Private company
Sage Therapeutics, Inc.
In its 2025 annual report the company says: “We are a biopharmaceutical company with a mission to pioneer solutions to deliver life-changing brain health medicines, so every person can thrive. Our product ZURZUVAE ® (zuranolone) was approved by the U.S. Food and Drug Administration, or FDA, in August 2023 for the treatment of PPD in adults.”5 It is headquartered in Cambridge, United States.2
Last updated Oct 20, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersCambridge, United States2
- Incorporated inDE3
- Business address55 Cambridge Parkway, Cambridge, Ma 021423
- Filer categoryLarge accelerated filer3
- Legal formCorporation2
- LEI5493000JX4BJS9W6CN352
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 48124552
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We are a biopharmaceutical company with a mission to pioneer solutions to deliver life-changing brain health medicines, so every person can thrive. Alongside our commercial product for the treatment of postpartum depression, or PPD, we are advancing a portfolio of internally discovered novel chemical entities with the potential to become differentiated treatments designed to improve brain health by primarily targeting 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 GABA A receptors. The NMDA-type receptors of the glutamate receptor system are a major excitatory receptor system in the CNS. Dysfunction in these systems is thought to be at the core of numerous neuropsychiatric and neurodevelopmen…5 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Research and development51¢$225.9M
- Selling, general and admin49¢$216.4M
Out of $41.2M in revenue.6 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $90.3M7 | $6.9M8 | $1.1B9 | $6.3M10 | $7.7M6 | $86.5M6 | $41.2M6 |
| Research and development | $282.1M7 | $368.8M8 | $292.7M9 | $283.2M10 | $326.2M6 | $356.2M6 | $225.9M6 |
| Selling, general and admin | $201.4M7 | $345.8M8 | $197.0M9 | $183.5M10 | $227.7M6 | $274.5M6 | $216.4M6 |
| Operating expenses | $467.2M10 | $554.7M6 | $666.3M6 | $473.6M6 | |||
| Operating income | -$393.2M7 | -$708.1M8 | $596.2M9 | -$460.9M10 | -$547.0M6 | -$579.8M6 | -$432.4M6 |
| Income before tax | -$457.9M10 | -$532.8M6 | -$541.5M6 | -$400.7M6 | |||
| Income tax | |||||||
| Net income | -$372.9M7 | -$680.2M8 | $606.1M9 | -$457.9M10 | -$532.8M6 | -$541.5M6 | -$400.7M6 |
| Earnings per share | -$8.087 | -$13.388 | $11.669 | -$7.8010 | -$8.986 | -$9.056 | -$6.596 |
| Earnings per share (diluted) | -$8.087 | -$13.388 | $11.439 | -$7.8010 | -$8.986 | -$9.056 | -$6.596 |
| Shares (weighted, basic) | 58.7M shares10 | 59.3M shares6 | 59.8M shares6 | 60.8M shares6 | |||
| Shares (weighted, diluted) | 58.7M shares10 | 59.3M shares6 | 59.8M shares6 | 60.8M shares6 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $190.9M13 | $126.7M7 | $1.7B8 | $294.2M9 | $162.7M6 | $71.0M6 | $81.0M6 |
| Receivables | $13.7M10 | $83.0M6 | $9.1M6 | ||||
| Current assets | $944.7M13 | $1.0B7 | $2.1B8 | $1.8B9 | $1.3B10 | $869.4M6 | $531.3M6 |
| Property, plant and equipment | $3.0M9 | $2.9M10 | $1.9M6 | $890.0K6 | |||
| Total assets | $952.7M13 | $1.1B7 | $2.2B8 | $1.8B9 | $1.4B10 | $882.3M6 | $547.2M6 |
