Axsome Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
March 01 2021 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders, today reported financial results
for the fourth quarter and year ended December 31, 2020.
“The focused execution of the Axsome team made
2020 a year of significant accomplishments. We had successful
pre-NDA meetings with the FDA for AXS-05 in major depressive
disorder and for AXS-07 in migraine, reported positive results from
the pivotal ADVANCE-1 trial of AXS-05 in Alzheimer’s disease
agitation, initiated the second pivotal trial of AXS-05 in this
indication, received two new FDA Breakthrough Therapy designations,
and built out our commercialization infrastructure,” said Herriot
Tabuteau, MD, Chief Executive Officer of Axsome. “So far this year,
we have submitted to the FDA the NDA for AXS-05 in major depressive
disorder, and are nearing submission of the NDA for AXS-07 in the
acute treatment of migraine, which is expected early in the second
quarter. Our focus for the remainder of the year will be on the
regulatory activities surrounding these NDAs, launch readiness to
ensure a successful transition to commercialization, assuming
product approvals, and continued advancement of the rest of our
differentiated late-stage CNS pipeline.”
Business Update
For the many people living with serious CNS
disorders, Axsome accelerates the invention and development of
life-changing medicines. The Company is developing a portfolio of
differentiated, patent-protected, CNS product candidates with four
in active clinical development.
CNS Pipeline
-
AXS-05: AXS-05 (dextromethorphan-bupropion) is
Axsome’s novel, oral, investigational NMDA receptor antagonist with
multimodal activity being developed for the following indications:
major depressive disorder (MDD), Alzheimer’s disease (AD)
agitation, and smoking cessation. AXS-05 has been granted U.S. Food
and Drug Administration (FDA) Breakthrough Therapy designations for
MDD, and for AD agitation.Depression: Axsome has
submitted a New Drug Application (NDA) to the FDA for AXS-05 for
the treatment of MDD. The Company intends to issue a press release
following the FDA’s decision on the filing of the application.In
December 2020, Axsome announced positive results from the COMET
Phase 3 long-term trial in patients with MDD and the three Phase 2
open-label MDD efficacy trials in patients who had failed one prior
antidepressant (COMET-AU), patients who had failed two prior
antidepressants (COMET-TRD), and patients with suicidal ideation.
Patients treated with AXS-05 in these trials experienced rapid,
substantial, and durable improvement in depressive symptoms and
functional impairment that was sustained over the 12-month
treatment period. AXS-05 was well tolerated over the long-term
treatment period with a safety profile consistent with that
observed in the previously reported controlled trials.AD
Agitation: In December 2020, Axsome initiated the ACCORD
study, a Phase 3, randomized, double-blind, placebo-controlled,
multicenter, randomized withdrawal trial to evaluate the efficacy
and safety of AXS-05 in the treatment of Alzheimer’s disease (AD)
agitation.Smoking Cessation: Axsome is scheduled
to meet with the FDA in the third quarter of 2021 to discuss the
continued clinical development of AXS-05 as an aid to smoking
cessation treatment. Axsome previously announced positive results
from a Phase 2 trial of AXS-05 for smoking cessation treatment
conducted under a research collaboration between Axsome and Duke
University.
-
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 is compiling the NDA for
AXS-07 for the acute treatment of migraine. Submission of this NDA
is expected in early second quarter.In December 2020, Axsome
announced positive results from the MOVEMENT Phase 3 long-term
trial of AXS-07 in the acute treatment of migraine. In this trial,
treatment with AXS-07 resulted in rapid, substantial, and durable
relief of migraine pain and associated symptoms. AXS-07 was well
tolerated over the 12-month treatment period with a safety profile
consistent with that observed in the previously reported controlled
trials.
-
AXS-12: AXS-12 (reboxetine) is Axsome’s novel,
oral, potent, and highly selective norepinephrine reuptake
inhibitor for the treatment of narcolepsy. AXS-12 has been granted
FDA Orphan Drug designation for the treatment of narcolepsy as well
as Breakthrough Therapy designation for the treatment of cataplexy
in patients with narcolepsy.Narcolepsy: Axsome is
planning to initiate a Phase 3 trial of AXS-12 in the treatment of
narcolepsy in the second quarter. The planned Phase 3 trial will be
a randomized, double-blind, placebo-controlled, parallel-group
study.
