Expected initiation of three new short-term
zuranolone clinical studies in 2020, with the potential for three
distinct indications
April restructuring to advance corporate
strategy and pipeline expected to result in approximate annualized
cost savings of $170M, with significant portion related to ZULRESSO
commercial and G&A support
Progress continues in neurology and
neuropsychiatry franchises with planned initiation of Phase 2
clinical trials of SAGE-324 in 1H and SAGE-718 in 2H, 2020
Mike Cloonan elevated to chief operating
officer
Conference call today at 4:30 p.m. ET
Today, Sage Therapeutics, Inc. (NASDAQ:SAGE), a
biopharmaceutical company committed to developing novel therapies
with the potential to transform the lives of people with
debilitating disorders of the brain, reported business highlights
and financial results for the first quarter ended March 31, 2020.
The Company also announced the promotion of Mike Cloonan to chief
operating officer; he will continue to report into Jeff Jonas,
Sage’s chief executive officer. In the newly created role, Mr.
Cloonan will strategically align the business functions to support
the ongoing development and commercialization of Sage’s brain
health portfolio.
“I want to take a moment to acknowledge the challenges resulting
from the global COVID-19 pandemic. I’m proud of the way our
employees, partners, and the community have responded in this
unprecedented time,” said Jeff Jonas, M.D., chief executive officer
at Sage Therapeutics. “The teams at Sage are handling virtual work
well, and progress across our pipeline remains strong. Our mission
is more important than ever as mental health issues are coming to
the forefront and will continue to have significant impact even
after the current phase of the COVID-19 pandemic is over. The
strategic decisions we made in the first quarter, and the promotion
of Mike to chief operating officer, have us on the right track, we
believe, to continue developing medicines that matter for people
with brain health disorders.”
Portfolio Updates Sage is
advancing a portfolio of novel and differentiated product
candidates designed to improve brain health by targeting the GABAA
and NMDA receptor systems. Dysfunction in these systems is thought
to be at the core of numerous neurological and neuropsychiatric
disorders.
Depression Franchise The
Depression Franchise includes zuranolone (SAGE-217), Sage’s
next-generation positive allosteric modulator (PAM) of GABAA
receptors, being evaluated in clinical development as a treatment
for various affective disorders, and ZULRESSO™ (brexanolone) CIV
injection, the first treatment approved by the U.S. Food and Drug
Administration (FDA) specifically for postpartum depression (PPD).
Zuranolone has received breakthrough therapy designation from the
FDA for the treatment of major depressive disorder (MDD).
- Zuranolone: Sage is evaluating the potential of
zuranolone as a rapid-acting, short-course treatment for PPD and
MDD. Following discussions with the FDA, Sage plans to initiate
three new short-term clinical studies in 2020, with the potential,
if successful, for three distinct indications: PPD, acute rapid
response therapy (RRT) in MDD when co-initiated with a newly
administered standard antidepressant, and episodic treatment of
MDD. These planned studies include:
- Oral therapy in women with PPD:
Placebo-controlled trial evaluating a two-week course of zuranolone
50 mg in women with PPD, with additional short-term follow-up.
- Topline data from this study is anticipated in 2021.
- RRT in patients with MDD when
co-initiated with a newly administered standard antidepressant
therapy: Placebo-controlled trial evaluating a two-week
course of zuranolone 50 mg, when co-initiated with an open-label
SSRI, in patients with MDD, with additional short-term follow-up.
- Topline data from this study is anticipated in 2021.
- Episodic therapy in patients with
MDD: Placebo-controlled trial evaluating a two-week course
of zuranolone 50 mg in patients with MDD, with additional
short-term follow-up.
- Topline data from this study is anticipated in 2021.
- Long-term safety data, including data from REDWOOD (MDD-302),
are expected to be required to support a new drug application (NDA)
filing for episodic treatment of depression.
- Ongoing study updates:
- SHORELINE Study (MDD-303): The
Company is on track to report topline data in 2020 from patients
with MDD who received zuranolone 30 mg in the SHORELINE Study.
- The protocol has been amended to allow currently enrolled
patients to receive retreatment with zuranolone 50 mg.
