Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
reported financial results for the third quarter ended September
30, 2023.
“Results for the third quarter evidenced
significant revenue momentum for Axsome driven by solid performance
from both Auvelity and Sunosi. This positive trajectory will be
further enhanced by our Auvelity field force expansion, which is
expected to be fully implemented by the first quarter,” said
Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We also
progressed our extensive and innovative neuroscience pipeline in
the quarter, enabling Axsome to potentially execute on numerous
important clinical and regulatory milestones over the next 12
months, including multiple potential NDA submissions, and multiple
pivotal trial readouts and initiations in new indications. The
advancement of our commercial portfolio and clinical programs
positions us well to continue to deliver potentially life-changing
new medicines to patients with serious brain disorders, and to
their health care providers.”
Third Quarter 2023 Financial
Highlights
- Total
product revenue for the third quarter of 2023 was $57.8 million,
representing 244% year-over-year growth, and consisting of net
product sales of $57.1 million and royalty revenue of $0.7 million.
Total product revenue for the comparable period in 2022 was $16.8
million.
-
Auvelity® net product sales were $37.7 million for the third
quarter of 2023, representing a 36% sequential increase versus the
second quarter of 2023. There were no Auvelity sales in the
comparable 2022 period as the product was launched in October
2022.
- Sunosi®
net product revenue was $20.1 million for the third quarter of
2023, representing 20% year-over-year growth, and consisting of
$19.4 million in net product sales and $0.7 million in royalty
revenue associated with Sunosi sales in out-licensed territories.
Sunosi net product revenue for the comparable period in 2022 was
$16.8 million.
- Total
cost of revenue was $6.5 million for the third quarter of 2023.
Total cost of revenue for the comparable period in 2022 was $1.9
million.
- Research
and development (R&D) expenses were $28.8 million for the third
quarter of 2023, compared to $14.9 million for the comparable
period in 2022. The increase was primarily related to the FOCUS
trial of solriamfetol in ADHD, the advancement of ongoing trials of
AXS-05 and AXS-12, CMC 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 $83.2
million for the third quarter of 2023, compared to $40.9 million
for the comparable period in 2022. The increase was primarily
related to commercial activities for Auvelity and Sunosi, and
higher personnel costs related to organizational growth, including
non-cash stock-based compensation.
- Net
loss for the third quarter of 2023 was $62.2 million or $(1.32) per
share, compared to a net loss of $44.8 million, or $(1.07) per
share, for the comparable period in 2022. The net loss in the third
quarter of 2023 reflects $18.0 million in non-cash charges,
comprised of $16.4 million of non-cash stock-based compensation
expense, and $1.6 million of non-cash intangible asset
amortization, partially offset by a $0.2 million of non-cash fair
value remeasurement gain in contingent consideration.
- Cash and cash
equivalents totaled $416.6 million at September 30, 2023, compared
to $200.8 million at December 31, 2022.
- Shares of
common stock outstanding were 47,317,381 at September 30,
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 69,000 prescriptions were reported for Auvelity in
the third quarter of 2023, representing a 30% sequential increase
versus the second quarter of 2023.
- The
previously announced expansion of the Auvelity sales force from 162
to 260 representatives is underway and expected to be completed in
the fourth quarter of 2023. The expansion will allow for greater
reach and call frequency to target health care providers,
potentially significantly broadening the prescriber base for
Auvelity. The increased number of representatives together with
Axsome’s innovative Digital Centric Commercialization (DCC™)
platform is expected to increase our reach from approximately
26,000 to approximately 44,000 physicians who write approximately
90% of new branded antidepressant prescriptions.
- Payer
coverage for Auvelity across all channels is currently 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. Active discussions with payers continue as coverage
further expands and evolves.
