[May 05, 2016] |
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Sage Therapeutics Announces First Quarter 2016 Financial Results
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 first quarter ended
March 31, 2016.
"We began 2016 with a clear focus on execution across our pipeline, and
continued expansion of our expertise and infrastructure through
strategic hires across key functions that support our goal of becoming a
fully integrated biopharmaceutical company," said Jeff Jonas, M.D.,
Chief Executive Officer of Sage. "In the near-term, anticipated data
readouts during the second quarter will inform our plans for Phase 2
trials of SAGE-217. These plans include potential trials in essential
tremor and orphan epilepsies, assuming a positive readout from the Phase
1 clinical program, and a potential Phase 2 clinical trial of SAGE-217
in severe postpartum depression (PPD) if the ongoing SAGE-547
proof-of-concept trial in severe PPD validates the potential for the
GABA mechanism of action in this indication. Later this year, we
anticipate providing top-line results from the Phase 3 STATUS Trial of
SAGE-547 in super-refractory status epilepticus (SRSE), and the
groundwork is being laid for a potential commercial launch assuming
positive data outcomes and regulatory approval."
Recent Highlights
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In January 2016, Sage raised approximately $140.4 million in net
proceeds, after underwriters' discounts and commissions and offering
expenses, through a follow-on public offering of 3,157,894 shares of
its common stock at a price of $47.50 per share.
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Sage presented data from five abstracts at the 68th American
Academy of Neurology (AAN) Annual Meeting on April 15-21, 2016
in Vancouver, Canada, including an oral platform presentation:
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Presented detailed data regarding effects of underlying disorders, and
treatment approaches from the open-label Phase 1/2 study of SAGE-547
in SRSE in a peer-reviewed setting for first time.
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Demonstrated that the key efficacy endpoint response rate in the Phase
1/2 SRSE study was not related to age, gender, ethnicity, co-morbid
medical condition, underlying medical condition, or previous
antiepileptic or third line agent treatment; identified additional
treatment characteristics subsequently incorporated into the Phase 3
STATUS Trial protocol.
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Identified an exploratory pharmacodynamic biomarker that was
significantly correlated with the plasma concentration of SAGE-547
during Phase 1/2 study.
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Estimated the health economic burden of illness of SRSE in the U.S.
through analysis of cases classified as SRSE using a treatment
algorithm applied to a database of certain patient-level demographics
and resource utilization data from 2012, highlighting significant
morbidity, lengthy hospitalizations and significant utilization of ICU
and overall hospital resources.
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Presented data from a proof-of-concept study using SAGE-547 in 25
patients to evaluate the GABA mechanism as a potential treatment for
essential tremor, and informing assessment and statistical methodology
for the anticipated Phase 2 trial with next-generation GABAA modulator,
SAGE-217, later this year.
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In April 2016, Sage was awarded Most Innovative Clinical Trial Design
for the Phase 1/2 clinical trial of SAGE-547 in SRSE at Informa's (News - Alert) 1st
Annual Clinical & Research Excellence (CARE) Awards. Sage was a
finalist in three award categories.
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Sage was announced as a finalist for the Most Valuable HCP or
Healthcare Initiative for the Phase 3 STATUS Trial app at the 2nd
Annual eyeforpharma Philadelphia Awards 2016.
Upcoming Milestones
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Upcoming data presentations at the Society of Biological Psychiatry
(SOBP) 71st Annual Scientific Meeting on May 12-14 in Atlanta, GA.
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Detailed data from the open-label, proof-of-concept study for SAGE-547
in four PPD patients.
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Late-breaking abstract highlighting pre-clinical data from the first
NMDA positive allosteric modulator candidate, SAGE-718, showing
effects in established animal models of psychosis and cerebrosterol
deficit disorders.
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Top-line results for the Phase 2 placebo-controlled, proof-of-concept
clinical trial of SAGE-547 in severe PPD is expected during the second
quarter of 2016.
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Top-line results for the Phase 1 clinical program of SAGE-217 is
expected during the second quarter of 2016.
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Top-line results for the Phase 3 STATUS Trial of SAGE-547 in SRSE is
expected during the second half of 2016.
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Phase 2 clinical trial initiations for SAGE-217 in at least two
indications, among essential tremor, orphan epilepsies and possibly,
severe PPD, planned for the second half of 2016, assuming successful
completion of Phase 1 and, in the case of severe PPD, positive data
from the ongoing SAGE-547 proof-of-concept trial.
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Initiation of the Phase 1 development program for SAGE-689, a next
generation positive allosteric modulator of GABAA receptors,
expected during the second half of 2016, assuming additional
non-clinical data is satisfactory to the FDA.
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Clinical development with the first NMDA candidate, SAGE-718, planned
to begin in 2017.
