ZURZUVAE™ (zuranolone), first and only oral
treatment approved for adults with postpartum depression (PPD),
designated Schedule IV by the DEA; progressing towards planned
commercial availability in December
Announces expected wholesale acquisition cost
of ZURZUVAE of $15,900
SAGE-718 granted FDA Orphan Drug Designation
for the treatment of Huntington’s Disease
Sage product pipeline provides potential for
significant value creation with topline data expected from multiple
ongoing Phase 2 trials in 2024
Strong financial foundation with $876 million
of cash, cash equivalents and marketable securities as of September
30, 2023
Sage Therapeutics, Inc. (Nasdaq: SAGE) today reported business
highlights and financial results for the third quarter ended
September 30, 2023.
“It has been an exciting time at Sage as we prepare for the
upcoming commercial launch of ZURZUVAE, the first and only oral
treatment specifically indicated for adults with postpartum
depression. Women with PPD are waiting for new treatment options
and we have an incredible opportunity to support them. Our goal is
to make ZURZUVAE available later this year and to enable broad and
equitable access for women with PPD who are prescribed this drug,”
said Barry Greene, Chief Executive Officer at Sage Therapeutics.
“We see the same opportunity to break new ground for patients as we
work to advance treatments that address cognitive impairment
associated with certain diseases and essential tremor where novel
and meaningful new options are long overdue.”
Third Quarter 2023 Portfolio
Updates
Sage is advancing a portfolio of clinical-stage programs with
internally discovered novel chemical entities that have the
potential to address urgent unmet needs in brain health by
targeting the GABAA and NMDA receptor systems. Dysfunction in these
systems is thought to be at the core of numerous neurological and
neuropsychiatric disorders.
Postpartum Depression Franchise
ZURZUVAE was approved by the U.S. Food and Drug
Administration (FDA) in August 2023 as the first and only oral
treatment specifically indicated for adults with PPD. ZURZUVAE is
being developed and commercialized in collaboration with Biogen
Inc. Sage also commercializes ZULRESSO® (brexanolone) CIV injection
in the treatment of PPD.
ZURZUVAE
ZURZUVAE (zuranolone) received a Schedule IV classification from
the U.S. Drug Enforcement Administration (DEA). Schedule IV drugs,
substances or chemicals are defined as drugs with a low potential
for abuse and low risk of dependence. ZURZUVAE is expected to be
commercially available for adults with PPD in December 2023 with
the broader complement of commercialization capabilities expected
to roll out in early 2024.
The recent FDA approval of ZURZUVAE has helped reinforce that
PPD is an urgent medical condition that is best treated with prompt
diagnosis and immediate intervention. Delayed improvements in
depressive symptoms associated with PPD have been shown to
significantly worsen outcomes for the woman and her child.1-3 As
the first and only oral, once-daily, 14-day treatment that can
provide rapid improvements in depressive symptoms by Day 15 and as
early as Day 3, ZURZUVAE provides women with PPD with an option
that may help address an important gap in the current treatment of
women with this condition.
Postpartum depression results in significantly higher healthcare
resource utilization and associated costs.4-6
- According to a 2017 model, the multi-year average cost of
untreated perinatal mood and anxiety disorders per affected
mother-child pair was approximately $32,000.7
- Women with PPD have more hospital admissions6 and overall
higher healthcare resource utilization and health expenditures than
women who do not have PPD.5,6
- Perinatal mood and anxiety disorders are also associated with
delayed or impaired long-term developmental, psychological,
cognitive, and physical outcomes in children. 8-12 In one study,
societal costs for these outcomes were estimated at nearly $2.0
billion for all impacted children through their first 5 years of
life. 7
The goal of broad affordable access for women with PPD who are
prescribed ZURZUVAE has been a key consideration for Sage and
Biogen in setting the planned wholesale acquisition cost of $15,900
for a full 14-day treatment course. The two companies are working
to enable women with PPD who are prescribed ZURZUVAE to be able to
access treatment with minimal restrictions and, where possible,
with little to no co-pay regardless of financial means. To this
end, Sage and Biogen are actively engaged with national, regional
and government payors. The companies are also planning to help
women with PPD through patient support programs that provide PPD
education, as well as financial assistance for eligible patients
prescribed ZURZUVAE to help cover costs, or free drug, and other
support.
Sage and Biogen plan to share details on these patient support
programs after the product becomes commercially available.
