[February 23, 2017] |
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Sage Therapeutics Announces Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
Sage Therapeutics, Inc. (NASDAQ: SAGE) today reported business
highlights and financial results for the fourth quarter and full year
ended December 31, 2016.
"Sage is continuing its vision to "rethink" the development of
treatments for central nervous system disorders and, in doing so,
attempting to close the innovation gap in an area of disease that
represents approximately one-third of the worldwide burden of illness.
We are now at a point of significant momentum following the pipeline
transformation witnessed in 2016, resulting in at least eight
anticipated data readouts across multiple different mood, movement and
neurological disorders this year, including the results we announced
earlier this month. In addition, plans are underway for our potential
first commercial launch in 2018," said Jeff Jonas, M.D., Chief Executive
Officer of Sage. "We believe that a key element of our success to date
has been our utilization of novel and efficient approaches to
translational science facilitating the discovery and clinical
development of our differentiated investigational medicines. Our new
Experimental Medicine group, led by Jim Doherty, Ph.D., will further
build on this expertise by establishing a translational foundation
across our discovery and clinical programs that we believe will better
position Sage for long-term success."
Recent Corporate Highlights
-
Jim Doherty, Ph.D., promoted to Chief Research Officer: Dr.
Doherty joined Sage in 2012 and most recently served as Senior Vice
President of Research. Before Sage, he served as Director and Head of
the Neuroscience Department for the CNS and Pain Innovative Medicine
Unit of AstraZeneca Pharmaceuticals in Sodertalje, Sweden, and prior
to that, he was Director and Head of the Neuroscience Department at
AstraZeneca Pharmaceuticals in Wilmington, Delaware. He has experience
with discovery, translational science and early development in several
areas of neuroscience research, including psychiatry, neurology,
cognition, epilepsy and analgesia. He has authored more than 30
peer-reviewed research and review articles. Dr. Doherty holds a B.A.
in biology from the University of Delaware and a Ph.D. in neuroscience
from Georgetown University. He was a postdoctoral fellow at Emory
University Medical School.
-
Experimental Medicine group to lead translational neuroscience
strategy: As part of his new role as Chief Research Officer, Dr.
Doherty will build and lead a new Experimental Medicine capability
within Sage. The Experimental Medicine group will have four key goals:
-
Identify functional biomarkers in animals that respond to target
engagement and can be deployed in human clinical trials
-
Identify genetic and biochemical criteria to identify patient
populations to increase the technical probability of success of a
clinical trial
-
Translate insights between compounds and indications for better
odds of success across the pipeline
-
Oversee small, exploratory human studies in new disease areas
-
Patent issued on SAGE-217: Sage was recently granted a patent
by the United States Patent and Trademark Office, patent number
9,512,165, with claims covering the composition of matter of SAGE-217.
-
SAGE-547 receives United States Adopted Name (USAN (News - Alert)), brexanolone:
Sage was recently informed that the USAN Council adopted brexanolone
(pronunciation: brek san' oh lone) as the USAN (nonproprietary or
generic name) for SAGE-547. Brexanolone is also under review as an
international nonproprietary name (INN) by the World Health
Organization (WHO).
Pipeline Update
Sage is advancing a portfolio of novel central nervous system (CNS)
product candidates targeting the GABA and NMDA receptor systems.
Dysfunction in these systems is known to be at the core of numerous
psychiatric and neurological disorders. Sage is pursuing a data-driven
approach to CNS drug development by employing efficient human
proof-of-concept studies to uncover both activity signals and to help
understand future trial methodology, before investing in larger clinical
programs.
-
Brexanolone (SAGE-547): Sage is currently developing
brexanolone in separate Phase 3 clinical programs as an acute
interventional treatment for super-refractory status epilepticus
(SRSE) and postpartum depression (PPD). Brexanolone is Sage's
proprietary IV formulation of allopregnanolone, a naturally occurring
neuroactive steroid that acts as a synaptic and extrasynaptic
modulator of the GABAA receptor.
-
SRSE: Sage is evaluating brexanolone (SAGE-547) in the
Phase 3 STATUS
Trial, a global, randomized, double-blind, placebo-controlled
trial, designed to evaluate brexanolone as a potential adjunctive
therapy for SRSE, a rare and life-altering seizure condition. The
Phase 3 clinical program is being conducted in agreement with the
U.S. Food and Drug Administration (FDA) under a Special Protocol
Assessment (SPA). Sage also received positive scientific advice in
the fourth quarter of 2016 from the European Medicines Agency
(EMA (News - Alert)). Based on this advice, the Company believes the Phase 3
clinical program, if successful, will be sufficient to support a
marketing authorization application (MAA) to the EMA seeking
approval of brexanolone for SRSE in the EU.
