Achieved $6.2 million in ZURZUVAE™ (zuranolone)
collaboration revenue during the first quarter of 2024,
representing 50% of the net revenues reported by Biogen
Encouraging initial demand for ZURZUVAE; More
than 700 prescriptions shipped and delivered in the first quarter
of 2024
Payor coverage now in place for a majority of
commercially covered lives for ZURZUVAE in the treatment of women
with postpartum depression (PPD) without step therapy or complex
prior authorizations, including coverage from two national Pharmacy
Benefit Managers (PBMs)
Phase 2 PRECEDENT Study did not show
statistically significant differences versus placebo on primary
endpoint in patients with mild cognitive impairment in Parkinson’s
Disease; Topline data expected for dalzanemdor (SAGE-718) in
Huntington’s Disease and Alzheimer’s Disease in 2024
Cash, cash equivalents and marketable
securities of $717 million as of March 31, 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
first quarter ended March 31, 2024.
“The launch of ZURZUVAE is off to an encouraging start,
reflected in the strong performance in the first full quarter of
the launch. We are seeing increasing demand among HCPs,
particularly OBGYNs, and hearing inspiring success stories from
women with PPD treated with ZURZUVAE. Importantly, momentum in
commercial and government payor coverage is helping to support our
goal of broad and equitable access for women with PPD,” said Barry
Greene, Chief Executive Officer at Sage Therapeutics. “In parallel,
we are working with urgency to advance efforts across our pipeline.
While we are disappointed by the results of the Phase 2 PRECEDENT
study given the significant burden of mild cognitive impairment on
people and families affected by Parkinson’s Disease, we look
forward to the other data readouts for dalzanemdor and SAGE-324
expected in 2024.”
First Quarter 2024 Portfolio
Updates
Sage is advancing a portfolio of clinical-stage programs
featuring 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 neurological and 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 PPD. ZURZUVAE was made commercially available in the U.S. in
December 2023. ZURZUVAE is being developed and commercialized in
collaboration with Biogen Inc. Sage also commercializes ZULRESSO®
(brexanolone) CIV injection in the U.S. 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 in the U.S. for women with PPD. ZURZUVAE was made commercially
available in the U.S. in December 2023. The companies are utilizing
a specialty pharmacy distribution model by which ZURZUVAE is
shipped directly to those who are prescribed the treatment.
As of the first quarter ended March 31, 2024, the following
results had been achieved:
- $6.2 million in collaboration revenue from ZURZUVAE,
representing 50% of the net revenues recorded when Biogen shipped
ZURZUVAE to the wholesalers. ZURZUVAE net revenues for the first
quarter can be attributed to a combination of wholesalers
purchasing ZURZUVAE to fill orders as well as building inventory in
anticipation of increasing demand for ZURZUVAE in the treatment of
women with PPD.
- Over 1,200 prescriptions written across a wide breadth of
physician types who treat PPD, including psychiatrists, OBGYNs and
primary care physicians (PCPs).
- In the first quarter of 2024, more than 700 prescriptions were
shipped and delivered.
Sage and Biogen field sales teams are engaging in promotional
dialogues with HCPs who actively identify and treat women with PPD.
In the first quarter of 2024, OBGYNs accounted for the largest
share of prescriptions, followed by psychiatrists and PCPs. The
number of new ZURZUVAE prescribers grew each month during the first
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.
- In the first quarter of 2024, the majority of prescriptions
were covered by payors.
- As of mid-April 2024, over 65% 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 PPD. Conversations are progressing with the third
national PBM.
- Medicaid reviews are ongoing with almost half of the states,
including several of the largest states, completing reviews during
the first quarter of 2024. The companies expect the majority of
Medicaid coverage decisions in PPD by the end of 2024.
Sage and Biogen’s patient support program, ZURZUVAE For You,
provides educational resources, helps with understanding insurance
coverage and assistance navigating the prescription fulfillment
process for women with PPD who are prescribed treatment. The
program also includes financial assistance, such as a copay
assistance program and product at no cost, for eligible patients.
In the first quarter of 2024, the 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 additional analyses of data from NEST clinical program,
including health economics and patient reported outcomes
Pipeline
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
certain 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 Huntington’s
Disease and entry into the Innovative Licensing and Access Pathway
(ILAP) by the U.K. Medicines and Healthcare products Regulatory
Agency (MHRA). SAGE-324, the Company’s next-generation PAM of GABAA
receptors, is in development as a potential oral therapy for
essential tremor (ET). SAGE-324 is being developed in collaboration
with Biogen Inc.
Dalzanemdor (SAGE-718)
Sage is advancing a robust clinical program for dalzanemdor with
multiple ongoing Phase 2 studies, including the DIMENSION and
SURVEYOR studies 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).
On April 17, 2024, Sage announced topline results from
PRECEDENT, a double-blind, placebo-controlled Phase 2 study of
dalzanemdor in people with MCI in Parkinson’s Disease. The
PRECEDENT Study did not meet its primary endpoint of demonstrating
statistically significant difference from baseline in participants
treated with once-daily dalzanemdor versus placebo on the Wechsler
Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test
score at Day 42. Dalzanemdor was generally well-tolerated, and
there were no new safety signals observed. Based on the data, the
Company does not plan any further development of dalzanemdor in
Parkinson’s Disease.
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 of dalzanemdor dosed over a
12-week period, 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 designed to generate evidence linking changes in
cognition to functioning, and is not designed or powered to
demonstrate a statistically significant difference between
dalzanemdor and placebo.