Sage expects the following milestones for ZURZUVAE in 2023 and
2024:
- Late 2023:
- Commercial availability of ZURZUVAE in December 2023
- Early 2024:
- Broader complement of commercialization capabilities for
ZURZUVAE in early 2024
Neuropsychiatry Pipeline
SAGE-718, the Company’s first-in-class NMDA receptor positive
allosteric modulator (PAM), is in development as a potential oral
therapy for cognitive disorders associated with NMDA receptor
dysfunction. SAGE-718 has received Fast Track Designation and
Orphan Drug Designation (ODD) from the FDA, and Orphan Drug
Designation from the European Medicines Agency (EMA) for the
potential treatment of Huntington’s Disease. SAGE-324, the
Company’s next-generation PAM of GABAA receptors, is in development
as a potential oral therapy for movement disorders, such as
essential tremor (ET). SAGE-324 is being developed in collaboration
with Biogen Inc.
SAGE-718
Sage is advancing a robust clinical program for SAGE-718 with
multiple ongoing Phase 2 studies, including the DIMENSION and
SURVEYOR Studies in people with Huntington’s Disease (HD) cognitive
impairment, the lead indication for SAGE-718, the PRECEDENT Study
in people with mild cognitive impairment (MCI) associated with
Parkinson’s Disease (PD) and a Phase 2 study (LIGHTWAVE) in people
with MCI and mild dementia due to Alzheimer’s Disease (AD). In
October 2023, Sage announced the FDA granted ODD to SAGE-718 for
the treatment of HD. Ongoing studies in the SAGE-718 clinical
program include:
- DIMENSION (CIH-201) Study: The
DIMENSION Study is a double-blind, placebo-controlled Phase 2 study
in people with cognitive impairment associated with HD. The study
is designed to evaluate the efficacy of once-daily SAGE-718 dosed
over three months, with a target enrollment of approximately 178
people. The DIMENSION Study is enrolling across 40 clinical
sites.
- SURVEYOR (CIH-202) Study: The
SURVEYOR Study is a double-blind, placebo-controlled Phase 2 study
in people with cognitive impairment associated with HD. The
SURVEYOR Study is being conducted with the goal of generating
evidence linking efficacy signals on cognitive performance to
domains of real-world functioning and is not designed or powered to
demonstrate a statistically significant difference between SAGE-718
and placebo.
- PURVIEW (CIH-301) Study: The
PURVIEW Study is an open-label Phase 3 safety study of SAGE-718 in
people with cognitive impairment associated with HD. The study is
designed to evaluate the long-term safety profile of those treated
for one year or more.
- PRECEDENT (CNP-202) Study: The
PRECEDENT Study is a double-blind, placebo-controlled Phase 2 study
in people with MCI due to PD. The study is designed to evaluate the
safety and efficacy of SAGE-718 dosed over 6 weeks.
- LIGHTWAVE (CNA-202) Study: The
LIGHTWAVE Study is a double-blind, placebo-controlled Phase 2 study
of SAGE-718 in people with MCI and mild dementia due to AD. The
study is designed to evaluate the safety and efficacy of SAGE-718
dosed over a 12-week period.
The Company expects the following milestones for SAGE-718 in
2023 and 2024:
- Late 2023:
- Progress recruitment in the ongoing DIMENSION, SURVEYOR,
PURVIEW, PRECEDENT and LIGHTWAVE Studies
- 2024:
- Report topline data from the DIMENSION, SURVEYOR, PRECEDENT and
LIGHTWAVE Studies
SAGE-324
Sage and its collaborator, Biogen, are actively enrolling
participants in the Phase 2b KINETIC 2 placebo-controlled study of
SAGE-324 in ET following positive results from the KINETIC Study.
The KINETIC 2 Study is a Phase 2b dose-ranging study with the
primary goal of defining the dose for SAGE-324 in ET with a
tolerability profile appropriate for chronic treatment and a dosing
schedule to maintain plasma concentrations needed for sustained
tremor symptom control in treating ET. Enrollment in the KINETIC 2
Study is on track for completion in late 2023 with an expected
topline data readout in mid-2024.
Sage is also currently enrolling patients in a Phase 2 long-term
open label safety study to evaluate the long-term safety and
tolerability of SAGE-324 in ET. The primary endpoint of the
open-label study is incidence of treatment-emergent adverse
events.
The Company expects the following milestones for SAGE-324 in
2023 and 2024:
- Late 2023:
- Targeted completion of enrollment in the Phase 2b KINETIC 2
Study
- Mid-2024:
- Report topline data from the Phase 2b KINETIC 2 Study
FINANCIAL RESULTS FOR THE THIRD QUARTER
2023
- Cash Position: Cash, cash equivalents and marketable
securities as of September 30, 2023 were $0.9 billion compared to
$1.0 billion at June 30, 2023.
