Sage Therapeutics, Inc.

Equities

SAGE

US78667J1088

Biotechnology & Medical Research

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SAGE THERAPEUTICS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-K)

February 24, 2022 at 07:26 am EST

You should read the following discussion and analysis of our financial condition
and results of operations together with our consolidated financial statements
and related notes appearing elsewhere in this Annual Report on Form 10-K, or
Annual Report. In addition to historical information, this discussion and
analysis contains forward-looking statements that involve risks, uncertainties
and assumptions. We caution you that forward-looking statements are not
guarantees of future performance, and that our actual results of operations,
financial condition and liquidity, and the developments in our business and the
industry in which we operate, may differ materially from the results discussed
or projected in the forward-looking statements contained in this Annual Report.
We discuss risks and other factors that we believe could cause or contribute to
these potential differences elsewhere in this report, including under Part I,
Item 1A, "Risk Factors" and under "Cautionary Note Regarding Forward-Looking
Statements" in this Annual Report. In addition, even if our results of
operations, financial condition and liquidity, and the developments in our
business and the industry in which we operate are consistent with the
forward-looking statements contained in this Annual Report, they may not be
predictive of results or developments in future periods. We caution readers not
to place undue reliance on any forward-looking statements made by us, as such
statements speak only as of the date they are made. We disclaim any obligation,
except as specifically required by law and the rules of the Securities and
Exchange Commission, or SEC, to publicly update or revise any such statements to
reflect any change in our expectations or in events, conditions or circumstances
on which any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the forward-looking
statements.

Information pertaining to fiscal year 2019 was included in the Company's Annual
Report on Form 10-K for the year-ended December 31, 2020, on pages 82 through
100, under Part II, Item 7, "Management's Discussion and Analysis of Financial
Condition and Results of Operations," which was filed with the SEC on February
24, 2021.

                                    Overview

We are a biopharmaceutical company committed to developing and commercializing
novel medicines with the potential to transform the lives of people with
debilitating disorders of the brain. Our first product, ZULRESSO® (brexanolone)
CIV injection, is approved in the U.S. for the treatment of postpartum
depression, or PPD, in adults. We have a portfolio of other product candidates
with a current focus on modulating two critical central nervous system, or CNS,
receptor systems, GABA and NMDA. The GABA receptor family, which is recognized
as the major inhibitory neurotransmitter in the CNS, mediates downstream
neurologic and bodily function via activation of GABAA receptors. The NMDA-type
receptors of the glutamate receptor system are a major excitatory receptor
system in the CNS. Dysfunction in these systems is implicated in a broad range
of CNS disorders. We are currently targeting diseases and disorders of the brain
with three key focus areas: depression, neurology and neuropsychiatry.

Our first product, ZULRESSO, is a proprietary intravenous formulation of
brexanolone, approved in the U.S. as a treatment for PPD in adults. Brexanolone
is chemically identical to allopregnanolone, a naturally occurring neuroactive
steroid that acts as a positive allosteric modulator of GABAA receptors. We
launched ZULRESSO commercially in the U.S. for the treatment of PPD in June
2019. Currently, ZULRESSO may only be administered in qualified,
medically-supervised healthcare settings. We have initiated an open-label
clinical trial designed to assess the potential for safe-use administration of
ZULRESSO in a patient's home for the treatment of PPD, known as the SUNBIRD
Study, which is anticipated to be completed in late 2022.

Our next most advanced product candidate is zuranolone (SAGE-217), a novel oral
compound being developed for certain affective disorders, including major
depressive disorder, or MDD, and PPD. Zuranolone is a neuroactive steroid that,
like brexanolone, is a positive allosteric modulator of GABAA receptors,
targeting both synaptic and extrasynaptic GABAA receptors. We plan to submit a
new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA,
in the second half of 2022 seeking approval of zuranolone for the treatment of
MDD. An associated NDA filing seeking approval of zuranolone for PPD is
anticipated in the first half of 2023, pending the completion and results of the
ongoing SKYLARK Study in PPD. The FDA granted Fast Track designation to
zuranolone in PPD in early 2022, and previously granted zuranolone Breakthrough
Therapy designation and Fast Track designation to zuranolone for the treatment
of MDD.


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To date, we have completed five pivotal clinical trials of zuranolone, four in
MDD and one in PPD. The completed pivotal trial evaluating zuranolone for the
treatment of PPD and three of the four completed pivotal trials evaluating
zuranolone for the treatment of MDD met their primary endpoints. We announced
results from the following pivotal clinical trials of zuranolone in either 2021
or early 2022:

  • CORAL Study (completed)



On February 16, 2022, we announced results from the CORAL Study, a
placebo-controlled Phase 3 clinical trial evaluating a two-week course of
zuranolone 50 mg, when co-initiated with a newly administered open-label
standard antidepressant therapy, or ADT, compared with open-label standard of
care ADT co-initiated with placebo, as an acute rapid response treatment in
patients with MDD. Patients in the clinical trial received zuranolone 50 mg
co-initiated with an open-label standard of care ADT or open-label standard of
care ADT co-initiated with placebo once nightly for 14 days followed by
continuation of the ADT for an additional short-term follow-up period. In the
CORAL Study, zuranolone 50 mg co-initiated with an ADT met the primary endpoint
of statistically significant reduction in depressive symptoms at Day 3 and met
the key secondary endpoint of a statistically significant improvement in
depressive symptoms over the two-week treatment period, in each case as compared
to ADT co-initiated with placebo.

• WATERFALL Study (completed)

In June 2021, we announced that the WATERFALL Study, a pivotal, Phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating the efficacy and safety of zuranolone 50 mg in adults aged 18 to 64 years with MDD, met its primary endpoint.

• SHORELINE Study (ongoing)





In 2021, we reported positive topline 12-month data from both the 30 mg cohort
and the 50 mg cohort of the SHORELINE Study, an open-label Phase 3 clinical
trial of zuranolone in MDD, which is designed to evaluate the safety,
tolerability, and need for repeat dosing of zuranolone in adults for up to one
year. Enrollment in the 50 mg cohort of the study is ongoing.

The SKYLARK Study, a Phase 3 placebo-controlled clinical trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up, is ongoing, and we expect to report topline results in mid-2022.



We are jointly developing zuranolone and another of our late-stage compounds,
SAGE-324, in the U.S. with Biogen MA Inc., or BIMA, and Biogen International
GmbH, or, together with BIMA, Biogen, under a collaboration and license
agreement, or the Biogen Collaboration Agreement, that became effective in
December 2020. Under the Biogen Collaboration Agreement, we will also jointly
commercialize products containing zuranolone, which we refer to as Licensed 217
Products, and products containing SAGE-324, which we refer to as Licensed 324
Products, with Biogen in the U.S. if our development efforts are successful. We
refer to the Licensed 217 Products and Licensed 324 Products collectively as the
Licensed Products. In addition, we have granted Biogen sole rights to develop
and commercialize the Licensed Products outside the U.S., other than in Japan,
Taiwan and South Korea, or the Shionogi Territory, with respect to zuranolone,
where we have granted such rights to Shionogi & Co., Ltd., or Shionogi. We refer
to the territories outside the U.S. to which Biogen has rights under the Biogen
Collaboration Agreement with respect to the applicable Licensed Product as the
Biogen Territory. Shionogi recently reported completion of a Phase 2 clinical
trial of zuranolone for the treatment of patients with moderate to severe MDD in
Japan, which Shionogi reported achieved its primary endpoints.

In addition to zuranolone, we have a portfolio of other novel compounds that
target GABAA receptors, including SAGE-324. SAGE-324 is a novel GABAA receptor
positive allosteric modulator intended for chronic oral dosing. In April 2021,
we announced that our placebo-controlled Phase 2 KINETIC Study
evaluating SAGE-324 for the treatment of adults with essential tremor had
achieved its primary endpoint. We initiated a Phase 2b dose-ranging clinical
trial of SAGE-324 in patients with essential tremor in late 2021, known as the
KINETIC 2 Study. Additional development plans for SAGE-324 will be determined as
part of our strategic collaboration with Biogen. We plan to initiate a Phase 2
clinical

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trial evaluating the safety of SAGE-324 in patients with essential tremor in
mid-2022. We believe SAGE-324 also has potential for the treatment of a number
of other neurological conditions, including epilepsy and Parkinson's disease.

Our second area of focus for development is novel compounds that target the NMDA
receptor. Our lead product candidate selected in this area is SAGE-718, an
oxysterol-based positive allosteric modulator of the NMDA receptor, which we are
exploring in certain cognition-related disorders associated with NMDA receptor
dysfunction, including cognition dysfunction associated with diseases such as
Huntington's disease, Parkinson's disease and Alzheimer's disease. We achieved
development milestones in 2021 evaluating SAGE-718 for the treatment of
cognitive issues associated with Huntington's disease, Parkinson's disease and
Alzheimer's disease.

SAGE-718 is currently being studied in a double-blind placebo-controlled Phase 2
clinical trial of SAGE-718 in patients with Huntington's disease cognitive
impairment, known as the DIMENSION Study. The DIMENSION Study is designed to
evaluate the efficacy of once-daily dosed SAGE-718 over three months. Dosing in
the DIMENSION Study commenced in early 2022. We plan to initiate, in mid-2022, a
second placebo-controlled Phase 2 clinical trial of SAGE-718 in patients with
Huntington's disease cognitive impairment, with a healthy volunteer component,
known as the SURVEYOR Study, with the goal of generating evidence linking
efficacy signals on cognitive performance to domains of real-world functioning.
We also plan to initiate a Phase 3 open-label study of SAGE-718 in patients with
Huntington's disease cognitive impairment in late 2022. The FDA has granted
SAGE-718 Fast Track designation as a potential treatment for patients with
Huntington's disease.