-
PPD: Sage is currently enrolling its Phase 3 clinical
program evaluating brexanolone (SAGE-547) as a potential treatment
for PPD, consisting of separate placebo-controlled trials in
severe PPD patients (202B)
and in moderate PPD patients (202C),
collectively known as the Hummingbird
Study. In 2016, the FDA granted Breakthrough Therapy
Designation and the EMA granted PRIority MEdicines (PRIME)
designation to brexanolone for the treatment of PPD.
-
SAGE-217: Sage's most advanced, next-generation
product candidate is SAGE-217, a novel, orally-active neuroactive
steroid that, like brexanolone (SAGE-547), is a positive allosteric
modulator of GABAA receptors, targeting both synaptic and
extrasynaptic GABAA receptors. In the fourth quarter of
2016, Sage initiated Phase 2 development for SAGE-217 in both mood and
movement disorders, with four Phase 2 clinical programs now underway.
-
Mood Disorders:
-
Major Depressive Disorder (MDD): Earlier this month,
Sage reported positive clinical results from Part A of a
two-part Phase 2 clinical trial evaluating the safety,
tolerability, pharmacokinetics and efficacy of SAGE-217 in
patients with moderate to severe MDD. Part A of the Phase 2
trial was an open-label study evaluating SAGE-217 in 13
patients. The primary endpoint for the Part A study was to
evaluate the safety and tolerability of SAGE-217. The
secondary endpoint was to evaluate the effect of SAGE-217
compared to baseline following two weeks of once-nightly
treatment as measured by the HAM-D total score. The Part B
phase, a randomized, double-blind, parallel-group,
placebo-controlled study evaluating SAGE-217 as a treatment
for MDD, is expected to be initiated in the first half of 2017.
-
PPD: Sage is currently enrolling its Phase 2 clinical
trial of SAGE-217 in PPD based on positive results to date
from the brexanolone (SAGE-547) PPD clinical program. The
Phase 2a multi-center, double-blind, placebo-controlled,
randomized trial will evaluate the efficacy, safety,
tolerability, and pharmacokinetics of SAGE-217 in the
treatment of patients with severe PPD. Top-line results from
the PPD study are expected in the second half of 2017.
-
Movement Disorders:
-
Essential tremor: Sage is currently enrolling its Phase
2 clinical trial of SAGE-217 in essential tremor. The
efficacy, safety, tolerability, and pharmacokinetics of
SAGE-217 are being evaluated in the Phase 2a multi-center,
double-blind, placebo-controlled, randomized withdrawal trial
in the treatment of patients with essential tremor. Top-line
results from the essential tremor study are expected in the
second half of 2017.
-
Parkinson's disease: Sage is currently enrolling Part A
of a two-part Phase 2 clinical trial of SAGE-217 in
Parkinson's disease. Part A of the Phase 2 trial is an
open-label, proof-of-concept study which, if positive, may
lead to a randomized, placebo-controlled Part B of the Phase 2
trial. Top-line results from the Part A study are expected in
the first half of 2017.
-
Other GABA Programs: Sage is currently evaluating a series of
novel GABA modulators in pre-clinical development, including SAGE-105,
SAGE-324 and SAGE-689. Sage recently initiated IND-enabling studies of
SAGE-105 and SAGE-324, which are novel, orally-active next-generation
GABA modulators that are intended to be developed for GABA-related
indications, such as orphan epilepsies and other disorders involving
GABA hypofunction.
-
NMDA: Sage is also developing novel compounds that target the
NMDA receptor. The first product candidate selected for development
from this program is SAGE-718, an oxysterol-based NMDA positive
allosteric modulator. Our initial focus for development of SAGE-718 is
on cerebrosterol deficit disorders, anti-NMDA receptor encephalitis,
and other indications involving NMDA hypofunction. SAGE-718 has
completed IND-enabling studies and Sage expects to initiate Phase 1
clinical development for SAGE-718 in the first half of 2017.