| Accounts payable | $10.4M9 | $18.9M10 | $10.3M6 | $12.7M6 | |||
| Current liabilities | $86.0M13 | $112.1M7 | $67.2M8 | $85.2M9 | $99.3M10 | $82.7M6 | $71.6M6 |
| Total liabilities | $89.7M13 | $139.5M7 | $86.9M8 | $96.3M9 | $103.8M10 | $82.7M6 | $82.1M6 |
| Retained earnings | -$1.5B9 | -$2.0B10 | -$2.6B6 | -$3.0B6 | |||
| Shareholders’ equity | $863.0M8 | $944.7M9 | $2.1B10 | $1.7B6 | $1.3B6 | $799.5M6 | $465.1M6 |
| Shares outstanding | 46.9M shares13 | 51.9M shares7 | 58.3M shares8 | 58.9M shares9 | 59.5M shares10 | 60.0M shares6 | 61.4M shares6 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$260.7M7 | -$528.7M8 | $664.3M9 | -$378.2M10 | -$460.0M6 | -$540.6M6 | -$267.2M6 |
| Stock-based compensation | $104.6M10 | $61.6M6 | $73.4M6 | $54.5M6 | |||
| Capital spending | $2.9M7 | $5.8M8 | $345.0K9 | $372.0K10 | $937.0K6 | $553.0K6 | $06 |
| Free cash flow | -$263.5M | -$534.5M | $663.9M | -$378.6M | -$461.0M | -$541.1M | -$267.2M |
| Cash from investing | -$1.0B10 | $325.4M6 | $442.9M6 | $266.7M6 | |||
| Cash from financing | $13.3M10 | $3.1M6 | $6.0M6 | $10.7M6 |
Corporate structure
Sage Therapeutics, Inc. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Sage Therapeutics, Inc.
- Madison Avenue Partners, LP Filed SCHEDULE 13G/A on Sage Therapeutics, Inc., latest Nov 14, 2025 (3 filings since Apr 1, 2025)
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Sage Therapeutics, Inc., latest Jul 29, 2025 (9 filings since Feb 10, 2022)
- FMR LLC Filed SCHEDULE 13G/A on Sage Therapeutics, Inc., latest Mar 7, 2025 (8 filings since Feb 9, 2022)
- Morgan Stanley Filed SCHEDULE 13G/A on Sage Therapeutics, Inc., latest Mar 6, 2025 (2 filings since Feb 5, 2025)
- RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Sage Therapeutics, Inc., latest Feb 14, 2025 (2 filings since Feb 14, 2024)
- BB Biotech Filed SCHEDULE 13G/A on Sage Therapeutics, Inc., latest Jan 17, 2025 (6 filings since Feb 11, 2022)
- BlackRock Filed SC 13G/A on Sage Therapeutics, Inc., latest Nov 8, 2024 (2 filings since Oct 21, 2024)
- State Street Corporation Filed SC 13G/A on Sage Therapeutics, Inc., latest Oct 18, 2024 (2 filings since Jan 24, 2024)
- Wellington Management Company Filed SC 13G/A on Sage Therapeutics, Inc., latest Jun 6, 2024 (5 filings since Feb 4, 2022)
- Sage Therapeutics, Inc. Cambridge, Massachusetts, United States
- England and Subsidiary · United Kingdom
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Sage Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $1.7M6 Dec 31, 2024 | $9.4M6 Dec 31, 2023 | −82.2% |
| Accumulated depreciation | $784.0K6 Dec 31, 2024 | $7.5M6 Dec 31, 2023 | −89.5% |
| Property and equipment, net | $890.0K6 Dec 31, 2024 | $1.9M6 Dec 31, 2023 | −53.7% |
| Operating-lease assets (leased space) | $10.8M6 Dec 31, 2024 | $4.5M6 Dec 31, 2023 | +141.2% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $81.0M6 Dec 31, 2024 | $71.0M6 Dec 31, 2023 | +14.1% |
| Marketable securities, current | $423.4M6 Dec 31, 2024 | $682.2M6 Dec 31, 2023 | −37.9% |
Properties, in its own words
Our corporate headquarters are located in Cambridge, Massachusetts. We lease 30,567 square feet of office space in a multi-tenant building pursuant to a lease dated as of January 2024, that will expire on February 28, 2030.
