Market Overview

Sage Therapeutics Announces Second Quarter 2018 Financial Results and Highlights Pipeline and Business Progress

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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 Information
Sage
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 Therapeutics
Sage
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 Statements
Various
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 Subsidiaries
Condensed
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 Subsidiaries
Condensed
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

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