- Revenue: Net revenue from sales of ZULRESSO was $2.7
million in the third quarter of 2023 compared to $1.7 million in
the same period of 2022.
- R&D Expenses: Research and development expenses were
$101.9 million, including $6.9 million of non-cash stock-based
compensation expense, in the third quarter of 2023 compared to
$81.6 million, including $6.0 million of non-cash stock-based
compensation expense, in the same period of 2022. The increase in
spending was primarily due to expenses related to cancelling excess
purchase commitments for manufacturing as a result of the complete
response letter received from the FDA for zuranolone for the
treatment of MDD. This purchase commitment cancellation also
contributed to an increase in the reimbursement from Biogen to Sage
pursuant to the Sage/Biogen Collaboration and License Agreement,
which was $28.2 million in the third quarter of 2023 compared to
$17.9 million in the same period of 2022.
- SG&A Expenses: Selling, general and administrative
expenses were $78.1 million, including $21.0 million of non-cash
stock-based compensation expense, in the third quarter of 2023
compared to $61.5 million, including $7.2 million of non-cash
stock-based compensation expense, in the same period of 2022. The
increase in SG&A expenses was primarily due to the recognition
of $13.6 million of stock-based compensation expense related to
performance-based vesting criteria during the third quarter of
2023. The reimbursement from Sage to Biogen pursuant to the
Sage/Biogen Collaboration and License Agreement was $5.8 million in
the third quarter of 2023 compared to $0.5 million of reimbursement
from Biogen to Sage in the same period of 2022. The primary reason
for the decrease in net reimbursement was an increase in the
collaboration costs incurred by Biogen in anticipation of the
expected commercialization of ZURZUVAE.
- Restructuring Expenses: Restructuring expenses were
$33.6 million in the third quarter of 2023 due to the August 2023
corporate reorganization. No restructuring expenses were incurred
in the same period of 2022.
- Net Loss: Net loss was $201.6 million in the third
quarter of 2023 compared to $137.3 million in the same period of
2022.
FINANCIAL GUIDANCE
- Sage expects that, based on its current estimates, its current
cash, cash equivalents and marketable securities, along with
anticipated funding from ongoing collaborations, collaboration
revenue from sales of ZURZUVAE, and a potential milestone payment
of $75.0 million from Biogen for the first commercial sale of
ZURZUVAE for the treatment of women with PPD, will support
operations into 2026.
- Additionally, Sage underwent a strategic reorganization and
pipeline reprioritization in August 2023. The company expects
annualized net savings of approximately $240 million, of which 60%
is related to R&D. The annualized net savings include $100
million related to the workforce reduction.
Conference Call Information
Sage will host a conference call and webcast today, Tuesday,
November 7, at 8:00 a.m. ET to review its third quarter 2023
financial results and discuss recent corporate updates. The live
webcast can be accessed on the investor page of Sage's website at
investor.sagerx.com. A replay of the webcast will be available on
Sage's website following the completion of the event and will be
archived for up to 30 days.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit http://www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: plans for launch, commercial availability and
commercialization of ZURZUVAE as a treatment for women with PPD,
and potential timing of such activities; our goals and planned
activities for commercial launch of ZURZUVAE in this indication and
to enable access; the potential benefit of ZURZUVAE in the
treatment of women with PPD; the number of women with PPD and the
potential market for ZURZUVAE for the treatment of women with PPD;
our belief in the potential of ZURZUVAE to be successful and to
meet an unmet need in the treatment of women with PPD; anticipated
timelines for completion of enrollment in clinical trials and
reporting of results with respect to certain of our other programs;
our belief in the potential profile and benefit of our product
candidates; potential indications for our product candidates; the
potential for success of our programs, and the opportunity to help
patients in various indications; the potential for value creation
opportunities; the mission and goals for our business; our
anticipated cash runway and related assumptions and estimates; the
expected annualized net savings from our recent restructuring; and
our expectations with respect to potential receipt of milestones
from collaborations and potential future revenue. These statements
constitute forward-looking statements as that term is defined in
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements, including the risks that: our
launch and commercialization efforts in the U.S. with respect to
ZURZUVAE for the treatment of women with PPD may not be successful,
and we may be unable to generate revenues from sales of ZURZUVAE at
the levels or on the timing we expect or at levels or on the timing
necessary to support our goals; the number of women with PPD, the
unmet need for additional treatment options, and the potential
market for ZURZUVAE in women with PPD, may be significantly smaller
than we expect; ZURZUVAE may not achieve the clinical benefit,