- The Company expects to enroll a new cohort of patients with MDD
who will receive zuranolone 50 mg.
- REDWOOD Study (MDD-302) and RAINFOREST
Study (MDD-304): The Company has paused enrollment in the
REDWOOD and RAINFOREST Studies, and is in the process of closing
active sites, to focus resources and activities on enrollment in
the three new planned Phase 3 clinical studies. The Company plans
to reevaluate whether and when to reinitiate the REDWOOD and
RAINFOREST studies at a later date.
- The Company is also currently evaluating the ongoing zuranolone
clinical pharmacology and safety program and plans to finalize
requirements to support a potential future NDA with the FDA.
- ZULRESSOTM (brexanolone) CIV injection:
- Revenue for Q1 2020 was $2.3 million, a 17% increase over Q4
2019. The Company continued focusing its efforts on navigating the
barriers to treatment with ZULRESSO. The number of patients infused
in the first quarter increased by more than 20% compared to the
previous quarter. The Company received approximately 320 start
forms and 12 new treating sites of care were added in the first
quarter, increasing the total number of sites that have treated
patients with ZULRESSO to 41 since launch.
- The recent rapid spread of COVID-19 in the U.S. has resulted in
a significant reduction in patient demand as well as sites of care
starting to pause treatment of new patients with ZULRESSO during
March 2020, and in increasing numbers since then. As a result of
the pandemic only approximately 15% of sites active in the first
quarter remained active in April. Concerns about exposure to the
virus have also caused a reduction in the number of women with PPD
seeking treatment with ZULRESSO, as evidenced by the approximately
75% decline in the monthly start form volume in April compared to
the average monthly volume for the first quarter of 2020.
- Sage recently executed a corporate restructuring. As a part of
the restructuring, Sage downsized commercial efforts, including
elimination of its entire salesforce. The Company now has a small
account management field-based team with a primary focus on working
with healthcare providers and supporting women with PPD in
geographies with active, ZULRESSO treating sites.
- Given the ongoing impact of the COVID-19 pandemic in the U.S.,
the Company expects de minimis revenues from sales of ZULRESSO in
the second quarter of 2020. The Company does not plan to provide
revenue guidance for the balance of 2020. The Company anticipates,
however, that the COVID-19 pandemic will continue to have an
adverse impact on sales of ZULRESSO even after pandemic-related
restrictions are eased as sites of care adjust to new processes and
address ongoing concerns as the situation evolves.
Neurology Franchise
SAGE-324, a next-generation PAM of GABAA receptors and Sage’s lead
neurology asset, is in development as a potential oral therapy for
neurological conditions, such as essential tremor (ET), epilepsy
and Parkinson’s disease.
- SAGE-324: The Company plans to initiate a
placebo-controlled Phase 2 study evaluating the safety and efficacy
of SAGE-324 in patients with ET in the first half of 2020. Patients
will receive a once-daily, four-week course of SAGE-324 60 mg or
placebo. ‒ The planned progression of SAGE-324 in ET is based on
results from a Phase 1 open-label study evaluating the safety and
pharmacokinetics of SAGE-324 in patients with ET. Data from the
study will be presented in 2020.
Neuropsychiatry Franchise
SAGE-718, Sage’s first-in-class NMDA receptor PAM and lead
neuropsychiatric drug candidate, is in development as a potential
oral therapy for cognitive disorders associated with NMDA receptor
dysfunction, including Huntington’s disease (HD).
- SAGE-718: The Company plans to initiate one or more
Phase 2a open-label studies in 2020 evaluating SAGE-718 in patients
with impaired cognitive function, which may include Parkinson’s
disease, Alzheimer’s disease, and other neuropsychiatric disorders.
Results from these studies will inform potential advancement of
SAGE-718 into further Phase 2 development. ‒ The planned
progression of SAGE-718 in disorders associated with impaired
cognitive function is based on results from a Phase 1 open-label
study evaluating the safety and pharmacokinetics of SAGE-718 in a
cohort of patients with early HD. Results from the study were
presented at the CHDI Foundation annual meeting in February
2020.