We have entered into other non-material leases and may lease additional space prior to the expiration of our leases to meet the needs of the business.
Item 2 of the 10-K filed Feb 11, 2025.5
Leadership
Who has led Sage Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerBarry E. Greene Jan 6, 2021 to now14
- Chief executive officerJeffrey M. Jonas Jan 27, 2015 to Apr 30, 202015
- PresidentBarry E. Greene Jan 6, 2021 to now14
- PresidentJeffrey M. Jonas Jan 27, 2015 to Apr 30, 202015
- Chief financial officerKimi Iguchi Jan 27, 2015 to now16
- Chief operating officerChristopher Benecchi Nov 14, 2024 to now17
Board members and other officers (23)
- OfficerMichael C. Quirk Apr 2, 2025 to now18
- OfficerGregory L. Shiferman Nov 1, 2024 to now19
- Chief Medical OfficerLaura Gault Nov 1, 2022 to now20
- Chief Commercial OfficerChristopher Benecchi Sep 13, 2021 to now21
- OfficerAnne Marie Cook Feb 8, 2017 to now22
- Chief Business OfficerMichael Cloonan Apr 25, 2017 to Feb 12, 202123
- Chief Scientific OfficerAlbert Robichaud Jul 17, 2014 to Feb 15, 202324
- OfficerJeffrey M. Jonas Jul 17, 2014 to Feb 18, 202225
- OfficerKimi Iguchi Jul 17, 2014 to Jun 8, 201526
- Chief Medical OfficerStephen Kanes Jul 17, 2014 to Oct 21, 202127
- Board memberJessica Federer Mar 17, 2023 to now28
- Board memberBarry E. Greene Oct 5, 2020 to now29
- Board memberElizabeth Barrett Jan 24, 2019 to now30
- Board memberGeorge Golumbeski Jan 24, 2019 to now31
- Board memberAsha Nayak Nov 8, 2017 to Jun 6, 201932
- Board memberGeno J. Germano Jul 19, 2016 to now33
- Board memberHoward H. Pien Jul 17, 2014 to Jun 24, 201634
- Board memberJames M. Frates Jul 17, 2014 to now35
- Board memberJeffrey M. Jonas Jul 17, 2014 to now25
- Board memberKevin P. Starr Jul 17, 2014 to Jun 16, 202336
- Board memberRobert Nelsen Jul 17, 2014 to Nov 12, 201537
- Board memberMichael F. Cola Sep 11, 2014 to now38
- General counselAnne Marie Cook Sep 17, 2015 to Apr 4, 201839
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- England and Wales4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Jul 31, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights40
- Jul 30, 20258-K Results of operations41
- Jun 16, 20258-K Entered a material agreement; Regulation FD disclosure42
- Jun 13, 20258-K Executive or director change; Shareholder vote43
- Apr 29, 20258-K Results of operations44
- Mar 4, 20258-K Executive or director change; Other events45
- Feb 11, 20258-K Results of operations46
- Jan 27, 20258-K Other events47
- Jan 13, 20258-K Regulation FD disclosure; Other events48
- Nov 26, 20248-K Executive or director change49
- Nov 20, 20248-K Other events50
- Nov 1, 20248-K Executive or director change51
- Jan 6, 2021New chief executive Barry E. Greene becomes CEO14
- Jan 27, 2015New chief executive Jeffrey M. Jonas becomes CEO15
- Apr 15, 2010Founded Sage Therapeutics, Inc. is founded2
Calendar
When it reported results
- Jul 30, 2025Reported quarterly or annual results41
- Apr 29, 2025Reported quarterly or annual results44
- Feb 11, 2025Reported quarterly or annual results46
- Oct 29, 2024Reported quarterly or annual results52
- Jul 31, 2024Reported quarterly or annual results53
- Apr 25, 2024Reported quarterly or annual results54
- Feb 14, 2024Reported quarterly or annual results55
- Nov 7, 2023Reported quarterly or annual results56
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
