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 second quarter ended June 30,
2023.
“We exhibited strong financial performance and
pipeline advancement in the second quarter. Given the positive
reception to date from clinicians to the Auvelity launch, we are
expanding the Auvelity sales force by approximately 100
representatives. The expansion combined with our innovative DCC
approach is expected to significantly increase our reach from
approximately 26,000 to 44,000 physicians who write greater than
80% of branded antidepressant prescriptions,” said Herriot
Tabuteau, MD, Chief Executive Officer of Axsome. “Our Q2 relaunch
of Sunosi is also well underway, and we are seeing positive results
from these efforts. Our late-stage CNS pipeline continues to
expand, and we are pleased to announce the launch of three new high
value potential indications for solriamfetol: ADHD, for which we
recently initiated the FOCUS Phase 3 trial, and binge eating
disorder and shift work disorder for which we intend to initiate
Phase 3 trials over the next two quarters based on positive FDA
feedback on their development plans. We also look forward to
topline results from the SYMPHONY Phase 3 trial of AXS-12 in
narcolepsy and the ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer’s
disease agitation, which remain on track. Following our recent
public offering of common stock, we are solidly positioned to
further build value across our commercial and development
portfolio.”
Second Quarter 2023 Financial
Highlights
- Total
product revenue for the second quarter of 2023 was $46.7 million,
consisting of net product sales of $46.0 million and royalty
revenue of $0.7 million. Total product revenue for the comparable
period in 2022 was $8.8 million.
-
Auvelity® net product sales were $27.6 million for the second
quarter of 2023, representing a 76% sequential increase versus the
first 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 $19.1 million for the second quarter of
2023, consisting of $18.4 million in net product sales and $0.7
million in royalty revenue associated with Sunosi sales in
out-licensed territories. Sunosi revenue to Axsome for the
comparable period in 2022 was $8.8 million.
- Total
cost of revenue was $4.6 million for the second quarter of 2023.
Total cost of revenue for the comparable period in 2022 was $1.0
million.
- Research
and development (R&D) expenses were $20.6 million for the
second quarter of 2023, compared to $15.8 million for the
comparable period in 2022. The increase was primarily related to
the initiation of the FOCUS trial of solriamfetol in ADHD, the
advancement of ongoing trials of AXS-05 and AXS-12, 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 $78.9
million for the second quarter of 2023, compared to $31.2 million
for the comparable period in 2022. The increase was primarily
related to the commercialization of Auvelity and Sunosi, and higher
personnel costs related to organizational growth, including
non-cash stock-based compensation.
- Net
loss for the second quarter of 2023 was $67.2 million or $(1.54)
per share, compared to a net loss of $41.4 million, or $(1.06) per
share, for the comparable period in 2022. The net loss in the
second quarter of 2023 reflects $23.6 million in non-cash charges,
comprised of $15.9 million of non-cash stock-based compensation
expense, $6.1 million of non-cash loss in fair value of contingent
consideration, and $1.6 million of non-cash intangible asset
amortization.
- In June
2023, Axsome completed an underwritten public offering of common
stock resulting in gross proceeds of $225 million. Subsequently, in
July 2023, the underwriters exercised their option to purchase an
additional 15% of common stock in connection with the public
offering (the “green shoe”), resulting in additional gross proceeds
to Axsome of $33.8 million.
- Cash and cash
equivalents totaled $437.1 million at June 30, 2023, compared to
$200.8 million at December 31, 2022. The cash balance includes net
proceeds from the June 2023 common stock offering and does not
reflect the subsequent green shoe exercise. Pro forma cash at June
30, 2023, inclusive of net proceeds from the green shoe, totaled
$468.8 million.
- Shares of
common stock outstanding were 46,726,794 at June 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 53,000 prescriptions were reported for Auvelity in
the second quarter of 2023, representing a 72% sequential increase
versus the first quarter of 2023.
