Sage Therapeutics Implements Strategic Reorganization to Support Plans for ZURZUVAE™ Commercial Launch and Pipeline Advancement
August 31 2023 - 6:30AM
Business Wire
Potential growth catalysts include planned
4Q 2023 launch of ZURZUVAE (zuranolone) and expected data read-outs
for SAGE-718 and SAGE-324 in 2024
Approximately 40% workforce reduction
supports focus on agile execution of business priorities
Strengthened financial position with
expected annualized net savings of approximately $240 million
anticipated to extend cash runway into 2026
Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced plans to
reorganize its business operations and pipeline priorities to
support goals for long-term business growth, including the planned
commercial launch of ZURZUVAE for women with postpartum depression
(PPD) in late 2023.
“Our goal is to think big, start small and scale fast as we look
to launch ZURZUVAE and help women suffering with PPD. Executing on
launch and our potential long-term growth catalysts requires us to
allocate resources strategically,” said Barry Greene, Chief
Executive Officer at Sage Therapeutics. “Part of our efforts to
become a leaner and stronger company means having to reorganize our
workforce. The departing employees contributed so much to our
mission and I’m grateful for their incredible dedication to helping
patients. Our business fundamentals are strong, we are well
capitalized, and our goal is to put Sage in a solid position to
optimize commercial execution and develop our pipeline with the
goal of significant value creation.”
Following a strategic review, the company will:
- Refine pipeline development efforts to advance SAGE-718 and
SAGE-324, as well as pause certain earlier-stage programs, with the
goal of making evidence-driven investments
- Implement a ~40% workforce reduction designed to right-size the
organization as the company works to achieve sustained growth and
allow for commercial hires to support the goal of a successful
launch of ZURZUVAE to treat women with PPD
- Align its leadership team structure to scale with pipeline and
commercial priorities
The changes to Sage’s leadership team are designed to help
support the company’s future priorities. Al Robichaud, Sage’s Chief
Scientific Officer since its founding in 2011, has decided to
depart Sage. Al will remain as a scientific consultant and member
of Sage’s Medicinal Chemistry and Pre-Clinical Scientific Advisory
Boards. Mike Quirk will be promoted from SVP of Discovery Research
to Chief Scientific Officer. In his new role, Dr. Quirk will lead
Sage’s Research and Non-Clinical Development organizations. Jim
Doherty, Chief Development Officer, also a founding member of Sage,
will leave the company to pursue new opportunities. Both Dr.
Robichaud and Dr. Doherty were pivotal in the development of the
scientific platforms that established the company’s robust brain
health pipeline. Both leaders played key roles in helping move the
company’s two approved compounds from early discovery through
approval. Laura Gault, Chief Medical Officer, will assume Dr.
Doherty’s responsibilities.
Chris Benecchi, Chief Business Officer, will oversee Medical
Affairs following the departure of Mark Pollack, SVP of Medical
Affairs who is leaving to pursue new opportunities. Dr. Pollack is
a recognized thought leader in the psychiatric field and made
significant contributions to Sage’s medical thought leader
engagement strategy since joining Sage over a year ago.
“Our new Chief Scientific Officer, Mike, has been with Sage for
almost a decade and will apply his deep knowledge of our science
and relentless commitment to innovation on behalf of patients,”
added Mr. Greene. “I also want to express my sincere gratitude for
the exceptional impact that Al, Jim, and Mark have made for the
company and for patients. Al and Jim have been with us from the
very beginning and have inspired us all to push forward in some of
the most challenging and rewarding areas of drug discovery and
development.”
The reorganization plan is intended to enable Sage to strengthen
its balance sheet and position the company for long-term growth
potential. Based on the post-reorganization operating plan which
includes Sage’s pipeline prioritization, workforce reduction, and
additional incremental commercial hires, the company expects:
- Annualized net savings of approximately $240 million, of which
60% is related to R&D
- A non-recurring charge of approximately $36 million to $38
million associated with the reorganization, primarily incurred in
the third quarter of 2023
- The potential to earn a milestone payment of $75 million from
Biogen related to the first commercial sale of ZURZUVAE for the
treatment of PPD
- Cash, cash equivalents, and marketable securities of
approximately $1.0 billion as of June 30, 2023 along with
anticipated funding from ongoing collaborations and potential
revenue will support operations into 2026
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit www.sagerx.com.
Sage Therapeutics Safe Harbor
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: the potential cost savings from our
reorganization; the amount and timing of the expected non-recurring
charge associated with our reorganization; our expectations that
the cost savings from the restructuring will help support
commercial launch, advance our late-stage pipeline and strengthen
our financial position; our expectations regarding our cash runway;
our expectations as to the timing of planned launch of ZURZUVAE in
the treatment of women with PPD; the potential for a milestone
payment related to first commercial sale; our goals for the launch
and the potential for success; potential growth catalysts for our
business and the potential for sustainable long-term growth; 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 not realize expected cost savings from the reorganization,
including the anticipated decrease in spend, at the levels we
expect; we may realize additional charges or expenses associated
with the reorganization; 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 expenses, cash usage, potential revenue, funding from
collaborations, including milestones, 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 if available
cash is sufficient; 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; 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 that impact the success of our
commercialization efforts; we may never achieve regulatory approval
of zuranolone in MDD; the FDA has taken the position that an
additional clinical trial or clinical trials of zuranolone are
required to support approval in MDD and may not change that
position; such trial or trials could be time-consuming,
significantly increase our expenses, and may not be feasible; even
if we conduct such clinical trials, they may not be successful; the
FDA may decide that the design, conduct or results of such clinical
trials, even if positive, are not sufficient for approval in MDD or
may find other deficiencies in our development program, data,
processes, or manufacturing sites; even if we receive regulatory
approval of zuranolone for the treatment of MDD, the FDA may
approve zuranolone for only a subset of MDD patients or with
limitations or restrictions; 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; 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 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 delays in conduct of our ongoing clinical trials,
including slower than expected site initiation or enrollment, that
may impact our ability to meet our expected time-lines and increase
our costs; 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
collaborators may hamper or delay our development and
commercialization efforts or increase our costs; and our business
may be adversely affected and our costs may increase if any of our
key collaborators fails to perform its obligations or terminates
our collaboration; 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/20230830124797/en/
MEDIA CONTACT: Sage Therapeutics Matthew Henson +1
917 930 7147 Matthew.Henson@sagerx.com INVESTOR CONTACT:
Sage Therapeutics Ashley Kaplowitz +1 786 252 1419
Ashley.Kaplowitz@sagerx.com
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