[February 22, 2018] |
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Sage Therapeutics Announces Fourth Quarter and Full Year 2017 Financial Results and Provides Pipeline Update
Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today reported
business highlights and financial results for the fourth quarter and
full year ended December 31, 2017.
"By thinking differently about CNS, Sage has accelerated innovation
across the development cycle, from discovery through development, and is
now progressing toward potential commercial operations and patient
care," said Jeff Jonas, M.D., chief executive officer of Sage. "While
our 2017 achievements demonstrate the strength of our R&D organization,
successful execution against our 2018 goals will drive our planned
transition to a commercial company with the opportunity to create a new
standard of care for women with postpartum depression. In addition, our
broad portfolio of fully-owned, internally developed molecules creates
further opportunity to transform the lives of patients with
life-altering CNS disorders and the potential to drive near and
long-term value."
Pipeline Updates
Sage is advancing a portfolio of novel 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.
GABA Programs
Sage is developing its proprietary intravenous (IV) formulation of
brexanolone and a pipeline of novel, next-generation positive allosteric
modulators of synaptic and extra-synaptic GABAA receptors.
-
Brexanolone IV in Postpartum Depression (PPD):
-
Following a pre-NDA meeting with the U.S. Food and Drug
Administration (FDA), Sage remains on track to file a New Drug
Application (NDA) with the FDA in 1H 2018.
-
Sage anticipates presenting detailed study results from the Phase
3 program of brexanolone IV in PPD at upcoming medical meetings
and through publication.
-
SAGE-217 in Major Depressive Disorder (MDD):
-
The FDA recently granted Breakthrough Therapy designation to
SAGE-217 for the treatment of MDD based on the positive results
from the Phase 2, placebo-controlled trial of SAGE-217 in 89 adult
patients with moderate to severe MDD.
-
Sage plans to initiate additional clinical trials of SAGE-217 in
MDD in 2018.
-
SAGE-217 in Postpartum Depression:
-
Sage is currently conducting a multi-center, double-blind,
placebo-controlled, randomized Phase 2 clinical trial of SAGE-217
in severe PPD.
-
Sage believes the positive Phase 2 trial of SAGE-217 in MDD and
positive Phase 3 trials of brexanolone in PPD support maximizing
the utility of the ongoing Phase 2 trial of SAGE-217 in PPD. Sage
increased the size of the ongoing trial and expects top-line
results in 4Q 2018.
-
SAGE-217 in Bipolar Depression, Parkinson's Disease and Insomnia:
-
Sage plans to initiate clinical development of SAGE-217 in bipolar
depression and continue further clinical development of SAGE-217
in Parkinson's disease and disorders of sleep in 2018. Sage
believes that available data from studies of MDD, Parkinson's
disease and a healthy volunteer insomnia model support further
exploration in these indications.
-
SAGE-324:
-
SAGE-324 is currently in IND-enabling studies and is intended to
be developed with a focus on indications involving GABA
hypofunction, such as essential tremor and epileptiform disorders.
-
Sage expects to initiate a Phase 1 trial of SAGE-324 in 1H 2018.
-
GABA Discovery Programs:
-
Sage is currently evaluating a series of novel GABAA
receptor modulators in pre-clinical development, including
SAGE-689, SAGE-105, and others.
NMDA Programs
Sage is developing novel, oral, first-in-class oxysterol-based positive
allosteric modulators of the NMDA receptor, which may have potential in
the treatment of a range of neurological disorders associated with a
variety of cognitive, neurological and behavioral symptoms.
-
SAGE-718:
-
Sage previously announced it completed a Phase 1 single-ascending
dose study of SAGE-718 in healthy volunteers. SAGE-718 was
generally well-tolerated with no severe adverse events. The
pharmacokinetics of SAGE-718 were highly predictable with low
variability.
-
Sage expects to initiate a Phase 1 multiple ascending dose program
of SAGE-718 in 1H 2018.
-
SAGE-904:
-
Sage recently announced it selected SAGE-904 as its second NMDA
receptor positive allosteric modulator product candidate for
development. SAGE-904 has a differentiated pharmacologic and
pharmacokinetic profile from SAGE-718.
-
SAGE-904 is currently in IND-enabling studies.