We also achieved development milestones in 2021 evaluating SAGE-718 for the
treatment of cognitive issues associated with Parkinson's disease and
Alzheimer's disease. In May 2021, we announced results from the first part of a
Phase 2a open-label study of SAGE-718 evaluating patients with mild cognitive
impairment due to Parkinson's disease, known as the PARADIGM Study. Data from
the PARADIGM Study showed that SAGE-718 had a positive impact on multiple
domains of cognition, including executive function and learning and memory,
while leaving domains altering simple attention or reaction time unaffected. A
four-week dosing cohort in the PARADIGM Study is ongoing to gather additional
data in the Parkinson's disease patient population. We plan to initiate a
placebo-controlled Phase 2 clinical trial of SAGE-718 in patients with mild
cognitive impairment due to Parkinson's disease in mid-2022. In December 2021,
we reported topline data from a Phase 2a open-label clinical trial of SAGE-718
in patients with mild cognitive impairment and mild dementia due to Alzheimer's
disease, known as the LUMINARY Study. Data from the LUMINARY Study showed
treatment with SAGE-718 resulted in consistent improvement across multiple tests
of executive performance, as well as improvement on key tests of learning and
memory. In addition, SAGE-718 has been well-tolerated in studies to date. We
also plan to initiate a randomized placebo-controlled Phase 2 clinical trial of
SAGE-718 in patients with mild cognitive impairment and mild dementia due to
Alzheimer's disease in late 2022.

We have other programs at earlier stages of development with a focus on both
acute and chronic brain health disorders. We expect to continue our work on
allosteric modulation of the GABAA and NMDA receptor systems in the brain. The
GABAA and NMDA receptor systems are broadly accepted as impacting many
psychiatric and neurological disorders, spanning disorders of mood, seizure,
cognition, anxiety, sleep, pain, and movement, among others. We believe that we
may have the opportunity to develop molecules from our internal portfolio with
the goal of addressing a number of these disorders in the future. We also
believe that we may have the opportunity to use our scientific approach to
explore targets beyond the GABAA and NMDA receptor systems and to develop
compounds in areas of unmet need outside of brain health.

We began to generate revenue from product sales in the second quarter of 2019 in
conjunction with the launch of our first product, ZULRESSO, in June 2019. In the
fourth quarter of 2020, we recorded revenue from the strategic collaboration
with and stock purchase by Biogen.

We have incurred net losses in each year since our inception, except for net
income of $606.1 million for the year ended December 31, 2020, reflecting
revenue recognized under the Biogen Collaboration Agreement, and we had an
accumulated deficit of $1.5 billion as of December 31, 2021. Our net losses were
$457.9 million and $680.2 million for the years ended December 31, 2021 and
2019, respectively. These losses have resulted principally from costs incurred
in connection with research and development activities and selling, general and
administrative costs associated with our operations and our commercial build. We
expect to incur significant expenses and increasing operating losses for the
foreseeable future.

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We expect that our expenses will increase significantly in the foreseeable future in connection with our ongoing activities, if and as we:

• complete ongoing Phase 3 clinical trials of zuranolone in MDD and PPD;

advance our regulatory, permitted pre-launch and launch-readiness

activities with respect to zuranolone, including activities focused on the

planned filing of an NDA for zuranolone in MDD in the U.S. in the second

half of 2022, and the planned associated NDA filing for zuranolone in PPD


        in the U.S. in the first half of 2023; and potentially advance the
        development of zuranolone in additional indications as part of our
        strategic collaboration with Biogen;

• continue our commercialization efforts with respect to ZULRESSO for the


        treatment of PPD in the U.S., with a primary focus on geographies that
        have existing, active ZULRESSO treating sites;


    •   complete the ongoing KINETIC 2 Study of SAGE-324 in patients with

essential tremor, and initiate additional development activities with

SAGE-324, including potential future development in epilepsy, Parkinson's

disease, and other neurological conditions, as part of our strategic

collaboration with Biogen;

• complete the ongoing Phase 2 clinical trials evaluating SAGE-718 in the

treatment of Huntington's disease and in patients with mild cognitive

impairment due to Parkinson's disease, and initiate the planned Phase 2

clinical trials evaluating SAGE-718 in the treatment of Huntingon's

disease cognitive impairment, in patients with mild cognitive impairment

due to Parkinson's disease, and in patients with mild cognitive impairment

and mild dementia due to Alzheimer's disease, and the planned open-label

Phase 3 clinical trial of SAGE-718 in patients with Huntington's disease

cognitive impairment;

• support our collaboration with Biogen with respect to zuranolone and

SAGE-324 in the U.S., and support Biogen's development of zuranolone and

SAGE-324 in Biogen's licensed territories outside the U.S. and Shionogi's


        development of zuranolone in the Shionogi Territory;


  • advance our earlier-stage compounds;

• continue our research and development efforts to evaluate the potential


        for our existing product candidates for the treatment of additional
        indications or in new formulations;

• identify new targets, and generate and test new compounds and product

candidates, with a focus on indications where we believe we can make

well-informed, rapid go/no-go decisions, with the goal of developing a

diversified portfolio of assets with differentiated features;




    •   prepare and file new drug applications with the U.S. Food and Drug
        Administration, or FDA, and conduct permitted pre-launch activities with
        respect to any of our other product candidates that we believe have been
        successfully developed;

• commercialize any product candidates for which we obtain regulatory

approval, including the manufacture of commercial supplies;

• as our development efforts progress, add personnel, including personnel to

support product development and ongoing and future commercialization

efforts;

• evaluate the market potential and regulatory pathways for our product


        candidates beyond zuranolone and SAGE-324 in the European Union and other
        countries outside the U.S., and determine how best to move forward where
        and when it may make business and strategic sense;

• continue to build, maintain, defend, leverage, and expand our intellectual

property portfolio, including by utilizing the strengths of our

proprietary chemistry platform and scientific know-how to expand our

portfolio of new chemical entities to lessen our long-term reliance on the

success of any one program and to facilitate long-term growth; and

• continue to explore opportunities to establish agreements or alliances


        with other pharmaceutical companies, at the appropriate time, where we
        believe a collaboration will add significant value to our efforts,
        including through capabilities, infrastructure, speed or financial

contributions, or to acquire new compounds, product candidates or products


        if we believe such opportunities will help us achieve our goals or meet
        other strategic objectives.


Until such time that we can generate significant revenue from product sales, if
ever, we expect to finance our operations primarily through a combination of
revenue, equity or debt financings and other sources, including our

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collaborations with Biogen and Shionogi and potential future collaborations. We
may not be successful in our commercialization of ZULRESSO or any other product,
and may not generate meaningful revenue or revenue at the levels or on the
timing necessary to support our investment and goals. We may never successfully
complete development of any of our current or future product candidates, file
for or obtain necessary regulatory approval for such product candidates, or
achieve commercial viability for any resulting approved product. We may not
obtain or maintain adequate patent protection or other exclusivity for our
products or product candidates. Adequate additional financing may not be
available to us on acceptable terms, or at all. Our inability to raise capital
if and when needed would have a negative impact on our financial condition and
on our ability to pursue our business strategy. Arrangements with our existing
collaborators have required us to relinquish rights to certain of our
technologies or product candidates, and any future collaborations may require us
to relinquish additional rights. We will need to generate significant revenue to
achieve profitability, and we may never do so.

We expect that our existing cash, cash equivalents and marketable securities as
of December 31, 2021, in addition to ongoing collaboration funding, will enable
us to fund our operating expenses and capital expenditure requirements, based on
our current operating plans, for at least the next 24 months from the filing
date of this Annual Report. See "-Liquidity and Capital Resources".

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                         Financial Operations Overview

Revenue

We began to generate revenue from product sales in the second quarter of 2019 in conjunction with the launch of our first product, ZULRESSO, in June 2019.



Our revenue from sales of ZULRESSO has been negatively impacted by significant
barriers arising from the complex requirements for treatment, and, more
recently, by the spread of COVID-19 in the U.S. ZULRESSO is administered as a
continuous infusion given over two and a half days. Because of the risk of
serious harm resulting from excessive sedation or sudden loss of consciousness
during the ZULRESSO infusion, ZULRESSO must be administered only in a
medically-supervised healthcare setting that has been certified under a Risk
Evaluation and Mitigation Strategies, or REMS, program and meets the other
requirements of the REMS program, including requirements related to monitoring
of the patient during the infusion. The actions required for a healthcare
setting to be ready and willing to treat women with PPD are complex and
time-consuming. These actions include: becoming REMS-certified; achieving
formulary approvals; establishing protocols for administering ZULRESSO; and
securing satisfactory reimbursement. Sites must often negotiate reimbursement on
a payor-by-payor basis under commercial coverage. These requirements have
created significant barriers to treatment, and are expected to continue to limit
future revenue growth. These barriers have been compounded by the COVID-19
pandemic. The spread of COVID-19 in the U.S. resulted in a significant number of
sites of care pausing, limiting or delaying treatment of new patients with
ZULRESSO and potential new sites of care pausing site activation activities for
a period of time. We believe concerns about exposure to the virus or its
variants as well as the disruption to the healthcare system in the U.S. caused
by the pandemic have also caused a significant reduction in the number of women
with PPD seeking treatment with ZULRESSO and in the number of physicians willing
to prescribe it. Given continuing concerns about the COVID-19 pandemic across
the country, including as a result of the spread of variants and "breakthrough"
cases among fully-vaccinated people, and the resulting disruption in many
locations to healthcare resources, we expect the significant adverse impact of
the pandemic on ZULRESSO revenues, and our results of operations from sales of
ZULRESSO, to continue for the foreseeable future. The scope and timing of the
expected negative impact will depend on, among other factors, the scope and
duration of the pandemic and the timing of any return to normal business
operations across the U.S.; the effectiveness of vaccination campaigns, vaccine
mandates, and other efforts to control the pandemic; the duration of the
vaccines' efficacy against COVID-19 and its variants; the extent to which
variants of the virus that causes COVID-19 negatively impact vaccination and
other efforts to control the pandemic; the duration and severity of any
restrictive measures taken to curb the spread of COVID-19; the extent of
healthcare staffing shortages due to COVID-19; and the impact of the pandemic on
our customers and vendors. Given the continued fluidity of the COVID-19
pandemic, we cannot predict its course or for how long and to what extent it
will have an adverse impact on ZULRESSO sales.