clinical use or market acceptance in the treatment of PPD we expect
or we may encounter reimbursement-related or other market-related
issues that impact the success of our commercialization efforts,
including our ability to achieve access goals; we may encounter
delays in initiation, conduct, completion of enrollment or
completion and reporting of data with respect to any of our ongoing
clinical trials, including as a result of slower than expected site
initiation, slower than expected enrollment, the need or decision
to expand the trials or other changes, that may impact our ability
to meet our expected timelines and may increase our costs; success
in earlier clinical trials of any of our product candidates may not
be repeated or observed in ongoing or future studies, and ongoing
and future clinical trials may not meet their primary or key
secondary endpoints which may substantially impair development;
unexpected concerns may arise from additional data, analysis or
results from any of our completed studies; decisions or actions of
the FDA may affect the initiation, timing, design, size, progress
and cost of clinical trials and our ability to proceed with further
development or may impair the potential for successful development;
we may encounter adverse events at any stage that negatively impact
further development and the potential for approval of our product
candidates or the potential for successful commercialization of any
our products or that require additional nonclinical and clinical
work which may not yield positive results; the need to align with
our collaborators may hamper or delay our development and
commercialization efforts for the products or product candidates
that are part of the collaboration or increase our costs; the
anticipated benefits of our ongoing collaborations, including the
receipt of milestone payments or the successful development or
commercialization of products and generation of revenue, may never
be achieved; our business may be adversely affected and our costs
may increase if any of our key collaborators fails to perform its
obligations or terminates our collaboration; the internal and
external costs required for our ongoing and planned activities, and
the resulting impact on expense and use of cash, may be higher than
expected which may cause us to use cash more quickly than we expect
or to change or curtail some of our plans or both; we may not be
successful in our efforts to gain regulatory approval of products
beyond ZURZUVAE and ZULRESSO; we may not achieve revenues from
other of our products that may be successfully developed in the
future, at levels we expect; our expectations as to cash runway,
cost savings from our recent restructuring and the sufficiency of
cash to fund future operations and expense levels may prove not to
be correct for these and other reasons such as changes in plans or
actual events being different than our assumptions; we may be
opportunistic in our future financing plans even if available cash
is sufficient; additional funding may not be available on
acceptable terms when we need it; any of the foregoing events could
impair the value creation opportunities for our business; and we
may encounter technical and other unexpected hurdles in the
development and manufacture of our product candidates or the
commercialization of any current or future marketed product which
may delay our timing or change our plans, increase our costs or
otherwise negatively impact our business; as well as those risks
more fully discussed in the section entitled "Risk Factors" in our
most recent quarterly report, as well as discussions of potential
risks, uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. In addition,
any forward-looking statements represent our views only as of today
and should not be relied upon as representing our views as of any
subsequent date. We explicitly disclaim any obligation to update
any forward-looking statements.
Financial Tables
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
September 30,2023 December 31,2022 Cash, cash
equivalents and marketable securities
$
876,052
$
1,272,494
Total assets
949,663
1,356,449
Total liabilities
133,004
103,850
Total stockholders' equity
816,659
1,252,599
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Statements of Operations (in thousands, except
share and per share data) (unaudited)
Three Months Ended
September 30, Nine Months Ended September 30,
2023
2022
2023
2022
Product revenue, net
$
2,716
$
1,739
$
8,469
$
4,821
Collaboration revenue
-
-
14
-
Total revenue
2,716
1,739
8,483
4,821
Operating costs and expenses: Cost of goods sold
905
184
1,339
670
Research and development
101,919
81,553
291,905
236,868
Selling, general and administrative
78,142
61,482
219,415
160,370
Restructuring
33,599
-
33,599
-
Total operating costs and expenses
214,565
143,219
546,258
397,908
Loss from operations
(211,849
)
(141,480
)
(537,775
)
(393,087
)
Interest income, net
10,274
4,127
29,276
7,397
Other income (expense), net
(55
)
30
(284
)
52
Net loss
$
(201,630
)
$
(137,323
)
$
(508,783
)
$
(385,638
)
Net loss per share - basic and diluted
$
(3.37
)
$
(2.31
)
$
(8.51
)
$
(6.51
)
Weighted average shares outstanding - basic and diluted
59,912,378
59,428,123
59,786,254
59,242,563
SELECT IMPORTANT SAFETY INFORMATION FOR
ZURZUVAE
ZURZUVAE (zuranolone) CIV, is a neuroactive steroid
gamma-aminobutyric acid (GABA) A receptor positive modulator
indicated for the treatment of postpartum depression in adults.
