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, 2022.
“Axsome’s transformation into a commercial
stage, fully integrated, research and development driven, CNS
focused biopharmaceutical company has accelerated with the
successful commercialization of Sunosi, and now the launch of
Auvelity for the treatment of major depressive disorder in adults,”
said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.
“While it is still extremely early days in the Auvelity launch, we
are very encouraged by the interest and reception from the
prescriber community thus far. Our first-in-class DCC, or digital
centric commercialization, platform is already demonstrating the
effectiveness and efficiency of a contemporary, integrated,
omni-channel approach to meaningful customer engagements. In
parallel with our commercial efforts, our industry leading
neuroscience development pipeline is progressing, setting the stage
for continued potentially significant value creation over the near,
intermediate and long term. This late-stage portfolio comprises
five differentiated, product candidates, including AXS-05 for
Alzheimer’s disease agitation and smoking cessation, solriamfetol
for ADHD, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. We
anticipate this portfolio to generate multiple clinical trial
readouts, clinical trial initiations, and NDA filings over the
remainder of this year and through 2023.”
Third Quarter 2022 Financial
Highlights
- Total
revenues were $16.8 million for the third quarter of 2022, compared
to none for the 2021 comparable period. U.S. net sales of Sunosi
were $16.8 million for the third quarter of 2022. No Sunosi sales
were reported by Axsome for the 2021 comparable period reflecting
the timing of the Sunosi acquisition.
- Total
cost of product sales were $1.9 million for the third quarter of
2022, compared to none for the 2021 comparable period.
- Research
and development (R&D) expenses were $14.9 million for the third
quarter of 2022 and $13.2 million for the comparable period in
2021. The increase was primarily related to higher costs associated
with ongoing clinical trials, including post-marketing commitments
assumed for Sunosi.
- Selling,
general, and administrative (SG&A) expenses were $40.9 million
for the third quarter of 2022 and $20.2 million for the comparable
period in 2021. The increase was primarily related to commercial
activities for Sunosi and Auvelity, including sales force
onboarding and marketing spend, and higher non-cash stock
compensation expense.
- Net loss was
$44.8 million, or $(1.07) per share, for the third quarter of 2022,
compared to a net loss of $34.9 million, or $(0.93) per share, for
the comparable period in 2021. The net loss for the current period
included $9.2 million of non-cash stock compensation expense
compared to $5.7 million in the comparable period in 2021.
- Cash and cash
equivalents totaled $227.5 million at September 30, 2022, compared
to $86.5 million at December 31, 2021. During the quarter, the
Company utilized its existing at-the-market equity facility and
received net proceeds of $175 million.
- Shares of
common stock outstanding were 43,425,709 at September 30,
2022.
Financial Guidance
- Axsome believes
that its current cash, along with the remaining committed capital
from the $300 million term loan facility, is sufficient to fund
anticipated operations into 2025, based on the current operating
plan, which includes the continued commercialization of Sunosi and
Auvelity.
- Axsome expects
that its operating expenses will increase year over year as the
Company commercializes Sunosi and Auvelity and continues to advance
its pipeline.
Commercial Highlights
Sunosi
-
Axsome’s first full quarter of U.S. Sunosi commercialization was
characterized by significantly increased sales force productivity
aided by the Company’s Digital Centric Commercialization™ (DDC)
approach. Third quarter U.S. Sunosi total prescriptions increased
by 15% versus the third quarter of 2021, and by 3% versus the
second quarter of 2022.
- Sunosi
has broad payer coverage in the commercial channel with 96% of
lives covered. Currently 64% of lives are covered in the Medicare
Part D and Medicaid channels.
- The
ex-U.S. acquisition of Sunosi is on track to close in the fourth
quarter of 2022.
Auvelity
- Axsome
announced the commercial launch of Auvelity on October 20, 2022,
following its approval by the FDA on August 18, 2022. Auvelity is
currently available by prescription in the U.S.
