Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced financial results for the first quarter of 2024.
“The first quarter was marked by strong
financial performance for our on-market products which are
delivering important and differentiated treatment options for
patients living with depression, narcolepsy and obstructive sleep
apnea,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We
also significantly advanced our innovative neuroscience pipeline in
the quarter. We announced positive Phase 3 results for AXS-12 in
narcolepsy, a major step toward making this new medicine available
to patients living with this debilitating condition, and we
launched two pivotal trials of solriamfetol in major depressive
disorder and binge eating disorder. In the coming months we look
forward to resubmitting our NDA for AXS-07 in migraine, and to
submitting our NDA for AXS-14 in fibromyalgia. Our Phase 3
ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation remains
on track for completion in the second half of 2024. Further, we
added to the robustness of this clinical development program with
the initiation of the ACCORD-2 study of AXS-05 in Alzheimer’s
disease agitation, a Phase 3 randomized withdrawal trial, for which
we expect to complete enrollment mid-year 2024.”
First Quarter 2024 Financial
Highlights
- Total net product revenue for the first quarter of 2024 was
$75.0 million, representing 160% year-over-year growth. Total net
product revenue for the comparable period in 2023 was $28.8
million. Overall total revenue for the first quarter of 2023 was
$94.6 million which included a one-time $65.7 million upfront
payment received for the out-licensing of Sunosi commercialization
rights in Europe and certain countries in the Middle East and North
Africa region.
- Auvelity net product sales were $53.4 million for the first
quarter of 2024, representing 240% year-over-year growth. Auvelity
net product sales for the comparable period in 2023 were $15.7
million.
- Sunosi net product revenue was $21.6 million for the first
quarter of 2024, consisting of $20.7 million in net product sales
and $0.9 million in royalty revenue associated with sales in
out-licensed territories, representing 64% year-over-year growth.
Sunosi net product revenue for the comparable period in 2023 was
$13.2 million, consisting of $12.9 million in net product sales and
$0.3 million in royalty revenue.
- Total cost of revenue was $6.3 million for the first quarter of
2024. Total cost of revenue for the comparable period in 2023 was
$7.6 million. The 2023 comparable period includes $5.0 million in
out-license fee sharing expense.
- Research and development (R&D) expenses were $36.8 million
for the first quarter of 2024, compared to $17.8 million for the
comparable period in 2023, respectively. The increase was primarily
related to the initiation and continuation of solriamfetol Phase 3
trials in major depressive disorder, binge eating disorder, and
ADHD, ongoing trials of AXS-05 and AXS-12, manufacturing associated
with the anticipated NDAs for AXS-07 and AXS-14, post-marketing
commitments for Auvelity and Sunosi, and higher personnel costs
including non-cash stock-based compensation.
- Selling, general, and administrative (SG&A) expenses were
$99.0 million for the first quarter of 2024, compared to $74.2
million for the comparable period in 2023. The increase was
primarily related to commercialization activities for Auvelity and
Sunosi specifically around field force expansion and organizational
growth, including non-cash stock-based compensation.
- Net loss for the first quarter of 2024 was $68.4 million or
$(1.44) per share, compared to a net loss of $11.2 million, or
$(0.26) per share for the comparable period in 2023. The net loss
in the first quarter of 2024 reflects $21.0 million in non-cash
charges. The 2023 comparable period includes $62.0 million in net
gain from the Sunosi out-licensing.
- Cash and cash equivalents totaled $331.4 million at March 31,
2024, compared to $386.2 million at December 31, 2023.
- Shares of common stock outstanding were 47,464,575 at March 31,
2024.
Financial Guidance
·Axsome believes that its current cash is
sufficient to fund anticipated operations into cash flow
positivity, based on the current operating plan.
Commercial Highlights
Auvelity
- Approximately 95,000 prescriptions were written for Auvelity in
the first quarter of 2024, representing a 12% sequential increase
versus the fourth quarter of 2023.
- Payer coverage for Auvelity across all channels is stable at
approximately 70% of all covered lives. The proportion of lives
covered in the commercial and government (Medicare and Medicaid)
channels are approximately 48% and approximately 100%,
respectively.
- Effective May 1, 2024, Axsome has contracted with a second
large group purchasing organization (GPO) for potential formulary
coverage of Auvelity. Pharmacy benefit managers and health plans
under this GPO are now able to make coverage decisions for Auvelity
based on the contracted terms. Axsome has now contracted with two
of the three largest GPOs for Auvelity.
Sunosi
- Approximately 42,000 prescriptions were written for Sunosi in
the U.S. in the first quarter of 2024, representing an 1.6%
decrease versus the fourth quarter of 2023.
