ZULRESSO™ (brexanolone) injection CIV, the
first treatment specifically indicated for postpartum depression,
commercially launched in the U.S. in late-June, with first patients
treated in July 2019
Commercial execution is progressing as expected
and on-track across key focus areas including enabling pathways to
care, facilitating patient access in the treatment of PPD, and
supporting women through Sage Central
Strong data signals from depression, neurology
and neuropsych franchises presented at FutureCast
Conference call today at 8:00 a.m. EDT
Today, Sage Therapeutics (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
second quarter ended June 30, 2019.
“Eight years ago, Sage laid the foundation to become the leading
brain health company during a time when there was tremendous
skepticism about the ability to develop novel medicines,” said Jeff
Jonas, M.D., chief executive officer at Sage. “Today, our first
compound is now our first commercially launched drug and our track
record of success is a direct result of our unique approach to
R&D and clinical development programs. Sage’s deliberate
decision-making approach around pipeline management has allowed us
to build what I think is a leading multi-franchise company focused
on getting patients better, sooner.”
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: Led by ZULRESSO™ (brexanolone) injection
CIV, 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, Sage’s next-generation
positive allosteric modulator (PAM) of GABAA receptors being
evaluated in clinical development as a treatment for various
affective disorders. SAGE-217 has received breakthrough therapy
designation from the U.S. FDA for the treatment of major depressive
disorder (MDD).
- ZULRESSO: The U.S. commercial launch of ZULRESSO
commenced on June 24, 2019 following scheduling by the U.S. Drug
Enforcement Administration (DEA) and finalization of the product
label. ZULRESSO is administered in a healthcare setting certified
under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)
program.
- Sites of Care:
- More than 100 healthcare facilities, including hospitals,
infusion centers, wellness centers, and fertility centers are
ZULRESSO REMS certified, covering 55 of the top 140 Metropolitan
Statistical Areas in the U.S
- ZULRESSO REMS certification is one step in the process for
sites of care to be treatment ready. Given the need to achieve
formulary approval, establish protocols for administering ZULRESSO
and secure satisfactory reimbursement, full activation of sites can
take an estimated 6 to 9 months or more. Sage anticipates launch
momentum to build in 4Q 2019 into 2020.
- Payer Coverage and Access:
- As of August 1, 2019, plans representing more than 65 percent
of all covered lives have committed to favorable coverage with
either light or no restrictions.
- Plans covering approximately 30 percent of covered lives are
still reviewing ZULRESSO, with decisions expected in the coming
months. We expect these payers to cover ZULRESSO on a medical
exception basis until a policy is in place.
- Patient Support:
- Sage Central, Sage’s patient support center, officially opened
in June and is providing a range of patient 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 more than 60 national and local
advocacy groups.
- SAGE-217: In July 2019, Sage announced clinical findings
from an open-label Phase 2 clinical trial of SAGE-217 in bipolar
depression (ARCHWAY Study), as well as analysis of datasets from
previously completed clinical studies in MDD and PPD showing
positive signals for potential development of SAGE-217 in
generalized anxiety disorder and treatment-resistant depression
(TRD). Sage plans to initiate a clinical study evaluating SAGE-217
in TRD. Timing for initiation of this study will be provided in 2H
2019.
- ARCHWAY Study: Results from this open-label Phase 2 clinical
trial evaluating the safety and activity of SAGE-217 in 35 adult
men and women with moderate to severe bipolar I/II disorder with a
major depressive episode demonstrated a rapid and durable response
to treatment as measured by the Montgomery–Åsberg Depression Rating
Scale (MADRS) and a statistically significant improvement compared
to baseline at Day 15; the effect was maintained through the end of
the follow-up period at Day 42. The most common adverse events
(AEs) in the trial were somnolence, headache, diarrhea, and
sedation. There were two cases of transient hypomania
off-treatment; no mania or serious AEs were reported in the
trial.
- SAGE-217 in patients who did not respond to anti-depressant
therapy at baseline: Results from a post-hoc analysis of 51
patients from the MDD-201B and ROBIN (PPD) studies with ongoing
symptoms of depression despite receiving standard anti-depressant
pharmacotherapy demonstrated a rapid response to treatment and
reduction in depressive symptoms in the SAGE-217-treated group
compared to the placebo group which was durable over the follow-up
period. The most common (>5%) AEs in the MDD-201B study were
headache, dizziness, nausea, and somnolence; the most common
(>5%) AEs in the ROBIN study were somnolence, headache,
dizziness, upper respiratory tract infection, diarrhea, and
sedation.
