Bausch Health Companies (BHC) FY2025 10-K Risk Factors: 19 New, 17 Dropped

What the changes say

Litigation and governmental scrutiny remain prominent, including possible additional proceedings tied to prior disclosure and Philidor matters.
Debt remains substantial at $20.232 billion, with refinancing dependent on cash flow and capital-market access.
The filing newly emphasizes third-party compliance, antitrust claims, pricing constraints, acquisitions, inventory forecasting, and reimbursement pressures.
Interest-rate exposure now includes Term CORRA, and BHC reports no outstanding interest-rate swaps at December 31, 2025.

What changed since the prior 10-K

New

NewLegal and Reputational Risks
We are the subject of and may become subject to additional legal and governmental proceedings, which have had and could continue to have a material adverse effect on our reputation and business, and could result in additional claims and material liabilities
Ongoing securities litigation and potential proceedings over disclosure, accounting, and Philidor-related matters could create liabilities and reputational damage.
NewLegal and Reputational Risks
In addition, in the U.S., it has become increasingly common for patent infringement actions to prompt claims that antitrust laws have been violated during the prosecution of the patent or during litigation involving the defense of that patent
Patent disputes and settlements may trigger private or governmental antitrust claims seeking treble damages, restitution, or other relief.
NewLegal and Reputational Risks
We depend on third parties to meet their contractual, legal, regulatory, and other obligations, and actions by these third parties could have a material adverse effect on our business
Distributors, suppliers, research organizations, and other partners may fail contractual, regulatory, anti-corruption, pricing, or marketing obligations.
NewLegal and Reputational Risks
Total debt obligations $ 58 $ 701 $ 4,240 $ 1,662 $ 4,118 $ 9,453 $ 20,232
BHC may lack sufficient cash to service $20.232 billion of debt and could need refinancing, asset sales, equity, or other financing.
NewLegal and Reputational Risks
We are exposed to risks related to interest rates, which could have an adverse effect on our business
Senior secured facilities expose BHC to higher payments when SOFR, prime rates, or Term CORRA increase; no swaps currently offset this exposure.
NewRisks Relating to Intellectual Property and Exclusivity
We operate in extremely competitive industries. If competitors develop or acquire more effective or less costly pharmaceutical or OTC products or medical devices for our target indications, it could have a material adverse effect on our business
Competitors with cheaper or more effective pharmaceuticals, OTC products, medical devices, or disruptive direct-to-consumer models could take market share.
NewRisks Relating to Our Business Strategy
We have previously made commitments and public statements with respect to limitations on pricing increases for certain of our products. These pricing decisions, or decisions to increase prices, could have a material adverse effect on our business
Prior commitments limiting price increases, or future pricing decisions, could reduce revenue and profitability.
NewRisks Relating to Our Business Strategy
We have completed a number of divestitures of our assets, products or businesses that were not considered core to our ongoing operations or the needs of our primary-customer base. We may, in the future, seek to complete additional divestitures
Additional divestitures could lower revenue and cash flow, create taxes or restructuring charges, and shrink BHC’s markets or product portfolio.
NewRisks Relating to Our Business Strategy
As a result of these factors, any divestiture (whether or not completed) could have a material adverse effect on our business
Acquisitions and in-licensing, including DURECT and Shibo, may be costly, fail to close, or deliver fewer benefits than expected.
NewRisks Relating to Our Business Strategy
Changes in inventory levels or fluctuations in buying patterns by our large distributor and retail customers may adversely affect our sales and earnings and add to sales variability from quarter to quarter, which could have a material adverse effect on our business
Demand-forecasting errors, complex product mixes, or inventory changes could cause manufacturing shortages, obsolete stock, and lost sales.
NewRisks Relating to Our Business Strategy
If our products fail to gain, or lose, market acceptance, our revenues would be adversely impacted and we may be required to take material impairment charges, all of which could have a material adverse effect on our business
Weak reimbursement, formulary exclusion, or reduced coverage by government and private payors could limit product use, sales, and market share.
NewRisks Relating to Our Business Strategy
Catastrophic events may disrupt our business
Natural disasters, terrorism, pandemics, disease outbreaks, and severe climate-related weather could disrupt product development, manufacturing, distribution, or demand.
NewRisks Relating to Our Business Strategy
The illegal distribution and sale of counterfeit versions of our products may reduce demand for our products or have a negative impact on the reputation of our products, which could have a material adverse effect on our business
NewRisks Relating to Our Business Strategy
We may experience declines in sales volumes or prices of certain of our products as the result of the concentration of sales to wholesalers and the continuing trend towards consolidation of such wholesalers and other customer groups and this could have a material adverse effect on our business
NewRisks Relating to the International Scope of our Business
Our business is subject to risks arising from the international scope of our operations, any of which could have a material adverse effect on our business
NewRisks Relating to the International Scope of our Business
Given the international scope of our operations, any of the above factors, including sanctions, export controls, tariffs, and/or retaliatory tariffs, trade wars and other governmental actions, could have a material adverse effect on our business
NewRisks Relating to Specific Legislation and Regulations
In the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could impact our ability to sell our products profitably, including the OBBBA and the IRA
NewRisks Relating to Specific Legislation and Regulations
The Health Care Reform Act and further changes to health care laws or regulatory framework that reduce our revenues or increase our costs could also have a material adverse effect on our business
NewOther Risks
In recent years, shareholder activism involving corporate governance, fiduciary duties of directors and officers, strategic direction and operations has become increasingly prevalent

