ZULRESSO™ (brexanolone) injection approved by U.S. FDA and on track
for launch in late June
Commercial team is launch ready; field teams focusing on payer
engagement and identifying pathways to care
Strong financial position with ~$1.4B in cash
Milestones anticipated throughout 2019 in clinical studies across all
three franchises: depression, neurology and neuropsychiatry
Conference call today at 8:00 A.M. ET
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company
developing novel medicines to treat life-altering central nervous system
(CNS) disorders, today reported business highlights and financial
results for the first quarter ended March 31, 2019.
“We started 2019 with positive data from a Phase 3 clinical trial of our
lead oral compound SAGE-217 in postpartum depression and this was
quickly followed by the FDA approval of ZULRESSO in PPD,” said Jeff
Jonas, M.D., chief executive officer at Sage. “It was gratifying that
our first drug approval generated extensive media coverage of a disorder
that for too long has been shrouded by stigma and shame. We anticipate
additional momentum in our development efforts during the remainder of
the year across our three franchises in depression, neurology and
neuropsychiatry and believe the depth and breadth of our novel portfolio
of compounds in these areas is unrivaled in the industry. We are
confident in our potential to create a paradigm shift in the way brain
health is thought about and treated.”
ZULRESSO™ (brexanolone) injection, approved by the U.S. Food and Drug
Administration (FDA) in March 2019 as the first treatment specifically
indicated for postpartum depression (PPD), and SAGE-217, which is being
evaluated in clinical studies as a treatment for major depressive
disorder (MDD), PPD, bipolar depression as well as comorbid MDD and
insomnia. SAGE-217 has received breakthrough therapy designation from
the FDA for the treatment of MDD.
ZULRESSO: Launch in the U.S. is on track for late June 2019 following
scheduling by the U.S. Drug Enforcement Administration (DEA). ZULRESSO
will only be available under a Risk Evaluation and Mitigation Strategy
(REMS) program called the ZULRESSO REMS. Prior to launch, Sage
continues to execute against its go-to-market strategy with a focus on
activating REMS-certified Centers of Excellence (COEs) and alternate
sites of care, with the goal of ensuring broad access for women with
Sage has identified a targeted list of COEs that the Company
believes are capable of providing ZULRESSO to patients at launch
and in subsequent periods. These COEs are sites of care that have
a PPD healthcare provider champion, ability to secure appropriate
payer reimbursement for ZULRESSSO, and the capabilities to operate
under the REMS. The commercial field teams are continuing to
educate medical and administrative leaders at these COEs on the
ZULRESSO REMS, as permitted, and we have been able to initiate the
process of REMS-certification at some of these COEs.
The Sage field market access team has completed more than 500
payer engagement meetings during the past several months, as
permitted, including meetings with the majority of commercial and
Medicaid payers. Since approval, these teams have conducted
productive meetings with payers representing 90 percent of covered
lives in the U.S.
The Sage patient support organization is launch ready and will
provide a range of patient support resources to assist women with
PPD and their families, including: dedicated case managers who can
provide information to help navigate the treatment journey;
personalized support to assist with understanding insurance and
coverage options; financial assistance programs for eligible
patients; and access to educational resources and assistance
through connections to local resources.
Sage is continuing to use digital health technology in its efforts
to raise awareness and reduce the stigma of PPD. Initiatives
Support of digital PPD education modules, reaching nearly
50,000 healthcare providers in the U.S. through the Medscape
Support of digital health solutions to pregnant women and new
moms, resulting in more than 100,000 digital screenings for
- Support of digital PPD education modules, reaching nearly
A U.S. patent, exclusively licensed to the Company, was recently
issued covering the method of treating PPD using brexanolone
injection; this patent will expire in 2033.
- Sage has identified a targeted list of COEs that the Company
SAGE-217: The pivotal program evaluating the potential of SAGE-217 as
a short-course episodic, rapidly-acting oral treatment for MDD and PPD
is progressing on target. This program includes two completed,
positive pivotal studies, one in MDD and one in PPD.
In January 2019, Sage announced statistically significant top-line
results in primary and secondary endpoints from the Phase 3 ROBIN
Study of SAGE-217 in women with severe PPD. These results
demonstrated a rapid, stable, and clinically meaningful
improvement in depressive symptoms in the SAGE-217 treatment group
compared to the placebo group after two weeks of treatment. The
effect was maintained through the end of the four-week follow-up
period. The most common adverse events in the treatment group were
somnolence, headache, dizziness, upper respiratory tract
infection, diarrhea, and sedation. Two subjects experienced
serious adverse events, one in each treatment group.
Ongoing or planned studies in the program include:
MOUNTAIN Study: Evaluates a dosing regimen of two weeks
of 20mg or 30mg SAGE-217 treatment compared to placebo in
approximately 450 patients with MDD, with four weeks of
blinded follow-up. Top-line data from the study are expected
in Q4 2019 or Q1 2020. As a separate observational phase, the
Company will continue to follow patients for up to six months.
