Achieved $7.4 million in ZURZUVAE™ (zuranolone)
collaboration revenue during the second quarter of 2024 (50% of the
net revenues recorded by Biogen), representing 19% growth from the
first quarter
More than 1,400 prescriptions shipped and
delivered during the second quarter of 2024, nearly doubling from
the first quarter
Dalzanemdor (SAGE-718) topline data from the
LIGHTWAVE (Alzheimer’s Disease) and DIMENSION (Huntington’s
Disease) Studies expected in late 2024; primary endpoint for
DIMENSION Study adjusted from HD-CAB composite to the Symbol Digit
Modalities Test (SDMT)
SAGE-324 did not meet the primary endpoint in
participants with essential tremor (ET); Sage and Biogen terminated
clinical development for the ET program
Cash, cash equivalents and marketable
securities of $647 million as of June 30, 2024
Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical
company leading the way to create a world with better brain health,
today reported business highlights and financial results for the
second quarter ended June 30, 2024.
“We are pleased with the strength of ZURZUVAE’s early commercial
launch performance and its positive, real-world impact on women
suffering from PPD. Supported by several tailwinds, including
increasing demand among a mix of providers, particularly OBGYNs, we
believe ZURZUVAE is well-positioned to become the first line
therapy and standard of care for women with PPD,” said Barry
Greene, Chief Executive Officer at Sage Therapeutics. “While we are
deeply disappointed by the results from the KINETIC 2 study and for
the essential tremor community, we remain focused on progressing
our pipeline and look forward to additional clinical data readouts
expected in late 2024.”
Second Quarter 2024 Portfolio
Updates
Sage is advancing a portfolio of internally discovered novel
chemical entities with the potential to become differentiated
products designed to improve brain health by targeting the GABAA
and NMDA receptor systems. Dysfunction in these systems is thought
to be at the core of numerous neuropsychiatric disorders.
Postpartum Depression Commercial Products
ZURZUVAE was approved by the FDA in August 2023 as the
first-and-only oral treatment specifically indicated for adults
with postpartum depression (PPD). ZURZUVAE was made commercially
available in December 2023. ZURZUVAE is being developed and
commercialized in collaboration with Biogen Inc. Sage also
commercializes ZULRESSO® (brexanolone) CIV injection in the
treatment of PPD.
ZURZUVAE
Sage and its collaborator, Biogen, are focused on the goal of
establishing ZURZUVAE as the first line therapy and standard of
care for women with PPD. The companies are utilizing a specialty
pharmacy distribution model by which ZURZUVAE is shipped directly
to women with PPD who are prescribed the treatment.
As of the second quarter ended June 30, 2024, the following
results had been achieved:
- $7.4 million in collaboration revenue from ZURZUVAE in the
second quarter of 2024, representing a 19% increase from the first
quarter. Collaboration revenues represent 50% of the net revenues
recorded when Biogen ships ZURZUVAE to the distributors.
- Approximately 2,000 prescriptions written in the second
quarter, representing a greater than 60% increase from the first
quarter.
- More than 1,400 prescriptions were shipped and delivered in the
second quarter, representing a greater than 95% increase from the
first quarter.
Sage and Biogen field sales teams are engaging in promotional
dialogues with HCPs who actively identify and treat women with PPD.
In the second quarter of 2024, OBGYNs accounted for more than 70%
of prescriptions written, followed by psychiatrists and PCPs. The
number of new and repeat ZURZUVAE prescribers grew during the
second quarter of 2024.
The companies continue to advance discussions with national,
regional and government payors to advocate for broad and equitable
access to ZURZUVAE for women with PPD with minimal restrictions and
expect formulary discussions to continue over the course of
2024.
- As of late July 2024, approximately 80% of all commercial lives
are covered by payor policies in PPD, with the majority having no
step therapy or complex prior authorizations, including two of
three national PBMs who have developed coverage policies for
ZURZUVAE in the treatment of women with PPD. Conversations with the
third national PBM continue to progress.
- Medicaid reviews are ongoing, with additional states, including
several of the largest states, completing reviews during the second
quarter of 2024. The majority of Medicaid coverage decisions have
already been made and the Company expects the remainder of
decisions to occur in the second half of 2024.
