Sage Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Highlights Pipeline and Business Progress

Planned U.S. commercial launch of ZULRESSO™ (brexanolone) injection,
if approved, on track for June 2019, based on PDUFA target date of March
19, 2019 and anticipated DEA scheduling

Topline data from Phase 3 trial of SAGE-217 in MDD expected in Q4
2019 or 1Q 2020

Neurology and neuropsychiatry franchises continue to progress with
positive Phase 1 data

Conference call today at 8:00 AM ET

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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, 2018.

“Eight years ago, Sage was founded to address the innovation void in CNS
drug development. Today we are establishing Sage as a CNS leader by
building multiple franchise opportunities – in depression, neurology and
neuropsychiatry, with the potential to treat millions of patients. Our
focused execution across these three franchises has led to a pipeline of
four clinical candidates across several indications, all using novel
mechanisms and approaches,” said Jeff Jonas, M.D., chief executive
officer at Sage. “The expected near-term approval of our lead product
candidate, ZULRESSO in the treatment of postpartum depression,
will mark a major milestone in our company’s journey and, along with our
broader portfolio, may help support a paradigm-shifting approach to
mental health. We want people to be treated as people with depression,
not depressed people, and we believe our development programs, if
successful, can help define this new normal.”

Depression Franchise:

Led by ZULRESSO™ (brexanolone) injection, which has been designated
as a breakthrough therapy by the U.S. Food and Drug Administration (FDA)
for the treatment of postpartum depression (PPD), and SAGE-217, which
has been designated as a breakthrough therapy for the treatment of major
depressive disorder (MDD).

  • ZULRESSO: Prescription Drug User Fee Act (PDUFA) goal date is March
    19, 2019.

    • If approved, Sage plans to launch ZULRESSO in the U.S. in June
      2019, following expected scheduling by the Drug Enforcement
      Administration (DEA), which is to occur within 90 days of
      approval. The Company’s commercial infrastructure build is
      complete and the sales organization is launch ready, pending
      approval and scheduling.
  • SAGE-217: Multiple studies are underway across the pivotal program
    studying SAGE-217 as a short-course oral treatment for depression,
    which includes two completed positive pivotal trials in MDD and PPD.

    • Based on enrollment progress in the ongoing Phase 3
      placebo-controlled MOUNTAIN Study in patients with MDD, topline
      results are now expected in Q4 2019 or Q1 2020.

      • The MOUNTAIN Study is evaluating two weeks of 20mg or 30mg
        SAGE-217 treatment compared to placebo and four weeks of
        follow-up in approximately 450 patients with MDD.
      • As a separate observational protocol, the Company will
        continue to follow patients from the MOUNTAIN Study after
        completion for up to 6 months.
    • Topline readouts from Phase 3 RAINFOREST and SHORELINE studies
      anticipated in 2020. Additional MDD-302 Study planned.

      • The RAINFOREST Study is evaluating two weeks of 30mg SAGE-217
        treatment compared to placebo in patients with MDD and
        co-morbid insomnia.
      • The SHORELINE Study will evaluate 30mg SAGE-217 open-label
        treatment, treatment-free intervals and as-needed retreatment
        for return of major depressive episodes over the course of up
        to a year.
      • Based on the positive results of the ROBIN Study in PPD and
        the ongoing Breakthrough dialog with the FDA, the SAGE-217
        depression program will be expanded to generate monotherapy
        maintenance data through an additional study, MDD-302. This
        placebo-controlled trial will evaluate fixed interval SAGE-217
        monotherapy (treatment without traditional antidepressants)
        for up to a year, and, if positive, would generate data that
        the Company believes will maximize value, help fulfill FDA
        registration requirements, and offer more treatment options to
        clinicians, if SAGE-217 is successfully developed and approved.
      • Sage believes that these studies will provide support for
        Sage’s vision to transform the treatment paradigm for MDD.
    • The open-label Phase 2 ARCHWAY Study is evaluating SAGE-217 as a
      treatment for bipolar depression, with topline results expected in
      the first half of 2019.

      • The ARCHWAY Study is evaluating open-label SAGE-217 treatment
        in up to 30 patients with bipolar I/II disorder with a current
        major depressive episode. Primary endpoints are safety and
        tolerability; secondary endpoints will measure improvements in
        depressive symptoms and sleep.