297 filings to the SEC since October 2021: 4 annual reports, 12 quarterly reports, 52 major events, 130 insider forms, 39 large holders, 60 other. The latest 20:
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Aug 14, 2025SCHEDULE 13G/A EDGAR
- Aug 11, 202515-12G EDGAR
- Aug 1, 2025POSASR EDGAR
- Aug 1, 2025POSASR EDGAR
- Aug 1, 2025POSASR EDGAR
- Aug 1, 2025POSASR EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
- Aug 1, 2025S-8 POS EDGAR
The 297 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
5 open-market trades by officers, directors and large owners since October 2021: 4 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 9, 2023 | Barrett ElizabethDirector | Buy | 2,000 | $18.64 | $37.3K | Form 4 |
| May 9, 2023 | Barrett ElizabethDirector | Buy | 1,000 | $50.50 | $50.5K | Form 4 |
| Feb 10, 2023 | JONAS JEFFREY MDirector | Sale | 11,643 | $44.61 | $519.4K | Form 4 |
| Nov 10, 2022 | Greene Barry EPresident and CEO | Buy | 14,500 | $34.48 | $500.0K | Form 4 |
| May 5, 2022 | Golumbeski GeorgeDirector | Buy | 8,000 | $31.45 | $251.6K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Madison Avenue Partners, LPSCHEDULE 13G/A, 3 filings Apr 1, 2025 to Nov 14, 202557
- VANGUARD GROUP INCSCHEDULE 13G/A, 9 filings Feb 10, 2022 to Jul 29, 202558
- FMR LLCSCHEDULE 13G/A, 8 filings Feb 9, 2022 to Mar 7, 202559
- Morgan StanleySCHEDULE 13G/A, 2 filings Feb 5, 2025 to Mar 6, 202560
- RTW INVESTMENTS, LPSCHEDULE 13G/A, 2 filings Feb 14, 2024 to Feb 14, 202561
- BB BiotechSCHEDULE 13G/A, 6 filings Feb 11, 2022 to Jan 17, 202562
- BlackRockSC 13G/A, 2 filings Oct 21, 2024 to Nov 8, 202463
- State Street CorporationSC 13G/A, 2 filings Jan 24, 2024 to Oct 18, 202464
- Wellington Management CompanySC 13G/A, 5 filings Feb 4, 2022 to Jun 6, 202465
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Barry E. Greene | 61 | $830.7K | $7.1M66 |
| 2024 | Kimi Iguchi | $421.3K | $3.1M66 | |
| 2024 | Christopher Benecchi | 53 | $532.2K | $2.6M66 |
| 2024 | Anne Marie Cook | $430.3K | $2.6M66 | |
| 2024 | Laura GaultM.D., Ph.D. | $550.2K | $2.2M66 | |
| 2024 | Gregory Shiferman | 40 | $435.5K | $1.2M66 |
| 2023 | Chief Executive Officer and | $798.8K | $6.2M66 | |
| 2023 | Chief Operating Officer and | $501.1K | $2.3M66 | |
| 2023 | Former Senior VicePresident, | $496.5K | $2.2M66 | |
| 2023 | Former Chief Financial Officer | $486.1K | $2.0M66 | |
| 2023 | Senior Vice PresidentGeneral | $407.2K | $1.3M66 | |
| 2023 | Former Chief Medical Officer | $529.0K | $1.3M66 | |
| 2022 | President | $760.7K | $5.7M66 | |
| 2022 | Former Chief Medical Officer | $89.5K | $4.0M66 | |
| 2022 | Treasurer | $461.1K | $1.9M66 | |
| 2022 | General Counsel and Secretary | $475.2K | $1.7M66 | |
| 2022 | and Treasurer | $458.6K | $1.6M66 | |
| 2022 | Counsel and Secretary | $374.8K | $686.4K66 |
SEC filer profile
How Sage Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARSage Therapeutics, Inc.1
- CIK0001597553
- Employer ID (EIN)27-44865805
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address55 Cambridge Parkway, Cambridge, MA 021421
- Phone617-299-83801
- Shares outstanding62,784,397 as of Jul 23, 202512
- Public float$590.5M as of Jun 28, 20245
- AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; it also attests to the company’s internal control over financial reporting5
- On EDGAR sinceJan 21, 20141
- Filings818 in all: 4 (375), 8-K (139), SC 13G/A (56), 10-Q (34), 3 (26), SC 13G (16), S-8 (15), S-8 POS (15)1
