ZULRESSO™ (brexanolone) CIV injection net
revenues of $2M and $4M for fourth quarter and full year 2019,
respectively
Evaluating path forward for the zuranolone
(SAGE-217) Landscape Program
Continued expansion of Neurology and
Neuropsychiatry franchises with planned initiation of additional
SAGE-324 and SAGE-718 studies in 2020
Conference call today at 8:00 a.m. EST
Today, Sage Therapeutics, Inc. (NASDAQ: SAGE), a
biopharmaceutical company committed to developing novel therapies
with the potential to transform the lives of people with
debilitating disorders of the brain, reported business highlights
and financial results for the fourth quarter and full year ended
December 31, 2019.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20200227005220/en/
“The progress we made in 2019 across our depression, neuropsych
and neurology franchises supports our vision to make medicines that
matter,” said Jeff Jonas, chief executive officer of Sage
Therapeutics. “Our focus in 2020 will be guided by perseverance,
disciplined execution and rigorous prioritization designed to
achieve an optimal pace of innovation for what we believe is a
leading, novel portfolio of NCEs dedicated to treating brain health
disorders. Our most immediate goal is to find the most efficient
pathway to bring new treatments to patients as quickly as
possible.”
Portfolio Updates Sage is
advancing a portfolio of novel and differentiated product
candidates designed to improve brain health by targeting the GABA
and NMDA receptor systems. Dysfunction in these systems is thought
to be at the core of numerous neurological and neuropsychiatric
disorders.
Depression Franchise The
Depression Franchise is led by ZULRESSO™ (brexanolone) CIV
injection, approved by the U.S. Food and Drug Administration (FDA)
as the first treatment specifically indicated for postpartum
depression (PPD), and zuranolone (SAGE-217), Sage’s next-generation
positive allosteric modulator (PAM) of GABAA receptors, being
evaluated in clinical development as a treatment for various
affective disorders. Zuranolone has received breakthrough therapy
designation from the FDA for the treatment of major depressive
disorder (MDD).
- ZULRESSOTM (brexanolone) CIV injection: Enabling broad
access to ZULRESSO for women with PPD and helping to activate
treatment-ready sites of care remain the key focus in the launch of
ZULRESSO. The Company continues to see positive indicators
suggesting the long-term potential of ZULRESSO, including strong
patient and health care provider (HCP) demand, as well as broad and
favorable payor coverage.
- Sites of care
- Sage continues to help sites of care advance through the
actions required to be treatment-ready to ensure women with PPD
have access to a healthcare setting capable of administering
ZULRESSO.
- Based on experience during the initial six months of the
ZULRESSO launch, Sage now anticipates the majority of interested
sites will take nine months or longer to complete the actions
required to be treatment ready. Many large hospital and healthcare
systems are estimated to take 12 months or longer.
- As of December 31, 2019, more than 175 healthcare facilities
were ZULRESSO REMS certified across 75 of the top 140 Metropolitan
Statistical Areas in the U.S., compared to 140 healthcare
facilities as of the end of the third quarter of 2019. Of these
healthcare facilities, 29 have completed all of the steps required
to be treatment-ready and infused patients with ZULRESSO by the end
of the year 2019, compared to 11 sites as of the end of the third
quarter of 2019.
- Payor coverage & reimbursement
- As of December 31, 2019, plans representing in aggregate 80
percent of all covered lives have committed to favorable coverage
with either light or no restrictions.
- Sites must often negotiate the reimbursement amount for each
payor under commercial coverage. Availability and sufficiency of
Medicaid reimbursement varies by state and often depends on whether
the state treats the ZULRESSO infusion as an outpatient or
inpatient administration.
- The Centers for Medicare & Medicaid Services assigned
ZULRESSO an HCPCS C-code in January 2020. The C-code is being
adopted by commercial and state Medicaid plans and is available for
use on qualifying claims reflecting ZULRESSO utilization to treat
women with PPD through the hospital out-patient department. Sage
anticipates activation by the end of the first quarter of 2020,
which could improve reimbursement transparency.
- Patient demand & support
- Sage continues to see strong patient demand with more than 300
start forms in the fourth quarter of 2019 compared to more than 200
in the third quarter of 2019, bringing the total to more than 500
start forms by end of year 2019. Additionally, the number of
referring HCPs more than doubled in the fourth quarter of 2019
compared to the third quarter of 2019, bringing the total to more
than 300 referring HCPs by the end of year 2019.
