Private company

Keenova Therapeutics plc

Pharmaceutical preparations company1

In its 2026 annual report the company says: “We operate our business in one operating and reportable segment with a clear and focused strategy centered on our branded therapeutics.”4

Last updated Oct 20, 2026.

Overview

  • IndustryPharmaceutical Preparations1
  • HeadquartersL21
  • Incorporated inIreland2
  • Business addressCollege Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, D152
  • Filer categoryNon-accelerated filer2

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Keenova Therapeutics plc, formerly Mallinckrodt plc, and its consolidated subsidiaries is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.4 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 2025

44.9%Gross margin5
-24.3%Operating margin5
-34.2%Net margin5
32.0%Revenue growth, 20255
-23.7%Return on equity5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue47¢$787.8M
  • Research and development5¢$90.7M
  • Selling, general and admin46¢$761.3M
  • Income tax1¢$23.8M

Out of $1.4B in revenue.5 The company lost money this year.

Financial statements

Revenue6785$1.4B in 2025−55% since 2019
0$1.0B$2.0B$3.0B$4.0B2019: $3.2B$3.2B20192020: $2.2B$2.2B2020−30%2021: $2.2B$2.2B2021−0%2024: $1.1B$1.1B2024−51%2025: $1.4B$1.4B2025+32%
Gross profit6785$642.8M in 2025−55% since 2019
0$500.0M$1.0B$1.5B2019: $1.4B$1.4B20192020: $669.4M$669.4M2020−53%2021: $891.7M$891.7M2021+33%2024: $539.3M$539.3M2024−40%2025: $642.8M$642.8M2025+19%
Operating income6785-$348.2M in 2025−81% since 2019
-$2.0B-$1.5B-$1.0B-$500.0M02019: -$1.8B-$1.8B20192020: -$651.6M-$651.6M2020−64%2021: -$202.9M-$202.9M2021−69%2024: -$65.9M-$65.9M2024−68%2025: -$348.2M-$348.2M2025+428%
Net income6785-$489.5M in 2025−51% since 2019
-$1.0B-$500.0M0$500.0M2019: -$996.5M-$996.5M20192020: -$944.6M-$944.6M2020−5%2021: -$717.4M-$717.4M2021−24%2024: $477.9M$477.9M20242025: -$489.5M-$489.5M2025
Fiscal year2019202020212022202320242025
Revenue$3.2B6$2.2B7$2.2B8$1.1B5$1.4B5
Cost of revenue$1.7B6$1.5B7$1.3B8$544.1M5$787.8M5
Gross profit$1.4B6$669.4M7$891.7M8$539.3M5$642.8M5
Research and development$349.4M6$290.8M7$205.2M8$89.3M5$90.7M5
Selling, general and admin$831.0M6$884.1M7$581.4M8$461.5M5$761.3M5
Operating income-$1.8B6-$651.6M7-$202.9M8-$65.9M5-$348.2M5
Interest$309.0M6$261.1M7$222.6M8$228.3M11
Income before tax-$829.8M8$457.6M5-$481.3M5
Income tax-$584.3M6$8.9M7-$106.3M8$113.3M5-$23.8M5
Net income-$996.5M6-$944.6M7-$717.4M8$477.9M5-$489.5M5
Earnings per share-$11.886-$11.187-$8.478$24.265-$17.505
Earnings per share (diluted)-$11.886-$11.187-$8.478$24.175-$17.505
Shares (weighted, basic)84.7M shares819.7M shares528.0M shares5
Shares (weighted, diluted)84.7M shares819.8M shares528.0M shares5

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Corporate structure

Keenova Therapeutics plc sits at the top of its group. 42 entities, 10 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Keenova Therapeutics plc