- Sunosi maintains broad payer coverage in the commercial channel
with 95% of lives covered. Currently 83% of total lives across all
channels are covered.
Development Pipeline
Axsome is advancing an industry-leading
neuroscience portfolio encompassing five innovative, late-stage,
patent-protected product candidates for 10 serious psychiatric and
neurologic conditions, which affect more than 150 million people in
the U.S. alone. Recent and anticipated progress for key pipeline
programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s
novel, oral, investigational NMDA receptor antagonist and sigma-1
agonist being developed for Alzheimer’s disease (AD) agitation and
smoking cessation. AXS-05 has been granted U.S. Food and Drug
Administration (FDA) Breakthrough Therapy designation for AD
agitation.
- Alzheimer’s Disease Agitation: Axsome is
conducting the ADVANCE-2 study, a Phase 3, placebo-controlled,
parallel group trial to evaluate the efficacy and safety of AXS-05
for the treatment of AD agitation. Patients completing ADVANCE-2
may enter a long-term open label safety extension trial. The
Company anticipates completion of ADVANCE-2 in the second half of
2024.Axsome recently initiated the ACCORD-2 study, a Phase 3,
double-blind, placebo-controlled, randomized withdrawal trial to
evaluate the efficacy and safety of AXS-05 in the treatment of AD
agitation. In this study, patients from the Company’s long-term
open label safety extension trial are treated with AXS-05 and
monitored for treatment response based on the Cohen-Mansfield
Agitation Inventory (CMAI). Approximately 140 patients who
experience a treatment response are planned to be randomized into
the double-blind treatment period, in a 1:1 ratio, to continue
treatment with AXS-05 or to switch to placebo, for up to 26 weeks
or until a relapse of agitation occurs. The primary endpoint will
be the time from randomization to relapse. The company anticipates
completion of enrollment in this study around mid-year.ACCORD-2
adds a fourth controlled efficacy trial to the robust development
program for AXS-05 in AD agitation, which now includes two parallel
group trials (ADVANCE-1 and ADVANCE-2) and two randomized
withdrawal trials (ACCORD-1 and ACCORD-2).
- Smoking Cessation: Axsome plans to initiate a
pivotal Phase 2/3 trial in this indication in 2024.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is
Axsome’s novel, oral, rapidly absorbed, multi-mechanistic,
investigational medicine for the acute treatment of migraine.
- Migraine: Activities for the resubmission of
the Company’s New Drug Application (NDA) for AXS-07 for the acute
treatment of migraine are nearing completion. The Company is on
track to resubmit the NDA in the second quarter of 2024. No
additional clinical efficacy or safety trials have been requested
by the FDA for a resubmission of the NDA. The Company expects the
NDA resubmission to be designated as Class 2 which would be subject
to a six-month review.Axsome is conducting the EMERGE study, a
multicenter, Phase 3, single-group trial evaluating the efficacy
and safety of AXS-07 in the acute treatment of migraine headache in
adults with a prior inadequate response to an oral CGRP inhibitor.
The Company anticipates topline results from the EMERGE study in
the second half of 2024.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral,
potent, investigational highly selective norepinephrine reuptake
inhibitor and cortical dopamine modulator for the treatment of
narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for
the treatment of narcolepsy.
- Narcolepsy: In March 2024, Axsome announced
positive topline results from the SYMPHONY trial, a Phase 3,
randomized, double-blind, multicenter, placebo-controlled trial of
AXS-12 in patients with narcolepsy. AXS-12 achieved the primary
endpoint by significantly reducing the frequency of cataplexy
attacks as compared to placebo in patients with narcolepsy. AXS-12
also reduced excessive daytime sleepiness severity (EDS), improved
cognitive function, reduced overall narcolepsy severity, and
improved patient function and quality of life, as compared to
placebo. AXS-12 was well tolerated in the trial.A Phase 3 open
label safety extension trial of AXS-12 is currently ongoing with
completion anticipated in the fourth quarter of 2024.In March 2024,
the Company also announced topline results from the CRESCENDO
(Characterizing Patient Perspectives on Unmet Needs in Narcolepsy)
survey of 203 narcolepsy patients with cataplexy (narcolepsy type 1
or NT1) who are currently receiving treatment. The results
demonstrated high rates of persistent symptoms with 77%, 64%, and
74% continuing to experience cataplexy, EDS, and cognitive
impairment, respectively, despite being on current treatments.
