INDV on Nasdaq

Indivior

Specialty pharmaceuticals company

Indivior is an American pharmaceuticals company. Established as a division of Reckitt Benckiser in 1994 and demerged from that company in December 2014, it is focussed on substitution products for opioid addiction. It is listed on the London Stock Exchange and on the NASDAQ Global Select Market.3 Its shares trade on Nasdaq under the symbol INDV.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

1994Founded1

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  • TickerINDV on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersRichmond1
  • Websiteindivior.com
  • Legal formpublic company1
  • Incorporated inDE5
  • Business address10710 Midlothian Turnpike, Suite 125, North Chesterfield, Va 232355
  • Filer categoryLarge accelerated filer5
  • LEI213800V3NCQTY7IED4714
  • StatusActive4
  • LEI statusIssued and current4
  • Registered address234 BATH ROAD, SL1 4EE Slough, United Kingdom4
  • Registered withCompanies House, 092378944
Suboxone SL Tabs
Photo: Jr de Barbosa, CC BY-SA 3.0, via Wikimedia Commons8

Indivior is an American pharmaceuticals company. Established as a division of Reckitt Benckiser in 1994 and demerged from that company in December 2014, it is focussed on substitution products for opioid addiction. It is listed on the London Stock Exchange and on the NASDAQ Global Select Market.3

Financials

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

Key numbers, fiscal 2025

80.2%Gross margin9
21.1%Operating margin9
16.9%Net margin9
4.3%Revenue growth, 20259
-$93.0MFree cash flow9

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue20¢$246.0M
  • Selling, general and admin51¢$634.0M
  • Other costs10¢$120.0M
  • Income tax2¢$29.0M
  • Profit17¢$210.0M

Out of $1.2B in revenue.9

Financial statements

Revenue109$1.2B in 2025+38% since 2022
0$500.0M$1.0B$1.5B2022: $901.0M$901.0M20222023: $1.1B$1.1B2023+21%2024: $1.2B$1.2B2024+9%2025: $1.2B$1.2B2025+4%
Gross profit11109$994.0M in 2025+50% since 2021
0$250.0M$500.0M$750.0M$1.0B2021: $664.0M$664.0M20212022: $749.0M$749.0M2022+13%2023: $919.0M$919.0M2023+23%2024: $957.0M$957.0M2024+4%2025: $994.0M$994.0M2025+4%
Operating income11129$262.0M in 2025+23% since 2021
-$200.0M0$200.0M$400.0M2021: $213.0M$213.0M20212022: -$77.0M-$77.0M20222023: -$152.0M-$152.0M2023+97%2024: $38.0M$38.0M20242025: $262.0M$262.0M2025+589%
Net income11129$210.0M in 2025+2% since 2021
-$200.0M-$100.0M0$100.0M$200.0M$300.0M2021: $205.0M$205.0M20212022: -$42.0M-$42.0M20222023: -$126.0M-$126.0M2023+200%2024: $7.0M$7.0M20242025: $210.0M$210.0M2025+2900%

Every line of the income statement as filed: the last 3 fiscal years (annual) or 4 quarters (quarterly), latest first.9

Period ending2025-12-312024-12-312023-12-31
Net revenue$1.2B$1.2B$1.1B
Cost of sales$246.0M$231.0M$174.0M
Gross profit$994.0M$957.0M$919.0M
Selling, general and administrative$634.0M$612.0M$565.0M
Research and development$97.0M$107.0M$116.0M
Acquired in-process research and development$0$1.0M$162.0M
Litigation settlement$3.0M$195.0M$239.0M
Other operating (income) expense, net-$3.0M$4.0M-$9.0M
Operating income (loss)$262.0M$38.0M-$152.0M
Interest income-$22.0M-$23.0M-$43.0M
Interest expense$45.0M$41.0M$35.0M
Income (loss) before income taxes$239.0M$20.0M-$145.0M
Income tax expense (benefit)$29.0M$13.0M-$19.0M
Net income (loss)$210.0M$7.0M-$126.0M
Basic (in dollars per share)$1.68$0.05-$0.92
Diluted (in dollars per share)$1.64$0.05-$0.92
Basic (in shares)125.0M shares132.0M shares137.0M shares
Diluted (in shares)128.0M shares133.0M shares137.0M shares

