Conditional acceptance granted by U.S. Food and
Drug Administration (FDA) for the proprietary name ZULRESSO™ for
Sage’s intravenous formulation of brexanolone
Continuing to execute commercial build and
launch readiness for ZULRESSO™ (brexanolone injection) in
postpartum depression ahead of PDUFA target date of December 19,
2018
Accelerating breakthrough pivotal program for
SAGE-217 in depression with key trial milestones expected in 4Q
2018
Progressed clinical pipeline with SAGE-718
Phase 1 multiple ascending dose and SAGE-324 Phase 1 single
ascending dose trial initiations and planned SAGE-217 Phase 2 trial
initiation in bipolar depression
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
second quarter ended June 30, 2018.
“This quarter we continued to make great
progress on our journey to become a multinational biotech company,”
said Jeff Jonas, M.D., chief executive officer of Sage. “This was
underscored by the regulatory milestones and commercial launch
readiness activities in support of ZULRESSO™ (brexanolone
injection), the initiation of our strategic collaboration with
Shionogi on the development and commercialization of SAGE-217 in
key Asian markets, and the ongoing advancement of our early stage
drug candidates, SAGE-718 and SAGE-324, into new Phase 1 clinical
studies. With the upcoming potential approval and launch of
ZULRESSO, we remain focused in our approach to forge news paths for
the treatments of CNS disorders.”
ZULRESSO Regulatory,
Commercial and Pre-Launch Activities Updates:
- The FDA has conditionally accepted the
proprietary name ZULRESSO for Sage’s intravenous (IV) formulation
of brexanolone;
- Sage’s New Drug Application for
ZULRESSO for the treatment of PPD was accepted for Priority Review
by the FDA. The FDA has assigned a Prescription Drug User Fee Act
(PDUFA) target date of December 19, 2018, and is planning to hold
an Advisory Committee meeting to discuss the ZULRESSO application
on November 2, 2018, consistent with FDA’s policy to seek advice on
new medicines with a new mechanism of action for a new
indication;
- Sage continues with preparations for a
potential 1H 2019 commercial launch of ZULRESSO for the treatment
of PPD, if the NDA is approved, including:
- Advancing development of a
family-centric site of care strategy for PPD patients with
potential options ranging from the in-patient hospital setting,
supervised home care, and alternate sites of care, subject to FDA
approval of each option and agreement on the final ZULRESSO
label;
- Partnering with Lash Group, a part of
AmerisourceBergen, to establish a robust patient support model
leveraging innovative technologies coupled with Sage-led case
management support for PPD patients, and completing preparations
for the opening of Sage’s National Patient Support Center in
Raleigh, North Carolina this fall;
- Continuing expansion of the commercial
organization, including considerable progress in the build of the
field team;
- Engaging in permitted discussions with
payers to raise awareness of PPD and on the value proposition of
the ZULRESSO product profile, conducting over 100 customer meetings
and having met with all National Payer Accounts.
- Sage presented a systematic literature
review on the humanistic burden of PPD at the 23rd Annual
International Society for Pharmacoeconomics and Outcomes Research
(ISPOR) Meeting. The review concluded that there is a considerable
body of literature suggesting that PPD has a substantial humanistic
burden on affected mothers as well as their children and families,
including impaired mother-infant bonding, lower rates of
breastfeeding, and the potential for significant long-term impact
on the physical and mental development of children. To further
understand real-world burdens of PPD, Sage has partnered with the
PatientsLikeMe patient network;
- Sage is also working with top U.S.
health economists on the value assessment of ZULRESSO as part of
broader health economics and outcomes research initiatives.
Pipeline
Updates:Beyond ZULRESSO, 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.
- SAGE-217 in Major Depressive Disorder
(MDD) and PPD:
- In June, Sage received support from the
FDA on an expedited pivotal development plan evaluating the novel
concept of episodic dosing using a short course treatment of
SAGE-217 in both MDD and PPD.
- Sage plans to initiate a Phase 3
placebo-controlled trial of SAGE-217 in MDD in 4Q 2018. The trial
will evaluate two weeks of 20mg or 30mg SAGE-217 treatment compared
to placebo in 450 patients with MDD, with four weeks of additional
follow-up.
- Sage is also evaluating SAGE-217 in a
Phase 3 placebo-controlled trial in 140 patients with PPD, and
plans to announce top-line results in 4Q 2018.