- In the second quarter of 2024, the majority of prescriptions
shipped were covered by commercial or government payors.
Sage and Biogen’s patient support program for women with PPD,
ZURZUVAE For You, provides educational resources, help with
understanding insurance coverage and assistance navigating the
prescription fulfillment process. The program also includes
financial assistance, such as a copay assistance program and
product at no cost, for eligible patients. In the second quarter of
2024, the vast majority of commercially insured patients using the
ZURZUVAE savings card paid no copay.
The Company expects the following milestones for ZURZUVAE in
2024:
- 2024:
- Ongoing commercialization of ZURZUVAE in the treatment of women
with PPD
- Present analyses of real-world evidence for ZURZUVAE including
health economics and patient reported outcomes
Pipeline
Dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718), the Company’s first-in-class NMDA
receptor positive allosteric modulator (PAM), is in development as
a potential oral therapy for cognitive impairment associated with
neurodegenerative disorders. Dalzanemdor 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. Dalzanemdor
has also been awarded an Innovation Passport Designation for
cognitive impairment associated with HD and entry into the
Innovative Licensing and Access Pathway (ILAP) by the U.K.
Medicines and Healthcare products Regulatory Agency (MHRA).
Sage is advancing a clinical program for dalzanemdor with
ongoing Phase 2 studies, including the DIMENSION study in people
with cognitive impairment associated with Huntington’s Disease
(HD), the lead indication for dalzanemdor, and the LIGHTWAVE study
in people with mild cognitive impairment (MCI) and mild dementia
due to Alzheimer’s Disease (AD).
In June, Sage announced topline results from the SURVEYOR Study.
The SURVEYOR Study met its primary endpoint demonstrating a
statistically significant difference as measured by the
HD-Cognitive Assessment Battery (HD-CAB) composite score at
baseline between healthy participants and participants with
Huntington’s Disease (HD) prior to any treatment with dalzanemdor
(SAGE-718) or placebo, further underscoring the cognitive impact of
HD. For participants with HD that received dalzanemdor or placebo,
dalzanemdor was generally well-tolerated with no new safety signals
observed. There was a small numerical difference observed between
dalzanemdor and placebo on the HD-CAB composite score at Day 28.
Other prespecified analyses suggested the potential for
directionally positive signals in a number of individual component
tests of the HD-CAB and in some functional assessments.
Based on the review of data from the SURVEYOR Study and other
relevant information, the Company has decided to adjust the primary
endpoint in the ongoing placebo-controlled DIMENSION Study in HD
from the HD-CAB composite to the Symbol Digit Modalities Test
(SDMT), one of the cognitive tests included in the composite. Other
secondary endpoints include additional measures of cognition,
functioning and safety. Topline data from the DIMENSION Study are
expected in late 2024.
Ongoing studies in the dalzanemdor 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 and safety of once-daily
dalzanemdor dosed over three months.
- PURVIEW (CIH-301) Study: The
PURVIEW Study is an open-label Phase 3 safety study designed to
evaluate the long-term safety and tolerability of dalzanemdor in
participants with HD.
- LIGHTWAVE (CNA-202) Study: The
LIGHTWAVE Study is a double-blind, placebo-controlled Phase 2 study
of dalzanemdor in people with MCI and mild dementia due to AD. The
study is designed to evaluate the safety and efficacy of
dalzanemdor dosed over a 12-week period.
The Company expects the following milestones for dalzanemdor in
2024:
- Late 2024:
- Report topline data from LIGHTWAVE Study in people with MCI and
mild dementia due to AD
- Report topline data from DIMENSION Study in people with HD
cognitive impairment
- 2024:
- Present additional analyses of data from the clinical
development program as well as disease state and burden of disease
research in HD and/or AD
SAGE-324 SAGE-324 is a
GABAA receptor PAM, being developed as a potential oral therapy in
collaboration with Biogen Inc.