Compare Indivior with another company

Corporate structure

Indivior sits at the top of its group. 29 entities, 13 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Indivior

  • Indivior Slough, United Kingdom
    • Indivior Canada Ltd Subsidiary · Canada
    • Indivior Deutschland GmbH Subsidiary · Germany
    • Indivior España S.L.U. Subsidiary · Spain
    • Indivior EU Limited Subsidiary · United Kingdom
    • Indivior Europe Limited Subsidiary · Ireland
    • Indivior Finance (2014) LLC Subsidiary · Delaware, United States
    • Indivior Finance LLC Subsidiary · Delaware, United States
    • Indivior France SAS Subsidiary · France
    • Indivior Global Holdings Limited Subsidiary · United Kingdom
    • Indivior Israel Ltd Subsidiary · Israel
    • Indivior Italia S.r.l Subsidiary · Italy
    • Indivior Jersey Finance (2021) Limited Subsidiary · Jersey
    • Indivior Jersey Finance LLC Subsidiary · Delaware, United States
    • Indivior Manufacturing LLC Subsidiary · Delaware, United States
    • Indivior Nordics ApS Subsidiary · Denmark
    • Indivior Schweiz AG Subsidiary · Switzerland
    • Indivior SMTM LLC Subsidiary · Delaware, United States
    • Indivior Solutions Inc. Subsidiary · Delaware, United States
    • Indivior South Africa (Pty) Ltd Subsidiary · South Africa
    • Indivior Treatment Services, Inc. Subsidiary · Delaware, United States
    • Indivior UK Finance No1 Limited Subsidiary · United Kingdom
    • Indivior UK Finance No2 Limited Subsidiary · United Kingdom
    • Indivior UK Finance No3 Limited Subsidiary · United Kingdom
    • Indivior UK Limited Subsidiary · United Kingdom
    • Indivior US Holdings Inc. Subsidiary · Delaware, United States
    • and 3 more

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 Indivior 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$251.0M9 Dec 31, 2025$190.0M9 Dec 31, 2024+32.1%
Accumulated depreciation$107.0M9 Dec 31, 2025$90.0M9 Dec 31, 2024+18.9%
Property and equipment, net$144.0M9 Dec 31, 2025$100.0M9 Dec 31, 2024+44.0%
Operating-lease assets (leased space)$26.0M9 Dec 31, 2025$39.0M9 Dec 31, 2024−33.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$195.0M9 Dec 31, 2025$319.0M9 Dec 31, 2024−38.9%
Marketable securities, current$09 Dec 31, 2025$1.0M9 Dec 31, 2024−100.0%
Long-term investments$28.0M9 Dec 31, 2025$27.0M9 Dec 31, 2024+3.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$2.0M9 Dec 31, 2025$2.0M9 Dec 31, 20240%
Accumulated amortization$251.0M9 Dec 31, 2025$246.0M9 Dec 31, 2024+2.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$153.0M9 Dec 31, 2025$167.0M9 Dec 31, 2024−8.4%
Work in process$49.0M9 Dec 31, 2025$51.0M9 Dec 31, 2024−3.9%
Finished goods$75.0M9 Dec 31, 2025$94.0M9 Dec 31, 2024−20.2%

Properties, in its own words

The following table contains information regarding the Company's principal physical properties.

Location · Tenure · Principal use

The rest of Item 2

Richmond, Virginia · Leased · Office space

Hull, England · Owned(1) · Fine Chemical Plant manufacturing facility

Hull, England · Owned(2) · Chapleo Building research and development facility

Raleigh, North Carolina · Owned · Manufacturing and warehousing

Fort Collins, Colorado · Leased(2) · Office space and research facility

Slough, England · Leased(2) · Office space

_____________

(1)The Hull, England property is leased for 150 years and accounted for as owned.

(2)The Company is actively marketing these properties in connection with the optimization of its operations.