Retreatment studies: These studies are designed
to provide longer-term retreatment and follow-up safety and
MDD-302 will evaluate fixed interval SAGE-217 monotherapy
maintenance (treatment without traditional
antidepressants) for up to a year. This placebo-controlled
trial is expected to commence in 3Q 2019 and, if
successful, is intended to help meet the expected
requirements for a New Drug Application for SAGE-217, and
enable inclusion of maintenance dosing as part of the
The SHORELINE Study evaluates 30mg SAGE-217 open-label
treatment, treatment-free intervals and as-needed
retreatment for return of major depressive episodes over
the course of up to a year. Patients will receive an
initial two-week course of SAGE-217 therapy and will be
assessed every eight weeks for potential relapse of
depressive symptoms. Data are expected in 2020.
- MDD-302 will evaluate fixed interval SAGE-217 monotherapy
RAINFOREST Study: Evaluates two weeks of 30mg SAGE-217
treatment compared to placebo in approximately 100 patients
with MDD and comorbid insomnia. Top-line data are expected in
- MOUNTAIN Study: Evaluates a dosing regimen of two weeks
The Company is also evaluating SAGE-217 in the Phase 2 open-label
ARCHWAY Study in approximately 30 patients with bipolar I/II
disorder with a current major depressive episode. Primary
endpoints are safety and tolerability; secondary endpoints will
measure improvements in depressive symptoms and sleep. Sage plans
to announce top-line data from this study in July 2019.
The Company is also evaluating the potential for development of
SAGE-217 in additional affective disorders and expects to provide
an update on those plans in July 2019.
- In January 2019, Sage announced statistically significant top-line
by SAGE-324, a next-generation positive allosteric modulator (PAM) of
GABAA receptors, in development as a potential
therapy for neurological conditions, such as essential tremor (ET) and
SAGE-324: In a Phase 1 single ascending dose study (SAD), SAGE-324 was
generally well-tolerated with no serious adverse events and
demonstrated a pharmacokinetic profile consistent with once-daily
Sage is continuing to evaluate SAGE-324 in a Phase 1 multiple
ascending dose (MAD) study in healthy volunteers and a Phase 1
single dose open-label study in patients with ET. These studies
are designed to evaluate the safety, tolerability and
pharmacokinetics of the compound. Target engagement using
pharmaco-EEG (β-band power) was observed in the SAD study and will
continue to be evaluated in the MAD study. Results from these
trials are expected to be announced in 2H 2019.
- Sage is continuing to evaluate SAGE-324 in a Phase 1 multiple
by SAGE-718, a first-in-class NMDA receptor PAM, in development as a
potential therapy for certain cognition-related disorders impacted by
NMDA receptor dysfunction.
SAGE-718: The completed Phase 1 single and multiple ascending dose
studies in healthy volunteers demonstrated a pharmacokinetic profile
consistent with once-daily dosing. SAGE-718 was generally
well-tolerated in the studies with no serious adverse events.
Results from ongoing Phase 1 target engagement biomarker studies
in healthy volunteers, focusing on electrophysiology and imaging,
are expected to be announced in July 2019.
Results from an ongoing Phase 1 study to determine the safety,
tolerability and pharmacokinetics in patients with early
Huntington’s disease are expected to be announced in 2H 2019.
- Results from ongoing Phase 1 target engagement biomarker studies
Anticipated Upcoming Milestones
Top-line data readouts:
- SAGE-217 Phase 2 ARCHWAY Study in bipolar depression (July 2019)
- SAGE-324 Phase 1 MAD study; cohorts 1-4 (July 2019)
- SAGE-718 Phase 1 biomarker data (July 2019)
- SAGE-718 early Huntington’s disease Phase 1 cohort data (2H 2019)
- SAGE-324 essential tremor Phase 1 topline data (2H 2019)
- SAGE-217 MDD Phase 3 MOUNTAIN Study (Q4 2019/Q1 2020)
- SAGE-217 MDD Phase 3 RAINFOREST and SHORELINE studies (2020)
Regulatory and commercial:
ZULRESSO commercial launch in the U.S., pending DEA scheduling
(late June 2019)
- ZULRESSO commercial launch in the U.S., pending DEA scheduling
Financial Results for the First Quarter of 2019
Cash Position: Cash, cash equivalents, and marketable
securities as of March 31, 2019 were approximately $1.4 billion,
compared to $922.8 million at December 31, 2018. The increase was
primarily due to proceeds from Sage’s follow-on public offering
completed in February 2019.