-
AXS-14: AXS-14 (esreboxetine) is Axsome’s novel,
oral, potent, and highly selective norepinephrine reuptake
inhibitor for the treatment of fibromyalgia. Esreboxetine, the
SS-enantiomer of reboxetine, is more potent and selective than
racemic reboxetine.Fibromyalgia: Axsome is
scheduled to meet with the FDA in the second quarter, to discuss
the further clinical development of AXS-14 for the treatment of
fibromyalgia. 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 treatment of
fibromyalgia.
Commercial
- Launch
readiness activities continue to advance and all functional
commercial leadership is in place. Sales force structure and design
have been finalized and the hiring of sales managers and
representatives is expected to commence in the coming months. The
infrastructure for Axsome’s proprietary DCC™, or digital centric
commercialization, platform is in place, and payer engagement
activities have started.
Corporate
- In
January 2021, Axsome appointed Kevin Laliberte, PharmD, as
Executive Vice President, Product Strategy. Prior to Axsome, Dr.
Laliberte was Senior Vice President, Product Development at Dova
Pharmaceuticals. Prior to Dova, he was Senior Vice President,
Product Development and Clinical Operations at United Therapeutics,
where he was responsible for all development activities for small
molecules. Dr. Laliberte earned his Doctor of Pharmacy degree from
the University of Michigan, Ann Arbor and completed his post
doctorate fellowship at the University of North Carolina, Chapel
Hill and GlaxoSmithKline.
Anticipated Milestones
-
NDA Submissions:
- AXS-07
for the acute treatment of migraine, submission (early 2Q
2021)
-
Clinical Trial Readouts:
- Phase 2
MERIT trial of AXS-05 in TRD, topline data (2H 2021)
-
Clinical Trial Initiations:
- Phase 3
trial of AXS-12 in the treatment of narcolepsy (2Q 2021)
-
FDA Meetings:
- AXS-14
for fibromyalgia (2Q 2021)
- AXS-05
for smoking cessation (3Q 2021)
Financial Results for the Fourth Quarter
and Full Year 2020
-
Research and development (R&D) expenses:
R&D expenses were $17.4 million for the quarter ended December
31, 2020 and $19.2 million for the comparable period in 2019. The
decrease was due to the completion of our Phase 3 efficacy and
safety trials for AXS-05 and AXS-07. R&D expenses for the year
ended December 31, 2020 were $70.2 million, compared to $53.6
million for the comparable period in 2019. The increase was
primarily due to a one-time upfront charge related to our licensing
agreement with Pfizer along with costs associated with NDA
preparations.
-
General and administrative (G&A) expenses:
G&A expenses were $10.4 million for the quarter ended December
31, 2020 and $5.2 million for the comparable period in 2019. The
increase was primarily due to increased personnel costs, mainly
associated with stock compensation expense, along with the
build-out of the commercial function. G&A expenses for the year
ended December 31, 2020 were $28.9 million, compared to $13.6
million for the comparable period in 2019. The increase was
primarily due to an increase in stock compensation expense along
with the build-out of the commercial function.
- Net
loss: Net loss was $29.2 million, or $(0.78) per share for
the quarter ended December 31, 2020 compared to a net loss of $24.8
million, or $(0.71) per share for the comparable period in 2019.
Net loss for the year ended December 31, 2020 was $102.9 million,
or $(2.77) per share, of which $22.3 million were non-cash charges
including stock compensation expense. Net loss for the year ended
December 31, 2019 was $68.3 million, or $(2.01) per share, of which
$6.1 million were non-cash charges consisting of stock compensation
expense.
-
Cash: At December 31, 2020, Axsome had $183.9
million of cash compared to $220.0 million at December 31,
2019.
- Shares
outstanding: At December 31, 2020, Axsome had 37,374,088
shares of common stock outstanding.
Financial Guidance
- Axsome expects
that its operating expenses will increase year over year in 2021 to
support continued pipeline advancement and build-out of the
commercial function.