- SAGE-217 in anxiety: Analysis evaluating response on the
Hamilton Anxiety Rating Scale (HAM-A) in 89 patients from the
MDD-201B study and 151 patients from the ROBIN (PPD) study
demonstrated rapid onset of a clinically meaningful anxiolytic
effect in the SAGE-217-treated group compared to the placebo group
which was durable past initial treatment over the study
period.
- The SAGE-217 clinical program evaluating the potential of
SAGE-217 as a short-course episodic, rapidly-acting oral treatment
for MDD and PPD is progressing as expected. In addition to the two
completed, positive pivotal studies, one in MDD and one in PPD,
there are four additional ongoing or planned studies, including:
- MOUNTAIN Study: Evaluating a dosing regimen of two weeks of
20mg or 30mg SAGE-217 treatment compared to placebo in patients
with MDD, with four weeks of blinded follow-up. Top-line data from
this pivotal study are expected in 4Q 2019 or 1Q 2020.
- Retreatment studies: These studies are designed to provide
longer-term retreatment and follow-up safety and tolerability data.
- REDWOOD Study (MDD-302): Placebo-controlled pivotal trial to
evaluate fixed interval SAGE-217 monotherapy maintenance treatment
(without traditional antidepressants) for up to a year. The trial
is expected to commence in 3Q 2019.
- SHORELINE Study: Open-label pivotal trial evaluating SAGE-217
in treatment-free intervals and as-needed over the course of up to
a year. Patients receive an initial two-week course of SAGE-217
therapy and are assessed every eight weeks for potential relapse of
depressive symptoms. Top-line data are expected in 2020.
- RAINFOREST Study: Phase 3 clinical trial evaluating two weeks
of 30mg SAGE-217 treatment compared to placebo in patients with MDD
and comorbid insomnia. Top-line data are expected in 2020.
Neurology Franchise: SAGE-324, a next-generation PAM of GABAA
receptors, is in development as a potential therapy for
neurological conditions, such as essential tremor (ET), epilepsy
and Parkinson’s disease.
- SAGE-324: In July 2019, Sage announced results from
Phase 1 single-ascending dose (SAD) and multiple-ascending dose
(MAD) studies of SAGE-324 in healthy volunteers, as well as results
from a Phase 1b single dose, open-label study of SAGE-324 in six
patients with ET.
- SAD and MAD studies: Results demonstrated a pharmacokinetic
(PK) profile suitable for chronic dosing in indications amenable to
the GABA PAM mechanism and a long half-life, an attribute
well-suited for development in neurological conditions where stable
plasma levels are a clinical challenge.
- SAGE-324 in ET: Data demonstrated a reduction in tremor from
baseline, with a maximum mean reduction in accelerometer upper limb
total score of 48 percent. A clear pharmacokinetic/pharmacodynamic
relationship was observed in plasma concentration over 24 hours.
Sage plans to initiate a Phase 2 clinical study of SAGE-324 in
essential tremor in 2H 2019.
- SAGE-324 was generally well tolerated. The most common (>5%)
AEs were feeling of relaxation, dizziness, and somnolence.
Neuropsychiatry Franchise:
SAGE-718, a first-in-class NMDA receptor PAM, is in development as
a potential therapy for cognitive disorders associated with NMDA
receptor dysfunction.
- SAGE-718: In July 2019, results from five Phase 1
healthy volunteer studies, including SAD, MAD, and three target
engagement biomarker studies demonstrated SAGE-718 was generally
well-tolerated in the studies with a long half-life consistent with
once-daily dosing. Additional results demonstrated SAGE-718 had
effects on electrophysiological, functional neuroimaging, and
cognitive measures consistent with CNS activity. Sage plans to
evaluate SAGE-718 in Phase 2 clinical development programs in
certain neurodegenerative disorders and other conditions where
executive function is impaired. Timing for initiation of these
studies will be provided in 2H 2019.