- Our
Auvelity field force is actively engaging healthcare providers to
provide comprehensive education on Auvelity. The vast majority of
our sales specialists have prior psychiatry experience. Successful
early engagement with target prescribers is being achieved through
remote and in-person interactions guided by our DCC platform. These
activities are being accompanied by digital marketing, peer-to-peer
medical education, and medical conference
presence. Interactions with payers continue to be active and
productive.
- Our
comprehensive patient and provider support services are fully
operational and performing as planned. These include the Auvelity
Savings Card to reduce out-of-pocket expenses for qualifying
patients, the Auvelity on My Side program, telehealth services,
samples program, and payer assistance to help clinicians provide
their patients access to Auvelity.
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 with
multimodal activity being developed for the 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: In September 2022,
Axsome initiated the ADVANCE-2 study, a Phase 3, randomized,
double-blind, placebo-controlled, multicenter, trial to assess the
efficacy and safety of AXS-05 for the treatment of agitation
associated with AD. Concurrent with the initiation of ADVANCE-2,
the Company has concluded the ACCORD randomized withdrawal trial.
Topline results from ACCORD are on track for the fourth quarter of
2022.
-
Smoking Cessation: Axsome plans to proceed to a
pivotal Phase 2/3 trial in this indication. The Company intends to
provide information on the timing of initiation of this study in
2022.
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: Axsome held a Type A meeting with the
FDA in the third quarter to discuss the Company’s approach to its
planned resubmission of the New Drug Application (NDA) for AXS-07
for the acute treatment of migraine. Following the meeting, the
Company intends to resubmit its NDA in the third quarter of 2023.
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. Enrollment in the trial is progressing and topline
results continue to be anticipated in the first half of 2023.
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: Manufacturing and other activities
related to the planned submission of an NDA for AXS-14 for the
management of fibromyalgia are ongoing. The Company expects to
submit the NDA in 2023. 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 dual-acting dopamine
and norepinephrine reuptake inhibitor in development for the
treatment of attention deficit hyperactivity disorder (ADHD).
-
ADHD: The Company is preparing to initiate a Phase
2/3 multi-center, randomized, double-blind, placebo-controlled
trial to evaluate the efficacy and safety of solriamfetol in adults
with ADHD in the fourth quarter of 2022.
-
Cognitive function: In October, the Company
announced that solriamfetol met the primary endpoint in the SHARP
study and significantly improved cognitive function, as measured by
the DSST RBANS, in cognitively impaired patients with excessive
daytime sleepiness associated with obstructive sleep apnea,
compared to placebo (p=0.009). Superiority of solriamfetol as
compared to placebo was further demonstrated using patient-reported
measures of cognitive function.
-
New mechanism of action data: New preclinical
pharmacology studies have identified agonist activity at the trace
amine-associated receptor 1 (TAAR1) and lower potency agonist
activity at 5-HT1A receptors for solriamfetol, in addition to its
activity as a dopamine and norepinephrine reuptake inhibitor
(DNRI). These findings were presented at the 2022 Psych Congress in
September. TAAR1 is a G-protein coupled receptor with affinity for
the trace amines, and TAAR1 agonists have demonstrated
pro-cognitive and wake-promoting effects in rodents and
primates.