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

The story

The company was established as the Buprenorphine division of Reckitt Benckiser in 1994. In December 2014, Reckitt Benckiser spun off its specialty pharmaceuticals business into a separate company named Indivior. By February 2015, the company was capitalised at £2.3 billion (US$3.1 billion) on the London Stock Exchange.

In 2019, Indivior was indicted over claims that it had made false marketing claims about the safety of its drug, Suboxone, and had concocted a scheme to direct patients towards doctors who were likely to prescribe Suboxone. Reckitt Benckiser has settled with the Justice Department to pay $1.4 billion to resolve a U.S. Federal investigation into sales and marketing of opioid addiction treatment.

In July 2020, Indivior Solutions, Indivior Inc., and Indivior PLC agreed to pay $600 million to resolve liability related to false marketing of Suboxone to MassHealth for use by patients with children under the age of six years old. Additionally, Indivior Solutions Inc pleaded guilty to one-count of felony information.

In November 2022, it was announced Indivior had acquired the Santa Monica-headquartered, NASDAQ-listed biopharmaceutical company, Opiant.

In June 2023, the company listed its shares on both the US Nasdaq and UK London Stock Exchange.

In July 2023, Indivior paid $20.4 million to C4X Discovery for the full rights to the orexin-1 receptor antagonist being developed for substance use disorder. Indivior had already made an upfront payment of $10 million in 2018 and pledged milestone payments of up to $284 million. Under the new agreement C4X Discovery waived any rights to further payment.

In May 2024, the company confirmed that it would transfer its primary share listing to the US, with its UK listing becoming secondary.

In February 2025, the company announced the appointment of Joe Ciaffoni as its chief executive, replacing Mark Crossley.

Read the full text

In June 2025, Indivior delisted from the UK's stock exchange but retained its US listing.

From Wikipedia’s article on Indivior, shared under CC BY-SA 4.0.6

Leadership

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

Chief financial officer

  1. Ryan Preblick2026–now
1995200020052010201520202025
Board members and other officers (10)

Products and brands

  • buprenorphine

Listed on Wikidata.1

The company's main products are Sublocade, Subutex and its Naloxone-combined preparation Suboxone, both substitution products for opioid addiction. Other products include remedies for cocaine and opioid analgesic overdose and treatment for alcohol dependence: the company claims this to be the largest pipeline of addiction drugs in the world.

From Wikipedia’s article on Indivior, shared under CC BY-SA 4.0.6

Subsidiaries and ownership

Owners

Subsidiaries (Exhibit 21)

  • Indivior Canada Ltd Canada7
  • Indivior Deutschland GmbH Germany7
  • Indivior EU Limited England and Wales7
  • Indivior España S.L.U. Spain7
  • Indivior Europe Limited Ireland7
  • Indivior Finance (2014) LLC Delaware (US)7
  • Indivior Finance LLC Delaware (US)7
  • Indivior France SAS France7
  • Indivior Global Holdings Limited England and Wales7
  • Indivior Inc. Delaware (US)7
  • Indivior Israel Ltd Israel7
  • Indivior Italia S.r.l Italy7
  • Indivior Jersey Finance (2021) Limited Jersey7
  • Indivior Jersey Finance LLC Delaware (US)7
  • Indivior Limited England and Wales (as of January 26, 2026).7
  • Indivior Manufacturing LLC Delaware (US)7
  • Indivior Nordics ApS Denmark7
  • Indivior Pty Ltd Australia7
  • Indivior SMTM LLC Delaware (US)7
  • Indivior Schweiz AG Switzerland7
  • Indivior Solutions Inc. Delaware (US)7
  • Indivior South Africa (Pty) Ltd South Africa7
  • Indivior Treatment Services, Inc. Delaware (US)7
  • Indivior UK Finance No1 Limited England and Wales7
All 31 listed subsidiaries
  • Indivior UK Finance No2 Limited England and Wales7
  • Indivior UK Finance No3 Limited England and Wales7
  • Indivior UK Limited England and Wales7
  • Indivior US Holdings Inc. Delaware (US)7
  • Indy 1 (UK) Limited England and Wales7
  • Opiant Pharmaceuticals UK Limited England and Wales7
  • RBP Global Holdings Limited England and Wales7

