Site icon pharmaceutical daily

Sage Therapeutics Announces First Quarter 2019 Financial Results and Highlights Pipeline and Business Progress

ZULRESSO™ (brexanolone) injection approved by U.S. FDA and on track
for launch in late June

Commercial team is launch ready; field teams focusing on payer
engagement and identifying pathways to care

Strong financial position with ~$1.4B in cash

Milestones anticipated throughout 2019 in clinical studies across all
three franchises: depression, neurology and neuropsychiatry

Conference call today at 8:00 A.M. ET

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sage Therapeutics, Inc. (NASDAQ: SAGE), a 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, 2019.

“We started 2019 with positive data from a Phase 3 clinical trial of our
lead oral compound SAGE-217 in postpartum depression and this was
quickly followed by the FDA approval of ZULRESSO in PPD,” said Jeff
Jonas, M.D., chief executive officer at Sage. “It was gratifying that
our first drug approval generated extensive media coverage of a disorder
that for too long has been shrouded by stigma and shame. We anticipate
additional momentum in our development efforts during the remainder of
the year across our three franchises in depression, neurology and
neuropsychiatry and believe the depth and breadth of our novel portfolio
of compounds in these areas is unrivaled in the industry. We are
confident in our potential to create a paradigm shift in the way brain
health is thought about and treated.”

Depression Franchise:
Led by
ZULRESSO™ (brexanolone) injection, approved by the U.S. Food and Drug
Administration (FDA) in March 2019 as the first treatment specifically
indicated for postpartum depression (PPD), and SAGE-217, which is being
evaluated in clinical studies as a treatment for major depressive
disorder (MDD), PPD, bipolar depression as well as comorbid MDD and
insomnia. SAGE-217 has received breakthrough therapy designation from
the FDA for the treatment of MDD.

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 (ET) and
epileptiform disorders.

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

Anticipated Upcoming Milestones

Financial Results for the First Quarter of 2019

Financial Guidance

Conference Call Information
Sage
will host a conference call and webcast today at 8:00 A.M. ET to discuss
its first quarter 2019 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 5968036. 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 biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with life-altering
central nervous system (CNS) disorders. Sage’s portfolio of novel
compounds targets critical receptor systems in the brain and includes
the first treatment specifically approved by the U.S. Food and Drug
Administration for postpartum depression as well as compounds being
developed as potential treatments for diseases such as major depressive
disorder, insomnia, bipolar disorder and essential tremor. 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
timing of scheduling and launch of ZULRESSO in the treatment of PPD; our
plans regarding anticipated future commercial and patient support
activities; our expectations regarding availability of REMS-certified
sites of care for the administration of ZULRESSO and access to treatment
for women with PPD; our statements regarding the potential for
reimbursement of ZULRESSO; our view as to
the potential for us to
change the way brain health is treated; our statements regarding the
target product profiles, plans and timelines for development of our
product candidates, including planned clinical activities and reporting
of results; our views as to the depth and breadth of our portfolio and
the opportunity represented by our programs and business; and our
expectations regarding our cash position at year-end and increases in
operating expense.
These statements constitute forward-looking
statements as that term is defined in the Private Securities Litigation
Reform Act of 1995. 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: scheduling and launch of ZULRESSO may not occur on the
timelines we expect; we may encounter issues or other challenges in
launching and commercializing ZULRESSO, including issues related to
market acceptance by healthcare providers, healthcare settings and women
with PPD, challenges with reimbursement, issues related to limitations
on the site of administration of ZULRESSO to REMS-certified supervised
healthcare settings and the other requirements of the REMS, and
challenges associated with execution of our sales and patient support
activities, which in each case could limit the potential of ZULRESSO;
results achieved with use of ZULRESSO in the treatment of PPD once we
have launched the product may be different than observed in clinical
trials, and may vary among patients; the number of women with PPD or the
unmet need for additional treatment options may be significantly smaller
than we expect; we may encounter unexpected safety or tolerability
issues with ZULRESSO or any of our product candidates; we may not be
successful in our development of any of our current or future 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 any of our 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 the development program for any of our product candidates, even if
positive, is not sufficient for a new drug application 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; we
may experience slower than expected enrollment in ongoing or future
clinical trials; the internal and external costs required for our
anticipated launch and commercialization activities and ongoing and
planned research and development efforts, and to build our organization
in connection with such activities, and the resulting expense increases
and 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 commercialization of ZULRESSO or in the
development 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 March 31,

2019

 

2018

Collaboration revenue $ 465 $
Operating expenses:
Research and development 86,398 49,270
General and administrative   83,919     28,849  
Total operating expenses   170,317     78,119  
 
Loss from operations (169,852 ) (78,119 )
Interest income, net 6,442 3,529
Other income (expense), net   4     (8 )
Net loss $ (163,406 ) $ (74,598 )
Net loss per share – basic and diluted $ (3.37 ) $ (1.68 )
Weighted average shares outstanding – basic and diluted   48,491,834     44,325,371  
 
 

Sage Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands)

(Unaudited)

       

March 31,
2019

December 31,
2018

Cash, cash equivalents, restricted cash and investments $ 1,353,618 $ 925,143
Total assets $ 1,422,914 $ 952,705
Total liabilities $ 103,380 $ 89,734
Total stockholders’ equity $ 1,319,534 $ 862,971
 

Important Safety Information:

What is ZULRESSO?

ZULRESSO is a prescription medicine used in adults to treat a certain
type of depression called Postpartum Depression.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZULRESSO?

ZULRESSO can cause serious side effects, including:

Before receiving ZULRESSO, tell your healthcare provider about all
your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.

ZULRESSO and some medicines may interact with each other and cause
serious side effects.

Especially tell your healthcare provider if you take other
antidepressants, opioids, or Central Nervous System (CNS) depressants
(such as benzodiazepines).

Know the medicines you take. Keep a list of them to show your healthcare
provider and pharmacist when you get a new medicine. Your healthcare
provider will decide if other medicines can be taken with ZULRESSO.

How will I receive ZULRESSO?

ZULRESSO is given to you by continuous intravenous (IV) infusion into
your vein. The infusion will last for a total of 60 hours (2.5 days).

What should I avoid while receiving ZULRESSO?

What are the possible side effects of ZULRESSO?

ZULRESSO can cause serious side effects, including:

How can I watch for and try to prevent suicidal thoughts and actions?

Tell your healthcare provider right away if you have any of the
following symptoms, especially if they are new, worse, or worry you:

The most common side effects of ZULRESSO include:

These are not all the side effects of ZULRESSO.

Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.

Please see full
Prescribing Information
, including Boxed WARNING, and Medication
Guide for ZULRESSO™ and discuss any questions you may have with your
healthcare provider.

Contacts

Investor Contact:
Maren Killackey, 617-949-4113
maren.killackey@sagerx.com

Media Contact:
Jeff Boyle, 617-949-4256
jeff.boyle@sagerx.com

Read full story here

Exit mobile version