This does not include all the information needed to use ZURZUVAE
safely and effectively. See full prescribing information for
ZURZUVAE.
ZURZUVAE may cause serious side effects, including decreased
awareness and alertness, which can affect your ability to drive
safely or safely do other dangerous activities. Do not drive,
operate machinery, or do other dangerous activities until at least
12 hours after taking each dose. You may not be able to tell on
your own if you can drive safely or tell how much ZURZUVAE is
affecting you. ZURZUVAE may cause central nervous system (CNS)
depressant effects including sleepiness, drowsiness, slow thinking,
dizziness, confusion, and trouble walking. Taking alcohol, other
medicines that cause CNS depressant effects such as
benzodiazepines, or opioids while taking ZURZUVAE can make these
symptoms worse and may also cause trouble breathing. ZURZUVAE is a
federally controlled substance schedule IV because it contains
zuranolone, which can be abused or lead to dependence. Tell your
healthcare provider right away if you become pregnant or plan to
become pregnant during treatment with ZURZUVAE. You should use
effective birth control (contraception) during treatment with
ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other
antidepressant medicines may increase the risk of suicidal thoughts
and actions in people 24 years of age and younger. ZURZUVAE is not
for use in children. The most common side effects of ZURZUVAE
include sleepiness or drowsiness, dizziness, common cold, diarrhea,
feeling tired, weak, or having no energy, and urinary tract
infection.
SELECT IMPORTANT SAFETY INFORMATION for
ZULRESSO
ZULRESSO (brexanolone) CIV, is a neuroactive steroid
gamma-aminobutyric acid (GABA) A receptor positive modulator
indicated for the treatment of postpartum depression in individuals
15 years and older.
This does not include all the information needed to use ZULRESSO
safely and effectively. See full prescribing information for
ZULRESSO.
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF
CONSCIOUSNESS See full prescribing information for complete
boxed warning Patients are at risk of excessive sedation or
sudden loss of consciousness during administration of
ZULRESSO.
Because of the risk of serious harm, patients must be
monitored for excessive sedation and sudden loss of consciousness
and have continuous pulse oximetry monitoring. Patients must be
accompanied during interactions with their child(ren).
ZULRESSO is available only through a restricted program
called the ZULRESSO REMS.
WARNINGS AND PRECAUTIONS Suicidal Thoughts and
Behaviors: Consider changing the therapeutic regimen, including
discontinuing ZULRESSO, in patients whose PPD becomes worse or who
experience emergent suicidal thoughts and behavior.
ADVERSE REACTIONS: Most common adverse reactions
(incidence ≥5% and at least twice the rate of placebo) were
sedation/somnolence, dry mouth, loss of consciousness, and
flushing/hot flush.
USE IN SPECIFIC POPULATIONS
- Pregnancy: ZULRESSO may cause fetal harm. Healthcare
providers are encouraged to register patients by calling the
National Pregnancy Registry for Antidepressants at 1-844-405-6185
or visiting online at
https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/
- Renal Impairment: Avoid use of ZULRESSO in patients with
end stage renal disease (ESRD)
To report SUSPECTED ADVERSE REACTIONS, contact Sage
Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch. Please see accompanying
full Prescribing Information including Boxed Warning.
References:
- Campbell SB, et al. Dev Psychol. 1995;31(3):349-357
- Habert J, et al. Prim Care Companion CNS Disord.
2016;18(5):e1-e11.
- Ciudad A, et al. J Clin Psychiatry. 2012;73(2):185-191.
- Dagher RK et al. J Occup Environ Med. 2012;54(2):210-215
- Epperson CN et al. Curr Med Res & Opinion.
2020;36(10):1707-1716
- Moore-Simas TA et al. J Med Economics. 2020;23(2):174-183
- Luca DL et al. Am J Public Health. 2020;110(6):888-896
- Eastwood JG, et al. BMC Pregnancy Childbirth. 2012;12:148.
- Koutra K, et al. Soc Psychiatry Psychiatr Epidemiol.
2013;48(8):1335-1345.
- Surkan PJ, et al. BMC Pediatr. 2014;14:185.
- Netsi E, et al. JAMA Psychiatry. 2018;75(3):247-253.
- Pearson RM, et al. JAMA Psychiatry. 2013;70(12):1312-1319.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231107571536/en/
Investor Contact Ashley Kaplowitz 786-252-1419
ashley.kaplowitz@sagerx.com
Media Contact Matthew Henson 917-930-7147
matthew.henson@sagerx.com
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From May 2024 to Jun 2024
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From Jun 2023 to Jun 2024