Expected Near-Term Clinical Milestones
-
Trial Initiations:
-
Part B of Phase 2 trial of SAGE-217 in MDD (1H 2017)
-
Phase 1 program of first NMDA candidate, SAGE-718 (1H 2017)
-
Top-Line Data Readouts:
-
Phase 3 STATUS Trial of brexanolone (SAGE-547) in SRSE (1H 2017)
-
Part A open-label portion of Phase 2 trial of SAGE-217 in
Parkinson's disease (1H 2017)
-
Phase 3 trial (202B) of brexanolone (SAGE-547) in PPD (2H 2017)
-
Phase 3 trial (202C) of brexanolone (SAGE-547) in PPD (2H 2017)
-
Phase 2 trial of SAGE-217 in essential tremor (2H 2017)
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Phase 2 trial of SAGE-217 in PPD (2H 2017)
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Phase 1 single-ascending dose (SAD) trial of SAGE-718 (2H 2017)
Financial Results for the Fourth Quarter and
Full Year 2016
-
Cash Position: Cash, cash equivalents and marketable securities
as of December 31, 2016 were $397.5 million, compared with $186.8
million at December 31, 2015.
-
R&D Expenses: Research and development expenses were $42.0
million, including $5.0 million of non-cash stock-based compensation
expense, in the fourth quarter of 2016, compared to $20.4 million,
including $1.6 million of non-cash stock-based compensation expense,
for the same period of 2015. For the year ended December 31, 2016,
research and development expenses were $120.8 million, including $11.2
million of non-cash stock-based compensation expense, compared to
$69.4 million, including $5.9 million of non-cash stock-based
compensation expense, for the same period of 2015. The increase in R&D
expenses year-over-year was primarily due to the ongoing clinical
development of brexanolone (SAGE-547) in SRSE and PPD; completion of
Phase 1 development for SAGE-217; initiation of the Phase 2 clinical
programs for SAGE-217; the ongoing IND-enabling studies for SAGE-718;
and investments in R&D headcount to support the growth in Sage's
pipeline and operations.
-
G&A Expenses: General and administrative expenses were
$14.4 million, including $5.1 million of non-cash stock-based
compensation expense, in the fourth quarter of 2016, compared to $8.2
million, including $2.5 million of non-cash stock-based compensation
expense, for the same period of 2015. For the year ended December 31,
2016, general and administrative expenses were $39.4 million,
including $11.8 million of non-cash stock-based compensation expense,
compared to $25.3 million, including $9.3 million of non-cash
stock-based compensation expense, for the same period of 2015. The
increase in G&A expenses year-over-year was primarily due to the
increase in personnel-related expenses, professional fees and
facilities-related costs to support expanding operations, as well as
continued preparations for a potential commercial launch.
-
Net Loss: Net loss was $55.9 million for the fourth quarter of
2016 and $159.0 million for the year ended December 31, 2016, compared
to a net loss of $28.6 million and $94.5 million, respectively, for
the comparable periods of 2015.
-
Financial Guidance: Sage expects that its existing cash, cash
equivalents and marketable securities will fund its anticipated level
of operations, based on its current operating plans, into the second
quarter of 2018.
Conference Call Information Sage
will host a conference call and webcast today at 8:00 AM ET to discuss
its fourth quarter and year-end 2016 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
69937798. 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 clinical-stage biopharmaceutical company committed to
developing novel medicines to transform the lives of patients with
life-altering central nervous system (CNS) disorders. Sage has a
portfolio of novel product candidates targeting critical CNS receptor
systems, GABA and NMDA. Sage's lead program, brexanolone (SAGE-547), is
in Phase 3 clinical development for super-refractory status epilepticus,
a rare and severe seizure disorder, and for postpartum depression. Sage
is developing its next generation modulators, including SAGE-217 and
SAGE-718, with a focus on acute and chronic CNS disorders. 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 expectations for 2017; our
expectations regarding development of our product candidates and their
potential in the treatment of various CNS disorders; the expected timing
of initiation and completion of clinical trials; the anticipated
availability and announcement of data and results from clinical trials
of our product candidates; our goals and expectations with respect to
our discovery and translational science efforts; our plans for
evaluation of new indications and new compounds; our expectations
regarding the regulatory pathway for brexanolone (SAGE-547) in the
treatment of SRSE in the EU, and our belief that the results of the
current development program for brexanolone in SRSE, if successful, will
be sufficient for an MAA filing in the EU; our expectations regarding a
potential future NDA filing and commercial launch of brexanolone, if
successfully developed and approved; and our expectations with respect
to future cash use and cash needs. 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 continue to experience slower than expected
enrollment and randomization of evaluable patients in the STATUS trial
or slower than expected clinical site initiation and enrollment in our
other clinical trials, or the potential need for additional analysis or
data or the need to enroll additional patients, leading to possible
delays in completion of trials or in the availability of data; we may
not be able to generate supportive non-clinical data or to successfully
demonstrate the efficacy and safety of our product candidates at each
stage of clinical development; success in our non-clinical studies or in
earlier stage clinical trials may not be repeated or observed in ongoing
or future studies involving the same compound or other product
candidates, and ongoing and future pre-clinical and clinical results may
not support further development of product candidates or be sufficient
to gain regulatory approval to launch and commercialize any product;
decisions or actions of regulatory agencies may affect the initiation,
timing, progress and cost of clinical trials, and our ability to proceed
with further clinical studies of a product candidate or to obtain
marketing approval, including the risk that the EMA may, despite
scientific advice, decide that the data from our Phase 3 trial in SRSE
are not sufficient to support approval; the internal and external costs
required for our activities, and to build our organization in connection
with such activities, and the resulting 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 development and
manufacture of our products which may delay our timing or increase our
expenses and use of cash, 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.