Expected Milestones
-
Trial Initiations:
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Phase 1 program for SAGE-324 (1H 2018)
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Phase 1 multiple ascending dose program of SAGE-718 (1H 2018)
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Trials of SAGE-217 in MDD, bipolar depression, Parkinson's
disease, and sleep disorders (2018)
-
Data Readouts:
-
Results from Phase 1 multiple ascending dose program of SAGE-718
(2H 2018)
-
Results from recently expanded Phase 2 trial of SAGE-217 in PPD
(4Q 2018)
-
Results from trials of SAGE-217 in MDD, bipolar depression,
Parkinson's disease, and sleep disorders (2018-2019)
-
Regulatory and Commercial:
-
NDA filing in U.S. for brexanolone in PPD (1H 2018)
-
Brexanolone commercial launch in PPD, if approved (1H 2019)
Financial Results for the Fourth Quarter and
Full Year 2017
"Sage has a track-record of executing with a very deliberate R&D
strategy and a disciplined investment philosophy," said Kimi Iguchi,
chief financial officer of Sage. "Our robust balance sheet and strategic
approach to spending facilitate the continued expansion of our
commercial, manufacturing, quality, and medical affairs capabilities as
part of our planned transition to a fully integrated biopharmaceutical
company and enable the continued development of Sage's broad CNS
pipeline."
-
Cash Position: Cash, cash equivalents, and marketable
securities as of December 31, 2017 were $518.8 million, compared with
$397.5 million at December 31, 2016. The increase was primarily due to
net proceeds of $325.8 million from Sage's follow-on public offering
completed in November 2017. In February 2018, Sage completed an
underwritten public offering, which included the full exercise of the
underwriters' option to purchase additional shares, resulting in net
proceeds of approximately $631.1 million.
-
R&D Expenses: Research and development expenses were $50.9
million, including $5.7 million of non-cash stock-based compensation
expense, in the fourth quarter of 2017, compared to $42.0 million,
including $5.0 million of non-cash stock-based compensation expense,
for the same period of 2016. For the year ended December 31, 2017,
research and development expenses were $210.3 million, including $19.9
million of non-cash stock-based compensation expense, compared to
$120.8 million, including $11.2 million of non-cash stock-based
compensation expense, for the same period of 2016. The increase in R&D
expenses year-over-year was primarily due to Phase 3 clinical
development of brexanolone and CMC work in preparation for a potential
filing for regulatory approval; the ongoing Phase 2 development of
SAGE-217; ongoing early-stage R&D programs and discovery efforts
focused on identifying new development candidates and additional
indications of interest; and investments in R&D headcount to support
the growth in Sage's pipeline and operations.
-
G&A Expenses: General and administrative expenses were
$19.6 million, including $4.6 million of non-cash stock-based
compensation expense, in the fourth quarter of 2017, compared to $14.4
million, including $5.1 million of non-cash stock-based compensation
expense, for the same period of 2016. For the year ended December 31,
2017, G&A expenses were $62.9 million, including $15.6 million of
non-cash stock-based compensation expense, compared to $39.4 million,
including $11.8 million of non-cash stock-based compensation expense,
for the same period of 2016. The increase in G&A expenses was
primarily due to the increase in personnel-related expenses,
professional fees to support expanding operations, costs related to
continued preparations for a potential commercial launch, and
facilities-related costs to support expanding operations.
-
Net Loss: Net loss was $69.4 million for the fourth quarter of
2017 and $270.1 million for the year ended December 31, 2017, compared
to a net loss of $55.9 million and $159.0 million, respectively, for
the comparable periods of 2016.
2018 Financial Guidance
-
Based upon its current operating plan, Sage anticipates that its
existing cash, cash equivalents and marketable securities, and
estimated brexanolone product sales, if the product is approved, will
enable Sage to fund its operating expenses and capital expenditure
requirements into 2020.
-
Sage expects that its operating expenses will increase year over year
in 2018 to support continued pipeline advancement and potential
product commercialization of brexanolone in PPD.