From Wikidata.1 The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • INDIVIOR PLCDec 2, 2014 to Jan 8, 20265

Timeline

  1. Oct 15, 20268-K Shareholder vote27
  2. Oct 6, 20268-K Other events28
  3. Sep 17, 20268-K Regulation FD disclosure; Other events29
  4. Sep 15, 20268-K Ended a material agreement30
  5. Aug 3, 20268-K Entered a material agreement; Regulation FD disclosure31
  6. Aug 3, 20268-K Results of operations; Regulation FD disclosure32
  7. Aug 3, 20268-K Regulation FD disclosure33
  8. May 15, 20268-K Executive or director change; Shareholder vote34
  9. May 4, 20268-K Regulation FD disclosure; Other events35
  10. Apr 30, 20268-K Results of operations; Regulation FD disclosure36
  11. Mar 17, 20268-K Entered a material agreement; Ended a material agreement; New debt or obligation37
  12. Mar 13, 20268-K Other events38
  13. Jan 7, 2026New chief executive Joseph Ciaffoni becomes CEO16
  14. 1994Founded Founded1

Calendar

Coming up

  1. Oct 29, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.72 a share, on Oct 30, 2025.39

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results32
  2. Apr 30, 2026Reported quarterly or annual results36
  3. Feb 26, 2026Reported quarterly or annual results40
  4. Oct 30, 2025Reported quarterly or annual results41
  5. Jul 31, 2025Reported quarterly or annual results42
  6. Apr 24, 2025Reported quarterly or annual results43

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

Filings

542 filings to the SEC since October 2021: 3 annual reports, 5 quarterly reports, 37 major events, 52 insider forms, 50 large holders, 395 other. The latest 20:

  1. Oct 15, 20268-K EDGAR
  2. Oct 6, 2026425 EDGAR
  3. Oct 6, 20268-K EDGAR
  4. Sep 30, 2026SCHEDULE 13G EDGAR
  5. Sep 17, 2026425 EDGAR
  6. Sep 17, 20268-K EDGAR
  7. Sep 15, 20268-K EDGAR
  8. Sep 11, 2026EFFECT EDGAR
  9. Sep 11, 2026424B3 EDGAR
  10. Sep 9, 2026S-4/A EDGAR
  11. Aug 28, 2026S-4 EDGAR
  12. Aug 27, 20264 EDGAR
  13. Aug 13, 2026SCHEDULE 13D/A EDGAR
  14. Aug 5, 20264 EDGAR
  15. Aug 3, 202610-Q EDGAR
  16. Aug 3, 2026425 EDGAR
  17. Aug 3, 20268-K EDGAR
  18. Aug 3, 2026425 EDGAR
  19. Aug 3, 20268-K EDGAR
  20. Aug 3, 2026425 EDGAR

The 542 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

13 open-market trades by officers, directors and large owners since October 2021: 10 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 27, 2026Anderson Woodrow DChief Accounting OfficerBuy1,500$35.69$53.5KForm 4
Aug 5, 2026Anderson Woodrow DChief Accounting OfficerBuy1,500$36.28$54.4KForm 4
Jul 10, 2026Heidbreder ChristianChief Scientific OfficerSale18,586$41.14$764.6KForm 4
Jun 11, 2026Heidbreder ChristianChief Scientific OfficerSale18,586$38.06$707.4KForm 4
Jun 8, 2026Preblick RyanChief Financial OfficerSale36,000$37.70$1.4MForm 4
Mar 13, 2026Ryan BarbaraDirectorBuy8$31.09$249Form 4
Mar 9, 2026Ryan BarbaraDirectorBuy31$32.56$1.0KForm 4
Mar 6, 2026Kingsley Stuart ADirectorBuy940$31.87$30.0KForm 4
Jan 5, 2026Humphreys KeithDirectorBuy775$35.39$27.4KForm 4
Jan 5, 2026Ryan BarbaraDirectorBuy775$35.39$27.4KForm 4
Jan 5, 2026Wheadon David E.DirectorBuy1,771$35.39$62.7KForm 4
Jan 5, 2026Stejbach MarkDirectorBuy775$35.39$27.4KForm 4
Jan 5, 2026NINIVAGGI DANIEL ADirectorBuy775$35.39$27.4KForm 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.

