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
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.”
Depression Franchise:Led by
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 PPD.
- 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 include:
- Support of digital PPD education
modules, reaching nearly 50,000 healthcare providers in the U.S.
through the Medscape platform;
- Support of digital health solutions to
pregnant women and new moms, resulting in more than 100,000 digital
screenings for PPD.
- 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-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 tolerability data.
- 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
label.
- 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.
- 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 2020.
- 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.
Neurology
Franchise:Led 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 epileptiform disorders.
- 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 dosing.
- 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.
Neuropsychiatry
Franchise:Led 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.
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)
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
operations.
- 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.
Financial Guidance
- 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
InformationSage 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
TherapeuticsSage 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.
Forward-Looking
StatementsVarious 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 forward-looking statements.
Sage Therapeutics, Inc. and
SubsidiariesCondensed Consolidated Statements of
Operations(in thousands, except share and per share
data)(Unaudited)
Three Months Ended March 31,
2019
2018
Collaboration revenue $ 465 $ - Operating expenses: 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 $ (163,406 ) $ (74,598 )
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
(in thousands)
(Unaudited)
March 31,2019
December 31,2018
Cash, cash equivalents, restricted cash and investments $ 1,353,618
$ 925,143 Total assets $ 1,422,914 $ 952,705 Total liabilities $
103,380 $ 89,734 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.
- 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/20190502005211/en/
Investor Contact:Maren Killackey,
617-949-4113maren.killackey@sagerx.com
Media Contact:Jeff Boyle,
617-949-4256jeff.boyle@sagerx.com
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