In April 2020, we implemented a workforce reduction that primarily affected the
ZULRESSO commercial operation and related support functions, including
eliminating the entirety of our salesforce at that time. While we remain
committed to working with healthcare providers and women with PPD seeking access
to ZULRESSO and plan to continue to evaluate opportunities to raise awareness
and help reduce hurdles to appropriate treatment, our ongoing commercial
efforts, including our account management field-based team and sales
representatives now in place, are primarily focused on geographies that have
existing, active ZULRESSO treating sites. We expect that this approach to our
commercial efforts may continue to substantially limit the revenue opportunity
for ZULRESSO.

We expect that ZULRESSO revenues are likely to fluctuate quarter to quarter. We
will not generate revenue from other products unless and until we or any of our
collaborators successfully develop, obtain regulatory approval of, and
commercialize one of our current or future product candidates. If we enter into
additional collaboration agreements with third parties for our product
candidates, we may generate revenue from those collaborations. We expect that
revenue, if any, that we may generate under our existing or future collaboration
agreements will fluctuate from quarter to quarter as a result of the timing and
amount of license fees, payments for clinical materials or manufacturing
services, milestone payments, royalties paid to us and our share of
collaboration profits or losses resulting from sales of any commercialized
products, and other payments.

In June 2018, we entered into a strategic collaboration with Shionogi for the
clinical development and commercialization of zuranolone for the treatment of
MDD and other potential indications in the Shionogi Territory. Under the terms
of the agreement, Shionogi is responsible for all clinical development,
regulatory filings and commercialization and manufacturing of zuranolone for
MDD, and potentially other indications, in the Shionogi

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Territory. In October 2018, we also entered into a supply agreement with
Shionogi for zuranolone clinical material. To date, revenue from our
collaboration with Shionogi has come from an initial, upfront license fee upon
execution of the collaboration agreement of $90.0 million, which was recorded as
collaboration revenue in the year ended December 31, 2018, and for the supply of
active pharmaceutical agreement, or API, for Shionogi's clinical trials.

In November 2020, we entered into the Biogen Collaboration Agreement with Biogen
for the development, manufacture and commercialization of the Licensed Products.
In connection with the execution of the Biogen Collaboration Agreement, we also
entered into a stock purchase agreement for the sale and issuance to BIMA of
6,241,473 shares of our common stock. The Biogen Collaboration Agreement became
effective in December 2020, and the sale of the common stock under the stock
purchase agreement closed on December 31, 2020. As a result of the purchase of
common stock by BIMA, Biogen has become a related party of ours. Under the terms
of the Biogen Collaboration Agreement, we will jointly develop and, if
successful, commercialize the Licensed Products in the U.S., and Biogen solely
will develop and commercialize the Licensed Products in the Biogen Territory. We
and Biogen have agreed to share equally all costs for activities under the
Biogen Collaboration Agreement solely for the U.S. Biogen is solely responsible
for all costs for activities under the Biogen Collaboration Agreement in the
Biogen Territory. In the year ended December 31, 2020, we recorded collaboration
revenue - related party of $1.1 billion, consisting of an upfront payment of
$875.0 million plus $232.5 million in excess proceeds from the equity investment
under the stock purchase agreement, when measured at fair value. For further
discussion regarding the accounting for the Biogen Collaboration Agreement,
please refer to Note 6, Collaboration Agreements, in the accompanying Notes to
Consolidated Financial Statements appearing elsewhere in this Annual Report.

Collaborative Arrangements



We analyze our collaboration arrangements to assess whether such arrangements
involve joint operating activities performed by parties that are both active
participants in the activities and exposed to significant risks and rewards
dependent on the commercial success of such activities and therefore within the
scope of Accounting Standards Codification, or ASC, Topic 808, Collaborative
Arrangements, or Topic 808. This assessment is performed throughout the life of
the arrangement based on changes in the responsibilities of all parties in the
arrangement. For collaboration arrangements within the scope of Topic 808 that
contain multiple elements, we first determine which elements of the
collaboration are deemed to be within the scope of Topic 808 and which elements
of the collaboration are more reflective of a vendor-customer relationship and
therefore within the scope of ASC Topic 606, Revenue from Contracts with
Customers, or Topic 606. For elements of collaboration arrangements that are
accounted for pursuant to Topic 808, an appropriate recognition method is
determined and applied consistently, either by analogy to authoritative
accounting literature or by applying a reasonable and rational policy election.
For those elements of the arrangement that are accounted for pursuant to Topic
606, we apply the five-step revenue recognition model and present the
arrangement as collaboration revenue in the consolidated statements of
operations and comprehensive income (loss). For further discussion regarding the
accounting for the Biogen Collaboration Agreement, please refer to Note 6,
Collaboration Agreements, in the accompanying Notes to Consolidated Financial
Statements appearing elsewhere in this Annual Report.

For collaboration arrangements that are within the scope of Topic 808, we
evaluate the income statement classification for presentation of amounts due
from or owed to other participants associated with multiple activities in a
collaboration arrangement based on the nature of each separate activity.
Payments or reimbursements that are the result of a collaborative relationship,
instead of a customer relationship, such as co-development and
co-commercialization activities, are recorded as research and development
expense or selling, general and administrative expense in the event of a payment
to the collaborative partner in a period, or a reduction to these expense line
items in the event of a reimbursement from the collaboration partner in a
period, as appropriate.

Cost of Goods Sold



Cost of goods sold includes direct and indirect costs related to the
manufacturing and distribution of ZULRESSO, including third-party manufacturing
costs, packaging services, freight, third-party royalties payable on our net
product revenues and amortization of intangible assets associated with ZULRESSO.
We estimate that our cost of goods sold as a percentage of net product revenue
will remain in the mid-single digit percentage range for the foreseeable future.
We expect to utilize zero-cost inventory with respect to ZULRESSO for an
extended period of time.

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Operating Expenses

Our operating expenses since inception have consisted primarily of costs associated with research and development activities and selling, general and administrative activities.

Research and Development Expenses



Research and development expenses, which consist primarily of costs associated
with our product research and development efforts, are expensed as incurred.
Research and development expenses consist primarily of:

• personnel costs, including salaries, benefits, stock-based compensation

and travel expenses, for employees engaged in research and development

functions;

• expenses incurred under agreements with contract research organizations,

or CROs, and sites that conduct our non-clinical studies and clinical

trials;

• expenses associated with manufacturing materials for use in non-clinical


        studies and clinical trials and developing external manufacturing
        capabilities;


    •   costs of outside consultants engaged in research and development
        activities, including their fees and travel expenses;

• other expenses related to our non-clinical studies and clinical trials and

expenses related to our regulatory activities, including the planned


        submission of NDAs to the FDA for zuranolone in 2022 and 2023;


  • payments made under our third-party license agreements; and

• a portion of our information technology, facilities and other related


        expenses, including rent, depreciation, maintenance of facilities,
        insurance and supplies.



We consider the collaborative activities associated with the co-development,
co-commercialization, and co-manufacturing of SAGE-217 products and SAGE-324
products in the U.S. to be separate units of account within the scope of Topic
808 as we and Biogen are both active participants in the development and
commercialization activities and are exposed to significant risks and rewards
that are dependent on the development and commercial success of the activities
in the arrangement. Payments to or reimbursements from Biogen related to the
co-development and co-manufacturing activities are accounted for as an increase
to or reduction of research and development expense. During the year ended
December 31, 2021, we recorded net reimbursement of $79.8 million from Biogen
that was deducted from our research and development expenses because we incurred
a greater amount of these expenses than Biogen. There were no comparable costs
or reimbursements in the year ended December 31, 2020.

Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.



We have been developing our product candidates and focusing on other research
and development programs, including exploratory efforts to identify new
compounds, target validation for identified compounds and lead optimization for
our earlier-validated programs. Our direct research and development expenses are
tracked on a program-by-program basis, and consist primarily of external costs,
such as fees paid to investigators, central laboratories, CROs and contract
manufacturing organizations, in connection with our non-clinical studies and
clinical trials; third-party license fees related to our product candidates; and
fees paid to outside consultants who perform work on our programs. We do not
allocate employee-related costs and other indirect costs to specific research
and development programs because these costs are deployed across multiple
product programs under research and development and, as such, are separately
classified as unallocated or stock-based compensation in research and
development expenses.

Research and development activities are central to our business. Product
candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials.
We expect that our research and development expenses will continue to increase
in the foreseeable future as we continue or initiate clinical trials and
non-clinical studies for certain product candidates and pursue later stages of
clinical development of our product candidates.