- Additional data regarding patient
safety and potential treatment of recurrent or new major depressive
episodes will be acquired through a long-term open-label study
program in which approximately 300 patients will be followed for
six months and 100 patients will be followed for a year after
initial SAGE-217 treatment and episodic retreatment as needed.
- In June, Sage entered into a strategic
collaboration with Shionogi & Co., Ltd. for the clinical
development and commercialization of SAGE-217 for the treatment of
MDD and other indications in Japan, Taiwan and South Korea.
- SAGE-217 in Other Psychiatric
Indications:
- Bipolar depression: Sage plans to
initiate a two-part Phase 2 trial initially evaluating four weeks
of open-label SAGE-217 treatment in up to 30 patients with bipolar
I/II disorder with a current major depressive episode. If
warranted, the study will progress to a randomized,
placebo-controlled study. The trial is intended to evaluate the
safety and tolerability of SAGE-217 (primary endpoint) and
secondary endpoints, including efficacy in improving depressive
symptoms and sleep. Sage plans to initiate this study in 4Q
2018.
- Sleep disorders: Sage recently
announced additional data on key secondary endpoints from a
placebo-controlled trial in a model of insomnia demonstrating an
encouraging impact of SAGE-217 on sleep architecture and that
treatment did not impact next-day cognitive performance. These data
are being planned for presentation at an upcoming medical meeting.
Sage plans to initiate a Phase 3 placebo-controlled polysomnography
trial in MDD patients with co-morbid insomnia in 4Q 2018, and also
plans to seek feedback later this year from the FDA on potential
development plans for SAGE-217 for the treatment of sleep
disorders.
- SAGE-324 in Neurological Indications:
- Sage recently received IND clearance to
initiate a Phase 1 single-ascending dose trial of SAGE-324 in
healthy volunteers. Based on its pre-clinical
pharmacokinetic/pharmacodynamic profile, SAGE-324 may be suitable
for chronic oral dosing, and is being developed as a potential
treatment for patients impacted by neurological conditions, such as
epileptiform disorders, essential tremor, and Parkinson’s disease.
Sage plans to release top-line results from the study, which is
intended to evaluate the safety, tolerability, pharmacokinetic and
pharmacodynamic profile of SAGE-324, in 4Q 2018.
- GABA Discovery Programs:
- Sage continues to evaluate additional
novel GABAA receptor modulators that are currently in pre-clinical
development, including SAGE-689, SAGE-105 and others.
- NMDA Programs:
- SAGE-718: Sage recently initiated a
Phase 1 multiple ascending dose trial of SAGE-718 in healthy
volunteers. Sage plans to release top-line results from the study,
which is intended to further evaluate the safety, tolerability,
pharmacokinetic and pharmacodynamic profile of SAGE-718, in 4Q
2018. If the Phase 1 program is successful, Sage expects to advance
SAGE-718 into clinical trials of certain CNS disorders
characterized by NMDA receptor hypofunction.
- SAGE-904: Sage’s second NMDA positive
allosteric modulator candidate, SAGE-904, is in IND-enabling
studies.
Disease Education
Initiatives:
- Sage is continuing to advance multiple
PPD disease awareness and screening efforts, through initiatives
led by Sage’s Medical Affairs organization. Sage is seeing tangible
signs of progress on these efforts to improve the urgency to manage
PPD, including the American Congress of Obstetricians and
Gynecologists’ (ACOG) Committee Opinion on Redefining the
Postpartum Visit and recommendation on comprehensive maternal
mental care support by Obstetricians/Gynecologists throughout the
fourth trimester of pregnancy. The following initiatives were led
by the Sage Medical Affairs team in the second quarter:
- Launched broad digital disease
awareness campaign and knowppd.com website for healthcare providers
to improve screening and care for PPD patients.
- Conducted live PPD educational symposia
at ACOG, American Psychiatric Association (APA), and Association of
Women's Health, Obstetric and Neonatal Nurses (AWHONN) Annual
Meetings to increase physician and nurse understanding of PPD.
- Supported development and launch of
independent digital medical education programs on screening and
current management of PPD via Medscape and WebMD.
- Continued collaboration with national
and local patient advocacy groups during maternal mental health
month to help reduce stigma of PPD and help patients and families
navigate to care.
- Ongoing, permitted engagement with a
broad number of maternal and psychiatric health centers across the
U.S. to develop in-depth profiles on their respective PPD
healthcare providers, unique management pathways, and unmet
needs.