- Sage Central, Sage’s patient support center, continues to
provide a range of patient resources to assist women with PPD and
their families in the treatment journey. As of December 31, 2019,
more than 95% of referred patients used Sage Central’s
resources.
- Revenue
- Sage expects ZULRESSO revenue growth will be modest over the
next couple of quarters with an increase in the rate of growth of
ZULRESSO revenue anticipated in the second half of 2020, assuming
an increase in the number of treatment-ready sites, including
larger hospitals administering ZULRESSO to treat women with PPD,
and an increase in the volume of patients treated at existing
sites. To accomplish this objective, Sage is guiding large sites
through the steps necessary to become treatment-ready and
supporting hospital administrations’ efforts to reduce the
complexity of those steps.
- Zuranolone: The Landscape Program, the clinical program
evaluating the potential of zuranolone as a rapid-acting, durable,
short-course treatment for MDD and PPD, currently includes three
completed pivotal efficacy studies, one in PPD (ROBIN Study) and
two in MDD (MDD-201, MOUNTAIN Study), and three other initiated
Phase 3 pivotal studies (REDWOOD, SHORELINE, RAINFOREST).
- Study updates
- MOUNTAIN Study (MDD-301): The
Company announced topline data from the pivotal Phase 3 study in
December 2019.
- The MOUNTAIN study did not meet its primary endpoint of a
statistically significant reduction from baseline compared to
placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D)
total score at Day 15. Patients in the zuranolone 30 mg group
achieved statistically significant reductions in the HAM-D total
score at Days 3, 8 and 12.
- Zuranolone was generally well-tolerated and showed a similar
safety profile as seen in earlier studies.
- REDWOOD Study (MDD-302): The study
is a placebo-controlled pivotal trial evaluating the efficacy –
time to first relapse – and long-term safety of fixed interval
zuranolone 30 mg monotherapy maintenance treatment. Randomized
patients receive a two-week course of zuranolone 30 mg or placebo
every two months until the first relapse for up to one year.
- The Company paused enrollment in the study in the fourth
quarter of 2019 and is evaluating potential study amendments as the
Company determines next steps in the Landscape Program.
- SHORELINE Study (MDD-303): The
study is an open-label, long-term pivotal trial evaluating the
safety of as-needed repeat treatment with zuranolone. Patients
receive an initial two-week course of zuranolone 30 mg and as
needed retreatment. Patients are assessed for potential relapse of
depressive symptoms for up to one year.
- The Company anticipates reporting topline data from the
SHORELINE Study in 2020.
- The Company is also assessing the potential of adding an
additional cohort to the study evaluating a higher dose of
zuranolone in patients with MDD.
- RAINFOREST Study (MDD-304): The
study is a placebo-controlled pivotal trial evaluating zuranolone
30 mg in patients with comorbid MDD and insomnia. The primary
endpoint of the study is change from baseline in sleep efficiency
as assessed by polysomnography.
- The Company paused enrollment in the study in the fourth
quarter of 2019 and is evaluating potential study amendments as the
Company determines next steps in the Landscape Program.
- Program next steps
- Sage previously announced that a meeting with the FDA to
discuss zuranolone would occur in the first quarter of 2020. The
Company continues to evaluate data from the MOUNTAIN Study and will
announce next steps in the Landscape Program upon completion of
relevant correspondence with the FDA, including receipt of meeting
minutes, and the determination of the development and regulatory
path forward.
Neurology Franchise
SAGE-324, a next-generation PAM of GABAA receptors and Sage’s lead
neurology asset, is in development as a potential oral therapy for
neurological conditions, such as essential tremor (ET), epilepsy
and Parkinson’s disease.
- SAGE-324: The Company plans to initiate a
placebo-controlled Phase 2 study evaluating the safety and efficacy
of SAGE-324 in patients with ET in the first half of 2020. Patients
will receive a once-daily, four-week course of SAGE-324 60 mg or
placebo.
- The planned progression of SAGE-324 in ET is based on results
from a Phase 1 open-label study evaluating the safety and
pharmacokinetics of SAGE-324 in patients with ET. Data from the
study will be presented in 2020.
Neuropsychiatry Franchise
SAGE-718, Sage’s first-in-class NMDA receptor PAM and lead
neuropsychiatric drug candidate, is in development as a potential
oral therapy for cognitive disorders associated with NMDA receptor
dysfunction, including Huntington’s disease (HD).
- SAGE-718: The Company reported data from a Phase 1
open-label study evaluating the safety and pharmacokinetics of
SAGE-718 in a cohort of patients with early HD in December 2019.