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We cannot determine with certainty the duration and costs of the current or future clinical trials of our product candidates. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:

• the scope, size, rate of progress, and expense of our ongoing as well as

any additional clinical trials, non-clinical studies, and other research


        and development activities;


    •   future results of ongoing, planned or future clinical trials and
        non-clinical studies;

• decisions by regulatory authorities related to our product candidates;




  • uncertainties in clinical trial enrollment rate or design;


  • significant and changing government regulation; and


  • the receipt and timing of regulatory approvals, if any.


In addition, the ongoing COVID-19 pandemic may also negatively impact our
ongoing and planned development activities and increase our research and
development costs. Concerns, precautions and restrictions arising from the
COVID-19 pandemic may substantially slow clinical site recruitment and
initiation and enrollment in our clinical trials, may impair the conduct,
auditing, monitoring, or completion of our trials, may impair or impede the
timeliness and completion of our data collection and analysis efforts or the
integrity of our data, or may cause us to pause trials, in each case which may
significantly impact our ability to meet our expected timelines or cause us to
change our plans and may significantly increase our research and development
costs. For example, we have seen some slower recruitment in certain of our
clinical trials, especially with respect to older patients and in our SKYLARK
Study in patients with PPD, which caused us to revise our expected timeline for
reporting topline data from that study.

A change in the outcome of any of these variables with respect to the
development of a product candidate could mean a significant change in the costs
and timing associated with the development of that product candidate. For
example, if the FDA or another regulatory authority were to require us to
conduct clinical trials beyond those that we currently anticipate will be
required for the completion of clinical development of a product candidate or
for regulatory approval, or if we experience significant delays in enrollment in
any of our clinical trials or need to enroll additional patients, we could be
required to expend significant additional financial resources and time on the
completion of clinical development.

Any failure to complete any stage of the development of any potential product
candidates in a timely manner could have a material adverse effect on our
operations, financial position and liquidity. A discussion of some of the risks
and uncertainties associated with not completing our programs on schedule, or at
all, and the potential consequences of failing to do so, are set forth in Part
I, Item 1A, "Risk Factors".

Selling, General and Administrative Expenses



Selling, general and administrative expenses consist primarily of personnel
costs, including salaries, benefits and travel expenses for our executive,
finance, business, commercial, corporate development and other administrative
functions, and stock-based compensation expense. Selling, general and
administrative expenses also include professional fees for expenses incurred
under agreements with third parties relating to the commercialization of
ZULRESSO; permitted pre-launch and launch-readiness activities related to
zuranolone; public relations, audit, tax and legal services, including legal
expenses to pursue patent protection of our intellectual property; and a portion
of our information technology, facilities and other related expenses, including
rent, depreciation, maintenance of facilities, insurance and supplies.

In April 2020, we implemented a workforce reduction that primarily affected the
ZULRESSO commercial operation and related support functions, including
eliminating the entirety of our salesforce at that time. While we remain
committed to working with healthcare providers and women with PPD seeking access
to ZULRESSO and plan to continue to evaluate opportunities to raise awareness
and help reduce hurdles to appropriate treatment, our ongoing commercial
efforts, including our account management field-based team and sales
representatives now in place, are primarily focused on geographies that have
existing, active ZULRESSO treating sites. We expect to continue to incur
significant commercialization expenses, including payroll and related expenses,
to support our ongoing commercial activities associated with ZULRESSO. We expect
that selling, general and administrative expenses will increase in the future as
we

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progress development efforts and prepare for potential commercialization of
zuranolone, if approved, and our other current or future product candidates, if
successfully developed and approved. We expect to continue to incur significant
expenses associated with general operations, including costs related to
accounting and legal services, director and officer insurance premiums,
facilities and other corporate infrastructure and office-related costs, such as
information technology costs.

We consider the collaborative activities associated with the co-development,
co-commercialization, and co-manufacturing of SAGE-217 products and SAGE-324
products in the U.S. to be separate units of account within the scope of Topic
808 as we and Biogen are both active participants in the development and
commercialization activities and are exposed to significant risks and rewards
that are dependent on the development and commercial success of the activities
in the arrangement. Payments to or reimbursements from Biogen related to the
co-commercialization activities are accounted for as an increase to or reduction
of selling, general and administrative expense. During the year ended
December 31, 2021, we recorded net reimbursement of $11.3 million from Biogen
that was deducted from our selling, general and administrative expenses because
we incurred a greater amount of these expenses than Biogen. There were no
comparable costs or reimbursements in the year ended December 31, 2020.

      Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements are prepared in accordance with generally
accepted accounting principles in the U.S. The preparation of our consolidated
financial statements and related disclosures requires us to make estimates and
assumptions that affect the reported amount of assets, liabilities, revenue,
costs and expenses, and related disclosures. We believe that the estimates and
assumptions involved in the accounting policies described below may have the
greatest potential impact on our consolidated financial statements and,
therefore, consider these to be our critical accounting policies. We evaluate
our estimates and assumptions on an ongoing basis. Our actual results may differ
from these estimates under different assumptions and conditions. While our
significant accounting policies are described in more detail in the notes to our
consolidated financial statements appearing elsewhere in this Annual Report, we
believe that the following accounting policies are those most critical to the
judgments and estimates used in the preparation of our consolidated financial
statements.

Revenue Recognition

We generate revenue from the sale of ZULRESSO and from collaboration and supply
agreements with our collaborators. To date, revenue from collaboration
agreements has come from initial, upfront payments allocated to licenses of
intellectual property delivered to our collaborators, from the sale of shares of
our common stock to Biogen in connection with the Biogen Collaboration
Agreement, or the Biogen Equity Purchase, and from the supply of material for
clinical trials under a supply agreement.

Under ASC Topic 606, Revenue from Contracts with Customers, or Topic 606, an
entity recognizes revenue when its customer obtains control of promised goods or
services, in an amount that reflects the consideration that the entity expects
to receive in exchange for those goods or services. To determine revenue
recognition for arrangements that an entity determines are within the scope of
Topic 606, the entity performs the following five steps: (i) identify the
contract(s) with a customer; (ii) identify the performance obligations in the
contract; (iii) determine the transaction price, including variable
consideration, if any; (iv) allocate the transaction price to the performance
obligations in the contract; and (v) recognize revenue when (or as) the entity
satisfies a performance obligation. Arrangements that include rights to
additional goods or services that are exercisable at a customer's discretion are
generally considered options. We assess if these options provide a material
right to the customer and if so, they are considered performance obligations.
The exercise of a material right may be accounted for as a contract modification
or as a continuation of the contract for accounting purposes.

For contracts determined to be within the scope of Topic 606, we assess whether
the goods or services promised within each contract are distinct to identify
those that are performance obligations. This assessment involves subjective
determinations and requires management to make judgments about the individual
promised goods or services and whether such are separable from the other aspects
of the contractual relationship. Promised goods and services are considered
distinct provided that: (i) the customer can benefit from the good or service
either on its own or together with other

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resources that are readily available to the customer and (ii) the entity's promise to transfer the good or service to the customer is separately identifiable from other promises in the contract.



We allocate the transaction price (the amount of consideration we expect to be
entitled to from a customer in exchange for the promised goods or services) to
each performance obligation and recognize the associated revenue when (or as)
each performance obligation is satisfied. Our estimate of the transaction price
for each contract includes all variable consideration to which we expect to be
entitled.

Collaboration and License Revenue



In assessing whether a promised good or service is distinct in the evaluation of
a collaboration or license arrangement subject to Topic 606, we consider factors
such as the research, manufacturing and commercialization capabilities of the
collaboration partner, and the availability of the associated expertise in the
general marketplace. We also consider the intended benefit of the contract in
assessing whether a promised good or service is separately identifiable from
other promises in the contract. If a promised good or service is not distinct,
we are required to combine that good or service with other promised goods or
services until we identify a bundle of goods or services that is distinct.

The transaction price is then determined and allocated to the identified
performance obligations in proportion to their standalone selling prices, or
SSP, on a relative SSP basis. SSP is determined at contract inception and is not
updated to reflect changes between contract inception and when the performance
obligations are satisfied. Determining the SSP for performance obligations
requires significant judgment. In developing the SSP for a performance
obligation, we consider applicable market conditions and relevant
entity-specific factors, including factors that were contemplated in negotiating
the agreement with the customer and estimated costs. In certain circumstances,
we may apply the residual method to determine the SSP of a good or service if
the standalone selling price is considered highly variable or uncertain. We
validate the SSP for performance obligations by evaluating whether changes in
the key assumptions used to determine the SSP will have a significant effect on
the allocation of arrangement consideration between multiple performance
obligations.

If the consideration promised in a contract includes a variable amount, we
estimate the amount of consideration to which we will be entitled in exchange
for transferring the promised goods or services to a customer. We determine the
amount of variable consideration by using the expected value method or the most
likely amount method. We include the unconstrained amount of estimated variable
consideration in the transaction price. The amount included in the transaction
price is constrained to the amount for which it is probable that a significant
reversal of cumulative revenue recognized will not occur. At the end of each
subsequent reporting period, we re-evaluate the estimated variable consideration
included in the transaction price and any related constraint, and if necessary,
adjust our estimate of the overall transaction price. Any such adjustments are
recorded on a cumulative catch-up basis in the period of adjustment.

If an arrangement includes development and regulatory milestone payments, we
evaluate whether the milestones are considered probable of being reached and
estimate the amount to be included in the transaction price using the most
likely amount method. If it is probable that a significant revenue reversal
would not occur, the associated milestone value is included in the transaction
price. Milestone payments that are not within our control or the licensee's
control, such as regulatory approvals, are generally not considered probable of
being achieved until those approvals are received.