Anticipated Upcoming
Milestones
- Top-line Data Readouts:
- SAGE-718 Phase 1 cohort data in Huntington’s disease (2H
2019)
- SAGE-217 MDD Phase 3 MOUNTAIN Study (4Q 2019/1Q 2020)
- SAGE-217 MDD Phase 3 RAINFOREST and SHORELINE Studies
(2020)
- Clinical Trial Initiations:
- Phase 2 placebo-controlled study with SAGE-324 in Essential
Tremor (2H 2019)
- Phase 3 REDWOOD (MDD-302) trial with SAGE-217 (3Q 2019)
Financial Results for the Second
Quarter of 2019
- Revenues: Sage recorded $0.9 million in revenues in the
second quarter of 2019, compared to $90.0 million for the same
period of 2018. Second quarter revenues in 2019 included $0.5
million of net revenues from sales of ZULRESSO, which consisted
entirely of channel stocking in preparation for the U.S. commercial
launch and $0.4 million in collaboration revenues from Shionogi
& Co., Ltd. related to reimbursement of product expense. All
revenues for the second quarter of 2018 were attributable to the
$90.0 million upfront payment from Sage’s strategic collaboration
with Shionogi & Co., Ltd.
- Cash Position: Cash, cash equivalents, restricted cash,
and marketable securities as of June 30, 2019 were approximately
$1.2 billion, compared to $925.1 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
$89.1 million, including $13.7 million of non-cash stock-based
compensation expense, in the second quarter of 2019, compared to
$69.0 million, including $12.1 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 and continued
research efforts across the Company’s early-stage clinical and
discovery pipeline.
- SG&A Expenses: Selling, general and administrative
expenses were $88.2 million, including $21.1 million of non-cash
stock-based compensation expense, in the second quarter of 2019,
compared to $43.2 million, including $16.9 million of non-cash
stock-based compensation expense, for the same period of 2018. The
increase in SG&A expenses was primarily due to the increase in
personnel-related expenses, professional fees to support expanding
operations, costs related to the commercial launch of ZULRESSO, and
facilities-related costs to support expanding operations.
- Net Loss: Net loss was $168.2 million for the second
quarter of 2019 compared to a net loss of $17.0 million, for the
comparable period of 2018. The difference in net loss was driven by
$90 million in revenue related to our Shionogi collaboration that
we recorded in the second quarter of 2018.
Financial Guidance
- Based on its current operating plan, Sage anticipates that its
balance of cash, cash equivalents, restricted cash, 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 commercialization of ZULRESSO in PPD.
Conference Call Information
Sage will host a conference call and webcast today at 8:00 a.m. EDT
to discuss its second 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. 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, including the potential timing of availability of sites
capable of administering ZULRESSO, the potential timing of revenue
momentum and the potential for reimbursement of ZULRESSO; our
development plans, goals and strategy and the potential timing and
results of our development efforts; our belief in the potential of
our product candidates in various indications; the potential
profile and benefit of our product candidates; the goals,
opportunity and potential for our 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: 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; 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 earlier stage 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 may generate results that are different than we expect or
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 initiation or
enrollment in ongoing or future clinical trials; we may encounter
unexpected safety or tolerability issues with our product
candidates; the internal and external costs required for our
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 which may cause us to change or curtail some of our plans;
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 quarterly 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
June 30, Six Months Ended June 30,
2019
2018
2019
2018
Product revenue, net
$
519
$
-
$
519
$
-
Collaboration revenue
354
90,000
819
90,000
Total revenue
873
90,000
1,338
90,000
Operating costs and expenses: Cost of goods sold
44
-
44
-
Research and development
89,059
68,980
175,457
118,250
Selling, general and administrative
88,227
43,167
172,146
72,016
Total operating costs and expenses
177,330
112,147
347,647
190,266
Loss from operations
(176,457)
(22,147)
(346,309)
(100,266)
Interest income, net
8,220
5,137
14,662
8,666
Other income, net
16
32
20
24
Net loss
$
(168,221)
$
(16,978)
$
(331,627)
$
(91,576)
Net loss per share - basic and diluted
$
(3.28)
$
(0.36)
$
(6.65)
$
(2.02)
Weighted average shares outstanding - basic and diluted
51,257,640
46,541,716
49,882,377
45,439,666
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
June 30,2019 December 31,2018 Cash, cash equivalents,
restricted cash and investments
$
1,238,916
$
925,143
Total assets
$
1,315,547
$
952,705
Total liabilities
$
112,672
$
89,734
Total stockholders' equity
$
1,202,875
$
862,971
About ZULRESSO™ (brexanolone) injection CIV
ZULRESSO, the first medicine specifically approved by the U.S.
Food and Drug Administration (FDA) for the treatment of postpartum
depression (PDD) 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.
What is ZULRESSO?
ZULRESSO™ (brexanolone) CIV 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/20190806005258/en/
Investor Contact: Maren Killackey, 617-949-4113
maren.killackey@sagerx.com Media Contact: Alexis Smith,
617-588-3740 alexis.smith@sagerx.com
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