- Study results
- SAGE-718 was well tolerated, with no serious adverse events or
adverse events leading to treatment discontinuation.
- Patients demonstrated improved performance, compared to
baseline, on assessments of executive functioning; executive
dysfunction is a core feature of early HD. Additional data will be
presented at an upcoming medical meeting.
- Next steps
- SAGE-718 is being developed as a potential treatment for
disorders where cognitive function is impaired. In 2020, the
Company plans to initiate one or more Phase 2a open-label studies
evaluating SAGE-718 in patients with impaired cognitive function,
which may include Parkinson’s disease, Alzheimer’s disease, and
other neuropsychiatric disorders. Results from these studies will
inform advancement of SAGE-718 into further Phase 2
development.
Anticipated Upcoming Milestones
- Regulatory Updates
- The Company previously announced that a meeting with the FDA to
discuss zuranolone would occur in the first quarter of 2020. The
Company continues to evaluate data from the MOUNTAIN Study and will
announce next steps in the Landscape Program upon completion of
relevant correspondence with the FDA, including receipt of meeting
minutes, and determination of the development and regulatory path
forward (2020)
- Topline Data
- Zuranolone Phase 3 MDD SHORELINE Study (2020)
- Planned Clinical Trial Initiations
- SAGE-324 Phase 2 placebo-controlled study in ET (1H 2020)
- SAGE-718 Phase 2a open-label study or studies in various
disorders associated with cognitive dysfunction (2020)
Financial Results for the Fourth
Quarter and Full Year 2019
- Revenues: Sage recorded $2.0 million in revenues in the
fourth quarter of 2019 from sales of ZULRESSO. Sage recorded $0.3
million in collaboration revenues from Shionogi & Co., Ltd.
related to reimbursement of product expense for the same period of
2018. For the year ended December 31, 2019, revenues were $6.9
million, including $4.0 million of net product revenues related to
sales of ZULRESSO and $2.9 million in collaboration revenues from
Shionogi & Co., Ltd. related to reimbursement of product
expense, compared to $90.3 million in collaboration revenues from
Shionogi & Co., Ltd., for the year ended December 31,
2018.
- Cash Position: Cash, cash equivalents, restricted cash,
and marketable securities as of December 31, 2019 were
approximately $1.0 billion compared to $925.1 million at December
31, 2018.
- R&D Expenses: Research and development expenses were
$91.3 million, including $11.4 million of non-cash stock-based
compensation expense, in the fourth quarter of 2019, compared to
$88.8 million, including $15.9 million of non-cash stock-based
compensation expense, for the same period of 2018. For the year
ended December 31, 2019, research and development expenses were
$368.8 million, including $62.9 million of non-cash stock-based
compensation expense, compared to $282.1 million, including $50.9
million of non-cash stock-based compensation expense, for the year
ended December 31, 2018. The increase in R&D expenses was
primarily due to the advancement of the pivotal program for
zuranolone in MDD and continued research and development efforts
across the Company’s early-stage clinical and discovery
pipeline.
- SG&A Expenses: Selling, general and administrative
expenses were $85.1 million, including $19.3 million of non-cash
stock-based compensation expense, in the fourth quarter of 2019,
compared to $75.7 million, including $15.8 million of non-cash
stock-based compensation expense, for the same period in 2018. For
the year ended December 31, 2019, SG&A expenses were $345.8
million, including $90.3 million of non-cash stock-based
compensation expense, compared to $201.4 million, including $51.1
million of non-cash stock-based compensation expense, for the year
ended December 31, 2018. The increase in SG&A expenses was
primarily due to an increase in personnel-related expenses, along
with facilities and corporate infrastructure costs to support
expanding operations and the ZULRESSO commercial launch.
- Net Loss: Net loss was $168.7 million for the fourth
quarter of 2019 and $680.2 million for the year ended December 31,
2019, compared to a net loss of $158.4 million and $372.9 million,
respectively, for the comparable periods of 2018.
Financial Guidance
- Sage expects ZULRESSO revenue growth will be modest over the
next couple of quarters with an increase in the rate of growth of
ZULRESSO revenue anticipated in the second half of 2020.
Conference Call Information Sage will host a conference
call and webcast today, Thursday, February 27, 2020, at 8:00 a.m.
EST to discuss its fourth quarter and full year 2019 financial
results and 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 approximately two hours after the completion of the
event and will be archived for up to 30 days.