In determining the transaction price, we adjust consideration for the effects of
the time value of money if the timing of payments provides us with a significant
benefit of financing. We do not assess whether a contract has a significant
financing component if the expectation at contract inception is such that the
period between payment by the licensees and the transfer of the promised goods
or services to the licensees will be one year or less. We assessed our
arrangements with Shionogi and Biogen and concluded that a significant financing
component does not exist for either arrangement. For arrangements with licenses
of intellectual property that include sales-based royalties, including milestone
payments based on the level of sales, and the license is deemed to be the
predominant item to which the royalties relate, we recognize royalty revenue and
sales-based milestones at the later of (i) when the related sales occur, or (ii)
when the performance obligation to which the royalty has been allocated has been
satisfied.

We then recognize as revenue the amount of the transaction price that is
allocated to the respective performance obligation when (or as) each performance
obligation is satisfied at a point in time or over time, and if over time this
is based on the use of an output or input method. Revenue from our collaboration
agreement with Shionogi has come from initial, upfront consideration upon
execution of the agreement and for the supply of drug product for Shionogi
clinical

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trials. Revenue from our collaboration agreement with Biogen has come from initial, upfront consideration related to the execution of the Biogen Collaboration Agreement and from the Biogen Equity Purchase. For additional information, refer to Note 6, Collaboration Agreements, to our consolidated financial statements appearing elsewhere in this Annual Report.

Product Revenue, Net



We recognize product revenues, net of variable consideration related to certain
allowances and accruals that are determined using the expected value method, in
our consolidated financial statements at the point in time when control
transfers to the customer, which is typically when the product has been
delivered to the customer's location. The amount included in the transaction
price is constrained to the amount for which it is probable that a significant
reversal of cumulative revenue recognized will not occur. Our only performance
obligation identified for ZULRESSO is to deliver the product to the location
specified by the customer's order. We record shipping and handling costs
associated with delivery of product to our customers within selling, general and
administrative expenses on our consolidated statements of operations and
comprehensive income (loss). We expense incremental costs of obtaining a
contract as incurred if the expected amortization period of the asset would be
less than one year. If we were to incur incremental costs with an amortization
period greater than a year, such costs would be capitalized as contract assets,
as they are expected to be recovered, and would be expensed by amortizing on a
systematic basis that is consistent with the transfer to the customer of the
goods or services to which the asset relates. We did not have any contract
assets (unbilled receivables) at December 31, 2021, as customer invoicing
generally occurs before or at the time of revenue recognition. We did not have
any contract liabilities at December 31, 2021, as we did not receive any
payments in advance of satisfying our performance obligations to our customers.
Amounts billed or invoiced that are considered trade accounts receivable are
included in prepaid expenses and other current assets on the consolidated
balance sheets. As of December 31, 2021 and 2020, the Company had not provided
any allowance for bad debts against the trade accounts receivable, and the
amount of trade accounts receivable was not significant.

We record reserves, based on contractual terms, for the following components of
variable consideration related to product sold during the reporting period, as
well as our estimate of product that remains in the distribution channel
inventory of our customers at the end of the reporting period. On a quarterly
basis, we update our estimates, if necessary, and record any material
adjustments in the period they are identified.

Chargebacks: We estimate chargebacks from our customers who directly purchase
the product from us for discounts resulting from contractual commitments to sell
products to eligible healthcare settings at prices lower than the list prices
charged to our customers. Customers charge us for the difference between what
they pay to us for the product and the selling price to the eligible healthcare
settings. Reserves for chargebacks consist of credits that we expect to issue
for units that remain in the distribution channel inventories at the end of each
reporting period that we expect will be sold to eligible healthcare settings,
and chargebacks that customers have claimed, but for which we have not yet
issued a credit.

Government Rebates: We are subject to discount obligations under government
programs, including Medicaid. We record reserves for rebates in the same period
the related product revenue is recognized, resulting in a reduction of ZULRESSO
product revenues and a current liability that is included in accrued expenses on
our consolidated balance sheets. Our liability for these rebates consists of
invoices received for claims from prior quarters that have not been paid or for
which an invoice has not yet been received, estimates of claims for the current
quarter, and estimates of future claims that will be made for product that has
been recognized as revenue, but which remains in the distribution channel at the
end of each reporting period.

Trade Discounts and Allowances: We generally provide customary invoice discounts
on ZULRESSO sales to our customers for prompt payment and we pay fees for sales
order management, data, and distribution services. We estimate our customers
will earn these discounts and fees and deduct these discounts and fees in full
from gross ZULRESSO revenues and accounts receivable at the time we recognize
the related revenues.

Financial Assistance: We provide voluntary financial assistance programs to
patients with commercial insurance that have coverage and reside in states that
allow financial assistance. We estimate the financial assistance amounts for
ZULRESSO and record any such amounts within accrued expenses on the consolidated
balance sheets. The calculation of the accrual for financial assistance is based
on an estimate of claims and the cost per claim that we expect to receive using
demographics for patients who have registered and been approved for assistance.
Any adjustments are recorded in the same period the related revenue is
recognized, resulting in a

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reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses on the consolidated balance sheets.



Product Returns: Consistent with industry practice, we offer product return
rights to customers for damaged, defective or expiring product, provided it is
within a specified period around the product expiration date as set forth in our
return goods policy. We estimate the amount of our product sales that may be
returned by our customers and record this estimate as a reduction of revenue in
the period the related product revenue is recognized, as well as a reserve
within accrued expenses on our consolidated balance sheets. Product returns have
been immaterial to date and are expected to remain immaterial in the future.


Collaborative Arrangements

We analyze our collaboration arrangements to assess whether such arrangements
involve joint operating activities performed by parties that are both active
participants in the activities and exposed to significant risks and rewards
dependent on the commercial success of such activities and therefore within the
scope of ASC Topic 808, Collaborative Arrangements, or Topic 808. This
assessment is performed throughout the life of the arrangement based on changes
in the responsibilities of all parties in the arrangement. For collaboration
arrangements within the scope of Topic 808 that contain multiple elements, we
first determine which elements of the collaboration are deemed to be within the
scope of Topic 808 and which elements of the collaboration are more reflective
of a vendor-customer relationship and therefore within the scope of Topic 606.
For elements of collaboration arrangements that are accounted for pursuant to
Topic 808, an appropriate recognition method is determined and applied
consistently, either by analogy to authoritative accounting literature or by
applying a reasonable and rational policy election. For those elements of the
arrangement that are accounted for pursuant to Topic 606, we apply the five-step
revenue recognition model described above and presents the arrangement as
collaboration revenue in the consolidated statements of operations and
comprehensive income (loss).

For collaboration arrangements that are within the scope of Topic 808, we
evaluate the income statement classification for presentation of amounts due
from or owed to other participants associated with multiple activities in a
collaboration arrangement based on the nature of each separate activity.
Payments or reimbursements that are the result of a collaborative relationship
instead of a customer relationship, such as co-development and
co-commercialization activities, are recorded as research and development
expense or selling, general and administrative expense, in the event of a
payment to the collaborative partner in a period, or a reduction to these
expense line items in the event of a reimbursement from the collaboration
partner in a period, as appropriate.

Accrued Research and Development Expenses



As part of the process of preparing our consolidated financial statements, we
are required to estimate our accrued research and development expenses. This
process involves reviewing open contracts and purchase orders, communicating
with our personnel and vendors to identify services that have been performed on
our behalf and estimating the level of service performed and the associated
costs incurred for the services when we have not yet been invoiced or otherwise
notified of the actual costs. The majority of our service providers invoice us
in arrears for services performed, on a pre-determined schedule or when
contractual milestones are met; however, some require advance payments. We make
estimates of our accrued expenses as of each balance sheet date in our
consolidated financial statements based on facts and circumstances known to us
at that time. Examples of estimated accrued research and development expenses
include fees paid to:

• CROs in connection with performing research and development services on


        our behalf;


  • other providers in connection with clinical trials;


  • vendors in connection with non-clinical development activities; and

• vendors related to product manufacturing, development and distribution of

clinical supplies.




We base our expenses related to clinical trials on our estimates of the services
received and efforts expended pursuant to contracts with multiple CROs that
conduct and manage clinical trials on our behalf. The financial terms of these
agreements vary from contract to contract and may result in uneven payment
flows. There may be instances in which payments made to our vendors will exceed
the level of services provided and result in a prepayment of the clinical
expense. Payments under some of these contracts depend on factors such as the
successful enrollment of patients and the

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completion of clinical trial milestones. When determining accruals, we estimate
the time period over which services will be performed, enrollment of patients,
number of sites activated and level of effort to be expended in each period. If
the actual timing of the performance of services or the level of effort varies
from our estimate, we adjust the accrual or prepaid accordingly. Although we do
not expect our estimates to be materially different from amounts actually
incurred, our understanding of the status and timing of services performed
relative to the actual status and timing of services performed may vary and may
result in reporting expenses that are too high or too low in any particular
period. To date, we have not made any material adjustments to our prior
estimates of accrued research and development expenses.

Stock-Based Compensation



We recognize compensation expense for stock-based awards, including grants of
stock options and restricted stock units, made to employees, non-employee
directors and non-employee consultants based on the estimated fair value on the
date of grant, over the requisite service period. We recognize stock-based
compensation expense for only the portion of awards that are expected to vest.

