IRWD on Nasdaq

Ironwood Pharmaceuticals

American pharmaceutical company

Ironwood Pharmaceuticals, Inc. is a publicly traded pharmaceutical company. It was originally called Microbia, Inc. Microbia was founded by postdocs from the lab of Gerald Fink at the Whitehead Institute to commercialize approaches that had been developed in the lab to improve industrial fermentation of fungi, to genetically engineer them to produce secondary metabolites more efficiently or to produce new ones as leads for drug discovery or as products for use in industry, and to identify drug targets in fungi for antifungal drug discovery.3 Its shares trade on Nasdaq under the symbol IRWD.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

1998Founded1

Compare with Evolus, Inc., RIGEL PHARMACEUTICALS INC or Xeris Biopharma Holdings, Inc., or pick any stock.

  • TickerIRWD on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCambridge1
  • Websitewww.ironwoodpharma.com
  • Legal formDelaware corporation1
  • Incorporated inDE5
  • Business address100 Summer Street, Suite 2300, Boston, Ma 021105
  • Filer categoryAccelerated filer, Smaller reporting company5
  • LEI549300PC8MR6QHH6P2964
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressc/o The Corporation Trust Company, 19801 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 28310754

Ironwood Pharmaceuticals, Inc. is a publicly traded pharmaceutical company. It was originally called Microbia, Inc.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

33.3%Operating margin7
8.1%Net margin7
-15.7%Revenue growth, 20257
$127.0MFree cash flow7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Collaborative Arrangements brought in 100% of the revenue Ironwood Pharmaceuticals broke down this way in fiscal 2025.

  1. Collaborative Arrangements$296.2M7100%down 16% from 2024
  2. Collaborative arrangement, other agreements$87.0K70%down 88% from 2024
Products and services by year
Products and services20242025
Collaborative Arrangements$351.4M$296.2M
Collaborative arrangement, other agreements$734.0K$87.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development32¢$95.1M
  • Selling, general and admin28¢$82.3M
  • Other costs16¢$48.7M
  • Income tax16¢$46.0M
  • Profit8¢$24.0M

Out of $296.2M in revenue.7

Where each dollar of operating cash went, fiscal 2025

  • Capital spending0¢$34.0K
  • Kept or used elsewhere100¢$127.0M

Out of $127.0M of cash from operations.7

Financial statements

Revenue8910117$296.2M in 2025−31% since 2019
0$200.0M$400.0M$600.0M2019: $428.4M$428.4M20192020: $389.5M$389.5M2020−9%2021: $413.8M$413.8M2021+6%2022: $410.6M$410.6M2022−1%2023: $442.7M$442.7M2023+8%2024: $351.4M$351.4M2024−21%2025: $296.2M$296.2M2025−16%
Operating income8910117$98.5M in 2025−18% since 2019
-$1.0B-$500.0M0$500.0M2019: $120.1M$120.1M20192020: $142.9M$142.9M2020+19%2021: $232.3M$232.3M2021+62%2022: $250.3M$250.3M2022+8%2023: -$945.4M-$945.4M20232024: $93.1M$93.1M20242025: $98.5M$98.5M2025+6%
Net income8910117$24.0M in 2025+12% since 2019
-$1.5B-$1.0B-$500.0M0$500.0M$1.0B2019: $21.5M$21.5M20192020: $106.2M$106.2M2020+394%2021: $528.4M$528.4M2021+398%2022: $175.1M$175.1M2022−67%2023: -$1.0B-$1.0B20232024: $880.0K$880.0K20242025: $24.0M$24.0M2025+2629%

Every line of the income statement as filed: the last 2 fiscal years (annual) or 8 quarters (quarterly), latest first.7

Period ending2025-12-312024-12-31
Total revenues$296.2M$351.4M
Research and development$95.1M$111.4M
Selling, general and administrative$82.3M$144.3M
Restructuring, net$20.3M$2.6M
Total costs and expenses$197.6M$258.3M
Income from operations$98.5M$93.1M
Interest expense and other financing costs-$32.7M-$33.0M
Interest and investment income$4.1M$4.5M
Other$193.0K$640.0K
Other income (expense), net-$28.5M-$27.9M
Income before income taxes$70.0M$65.2M
Income tax expense-$46.0M-$64.3M
Net income$24.0M$880.0K
Net income per share - basic (in dollars per share)$0.15$0.01
Net income per share - diluted (in dollars per share)$0.15$0.01
Weighted average shares used in computing net income per share - basic (in shares)161.8M shares159.1M shares
Weighted average shares used in computing net income per share - diluted (in shares)163.0M shares160.1M shares