Anticipated Upcoming Milestones and
Potential Impact of COVID-19 Sage has implemented
business continuity policies and practices intended to safeguard
employees and help reduce the spread of COVID-19, including
initiating a work from home policy for all employees. Sage is
working closely with clinical development teams to develop
strategies to help mitigate potential disruptions caused by
COVID-19 and at this time the Company does not anticipate there
will be a significant impact to timelines for its planned or
ongoing clinical programs.
1H2020
- SAGE-324: ‒ Initiate Phase 2 placebo-controlled study in
ET
2H 2020
- Zuranolone: ‒ Initiate Phase 3 trial evaluating a two-week
course of zuranolone 50 mg in women with PPD ‒ Initiate Phase 3
trial evaluating a two-week course of zuranolone 50 mg, when
co-initiated with an open-label SSRI, as an acute rapid response
therapy in patients with MDD ‒ Initiate Phase 3 trial evaluating a
two-week course of zuranolone 50 mg in patients with MDD (acute
study intended to support episodic indication) ‒ Report topline
data from Phase 3 MDD SHORELINE Study (30 mg)
- SAGE-718: ‒ Initiate Phase 2a open-label study or studies in
various disorders associated with cognitive dysfunction
2021
- Zuranolone: ‒ Report topline data from Phase 3 trials in PPD,
RRT, and MDD
- SAGE-324: ‒ Report topline data from Phase 2 placebo-controlled
study in ET
- SAGE-718: ‒ Report topline data from Phase 2a open-label study
or studies in various disorders associated with cognitive
dysfunction
Financial Results for the First Quarter
2020
- Revenues: Sage recorded $2.3 million in net revenues in
the first quarter of 2020 from sales of ZULRESSO. Sage recorded
$0.5 million in collaboration revenues from Shionogi & Co.,
Ltd. related to reimbursement of product expense for the same
period of 2019.
- Cash Position: Cash, cash equivalents, restricted cash,
and marketable securities as of March 31, 2020 were approximately
$0.9 billion compared to $1.0 billion at December 31, 2019.
- R&D Expenses: Research and development expenses were
$63.6 million, including $12.2 million of non-cash stock-based
compensation expense, in the first quarter of 2020, compared to
$86.4 million, including $20.7 million of non-cash stock-based
compensation expense, for the same period of 2019. The decrease in
R&D expenses was primarily related to pauses in enrollment of
certain Phase 3 clinical trials of zuranolone in MDD and the
completion of the MOUNTAIN Study, a Phase 3 clinical trial of
zuranolone in MDD.
- SG&A Expenses: Selling, general and administrative
expenses were $70.1 million, including $18.9 million of non-cash
stock-based compensation expense, in the first quarter of 2020,
compared to $83.9 million, including $23.4 million of non-cash
stock-based compensation expense, for the same period in 2019. The
decrease in SG&A expenses was primarily due to a decrease in
professional fees, primarily due to costs incurred in the three
months ended March 31, 2019, related to preparations for the
commercial launch of ZULRESSO in the U.S., which commenced on June
24, 2019.
- Net Loss: Net loss was $126.7 million for the first
quarter of 2020, compared to a net loss of $163.4 million for the
comparable period of 2019.
Financial Guidance
- Sage anticipates a cash balance of at least $550 million at end
of 2020, which the Company anticipates will support operations into
2022 based on current operating plans.