Dropped

DroppedRisks Relating to Economic and Market Conditions
Inflation and other macroeconomic factors could materially adversely affect our financial results and operations
DroppedRisks Relating to the B+L Separation
proceedings, see Note 20, “LEGAL PROCEEDINGS” to our audited Consolidated Financial Statements elsewhere in this Form 10-K
Inflation, supply-chain constraints, labor shortages, tariffs, and other macroeconomic pressures affecting costs and revenues.
DroppedRisks Relating to the B+L Separation
Certain contracts used in our business may need to be replaced in connection with any B+L Separation and failure to obtain such replacement contracts could increase our expenses or otherwise adversely affect our business, results of operations and financial condition
DroppedLegal and Reputational Risks
pay substantial damages in personal injury cases or product liability cases, could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
Costs, management distraction, damages, fines, penalties, settlements, and sanctions from legal proceedings and investigations.
DroppedLegal and Reputational Risks
Total debt obligations $ 2,380 $ 767 $ 6,963 $ 7,168 $ 1,609 $ 1,130 $ 463 $ 20,480
DroppedLegal and Reputational Risks
We are exposed to risks related to interest rates, which could have an adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
DroppedLegal and Reputational Risks
The loss of the services of, or our inability to recruit, retain or motivate, our executives and other key employees could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
DroppedRisks Relating to Intellectual Property and Exclusivity
Intellectual property litigation could cause us to spend substantial resources, distract our personnel from their normal responsibilities and cause the market value of our common shares and/or debt securities to decline
Replacing shared contracts after a Bausch + Lomb Separation and potentially losing favorable contractual terms.
DroppedRisks Relating to Our Business Strategy
thereof) from certain asset sales to repay the term loans under the 2022 Amended Credit Agreement, subject to certain reinvestment rights
Self-insured product liability claims, including uncertain future losses and inadequate historical reserves.
DroppedRisks Relating to Our Business Strategy
As a result of these factors, any divestiture (whether or not completed) could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
DroppedRisks Relating to Our Business Strategy
Catastrophic events may disrupt our business and could cause the market value of our common shares and/or debt securities to decline
Debt repayment risk under the prior $20.480 billion debt-obligation schedule.
DroppedRisks Relating to the International Scope of our Business
As a result of changes to U.S. trade policy, especially in light of recent comments made by the new Trump administration, there may be changes to existing trade agreements, the imposition of new tariffs and greater restrictions on trade generally
DroppedRisks Relating to Information Technology
business needs or adequately safeguard our operations. Furthermore, modification, upgrade or replacement of such systems and infrastructure may be costly or out of our control
Interest-rate exposure, including possible effects on cash flows, securities values, and results.
DroppedRisks Relating to Information Technology
contracts, including with vendors and service providers, for a security lapse or breach or other security incident would be enforceable or adequate or would otherwise protect us from any liabilities or damages with respect to any particular claim
DroppedRisks Relating to Specific Legislation and Regulations
which could limit our ability to collect, use and share EU data, and could cause our compliance costs to increase, ultimately having an adverse impact on our business, and harm our business and financial condition
Losing, recruiting, or motivating executives and other key employees.
DroppedRisks Relating to Specific Legislation and Regulations
reasonableness of the logistics, and measure the public reaction of such a plan have not been performed. We cannot provide assurance as to the ultimate content, timing, effect or impact of such a plan
DroppedOther Risks
Our business and operations could be negatively affected by shareholder activism, which could cause us to incur significant expenses, hinder execution of our business strategy and impact the market value of our common shares and/or debt securities
Intellectual-property litigation costs, management distraction, and potential disclosure of confidential information.