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
2025Joe Ciaffoni$680.1K$18.5M57
2025Pat BarryChief$408.3K$4.9M57
2025Christian Heidbreder$652.6K$4.2M57
2025Richard Simkin$325.0K$4.0M57
2025Ryan Preblick$558.8K$3.6M57
2025Jeff Burris$569.0K$3.5M57
2025Mark Crossley$902.3K$3.2M57
2024Former Chief$871.8K$3.9M57
2024Chief Scientific$630.6K$2.5M57
2024Chief Financial$539.9K$2.3M57
2024Chief Legal$500.9K$2.0M57
2023Executive Officer$834.2K$4.4M57
2023Commercial Officer$721.2K$3.6M57
2023Officer$516.7K$2.4M57

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.18,709,432$767.6M0.0%+167,212
Vanguard Portfolio Management LLC7,572,287$310.7M0.0%−319,532
Oaktree Capital Management LP6,127,212$251.4M6.7%−856,890
Vanguard Capital Management LLC5,495,486$225.5M0.0%−91,090
State Street Corp4,992,071$204.8M0.0%+88,078
Fuller & Thaler Asset Management, Inc.4,615,816$189.4M0.5%+86,233
Two Seas Capital LP3,479,493$142.8M5.4%−1,267,017
Morgan Stanley3,395,702$139.3M0.0%−110,115
Franklin Resources Inc3,316,358$136.1M0.0%+3,204,765
Geode Capital Management, LLC3,159,866$129.7M0.0%+234,178
Assenagon Asset Management S.A.3,081,856$126.4M0.1%New
Madison Avenue Partners, LP2,874,368$117.9M5.1%−1,440,794
Mangrove Partners Im, LLC2,676,730$109.8M7.2%−65,704
Citadel Advisors LLC2,667,827$109.5M0.1%−906,217
Driehaus Capital Management LLC2,299,054$94.3M0.5%+419,015
Millennium Management LLC2,098,945$86.1M0.1%−2,496,590
Dimensional Fund Advisors LP1,896,605$77.8M0.0%+564,477
Invesco Ltd.1,842,983$75.6M0.0%+281,220
Deerfield Management Company, L.P.1,648,895$67.7M0.8%−1,448,895
Arrowstreet Capital, Limited Partnership1,642,086$67.4M0.0%−681,178
Federated Hermes, Inc.1,468,749$60.3M0.1%+251,028
Newtyn Management, LLC1,305,795$53.6M6.7%−694,205
Point72 Asset Management, L.P.1,250,639$51.3M0.1%+1,155,696
Northern Trust Corp1,241,772$50.9M0.0%+80,369
Charles Schwab Investment Management Inc1,224,609$50.2M0.0%+82,724

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

SEC filer profile

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

  • Name on EDGARIndivior Pharmaceuticals, Inc.2
  • CIK0001625297
  • Employer ID (EIN)41-252087315
  • Filer statusLarge accelerated filer not an emerging growth company; not 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 address10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 232352
  • Phone804-379-10902
  • Shares outstanding118,013,649 as of Jul 28, 202614
  • Public float$1.8B as of Jun 30, 202515
  • AuditorPricewaterhouseCoopers LLP, Richmond, Virginia PCAOB ID 238; it also attests to the company’s internal control over financial reporting15
  • On EDGAR sinceDec 2, 20142
  • Filings549 in all: 6-K (337), 4 (39), 8-K (34), SCHEDULE 13D/A (15), 3 (13), SCHEDULE 13G/A (11), 144 (10), SCHEDULE 13G (9)2
    All 41 form types

