Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced reported financial results for the fourth quarter and
full year of 2023.
“2023 was a transformational year for Axsome,
based on successful commercial execution as well as substantial
pipeline advancement and expansion. During our first full year as a
commercial company, Auvelity and Sunosi were prescribed for more
than 100,000 patients combined. We expanded our Auvelity
neuropsychiatry sales force and progressed our NDAs for AXS-07 in
migraine and AXS-14 in fibromyalgia. We advanced our Phase 3 trials
of AXS-12 in narcolepsy and AXS-05 in Alzheimer’s disease
agitation, initiated a Phase 3 pivotal trial program for
solriamfetol in ADHD, and announced three additional new
indications for solriamfetol,” said Herriot Tabuteau, MD, Chief
Executive Officer of Axsome. “We expect to continue the momentum in
2024 as we drive further growth for our two currently marketed
products, and potentially submit two NDAs for migraine and
fibromyalgia, read out three Phase 3 trials in narcolepsy,
Alzheimer’s disease agitation, and ADHD, and, in the near term,
initiate an equal number of new pivotal trials in depression, binge
eating disorder, and shift work disorder. Enrollment in the
SYMPHONY Phase 3 trial of AXS-12 in narcolepsy is now complete and
we are on track to report topline results this quarter.”
Fourth Quarter 2023 and Full Year
Financial Highlights
- Total net product revenues were
$71.5 million and $204.9 million for the fourth quarter and full
year of 2023, representing year-over-year growth of 193% and 309%,
respectively. Total product revenues for the comparable periods in
2022 were $24.4 million and $50.0 million, respectively. Total
revenue for the full year of 2023 was $270.6 million, which
includes license revenue of $65.7 million from out-licensing
Sunosi® in certain ex-U.S. territories.
- Auvelity® net product sales were
$49.0 million and $130.1 million for the fourth quarter and full
year of 2023, the first full year of launch. Auvelity was launched
on October 19, 2022, and had U.S. net sales of $5.2 million for the
fourth quarter of 2022.
- Sunosi net product revenues were
$22.5 million and $74.8 million for the fourth quarter and full
year of 2023, representing 17% and 67% year-over-year growth,
respectively, consisting of $21.7 million and $72.4 million in net
product sales and $0.8 million and $2.4 million in royalty revenue
associated with Sunosi sales in out-licensed territories,
respectively. Sunosi net sales for the comparable periods in 2022
were $19.2 million and $44.9 million, respectively. The U.S.
portion of the acquisition of Sunosi closed in May 2022 and the
ex-U.S. portion closed in November of 2022. Total Sunosi revenue
for the full year of 2023 was $140.5 million, which includes
license revenue of $65.7 million from out-licensing Sunosi in
certain ex-U.S. territories.
- Total costs of revenue were $7.4
million and $26.1 million for the fourth quarter and full year of
2023, respectively. Total costs of revenue for the comparable
periods in 2022 was $2.3 million and $5.2 million, respectively.
Total cost of revenue for the full year of 2023 included a one-time
cost of $5.0 million associated with the upfront fee received for
the Sunosi out licensing transaction.
- Research and development (R&D)
expenses were $30.8 million and $97.9 million for the fourth
quarter and full year of 2023, respectively, compared to $14.7
million and $57.9 million for the comparable periods in 2022,
respectively. The increase was primarily related to the FOCUS trial
of solriamfetol in ADHD, the advancement of ongoing trials of
AXS-05 and AXS-12, manufacturing costs 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 $86.8 million and $323.1
million for the fourth quarter and full year of 2023, respectively,
compared to $61.5 million and $159.3 million for the comparable
periods in 2022, respectively. The increase was primarily related
to commercialization activities for Auvelity and Sunosi, including
sales force and marketing expenses, and higher personnel costs
related to organizational growth, including non-cash stock-based
compensation.
- Net loss for the fourth quarter of
2023 was $98.7 million or $(2.08) per share, compared to a net loss
of $61.2 million, or $(1.41) per share, for the comparable period
in 2022. The net loss in the fourth quarter of 2023 includes $63.7
million in non-cash charges, comprised of $43.2 million in
acquisition-related contingent consideration expense reflecting
updated sales projections for the recently announced new
indications in solriamfetol, $18.9 million of non-cash stock-based
compensation expense, and $1.6 million of non-cash intangible asset
amortization. Net loss was $239.2 million, or $(5.27) per share,
for the full year of 2023, compared to a net loss of $187.1
million, or $(4.60) per share, for the full year of 2022. The net
loss for the full year includes total non-cash charges of $117.9
million which includes $62.6 million of stock-based compensation
expense, $48.9 million in fair value of contingent consideration
expense, and $6.4 million in intangible amortization compared to
$37.7 million, $3.3 million, and $4.1 million respectively for the
full year 2022.