Compare Ironwood Pharmaceuticals with another company

Corporate structure

Ironwood Pharmaceuticals sits at the top of its group. 5 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Ironwood Pharmaceuticals

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest Aug 14, 2026 (7 filings since Nov 14, 2024)
  • State Street Corporation Filed SCHEDULE 13G on Ironwood Pharmaceuticals, latest Aug 7, 2026 (6 filings since Feb 2, 2023)
  • BlackRock Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest Jul 28, 2026 (9 filings since Feb 3, 2022)
  • RENAISSANCE TECHNOLOGIES LLC Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest May 14, 2026 (2 filings since Nov 13, 2024)
  • Bank of America Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest Apr 27, 2026 (2 filings since Nov 14, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest Mar 27, 2026 (9 filings since Feb 10, 2022)
  • Sarissa Capital Management LP Filed SCHEDULE 13D/A on Ironwood Pharmaceuticals, latest Mar 19, 2026
  • Barclays Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest Nov 12, 2025 (2 filings since Aug 12, 2025)
  • Pacer Advisors, Inc. Filed SCHEDULE 13G/A on Ironwood Pharmaceuticals, latest May 2, 2025 (2 filings since May 2, 2025)
  • LSV ASSET MANAGEMENT Filed SC 13G/A on Ironwood Pharmaceuticals, latest Feb 9, 2024 (2 filings since Feb 10, 2023)
  • WESTFIELD CAPITAL MANAGEMENT CO LP Filed SC 13G/A on Ironwood Pharmaceuticals, latest Jul 5, 2023 (2 filings since Feb 1, 2022)
  • Wellington Management Company Filed SC 13G/A on Ironwood Pharmaceuticals, latest May 10, 2023 (3 filings since Feb 4, 2022)
  • Ironwood Pharmaceuticals Boston, Massachusetts, United States
    • VectivBio Holding AG Stake · V8
    • GlyPharma Therapeutic Inc Subsidiary · Canada
    • Ironwood Pharmaceuticals Securities Corporation Subsidiary · Massachusetts, United States
    • VectivBio AG Subsidiary · Switzerland

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; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.

What it owns

What Ironwood Pharmaceuticals 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$11.4M7 Dec 31, 2025$12.9M7 Dec 31, 2024−11.3%
Accumulated depreciation$8.0M7 Dec 31, 2025$8.4M7 Dec 31, 2024−4.3%
Property and equipment, net$3.4M7 Dec 31, 2025$4.5M7 Dec 31, 2024−24.2%
Operating-lease assets (leased space)$9.3M7 Dec 31, 2025$11.0M7 Dec 31, 2024−15.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$215.5M7 Dec 31, 2025$88.6M7 Dec 31, 2024+143.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$2.0M7 Dec 31, 2025$2.9M7 Dec 31, 2024−28.7%

Properties, in its own words

Our corporate headquarters are located in Boston, Massachusetts, where, as of December 31, 2025, we occupied approximately 39,000 square feet of office space under our lease expiring in June 2030. We also have operations in Basel, Switzerland. We believe that our facilities are suitable and adequate for our needs for the foreseeable future.

