ZULRESSO™ (brexanolone) CIV injection revenues
of $1.5M in third quarter
Enrollment completed in SAGE-217 Phase 3
MOUNTAIN and SHORELINE studies with topline data expected in 4Q
2019 and 2020, respectively
Planning to expand pipeline with two new GABA
and NMDA clinical-stage assets
Conference call today at 8:00 a.m. EST
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
third quarter ended September 30, 2019.
“Sage’s approach to drug discovery and development has led to
the significant progress we have made during the third quarter,”
said Jeff Jonas, M.D., chief executive officer of Sage
Therapeutics. “We are pleased with the execution by our teams at
Sage. Our Depression Franchise continues to advance, our SAGE-217
studies are progressing well, and the launch of ZULRESSO in
postpartum depression is yet another step towards upending
conventional wisdom about treating psychiatric disorders. On top of
this, our early stage pipeline continues to expand. We are looking
forward to the upcoming data readout for SAGE-217, and we are
excited by the possibilities in front of us.”
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
Sage’s Depression Franchise includes ZULRESSO™ (brexanolone) CIV
injection, the first treatment specifically approved by the U.S.
Food and Drug Administration (FDA) for postpartum depression (PPD),
and SAGE-217, Sage’s investigational oral neuroactive steroid GABAA
receptor positive allosteric modulator (PAM), that is being
evaluated as a treatment for various affective disorders. SAGE-217
received breakthrough therapy designation from the FDA for the
treatment of major depressive disorder (MDD).
- ZULRESSO: Following the U.S. commercial launch of
ZULRESSO on June 24, 2019, Sage remains focused on enabling broad
access to ZULRESSO for women with PPD and establishing
treatment-ready sites of care. The Company is encouraged by
positive indicators in the first few months that suggest the
long-term potential of ZULRESSO, including patient demand, interest
from HCPs, and favorable payer coverage.
- Sites of Care
- Sage continues to focus on helping 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. Sage continues to expect the majority of
healthcare sites will take an estimated six to nine months or more
to complete the actions required to be treatment-ready, which
include:
- establishing protocols for administering ZULRESSO;
- certifying under the ZULRESSO REMS (Risk Evaluation and
Mitigation Strategy);
- achieving formulary approval; and
- securing satisfactory reimbursement from payers.
- Sage expects some treatment-ready sites to wait to gain
familiarity with the clinical profile of ZULRESSO and to secure
direct experience with reimbursement prior to increasing patient
intake. As a result, Sage expects that revenue momentum may lag the
expected increase in site of care activation.
- As of September 30, 2019, more than 140 healthcare facilities,
including hospitals, infusion centers, wellness centers, and
fertility centers were ZULRESSO REMS certified across 66 of the top
140 Metropolitan Statistical Areas in the U.S. Of these healthcare
facilities, 11 sites were able to accelerate the activation process
for treatment-readiness and infused patients with ZULRESSO in the
third quarter of 2019.
- Payer Coverage & Reimbursement
- As of September 30, 2019, plans representing in aggregate more
than 75 percent of all covered lives have committed to favorable
coverage with either light or no restrictions.
- The Company has made progress with coverage and reimbursement
across national commercial payers and several state Medicaid
plans.
- Patient Support
- 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. In the third quarter of
2019, more than 90% of referred patients have used Sage Central’s
resources.
- SAGE-217: The clinical program evaluating the potential
of SAGE-217 as a rapid-acting, durable, short-course treatment for
MDD and PPD is progressing. In addition to the two completed
positive pivotal studies, one in MDD (MDD-201) and one in PPD
(ROBIN Study), ongoing or planned Phase 3 studies include:
- MOUNTAIN Study (MDD-301):
Placebo-controlled pivotal trial evaluating the safety and efficacy
of SAGE-217 in patients with MDD. Patients received a two-week
course of SAGE-217, 20mg or 30mg, or placebo, with four weeks of
blinded follow-up and will have up to six months of open-label
follow-up.
- Enrollment completed in September 2019. The Company anticipates
reporting topline data in 4Q 2019.
- REDWOOD Study (MDD-302):
Placebo-controlled pivotal trial evaluating the efficacy – time to
first relapse – and long-term safety of fixed interval SAGE-217
monotherapy maintenance treatment. Randomized patients receive a
two-week course of SAGE-217 or placebo every two months until the
first relapse for up to one year.
- Dosing in the study commenced in 3Q 2019.
- SHORELINE Study (MDD-303):
Open-label, long-term pivotal trial evaluating the safety of as
needed repeat treatment with SAGE-217. Patients receive an initial
two-week course of therapy and as needed retreatment and are
assessed for potential relapse of depressive symptoms for up to one
year.
- Enrollment completed in October 2019. The Company anticipates
reporting topline data in 2020.
- RAINFOREST Study (MDD-304):
Placebo-controlled pivotal trial evaluating SAGE-217 in patients
with comorbid MDD and insomnia. The study will evaluate the effects
on sleep as measured by polysomnography.
- The Company anticipates reporting topline data in 2020.