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Sage Therapeutics, Inc. and Subsidiaries
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Condensed Consolidated Balance Sheets
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(in thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
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December 31, 2016
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December 31, 2015
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Assets
|
|
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|
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|
|
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Current Assets:
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|
|
|
|
|
|
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Cash and cash equivalents
|
|
|
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$
|
168,517
|
|
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$
|
186,753
|
Marketable securities
|
|
|
|
|
228,962
|
|
|
|
-
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Prepaid expenses and other current assets
|
|
|
|
|
5,100
|
|
|
|
1,738
|
Total current assets
|
|
|
|
|
402,579
|
|
|
|
188,491
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Property and equipment and other long-term assets
|
|
|
|
|
1,952
|
|
|
|
525
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Total assets
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|
|
|
$
|
404,531
|
|
|
$
|
189,016
|
|
|
|
|
|
|
|
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Liabilities and Stockholders' Equity
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|
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|
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|
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Current Liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
$
|
12,817
|
|
|
$
|
5,159
|
Accrued expenses
|
|
|
|
|
22,352
|
|
|
|
10,148
|
Total current liabilities
|
|
|
|
|
35,169
|
|
|
|
15,307
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Other liabilities
|
|
|
|
|
845
|
|
|
|
14
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Total liabilities
|
|
|
|
|
36,014
|
|
|
|
15,321
|
Total stockholders' equity
|
|
|
|
|
368,517
|
|
|
|
173,695
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
404,531
|
|
|
$
|
189,016
|
|
|
|
|
|
|
|
|
|
|
Sage Therapeutics, Inc. and Subsidiaries
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Condensed Consolidated Statements of Operations
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(in thousands, except share and per share data)
|
(unaudited)
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Year Ended December 31,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$
|
42,004
|
|
|
|
$
|
20,376
|
|
|
|
$
|
120,756
|
|
|
|
$
|
69,357
|
|
General and administrative
|
|
|
|
|
14,375
|
|
|
|
|
8,236
|
|
|
|
|
39,407
|
|
|
|
|
25,293
|
|
Total operating expenses
|
|
|
|
|
56,379
|
|
|
|
|
28,612
|
|
|
|
|
160,163
|
|
|
|
|
94,650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Loss from operations
|
|
|
|
|
(56,379
|
)
|
|
|
|
(28,612
|
)
|
|
|
|
(160,163
|
)
|
|
|
|
(94,650
|
)
|
Interest income, net
|
|
|
|
|
494
|
|
|
|
|
63
|
|
|
|
|
1,211
|
|
|
|
|
178
|
|
Other expense, net
|
|
|
|
|
(16
|
)
|
|
|
|
(13
|
)
|
|
|
|
(35
|
)
|
|
|
|
(23
|
)
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Net loss
|
|
|
|
$
|
(55,901
|
)
|
|
|
$
|
(28,562
|
)
|
|
|
$
|
(158,987
|
)
|
|
|
$
|
(94,495
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)
|
Net loss per share - basic and diluted
|
|
|
|
$
|
(1.50
|
)
|
|
|
$
|
(0.99
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)
|
|
|
$
|
(4.75
|
)
|
|
|
$
|
(3.40
|
)
|
Weighted average shares outstanding - basic and diluted
|
|
|
|
|
37,198,631
|
|
|
|
|
28,810,565
|
|
|
|
|
33,492,795
|
|
|
|
|
27,778,288
|
|
|
|
|
|
|
|
|
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|
|
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