- Cash and cash equivalents totaled
$386.2 million at December 31, 2023, compared to $200.8 million at
December 31, 2022.
- Shares of common stock outstanding
were 47,351,363 at December 31, 2023.
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 84,000 prescriptions were written for Auvelity in
the fourth quarter of 2023, representing a 23% sequential increase
versus the third quarter of 2023.
- The previously announced expansion of the Auvelity
neuropsychiatry sales force from 162 to 260 representatives is now
complete. The sales force expansion along with Axsome’s pioneering,
technology-driven Digital Centric Commercialization (DCC™) platform
is expected to increase our reach to approximately 44,000 health
care providers, who write nearly 90% of new branded antidepressant
prescriptions.
- Payer coverage for Auvelity across all channels is stable at
approximately 70% of all covered lives. Commercial coverage is at
approximately 48%, and Auvelity is a protected class product which
must be covered by all payors in the Medicare channel and is
covered by all state Medicaid programs. Axsome expects coverage to
continue to expand and evolve.
Sunosi
- Approximately 42,000 prescriptions were written for Sunosi in
the U.S. in the fourth quarter of 2023, representing an 18%
increase versus the fourth quarter of 2022 and a 2% sequential
increase versus the third 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: The Company is
conducting the ADVANCE-2 study, a Phase 3, placebo-controlled,
parallel group trial to assess 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. Based on
anticipated enrollment trends and recent changes to treatment
market dynamics, the Company now anticipates completion of
ADVANCE-2 in the second half of 2024.
- 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: Manufacturing activities related to
the planned resubmission of the New Drug Application (NDA) for
AXS-07 for the acute treatment of migraine continue to progress.
The Company continues to anticipate resubmission of the NDA in the
first half 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.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral,
potent, investigational highly selective norepinephrine reuptake
inhibitor for the treatment of narcolepsy. AXS-12 has been granted
FDA Orphan Drug designation for the treatment of narcolepsy.
- Narcolepsy: Enrollment in the SYMPHONY study,
a Phase 3 randomized, multicenter, double-blind,
placebo-controlled, parallel-group trial of AXS-12 in the treatment
of narcolepsy has been completed. The Company is on track to
announce topline results for SYMPHONY in the first quarter of
2024.
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: Axsome is compiling the NDA for
AXS-14 for the management of fibromyalgia. The Company is on track
to submit the NDA in the first half 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
trial in the second half of 2024.
- Major Depressive Disorder: The Company plans
to initiate a Phase 3 trial of solriamfetol for the treatment of
MDD in the first quarter of 2024.
- Binge Eating Disorder: The Company plans to
initiate a Phase 3 trial of solriamfetol for the treatment of BED
in the first quarter of 2024.
- Shift Work Disorder: The Company plans to
initiate a Phase 3 trial of solriamfetol for the treatment of
excessive sleepiness (ES) associated with SWD in the first quarter
of 2024.
Anticipated Milestones
- Regulatory and Commercial:
- AXS-07 for migraine, NDA resubmission (1H 2024)
- AXS-14 for fibromyalgia, NDA submission (1H 2024)
- Clinical Trial Topline Results:
- Phase 3 SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)
- Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease
agitation (2H 2024)
- Phase 3 FOCUS trial of solriamfetol in attention deficit
hyperactivity disorder (ADHD) in adults (2H 2024)
- Clinical Trial Initiations:
- Phase 3 trial of solriamfetol in major depressive disorder
(MDD) (1Q 2024)
- Phase 3 trial of solriamfetol for binge eating disorder (BED)
(1Q 2024)
- Phase 3 trial of solriamfetol in shift work disorder (SWD) (1Q
2024)
- Pivotal Phase 2/3 trial of AXS-05 for smoking cessation
(2024)