  • GOLDENTREE ASSET MANAGEMENT LP Filed SCHEDULE 13D/A on Keenova Therapeutics plc, latest Oct 6, 2026 (4 filings since Dec 13, 2023)
  • Silver Point Capital, L.P. Filed SCHEDULE 13D/A on Keenova Therapeutics plc, latest May 22, 2026 (8 filings since Nov 24, 2023)
  • MARATHON ASSET MANAGEMENT LP Filed SCHEDULE 13G/A on Keenova Therapeutics plc, latest May 15, 2026 (4 filings since Feb 6, 2024)
  • Hein Park Capital Management LP Filed SCHEDULE 13G on Keenova Therapeutics plc, latest Feb 13, 2026 (7 filings since Jan 17, 2024)
  • Hudson Bay Capital Management LP Filed SCHEDULE 13G/A on Keenova Therapeutics plc, latest Feb 11, 2026 (5 filings since Feb 9, 2023)
  • James E. Flynn Filed SCHEDULE 13G/A on Keenova Therapeutics plc, latest May 13, 2025 (4 filings since Nov 20, 2023)
  • Bracebridge Capital, LLC Filed SC 13D/A on Keenova Therapeutics plc, latest Nov 21, 2024 (5 filings since Jun 27, 2022)
  • Squarepoint Ops LLC Filed SC 13D/A on Keenova Therapeutics plc, latest Mar 15, 2024 (2 filings since Nov 24, 2023)
  • Alta Fundamental Advisers LLC Filed SC 13G/A on Keenova Therapeutics plc, latest Feb 14, 2024 (3 filings since May 30, 2023)
  • CONTINENTAL GENERAL INSURANCE CO Filed SC 13G/A on Keenova Therapeutics plc, latest Feb 14, 2024 (2 filings since May 30, 2023)
  • Sculptor Capital LP Filed SC 13G/A on Keenova Therapeutics plc, latest Feb 14, 2024 (4 filings since Aug 30, 2022)
  • JPMorgan Chase Filed SC 13G/A on Keenova Therapeutics plc, latest Jan 4, 2024 (2 filings since Jan 11, 2023)
  • Keenova Therapeutics plc L2
    • Cache Holdings Limited Subsidiary · Bermuda
    • Carnforth Limited Subsidiary · Bermuda
    • EFHI GP Limited Subsidiary · Ireland
    • ELP 2025 GP Limited Subsidiary · Ireland
    • Endo Biologics Limited Subsidiary · Ireland
    • Endo Operations Limited Subsidiary · Ireland
    • Ikaria Australia Pty Ltd Subsidiary · Australia
    • Ikaria Canada Inc. Subsidiary · Canada
    • Keenova Therapeutics Group Limited Subsidiary · Ireland
    • Keenova Therapeutics Public Limited Company Subsidiary · Ireland
    • Mallinckrodt ARD Holdings Limited Subsidiary · United Kingdom
    • Mallinckrodt Canada Cooperatie U.A. Subsidiary · Netherlands
    • Mallinckrodt Equinox Limited Subsidiary · United Kingdom
    • Mallinckrodt Finance Management Ireland Limited Subsidiary · Ireland
    • Mallinckrodt Group S.à r.l. Subsidiary · Luxembourg
    • Mallinckrodt Group S.à r.l., Luxembourg (LU) Schaffhausen Branch Subsidiary · Switzerland
    • Mallinckrodt Holdings GmbH Subsidiary · Switzerland
    • Mallinckrodt International Finance SA Subsidiary · Luxembourg
    • Mallinckrodt International Holdings S.à r.l. Subsidiary · Luxembourg
    • Mallinckrodt Lux IP S.à r.l. Subsidiary · Luxembourg
    • Mallinckrodt Medical Holdings (UK) Limited Subsidiary · United Kingdom
    • Mallinckrodt Medical Holdings (UK) Limited, Zweigniederlassung Deutschland (the German Branch) Subsidiary · Germany
    • Mallinckrodt Petten Holdings B.V. Subsidiary · Netherlands
    • Mallinckrodt Pharma IP Trading Limited Subsidiary · Ireland
    • Mallinckrodt Pharma K.K. Subsidiary · Japan
    • and 16 more

