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 first quarter ended March 31,
2023.
“The first quarter of 2023 was another important
milestone for Axsome as it marked the first full quarter of launch
for Auvelity. Based on the performance in the quarter, we are
pleased that our marketed products are making a difference in the
lives of a growing number of patients with major depressive
disorder for Auvelity, and with excessive daytime sleepiness
associated with narcolepsy or obstructive sleep apnea for Sunosi,”
said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “At
the same time, our broad late-stage pipeline continues to advance
with important near and intermediate term clinical and regulatory
milestones including pivotal trial initiations, read-outs, and NDA
filings. Our strong commercial, research, and financial profile
positions us to continue to develop and deliver differentiated
treatments for the millions of patients living with
difficult-to-treat CNS disorders.”
First Quarter 2023 Financial
Highlights
- Total
revenue for the first quarter of 2023 was $94.6 million, consisting
of net product sales of $28.6 million, license revenue of $65.7
million, and royalty revenue of $0.3 million. The license revenue
represents the upfront payment from Pharmanovia for Sunosi
commercialization rights in Europe and certain countries in
the Middle East and North Africa region, and the
royalty revenue associated with sales of Sunosi in the out-licensed
territories. There was no revenue for the 2022 comparable period
reflecting the timing of the Auvelity launch and the Sunosi
acquisition.
- Auvelity
net product sales were $15.7 million for the first quarter of
2023.
- Sunosi
net product sales were $12.9 million for the first quarter of 2023,
including $1.7 million in international net sales booked by Axsome.
An additional $0.3 million in royalty revenue associated with
Sunosi sales in the out-licensed territories was recognized.
Reported Sunosi net sales in the first quarter were negatively
impacted by an estimated one-time $3.3 million reduction in
inventory due to a change in distribution from a title to a
traditional 3PL model in the U.S, as anticipated.
- Total
cost of revenue was $7.6 million for the first quarter of 2023,
consisting of cost of goods sold of $2.6 million and a one-time $5
million license revenue sharing expense related to the Pharmanovia
agreement.
- Research
and development (R&D) expenses were $17.8 million for the first
quarter of 2023, compared to $12.6 million for the comparable
period in 2022. The increase was primarily related to higher
personnel costs associated with ongoing clinical trials,
post-marketing commitments for Auvelity and Sunosi and non-cash
stock-based compensation expense.
- Selling,
general, and administrative (SG&A) expenses were $74.2 million
for the first quarter of 2023, compared to $25.7 million for the
comparable period in 2022. The increase was primarily related to
commercial activities for Auvelity and Sunosi and higher non-cash
stock-based compensation expense.
- Net loss for
the first quarter of 2023 was $11.2 million or $(0.26) per share,
compared to a net loss of $39.6 million, or $(1.03) per share, for
the comparable period in 2022. The net loss in the first quarter of
2023 reflects the upfront license revenue received from Pharmanovia
and includes $12.9 million of non-cash stock-based compensation
expense compared to $7.6 million for the comparable period in
2022.
- Cash and cash
equivalents totaled $246.5 million at March 31, 2023, compared to
$200.8 million at December 31, 2022.
- In January
2023, Axsome amended its term loan facility agreement with Hercules
Capital increasing the size of the facility to $350 million,
reducing the interest rate, and extending the maturity and
interest-only period, while accessing a new $55 million tranche.
There is currently $200 million available on the term loan
facility.
- Shares of
common stock outstanding were 43,548,466 at March 31, 2023.
Financial Guidance
- Axsome believes
that its current cash, along with the remaining committed capital
from the $350 million term loan facility, is sufficient to fund
anticipated operations into cash flow positivity, based on the
current operating plan.
Commercial Highlights
Auvelity
- The
first quarter of 2023 was the first full quarter of sales for
Auvelity, which was launched in October 2022. Approximately 31,000
prescriptions were reported for Auvelity in the first quarter of
2023, representing a 298% sequential increase versus the fourth
quarter of 2022.
- Payer
coverage for Auvelity across all channels is currently
approximately 65% of all covered lives. The proportion of lives
covered in the commercial and government (Medicare and Medicaid)
channels are approximately 40% and approximately 100%,
respectively.
-
Axsome’s comprehensive patient and provider support services for
Auvelity continue to perform as planned. The Auvelity on My Side
program is designed to help clinicians and patients easily access
Auvelity and the program includes: the Auvelity Savings Card to
reduce out-of-pocket expenses for qualifying patients, telehealth
services, HCP samples, and prior authorization assistance.
Sunosi
- First
quarter 2023 U.S. Sunosi total prescriptions increased by 13%
versus the first quarter of 2022, and by 4% versus the fourth
quarter of 2022.
- Sunosi
maintains broad payer coverage in the commercial channel with 96%
of lives covered. Currently 83% of total lives across all channels
are covered.
-
Axsome’s patient and provider support services for Sunosi,
including the Sunosi Savings Card, continue to perform as
planned.