Conference Call Information Sage will host a conference
call and webcast today, Thursday, May 7, 2020, at 4:30 p.m. ET to
discuss its first quarter 2020 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 revenues from sales of
ZULRESSO and factors that may impact revenues, including the
expected impact of the COVID-19 pandemic on ZULRESSO revenues; our
clinical development plans and expected timelines, including our
belief as to our ability to mitigate the possible impact of the
COVID-19 pandemic on our clinical development timelines; the amount
of the expected one-time cost associated with our restructuring;
expected reductions in external expenses; our expectations with
respect to 2020 operating expenses and year-end cash; our belief
that existing cash will support operations into 2022; our belief in
the potential of our product candidates in various indications; the
potential profile and benefit of our product candidates; and the
goals, opportunity and potential for our business. These statements
constitute forward-looking statements as that term is defined in
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements, including the risks that: we
may never be able to generate meaningful revenues from sales of
ZULRESSO or to generate revenues at levels necessary to justify our
investment; the impact of the COVID-19 pandemic on sales of
ZULRESSO may last longer than we expect or may reoccur in waves;
our post-restructuring focus on geographies where there are
existing, active ZULRESSO treating sites may not be sufficient for
us to achieve success from the sale of ZULRESSO or to generate
revenues at meaningful levels or at levels necessary to justify our
investment even after the impact of the COVID-19 pandemic lessens;
we may not be able to overcome the barriers to treatment with
ZULRESSO or we may continue to encounter other issues or challenges
in commercializing ZULRESSO which could further 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 not realize expected cost savings from our
restructuring, including the anticipated decrease in external
spend, at the levels we expect; we may encounter delays in
initiation or conduct of our planned clinical trials, including
slower than expected site initiation or enrollment, that may impact
our ability to meet our expected time-lines and increase our costs;
we may not be able to mitigate the impact of COVID-19 on our
clinical development timelines and the impact may be more
significant than we expect and may negatively impact expected site
initiation or enrollment in our clinical trials, or cause us to
pause trials or not be able to use data, in each case which may
significantly impact our ability to meet our expected time-lines or
may significantly impact the integrity or sufficiency of the data
from our trials or increase our costs or cause us to have to change
our plans; the internal and external costs required for our ongoing
and planned activities, and the resulting impact on expense and use
of cash, may be higher than expected which may cause us to use cash
more quickly than we expect or change or curtail some of our plans
or both; our expectations as to expenses, year-end cash and cash
needs may prove not to be correct for other reasons such as changes
in plans or actual events being different than our assumptions; we
may be opportunistic in our future financing plans even if
available cash is sufficient; we may not be successful in our
development of any of our product candidates in any indication we
are currently pursuing or may in the future pursue; success in our
non-clinical studies or in earlier clinical trials may not be
repeated or observed in ongoing or future studies, and ongoing and
future non-clinical and clinical results may not meet their primary
or key secondary endpoints or be sufficient to file for or gain
regulatory approval to market the product without further
development work or may not support further development at all; we
may encounter adverse events at any stage of development that
negatively impact further development or that require additional
nonclinical and clinical work which may not yield positive results;
we may encounter different or more severe adverse events at the
higher doses we are planning to study in new trials; we may
encounter issues with the efficacy or durability of short-term
treatment, or co-initiated treatment with zuranolone or safety and
efficacy concerns with respect to retreatment that require
additional studies be conducted; the FDA may ultimately decide that
the design or results of our completed and planned clinical trials
for any of our product candidates, even if positive, are not
sufficient for regulatory approval in the indications that are the
focus of our development plan; other 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 encounter technical and
other unexpected hurdles in the development and manufacture of our
product candidates which may delay our timing or change our plans
or increase our costs; as well as those risks more fully discussed
in the section entitled "Risk Factors" in our most recent Quarterly
Report on Form 10-Q, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. 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 March
31,
2020
2019
Product revenue, net
$
2,286
$
-
Collaboration revenue
-
465
Total revenue
2,286
465
Operating costs and expenses: Cost of goods sold
170
-
Research and development
63,610
86,398
Selling, general and administrative
70,130
83,919
Total operating costs and expenses
133,910
170,317
Loss from operations
(131,624
)
(169,852
)
Interest income, net
4,729
6,442
Other income, net
155
4
Net loss
$
(126,740
)
$
(163,406
)
Net loss per share - basic and diluted
$
(2.44
)
$
(3.37
)
Weighted average shares outstanding - basic and diluted
51,908,760
48,491,834
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
March 31,2020 December 31,2019 Cash, cash
equivalents, restricted cash and investments
$
875,124
$
1,010,760
Total assets
$
944,973
$
1,084,150
Total liabilities
$
95,767
$
139,495
Total stockholders' equity
$
849,206
$
944,655
About ZULRESSO™ (brexanolone) CIV injection ZULRESSO, the
first medicine specifically approved by the U.S. Food and Drug
Administration (FDA) for the treatment of postpartum depression
(PPD) in adults, is a positive allosteric modulator of both
synaptic and extrasynaptic GABAA receptors. Allosteric modulation
of neurotransmitter receptor activity results in varying degrees of
desired activity rather than complete activation or inhibition of
the receptor.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ZULRESSO?