CRESCENDO was conducted by a third-party research firm that worked
with Narcolepsy Network to ensure patient privacy. Narcolepsy
Network is a national non-profit patient support organization for
people with narcolepsy, idiopathic hypersomnia and related sleep
disorders.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral,
potent, highly selective investigational norepinephrine reuptake
inhibitor for the management of fibromyalgia. Esreboxetine, the
SS-enantiomer of reboxetine, is more potent and selective than
racemic reboxetine.
- Fibromyalgia: Pre-submission activities for
the Company’s NDA for AXS-14 for the management of fibromyalgia are
nearing completion. The Company is targeting submission of the NDA
in the second quarter of 2024. AXS-14 has previously met the
primary endpoints and demonstrated positive and statistically
significant results in a Phase 3 and in a Phase 2 trial for the
management of fibromyalgia.
Solriamfetol
Solriamfetol is Axsome’s dopamine and
norepinephrine reuptake inhibitor and TAAR1 agonist in development
for the treatment of attention deficit hyperactivity disorder
(ADHD), major depressive disorder (MDD), binge eating disorder
(BED), and excessive sleepiness associated with shift work disorder
(SWD).
- Attention Deficit Hyperactivity Disorder:
Axsome is conducting the FOCUS study, a Phase 3, randomized,
double-blind, placebo-controlled, multicenter trial to assess the
efficacy and safety of solriamfetol for the treatment of ADHD in
adults. The Company anticipates topline results from the FOCUS
study in the second half of 2024.
- Major Depressive Disorder: In March 2024,
Axsome initiated the PARADIGM study, a Phase 3, randomized,
double-blind, placebo-controlled, multicenter trial of solriamfetol
for the treatment of MDD. The Company anticipates topline results
from the PARADIGM study in 2025.
- Binge Eating Disorder: In March 2024, Axsome
initiated the ENGAGE study, a Phase 3, randomized, double-blind,
placebo-controlled, multicenter trial of solriamfetol for the
treatment of BED. The Company anticipates topline results from the
ENGAGE study in 2025.
- Shift Work Disorder: The Company is on track
initiate a Phase 3 trial of solriamfetol for the treatment of
excessive sleepiness (ES) associated with SWD in the second quarter
of 2024.
Anticipated Milestones
- Regulatory and Commercial:
- AXS-07 for migraine, NDA resubmission (2Q 2024)
- AXS-14 for fibromyalgia, NDA submission (2Q 2024)
- Clinical Trial Topline Results:
- Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease
agitation (2H 2024)
- Phase 3 open-label safety extension trial of AXS-12 in
narcolepsy (2H 2024)
- Phase 3 FOCUS trial of solriamfetol in ADHD in adults (2H
2024)
- Phase 3 PARADIGM trial of solriamfetol in major depressive
disorder (2025)
- Phase 3 ENGAGE trial of solriamfetol in binge eating disorder
(2025)
- Phase 3 EMERGE trial of AXS-07 in migraine with inadequate
response to oral CGRP inhibitors (2H 2024)
- Clinical Trial Initiations and Progress:
- Phase 3 trial of solriamfetol in shift work disorder,
initiation (2Q 2024)
- Phase 3 ACCORD-2 trial of AXS-05 for Alzheimer's disease
agitation, enrollment completion (mid-year 2024)
- Pivotal Phase 2/3 trial of AXS-05 for smoking cessation,
initiation (2024)
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss first quarter 2024 financial
results as well as to provide a corporate update. To participate in
the live conference call, please dial (877) 405-1239 (toll-free
domestic). The live webcast can be accessed on the "Webcasts &
Presentations" page of the "Investors" section of the Company’s
website at axsome.com. A replay of the webcast will be available
for approximately 30 days following the live event.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for central
nervous system (CNS) conditions that have limited treatment
options. Through development of therapeutic options with novel
mechanisms of action, we are transforming the approach to treating
CNS conditions. At Axsome, we are committed to developing products
that meaningfully improve the lives of patients and provide new
therapeutic options for physicians. For more information, please
visit the Company’s website at axsome.com. The Company may
occasionally disseminate material, nonpublic information on the
company website.
Forward Looking Statements
Certain matters discussed in this press release
are “forward-looking statements”. We 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 our Sunosi® and Auvelity® products
and the success of our efforts to obtain any additional
indication(s) with respect to solriamfetol and/or AXS-05; the
success, timing and cost of our ongoing clinical trials and
anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation, pace of
enrollment and completion of the trials (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected revenues or expenses), futility
analyses and receipt of interim results, which are not necessarily
indicative of the final results of our 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 our current product candidates; our
ability to fund additional clinical trials to continue the
advancement of our product candidates; the timing of and our
ability to obtain and maintain U.S. Food and Drug Administration
(“FDA”) or other regulatory authority approval of, or other action
with respect to, our 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 our 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; unforeseen circumstances or other disruptions to
normal business operations arising from or related to 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.