Expected
Milestones
- Medical Meeting Presentations:
- 24th Congress of the European Sleep
Research Society (ESRS), September 25 – September 28, 2018 in
Basel, Switzerland
- International Marce Society for
Perinatal Health Biennial Scientific Meeting 2018, September 26 –
September 28, 2018 in Bangalore, India
- 31st European College of
Neuropsychopharmacology Congress (ECNP), October 6 – October 9,
2018 in Barcelona, Spain
- 48th Annual Meeting of the Society for
Neuroscience (SfN), November 3 – November 7, 2018 in San Diego,
CA
- Trial Initiations:
- SAGE-217 Phase 3 placebo-controlled
trial in MDD (4Q 2018)
- SAGE-217 Phase 3 placebo-controlled
polysomnography trial in MDD patients with co-morbid insomnia (4Q
2018)
- SAGE-217 Phase 2 trial in bipolar
depression (4Q 2018)
- Data Readouts:
- SAGE-217 Phase 3 placebo-controlled
trial in PPD (4Q 2018)
- SAGE-718 Phase 1 multiple ascending
dose trial (4Q 2018)
- SAGE-324 Phase 1 single ascending dose
trial (4Q 2018)
- Regulatory and Commercial:
- EMA Scientific Advice for brexanolone
in PPD (4Q 2018)
- FDA planned Advisory Committee Meeting
for ZULRESSO in PPD (November 2, 2018)
- ZULRESSO in PPD PDUFA target date
(December 19, 2018)
- ZULRESSO in PPD commercial launch, if
approved (1H 2019)
Financial Results for
the Second Quarter of 2018“We are excited to announce
that our collaboration with Shionogi, in the second quarter,
enabled Sage to book revenue for the first time,” said Kimi Iguchi,
chief financial officer of Sage. “This capital further strengthens
our financial position and provides us the ability to make
aggressive investments in our late-stage assets, ZULRESSO and
SAGE-217, as well as in earlier-stage assets, such as SAGE-324 and
SAGE-718. Sage’s cost-efficient approach to drug development, our
diverse pipeline, and our focus on larger markets with substantial
patient populations, represents a unique value proposition with
near, intermediate and long-term opportunities.”
- Revenues: Collaboration revenues
were $90.0 million in the second quarter of 2018, compared with no
revenues for the same period of 2017. All revenues for the second
quarter of 2018 are attributable to an upfront payment from Sage’s
strategic collaboration with Shionogi & Co., Ltd.
- R&D Expenses: Research and
development expenses were $69.0 million, including $12.1 million of
non-cash stock-based compensation expense, in the second quarter of
2018, compared to $55.9 million, including $5.2 million of non-cash
stock-based compensation expense, for the same period of 2017. The
increase in R&D expenses year-over-year was primarily due to
increases in ongoing R&D programs and discovery efforts focused
on identifying new clinical candidates and additional indications
of interest and investments in R&D headcount to support the
growth in Sage's pipeline and operations, offset by decreases in
expenses due to the completion of Phase 3 clinical development of
ZULRESSO.
- G&A Expenses: General and
administrative expenses were $43.2 million, including $16.9 million
of non-cash stock-based compensation expense, in the second quarter
of 2018, compared to $15.0 million, including $4.1 million of
non-cash stock-based compensation expense, for the same period of
2017. 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 $17.0
million for the second quarter of 2018 compared to a net loss of
$70.2 million for the comparable period of 2017.
- Cash Position: Cash, cash
equivalents, and marketable securities as of June 30, 2018 were
$1.1 billion, compared with $518.8 million at December 31, 2017.
The increase was primarily due to net proceeds of $631.2 million
from Sage's follow-on public offering completed in February
2018.
Financial Guidance:
- Based on its current operating plan,
Sage anticipates that its existing cash, cash equivalents and
marketable securities 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, including ongoing Phase 3 development of
SAGE-217, and preparations for potential commercialization of
ZULRESSO in PPD, if approved.