Item 2 of the 10-K filed Feb 26, 2026.15

Leadership

Who has led Ironwood Pharmaceuticals, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (35)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • GlyPharma Therapeutic Inc Canada6
  • Ironwood Pharmaceuticals GmbH Switzerland6
  • Ironwood Pharmaceuticals Securities Corporation Massachusetts6
  • VectivBio AG Switzerland6

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Aug 6, 20268-K Results of operations60
  2. Jun 18, 20268-K Executive or director change; Shareholder vote61
  3. Jun 15, 20268-K Other events62
  4. May 21, 20268-K Executive or director change63
  5. May 13, 20268-K Executive or director change64
  6. May 7, 20268-K Results of operations65
  7. Mar 11, 20268-K Other events66
  8. Feb 25, 20268-K Results of operations67
  9. Jan 2, 20268-K Results of operations68
  10. Dec 23, 20258-K Entered a material agreement; Other events69
  11. Nov 26, 20258-K Other events70
  12. Nov 10, 20258-K Results of operations71
  13. Mar 30, 2021New chief executive Thomas A. McCourt becomes CEO16
  14. Apr 3, 2019New chief executive Mark Mallon becomes CEO17
  15. Feb 3, 2010Went public Listed on NASDAQ1
  16. Feb 2, 2010New chief executive Peter M. Hecht becomes CEO18
  17. 1998Founded Founded1

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.24 a share, on Nov 10, 2025.72

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results60
  2. May 7, 2026Reported quarterly or annual results65
  3. Feb 25, 2026Reported quarterly or annual results67
  4. Jan 2, 2026Reported quarterly or annual results68
  5. Nov 10, 2025Reported quarterly or annual results71
  6. Aug 7, 2025Reported quarterly or annual results73
  7. May 7, 2025Reported quarterly or annual results74
  8. Apr 25, 2025Reported quarterly or annual results75

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

398 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 52 major events, 205 insider forms, 49 large holders, 72 other. The latest 20:

  1. Sep 23, 2026144 EDGAR
  2. Sep 17, 20264 EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 7, 2026SCHEDULE 13G EDGAR
  5. Aug 6, 202610-Q EDGAR
  6. Aug 6, 20268-K EDGAR
  7. Jul 28, 2026SCHEDULE 13G/A EDGAR
  8. Jul 22, 20264 EDGAR
  9. Jul 22, 20263 EDGAR
  10. Jul 9, 20264 EDGAR
  11. Jul 7, 2026144 EDGAR
  12. Jun 18, 20268-K EDGAR
  13. Jun 17, 20264 EDGAR
  14. Jun 17, 20264 EDGAR
  15. Jun 17, 20264 EDGAR
  16. Jun 17, 20264 EDGAR
  17. Jun 17, 20264 EDGAR
  18. Jun 17, 20264 EDGAR
  19. Jun 17, 20264 EDGAR
  20. Jun 16, 2026144 EDGAR

The 398 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

104 open-market trades by officers, directors and large owners since October 2021: 3 buys and 101 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 7, 2026Silver RonaldPFO & PAOSale127,890$4.52$578.1KForm 4
Jun 16, 2026McHugh JulieDirectorSale21,571$3.73$80.5KForm 4
Mar 17, 2026DENNER ALEXANDER JDirectorSale6,730,800$3.05$20.5MForm 4
Feb 24, 2026Martini Gregory S.Chief Financial OfficerSale11,457$3.66$41.9KForm 4
Feb 24, 2026John MinardoChief Legal OfficerSale19,053$3.66$69.7KForm 4
Feb 24, 2026Shetzline MichaelSVP, CMO, Head-Res&DrugSale17,012$3.66$62.3KForm 4
Feb 24, 2026Gaskins Tammi LChief Commercial OfficerSale11,239$3.66$41.1KForm 4
Feb 24, 2026MCCOURT Thomas AChief Executive OfficerSale103,526$3.66$378.9KForm 4
Feb 24, 2026Silver RonaldPFO & PAOSale12,621$3.66$46.2KForm 4
Feb 23, 2026Martini Gregory S.Chief Financial OfficerSale10,487$3.81$40.0KForm 4
Feb 23, 2026John MinardoChief Legal OfficerSale17,439$3.81$66.4KForm 4
Feb 23, 2026Shetzline MichaelSVP, CMO, Head-Res&DrugSale15,570$3.81$59.3KForm 4
Feb 23, 2026Gaskins Tammi LChief Commercial OfficerSale10,287$3.81$39.2KForm 4
Feb 23, 2026MCCOURT Thomas AChief Executive OfficerSale94,757$3.81$361.0KForm 4
Feb 23, 2026Silver RonaldPFO & PAOSale11,552$3.81$44.0KForm 4
Jan 5, 2026Silver RonaldPFO & PAOSale35,416$4.60$162.9KForm 4
Nov 17, 2025Gaskins Tammi LChief Commercial OfficerSale6,016$3.32$20.0KForm 4
Aug 11, 2025Gaskins Tammi LChief Commercial OfficerSale1,316$0.84$1.1KForm 4
Aug 11, 2025John MinardoChief Legal OfficerSale7,754$0.84$6.5KForm 4
Aug 11, 2025Silver RonaldPFO & PAOSale2,846$0.84$2.4KForm 4

All 104 trades can be filtered by person here when JavaScript is on.