On July 24, 2024, Sage and Biogen announced topline results from
the Phase 2 KINETIC 2 study of SAGE-324 as a potential treatment in
ET. The KINETIC 2 Study did not demonstrate a statistically
significant dose-response relationship in change from baseline to
Day 91 based on the primary endpoint, The Essential Tremor Rating
Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper
limb) Total Score, in participants with ET. In addition, there were
no statistically significant differences demonstrated for any dose
of SAGE-324 versus placebo in the change from baseline to Day 91 on
the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily
Living (ADL) Composite Score. Given these results, Sage and Biogen
do not plan to conduct further clinical development of SAGE-324 in
ET and will close the ongoing open label safety study. The
companies are evaluating next steps, if any, for other potential
indications.
FINANCIAL RESULTS FOR THE SECOND
QUARTER 2024
- Cash Position: Cash, cash equivalents and marketable
securities as of June 30, 2024 were $647 million compared to $717
million at March 31, 2024.
- Revenue: Collaboration revenue from sales of ZURZUVAE
was $7.4 million in the second quarter of 2024, representing a 19%
increase compared to the first quarter of 2024. Reported
collaboration revenue is 50% of the net revenues Biogen records for
ZURZUVAE in the U.S. A key factor impacting revenue in the second
quarter of 2024 was wholesalers bringing down initial inventory
levels. Net revenue from sales of ZULRESSO was $0.6 million in the
second quarter of 2024, compared to $2.5 million in the same period
of 2023.
- R&D Expenses: Research and development expenses were
$62.6 million, including $6.1 million of non-cash stock-based
compensation expense, in the second quarter of 2024 compared to
$97.2 million, including $4.5 million of non-cash stock-based
compensation expense, for the same period in 2023. The decrease in
R&D expenses as compared to the same period in 2023 was related
to the Q3 2023 restructuring which reduced headcount, and decreased
spend on the early stage pipeline, zuranolone clinical development,
and manufacturing. The reimbursement from Biogen to Sage for
R&D expenses pursuant to the Sage/Biogen Collaboration and
License Agreement was $3.3 million in the second quarter of 2024
compared to $22.4 million in the same period of 2023, the reduction
is a result of the lower spend on zuranolone clinical development
and manufacturing.
- SG&A Expenses: Selling, general and administrative
expenses were $56.0 million, including $11.0 million of non-cash
stock-based compensation expense, in the second quarter of 2024,
compared to $75.6 million, including $7.2 million of non-cash
stock-based compensation expense, for the same period in 2023. The
decrease in SG&A expenses as compared to the same period in
2023 was primarily due decreased headcount, overhead and technology
spend as a result of the Q3 2023 restructuring. The reimbursement
from Sage to Biogen for SG&A expenses pursuant to the
Sage/Biogen Collaboration and License Agreement was $1.0 million in
the second quarter of 2024 as compared to $7.5 million in the same
period of 2023.
- Net Loss: Net loss was $102.9 million for the second
quarter of 2024 compared to $160.3 million for the same period in
2023.
FINANCIAL GUIDANCE
- Based upon the Company's current operating plan, Sage
anticipates that its existing cash, cash equivalents and marketable
securities, anticipated funding from ongoing collaborations, and
estimated revenues, will support its operations into 2026.
- The Company does not anticipate receipt of any milestone
payments from collaborations in the remainder of 2024.
- The Company anticipates operating expenses will decrease in
2024 relative to 2023.
- With the availability of ZURZUVAE as an additional treatment
for women with PPD, the Company anticipates ZULRESSO revenues will
continue to decrease over time.
Conference Call Information Sage will host a conference
call and webcast today, July 31, 2024, at 4:30 p.m. ET to review
its second quarter 2024 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 (Nasdaq: SAGE) is a biopharmaceutical company
committed to our mission of pioneering solutions to deliver
life-changing brain health medicines, so every person can thrive.