- Treatment-resistant depression
(TRD): Planned placebo-controlled pivotal trial evaluating
SAGE-217 as a potential therapy for TRD.
- The Company is in the process of evaluating the design and
timing of the study.
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 study-related
activities for a Phase 2 study evaluating SAGE-324 as a potential
therapy for ET in 4Q 2019.
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. SAGE-718 represents a
new and complementary set of opportunities for the Sage
portfolio.
- SAGE-718: The Company expects to report data from a
Phase 1 clinical trial evaluating the safety and pharmacokinetics
of SAGE-718 in a cohort of patients with early Huntington’s Disease
in 4Q 2019.
Early Development
- SAGE-904: Sage’s second NMDA receptor PAM
product-candidate is in development as a potential oral therapy for
disorders associated with NMDA hypofunction. Dosing in a Phase 1
clinical trial of SAGE-904 in healthy volunteers commenced in 3Q
2019.
- SAGE-689: Sage is developing an intramuscular GABAA
receptor PAM, SAGE-689, as a potential therapy for disorders
associated with GABA hypofunction. The IND for SAGE-689 was cleared
by the FDA and the Company expects to commence dosing in a Phase 1
clinical trial in healthy volunteers in 2020.
Anticipated Upcoming
Milestones
- Top-line Data Readouts:
- SAGE-217 Phase 3 MDD MOUNTAIN Study (4Q 2019)
- SAGE-718 Phase 1 cohort data in early Huntington’s disease (4Q
2019)
- SAGE-217 Phase 3 MDD SHORELINE Study (2020)
- SAGE-217 Phase 3 MDD and Comorbid Insomnia RAINFOREST Study
(2020)
- Planned Clinical Trial Initiations:
- SAGE-324 Phase 2 placebo-controlled study in ET (4Q 2019 for
study-related activities; 1H 2020 for dosing)
- SAGE-689 Phase 1 study in healthy volunteers (2020)
Financial Results for the Third Quarter
of 2019
- Revenues: Sage recorded $3.6 million in revenues in the
third quarter of 2019, including $1.5 million of net revenues from
sales of ZULRESSO and $2.1 million in collaboration revenues from
Shionogi & Co., Ltd. related to reimbursement of product
expense. Sage recorded no revenue for the same period in 2018.
- Cash Position: Cash, cash equivalents, restricted cash,
and marketable securities as of September 30, 2019 were
approximately $1.1 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
$102.1 million, including $17.1 million of non-cash stock-based
compensation expense in the third quarter of 2019, compared to
$75.1 million, including $14.0 million of non-cash stock-based
compensation expense, for the same period in 2018. The increase in
R&D expenses was primarily due to advancement of the pivotal
program for SAGE-217 in MDD and continued research efforts across
the Company’s early-stage clinical and discovery pipeline.
- SG&A Expenses: Selling, general and administrative
expenses were $88.5 million, including $26.6 million of non-cash
stock-based compensation expense in the third quarter of 2019,
compared to $53.7 million, including $11.5 million of non-cash
stock-based compensation expense, for the same period in 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 $180.0 million for the third
quarter of 2019 compared to a net loss of $122.9 million for the
same period in 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 ZULRESSO revenue growth will be modest over the
next few quarters and anticipates a meaningful increase in ZULRESSO
revenue in the second half of 2020.
Conference Call
Information
Sage will host a conference call and webcast today, Tuesday,
November 12, 2019, at 8:00 a.m. EST to discuss its third 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 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 momentum 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 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 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 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;
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
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
September 30, Nine Months Ended September 30,
2019
2018
2019
2018
Product revenue, net
$
1,478
$
-
$
1,997
$
-
Collaboration revenue
2,092
-
2,911
90,000
Total revenue
3,570
-
4,908
90,000
Operating costs and expenses: Cost of goods sold
137
-
181
-
Research and development
102,108
75,052
277,565
193,302
Selling, general and administrative
88,502
53,693
260,648
125,709
Total operating costs and expenses
190,747
128,745
538,394
319,011
Loss from operations
(187,177
)
(128,745
)
(533,486
)
(229,011
)
Interest income, net
7,227
5,817
21,889
14,483
Other income (expense), net
(8
)
10
12
34
Net loss
$
(179,958
)
$
(122,918
)
$
(511,585
)
$
(214,494
)
Net loss per share - basic and diluted
$
(3.48
)
$
(2.63
)
$
(10.13
)
$
(4.68
)
Weighted average shares outstanding - basic and diluted
51,704,687
46,706,770
50,496,489
45,866,676
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
September 30,2019 December 31,2018 Cash, cash
equivalents, restricted cash and investments
$
1,124,617
$
925,143
Total assets
$
1,203,727
$
952,705
Total liabilities
$
122,656
$
89,734
Total stockholders' equity
$
1,081,071
$
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/20191112005558/en/
Investor Contact Matt Calistri 617-914-2635
matthew.calistri@sagerx.com
Media Contact Alexis Smith 617-588-3740
alexis.smith@sagerx.com
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