All 49 form types
DEFA14A (13), DEF 14A (12), 10-K (11), 424B5 (11), SCHEDULE 13G/A (10), CORRESP (8), UPLOAD (7), CT ORDER (6), POSASR (5), 5 (4), S-1/A (4), S-3ASR (4), SC TO-I/A (4), ARS (3), D (3), SC 14D9/A (3), SC TO-C (3), 424B4 (2), DRS/A (2), EFFECT (2), S-1 (2), SC TO-T/A (2), SCHEDULE 13D/A (2), SCHEDULE 13G (2), 10-K/A (1), 10-Q/A (1), 144 (1), 15-12G (1), 25-NSE (1), 8-A12B (1), CERTNAS (1), DRS (1), FWP (1), POS AM (1), PRE 14A (1), S-1MEF (1), SC 14D9 (1), SC TO-I (1), SC TO-T (1), SC14D9C (1), SCHEDULE 13D (1)
- Latest filingsAnnual report (10-K) Feb 11, 2025
Quarterly report (10-Q) Jul 30, 2025
Proxy statement (DEF 14A) Apr 24, 2025
Latest 8-K (8-K) Jul 31, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | SAGE | The Nasdaq Global Market |
From the cover page of the 10-K filed Feb 11, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Sage Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 11, 2025: 46 risks under these headings, as written.5
- Risks Related to Product Development, Regulatory Approval and Commercialization
- Our future business prospects depend heavily on our ability, with our collaboration partner, Biogen MA Inc., and Biogen International GmbH, or together, Biogen, to successfully commercialize ZURZUVAE® (zuranolone) for the treatment of women with postpartum depression, or PPD, in the U.S. There is no assurance that our commercialization efforts in the U.S. with respect to ZURZUVAE for the treatment of women with PPD will be successful or that we will be able to generate revenues at the levels or on the timing we expect or at levels or on the timing necessary to support our goals.
- Our plans to explore strategic alternatives and our rejection of an unsolicited, non-binding acquisition proposal from Biogen to acquire all of our outstanding shares not owned by Biogen may have a material adverse effect on our business.
- Our future business prospects depend heavily on our ability, alone or through our collaborations, to successfully develop, gain regulatory approval of and commercialize our current and future product candidates. We cannot be certain that we will be able to initiate planned clinical trials, to complete ongoing clinical trials or to announce results of such trials with respect to any of our product candidates, on the timelines we expect or at all, or that the results of our clinical trials or other activities under our development programs will be positive. We cannot be certain that we or
- our collaborators will be able to advance such product candidates into additional trials or to successfully develop, obtain regulatory approval for, or successfully commercialize any such product candidates, if approved.
- We may never be able to generate meaningful revenues from sales of our current or future products at levels or on timing necessary to support our investment and goals, and we may ultimately decide to discontinue commercial availability of products that we are unable to successfully commercialize or as a result of market changes.
- Any product or product candidate that we develop may cause undesirable side effects that limit their commercial profile; delay or prevent further development or regulatory approval; cause regulatory authorities to require labeling statements, such as a boxed warning or a REMS; or result in other negative consequences.