About Sage Therapeutics Sage Therapeutics is a
biopharmaceutical company committed to developing novel therapies
with the potential to transform the lives of people with
debilitating disorders of the brain. We are pursuing new pathways
with the goal of improving brain health, and our depression,
neurology and neuropsychiatry franchise programs aim to change how
brain disorders are thought about and treated. Our mission is to
make medicines that matter so people can get better, sooner. For
more information, please visit www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation:
our views and expectations regarding our commercial launch of
ZULRESSO and its long-term potential, including the potential
timing for sites to become ready to administer ZULRESSO and
expectations regarding an increase in the number of activated
sites, the potential timing of revenue growth, an increase in the
volume of treated patients at existing sites, and the potential for
favorable reimbursement of ZULRESSO; our development plans, goals
and strategy and the potential timing and results of our
development efforts; our plans to determine next steps with respect
to the development and regulatory path forward for zuranolone and
the Landscape Program, including any potential amendments to our
clinical trials of zuranolone; our belief in the potential of our
product candidates in various indications; the potential profile
and benefit of our product candidates; and the goals, opportunity
and potential 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: we
may encounter issues or other challenges in commercializing
ZULRESSO, including issues related to market acceptance by
healthcare providers, healthcare settings and women with PPD,
issues related to the willingness of sites to administer ZULRESSO,
issues related to reimbursement, issues related to the requirements
of the REMS, and challenges associated with execution of our sales
and patient support activities, which in each case could limit the
potential of ZULRESSO and the timing and amount of future revenues;
results achieved with use of ZULRESSO in the treatment of PPD in
commercial use may be different than observed in clinical trials,
and may vary among patients; the number of women with PPD or the
unmet need for additional treatment options may be significantly
smaller than we expect; we may encounter unexpected safety or
tolerability issues with ZULRESSO or any of our product candidates,
including, for zuranolone or other product candidates, as a result
of any increase in dosing in our clinical trials; we may not be
successful in our development of any of our current or future
product candidates in any indication we are currently pursuing or
may in the future pursue; success in prior clinical trials or
nonclinical studies may not be repeated or observed in ongoing or
future studies of any of our product candidates; ongoing and future
clinical or nonclinical results for our product candidates may
generate results that are different than we expect or may not
support further development of the product candidate or be
sufficient to gain regulatory approval of our product candidates on
the timelines we expect or at all, or may require additional
clinical trials or nonclinical studies; we may decide that a
development pathway for one of our product candidates in one or
more indications is no longer feasible or advisable or that the
unmet need no longer exists; the FDA may decide that the
development program for any of our product candidates, even if
positive, is not sufficient for a new drug application filing or
approval; decisions or actions of the FDA or other regulatory
agencies may affect the initiation, timing, design, size, progress
and cost of clinical trials and our ability to proceed with further
development; we may experience slower than expected initiation or
enrollment in ongoing or future clinical trials; the internal and
external costs required for our ongoing and planned research and
development efforts, and to manage our organization in connection
with such activities, and the resulting expense increases and use
of cash, may be higher than expected which may cause us to change
or curtail some of our plans; we may change our plans for other
business reasons; and we may encounter technical and other
unexpected hurdles in the development of our product candidates; as
well as those risks more fully discussed in the section entitled
"Risk Factors" in our most recent annual report filed with the
Securities and Exchange Commission (SEC), and discussions of
potential risks, uncertainties, and other important factors in our
subsequent filings with the SEC. 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.
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended December 31, Year Ended
December 31,
2019
2018
2019
2018
Product revenue, net
$
1,960
$
-
$
3,957
$
-
Collaboration revenue
-
273
2,911
90,273
Total revenue
1,960
273
6,868
90,273
Operating costs and
expenses: Cost of goods sold
219
-
400
-
Research and development
91,250
88,805
368,815
282,107
Selling, general and administrative
85,129
75,695
345,777
201,404
Total operating costs and expenses
176,598
164,500
714,992
483,511
Loss from operations
(174,638
)
(164,227
)
(708,124
)
(393,238
)
Interest income, net
5,915
5,851
27,804
20,334
Other income (expense), net
70
(12
)
82
22
Net loss
$
(168,653
)
$
(158,388
)
$
(680,238
)
$
(372,882
)
Net loss per share - basic and diluted
$
(3.25
)
$
(3.38
)
$
(13.38
)
$
(8.08
)
Weighted average shares outstanding - basic and diluted
51,834,880
46,876,452
50,833,837
46,121,194
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets (in
thousands) (unaudited)
December 31,2019
December 31,2018 Cash,
cash equivalents, restricted cash and investments
$
1,010,760
$
925,143
Total assets
$
1,084,150
$
952,705
Total liabilities
$
139,495
$
89,734
Total stockholders' equity
$
944,655
$
862,971
About ZULRESSO™ (brexanolone) CIV injection ZULRESSO, the
first medicine specifically approved by the U.S. Food and Drug
Administration (FDA) for the treatment of postpartum depression
(PPD) in adults, is a positive allosteric modulator of both
synaptic and extrasynaptic GABAA receptors. Allosteric modulation
of neurotransmitter receptor activity results in varying degrees of
desired activity rather than complete activation or inhibition of
the receptor.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ZULRESSO?