- Based
on the initial positive market reception to the Auvelity launch,
Axsome is expanding the Auvelity sales force from 162 to 260
representatives. The expansion will allow for greater reach and
call frequency to target physicians, potentially significantly
broadening the prescriber base for Auvelity. The increased number
of representatives together with our innovative Digital Centric
Commercialization (DCC™) platform is expected to increase our reach
from approximately 26,000 to approximately 44,000 physicians who
write greater than 80% of branded antidepressant
prescriptions.
- Payer
coverage for Auvelity across all channels is currently at
approximately 68% of all covered lives. The proportion of lives
covered in the commercial and government (Medicare and Medicaid)
channels are approximately 46% and approximately 100%,
respectively. Interactions with payers are ongoing as coverage
expansion continues.
Sunosi
- Second
quarter 2023 U.S. Sunosi total prescriptions increased by 15%
versus the second quarter of 2022, and sequentially by 8% versus
the first 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 proceed to a
pivotal Phase 2/3 trial in this indication. The Company anticipates
initiation of this study in the fourth quarter of 2023 or the first
quarter of 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 are progressing. The Company
now anticipates 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 anticipates completion of the SYMPHONY
trial in the fourth 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 now expects to
submit the NDA in the fourth quarter of 2023 or 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: In July
2023, Axsome initiated 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. An estimated 11.4 million adults in the U.S. are diagnosed
with ADHD, and the condition affects an estimated 5% of children
and adolescents.1,2 The disease burden for ADHD is high, with total
annual societal excess costs estimated at $122.8 billion for adult
ADHD in the U.S.3 The Company anticipates topline results from the
FOCUS trial in the second half of 2024.
-
Binge Eating Disorder: Axsome recently received
positive pre-IND meeting feedback from the FDA on the development
of solriamfetol for the treatment of BED, a potentially new
indication for solriamfetol. BED is the most common eating
disorder, affecting an estimated 2.8% of U.S. adults.4 Treatment
options are limited with only one product currently approved for
the treatment of BED. Based on the FDA’s feedback, the Company is
preparing to initiate a Phase 3 trial of solriamfetol in patients
with BED in the fourth quarter of 2023.
-
Shift Work Disorder: Axsome recently 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.
An estimated one third of Americans perform shift work, of whom
10-43% are diagnosed with SWD.5-7 Treatment options are limited
with only two products currently approved for the treatment of ES
associated with SWD. Based on the FDA’s feedback, the Company is
preparing to initiate a Phase 3 trial of solriamfetol in patients
with 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 (4Q 2023 – 1Q 2024)
- Clinical
Trial Readouts:
- Phase 3 SYMPHONY
trial of AXS-12 in narcolepsy (4Q 2023)
- 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 binge eating disorder (4Q 2023)
- Phase 3 trial of
solriamfetol in shift work disorder (1Q 2024)
- Pivotal Phase 2/3
trial of AXS-05 for smoking cessation (4Q 2023 – 1Q 2024)
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 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)
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
437,113 |
|
$ |
200,842 |
|
Accounts
receivables, net |
|
67,410 |
|
|
37,699 |
|
Inventories, net |
|
9,252 |
|
|
4,320 |
|
Prepaid
and other current assets |
|
5,911 |
|
|
2,781 |
|
Total current assets |
|
519,686 |
|
|
245,642 |
|
Equipment, net |
|
736 |
|
|
722 |
|
Right-of-use asset - operating
lease |