    425 (7), SC 13G (6), 10-Q (5), DFAN14A (4), DRS/A (4), SC 13D/A (4), UPLOAD (4), 20FR12B/A (3), 6-K/A (3), 8-K/A (3), DRSLTR (3), S-8 (3), S-8 POS (3), SC 13G/A (3), 10-K (2), 20FR12B (2), ARS (2), CORRESP (2), EFFECT (2), SC 13D (2), SEC STAFF LETTER (2), 144/A (1), 15-12G (1), 20-F (1), 424B3 (1), CERT (1), DEF 14A (1), DEFA14A (1), DRS (1), F-6 (1), S-4 (1), S-4/A (1), SEC STAFF ACTION (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 3, 2026
    Proxy statement (DEF 14A) Mar 27, 2026
    Latest 8-K (8-K) Oct 15, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par value per shareINDVThe Nasdaq Stock Market LLC

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 Indivior names in Item 1A of its 10-K filed Feb 26, 2026: 55 risks under these headings, as written.15

  • Risks Related to our Company and Its Business
  • We are subject to risks related to the manufacture and distribution of our products globally and must meet stringent current Good Manufacturing Practices.
  • We rely heavily on SUBLOCADE for a significant portion of our revenues.
  • Our revenues may grow at a slower than expected rate or decrease due to many factors.
  • We rely on third parties to manufacture, package, test, and distribute our products and their facilities and processes must meet stringent regulatory requirements.
  • Our ability to generate revenues from our products is subject to attaining significant market acceptance among key healthcare stakeholders and our ability to successfully develop and execute commercialization strategies for each of our products. Failure to do so would adversely impact our financial condition and prospects.
  • We are currently, in the past have been, and in the future may be, subject to substantial litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business.
  • We must comply with the terms and conditions of the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the U.S. Federal Trade Commission (“FTC”), along with a similar injunction with certain State Attorneys General related to certain product launches and applications for product approvals and we could be subject to criminal charges or penalties if we fail to comply.
  • We are subject to additional risks because we import, manufacture, and distribute controlled substances.
  • Acquisitions, partnerships, joint ventures, dispositions, and other business combinations or strategic transactions involve several inherent risks, any of which could result in the benefits anticipated not being realized and could have an adverse effect on our business, financial condition, and results of operations.
  • The clinical study or commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our products, business and share price.
  • Revenues generated by sales of our products depend on the availability from third-party payors for reimbursement for our products and the extent of cost-sharing arrangements for patients (e.g., patient co-payment, co-insurance, and deductible obligations) and cost-control measures imposed, and any reductions in payment rate or reimbursement or increases in our or in patients’ financial obligation to payors could result in decreased sales of our products and/or decreased revenues.
The other 44 risks
  • Congressional action to reduce spending may result in cuts to Medicaid which in turn might impair access to our products in the U.S., thereby adversely affecting our revenues and results of operations.
  • We operate in a highly competitive industry, which includes companies with greater resources than us. The approval and launch of generic or branded products that compete with SUBLOCADE, and an additional generic competitor for SUBOXONE Film, could have a material adverse effect on our business, prospects, results of operations and financial condition.
  • Failure to retain key personnel or attract new personnel could have a material adverse effect on us.
  • We are subject, directly or indirectly, to a variety of U.S. and international laws and regulations related to fraud and abuse, transparency, and privacy. Enforcement actions under such laws have increased in recent years. If we fail to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We may be subject to adverse public opinion.
  • We use hazardous materials in our manufacturing facilities, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive.
  • Actual costs to exit various businesses may differ materially from our estimates.
  • Most of our pharmaceutical pipeline relies on collaborations with third parties, which may adversely affect the development and sale of our products.
  • Clinical trials for the development of products, including our key pipeline products, may be unsuccessful and our product candidates may not receive authorization for manufacture and sale.
  • Risks Related to Intellectual Property
  • Failure to obtain and maintain patents and protect other proprietary rights, including in-licenses of such rights from third parties, may adversely affect us.
  • We may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights, and we may be unable to protect our rights to, or commercialize our products.
  • Risks Related to Regulatory or Legal Matters
  • The FDA, the DEA, or other regulatory agencies may impose limitations or post-approval requirements on approvals for our products.
  • Post-Approval or Post-Marketing Studies.
  • Scheduling Under the Controlled Substances Act.