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.

Stakes it holds

Ironwood Pharmaceuticals has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).

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.

YearExecutiveAgeSalaryTotal pay
2025Thomas McCourtChief Executive Officer68$867.6K$1.9M90
2025Tammi Gaskins*Senior Vice President, Chief Commercial Officer53$274.4K$1.2M90
2025Gregory Martini*Senior Vice President, Chief Financial Officer38$274.4K$1.2M90
2024Thomas McCourtChief Executive Officer68$867.6K$6.1M90

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.17,788,557$74.9M0.0%+4,425,627
Armistice Capital, LLC13,932,000$58.7M1.6%−1,096,000
Sarissa Capital Management LP9,188,635$38.7M21.7%No change
State Street Corp8,809,601$37.1M0.0%+1,352,657
Bank Of America Corp /de/8,683,803$36.6M0.0%+896
Renaissance Technologies LLC7,993,226$33.7M0.0%−67,847
Vanguard Capital Management LLC6,608,508$27.8M0.0%+511,054
Aqr Capital Management LLC6,465,921$27.2M0.0%−1,069,159
Vanguard Portfolio Management LLC5,513,355$23.2M0.0%−1,168,682
Geode Capital Management, LLC4,831,657$20.3M0.0%+288,135
Two Sigma Investments, LP4,556,089$19.2M0.0%−1,292,187
Marshall Wace, Llp4,290,093$18.1M0.0%−234,971
Jacobs Levy Equity Management, Inc4,065,964$17.1M0.1%+433,487
Goldman Sachs Group Inc3,313,808$14.0M0.0%+623,174
Charles Schwab Investment Management Inc3,302,242$13.9M0.0%−1,435,615
Federated Hermes, Inc.3,231,238$13.6M0.0%−117,568
Arrowstreet Capital, Limited Partnership3,017,089$12.7M0.0%−380,153
Dimensional Fund Advisors LP2,522,891$10.6M0.0%+440,836
Mackenzie Financial Corp2,367,493$10.0M0.0%+1,807,459
Morgan Stanley1,859,914$7.8M0.0%+1,035,095
Connor, Clark & Lunn Investment Management Ltd.1,811,714$7.6M0.0%−23,710
Northern Trust Corp1,373,974$5.8M0.0%+108,132
Hillsdale Investment Management Inc.1,250,428$5.3M0.1%+13,800
Wells Fargo & Company/mn1,206,198$5.1M0.0%+1,147,348
Deutsche Bank Ag\1,158,138$4.9M0.0%+33,149

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Ironwood Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARIRONWOOD PHARMACEUTICALS INC2
  • CIK0001446847
  • Employer ID (EIN)04-340417615
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company15
  • Incorporated inDelaware15
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address100 Summer Street, Suite 2300, Boston, MA 021102
  • Phone617-621-77222
  • Shares outstanding165,239,947 as of Jul 31, 202613
  • Public float$102.7M as of Jun 30, 202515
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; it also attests to the company’s internal control over financial reporting15
  • On EDGAR sinceSep 26, 20082
  • Filings1,429 in all: 4 (756), 8-K (191), SC 13G/A (112), 10-Q (50), 3 (46), 144 (44), SC 13G (29), DEFA14A (24)2
    All 47 form types

