statements
Certain matters discussed in this press release
are “forward-looking statements”. The Company may, in some cases,
use terms such as “predicts,” “believes,” “potential,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company’s statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
continued commercial success of the Company’s Sunosi® and Auvelity®
products and the success of the Company’s efforts to obtain any
additional indication(s) with respect to solriamfetol and/or
AXS-05; the Company’s ability to maintain and expand payer
coverage; the success, timing and cost of the Company’s ongoing
clinical trials and anticipated clinical trials for the Company’s
current product candidates, including statements regarding the
timing of initiation, pace of enrollment and completion of the
trials (including the Company’s ability to fully fund the Company’s
disclosed clinical trials, which assumes no material changes to the
Company’s currently projected revenues or expenses), futility
analyses and receipt of interim results, which are not necessarily
indicative of the final results of the Company’s ongoing clinical
trials and/or data readouts, and the number or type of studies or
nature of results necessary to support the filing of a new drug
application (“NDA”) for any of the Company’s current product
candidates, including statements regarding the ability of the
ACCORD and ADVANCE clinical trials to support the filing of an NDA
for Alzheimer’s disease agitation; the Company’s ability to fund
additional clinical trials to continue the advancement of the
Company’s product candidates; the timing of and the Company’s
ability to obtain and maintain U.S. Food and Drug Administration
(“FDA”) or other regulatory authority approval of, or other action
with respect to, the Company’s product candidates, including
statements regarding the timing of any NDA submission; whether
issues identified by FDA in the complete response letter may impact
the potential approvability of the Company’s NDA for AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to the Company’s special protocol assessment for the
MOMENTUM clinical trial; the Company’s ability to successfully
defend its intellectual property or obtain the necessary licenses
at a cost acceptable to the Company, if at all; the successful
implementation of the Company’s research and development programs
and collaborations; the success of the Company’s license
agreements; the acceptance by the market of the Company’s products
and product candidates, if approved; the Company’s anticipated
capital requirements, including the amount of capital required for
the continued commercialization of Sunosi and Auvelity and for the
Company’s commercial launch of its other product candidates, if
approved, and the potential impact on the Company’s anticipated
cash runway; differences between the Company’s 2024 preliminary
financial information disclosed herein as compared to the Company’s
final 2024 audited financial statements; the fact that estimated
net product revenue is not a comprehensive statement of the
Company’s financial results and is subject to completion of
Company’s financial closing procedures; the Company’s ability to
convert sales to recognized revenue and maintain a favorable gross
to net sales; unforeseen circumstances or other disruptions to
normal business operations arising from or related to domestic
political climate, geo-political conflicts or a global pandemic and
other factors, including general economic conditions and regulatory
developments, not within the Company’s control. The factors
discussed herein could cause actual results and developments to be
materially different from those expressed in or implied by such
statements. The forward-looking statements are made only as of the
date of this press release, and the Company undertakes no
obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstance.
Investors:
Mark JacobsonChief Operating OfficerTel: 212-332-3243Email:
mjacobson@axsome.com
Media:
Darren OplandDirector, Corporate CommunicationsTel:
929-837-1065Email: dopland@axsome.com
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