- PURVIEW (CIH-301) Study: The
PURVIEW Study is an open-label Phase 3 safety study of dalzanemdor
in people with cognitive impairment associated with HD. The study
is designed to evaluate the long-term safety profile and long-term
functioning compared to HD natural history of those treated for one
year or more.
- 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:
- Mid-2024:
- Report topline data from SURVEYOR Study in people with HD
cognitive impairment
- 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 clinical development
program as well as disease state and burden of disease research in
HD and/or AD
SAGE-324
Sage and its collaborator, Biogen, have completed enrollment in
the Phase 2b KINETIC 2 placebo-controlled study of SAGE-324 in ET,
which follows positive results from the completed KINETIC Study of
SAGE-324 in ET. KINETIC 2 is a Phase 2b dose-ranging study with the
primary goal of defining the dose for SAGE-324 with an efficacy and
tolerability profile that maintains plasma concentrations needed
for sustained tremor symptom control in treating ET. Topline data
from the KINETIC 2 Study are expected in mid-2024.
Sage is also 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 is incidence
of treatment-emergent adverse events.
The Company expects the following milestones for SAGE-324 in
2024:
- Mid-2024:
- Report topline data from Phase 2b KINETIC 2 Study in people
with ET
- 2024:
- Present additional analyses of data from clinical development
program as well as disease state and burden of disease research in
ET
FINANCIAL RESULTS FOR THE FIRST QUARTER
2024
- Cash Position: Cash, cash equivalents and marketable
securities as of March 31, 2024 were $717 million compared to $753
million at December 31, 2023.
- Revenue: Collaboration revenue from sales of ZURZUVAE
was $6.2 million in the first quarter of 2024, the first full
quarter of sales. Reported collaboration revenue is 50% of the net
revenues Biogen reports for ZURZUVAE in the U.S. ZURZUVAE net
revenues for the first quarter can be attributed to a combination
of wholesalers purchasing ZURZUVAE to fill orders as well as
building inventory in anticipation of increasing demand for
ZURZUVAE in the treatment of women with PPD. A $75.0 million
milestone payment was earned in the fourth quarter of 2023 upon the
first commercial sale of ZURZUVAE in PPD and was received from
Biogen in January 2024. Net revenue from sales of ZULRESSO was $1.7
million in the first quarter of 2024, compared to $3.3 million in
the same period of 2023.
- R&D Expenses: Research and development expenses were
$71.7 million, including $5.0 million of non-cash stock-based
compensation expense, in the first quarter of 2024 compared to
$92.8 million, including $8.8 million of non-cash stock-based
compensation expense, for the same period in 2023. The decrease in
R&D expenses was primarily due to decreased headcount,
decreased spend on early-stage pipeline, decreased zuranolone
clinical trials and manufacturing as result of the Q3 2023
restructuring, partially offset by higher spend on dalzanemdor
trials. The reimbursement from Biogen to Sage for R&D expenses
pursuant to the Sage/Biogen Collaboration and License Agreement was
$5.7 million in the first quarter of 2024 compared to $17.3 million
in the same period of 2023, the reduction a result of the lower
spend on zuranolone clinical development and manufacturing.
- SG&A Expenses: Selling, general and administrative
expenses were $52.6 million, including $8.7 million of non-cash
stock-based compensation expense, in the first quarter of 2024,
compared to $65.7 million, including $11.3 million of non-cash
stock-based compensation expense, for the same period in 2023. The
decrease in SG&A expenses was primarily due to 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 $2.3 million in the first quarter of 2024 as compared
to $3.0 million in the same period of 2023.
- Net Loss: Net loss was $108.5 million for the first
quarter of 2024 compared to $146.8 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 additional
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 in the U.S. 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, Thursday,
April 25, at 8:00 a.m. ET to review its first 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 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; 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 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; 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 recently announced from the PRECEDENT
study in MCI in PD; unexpected concerns may arise from
additional data, analysis or results from any of our completed
studies; decisions or actions of the FDA or the timing of meetings
with the FDA may affect the timing, design, size, progress and cost
of clinical trials, 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
when we need it 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)
March 31, 2024 December 31, 2023 Cash, cash
equivalents and marketable securities
$
717,013
$
753,184
Total assets
767,600
882,277
Total liabilities
61,799
82,747
Total stockholders' equity
705,801
799,530
Sage Therapeutics, Inc. and
Subsidiaries Condensed Consolidated Statements of
Operations (in thousands, except share and per share data)
(unaudited)
Three Months Ended March 31,
2024
2023
Product revenue, net
$
1,690
$
3,294
Collaboration revenue - related party
6,212
-
Total revenue
7,902
3,294
Operating costs and expenses: Cost of revenues
1,269
230
Research and development
71,734
92,826
Selling, general and administrative
52,574
65,708
Total operating costs and expenses
125,577
158,764
Loss from operations
(117,675
)
(155,470
)
Interest income, net
9,204
8,830
Other expense, net
(12
)
(188
)
Net loss
$
(108,483
)
$
(146,828
)
Net loss per share - basic and diluted
$
(1.80
)
$
(2.46
)
Weighted average shares outstanding - basic and diluted
60,136,198
59,674,127
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/20240425567718/en/
Investors Ashley Kaplowitz 786-252-1419
ashley.kaplowitz@sagerx.com Media Matthew Henson
917-930-7147 matthew.henson@sagerx.com
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