For awards that vest upon achievement of a performance condition, we recognize
compensation expense when achievement of the performance condition is met or
during the period from which meeting the condition is deemed probable until the
expected date of meeting the performance condition, using management's best
estimates, which consider the inherent risk and uncertainty regarding the future
outcomes of the milestones.

The fair value of each stock option grant is estimated using the Black-Scholes
option-pricing model. Through the year ended December 31, 2019, we estimated our
expected volatility using a weighted average of the historical volatility of
publicly-traded peer companies and the volatility of our common stock. Effective
January 1, 2020, we began using the historical volatility of only our common
stock, as there is adequate historical data for the duration of the expected
term.

The expected term of the stock options granted to employees, non-employee
directors and non-employee consultants by us has been determined utilizing the
"simplified" method for awards that qualify as "plain-vanilla" stock options.
The risk-free interest rate is determined by reference to the U.S. Treasury
yield curve in effect at the date of grant for time periods approximately equal
to the expected term of the award. The expected dividend yield is based on the
fact that we have never paid cash dividends and do not expect to pay any cash
dividends in the foreseeable future.

We also apply a forfeiture rate in order to calculate stock-based compensation expense. Expected forfeitures are based on our historical experience and management's expectations of future forfeitures. To the extent actual forfeitures differ from the estimates, the difference is recorded as a cumulative adjustment in the period in which the estimates are revised.



The fair value of each stock option granted under our equity plans has been
calculated on the date of grant using the following weighted average
assumptions:

                                     Year Ended December 31,
                              2021             2020             2019
Expected dividend yield              0 %              0 %              0 %
Expected volatility              75.92 %          77.86 %          71.34 %
Risk-free interest rate           0.63 %           0.97 %           2.21 %
Expected term               5.92 years       5.98 years       6.05 years



These assumptions represented our best estimates, but the estimates involve
inherent uncertainties and the application of our judgment. As a result, if
factors change and we use significantly different assumptions or estimates when
valuing our stock options, our stock-based compensation expense could be
materially different. In developing a forfeiture rate estimate for pre-vesting
forfeitures, we have considered our historical experience of actual forfeitures.
In the future, if our actual forfeiture rate is materially different from our
estimate, then our stock-based compensation expense could be significantly
different from what we have recognized in the current period.


As of December 31, 2021, we had unrecognized stock-based compensation expense
related to our unvested time-based stock option awards of $86.0 million, which
is expected to be recognized over the remaining weighted average vesting period
of 2.62 years.

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As of December 31, 2021, 684,010 performance-based stock options were both
outstanding and unvested, the total unrecognized stock-based compensation
expense related to those awards was $10.8 million and the timing of recognition
of this stock-based compensation expense is subject to our judgment as to when
the performance conditions are considered probable of being achieved.

As of December 31, 2021, 1,256,098 time-based restricted stock units and
performance restricted stock units were both outstanding and unvested, and the
total unrecognized stock-based compensation expense related to those awards was
$59.2 million.

Recently Issued Accounting Pronouncements



A description of recently issued accounting pronouncements that may potentially
impact our financial position and results of operations is set forth in Note 2,
Summary of Significant Accounting Policies, to the consolidated financial
statements appearing elsewhere in this Annual Report.

Results of Operations

Comparison of the Years Ended December 31, 2021 and 2020



The following table summarizes our results of operations for the years ended
December 31, 2021 and 2020:

                                          Year Ended December 31,          Increase
                                            2021            2020          (Decrease)
                                                       (in thousands)
Product revenue, net                    $      6,308     $     6,700     $       (392 )
Collaboration revenue - related party              -       1,107,500       (1,107,500 )
Total revenue                                  6,308       1,114,200       (1,107,892 )
Operating costs and expenses:
Cost of goods sold                               553             565              (12 )
Research and development                     283,166         292,714           (9,548 )
Selling, general and administrative          183,498         196,952          (13,454 )
Restructuring                                      -          27,743          (27,743 )
Total operating costs and expenses           467,217         517,974          (50,757 )
Income (loss) from operations               (460,909 )       596,226       (1,057,135 )
Interest income, net                           2,883           9,597           (6,714 )
Other income, net                                134             250             (116 )
Net income (loss)                       $   (457,892 )   $   606,073     $ (1,063,965 )




Product Revenue, Net

During the years ended December 31, 2021 and 2020, we recognized $6.3 million
and $6.7 million, respectively, of net product revenues related to sales of
ZULRESSO. Sales allowances and accruals consisted of chargebacks, discounts,
distribution fees and patient financial assistance, and were not significant
during either year.


Collaboration Revenue

During the year ended December 31, 2021, we recognized no collaboration revenue
- related party from our agreement with Biogen. During the year ended
December 31, 2020, we recognized collaboration revenue - related party of $1.1
billion related to the execution of the Biogen Collaboration Agreement and the
Biogen Equity Purchase. The revenue consisted of an upfront payment of $875.0
million plus $232.5 million in excess proceeds from the Biogen Equity Purchase,
when measured at fair value.

During the years ended December 31, 2021 and 2020, we recognized no collaboration revenue from our agreement with Shionogi.


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We expect that revenue, if any, that we may generate under our collaboration
agreements will fluctuate from quarter to quarter as a result of the timing and
amount of license fees, payments for clinical materials or manufacturing
services, milestone payments, royalties paid to us and our share of
collaboration profits or losses resulting from sales of any commercialized
products, and other payments. For further discussion regarding our collaboration
agreements with Shionogi and Biogen and the accounting for revenue from
collaboration agreements, please refer to Note 2, Summary of Significant
Accounting Policies; and Note 6, Collaboration Agreements in the Notes to
Consolidated Financial Statements, appearing elsewhere in this Annual Report.


Cost of Goods Sold

During the years ended December 31, 2021 and 2020, cost of goods sold was $0.6
million and $0.6 million, respectively, and is made up of a low-single digit
royalty paid to CyDex Pharmaceuticals, Inc., a wholly owned subsidiary of Ligand
Pharmaceuticals Incorporated, or CyDex and The Regents of the University of
California, or the Regents, on net product revenue from sales of ZULRESSO, the
amortization of intangible assets associated with ZULRESSO and third-party
manufacturing and distribution costs associated with labeling, packaging, and
shipping of ZULRESSO. Prior to receiving initial FDA approval for ZULRESSO in
March 2019, we manufactured ZULRESSO inventory to be sold upon commercialization
and recorded $8.9 million related to this inventory build-up as research and
development expense. As a result, the manufacturing costs related to the
ZULRESSO inventory build-up incurred before FDA approval were already expensed
in a prior period and are therefore excluded from the cost of goods sold for the
years ended December 31, 2021 and 2020. We estimate that our cost of goods sold
as a percentage of net product revenue will remain in the mid-single digit
percentage range for the foreseeable future. We expect to utilize zero-cost
inventory with respect to ZULRESSO for an extended period of time.

Research and Development Expenses



                                            Year Ended December 31,          Increase
                                              2021             2020         (Decrease)
                                                         (in thousands)
zuranolone (SAGE-217)                     $    122,256       $ 116,614     $      5,642
SAGE-324                                        18,771          19,482             (711 )
SAGE-718                                        25,440           6,388           19,052

Other research and development programs 59,633 38,222


     21,411
Unallocated expenses                            87,168          69,638           17,530
Stock-based compensation                        49,746          42,370            7,376
Net reimbursement from Biogen                  (79,848 )             -

(79,848 ) Total research and development expenses $ 283,166 $ 292,714 $ (9,548 )

Research and development expenses for the year ended December 31, 2021 were $283.2 million, compared to $292.7 million for the year ended December 31, 2020. The decrease of $9.5 million was primarily due to the following:

• an increase of $5.6 million in expenses for development of zuranolone. The

increase in expenses was primarily due to spending on

manufacturing-related activities, including process validation and

production of zuranolone for clinical and commercial use, if approved for

commercial sale; offset by a decrease in spending on the WATERFALL Study;

• an increase of $19.1 million in expenses for development of SAGE-718. The

increase in expenses was primarily due to the initiation of a Phase 2

clinical trial and clinical pharmacology studies that were initiated


        during 2021;



    •   an increase of $21.4 million in expenses for other research and


        development programs. The increase in expenses was primarily due to Phase
        1 clinical trials of SAGE-689 and SAGE-904 and increased work on
        early-stage research programs;




                                      104


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• an increase of $17.5 million in expenses for unallocated expenses. The


        increase in expenses was primarily due to an increase in the hiring of
        employees and corporate infrastructure costs, such as information
        technology costs;


    •   an increase of $7.4 million in expenses for non-cash stock-based

compensation expense. The increase in expenses was primarily due to the

achievement of milestones for certain outstanding performance restricted

stock units, resulting in the recognition of $9.8 million of expense

during the year ended December 31, 2021, offset by the cancellation of

stock options held by former employees. During the year ended December 31,

2020, no non-cash stock-based compensation expense was recognized related

to the achievement of performance-based vesting criteria; and

• during the year ended December 31, 2021, the reduction in expenses due to


        net reimbursement from Biogen pursuant to the Biogen Collaboration
        Agreement was $79.8 million. The amount of net reimbursement was $61.1
        million for zuranolone, $9.4 million for SAGE-324 and $9.3 million for
        costs that are reimbursable and included in unallocated expenses.