Built from 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 Keenova Therapeutics plc 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$208.2M5 Dec 31, 2025$124.9M5 Dec 27, 2024+66.7%
Accumulated depreciation$22.8M5 Dec 31, 2025$7.7M5 Dec 27, 2024+196.1%
Property and equipment, net$185.4M5 Dec 31, 2025$117.2M5 Dec 27, 2024+58.2%
Finance-lease assets$5.8M11 Dec 27, 2024$011 Dec 29, 2023
Operating-lease assets (leased space)$59.2M5 Dec 31, 2025$23.1M5 Dec 27, 2024+156.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$812.8M5 Dec 31, 2025$319.0M5 Dec 27, 2024+154.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$31.8M5 Dec 31, 2025$05 Dec 27, 2024
Intangible assets, net (excluding goodwill)$2.2B5 Dec 31, 2025$171.7M5 Dec 27, 2024+1198.5%
Finite-lived intangibles, gross$2.4B5 Dec 31, 2025$231.7M5 Dec 27, 2024+937.9%
Accumulated amortization$175.1M5 Dec 31, 2025$60.0M5 Dec 27, 2024+191.8%
Finite-lived intangibles, net$2.2B5 Dec 31, 2025$171.7M5 Dec 27, 2024+1198.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$553.5M5 Dec 31, 2025$313.9M5 Dec 27, 2024+76.3%
Work in process$253.7M5 Dec 31, 2025$135.9M5 Dec 27, 2024+86.7%
Finished goods$245.7M5 Dec 31, 2025$132.1M5 Dec 27, 2024+86.0%

Properties, in its own words

As of December 31, 2025, we owned or leased building space in 24 locations globally. Our principal executive offices are located at College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Ireland, with additional office facilities in New Jersey, Pennsylvania, Missouri, D.C., and Japan, among others. We have a strong U.S. manufacturing footprint, with five facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin. Our sites consist of 123,000 and 569,000 square feet of owned and leased property, respectively. We believe our facilities are in good condition and suitable for their current use. We may reduce, add or replace facilities as considered appropriate to meet the needs of our business. See Note 13 of the Notes to Consolidated Financial Statements included within Item 8. Financial Statements and Supplementary Data of this Annual Report for additional information regarding our leased facilities.

Item 2 of the 10-K filed Apr 15, 2026.4

Leadership

Who has led Keenova Therapeutics plc, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Mark Trudeau2013–2022
  2. Sigurdur O. Olafsson2022–now

President

  1. Mark Trudeau2013–2022
  2. Matthew K. Harbaugh2019
  3. Sigurdur O. Olafsson2022–2025
  4. Christiana Stamoulis2025–now