Conference Call Information Sage
will host a conference call and webcast today at 8:00 AM ET to discuss
its fourth quarter and full year 2017 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 6272049. 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, a proprietary IV
formulation of brexanolone (SAGE-547), has completed Phase 3 clinical
development for postpartum depression. Sage is developing its next
generation modulators, including SAGE-217 and SAGE-718, in various 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 regarding the
timing of a potential NDA filing and launch of our proprietary
formulation of brexanolone in PPD, and the expected build of commercial
infrastructure; our statements regarding plans and timelines for further
development of SAGE-217 and our other product candidates and related
activities and our view of the potential for successful development; our
statements as to the potential for expedited development for SAGE-217 in
MDD as a result of the Breakthrough Therapy designation; our views as to
the opportunity represented by Sage's portfolio and business, and the
potential for value creation; and our expectations with respect to
future use of cash. 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: the clinical and non-clinical data we have generated with
our proprietary formulation of brexanolone to date may be determined by
regulatory authorities, despite prior advice, to be insufficient to file
for or gain regulatory approval to launch and commercialize our product
in PPD and regulatory authorities may determine that additional trials
or data are necessary in order to file for or obtain approval;
regulatory authorities may find fault with the data generated at
particular clinical site or sites or with the activities of our trial
monitor or may disagree with our analyses of the results of our trials
or identify issues with our manufacturing or quality systems, and any
such findings or issues could require additional data or analyses or
changes to our systems that could delay or prevent us from gaining
approval of brexanolone IV; we may encounter unexpected safety or
tolerability issues with brexanolone IV, SAGE-217 or any of our other
product candidates in ongoing or future development; we may not be able
to successfully demonstrate the efficacy and safety of SAGE-217 or any
of our other product candidates at each stage of development; success in
early stage clinical trials may not be repeated or observed in ongoing
or future studies of SAGE-217 or any of our other product candidates;
ongoing and future clinical results may not support further development
or be sufficient to gain regulatory approval to market SAGE-217 or any
of our other 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;
we may not achieve expedited development or review of SAGE-217 as a
result of the Breakthrough Therapy designation; decisions or actions of
the FDA or other regulatory agencies may affect the initiation, timing,
design, size, progress and cost of clinical trials and our ability to
proceed with further development; we may experience slower than expected
enrollment in ongoing clinical trials; 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 product candidates; as well as those risks more fully
discussed in the section entitled "Risk Factors" in our most recent
Quarterly Report on Form 10-Q and Annual Report on Form 10-K, and
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 Condensed
Consolidated Balance Sheets (in thousands) (Unaudited)
|
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|
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|
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December 31, 2017
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December 31, 2016
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Assets
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Current Assets:
|
|
|
|
|
|
|
|
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Cash and cash equivalents
|
|
|
|
|
|
$
|
306,235
|
|
|
|
$
|
168,517
|
Marketable securities
|
|
|
|
|
|
|
212,613
|
|
|
|
|
228,962
|
Prepaid expenses and other current assets
|
|
|
|
|
|
|
6,227
|
|
|
|
|
5,100
|
Total current assets
|
|
|
|
|
|
|
525,075
|
|
|
|
|
402,579
|
Property and equipment and other long-term assets
|
|
|
|
|
|
|
4,862
|
|
|
|
|
1,952
|
Total assets
|
|
|
|
|
|
$
|
529,937
|
|
|
|
$
|
404,531
|
|
|
|
|
|
|
|
|
|
|
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Liabilities and Stockholders' Equity
|
|
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|
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Current Liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
|
$
|
9,350
|
|
|
|
$
|
12,817
|
Accrued expenses
|
|
|
|
|
|
|
42,601
|
|
|
|
|
22,352
|
Total current liabilities
|
|
|
|
|
|
|
51,951
|
|
|
|
|
35,169
|
Other liabilities
|
|
|
|
|
|
|
2,511
|
|
|
|
|
845
|
Total liabilities
|
|
|
|
|
|
|
54,462
|
|
|
|
|
36,014
|
Total stockholders' equity
|
|
|
|
|
|
|
475,475
|
|
|
|
|
368,517
|
Total liabilities and stockholders' equity
|
|
|
|
|
|
$
|
529,937
|
|
|
|
$
|
404,531
|
|
|
|
|
|
|
|
|
|
|
|
|
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Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Statements of Operations (in thousands,
except share and per share data) (Unaudited)
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Three Months Ended December 31,
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Year Ended December 31,
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|
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2017
|
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|
2016
|
|
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2017
|
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2016
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development
|
|
|
|
$
|
50,890
|
|
|
$
|
42,004
|
|
|
|
|
$
|
210,277
|
|
|
$
|
120,756
|
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General and administrative
|
|
|
|
|
19,558
|
|
|
|
14,375
|
|
|
|
|
|
62,878
|
|
|
|
39,407
|
|
Total operating expenses
|
|
|
|
|
70,448
|
|
|
|
56,379
|
|
|
|
|
|
273,155
|
|
|
|
160,163
|
|
Loss from operations
|
|
|
|
|
(70,448
|
)
|
|
|
(56,379
|
)
|
|
|
|
|
(273,155
|
)
|
|
|
(160,163
|
)
|
Interest income, net
|
|
|
|
|
1,042
|
|
|
|
494
|
|
|
|
|
|
3,099
|
|
|
|
1,211
|
|
Other expense, net
|
|
|
|
|
(15
|
)
|
|
|
(16
|
)
|
|
|
|
|
(64
|
)
|
|
|
(35
|
)
|
Net loss
|
|
|
|
$
|
(69,421
|
)
|
|
$
|
(55,901
|
)
|
|
|
|
$
|
(270,120
|
)
|
|
$
|
(158,987
|
)
|
Net loss per share - basic and diluted
|
|
|
|
$
|
(1.75
|
)
|
|
$
|
(1.50
|
)
|
|
|
|
$
|
(7.09
|
)
|
|
$
|
(4.75
|
)
|
Weighted average shares outstanding - basic and diluted
|
|
|
|
|
39,583,004
|
|
|
|
37,198,631
|
|
|
|
|
|
38,113,678
|
|
|
|
33,492,795
|
|
|
|
|
|
|
|
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