Sage developed the only two FDA-approved treatments indicated for
postpartum depression and is advancing a robust pipeline to target
unmet needs in brain health. Sage was founded in 2010 and is
headquartered in Cambridge, Mass. Find out more at www.sagerx.com
or engage with us on Facebook, LinkedIn, Instagram, and X.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: our plans, expectations and goals for
commercialization of ZURZUVAE as a treatment for women with PPD,
including our goal for ZURZUVAE to become the first line treatment
and standard of care in this indication; our expectations as to
coverage decisions related to ZURZUVAE in PPD and our goal of broad
and equitable access to ZURZUVAE for women with PPD who are
prescribed treatment; our belief in the commercial potential and
profile for ZURZUVAE in the treatment of women with PPD and our
expectations as launch progresses; anticipated timelines for
reporting of results with respect to ongoing clinical trials of
dalzanemdor and other planned activities; plans to evaluate other
potential indications for SAGE-324; 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; our expectations as to our cash runway, future expense
levels and other financial guidance and statements as to the
mission and goals for our business. 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; early positive signs from launch or
from our engagements with healthcare professionals, patients and
payors related to ZURZUVAE may not be a signal of the potential for
future success; 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
level of market acceptance from healthcare professionals, patients
or payors in the treatment of PPD we expect or we may encounter
reimbursement-related or other market-related issues or issues with
our distribution network that impact the success of our
commercialization efforts, including our ability to achieve access
goals; ZURZUVAE may never become the first line treatment and
standard of care for women with PPD; we may encounter delays in
reporting of data with respect to any of our ongoing clinical
trials, including as a result of changes in the trials, 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 or cause us to discontinue development; in particular
with respect to dalzanemdor, the results of our ongoing clinical
studies of dalzanemdor in HD and AD may be negative like the
results we previously announced from the PRECEDENT study in MCI in
Parkinson’s Disease; potentially directionally positive signals in
certain measures of the treatment phase of the SURVEYOR study of
dalzanemdor may not prove to be actual signals or meaningful to the
development program; we do not know if adjusting the primary
endpoint of the DIMENSION Study will increase the probability of
success, and it may not; unexpected concerns may arise from
additional data, analysis or results from any of our completed
studies; we and our collaborator, Biogen, may jointly or
individually determine not to proceed with further development of
SAGE-324 in any indication or at all; decisions or actions of the
FDA or the timing of meetings with the FDA may affect the timing,
design, size, progress and cost of ongoing or future clinical
trials of our current or future product candidates, the timing of
data read-outs, the planned regulatory pathway or our ability to
proceed with further development or may impair the potential for
successful development or the timing or success of filing for and
gaining regulatory approval; 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 approved 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 future receipt of
payments or the successful development or commercialization of
products and generation of revenue, may never be achieved at the
levels or timing we expect or at all; 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 not meet
our cash runway or expense expectations or we may 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 our currently marketed
products or any potential future products, at levels we expect; if
we do not achieve revenues at the levels we expect from our
currently marketed products, we may not achieve our expected cash
runway; additional funding may not be available on acceptable terms
which could hamper our development and commercialization
activities; 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 filed with the Securities and Exchange Commission, 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)
June 30, 2024 December 31, 2023 Cash, cash
equivalents and marketable securities
$
646,793
$
753,184
Total assets
697,105
882,277
Total liabilities
69,043
82,747
Total stockholders' equity
628,062
799,530
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Statements of Operations (in thousands, except
share and per share data) (unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Product revenue, net
$
600
$
2,460
$
2,289
$
5,754
Collaboration revenue - related party
7,420
-
13,633
-
Other collaboration revenue
634
14
634
14
Total revenues
8,654
2,474
16,556
5,768
Operating costs and expenses: Cost of revenues
1,407
205
2,676
435
Research and development
62,564
97,161
134,297
189,987
Selling, general and administrative
55,983
75,565
108,556
141,273
Total operating costs and expenses
119,954
172,931
245,529
331,695
Loss from operations
(111,300
)
(170,457
)
(228,973
)
(325,927
)
Interest income, net
8,431
10,173
17,634
19,003
Other income (expense), net
15
(41
)
2
(229
)
Net loss
$
(102,854
)
$
(160,325
)
$
(211,337
)
$
(307,153
)
Net loss per share - basic and diluted
$
(1.70
)
$
(2.68
)
$
(3.50
)
$
(5.14
)
Weighted average shares outstanding - basic and diluted
60,538,319
59,769,640
60,337,258
59,722,147
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240731771837/en/
Investor Contact Ashley Kaplowitz 786-252-1419
ashley.kaplowitz@sagerx.com
Media Contact Francesca Dellelci 856.261.5975
francesca.dellelci@sagerx.com
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