Axsome Therapeutics, Inc.Selected
Consolidated Financial Data |
|
Axsome Therapeutics, Inc.Consolidated
Balance Sheets(In thousands, except share and per share
amounts) |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
331,441 |
|
|
$ |
386,193 |
|
Accounts receivables, net |
|
|
101,434 |
|
|
|
94,820 |
|
Inventories, net |
|
|
15,583 |
|
|
|
15,135 |
|
Prepaid and other current assets |
|
|
12,032 |
|
|
|
8,115 |
|
Total
current assets |
|
|
460,490 |
|
|
|
504,263 |
|
Equipment, net |
|
|
812 |
|
|
|
846 |
|
Right-of-use asset - operating lease |
|
|
6,411 |
|
|
|
6,772 |
|
Goodwill |
|
|
12,042 |
|
|
|
12,042 |
|
Intangible asset, net |
|
|
51,697 |
|
|
|
53,286 |
|
Non-current inventory and other assets |
|
|
14,276 |
|
|
|
11,027 |
|
Total
assets |
|
$ |
545,728 |
|
|
$ |
588,236 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
53,791 |
|
|
$ |
40,679 |
|
Accrued expenses and other current liabilities |
|
|
82,716 |
|
|
|
90,501 |
|
Operating lease liability, current portion |
|
|
1,153 |
|
|
|
1,267 |
|
Contingent consideration, current |
|
|
6,388 |
|
|
|
6,407 |
|
Total
current liabilities |
|
|
144,048 |
|
|
|
138,854 |
|
Contingent consideration, non-current |
|
|
70,000 |
|
|
|
73,300 |
|
Loan
payable, long-term |
|
|
178,689 |
|
|
|
178,070 |
|
Operating lease liability, long-term |
|
|
7,258 |
|
|
|
7,035 |
|
Finance
lease liability, long-term |
|
|
1,697 |
|
|
|
— |
|
Total
liabilities |
|
|
401,692 |
|
|
|
397,259 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value per share (10,000,000 shares
authorized, none issued and outstanding) |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value per share (150,000,000 shares
authorized, 47,464,575 and 47,351,363 shares issued and outstanding
at March 31, 2024 and December 31, 2023, respectively) |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
1,047,959 |
|
|
|
1,026,543 |
|
Accumulated deficit |
|
|
(903,928 |
) |
|
|
(835,571 |
) |
Total
stockholders’ equity |
|
|
144,036 |
|
|
|
190,977 |
|
Total
liabilities and stockholders’ equity |
|
$ |
545,728 |
|
|
$ |
588,236 |
|
Axsome Therapeutics, Inc.Consolidated
Statements of Operations (Unaudited)(In thousands, except
share and per share amounts) |
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Revenues: |
|
|
|
|
|
|
Product sales, net |
|
$ |
74,096 |
|
|
$ |
28,569 |
|
License revenue |
|
|
— |
|
|
|
65,735 |
|
Royalty revenue |
|
|
903 |
|
|
|
272 |
|
Total
revenues |
|
|
74,999 |
|
|
|
94,576 |
|
Operating expenses: |
|
|
|
|
|
|
Cost of revenue (excluding amortization and depreciation) |
|
|
6,297 |
|
|
|
7,556 |
|
Research and development |
|
|
36,830 |
|
|
|
17,793 |
|
Selling, general and administrative |
|
|
98,970 |
|
|
|
74,191 |
|
Gain in fair value of contingent consideration |
|
|
(1,412 |
) |
|
|
(162 |
) |
Intangible asset amortization |
|
|
1,589 |
|
|
|
1,572 |
|
Total
operating expenses |
|
|
142,274 |
|
|
|
100,950 |
|
Loss
from operations |
|
|
(67,275 |
) |
|
|
(6,374 |
) |
Interest expense, net |
|
|
(1,082 |
) |
|
|
(2,264 |
) |
Loss
before income taxes |
|
|
(68,357 |
) |
|
|
(8,638 |
) |
Income tax expense |
|
|
— |
|
|
|
(2,580 |
) |
Net
loss |
|
$ |
(68,357 |
) |
|
$ |
(11,218 |
) |
Net loss
per common share, basic and diluted |
|
$ |
(1.44 |
) |
|
$ |
(0.26 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
47,393,563 |
|
|
|
43,523,631 |
|
|
Axsome Contacts:
Investors:Mark JacobsonChief Operating OfficerAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
Media:Darren OplandDirector, Corporate CommunicationsAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com
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