Anticipated Milestones
-
Regulatory and Commercial:
- AXS-07
for migraine, NDA resubmission (3Q 2023)
- AXS-14
for fibromyalgia, NDA submission (2023)
-
Clinical Trial Readouts:
- Phase 3
ACCORD trial of AXS-05 for Alzheimer’s disease agitation, topline
data (4Q 2022)
- Phase 3
SYMPHONY trial of AXS-12 in narcolepsy, topline data (1H 2023)
- Phase 3
ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation
(2025)
-
Clinical Trial Initiations:
- Phase 2/3
trial of solriamfetol for ADHD in adults (4Q 2022)
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss third quarter 2022 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 expenses), futility analyses and
receipt of interim results, which are not necessarily indicative of
the final results of our ongoing clinical trials, 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; 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, 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
|
|
September 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
227,520,218 |
|
|
$ |
86,472,854 |
|
Accounts receivables, net |
|
|
20,302,222 |
|
|
|
— |
|
Inventories, net |
|
|
2,103,477 |
|
|
|
— |
|
Prepaid and other current assets |
|
|
2,457,513 |
|
|
|
45,286 |
|
Total
current assets |
|
|
252,383,430 |
|
|
|
86,518,140 |
|
Equipment, net |
|
|
626,990 |
|
|
|
283,846 |
|
Right-of-use asset - operating lease |
|
|
384,568 |
|
|
|
660,162 |
|
Goodwill |
|
|
11,897,000 |
|
|
|
— |
|
Intangible asset, net |
|
|
61,267,561 |
|
|
|
— |
|
Non-current inventory and other assets |
|
|
12,398,220 |
|
|
|
322,910 |
|
Total
assets |
|
$ |
338,957,769 |
|
|
$ |
87,785,058 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
12,844,629 |
|
|
$ |
13,149,329 |
|
Accrued expenses and other current liabilities |
|
|
40,021,759 |
|
|
|
9,295,180 |
|
Operating lease liability, current portion |
|
|
416,876 |
|
|
|
620,675 |
|
Contingent consideration, current |
|
|
7,000,000 |
|
|
|
— |
|
Total
current liabilities |
|
|
60,283,264 |
|
|
|
23,065,184 |
|
Contingent consideration, non-current |
|
|
27,400,000 |
|
|
|
— |
|
Loan
payable, long-term |
|
|
93,913,159 |
|
|
|
49,089,522 |
|
Total
liabilities |
|
|
181,596,423 |
|
|
|
72,154,706 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value per share (10,000,000 shares
authorized, none issued and outstanding at September 30, 2022 and
December 31, 2021, respectively) |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value per share (150,000,000 shares authorized,
43,425,707 and 37,816,794 shares issued and outstanding at
September 30, 2022 and December 31, 2021, respectively) |
|
|
4,342 |
|
|
|
3,782 |
|
Additional paid-in capital |
|
|
692,450,128 |
|
|
|
424,825,655 |
|
Accumulated deficit |
|
|
(535,093,124 |
) |
|
|
(409,199,085 |
) |
Total
stockholders’ equity |
|
|
157,361,346 |
|
|
|
15,630,352 |
|
Total
liabilities and stockholders’ equity |
|
$ |
338,957,769 |
|
|
$ |
87,785,058 |
|
Axsome Therapeutics,
Inc.Consolidated Statements of
Operations(Unaudited)
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2022 |
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
Product sales, net |
|
$ |
16,845,792 |
|
|
$ |
|
— |
|
Operating expenses: |
|
|
|
|
|
|
Cost of product sales (excluding amortization and
depreciation) |
|
|
1,923,831 |
|
|
|
|
— |
|
Research and development |
|
|
14,877,021 |
|
|
|
|
13,180,258 |
|
Selling, general and administrative |
|
|
40,892,443 |
|
|
|
|
20,226,884 |
|
Gain in fair value of contingent consideration |
|
|
(42,120 |
) |
|
|
|
— |
|
Intangible asset amortization |
|
|
1,606,789 |
|
|
|
|
— |
|
Total
operating expenses |
|
|
59,257,964 |
|
|
|
|
33,407,142 |
|
Loss
from operations |
|
|
(42,412,172 |
) |
|
|
|
(33,407,142 |
) |
Interest
expense, net |
|
|
(2,411,040 |
) |
|
|
|
(1,475,535 |
) |
Net
loss |
|
$ |
(44,823,212 |
) |
|
$ |
|
(34,882,677 |
) |
Net loss
per common share, basic and diluted |
|
$ |
(1.07 |
) |
|
$ |
|
(0.93 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
41,704,362 |
|
|
|
|
37,680,966 |
|
Axsome Contact: Mark
JacobsonChief Operating OfficerAxsome Therapeutics, Inc.22
Cortlandt Street, 16th FloorNew York, NY 10007Tel:
212-332-3243Email: mjacobson@axsome.com www.axsome.com
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