Neurology Franchise:

Led by SAGE-324, a next-generation positive allosteric modulator
(PAM) of GABA
A receptors in development as a
potential therapy for neurological conditions, such as essential tremor
and epileptiform disorders.

  • SAGE-324: Results from a Phase 1 single ascending dose study
    demonstrated that the profile of SAGE-324 includes good oral
    bioavailability and a pharmacokinetic profile consistent with
    once-daily dosing. SAGE-324 demonstrated clear target engagement in
    the brain using pharmaco-EEG (β-band power) as a functional biomarker.
  • SAGE-324 was generally well-tolerated with no serious adverse events
    and with a safety profile consistent with GABAA positive
    allosteric modulation.
  • The Phase 1 multiple ascending dose study is ongoing and a Phase 1
    study to determine the safety, tolerability and pharmacokinetics of
    SAGE-324 in patients with essential tremor has been initiated.

Neuropsychiatry Franchise:

Led by first-in-class NMDA receptor PAM, SAGE-718, which is in
development as a potential therapy for certain cognition-related
disorders impacted by NMDA receptor dysfunction.

  • SAGE-718: Results from Phase 1 studies demonstrated that the profile
    of SAGE-718 includes good oral bioavailability and a pharmacokinetic
    profile consistent with once-daily dosing.
  • SAGE-718 was generally well-tolerated with no serious adverse events
    reported.
  • Results from target engagement biomarker studies in healthy
    volunteers, focusing on electrophysiology and imaging, are ongoing
    with results expected later in 1H 2019.
  • Initiated a Phase 1 study to determine the safety, tolerability and
    pharmacokinetics of SAGE-718 in patients with early manifest
    Huntington’s disease.

Expected Milestones

  • Data readouts:

    • SAGE-217 Phase 2 ARCHWAY Study in bipolar depression (1H 2019)
    • SAGE-718 Phase 1 biomarker data (1H 2019)
    • SAGE-324 Phase 1 MAD study (2H 2019)
    • SAGE-324 essential tremor Phase 1 cohort data (2H 2019)
    • SAGE-718 Huntington’s Disease Phase 1 cohort data (2H 2019)
    • SAGE-217 MDD Phase 3 MOUNTAIN Study (Q4 2019/Q1 2020)
    • SAGE-217 MDD Phase 3 RAINFOREST and SHORELINE studies (2020)
  • Regulatory and commercial:

    • ZULRESSO in PPD PDUFA target date (March 19, 2019)
    • ZULRESSO in PPD commercial launch, if approved (June 2019)

Financial Results for the Fourth Quarter and
Full Year 2018

  • Cash Position: Cash, cash equivalents, and marketable
    securities as of December 31, 2018 were $922.8 million, 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, and an upfront milestone payment
    from Shionogi & Co., Ltd. related to the strategic collaboration on
    SAGE-217 in Japan, Taiwan and South Korea that we entered into in June
    2018.
  • R&D Expenses: Research and development expenses were $88.8
    million, including $15.9 million of non-cash stock-based compensation
    expense, in the fourth quarter of 2018, compared to $50.9 million,
    including $5.7 million of non-cash stock-based compensation expense,
    for the same period of 2017. For the year ended December 31, 2018,
    research and development expenses were $282.1 million, including $50.9
    million of non-cash stock-based compensation expense, compared
    to $210.3 million, including $19.9 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 Phase 3 clinical
    development of SAGE-217 in PPD and MDD; the continuation of Phase 1
    studies of SAGE-324 and SAGE-718 and supporting clinical
    activities; 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. These expenses were
    offset by a decrease in expense related to the ZULRESSO clinical
    development program.
  • G&A Expenses: General and administrative expenses
    were $75.7 million, including $15.8 million of non-cash stock-based
    compensation expense, in the fourth quarter of 2018, compared to $19.6
    million, including $4.6 million of non-cash stock-based compensation
    expense, for the same period of 2017. For the year ended December 31,
    2018, G&A expenses were $201.4 million, including $51.1 million of
    non-cash stock-based compensation expense, compared to $62.9 million,
    including $15.6 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 $158.4 million for the fourth quarter of
    2018 and $372.9 million for the year ended December 31, 2018, compared
    to a net loss of $69.4 million and $270.1 million, respectively, for
    the comparable periods of 2017.