R&D Expenses: Research and development expenses were $86.4
million, including $20.7 million of non-cash stock-based compensation
expense, in the first quarter of 2019, compared to $49.3 million,
including $8.9 million of non-cash stock-based compensation expense,
for the same period of 2018. The increase in R&D expenses
year-over-year was primarily due to advancement of the pivotal program
for SAGE-217 in depression; continued research efforts across the
Company’s early-stage clinical and discovery pipeline; and investments
in R&D headcount to support the growth in Sage’s pipeline and
G&A Expenses: General and administrative expenses
were $83.9 million, including $23.4 million of non-cash stock-based
compensation expense, in the first quarter of 2019, compared to $28.8
million, including $6.9 million of non-cash stock-based compensation
expense, for the same period of 2018. The increase in G&A expenses was
primarily due to the increase in personnel-related expenses,
professional fees to support expanding operations, costs related to
continued preparations for the anticipated commercial launch of
ZULRESSO, and facilities-related costs to support expanding operations.
Net Loss: Net loss was $163.4 million for the first quarter of
2019 compared to a net loss of $74.6 million, for the comparable
period of 2018.
Based on its current operating plan, Sage now anticipates that its
balance of cash, cash equivalents and marketable securities will be at
least $950 million at the end of 2019.
Sage expects that its operating expenses will increase year-over-year
in 2019 to support continued pipeline advancement and anticipated
commercialization of ZULRESSO in PPD.
Conference Call Information
will host a conference call and webcast today at 8:00 A.M. ET to discuss
its first quarter 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. The conference call can be accessed by dialing
1-866-450-8683 (toll-free domestic) or 1-281-542-4847 (international)
and using the conference ID 5968036. 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
Therapeutics is a biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with life-altering
central nervous system (CNS) disorders. Sage’s portfolio of novel
compounds targets critical receptor systems in the brain and includes
the first treatment specifically approved by the U.S. Food and Drug
Administration for postpartum depression as well as compounds being
developed as potential treatments for diseases such as major depressive
disorder, insomnia, bipolar disorder and essential tremor. For more
information, please visit www.sagerx.com.
statements in this release concern Sage’s future expectations, plans and
prospects, including without limitation: our expectations regarding the
timing of scheduling and launch of ZULRESSO in the treatment of PPD; our
plans regarding anticipated future commercial and patient support
activities; our expectations regarding availability of REMS-certified
sites of care for the administration of ZULRESSO and access to treatment
for women with PPD; our statements regarding the potential for
reimbursement of ZULRESSO; our view as to the potential for us to
change the way brain health is treated; our statements regarding the
target product profiles, plans and timelines for development of our
product candidates, including planned clinical activities and reporting
of results; our views as to the depth and breadth of our portfolio and
the opportunity represented by our programs and business; and our
expectations regarding our cash position at year-end and increases in
operating expense. 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: scheduling and launch of ZULRESSO may not occur on the
timelines we expect; we may encounter issues or other challenges in
launching and commercializing ZULRESSO, including issues related to
market acceptance by healthcare providers, healthcare settings and women
with PPD, challenges with reimbursement, issues related to limitations
on the site of administration of ZULRESSO to REMS-certified supervised
healthcare settings and the other 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;
results achieved with use of ZULRESSO in the treatment of PPD once we
have launched the product 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; 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 early stage clinical trials may not be
repeated or observed in ongoing or future studies of any of our product
candidates; ongoing and future clinical results may not support further
development or be sufficient to gain regulatory approval of our product
candidates; 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 enrollment in ongoing or future
clinical trials; the internal and external costs required for our
anticipated launch and commercialization activities and ongoing and
planned research and development efforts, and to build our organization
in connection with such activities, and the resulting expense increases
and use of cash, may be higher than expected, or we may conduct
additional clinical trials or pre-clinical studies, or engage in new
activities, requiring additional expenditures and using cash more
quickly than anticipated and we may encounter technical and other
unexpected hurdles in the commercialization of ZULRESSO or 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
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
Sage Therapeutics, Inc. and Subsidiaries
|Three Months Ended March 31,|
|Research and development||86,398||49,270|
|General and administrative||83,919||28,849|
|Total operating expenses||170,317||78,119|
|Loss from operations||(169,852||)||(78,119||)|
|Interest income, net||6,442||3,529|
|Other income (expense), net||4||(8||)|
|Net loss per share – basic and diluted||$||(3.37||)||$||(1.68||)|
|Weighted average shares outstanding – basic and diluted||48,491,834||44,325,371|
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
|Cash, cash equivalents, restricted cash and investments||$||1,353,618||$||925,143|
|Total stockholders’ equity||$||1,319,534||$||862,971|
Important Safety Information:
What is ZULRESSO™?
ZULRESSO is a prescription medicine used in adults to treat a certain
type of depression called Postpartum Depression.
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.
- During your ZULRESSO infusion, tell your healthcare provider right
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/
- There is a pregnancy registry for females who are exposed to
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
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
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
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
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
Maren Killackey, 617-949-4113
Jeff Boyle, 617-949-4256