Conference Call
InformationSage will host a conference call and webcast
on Tuesday, August 7, 2018 at 8:00 A.M. ET to report its second
quarter 2018 financial results and to discuss 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 (866) 450-8683 (toll-free domestic) or (281)
542-4847 (international) and using the conference ID 5396188. 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 CNS
disorders. Sage's lead product candidate, ZULRESSO™ (brexanolone
injection), has completed Phase 3 clinical development for
postpartum depression and a New Drug Application is currently under
review with the U.S. Food and Drug Administration. Sage is
developing a portfolio of novel product candidates targeting
critical CNS receptor systems, including SAGE-217, which is in
Phase 3 development in major depressive disorder and postpartum
depression. 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 potential for approval
of our NDA for brexanolone IV in the treatment of PPD; our
expectations regarding our possible transition to a
commercial-stage company, including the timing of a potential
decision by the FDA and potential launch of brexanolone IV in PPD;
our plans and expectations regarding our future commercial
activities in the U.S., if brexanolone IV is approved, including
the potential availability of home infusion and other potential
sites of care and the nature of our planned patient support model;
our statements regarding plans and timelines for further
development of SAGE-217 and our other product candidates and
planned clinical and regulatory activities; our expectations
regarding the potential sufficiency of our planned SAGE-217
development program, if successful, to support regulatory filing
and approval of SAGE-217 in MDD and PPD; our views as to the
potential of SAGE-217 to represent a potential paradigm shift in
the treatment of MDD; our views as to the opportunity represented
by Sage’s portfolio and business, and the potential for value
creation; and our expectations regarding the strength of our
balance sheet, the potential for future revenue 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: the FDA may decide not to approve our NDA for
brexanolone IV in PPD; the clinical and non-clinical data we have
generated with our proprietary formulation of brexanolone to date
may be determined by the FDA and other regulatory authorities,
despite prior advice, to be insufficient to 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 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; even if brexanolone IV is approved in
PPD, regulatory authorities may impose significant restrictions or
conditions on use or on administration, including on sites of care;
we may encounter issues, delays or other challenges in launching or
commercializing the product, including issues related to market
acceptance and reimbursement, challenges associated with any
restrictions or conditions that may be imposed by regulatory
authorities, including any challenges or restrictions related to
enabling home infusion and other venues as viable options for site
of administration of brexanolone IV, and challenges associated with
the build of our sales and patient support organizations and their
activities, which in each case could limit the potential of our
product; 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 achieve
expedited development or review of SAGE-217; the FDA may ultimately
decide that the design or results of our planned clinical trials
for SAGE-217 even if positive are not sufficient for regulatory
approval in MDD, PPD or any other indication or do not support
episodic treatment of MDD which is the focus of our expedited
development plan; we may not be successful in our development of
SAGE-217 or in our development of any of our product candidates in
any indication we are currently pursuing or may in the future
pursue; 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 of our 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; 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, manufacture and
potential future commercialization 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 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 Statements of
Operations(in thousands, except share and per share
data)(unaudited)
Three Months
Ended June 30, Six Months Ended June 30, 2018
2017 2018 2017 Collaboration revenue $ 90,000
$ - $ 90,000 $ - Operating expenses: Research and development
68,980 55,900 118,250 101,100 General and administrative
43,167 14,954 72,016
27,234 Total operating expenses 112,147
70,854 190,266 128,334
Loss from operations (22,147 ) (70,854 ) (100,266 ) (128,334 )
Interest income, net 5,137 672 8,666 1,379 Other expense, net
32 (20 ) 24 (24 ) Net
loss $ (16,978 ) $ (70,202 ) $ (91,576 ) $ (126,979 ) Net loss per
share - basic and diluted $ (0.36 ) $ (1.88 ) $ (2.02 ) $ (3.40 )
Weighted average shares outstanding - basic and diluted
46,541,716 37,361,129 45,439,666
37,315,393
Sage Therapeutics, Inc. and
SubsidiariesCondensed Consolidated Balance Sheets(in
thousands)(unaudited)
June 30, 2018 December
31, 2017 Assets Current Assets: Cash and cash
equivalents $ 325,830 $ 306,235 Marketable securities 766,603
212,613 Prepaid expenses and other current assets 12,958 6,227
Receivable from collaborator 18,378 - Total current
assets 1,123,769 525,075 Property and equipment and other long-term
assets 5,714 4,862 Total assets $ 1,129,483 $ 529,937
Liabilities and Stockholders' Equity Current
Liabilities: Accounts payable $ 8,338 $ 9,350 Accrued expenses
39,581 42,601 Total current liabilities 47,919 51,951
Other liabilities 3,801 2,511 Total liabilities
51,720 54,462 Total stockholders' equity 1,077,763
475,475 Total liabilities and stockholders' equity $ 1,129,483 $
529,937
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180807005172/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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