Selling, General and Administrative Expenses



                                               Year Ended December 31,            Increase
                                               2021                2020          (Decrease)
                                                             (in thousands)
Personnel-related                          $      52,100       $     58,403     $      (6,303 )
Stock-based compensation                          54,883             51,836             3,047
Professional fees                                 43,428             50,533            (7,105 )
Other                                             44,369             36,180             8,189
Net reimbursement from Biogen                    (11,282 )                -           (11,282 )
Total selling, general and
administrative expenses                    $     183,498       $    196,952     $     (13,454 )

Selling, general and administrative expenses for the year ended December 31, 2021 were $183.5 million, compared to $197.0 million for the year ended December 31, 2020. The decrease of $13.5 million was primarily due to the following:

• a decrease of $6.3 million of expenses for personnel-related costs. The

decrease in expenses was primarily due to the termination of employees in


        the April 2020 restructuring;



    •   an increase of $3.0 million of expenses for non-cash stock-based

compensation expense. The increase in expenses was primarily due to the

achievement of milestones for certain outstanding performance restricted

stock units, resulting in the recognition of $6.7 million of expense

during the year ended December 31, 2021, offset by the cancellation of

stock options held by former employees. During the year ended December 31,

2020, no non-cash stock-based compensation expense was recognized related


        to the achievement of performance-based vesting criteria;

• a decrease of $7.1 million in expenses for professional fees. The decrease

in expenses was primarily due to transaction-related expenses for the

Biogen Collaboration Agreement that were incurred in the year ended

December 31, 2020, with no corresponding costs in the year ended December

31, 2021; the decrease was offset by an increase in activities focused on


        commercialization, including disease awareness and increased
        launch-readiness activities for a potential product launch, if our
        zuranolone development and regulatory efforts are successful;

• an increase of $8.2 million in expenses for other costs. The increase in


        expenses was primarily due to corporate infrastructure costs, such as
        information technology costs; and

• during the year ended December 31, 2021, the reduction in expenses due to


        net reimbursement from Biogen pursuant to the Biogen Collaboration
        Agreement was $11.3 million. The amount of net reimbursement was $9.3
        million for external costs and $2.0 million for personnel-related costs.




                                      105


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Restructuring



In the year ended December 31, 2021, we recorded no expense for restructuring.
In April 2020, we announced a restructuring plan to enable us to advance our
corporate strategy and pipeline that included the elimination of approximately
53% of our workforce. The workforce reduction primarily affected the ZULRESSO
commercial operation and related selling, general and administrative support
functions. In the year ended December 31, 2020, we recorded $27.7 million of
expense for restructuring, primarily for one-time termination benefits to the
affected employees, primarily for cash payments of severance, healthcare
benefits and outplacement assistance.

Interest Income, Net and Other income, Net

Interest income, net, and other income, net, for the years ended December 31, 2021 and 2020 were $3.0 million and $9.8 million, respectively. The primary reason for the decrease was the reduction in interest rates that started in early 2020.

Liquidity and Capital Resources



We began to generate revenue from product sales in the second quarter of 2019 in
conjunction with the launch of our first product, ZULRESSO, in June 2019. To
date, we have incurred recurring net losses, except for net income of $606.1
million for the year ended December 31, 2020, reflecting revenue recognized
under the Biogen Collaboration Agreement. As of December 31, 2021, we had an
accumulated deficit of $1.5 billion. On December 31, 2020, we completed the sale
of 6,241,473 shares of our common stock in a private placement to BIMA at a
price of approximately $104.14 per share, resulting in aggregate gross proceeds
of $650.0 million. From our inception through December 31, 2021, we have
received aggregate net proceeds of $2.8 billion from the sales of redeemable
convertible preferred stock prior to our initial public offering, the issuance
of convertible notes, and the sales of common stock in our initial public
offering in July 2014, follow-on offerings and in the Biogen Equity Purchase. We
also received $1.0 billion in upfront payments under our collaborations with
Biogen and Shionogi.

As of December 31, 2021, our primary sources of liquidity were our cash, cash
equivalents and marketable securities, which totaled $1.7 billion. We invest our
cash in money market funds, U.S. government securities, corporate bonds and
commercial paper, and our primary objectives are to preserve principal, provide
liquidity and maximize income without significantly increasing risk.

The following table summarizes the primary sources and uses of cash for the years ended December 31, 2021 and 2020:



                                    Year Ended December 31,
                                      2021            2020
                                         (in thousands)
Net cash provided by (used in):
Operating activities              $   (378,182 )   $   664,280
Investing activities                (1,002,448 )       442,684
Financing activities                    13,334         426,762
Total                             $ (1,367,296 )   $ 1,533,726




Operating Activities

During the year ended December 31, 2021, net cash used in operating activities
primarily resulted from our net loss of $457.9 million, which was primarily
attributable to our research and development activities and our selling, general
and administrative expenses, along with changes in our operating assets and
liabilities of $18.5 million, partially offset by $98.2 million of non-cash
items.

During the year ended December 31, 2020, net cash provided by operating activities primarily resulted from our net income of $606.1 million, which was primarily attributable to collaboration revenue - related party from our collaboration with Biogen, partially offset by our research and development activities and our selling, general and administrative

--------------------------------------------------------------------------------

expenses; and $97.9 million of non-cash items. It was partially offset by changes in our operating assets and liabilities of $39.7 million.

Investing Activities



During the years ended December 31, 2021 and 2020, net cash used by investing
activities was $1.0 billion and net cash provided by investing activities was
$442.7 million, respectively. During the years ended December 31, 2021 and 2020,
we purchased marketable securities and had sales and maturities of our
marketable securities as part of managing our cash and investments portfolio.
Additionally, during the year ended December 31, 2021, we invested the majority
of the cash that we received from Biogen under the Biogen Collaboration
Agreement and the Biogen Equity Purchase in marketable securities.

Financing Activities



During the years ended December 31, 2021 and 2020, net cash provided by
financing activities was $13.3 million and $426.8 million, respectively. During
the year ended December 31, 2021, the amounts were mainly from proceeds from the
exercises of stock options. During the year ended December 31, 2020, we received
$650.0 million of proceeds from our sale of 6,241,473 shares of our common stock
to Biogen under the stock purchase agreement, of which $417.5 million was
recorded as equity and the remainder was recorded as revenue.

Operating Capital Requirements



We began to generate revenue from product sales in the second quarter of 2019 in
conjunction with the launch of our first product, ZULRESSO. We anticipate that
we will continue to generate losses for the foreseeable future, and we expect
the losses to increase as we continue the development of our current and future
product candidates, and seek regulatory approvals for zuranolone and those other
product candidates that are successfully developed; prepare for potential future
commercialization of zuranolone and other product candidates beyond ZULRESSO
that are successfully developed and approved, including pre-launch and
launch-readiness activities; begin to commercialize any such products, if
approved; and continue our efforts to identify and develop new product
candidates beyond our current portfolio. We also expect to incur significant
costs associated with general operations. In addition, we expect to incur
significant commercialization expenses for product sales, marketing and
outsourced manufacturing with respect to ZULRESSO, zuranolone, if approved and
any other future products that are successfully developed and approved.
Accordingly, we anticipate that we will need substantial additional funding in
connection with our continuing operations.

Based on our current operating plans, we expect that our existing cash, cash
equivalents and marketable securities as of December 31, 2021, in addition to
ongoing collaboration funding, will enable us to fund our operating expenses and
capital expenditure requirements for at least the next 24 months from the filing
date of this Annual Report. During that time, we expect to incur significant
expenses as we continue to commercialize ZULRESSO; complete ongoing clinical
trials of zuranolone and advance regulatory, permitted pre-launch and
launch-planning activities; advance development of our other product candidates;
expand our research activities; and pursue our strategic plan.

Our current operating plan does not contemplate other activities that we may
pursue or that all of our currently planned activities will proceed at the same
pace, or that all of these activities will be fully initiated or completed
during that time. We have based our estimates on assumptions that could change,
and we may use our available capital resources sooner than we currently expect.
We may also choose to change or increase our development, commercialization or
other efforts. Because of the numerous risks and uncertainties associated with
the development and commercialization of any product or product candidates, we
are unable to estimate the amounts of increased capital outlays and operating
expenditures necessary to complete development of our current or future product
candidates or to commercialize any approved product.

Our future capital requirements will depend on many factors, including:

• the amount and timing of revenues from sales of ZULRESSO, which we expect

will continue to be impacted by a number of factors, including: the rate,

degree and level of market acceptance for ZULRESSO for the treatment of


        PPD in the U.S.; our decision to focus our efforts primarily on
        geographies that have existing, active ZULRESSO treating sites; the
        continued availability of healthcare settings in those geographies to

administer ZULRESSO and the ability and willingness of such healthcare

settings to make sufficient capacity

--------------------------------------------------------------------------------

available; the level of reimbursement for both ZULRESSO and the infusion


        in the healthcare setting both by commercial and government payors, and
        the nature of limitations on coverage and reimbursement; the number of

healthcare professionals willing to prescribe ZULRESSO and women with PPD

who agree to be treated with ZULRESSO; and the scope, duration and timing

of the impact of the COVID-19 pandemic;

• the timing and amount of costs associated with our commercialization of

ZULRESSO;

• the costs of regulatory, permitted pre-launch and launch-readiness

activities associated with zuranolone and, if zuranolone is approved for


        one or more indications, the costs associated with its commercial launch;


    •   the initiation, progress, completion, timing, costs, and results of

ongoing, planned and future non-clinical studies and clinical trials for

our existing and future product candidates; the number and length of

clinical trials required by regulatory authorities to support regulatory

approval; and the costs of preparing, submitting and supporting regulatory

filings for our product candidates;

• the length, severity and costs of disruptions, if any, associated with the


        COVID-19 pandemic on initiation and conduct of our clinical trials or on
        our supply chain;