|
7,412 |
|
|
420 |
|
Goodwill |
|
12,042 |
|
|
10,310 |
|
Intangible asset, net |
|
56,500 |
|
|
59,661 |
|
Non-current inventory and other
assets |
|
15,262 |
|
|
14,721 |
|
Total assets |
$ |
611,638 |
|
$ |
331,476 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts
payable |
$ |
42,958 |
|
$ |
38,605 |
|
Accrued
expenses and other current liabilities |
|
65,324 |
|
|
51,631 |
|
Operating lease liability, current portion |
|
350 |
|
|
425 |
|
Contingent consideration, current |
|
6,342 |
|
|
5,900 |
|
Total current liabilities |
|
114,974 |
|
|
96,561 |
|
Contingent consideration,
non-current |
|
33,500 |
|
|
31,100 |
|
Loan payable, long-term |
|
176,820 |
|
|
94,259 |
|
Operating lease liability,
long-term |
|
7,540 |
|
|
— |
|
Total liabilities |
|
332,834 |
|
|
221,920 |
|
Stockholders’ equity: |
|
|
|
|
Preferred stock, $0.0001 par
value per share (10,000,000 shares authorized, none issued and
outstanding at June 30, 2023 and December 31, 2022,
respectively) |
|
— |
|
|
— |
|
Common stock, $0.0001 par value
per share (150,000,000 shares authorized, 46,726,794 and 43,498,617
shares issued and outstanding at June 30, 2023 and December 31,
2022, respectively) |
|
5 |
|
|
4 |
|
Additional paid-in capital |
|
953,520 |
|
|
705,885 |
|
Accumulated deficit |
|
(674,721 |
) |
|
(596,333 |
) |
Total stockholders’ equity |
|
278,804 |
|
|
109,556 |
|
Total liabilities and
stockholders’ equity |
$ |
611,638 |
|
$ |
331,476 |
|
Axsome Therapeutics,
Inc.Consolidated Statements of Operations
(Unaudited)(In thousands, except share and per
share amounts)
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
46,017 |
|
$ |
8,820 |
|
$ |
74,586 |
|
$ |
8,820 |
|
License
revenue |
|
— |
|
|
— |
|
|
65,735 |
|
|
— |
|
Royalty
revenue |
|
683 |
|
|
— |
|
|
955 |
|
|
— |
|
Total Revenues |
|
46,700 |
|
|
8,820 |
|
|
141,276 |
|
|
8,820 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of
revenue (excluding amortization and depreciation) |
|
4,599 |
|
|
983 |
|
|
12,155 |
|
|
983 |
|
Research
and development |
|
20,581 |
|
|
15,792 |
|
|
38,374 |
|
|
28,377 |
|
Selling,
general and administrative |
|
78,935 |
|
|
31,160 |
|
|
153,126 |
|
|
56,864 |
|
Loss
(Gain) in fair value of contingent consideration |
|
6,053 |
|
|
(860 |
) |
|
5,891 |
|
|
(860 |
) |
Intangible asset amortization |
|
1,589 |
|
|
926 |
|
|
3,161 |
|
|
926 |
|
Total operating expenses |
|
111,757 |
|
|
48,001 |
|
|
212,707 |
|
|
86,290 |
|
Loss from operations |
|
(65,057 |
) |
|
(39,181 |
) |
|
(71,431 |
) |
|
(77,470 |
) |
Interest
expense, net |
|
(2,730 |
) |
|
(2,257 |
) |
|
(4,994 |
) |
|
(3,601 |
) |
Loss before income taxes |
|
(67,787 |
) |
|
(41,438 |
) |
|
(76,425 |
) |
|
(81,071 |
) |
Income
tax benefit (expense) |
|
617 |
|
|
— |
|
|
(1,963 |
) |
|
— |
|
Net loss |
$ |
(67,170 |
) |
$ |
(41,438 |
) |
$ |
(78,388 |
) |
$ |
(81,071 |
) |
Net loss per common share, basic
and diluted |
$ |
(1.54 |
) |
$ |
(1.06 |
) |
$ |
(1.80 |
) |
$ |
(2.09 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
43,669,820 |
|
|
39,081,100 |
|
|
43,597,131 |
|
|
38,704,227 |
|
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:
- Faraone, S.,
Asherson, P., Banaschewski, T. et al.
Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers 1,
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- Kessler RC, et
al. The prevalence and correlates of adult ADHD in the United
States: results from the National Comorbidity Survey Replication.
Am J Psychiatry. 2006 Apr;163(4):716-23. doi:
10.1176/ajp.2006.163.4.716
- Schein J, et al.
Economic burden of attention-deficit/hyperactivity disorder among
adults in the United States: a societal perspective. JMCP. 2022.
28:2, 168-179. doi: 10.18553/jmcp.2021.21290
- 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).
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Geiger-Brown, J., Scharf, S. M. & Drake, C. L. Shift Work and
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