- Obtaining regulatory approval to market any of our product candidates is a complex, lengthy, expensive and uncertain process, and regulatory authorities may delay, limit or deny approval of any of our product candidates for many reasons. Any setback or delay in obtaining regulatory approval for any of our product candidates or in our, or our collaborators’, ability to commence or continue marketing of our products, if approved, may have a material adverse effect on our business and prospects.
- We or our collaborators may not be able to obtain orphan drug exclusivity for any product candidates we, or they, may develop. Even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.
- The number of people with the diseases and disorders for which our products are indicated and for which our product candidates are targeted may be smaller than we expect or our other assumptions with respect to the potential markets for our products and product candidates may not be correct and the markets may be significantly smaller than we expect.
- Failures or delays by us or our collaborators in the commencement, enrollment or completion of our ongoing and planned clinical trials of our current and future product candidates could cause us not to meet our expected timelines or result in increased costs to us, and could delay, prevent or limit our ability to gain regulatory approval of any such product candidate and to generate revenue from resulting products, if any.
- We or our collaborators may never seek or receive regulatory approval to market any of our products or product candidates outside of the U.S. or receive pricing and reimbursement outside the U.S. at acceptable levels.
The other 35 risks
- We rely completely on third-party suppliers to manufacture commercial supplies of our products and clinical drug supplies for our product candidates, and we intend to rely on third parties to produce non-clinical, clinical and commercial supplies of our products and product candidates in the future.
- Any of our current or future products or product candidates, including ZURZUVAE, may not achieve and maintain broad market acceptance or reimbursement at sufficient levels, which would limit the revenue that we generate from sales.
- Even if marketing approval is granted for a product, we may face significant post-marketing obligations and future development and regulatory difficulties.
- Competing therapies may exist or could be approved that adversely affect the amount of revenue we are able to generate from the sale of ZURZUVAE or any of our other current or future product candidates, if successfully developed and approved.
- We may not be successful in our efforts to identify or discover additional product candidates beyond our existing product candidates or to file IND applications for clinical development of new compounds at the rate we expect, or we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- We rely, and expect that we will continue to rely, on third parties to conduct any clinical trials for our product candidates. If these third parties do not successfully carry out their contractual duties, comply with applicable standards and meet expected deadlines, we may not be able to successfully develop and obtain regulatory approval for our product candidates, and our business could be substantially harmed.
- Our future success depends on our ability to attract, retain and motivate qualified personnel.
- We face potential product liability exposure, and, if claims are brought against us, we may incur substantial liability.
- If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
- We are subject to other laws and regulations, which could expose us to investigation, criminal sanctions, civil penalties, administrative penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Data collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information. Compliance with these regulations can be time-consuming and onerous. If we are found to have improperly handled personal information, we may become subject to fines and penalties, litigation and reputational harm.
- The FDA and other regulatory and enforcement agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.
- Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens, price controls, reimbursement issues and other risks and uncertainties, and could negatively impact our U.S. business.
- Risks Related to Our Intellectual Property Rights
- If we are unable to adequately protect our proprietary technology, or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.
- We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing ZURZUVAE or any of our product candidates that we may successfully develop.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming, and unsuccessful.
- Issued patents covering our products or any of our product candidates could be found invalid or unenforceable if challenged in court.
- We will not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
- For certain of our products and product candidates, we are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing certain of our products or product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our products, product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.
- Some intellectual property which we have licensed, or may in the future license, may have been discovered through government-funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with non-U.S. manufacturers.
- If we do not obtain new chemical entity or other types of marketing and data exclusivity for our product candidates and if we do not obtain additional protection under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act, and similar foreign legislation by extending the patent terms of our product candidates, our business may be materially harmed.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
- With passage of the CREATES Act, we are exposed to possible litigation and damages by competitors. In addition, existing statutes, including the CREATES Act, and proposed legislation in Congress, if passed into law, could limit the patent exclusivity on our products or facilitate earlier entry of generic competition.
