Sage Therapeutics Announces Strategic Reorganization to Prioritize ZURZUVAE® Commercialization and Focus its Development Portfolio
17 October 2024 - 10:00PM
Business Wire
Planned workforce reduction of approximately
33% of employees expected to extend the company’s cash
runway
Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced a
strategic reorganization of its business operations to support the
ongoing launch of ZURZUVAE in postpartum depression and focus
pipeline development efforts ahead of a clinical study readout for
dalzanemdor in Huntington’s Disease expected later this year. The
reorganization is intended to enable Sage to strengthen its balance
sheet, extend cash runway, and position the company for long-term
growth potential.
The reorganization is planned to be substantially completed by
the end of the 4th quarter of 2024 and expected to:
- Impact over 165 employees (approximately 33% of the company’s
total workforce and approximately 55% of the company’s R&D
workforce), including changes to the leadership team
- Implement early-stage pipeline prioritization
“We are being deliberate and purposeful in our efforts to
reorganize the company with the goal of having the flexibility to
execute immediate priorities and build for long term growth and
value creation. This is difficult but necessary and we believe it
will right-size Sage for future growth potential. This move allows
for continued focused investment in the ongoing launch of ZURZUVAE
for women with postpartum depression and development of our
prioritized portfolio,” said Barry Greene, Chief Executive Officer
at Sage Therapeutics. “I want to extend my deepest gratitude to our
departing employees for their significant contributions to our work
and their dedication to making a difference for patients.”
The changes to Sage’s leadership team include:
- Anne Marie Cook, Senior Vice President, General Counsel;
Kimi Iguchi, Chief Financial Officer; Matt Lasmanis,
Chief Technology and Innovation Officer; Heinrich Schlieker,
Ph.D., Senior Vice President of Technical Operations; and Amy
Schacterle, Ph.D., Senior Vice President of R&D Strategy
and Business Management will depart Sage.
- Chris Benecchi will take on an expanded role as Chief
Operating Officer and will oversee Finance, Information Technology,
and Technical Operations in addition to continuing to oversee
Business Development, Medical Affairs and Commercial.
- Greg Shiferman will be promoted to Senior Vice
President, General Counsel.
- Vanessa Procter will take on an expanded role as Senior
Vice President of Corporate Affairs and will oversee Investor
Relations in addition to Corporate Communications, Government
Affairs and Patient Advocacy.
Sage expects a non-recurring charge of approximately $26 million
to $28 million associated with the reorganization, primarily
incurred in the fourth quarter of 2024. The company anticipates
that the implementation of the restructuring will extend its cash
runway and expects to provide updated cash runway guidance in the
near future.
SELECT IMPORTANT SAFETY INFORMATION FOR ZURZUVAE:
ZURZUVAE (zuranolone) CIV, is a neuroactive steroid
gamma-aminobutyric acid A (GABAA) receptor positive modulator
indicated for the treatment of postpartum depression in adults.
This does not include all the information needed to use ZURZUVAE
safely and effectively. See full prescribing information for
ZURZUVAE.
ZURZUVAE may cause serious side effects. The most common side
effects of ZURZUVAE include sleepiness or drowsiness, dizziness,
common cold, diarrhea, feeling tired, weak, or having no energy,
and urinary tract infection. ZURZUVAE may decrease your awareness
and alertness, which can affect your ability to drive safely or
safely do other dangerous activities. Do not drive, operate
machinery, or do other dangerous activities until at least 12 hours
after taking each dose during your 14-day treatment course of
ZURZUVAE. You may not be able to tell on your own if you can drive
safely or tell how much ZURZUVAE is affecting you. ZURZUVAE may
cause sleepiness, drowsiness, slow thinking, dizziness, confusion,
and trouble walking. Because of these symptoms, you may be at a
higher risk for falls during treatment with ZURZUVAE. Taking
alcohol, other medicines that cause CNS depressant effects, or
opioids while taking ZURZUVAE can make these symptoms worse and may
also cause trouble breathing. Tell your healthcare provider if you
develop any of these symptoms, or if they get worse during
treatment with ZURZUVAE. Your healthcare provider may decrease your
dose or stop ZURZUVAE treatment if you develop these symptoms.
ZURZUVAE is a federal controlled substance (C-IV) because it
contains zuranolone, which can be abused or lead to dependence.