ZULRESSO can cause serious side effects, including:
- Excessive sedation and sudden loss of consciousness.
ZULRESSO may cause you to feel very sleepy (excessive sedation) or
pass out (loss of consciousness). Your healthcare provider should
check you for symptoms of excessive sleepiness every 2 hours while
you are awake.
- During your ZULRESSO infusion, tell your healthcare provider
right away if you feel like you cannot stay awake during the time
you are normally awake or if you feel like you are going to pass
out. Your healthcare provider may lower your dose or stop the
infusion until symptoms go away.
- You must have a caregiver or family member with you to help
care for your child(ren) during your ZULRESSO infusion.
- Because of the risk of serious harm resulting from excessive
sedation or sudden loss of consciousness, ZULRESSO is only
available through a restricted program called the ZULRESSO
REMS.
Before receiving ZULRESSO, tell your healthcare provider
about all your medical conditions, including if you:
- drink alcohol
- have kidney problems
- are pregnant or think you may be pregnant. It is not known if
ZULRESSO will harm your unborn baby.
- There is a pregnancy registry for females who are exposed to
ZULRESSO during pregnancy. The purpose of the registry is to
collect information about the health of females exposed to ZULRESSO
and their baby. If you become pregnant during treatment with
ZULRESSO, talk to your healthcare provider about registering with
the National Pregnancy Registry for Antidepressants at
1-844-405-6185 or visit
https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
- are breastfeeding or plan to breastfeed. ZULRESSO passes into
breast milk. Talk to your healthcare provider about the risks and
benefits of breastfeeding and about the best way to feed your baby
while receiving ZULRESSO.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and
cause serious side effects.
Especially tell your healthcare provider if you take
other antidepressants, opioids, or Central Nervous System (CNS)
depressants (such as benzodiazepines).
Know the medicines you take. Keep a list of them to show your
healthcare provider and pharmacist when you get a new medicine.
Your healthcare provider will decide if other medicines can be
taken with ZULRESSO.
How will I receive ZULRESSO? ZULRESSO is given to you by
continuous intravenous (IV) infusion into your vein. The infusion
will last for a total of 60 hours (2.5 days).
What should I avoid while receiving ZULRESSO?
- ZULRESSO may make you feel dizzy and sleepy. Do not drive a car
or do other dangerous activities after your ZULRESSO infusion until
your feeling of sleepiness has completely gone away. See “What
is the most important information I should know about
ZULRESSO?”
- Do not drink alcohol while receiving ZULRESSO.
What are the possible side effects of ZULRESSO?
ZULRESSO can cause serious side effects, including:
- See “What is the most important information I should know
about ZULRESSO?”
- Increased risk of suicidal thoughts or actions. ZULRESSO
and other antidepressant medicines may increase suicidal thoughts
and actions in some people 24 years of age and younger. Depression
or other serious mental illnesses are the most important causes of
suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and
actions?
- Pay close attention to any changes, especially sudden changes
in mood, behavior, thoughts, or feelings, or if you develop
suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or
sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as
scheduled. Call your healthcare provider between visits as needed,
especially if you have concerns about symptoms.
Tell your healthcare provider right away if you have any of
the following symptoms, especially if they are new, worse, or worry
you:
- Attempts to commit suicide, thoughts about suicide or dying,
new or worse depression, other unusual changes in behavior or
mood
The most common side effects of ZULRESSO include:
- Sleepiness, dry mouth, passing out, flushing of the skin or
face.
These are not all the side effects of ZULRESSO.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please see Full Prescribing Information
including Boxed Warning and Medication Guide for ZULRESSO and discuss any
questions you may have with your healthcare provider.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200227005220/en/
Investor Contact Jeff Boyle 617-949-4256
jeff.boyle@sagerx.com
Media Contact Alexis Smith 617-588-3740
alexis.smith@sagerx.com
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