    S-8 (21), 10-K (17), SCHEDULE 13G/A (16), DEF 14A (15), CT ORDER (14), UPLOAD (10), ARS (8), CORRESP (7), SCHEDULE 13G (7), 8-K/A (6), D (5), S-3ASR (5), 424B5 (4), S-1/A (4), SC TO-T/A (4), 5 (3), SC 13D/A (3), SC TO-C (3), 10-K/A (2), 424B2 (2), PRE 14A (2), SC 13D (2), 3/A (1), 424B4 (1), 8-A12B (1), 8-A12B/A (1), CERTNAS (1), D/A (1), DEFC14A (1), EFFECT (1), FWP (1), NT 10-K (1), PREC14A (1), PREN14A (1), PRRN14A (1), REGDEX (1), S-1 (1), SC TO-T (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Class A Common Stock, $0.001 par valueIRWDNasdaq Global Select Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).15

Risk factors and legal proceedings

The risks Ironwood Pharmaceuticals names in Item 1A of its 10-K filed Feb 26, 2026: 47 risks under these headings, as written.15

  • In addition to the other information in this Annual Report on Form 10-K, any of the factors described below could significantly and negatively affect our business, financial condition, results of operations or prospects. The trading price of our Class A Common Stock may decline due to these risks.
  • Risks Related to LINZESS, Apraglutide and Other Product Candidates
  • We are highly dependent on the commercial success of LINZESS (linaclotide) in the U.S. for the foreseeable future.
  • We are subject to uncertainty relating to pricing and reimbursement policies in the U.S., including recent and future healthcare reform measures, which, if not favorable for our products, could hinder or prevent our products’ commercial success.
  • Healthcare reform and other governmental and private payor initiatives may have an adverse effect upon, and could prevent, our products’ or product candidates’ commercial success.
  • We must work effectively and collaboratively with AbbVie to market and sell LINZESS in the U.S., and we must adapt our commercial model and market strategy to the evolving landscape for LINZESS to achieve its maximum commercial potential.
  • We cannot give any assurance that apraglutide will receive regulatory approval, which is necessary before it can be commercialized.
  • The regulatory approval processes in the U.S., in the E.U. and in other foreign jurisdictions are onerous, lengthy, time consuming, expensive and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for apraglutide or our other product candidates, our business will be harmed.
  • Our failure to successfully develop and commercialize additional product candidates or approved products would impair our ability to grow and/or adversely affect our business.
  • Delays in the completion of clinical testing of any of our products or product candidates could result in increased costs and could delay or limit our ability to generate revenues.
  • The pricing of apraglutide and our other product candidates, if and when approved for marketing, will depend in part on pricing and reimbursement strategies adopted by our competitors.
  • We face competition and new products may emerge that provide different or better alternatives for treatment of the conditions that our products are approved to treat.
The other 36 risks
  • Our products or product candidates may cause undesirable side effects or have other properties that could delay or prevent their development, create unpredictable clinical trial results, impact their regulatory approval or limit their commercial potential.
  • Even though LINZESS is approved by the U.S. FDA for use in adult and certain pediatric patients, post-approval development and regulatory requirements still remain, which may present additional challenges, and we may not be successful in obtaining approval for additional indications for LINZESS that we are seeking or may seek in the future.
  • We and our linaclotide partners are subject to uncertainty relating to pricing and reimbursement policies outside the U.S., as well as risks relating to the improper importation of linaclotide and sale of counterfeit versions of linaclotide. If such policies are not favorable, or if linaclotide is improperly imported or is counterfeited, our business and financial results could be adversely affected.
  • Even though linaclotide is approved for marketing in the U.S. and in a number of other countries, we or our partners may never receive approval to commercialize linaclotide in additional parts of the world.
  • If we are unable to successfully partner with other companies to develop and commercialize products and/or product candidates, our ability to grow would be impaired and our business would be adversely affected.
  • Risks Related to the VectivBio Acquisition
  • We may not realize the expected benefits and anticipated synergies of the VectivBio Acquisition.
  • Risks Related to Our Dependence on Third Parties
  • Because we work with partners to develop, manufacture and commercialize linaclotide, we and our partners are dependent upon third parties, and our and our partners’ relationships with those third parties, in our and our partners’ efforts to obtain regulatory approval for, and to commercialize, linaclotide, as well as to comply with regulatory and other obligations with respect to linaclotide.
  • We rely entirely on contract manufacturers, our partners and other third parties to manufacture linaclotide, apraglutide, and our other product candidates and to distribute linaclotide. If they are unable to comply with applicable regulatory requirements, unable to source sufficient raw materials, experience manufacturing or distribution difficulties, or are otherwise unable to manufacture and distribute sufficient quantities to meet demand, our development and commercialization efforts may be materially harmed.