Tell your healthcare provider right away if you become pregnant or
plan to become pregnant during treatment with ZURZUVAE. You should
use effective birth control (contraception) during treatment with
ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other
antidepressant medicines may increase the risk of suicidal thoughts
and actions in people 24 years of age and younger. ZURZUVAE is not
for use in children.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company
committed to our mission of pioneering solutions to deliver
life-changing brain health medicines, so every person can thrive.
Sage developed the only two FDA-approved treatments indicated for
postpartum depression and is advancing a robust pipeline to target
unmet needs in brain health. Sage was founded in 2010 and is
headquartered in Cambridge, Mass.
Find out more at www.sagerx.com or engage with us on Facebook,
LinkedIn, Instagram, and X.
Sage Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: the amount and timing of the expected
non-recurring charge associated with the reorganization; our
expectation that the reorganization will strengthen our balance
sheet and extend our cash runway; the number of employees expected
to be impacted by the reorganization; our belief that the
reorganization will right-size the organization for future growth
potential; our goal to position the company for long-term growth
and value creation and the potential to achieve that goal; our
plans to implement our early-stage pipeline prioritization; the
expected timing of readout of the DIMENSION Study of dalzanemdor in
Huntington’s Disease; the potential for ongoing success in the
launch of ZURZUVAE in the treatment of women with PPD; and the
mission and goals for our business. 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: we
may incur additional charges or expenses associated with the
reorganization; we may not realize cost savings from the
reorganization at the levels we expect, and as a result, the
reorganization may not strengthen our balance sheet or enable us to
extend our cash runway; the internal and external costs required
for our ongoing, planned and other future activities, and the
resulting impact on expense and use of cash, may be higher than
expected which may cause us to use cash more quickly than we expect
or change or curtail some of our plans, or both; our expectations
as to cash runway and cash needs may prove not to be correct for
other reasons such as changes in plans or actual events being
different than our assumptions; we may be opportunistic in our
future financing plans even with our expectations regarding
extending the cash runway; our launch and commercialization efforts
in the U.S. with respect to ZURZUVAE for the treatment of women
with PPD may not be successful, and we may be unable to generate
revenues at the levels or on the timing we expect or at levels or
on the timing necessary to support our goals, including our value
creation goals; the number of women with PPD, the unmet need for
additional treatment options, and the potential market for ZURZUVAE
in this indication may be significantly smaller than we expect;
ZURZUVAE may not achieve the clinical benefit, clinical use or
market acceptance we expect in the treatment of women with PPD or
we may encounter reimbursement-related or other market-related
issues, including competition in the market, that impact the
success of our commercialization efforts; we may not be successful
in our development of any of our product candidates in any
indication we are currently pursuing or may in the future pursue;
we may encounter unexpected issues that delay our plans to disclose
the results of the DIMENSION Study; success in our non-clinical
studies or in earlier clinical trials may not be repeated or
observed in ongoing or future studies, and ongoing and future
non-clinical and clinical results, including the DIMENSION Study,
may not meet their primary or key secondary endpoints or be
sufficient to file for or gain regulatory approval to market the
product without further development work or may not support further
development at all; we may encounter adverse events for ZURZUVAE at
any stage that negatively impact commercialization in women with
PPD; we may encounter adverse events for any of our product
candidates that impact further development or the potential for
future regulatory approval; decisions or actions of the FDA may
affect the initiation, timing, design, size, progress, cost and
potential for success of clinical trials of our product candidates
and our ability to proceed with further development or may impair
the potential for successful development; the need to align with
our collaborator may hamper our ongoing commercialization efforts
or increase our costs; any issues related to our development or
commercialization efforts or our financial position may negatively
impact the opportunity for our business or our ability to achieve
our goals, including our value creation goal; as well as those
risks more fully discussed in the section entitled "Risk Factors"
in our most recent quarterly report, 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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version on businesswire.com: https://www.businesswire.com/news/home/20241016563060/en/
MEDIA CONTACTS: Sage Therapeutics Matthew Henson +1 917
930 7147 Matthew.Henson@sagerx.com
INVESTOR CONTACTS: Sage Therapeutics Katie Plante +1 978
968 9099 Katie.Plante@sagerx.com
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