Chief financial officer

  1. Matthew K. Harbaugh2013–2018
  2. George A. Kegler2018–2019
  3. Bryan M. Reasons2019–2025
  4. Christiana Stamoulis2025–now
201520202025
Board members and other officers (67)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Cache Holdings Limited Bermuda3
  • Carnforth Limited Bermuda3
  • EFHI GP Limited Ireland3
  • ELP 2025 GP Limited Ireland3
  • Endo Biologics Limited Ireland3
  • Endo Operations Limited Ireland3
  • Ikaria Australia Pty Ltd Australia3
  • Ikaria Canada Inc. Canada3
  • Keenova Therapeutics Group Limited Ireland3
  • Keenova Therapeutics Public Limited Company Ireland3
  • Mallinckrodt ARD Holdings Limited United Kingdom3
  • Mallinckrodt Canada Cooperatie U.A. Netherlands3
  • Mallinckrodt Equinox Limited United Kingdom3
  • Mallinckrodt Finance Management Ireland Limited Ireland3
  • Mallinckrodt Group S.à r.l. Luxembourg3
  • Mallinckrodt Group S.à r.l., Luxembourg (LU) Schaffhausen Branch Switzerland3
  • Mallinckrodt Holdings GmbH Switzerland3
  • Mallinckrodt International Finance SA Luxembourg3
  • Mallinckrodt International Holdings S.à r.l. Luxembourg3
  • Mallinckrodt Lux IP S.à r.l. Luxembourg3
  • Mallinckrodt Medical Holdings (UK) Limited United Kingdom3
  • Mallinckrodt Medical Holdings (UK) Limited, Zweigniederlassung Deutschland (the German Branch) Germany3
  • Mallinckrodt Petten Holdings B.V. Netherlands3
  • Mallinckrodt Pharma IP Trading Limited Ireland3
All 41 listed subsidiaries
  • Mallinckrodt Pharma K.K. Japan3
  • Mallinckrodt Pharmaceuticals Ireland Limited Ireland3
  • Mallinckrodt Pharmaceuticals Limited United Kingdom3
  • Mallinckrodt Quincy S.à r.l. Luxembourg3
  • Mallinckrodt SAG Holdings GmbH Switzerland3
  • Mallinckrodt UK Finance LLP United Kingdom3
  • Mallinckrodt UK Ltd United Kingdom3
  • Mallinckrodt Windsor S.à r.l. Luxembourg3
  • Montjeu Limited Ireland3
  • Operand Pharmaceuticals Holdco I Unlimited Company Ireland3
  • Paladin Pharma Inc. Canada3
  • Profibrix B.V. Netherlands3
  • Questcor International Limited Ireland3
  • Sonorant Therapeutics Limited Ireland3
  • Sucampo GmbH Switzerland3
  • Sucampo International Holdings Limited United Kingdom3
  • Sucampo Pharma, LLC Japan3

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

Former names

  • Mallinckrodt plcFeb 1, 2013 to Nov 10, 20252

Timeline

  1. Aug 11, 20268-K Results of operations86
  2. Aug 3, 20268-K Other events87
  3. Jul 8, 20268-K Regulation FD disclosure; Other events88
  4. Jun 15, 20268-K Other events89
  5. Jun 3, 20268-K Shareholder vote90
  6. May 12, 20268-K Results of operations91
  7. Mar 31, 20268-K Results of operations; Other events92
  8. Feb 24, 20268-K Executive or director change93
  9. Feb 20, 20268-K Executive or director change94
  10. Nov 10, 20258-K Results of operations95
  11. Nov 10, 20258-K Entered a material agreement; Ended a material agreement; Completed an acquisition or sale96
  12. Nov 7, 20258-K Bylaws or fiscal year changed97
  13. Jun 30, 2022New chief executive Sigurdur O. Olafsson becomes CEO13
  14. Jul 2, 2013New chief executive Mark Trudeau becomes CEO14

Calendar

Coming up

  1. Around Nov 10, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results86
  2. May 12, 2026Reported quarterly or annual results91
  3. Mar 31, 2026Reported quarterly or annual results92
  4. Nov 10, 2025Reported quarterly or annual results95
  5. Oct 6, 2025Reported quarterly or annual results98
  6. Aug 6, 2025Reported quarterly or annual results99
  7. Aug 1, 2025Reported quarterly or annual results100
  8. May 6, 2025Reported quarterly or annual results101

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

Filings

529 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 106 major events, 276 insider forms, 60 large holders, 67 other. The latest 20:

  1. Oct 6, 20264 EDGAR
  2. Oct 6, 2026SCHEDULE 13D/A EDGAR
  3. Aug 11, 202610-Q EDGAR
  4. Aug 11, 20268-K EDGAR
  5. Aug 3, 20268-K EDGAR
  6. Jul 23, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Jul 23, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Jul 23, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  15. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  16. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Jul 17, 20264/A OWNERSHIP DOCUMENT EDGAR
  18. Jul 8, 20268-K EDGAR
  19. Jun 15, 20268-K EDGAR
  20. Jun 4, 20264 OWNERSHIP DOCUMENT EDGAR