ZULRESSO can cause serious side effects, including:
- Excessive sedation and sudden loss of consciousness.
ZULRESSO may cause you to feel very sleepy (excessive sedation) or
pass out (loss of consciousness). Your healthcare provider should
check you for symptoms of excessive sleepiness every 2 hours while
you are awake. - During your ZULRESSO infusion, tell your
healthcare provider right away if you feel like you cannot stay
awake during the time you are normally awake or if you feel like
you are going to pass out. Your healthcare provider may lower your
dose or stop the infusion until symptoms go away. - You must have a
caregiver or family member with you to help care for your
child(ren) during your ZULRESSO infusion.
- Because of the risk of serious harm resulting from excessive
sedation or sudden loss of consciousness, ZULRESSO is only
available through a restricted program called the ZULRESSO
REMS.
Before receiving ZULRESSO, tell your healthcare provider
about all your medical conditions, including if you:
- drink alcohol
- have kidney problems
- are pregnant or think you may be pregnant. It is not known if
ZULRESSO will harm your unborn baby. - There is a pregnancy
registry for females who are exposed to ZULRESSO during pregnancy.
The purpose of the registry is to collect information about the
health of females exposed to ZULRESSO and their baby. If you become
pregnant during treatment with ZULRESSO, talk to your healthcare
provider about registering with the National Pregnancy Registry for
Antidepressants at 1-844-405-6185 or visit
https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
- are breastfeeding or plan to breastfeed. ZULRESSO passes into
breast milk. Talk to your healthcare provider about the risks and
benefits of breastfeeding and about the best way to feed your baby
while receiving ZULRESSO.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and
cause serious side effects.
Especially tell your healthcare provider if you take
other antidepressants, opioids, or Central Nervous System (CNS)
depressants (such as benzodiazepines).
Know the medicines you take. Keep a list of them to show your
healthcare provider and pharmacist when you get a new medicine.
Your healthcare provider will decide if other medicines can be
taken with ZULRESSO.
How will I receive ZULRESSO? ZULRESSO is given to you by
continuous intravenous (IV) infusion into your vein. The infusion
will last for a total of 60 hours (2.5 days).
What should I avoid while receiving ZULRESSO?
- ZULRESSO may make you feel dizzy and sleepy. Do not drive a car
or do other dangerous activities after your ZULRESSO infusion until
your feeling of sleepiness has completely gone away. See “What
is the most important information I should know about
ZULRESSO?”
- Do not drink alcohol while receiving ZULRESSO.
What are the possible side effects of ZULRESSO?
ZULRESSO can cause serious side effects, including:
- See “What is the most important information I should know
about ZULRESSO?”
- Increased risk of suicidal thoughts or actions. ZULRESSO
and other antidepressant medicines may increase suicidal thoughts
and actions in some people 24 years of age and younger. Depression
or other serious mental illnesses are the most important causes of
suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and
actions?
- Pay close attention to any changes,
especially sudden changes in mood, behavior, thoughts, or feelings,
or if you develop suicidal thoughts or actions. - Tell your
healthcare provider right away if you have any new or sudden
changes in mood, behavior, thoughts, or feelings. - Keep all
follow-up visits with your healthcare provider as scheduled. Call
your healthcare provider between visits as needed, especially if
you have concerns about symptoms.
Tell your healthcare provider right away
if you have any of the following symptoms, especially if they are
new, worse, or worry you: - Attempts to commit suicide,
thoughts about suicide or dying, new or worse depression, other
unusual changes in behavior or mood
The most common side effects of ZULRESSO include:
- Sleepiness, dry mouth, passing out, flushing of the skin or
face.
These are not all the side effects of ZULRESSO.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please see Full Prescribing Information
including Boxed Warning and Medication Guide for ZULRESSO and discuss any
questions you may have with your healthcare provider.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200507005952/en/
Investors Jeff Boyle 347-247-5089
jeff.boyle@sagerx.com
Media Maureen L. Suda 617-949-4289
maureen.suda@sagerx.com
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