Sunosi
- Third
quarter 2023 U.S. Sunosi total prescriptions increased by 16%
versus the third quarter of 2022, and sequentially by 5% versus the
second 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 a portfolio of
differentiated, patent-protected, CNS product candidates with five
in active clinical development. 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
current enrollment trends, the Company continues to anticipate
completion of ADVANCE-2 in the first 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: Axsome is conducting the SYMPHONY
study, a Phase 3 randomized, multicenter, double-blind,
placebo-controlled, parallel-group trial of AXS-12 in the treatment
of narcolepsy. The Company is on track to complete enrollment in
the SYMPHONY trial in the fourth quarter of 2023, with announcement
of topline results anticipated in the first quarter of 2024.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral,
potent, investigational highly selective 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 related to
the planned submission of an NDA to the FDA for AXS-14 for the
management of fibromyalgia are ongoing. The Company expects to
submit the NDA in the first 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), 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.
-
Binge Eating Disorder: The Company previously
received positive pre-IND meeting feedback from the FDA on the
development of solriamfetol for the treatment of BED and is on
track to initiate a Phase 3 trial in the fourth quarter of 2023.
BED is the most common eating disorder, affecting an estimated 2.8%
of U.S. adults.1 Treatment options are limited with only one
product currently approved for the treatment of BED.
-
Shift Work Disorder: Axsome previously received
positive pre-IND meeting feedback from the FDA on the development
of solriamfetol for the treatment of excessive sleepiness (ES)
associated with SWD, a potentially new indication for solriamfetol
and is on track to initiate a Phase 3 trial in patients with ES
associated with SWD in the first quarter of 2024. An estimated one
third of Americans perform shift work, of whom 10-43% are diagnosed
with SWD.2-4 Treatment options are limited with only two products
currently approved for the treatment of ES associated with
SWD.
Corporate Update
- In
October 2023, Axsome announced the appointment of Susan Mahony,
PhD, to its board of directors. Dr. Mahony most recently served on
the board of directors of Horizon Therapeutics from 2019 until its
acquisition by Amgen in October 2023. She was formerly Senior Vice
President of Eli Lilly and Company and President of Lilly
Oncology.
Anticipated Milestones
- Regulatory
and Commercial:
- AXS-07 for
migraine, NDA resubmission (1H 2024)
- AXS-14 for
fibromyalgia, NDA submission (1Q 2024)
- Clinical
Trial 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 (1H 2024)
- Phase 3 FOCUS trial
of solriamfetol in ADHD in adults (2H 2024)
- Clinical
Trial Initiations:
- Phase 3 trial of
solriamfetol for BED (4Q 2023)
- Phase 3 trial of
solriamfetol in 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 third quarter 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 COVID-19; 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 for share and par
value amounts)
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
416,564 |
|
|
$ |
200,842 |
|
Accounts receivables, net |
|
|
78,415 |
|
|
|
37,699 |
|
Inventories, net |
|
|
9,985 |
|
|
|
4,320 |
|
Prepaid and other current assets |
|
|
6,799 |
|
|
|
2,781 |
|
Total current assets |
|
|
511,763 |
|
|
|
245,642 |
|
Equipment, net |
|
|
971 |
|
|
|
722 |
|
Right-of-use asset - operating
lease |
|
|
7,068 |
|
|
|
420 |
|
Goodwill |
|
|
12,042 |
|
|
|
10,310 |
|
Intangible asset, net |
|
|
54,893 |
|
|
|
59,661 |
|
Non-current inventory and other
assets |
|
|
14,120 |
|
|
|
14,721 |
|
Total assets |
|
$ |
600,857 |
|
|
$ |
331,476 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
29,098 |
|
|
$ |
38,605 |
|