The 529 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

27 open-market trades by officers, directors and large owners since October 2021: 26 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 20, 2026Silver Point Capital L.P.10% ownerBuy210,000$90.50$19.0MForm 4
May 19, 2026Silver Point Capital L.P.10% ownerBuy187,500$90.50$17.0MForm 4
Apr 17, 2026MULE EDWARD A10% ownerBuy410,000$90.50$37.1MForm 4
Apr 15, 2026MULE EDWARD A10% ownerBuy275,000$88.50$24.3MForm 4
Jan 7, 2026MULE EDWARD A10% ownerBuy250,000$92.25$23.1MForm 4
Dec 8, 2025O'Shea Robert J10% ownerBuy130,974$88.75$11.6MForm 4
Nov 19, 2025Silver Point Capital L.P.10% ownerBuy42,000$88.88$3.7MForm 4
Nov 17, 2025Silver Point Capital L.P.10% ownerBuy26,000$88.88$2.3MForm 4
Nov 10, 2025Silver Point Capital L.P.10% ownerBuy290,000$93.75$27.2MForm 4
Aug 6, 2025GoldenTree Asset Management LLC10% ownerBuy6,700$92.50$619.8KForm 4
Aug 4, 2025GoldenTree Asset Management LLC10% ownerBuy30,000$87.25$2.6MForm 4
Aug 1, 2025GOLDENTREE ASSET MANAGEMENT LP10% ownerBuy50,000$86.50$4.3MForm 4
Jul 8, 2024GoldenTree Asset Management LLC10% ownerBuy13,300$54.50$724.9KForm 4
Jun 14, 2024GoldenTree Asset Management LLC10% ownerBuy275,000$52.75$14.5MForm 4
May 24, 2024GoldenTree Asset Management LLC10% ownerBuy165,000$50.00$8.2MForm 4
May 9, 2024Tananbaum Steven A.10% ownerBuy475,000$55.37$26.3MForm 4
Mar 8, 2024GoldenTree Asset Management LLC10% ownerBuy83,000$43.63$3.6MForm 4
Feb 15, 2024Tananbaum Steven A.10% ownerBuy225,000$38.25$8.6MForm 4
Feb 2, 2024Tananbaum Steven A.10% ownerBuy20,000$37.55$751.0KForm 4
Dec 5, 2023GOLDENTREE ASSET MANAGEMENT LP10% ownerBuy75,000$37.50$2.8MForm 4

All 27 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.

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
2025Sigurdur O. OlafssonPresident and Chief Executive Officer$1.2M$47.4M116
2025Bryan M. ReasonsFormer Executive Vice President and Chief Financial Officer$506.1K$10.1M116
2025Christiana StamoulisPresident and Chief Financial Officer$235.6K$9.9M116
2025Henriette NielsenExecutive Vice President and Chief Transformation Officer$659.0K$8.6M116
2025Lisa FrenchExecutive Vice President and Chief Commercial Officer$631.6K$8.5M116
2025Mark A. TyndallExecutive Vice President and Chief Legal Officer and Corporate Secretary$626.4K$8.5M116
2024Sigurdur O. OlafssonPresident and Chief Executive Officer$1.1M$27.3M116
2024Bryan M. ReasonsFormer Executive Vice President and Chief Financial Officer$647.0K$5.8M116
2024Henriette NielsenExecutive Vice President and Chief Transformation Officer$636.7K$5.0M116
2024Lisa FrenchExecutive Vice President and Chief Commercial Officer$606.9K$4.9M116
2024Mark A. TyndallExecutive Vice President and Chief Legal Officer and Corporate Secretary$601.9K$4.8M116
2023Sigurdur O. OlafssonPresident and Chief Executive Officer$1.1M$14.1M116
2023Bryan M. ReasonsFormer Executive Vice President and Chief Financial Officer$630.0K$6.8M116
2023Henriette NielsenExecutive Vice President and Chief Transformation Officer$620.0K$6.3M116
2023Lisa FrenchExecutive Vice President and Chief Commercial Officer$580.0K$5.7M116
2023Mark A. TyndallExecutive Vice President and Chief Legal Officer and Corporate Secretary$575.0K$5.2M116

