On track to submit New Drug Application for
brexanolone for postpartum depression in 1H 2018 following pre-NDA
meeting; buildout of commercial infrastructure underway for
potential 1H 2019 launch
Breakthrough Therapy designation for SAGE-217
offers potential for expedited development of major depressive
disorder program
Strong balance sheet of more than $1.0 billion
in cash supports expected pipeline advancement in 2018
Conference call today at 8:00 AM ET
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:
- Phase 1 program for SAGE-324 (1H
2018)
- Phase 1 multiple ascending dose program
of SAGE-718 (1H 2018)
- 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
InformationSage 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 TherapeuticsSage
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
StatementsVarious 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.
Sage Therapeutics, Inc. and
SubsidiariesCondensed Consolidated Balance Sheets(in
thousands)(Unaudited)
December 31, 2017
December 31, 2016
Assets
Current Assets: 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
Liabilities and Stockholders'
Equity
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
Sage Therapeutics, Inc. and
SubsidiariesCondensed Consolidated Statements of
Operations(in thousands, except share and per share
data)(Unaudited)
Three
Months Ended December 31, Year Ended December 31,
2017 2016 2017
2016 Operating expenses: Research and
development $ 50,890 $ 42,004 $ 210,277 $ 120,756 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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version on businesswire.com: http://www.businesswire.com/news/home/20180222005281/en/
Sage TherapeuticsInvestor Contact:Paul Cox,
617-299-8377paul.cox@sagerx.comorMedia Contact:Maureen L.
Suda, 585-355-1134maureen.suda@sagerx.com
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