- In
February 2023, Axsome licensed the marketing rights for Sunosi in
Europe and certain countries in the Middle East and North Africa to
Pharmanovia. In consideration, Axsome received an upfront payment
of $66M, with potential milestones up to $101M. Axsome will receive
a royalty percentage in the mid-twenties on net sales in the
licensed territory. Pharmanovia will assume responsibility for all
local clinical and regulatory activities and requirements including
studies in pediatric patients with narcolepsy.
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 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 proceed to a
pivotal Phase 2/3 trial in this indication. The Company anticipates
initiation of this study in the fourth quarter of 2023.
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 are ongoing. The Company
continues to anticipate resubmission of the NDA in the second half
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 second quarter 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 on track to initiate a Phase
3 multi-center, randomized, double-blind, placebo-controlled trial
to evaluate the efficacy and safety of solriamfetol in adults with
ADHD in the second quarter of 2023.
Anticipated Milestones
-
Regulatory and Commercial:
- AXS-07
for migraine, NDA resubmission (2H 2023)
- AXS-14
for fibromyalgia, NDA submission (4Q 2023)
-
Clinical Trial Readouts:
- Phase 3
SYMPHONY trial of AXS-12 in narcolepsy, topline data (2Q 2023)
- Phase 3
ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (1H
2024)
-
Clinical Trial Initiations:
- Phase 3
trial of solriamfetol for ADHD in adults (2Q 2023)
- Pivotal
Phase 2/3 trial of AXS-05 for smoking cessation (4Q 2023)
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss first 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 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(In thousands, except for share and par
value amounts)
|
March 31, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
246,515 |
|
|
$ |
200,842 |
|
Accounts receivables, net |
|
44,793 |
|
|
|
37,699 |
|
Inventories, net |
|
7,940 |
|
|
|
4,320 |
|
Prepaid and other current assets |
|
5,201 |
|
|
|
2,781 |
|
Total
current assets |
|
304,449 |
|
|
|
245,642 |
|
Equipment, net |
|
703 |
|
|
|
722 |
|
Right-of-use asset - operating lease |
|
106 |
|
|
|
420 |
|
Goodwill |
|
10,310 |
|
|
|
10,310 |
|
Intangible asset, net |
|
58,089 |
|
|
|
59,661 |
|
Non-current inventory and other assets |
|
15,522 |
|
|
|
14,721 |
|
Total
assets |
$ |
389,179 |
|
|
$ |
331,476 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
35,770 |
|
|
$ |
38,605 |
|
Accrued expenses and other current liabilities |
|
58,774 |
|
|
|
51,631 |
|
Operating lease liability, current portion |
|
108 |
|
|
|
425 |
|
Contingent consideration, current |
|
6,000 |
|
|
|
5,900 |
|
Total
current liabilities |
|
100,652 |
|
|
|
96,561 |
|
Contingent consideration, non-current |
|
29,100 |
|
|
|
31,100 |
|
Loan
payable, long-term |
|
147,615 |
|
|
|
94,259 |
|
Total
liabilities |
|
277,367 |
|
|
|
221,920 |
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.0001 par value per share (10,000,000 shares
authorized, none issued and outstanding at March 31, 2023 and
December 31, 2022, respectively) |
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value per share (150,000,000 shares authorized,
43,548,466 and 43,498,617 shares issued and outstanding at March
31, 2023 and December 31, 2022, respectively) |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
719,359 |
|
|
|
705,885 |
|
Accumulated deficit |
|
(607,551 |
) |
|
|
(596,333 |
) |
Total
stockholders’ equity |
|
111,812 |
|
|
|
109,556 |
|
Total
liabilities and stockholders’ equity |
$ |
389,179 |
|
|
$ |
331,476 |
|
Axsome Therapeutics,
Inc.Consolidated Statements of Operations
(Unaudited)(In thousands, except share and per
share amounts)
|
Three Months Ended |
|
|
March 31, |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
Product sales, net |
$ |
28,569 |
|
|
$ |
— |
|
License revenue |
|
65,735 |
|
|
|
— |
|
Royalty revenue |
|
272 |
|
|
|
— |
|
Total Revenues |
|
94,576 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
Cost of revenue (excluding amortization and depreciation) |
|
7,556 |
|
|
|
— |
|
Research and development |
|
17,793 |
|
|
|
12,585 |
|
Selling, general and administrative |
|
74,191 |
|
|
|
25,704 |
|
Gain in fair value of contingent consideration |
|
(162 |
) |
|
|
— |
|
Intangible asset amortization |
|
1,572 |
|
|
|
— |
|
Total operating expenses |
|
100,950 |
|
|
|
38,289 |
|
Loss from operations |
|
(6,374 |
) |
|
|
(38,289 |
) |
Interest expense, net |
|
(2,264 |
) |
|
|
(1,343 |
) |
Income before provision for
income taxes |
|
(8,638 |
) |
|
|
(39,632 |
) |
Provision for income taxes |
|
(2,580 |
) |
|
|
— |
|
Net loss |
$ |
(11,218 |
) |
|
$ |
(39,632 |
) |
Net loss per common share,
basic and diluted |
$ |
(0.26 |
) |
|
$ |
(1.03 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
43,523,631 |
|
|
|
38,323,167 |
|
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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