  • If any of our linaclotide partners undergoes a change of control or in management, this may adversely affect our collaborative relationship or the success of the commercialization of linaclotide in the U.S. or in the other countries where it is approved, or the ability to achieve regulatory approval, launch and commercialize linaclotide in other territories.
  • We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to continue the development of our product candidates, obtain regulatory approval for or commercialize our product candidates and our business could be harmed.
  • Risks Related to Regulatory, Legal and Compliance Matters
  • We face potential product liability exposure, and, if claims brought against us are successful, we could incur substantial liabilities.
  • We will incur significant liability if it is determined that we are promoting any “off-label” uses of our products.
  • If we fail to comply with healthcare and other regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
  • We are subject to stringent and changing U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; disruptions of our operating results and business; and other adverse business consequences.
  • The VectivBio Acquisition increases our exposure to doing business in foreign jurisdictions.
  • Risks Related to Intellectual Property
  • Limitations on our ability to obtain patent protection and/or the patent rights relating to our products and our product candidates may limit our ability to prevent third parties from competing against us.
  • If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in such litigation could have a material adverse effect on our business.
  • If we fail to comply with our obligations or have disagreements over contract interpretation in agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business
  • relationship with our licensor, the scope of our intellectual property or technology rights could be narrowed and we could lose license rights that are important to our business.
  • We may be unable to maintain the benefits associated with orphan drug designation, including market exclusivity, which may harm our business.
  • We have received notices of Paragraph IV certifications related to LINZESS in conjunction with ANDAs filed by generic drug manufacturers, and we may receive additional notices from others in the future. We have, and may continue to, become involved in legal proceedings to protect or enforce intellectual property rights relating to our products and our product candidates, which could be expensive and time consuming, and unfavorable outcomes in such proceedings could have a material adverse effect on our business.
  • Risks Related to Our Finances and Capital Requirements
  • We incurred significant losses from our inception in 1998 through the year ended December 31, 2018, and we may incur losses in future periods.
  • We may need additional funding and may be unable to raise capital when needed, which could cause us to delay, reduce or eliminate our corporate or product development or commercialization efforts.
  • Our ability to pay principal of and interest on our outstanding debt will depend in part on the receipt of payments from AbbVie under our collaboration agreement for North America.
  • Our indebtedness could adversely affect our financial condition or restrict our future operations.
  • The capped call transactions entered into in connection with our Convertible Senior Notes may affect the value of our Class A Common Stock.
  • Our quarterly and annual operating results may fluctuate significantly.
  • Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code, and it is possible that our net operating loss and tax credit carryforwards may expire before we generate sufficient taxable income to use such carryforwards, or that certain transactions or a combination of certain transactions may result in material additional limitations on our ability to use our net operating loss and tax credit carryforwards.
  • Our ability to use foreign tax loss carryforwards acquired in the VectivBio Acquisition may be limited.
  • If the distribution of the shares of Cyclerion Therapeutics, Inc., or Cyclerion, common stock in connection with the Separation is not generally tax- free for U.S. federal income tax purposes, we and our stockholders could be subject to significant tax liabilities.
  • General Risk Factors
  • We may not be able to manage our business effectively if we lose any of our current management team or if we are unable to attract, motivate and retain key personnel.
  • Security breaches and other disruptions to our information technology structure could compromise our information, disrupt our business and expose us to liability, which would cause our business and reputation to suffer.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could negatively impact the market price of our Class A Common Stock.
  • If we identify a material weakness in our internal control over financial reporting, it could have an adverse effect on our business and financial results, and our ability to meet our reporting obligations could be negatively affected, each of which could negatively affect the trading price of our Class A Common Stock.
  • We expect that the price of our Class A Common Stock will fluctuate substantially.
  • Our business could be negatively affected as a result of a proxy contest or certain other stockholder actions.

Legal proceedings

Apraglutide

The opening of Item 3, Legal Proceedings.15

Sources

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