Upcoming Events and Presentations
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Society of Biological Psychiatry 71st Annual Scientific Meeting, Atlanta,
May 12-14
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2nd Congress of the European Academy of
Neurology (EAN), Copenhagen, May 28-May 31
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American Society of Clinical Psychopharmacology (ASCP) 2016 Annual
Meeting, Scottsdale, May 30-June 3
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Goldman Sachs Global Healthcare Conference, Rancho Palos
Verdes, June 7-9
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Eilat Conference on New Antiepileptic Drugs (Eilat XIII), Madrid,
June 26-29
First Quarter 2016 Financial Results
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Cash Position: Cash and cash equivalents as of March 31, 2016
were $299.7 million, compared with $186.8 million at December 31,
2015. In January 2016, Sage completed an underwritten public offering
resulting in net proceeds of $140.4 million.
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R&D Expenses: Research and development expenses in the
first quarter of 2016 were $23.6 million, including $1.6 million of
non-cash stock-based compensation expense, compared to $12.9 million,
including $0.5 million of non-cash stock-based compensation expense,
for the same period of 2015. The increase in R&D expense was primarily
due to increased spending on clinical activities related to the
continued advancement of the SAGE-547 Phase 3 development program, the
Phase 2 proof-of-concept trial of SAGE-547 in severe PPD, and the
SAGE-217 Phase 1 development program; increased personnel-related R&D
expenses supporting the advancement of Sage's pipeline of product
candidates; and increased non-cash stock-based compensation expense.
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G&A Expenses: General and administrative expenses in the
first quarter of 2016 were $7.1 million, including $2.1 million of
non-cash stock-based compensation expense, compared to $4.0 million,
including $0.8 million of non-cash stock-based compensation expense,
for the same period of 2015. The increase in G&A expenses was
primarily due to an increase in personnel-related costs to support
general operations.
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Net Loss: Net loss was $30.5 million for the first quarter of
2016 compared to net loss of $16.9 million for the same period of 2015.
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Financial Guidance: Sage reiterates its expectation that its
existing cash and cash equivalents will be sufficient to fund
operations into the beginning of 2018 based on its current operating
plans.
Conference Call Information
SAGE will host a conference call and webcast today at 4:30 PM ET to
discuss its first quarter 2016 financial results and recent business
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
99951496. 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, SAGE-547, is in
Phase 3 clinical development for super-refractory status epilepticus, a
rare and severe seizure disorder. Sage is developing its next generation
modulators, including SAGE-217, SAGE-689 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 concerning Sage's future
expectations, plans and prospects, including without limitation, our
expectations regarding development of our product candidates and their
potential in the treatment of various CNS disorders; the expected timing
of clinical activities; the anticipated availability and announcement of
data and results from clinical trials of our product candidates;
estimates as to burden of illness of SRSE; and our expectations with
respect to our use of cash and future 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 experience slower than planned clinical
site initiation, slower than planned identification and enrollment of
evaluable patients, 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 development; success in our non-clinical studies or in early
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 market 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; the
actual size of the patient populations and healthcare costs associated
with the diseases for which we are developing our product candidates may
be significantly lower than our estimates; the internal and external
costs required for our activities, and to build the organization in
connection with such activities, may be higher than expected, or we may
engage in new activities requiring additional expenditures; and we
may encounter technical and other unexpected hurdles in the development
and manufacture of our products, as well as those risks more fully
discussed in the section entitled "Risk Factors" in our most recent
Annual Report on Form 10-K, 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 Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
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March 31, 2016
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December 31, 2015
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Assets
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Current Assets:
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Cash and cash equivalents
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$
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299,680
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$
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186,753
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Prepaid expenses and other current assets
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2,926
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1,738
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Total current assets
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302,606
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188,491
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Property and equipment and other long-term assets
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904
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525
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Total assets
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$
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303,510
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$
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189,016
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Liabilities and Stockholders' Equity
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Current Liabilities:
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Accounts payable
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$
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4,540
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$
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5,159
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Accrued expenses
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11,430
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10,148
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Total current liabilities
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15,970
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15,307
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Other liabilities
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40
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14
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Total liabilities
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16,010
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15,321
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Total Stockholders' Equity
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287,500
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173,695
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Total liabilities and stockholders' equity
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$
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303,510
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$
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189,016
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Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Statements of Operations and Comprehensive Loss (in
thousands, except share and per share data) (unaudited)
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Three Months Ended March 31,
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2016
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2015
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Operating expenses:
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Research and development
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$
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23,581
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$
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12,900
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General and administrative
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7,133
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3,997
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Total operating expenses
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30,714
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16,897
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Loss from operations
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(30,714
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)
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(16,897
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Interest income, net
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175
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21
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Other income (expense), net
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(4
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5
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Net loss and comprehensive loss
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$
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(30,543
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)
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$
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(16,871
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Net loss per share - basic and diluted
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$
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(0.97
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)
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$
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(0.66
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)
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Weighted-average shares outstanding - basic and diluted
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31,643,216
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25,655,883
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