Financial Guidance

  • Based upon its current operating plan, Sage now anticipates that its
    existing cash, cash equivalents and marketable securities, and
    estimated product sales of ZULRESSO, if the product is approved, will
    enable Sage to fund its operating expenses and capital expenditure
    requirements into 2H 2020.
  • Sage expects that its operating expenses will increase year over year
    in 2019 to support continued pipeline advancement and anticipated
    commercialization of ZULRESSO 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 2018 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 6968949. 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 approval of our new drug application (NDA) for
ZULRESSO in the treatment of PPD, including the target timing of a
decision by the FDA; our plans regarding the timing of launch of
ZULRESSO in PPD, future commercial activities, and the potential for
future revenues, if the NDA for ZULRESSO is approved; our statements
regarding plans and timelines for development of SAGE-217 and our other
product candidates, including planned clinical and regulatory
activities; our view of the potential for the data from our development
program with SAGE-217 in MDD, if positive, to create value and be
supportive of a regulatory submission and approval; our views as to the
opportunity represented by Sage’s portfolio and business in CNS,
including the potential, if we are successful, to treat millions of
patients and to change treatment paradigms; and our expectations
regarding increases in operating expense, 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: the FDA may
decide not to approve our NDA for ZULRESSO in PPD; the clinical and
non-clinical data we have generated with ZULRESSO to date may be
determined by the FDA to be insufficient to gain regulatory approval to
launch and commercialize our product in PPD and FDA may determine that
additional trials or data are necessary in order to file for or obtain
approval; the FDA may not complete its review of our filing within the
target timelines; even if ZULRESSO is successfully approved for PPD in
the U.S., 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
restrictions or conditions that may be imposed by regulatory
authorities, including challenges related to limiting the site of
administration to a certified healthcare facility monitored by a
qualified healthcare provider, and the necessity for a REMS; and
challenges associated with execution of our sales and patient support
activities, which in each case could limit the potential of our product;
we may encounter unexpected safety or tolerability issues with ZULRESSO,
SAGE-217 or any of our other product candidates in ongoing or future
development; we may not be successful in our development of SAGE-217 or
any of our other 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; the FDA may decide that our development program for
SAGE-217, even if positive, is not sufficient for an NDA filing or
approval; 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 or
may impact the regulatory pathway; 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 report filed
with the Securities and Exchange Commission (SEC), and discussions of
potential risks, uncertainties, and other important factors in our
subsequent filings with the SEC. 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 December 31,     Year Ended December 31,
  2018       2017     2018       2017  
Collaboration revenue $ 273 $ $ 90,273 $
Operating expenses:
Research and development 88,805 50,890 282,107 210,277
General and administrative   75,695     19,558     201,404     62,878  
Total operating expenses   164,500     70,448     483,511     273,155  
 
Loss from operations (164,227 ) (70,448 ) (393,238 ) (273,155 )
Interest income, net 5,851 1,042 20,334 3,099
Other income (expense), net   (12 )   (15 )   22     (64 )
Net loss $ (158,388 ) $ (69,421 ) $ (372,882 ) $ (270,120 )
Net loss per share – basic and diluted $ (3.38 ) $ (1.75 ) $ (8.08 ) $ (7.09 )
Weighted average shares outstanding – basic and diluted   46,876,452     39,583,004     46,121,194     38,113,678  
 
 
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands)

(Unaudited)

 
      December 31, 2018     December 31, 2017
Assets
Current Assets:
Cash and cash equivalents $ 190,943 $ 306,235
Marketable securities 731,833 212,613
Prepaid expenses and other current assets   21,919   6,227
Total current assets 944,695 525,075
Property and equipment and other long-term assets   8,010   4,862
Total assets $ 952,705 $ 529,937
 
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable $ 34,036 $ 9,350
Accrued expenses   51,994   42,601
Total current liabilities 86,030 51,951
Other liabilities   3,704   2,511
Total liabilities 89,734 54,462
Total stockholders’ equity   862,971   475,475
Total liabilities and stockholders’ equity $ 952,705 $ 529,937
 

Contacts

Investor Contact:
Paul Cox
617-299-8377
[email protected]

Media Contact:
Maureen L. Suda
585-355-1134
[email protected]

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