- Axsome believes
that its cash at December 31, 2020, along with the remaining
committed capital from the $225 million term loan facility, is
sufficient to fund anticipated operations, based on the current
operating plan which includes costs for the commercial launch of
AXS-05 in MDD and AXS-07 in migraine, into at least 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
2020 financial results as well as to provide a corporate update. To
participate in the live conference call, please dial (866) 393-4306
(toll-free domestic) or (734) 385-2616 (international), and use the
conference ID 3782547. 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 novel therapies for the management of central
nervous system (CNS) disorders for which there are limited
treatment options. For the many people facing unsatisfactory
treatments for CNS disorders, Axsome accelerates the invention and
adoption of life-changing medicines. Axsome’s core CNS product
candidate portfolio includes five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being
developed for major depressive disorder (MDD), Alzheimer’s disease
(AD) agitation, and as a treatment for smoking cessation. AXS-07 is
being developed for the acute treatment of migraine. AXS-12 is
being developed for the treatment of narcolepsy. AXS-14 is being
developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and
AXS-14 are investigational drug products not approved by the FDA.
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
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 (including,
but not limited to, whether the FDA will accept and subsequently
approve of the Company’s NDA submission for AXS-05 in MDD and the
timing of such approval, and whether the FDA will agree with the
Company’s discontinuation of the bupropion treatment arm of the
ADVANCE study in accordance with the independent data monitoring
committee’s recommendations); the successful submission of and
approval by the FDA of an 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 potential
for the ASCEND clinical trial, combined with the GEMINI clinical
trial results, to provide a basis for approval of AXS-05 for the
treatment of major depressive disorder and accelerate its
development timeline and commercial path to patients; 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 product candidates, if approved; the Company’s
anticipated capital requirements, including the amount of capital
required for the Company’s commercial launch of its product
candidates, and the potential impact on the Company’s anticipated
cash runway; as well as 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
Statements of Operations Information:
|
|
Three months ended |
|
|
Twelve months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
17,384,729 |
|
|
$ |
19,205,271 |
|
|
$ |
70,244,579 |
|
|
$ |
53,647,067 |
|
General and administrative |
|
|
10,359,507 |
|
|
|
5,222,899 |
|
|
|
28,896,749 |
|
|
|
13,598,030 |
|
Total operating expenses |
|
|
27,744,236 |
|
|
|
24,428,170 |
|
|
|
99,141,328 |
|
|
|
67,245,097 |
|
Loss from operations |
|
|
(27,744,236 |
) |
|
|
(24,428,170 |
) |
|
|
(99,141,328 |
) |
|
|
(67,245,097 |
) |
Interest and amortization of
debt discount (expense) |
|
|
(1,473,989 |
) |
|
|
(378,814 |
) |
|
|
(2,565,838 |
) |
|
|
(1,239,537 |
) |
Tax Credit |
|
|
53,578 |
|
|
|
— |
|
|
|
53,578 |
|
|
|
139,448 |
|
Loss on extinguishment of
debt |
|
|
— |
|
|
|
— |
|
|
|
(1,247,012 |
) |
|
|
— |
|
Net loss |
|
$ |
(29,164,647 |
) |
|
$ |
(24,806,984 |
) |
|
$ |
(102,900,600 |
) |
|
$ |
(68,345,186 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.71 |
) |
|
$ |
(2.77 |
) |
|
$ |
(2.01 |
) |
Weighted average common shares
outstanding, basic and Diluted |
|
|
37,351,117 |
|
|
|
34,757,910 |
|
|
|
37,206,928 |
|
|
|
34,020,257 |
|
Balance Sheet Information:
|
|
December 31,2020 |
|
|
December 31,2019 |
|
Cash and cash equivalents |
|
$ |
183,876,453 |
|
|
$ |
219,966,167 |
|
Total assets |
|
|
186,134,323 |
|
|
|
220,549,760 |
|
Loan payable, current and
long-term |
|
|
48,321,848 |
|
|
|
19,934,918 |
|
Accumulated deficit |
|
|
(278,796,093 |
) |
|
|
(175,895,493 |
) |
Stockholders’ equity |
|
$ |
113,792,909 |
|
|
$ |
178,722,389 |
|
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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