  • We are subject to ongoing obligations and continued regulatory inspection by the FDA and equivalent foreign regulatory agencies, and we may be subject to penalties and litigation and large incremental expenses if we fail to comply with regulatory requirements or experience problems with our products.
  • Product liability and product recalls could have a material adverse effect on us.
  • We are subject to federal, state and foreign healthcare laws and regulations and implementation or changes to such healthcare laws and regulations could adversely affect our business and results of operations.
  • Guidelines and coverage determinations published by the government, professional societies, insurance carriers, physician groups, science foundations, and other organizations may affect the use of the Company’s products.
  • Failure to comply with payment and reporting obligations under the Medicaid Drug Rebate program or other governmental pricing programs in the U.S. could result in additional reimbursement requirements, penalties, sanctions and fines.
  • Failure to comply with anti-corruption laws and regulations, anti-money laundering laws and regulations, and/or economic sanctions could result in us becoming subject to fines or penalties.
  • The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, and any failure to comply, may expose us to significant damages and commercial restrictions that can materially and adversely affect our business.
  • The regulatory approval process is expensive, time-consuming, and uncertain and may prevent us or our partners from obtaining approvals for the commercialization of some or all of our product candidates. Further, the FDA or other regulatory agencies may not agree with our regulatory approval strategies or components of our filings for our products and may not approve, or may delay the approval of, our products.
  • Risks Related to our Financial Condition and Tax Matters
  • Our balance sheet is leveraged, and any reduction in revenue or change in our estimates may adversely affect our liquidity and profitability.
  • Our business strategy may involve future transactions that may harm the market price of our common stock or require us to seek additional funds, and such funding may not be available on commercially favorable terms or at all and may cause dilution to our existing stockholders. The issuance of additional common stock in connection with future acquisitions, any stock incentive or stock option plan, or otherwise, may dilute all other stock holdings.
  • Our effective tax rate may increase, and changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition.
  • Our deferred tax assets may not be realized.
  • Tariffs on pharmaceutical products, and potential reciprocal responses by other countries, may adversely affect our revenues or profitability.
  • Weakness in the economy, geopolitics, market trends, disruptions in our supply chain, uncertainty, and other conditions in the markets in which we operate, particularly in the U.S., may adversely affect our sales growth and results of operations.
  • Our operating results may fluctuate significantly.
  • Any future pandemic, and governmental and societal responses thereto, may harm our business, results of operations, and financial condition.
  • Our insurance coverage may not be adequate.
  • Our term loan contains certain covenants that could limit our ability to plan for or respond to changes in our business.
  • Risks Related to Our Common Stock
  • Our common stock is subject to market price volatility and the market price may decline disproportionately in response to developments that are unrelated to our operating performance.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • The Parent Company is a holding company with no business operations of its own and depends on its subsidiaries for cash, including in order to pay dividends or repurchase shares.
  • We may not pay dividends or repurchase our shares in the future. Our ability to pay dividends, repurchase our shares, or make other returns of capital in the future depends, among other things, on our financial performance.
  • We are subject to anti-takeover provisions in our certificate of incorporation and bylaws and under Delaware law that could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders.
  • Provisions of our Note Purchase Agreement may deter or prevent an otherwise beneficial takeover attempt of us.
  • Risks Related to Information Security and Data Privacy
  • Business interruptions or breaches of data security could disrupt our product sales and delay the development of our product candidates.
  • We are required to maintain the privacy and security of personal information in compliance with privacy and data protection regulations worldwide. Failure to meet the requirements could result in fines, penalties, or private actions, harm our business and damage our reputation with customers, suppliers, and associates.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
  • Risks Related to Our International Status and Operations
  • We are exposed to risks related to currency exchange rates.
  • Risks Related to Being a Publicly-Traded Company in the U.S.
  • Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters, could significantly affect our financial results or financial condition.

Legal proceedings

The descriptions of our litigation and regulatory matters, and other matters, contained in Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 16. Commitments and Contingencies to our financial statements are incorporated herein by reference.

The opening of Item 3, Legal Proceedings.15

Sources

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