SEC filer profile

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

  • Name on EDGARKeenova Therapeutics plc1
  • CIK0001567892
  • Employer ID (EIN)98-10883254
  • Filer statusNon-accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inIreland4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business addressCollege Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, D15, Ireland1
  • Phone353 1 69600001
  • Shares outstanding39,646,277 as of Aug 4, 202610
  • Public float$0 as of Jun 27, 20255
  • AuditorPricewaterhouseCoopers LLP, Florham Park, New Jersey PCAOB ID 238; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 1, 20131
  • Filings1,442 in all: 4 (694), 8-K (237), 3 (84), SC 13G/A (53), 425 (46), 10-Q (39), SC 13G (33), 4/A (24)1
    All 47 form types

    SC 13D/A (24), CORRESP (17), UPLOAD (16), SC TO-T/A (15), DEF 14A (14), DEFA14A (14), 10-K (13), SD (13), 8-K/A (11), S-8 POS (11), S-8 (8), SCHEDULE 13D/A (8), SC 13D (7), ARS (6), 10-12B/A (5), PRE 14A (5), SC TO-C (5), SCHEDULE 13G/A (5), S-4/A (4), 424B3 (3), EFFECT (3), S-4 (3), SC TO-T (3), 25-NSE (2), 8-A12B (2), CERTNYS (2), 10-12B (1), 10-K/A (1), 10-QT (1), 144 (1), 5 (1), 8-A12B/A (1), CERT (1), CT ORDER (1), IRANNOTICE (1), NT 10-K (1), PX14A6G (1), SCHEDULE 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Apr 15, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 11, 2026

Risk factors and legal proceedings

The risks Keenova Therapeutics plc names in Item 1A of its 10-K filed Apr 15, 2026: 60 risks under these headings, as written.4