- Risks Related to our Industry
- Healthcare regulations aimed at reducing healthcare costs may have a material adverse effect on our business or results of operations.
- Our internal computer systems or networks or cloud platforms, or those of our collaborators, our third-party CROs or our other contractors, consultants or service providers, may fail or suffer security breaches, which could result in a material disruption of our development programs, compromise personal or sensitive information related to our business, or cause us to incur significant liabilities which could adversely impact our business.
- Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our employees, independent contractors, consultants, collaborators and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and/or requirements and insider trading, which could cause significant liability for us and harm our reputation.
- Risks Related to Our Financial Position and Need for Capital
- We are a biopharmaceutical company that has not generated significant revenue to date. We have incurred significant operating losses since our inception and anticipate that we will incur losses for the foreseeable future.
- Risks Related to Our Common Stock
- Market volatility may cause our stock price, and the value of an investment in our stock, to fluctuate.
- We are currently subject to legal actions and proceedings, which could distract our management and could result in substantial costs or large judgments against us.
- We have broad discretion in how we use our existing cash and the proceeds from potential future follow-on public offerings, and may not use such cash and proceeds effectively, which could affect our results of operations and cause our stock price to decline.
- Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, even one that may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Future sales of our common stock may cause our stock price to decline.
Legal proceedings
On August 28, 2024, named plaintiff Darren Korver filed a purported federal securities class action lawsuit in the Southern District of New York against us and individuals, Barry E. Greene and Kimi Iguchi, or the Securities Class Action. The complaint in the Securities Class Action alleges violations of U.S. securities laws under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder and seeks an as-yet unspecified amount of damages allegedly sustained by parties who purchased Sage stock between April 12, 2021 and July 23, 2024, as well as applicable attorneys’ fees and costs. We deny any allegations of wrongdoing and intend to vigorously defend against the Securities Class Action.
On October 16, 2024, we received a subpoena from the Enforcement Division of the U.S. Securities and Exchange Commission, or the SEC, requesting documents and information related to our new drug application for zuranolone for the treatment of MDD, including communications with the FDA and any communications containing material nonpublic information. We are cooperating with the SEC and intend to continue to provide information responsive to the SEC’s requests.
At this time, we are unable to predict the outcome of the Securities Class Action or the SEC investigation or reasonably estimate a range of possible losses.
The opening of Item 3, Legal Proceedings.5
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 16SEC EDGARKimi Iguchi, Chief financial officer
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- 18SEC EDGARMichael C. Quirk, Officer
- 19SEC EDGARGregory L. Shiferman, Officer
- 20SEC EDGARLaura Gault, Chief Medical Officer
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- 22SEC EDGARAnne Marie Cook, Officer
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- 25SEC EDGARJeffrey M. Jonas, Officer
- 26SEC EDGARKimi Iguchi, Officer
- 27SEC EDGARStephen Kanes, Chief Medical Officer
- 28SEC EDGARJessica Federer, Board member
- 29SEC EDGARBarry E. Greene, Board member
- 30SEC EDGARElizabeth Barrett, Board member
- 31SEC EDGARGeorge Golumbeski, Board member
- 32SEC EDGARAsha Nayak, Board member
- 33SEC EDGARGeno J. Germano, Board member
- 34SEC EDGARHoward H. Pien, Board member
- 35SEC EDGARJames M. Frates, Board member
- 36SEC EDGARKevin P. Starr, Board member
- 37SEC EDGARRobert Nelsen, Board member
- 38SEC EDGARMichael F. Cola, Board member
- 39SEC EDGARAnne Marie Cook, General counsel
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- 41SEC EDGARResults of operations
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- 44SEC EDGARResults of operations
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- 46SEC EDGARResults of operations
- 47SEC EDGAROther events
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- 49SEC EDGARExecutive or director change
- 50SEC EDGAROther events
- 51SEC EDGARExecutive or director change
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