Accrued expenses and other current liabilities |
|
|
78,454 |
|
|
|
51,631 |
|
Operating lease liability, current portion |
|
|
438 |
|
|
|
425 |
|
Contingent consideration, current |
|
|
6,672 |
|
|
|
5,900 |
|
Total current liabilities |
|
|
114,662 |
|
|
|
96,561 |
|
Contingent consideration,
non-current |
|
|
31,550 |
|
|
|
31,100 |
|
Loan payable, long-term |
|
|
177,446 |
|
|
|
94,259 |
|
Operating lease liability,
long-term |
|
|
7,691 |
|
|
|
— |
|
Total liabilities |
|
|
331,349 |
|
|
|
221,920 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par
value per share (10,000,000 shares authorized, none issued and
outstanding at September 30, 2023 and December 31, 2022,
respectively) |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value
per share (150,000,000 shares authorized, 47,317,381 and 43,498,617
shares issued and outstanding at September 30, 2023 and December
31, 2022, respectively) |
|
|
5 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
1,006,423 |
|
|
|
705,885 |
|
Accumulated deficit |
|
|
(736,920 |
) |
|
|
(596,333 |
) |
Total stockholders’ equity |
|
|
269,508 |
|
|
|
109,556 |
|
Total liabilities and
stockholders’ equity |
|
$ |
600,857 |
|
|
$ |
331,476 |
|
Axsome Therapeutics,
Inc.Consolidated Statements of Operations
(Unaudited)(In thousands, except share and per
share amounts)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
57,127 |
|
|
$ |
16,846 |
|
|
$ |
131,713 |
|
|
$ |
25,666 |
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
65,735 |
|
|
|
— |
|
Royalty revenue |
|
|
667 |
|
|
|
— |
|
|
|
1,622 |
|
|
|
— |
|
Total Revenues |
|
|
57,794 |
|
|
|
16,846 |
|
|
|
199,070 |
|
|
|
25,666 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (excluding amortization and depreciation) |
|
|
6,532 |
|
|
|
1,924 |
|
|
|
18,687 |
|
|
|
2,907 |
|
Research and development |
|
|
28,767 |
|
|
|
14,877 |
|
|
|
67,141 |
|
|
|
43,254 |
|
Selling, general and administrative |
|
|
83,188 |
|
|
|
40,892 |
|
|
|
236,314 |
|
|
|
97,756 |
|
Loss (Gain) in fair value of contingent consideration |
|
|
(180 |
) |
|
|
(42 |
) |
|
|
5,711 |
|
|
|
(902 |
) |
Intangible asset amortization |
|
|
1,607 |
|
|
|
1,607 |
|
|
|
4,768 |
|
|
|
2,532 |
|
Total operating expenses |
|
|
119,914 |
|
|
|
59,258 |
|
|
|
332,621 |
|
|
|
145,547 |
|
Loss from operations |
|
|
(62,120 |
) |
|
|
(42,412 |
) |
|
|
(133,551 |
) |
|
|
(119,881 |
) |
Interest expense, net |
|
|
(757 |
) |
|
|
(2,411 |
) |
|
|
(5,751 |
) |
|
|
(6,012 |
) |
Loss before income taxes |
|
|
(62,877 |
) |
|
|
(44,823 |
) |
|
|
(139,302 |
) |
|
|
(125,893 |
) |
Income tax benefit (expense) |
|
|
678 |
|
|
|
— |
|
|
|
(1,285 |
) |
|
|
— |
|
Net loss |
|
$ |
(62,199 |
) |
|
$ |
(44,823 |
) |
|
$ |
(140,587 |
) |
|
$ |
(125,893 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(1.32 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.14 |
) |
|
$ |
(3.17 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
47,117,196 |
|
|
|
41,704,362 |
|
|
|
44,783,380 |
|
|
|
39,715,261 |
|
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
References:
- J. I. Hudson, E.
Hiripi, H. G. Pope, and R. C. Kessler, “The Prevalence and
Correlates of Eating Disorders in the National Comorbidity Survey
Replication,” Biol. Psychiatry, vol. 61, no. 3, pp. 348–358, Feb.
2007, doi: 10.1016/j.biopsych.2006.03.040.
- Alterman, T.,
Luckhaupt, S. E., Dahlhamer, J. M., Ward, B. W. & Calvert, G.
M. Prevalence rates of work organization characteristics among
workers in the U.S.: data from the 2010 National Health Interview
Survey. Am. J. Ind. Med. 56, 647–659 (2013).
- Drake, C. L.,
Roehrs, T., Richardson, G., Walsh, J. K. & Roth, T. Shift work
sleep disorder: prevalence and consequences beyond that of
symptomatic day workers. Sleep 27, 1453–1462 (2004).
- Wickwire, E. M.,
Geiger-Brown, J., Scharf, S. M. & Drake, C. L. Shift Work and
Shift Work Sleep Disorder: Clinical and Organizational
Perspectives. Chest 151, 1156–1172 (2017).
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