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss fourth quarter and full year
2023 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 (Unaudited, in thousands, except for share and per
share amounts) |
|
|
December 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
386,193 |
|
|
$ |
200,842 |
|
Accounts receivables, net |
|
|
94,820 |
|
|
|
37,699 |
|
Inventories, net |
|
|
15,135 |
|
|
|
4,320 |
|
Prepaid and other current assets |
|
|
8,115 |
|
|
|
2,781 |
|
Total
current assets |
|
|
504,263 |
|
|
|
245,642 |
|
Equipment,
net |
|
|
846 |
|
|
|
722 |
|
Right-of-use
asset - operating lease |
|
|
6,772 |
|
|
|
420 |
|
Goodwill |
|
|
12,042 |
|
|
|
10,310 |
|
Intangible
asset, net |
|
|
53,286 |
|
|
|
59,661 |
|
Non-current
inventory and other assets |
|
|
11,027 |
|
|
|
14,721 |
|
Total
assets |
|
$ |
588,236 |
|
|
$ |
331,476 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
40,679 |
|
|
$ |
38,605 |
|
Accrued expenses and other current liabilities |
|
|
90,501 |
|
|
|
51,631 |
|
Operating lease liability, current portion |
|
|
1,267 |
|
|
|
425 |
|
Contingent consideration, current |
|
|
6,407 |
|
|
|
5,900 |
|
Total
current liabilities |
|
|
138,854 |
|
|
|
96,561 |
|
Contingent
consideration, non-current |
|
|
73,300 |
|
|
|
31,100 |
|
Loan
payable, long-term |
|
|
178,070 |
|
|
|
94,259 |
|
Operating
lease liability, long-term |
|
|
7,035 |
|
|
|
— |
|
Total
liabilities |
|
|
397,259 |
|
|
|
221,920 |
|
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, 47,351,363 and 43,498,617 shares issued and outstanding
at December 31, 2023 and December 31, 2022, respectively) |
|
|
5 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
1,026,543 |
|
|
|
705,885 |
|
Accumulated deficit |
|
|
(835,571 |
) |
|
|
(596,333 |
) |
Total
stockholders’ equity |
|
|
190,977 |
|
|
|
109,556 |
|
Total
liabilities and stockholders’ equity |
|
$ |
588,236 |
|
|
$ |
331,476 |
|
Axsome
Therapeutics, Inc. Consolidated Statements of
Operations (Unaudited, in thousands, except share and per
share amounts) |
|
|
|
Three Months
Ended |
|
|
Twelve
Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
70,747 |
|
|
$ |
24,372 |
|
|
$ |
202,460 |
|
|
$ |
50,037 |
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
65,735 |
|
|
|
— |
|
Royalty revenue |
|
|
784 |
|
|
|
— |
|
|
|
2,405 |
|
|
|
— |
|
Total
revenues |
|
|
71,531 |
|
|
|
24,372 |
|
|
|
270,600 |
|
|
|
50,037 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (excluding amortization and depreciation) |
|
|
7,377 |
|
|
|
2,291 |
|
|
|
26,065 |
|
|
|
5,198 |
|
Research and development |
|
|
30,803 |
|
|
|
14,693 |
|
|
|
97,944 |
|
|
|
57,947 |
|
Selling, general and administrative |
|
|
86,810 |
|
|
|
61,498 |
|
|
|
323,123 |
|
|
|
159,254 |
|
Loss in fair value of contingent consideration |
|
|
43,207 |
|
|
|
4,200 |
|
|
|
48,918 |
|
|
|
3,298 |
|
Intangible asset amortization |
|
|
1,607 |
|
|
|
1,607 |
|
|
|
6,375 |
|
|
|
4,139 |
|
Total
operating expenses |
|
|
169,804 |
|
|
|
84,289 |
|
|
|
502,425 |
|
|
|
229,836 |
|
Loss from
operations |
|
|
(98,273 |
) |
|
|
(59,917 |
) |
|
|
(231,825 |
) |
|
|
(179,799 |
) |
Interest expense, net |
|
|
(703 |
) |
|
|
(1,323 |
) |
|
|
(6,453 |
) |
|
|
(7,335 |
) |
Loss before
income taxes |
|
|
(98,976 |
) |
|
|
(61,240 |
) |
|
|
(238,278 |
) |
|
|
(187,134 |
) |
Income tax benefit (expense) |
|
|
325 |
|
|
|
— |
|
|
|
(960 |
) |
|
|
— |
|
Net
loss |
|
$ |
(98,651 |
) |
|
$ |
(61,240 |
) |
|
$ |
(239,238 |
) |
|
$ |
(187,134 |
) |
Net loss per
common share, basic and diluted |
|
$ |
(2.08 |
) |
|
$ |
(1.41 |
) |
|
$ |
(5.27 |
) |
|
$ |
(4.60 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
47,329,782 |
|
|
|
43,447,309 |
|
|
|
45,425,212 |
|
|
|
40,655,941 |
|
Axsome Contacts:
Investors: Mark Jacobson Chief Operating Officer
Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New
York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com
www.axsome.com
Media:
Darren Opland Director, Corporate Communications
Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New
York, NY 10007 Tel: 929-837-1065 Email: dopland@axsome.com
www.axsome.com
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