  • Risks Related to the Business Combination with Endo and Separation of Par Health
  • We may not realize the anticipated benefits and synergies from our Business Combination with Endo.
  • The estimated fair values of the net assets acquired by us in connection with the acquisition of Endo are preliminary and subject to change if new information becomes available.
  • We could incur additional payment obligations pursuant to the U.S. Government Economic Settlement upon the achievement of certain EBITDA outperformance targets.
  • We may not achieve growth opportunities, profit improvements, cost savings and other benefits, and may incur unanticipated costs associated with the Separation, and our results of operations, financial condition and valuation could be adversely affected as a result.
  • As a result of the Separation, we may lose the benefits of services provided by Par Health or certain of its subsidiaries and we may incur incremental costs as a result.
  • We are a smaller and less diversified company than before the Separation.
  • The Separation may result in litigation and/or regulatory inquiries and investigations, which could harm our business, financial condition and operating results and could divert management attention.
  • Risks Related to Our Business
  • Pharmaceutical companies like us have been under increasing scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices, and changes to, or non-compliance with, relevant policies, laws, regulations or government guidance may result in actions that could adversely affect our business.
  • We have various contractual and court-ordered compliance obligations that, if violated could result in monetary, injunctive or other penalties.
  • We face significant competition and may not be able to compete effectively.
The other 50 risks
  • We experience pricing pressure on certain of our products due to legal changes or changes in insurers' reimbursement practices, including as a result of increased public scrutiny of healthcare and pharmaceutical costs, which could reduce our future revenue and profitability.
  • Sales of our products are affected by, and we may be negatively impacted by any changes to, the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers. In addition, reimbursement criteria, policies and practices outside the U.S. could reduce prices for our products or reduce our market opportunities.
  • Our reporting and payment obligations under the Medicare and Medicaid rebate programs, and other governmental purchasing and rebate programs, are complex. Any determination of failure to comply with these obligations or those relating to healthcare fraud and abuse laws could have a material adverse effect on our business.
  • administration authorities, private health coverage insurers and other third-party payers. In addition, reimbursement criteria, policies or practices outside the U.S. could reduce prices for our products or reduce our market opportunities.” for additional information.
  • Cost-containment efforts of our customers, purchasing groups, third-party payers and governmental organizations could materially adversely affect our business.
  • Extensive laws and regulations govern the industry in which we operate and any failure to comply with such laws and regulations, including any changes to those laws and regulations, may materially adversely affect us.
  • Our approved products and investigational products, if successfully developed and approved, 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 boxed warnings or a REMS, or result in other negative consequences.
  • We have limited resources, and may not be successful in our efforts to acquire additional products or product candidates at the rate we expect. In addition, we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We may be unable to successfully develop, commercialize or launch new products or expand commercial opportunities for existing products or adapt to a changing technology and, as a result, our business may suffer.
  • We may not achieve the anticipated benefits of price increases for our products, which may adversely affect our business.
  • Our customer concentration may materially adversely affect our business.
  • Our product concentration may materially adversely affect our business.
  • We may be unable to protect our intellectual property rights, intellectual property rights may be limited or we may be subject to claims that we infringe on the intellectual property rights of others.
  • Clinical trials demonstrating the efficacy of Acthar Gel are limited, which could cause physicians not to prescribe Acthar Gel, or payers not to reimburse the drug, which could negatively impact our business.
  • Clinical studies required for our product candidates and new indications of our marketed products are expensive and time-consuming, and their outcome is highly uncertain. If any such studies are delayed or yield unfavorable results, regulatory approval for our product candidates or new indications of our marketed products may be delayed or become unobtainable or, even if approved, physicians might not prescribe our marketed products.
  • We may incur litigation liability, including but not limited to product liability losses.
  • Our operations expose us to the risk of violations of applicable health, safety and environmental laws and regulations and related liabilities and litigation.
  • If our business development activities or other transactions are unsuccessful, it may adversely affect us.
  • If we are unable to attract and retain qualified personnel in key fields (including scientific, technical, manufacturing, regulatory, compliance and commercial), we may be unable to maintain or expand our business.
  • Our business depends on the continued effectiveness and availability of our information technology infrastructure, and failures of this infrastructure could harm our operations.
  • We face risks related to our collection and use of data, which could result in investigations, inquiries, litigation, fines, legislative and regulatory action.
  • Governmental investigations, inquiries and regulatory actions and lawsuits brought against us by government agencies and private parties, in addition to future legislative actions, with respect to our manufacture or sale of opioids could adversely affect our reputation, business, financial condition, results of operations and cash flows.