    •   the ability of zuranolone, SAGE-324 and SAGE-718 and our other

clinical-stage product candidates to progress through clinical development

successfully; the outcome of discussions with regulatory authorities on

regulatory pathways with respect to our product candidates; the timing,

scope and outcome of regulatory filings and reviews and approvals of such

product candidates, if we are successful in our development efforts; the

scope and cost of any clinical trials or other commitments required

post-approval for any approved products resulting from such development

efforts, if successful; and the level, timing and amount of costs

associated with permitted prelaunch activities and preparing for a

potential future commercial launch of any such product candidate that is

successfully developed and approved;

• the amounts we are entitled to receive, if any, from Biogen and Shionogi


        under our collaborations for cost-sharing, development, regulatory, and
        sales milestones, and royalty payments;

• the size of the PPD market and the portion of the population for which

ZULRESSO may be prescribed; the size of the markets for which zuranolone

and our other product candidates may be approved in the future, if

successfully developed; the portion of the population in the approved

indications for which our future products are actually prescribed; the

rate and degree of market acceptance for our products, and the pricing,

availability and level of reimbursement for our products;

• the number and characteristics of the product candidates we pursue in

development and the nature and scope of our discovery and development

programs;

• the costs of preparing, filing and prosecuting patent applications,

maintaining and enforcing our intellectual property rights and defending


        intellectual property-related claims;


    •   the extent to which we acquire or in-license other products and
        technologies; and


    •   our ability to establish any future collaboration arrangements on
        favorable terms, if at all.



Until such time, if ever, as we can generate substantial product revenue and
achieve profitability, we expect to also finance our cash needs through a
combination of equity offerings, debt financings, collaborations, strategic
alliances, licensing arrangements and other sources of funding. Even if we
believe we have sufficient funds for our current or future operating plans, we
may seek additional capital if market conditions are favorable or in light of
other strategic considerations. To the extent that we raise additional capital
through the sale of equity or convertible debt securities, the ownership
interest of our stockholders will be diluted, and the terms of these securities
may include liquidation or other preferences that adversely affect the rights of
our common stockholders. Debt financing, if available, may involve agreements
that include covenants limiting or restricting our ability to take specific
actions, such as incurring additional debt, making capital expenditures or
declaring dividends and may require the issuance of warrants, which could
potentially dilute the ownership interest of our stockholders. If we raise
additional funds through collaborations, strategic alliances or licensing
arrangements with third parties, we may have to relinquish valuable rights to
our technologies, future revenue streams or research programs or to grant
licenses on terms that may not be favorable to us. Raising funds may present
challenges. Markets may experience volatility or become disrupted in the future
for any number of reasons,

                                      108
--------------------------------------------------------------------------------
including if current efforts to control the COVID-19 pandemic are not
successful. If we are unable to raise additional funds through equity or debt
financings or other means when needed, we may be required to delay, limit,
reduce or terminate our product development or future commercialization efforts
or grant rights to develop and market products or product candidates that we
would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments



The following table summarizes our contractual obligations at December 31, 2021
and the effect such obligations are expected to have on our liquidity and cash
flow in future periods:

                                                                Payments Due by Period
                                                    Less Than                                        More Than
                                       Total         1 Year         1-3 Years       3-5 Years         5 Years
                                                                    (in thousands)
Operating lease commitments(1)        $ 20,427     $     7,468     $    12,959     $          -     $          -
Total(1)(2)(3)                        $ 20,427     $     7,468     $    12,959     $                $          -



Amounts related to contingent milestone payments are not considered contractual
obligations as they are contingent on the successful achievement of certain
milestones. These contingent milestones may not be achieved. We have not
included any of these amounts in the table as we cannot estimate or predict
when, or if, these amounts will become due. We do not include amounts related to
milestones for indications that we are no longer pursuing.

(1) We lease office space in two multi-tenant buildings in Cambridge,

Massachusetts, consisting, as of December 31, 2021, of 63,017 square feet in

the first building under an operating lease, as amended, that will expire on

August 31, 2024 and 40,419 square feet in the second building under an

operating lease, as amended, that will expire on August 31, 2024. We lease

office space in a multi-tenant building in Raleigh, North Carolina,

consisting of 15,525 square feet under an operating lease that will expire on

November 30, 2024. We may lease additional space prior to the expiration of

our leases to meet the needs of the business. The minimum lease payments in

the table do not include related common area maintenance costs or real estate

taxes, because those costs are variable.

--------------------------------------------------------------------------------

(2) We have acquired exclusive and non-exclusive rights to use, research, develop

and offer for sale certain products and patents under license agreements. The

license agreements obligate us to make payments to the licensors for license

fees, milestones, license maintenance fees and royalties. We are obligated to

make future remaining milestone payments under these agreements of up to an

aggregate of $23.8 million upon achieving certain milestones, related to

clinical development, regulatory approvals and sales. During the year ended

December 31, 2021, we recorded expense of $0.2 million for milestones under

these license agreements.

(3) We enter into contracts in the normal course of business with CROs for

clinical trials, non-clinical research studies and testing, manufacturing and

other services and products as part of general operations. These contracts

generally provide for termination upon notice, and we believe that our

non-cancelable obligations under these agreements are not material.

Latest news about Sage Therapeutics, Inc.

TD Cowen Cuts Sage Therapeutics Price Target to $16 From $30, Maintains Buy Rating	Apr. 18	MT
Scotiabank Cuts Price Target on Sage Therapeutics to $19 From $34, Maintains Sector Outperform Rating	Apr. 18	MT
Oppenheimer Adjusts Sage Therapeutics Price Target to $17 From $25, Maintains Perform Rating	Apr. 18	MT
Top Midday Decliners	Apr. 17	MT
BofA Securities Downgrades Sage Therapeutics to Underperform From Neutral, Adjusts Price Target to $14 From $24	Apr. 17	MT
Sector Update: Health Care Stocks Advance Premarket Wednesday	Apr. 17	MT
Sector Update: Health Care	Apr. 17	MT
Earnings Focus Lifts Exchange-Traded Funds, Equity Futures Pre-Bell Wednesday	Apr. 17	MT
Transcript : Sage Therapeutics, Inc. - Special Call	Apr. 17
Top Premarket Decliners	Apr. 17	MT
Sage Therapeutics' Phase 2 Study of Dalzanemdor Fails to Meet Primary Endpoint	Apr. 17	MT
Sage Therapeutics, Inc. Announces Topline Results from Phase 2 PRECEDENT Study of DalzanemDor (SAGE-718) in the Treatment of Mild Cognitive Impairment in Parkinson's Disease	Apr. 17	CI
JPMorgan Raises Price Target on Sage Therapeutics to $29 From $24, Maintains Overweight Rating	Mar. 26	MT
Sage Therapeutics, Inc. Announces the Retirement of Steven Paul from the Board	Mar. 26	CI
Deutsche Bank Adjust Sage Therapeutics Price Target to $18 From $21, Maintains Hold Rating	Feb. 15	MT
Oppenheimer Adjusts Sage Therapeutics Price Target to $25 From $23, Maintains Perform Rating	Feb. 15	MT
RBC Raises PT on Sage Therapeutics to $26 From $21, Says Early Metrics From Zurzuvae Launch Suggest Promising Signs; Keeps Sector Perform, Speculative Risk	Feb. 15	MT
Sector Update: Health Care Stocks Edge Higher Premarket Wednesday	Feb. 14	MT
Sage Therapeutics Q4 Net Loss Narrows, Net Product Revenue Declines	Feb. 14	MT
Transcript : Sage Therapeutics, Inc., Q4 2023 Earnings Call, Feb 14, 2024	Feb. 14
Sage Therapeutics, Inc. Reports Earnings Results for the Full Year Ended December 31, 2023	Feb. 14	CI
Earnings Flash (SAGE) SAGE THERAPEUTICS Posts Q4 Revenue $78M, vs. Street Est of $61M	Feb. 14	MT
Sage Therapeutics, Inc. Reports Earnings Results for the Fourth Quarter Ended December 31, 2023	Feb. 14	CI
Wedbush Adjusts Sage Therapeutics' Price Target to $24 From $22, Keeps Neutral Rating	Jan. 29	MT
Sage Therapeutics, Inc. Enters into Lease Agreement with 55 Cambridge Parkway, LLC	Jan. 24	CI

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Company Profile

Sage Therapeutics, Inc. is a biopharmaceutical company. The Company has developed the two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health. The Company is targeting diseases and disorders of the brain across its clinical development and earlier stage pipeline. Its product ZURZUVAE is for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid that is a positive allosteric modulator of GABA receptors, targeting both synaptic and extra synaptic GABA receptors. Its product ZULRESSO (brexanolone) CIV injection is for the treatment of PPD in individuals 15 years old and older. It is also developing a portfolio of other novel compounds that target GABA receptors, including SAGE-324, which is a novel GABAA receptor positive allosteric modulator intended for chronic oral dosing. Its second area of focus for development is novel compounds that target the NMDA receptor.

Sector

Biotechnology & Medical Research

Calendar

2024-04-25 - Q1 2024 Earnings Release

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Russell 2000

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Ratings for Sage Therapeutics, Inc.

Trading Rating

Investor Rating

ESG Refinitiv

C+

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Analysts' Consensus

Sell

Buy

Mean consensus

HOLD

Number of Analysts

Last Close Price

13.04 USD

Average target price

24.39 USD

Spread / Average Target

+87.10%

Consensus

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Company calendar

Sector Bio Therapeutic Drugs

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