  • Some of our products are regulated as controlled substances, the manufacture, sale, importation, exportation, distribution and dispensing and administration of which are subject to significant regulation by the DEA and other regulatory agencies and authorities.
  • The manufacture of our products is highly exacting and complex, and our business could suffer if we, or our suppliers, manufacturers, distributors or collaboration partners encounter manufacturing, supply or other problems.
  • Our operations expose us to risks and challenges associated with conducting business internationally and potential impacts of geopolitical uncertainty.
  • New or increased tariffs and evolving trade relations between the United States and other countries, as well as changes in U.S. international trade and taxation policy, could have a material adverse effect on our business, financial condition, results of operations and cash flows.
  • We have significant levels of intangible assets, including those acquired in the Business Combination, which rely on projections of future cash flows in impairment testing. Should we experience unfavorable variances from these projections these assets may have an increased risk of future loss of value and impairment.
  • We are subject to labor and employment laws and regulations, which could increase our costs and restrict our operations in the future.
  • We have implemented changes to our Acthar Gel patient assistance program, which may receive additional review from governmental regulators and, if challenged, could have a material adverse effect on future net sales of Acthar Gel.
  • Our actual financial results are not comparable to our historical financial statements.
  • Risks Related to Our Indebtedness and Settlement Obligation
  • Our substantial indebtedness and settlement obligation could adversely affect our financial condition and prevent us from fulfilling our obligations.
  • We may not be able to generate sufficient cash to service all of our indebtedness and settlement obligation and we may be forced to take other actions to satisfy our obligations under our indebtedness and settlement obligation, which may not be successful.
  • The terms of the agreements that govern our indebtedness and Acthar Gel-Related Litigation Settlement restrict our current and future operations, particularly our ability to respond to changes or to pursue our business strategies.
  • Our variable-rate indebtedness exposes us to interest rate risk, which could cause our debt service obligations to increase significantly.
  • We may incur additional debt in the future. This could further exacerbate the risks described above.
  • We may need additional financing in the future to meet our capital needs or to make acquisitions, and such financing may not be available on favorable or acceptable terms, and may be dilutive to existing shareholders. The use of proceeds from future financings will be subject to the restrictions from our existing indebtedness.
  • Risks Related to Tax Matters
  • The United States could treat Keenova Therapeutics plc as a U.S. taxpayer or otherwise subject Keenova Therapeutics plc to certain adverse U.S. federal income tax consequences under Internal Revenue Code Section 7874.
  • The IRS may interpret IRC Section 382 limitation and cancellation of debt income attribution rules differently.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • A loss of a major tax dispute, if one were to arise, or a challenge to our operating structure or intercompany pricing policies could result in a higher tax rate on our worldwide earnings, which could result in a material adverse effect on our financial condition, results of operations and cash flows.
  • Our status as a foreign corporation for U.S. federal tax purposes could be affected by a change in law.
  • Future changes to U.S. and foreign tax laws could adversely affect us.
  • We may not be able to maintain a competitive worldwide effective corporate tax rate.
  • Risks Related to Our Jurisdiction of Incorporation
  • Irish law differs from the laws in effect in the U.S. and may afford less protection to holders of our securities.
  • Irish law imposes restrictions on certain aspects of capital management.
  • Risks Related to Our Ordinary Shares
  • Our ordinary shares are not listed on any national securities exchange and our plans to list on an exchange and to conduct a concurrent underwritten public offering are subject to a variety of factors, several of which are outside our control.
  • Our shareholders may experience dilution in the future.
  • Subject to our shares being listed on a recognized stock exchange (including the NYSE), any attempts to acquire us may be subject to the Irish Takeover Rules and subject to the supervisory jurisdiction of the Irish Takeover Panel and our Board of Directors may be limited by the Irish Takeover Rules in its ability to defend an unsolicited takeover attempt.
  • The operation of the Irish Takeover Rules in the event that our ordinary shares are listed on a recognized stock exchange (including the NYSE) and/or provisions of our Articles of Association may affect the ability of certain parties to acquire our ordinary shares.
  • Our ability to pay dividends and fund share repurchases is limited, and Irish law requires that we meet certain financial requirements before we pay dividends or fund repurchases of our ordinary shares

Legal proceedings

We are subject to various legal proceedings and claims, including government investigations, environmental matters, product liability matters, patent infringement claims, antitrust matters, securities class action lawsuits, personal injury claims, employment disputes, contractual and other commercial disputes, and other legal proceedings, sometimes in the ordinary course of business. Although it is not feasible to predict the outcome of these matters, we believe, unless otherwise indicated, given the information currently available, that the ultimate resolution of any particular matter, or matters that have the same legal or factual issues, would not have a material adverse effect on our financial condition, results of operations and cash flows.

For further information regarding our material pending legal proceedings, refer to Note 20 of the Notes to Consolidated Financial Statements included within Item 8. Financial Statements and Supplementary Data of this Annual Report, which is incorporated by reference into this Item 3. Legal Proceedings.

The opening of Item 3, Legal Proceedings.4

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