Reworded

100% rewrittenRisks Relating to Specific Legislation and Regulations
Legislative or regulatory reform of the health care system may affect our ability to sell our products profitably and could have a material adverse effect on our business
The current-year risk text is blank in the supplied excerpt, so its change from the prior health-care-reform discussion cannot be assessed.
Was: Legislative or regulatory reform of the health care system may affect our ability to sell our products profitably and could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
92% rewrittenRisks Relating to the B+L Separation
The B+L Separation has been subject to challenge and could be subject to further challenges in the future, any of which could delay or prevent the consummation of such transactions or cause them to occur on terms that are different or less favorable than we originally anticipated
The wording changes a possible challenge to the Bausch + Lomb Separation to possible further challenges and adds future legal proceedings, investigations, costs, and management distraction.
Was: The B+L Separation is subject to challenge and could be subject to further challenges in the future, any of which could delay or prevent the consummation of such transactions or cause them to occur on terms that are different or less favorable than we originally anticipated
70% rewrittenLegal and Reputational Risks
Since the B+L IPO, we have experienced transition in key management positions, and the failure to successfully manage such transitions or attract and retain executives and other key employees could have a material adverse effect on our business
No substantive wording change is shown; the prior and current text identify the same management transitions and retention risk.
Was: Since the B+L IPO, we have experienced transition in key management positions, and the failure to successfully manage such transitions could adversely impact our business and could have a material adverse effect on our business, financial condition, cash flows and results of operations
62% rewrittenRisks Relating to Our Business Strategy
Our policies regarding returns, allowances and chargebacks, and marketing programs adopted by wholesalers, may reduce our revenues in future fiscal periods
No substantive wording change is shown; the prior and current text describe the same rebates, allowances, chargebacks, returns, and wholesaler programs.
61% rewrittenRisks Relating to the B+L Separation
Any of the above factors could cause the B+L Separation process (or the failure to consummate the B+L Separation) to have a material adverse effect on our business
No substantive wording change is shown; the same Canadian tax-free Distribution constraints and potential tax liabilities remain described.
Was: Any of the above factors could cause the B+L Separation process (or the failure to consummate the B+L Separation) to have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
56% rewrittenRisks Relating to Market and Macroeconomic Conditions
Current market and macroeconomic conditions in one or more of our markets could impact our business, liquidity, financial condition, cash flows and results of operations
The current text retains macroeconomic, capital-market, inflation, and trade-war risks but removes explicit impacts on liquidity, cash flows, results, and securities values.
Was: Current market and economic conditions in one or more of our markets could impact our business, liquidity, financial condition, cash flows and results of operations
54% rewrittenOther Risks
See Note 8, “INTANGIBLE ASSETS AND GOODWILL” to our audited Consolidated Financial Statements included elsewhere in this Form 10-K for further information on these impairment charges
No substantive wording change is shown; future goodwill and intangible-asset impairment charges remain the stated risk.
53% rewrittenRisks Relating to Information Technology
We utilize artificial intelligence, which could expose us to liability or could have a material adverse effect on our business and financial condition
The wording changes AI use from having begun to currently using proprietary and third-party AI across various business and operational areas.
51% rewrittenOther Risks
We have significant goodwill and other intangible assets and potential impairment of goodwill and other intangibles may have a significant adverse impact on our financial condition and results of operations
51% rewrittenTax-related Risks
Our effective tax rates may increase, which could adversely affect our financial condition and results of operations
47% rewrittenRisks Relating to Our Business Strategy
Our approved products may not achieve or maintain expected levels of market acceptance, which could have a material adverse effect on our business
Was: Our approved products may not achieve or maintain expected levels of market acceptance, which could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
45% rewrittenRisks Relating to Our Business Strategy
Manufacturing and Supply Risks
41% rewrittenRisks Relating to Our Business Strategy
We have formed a Patient Access and Pricing Team which is committed to maintaining patients’ ability to access our branded prescription pharmaceutical products. All future pricing actions will be subject to review by the Patient Access and Pricing Team
39% rewrittenRisks Relating to Our Business Strategy
Development and Regulatory Risks
39% rewrittenRisks Relating to the International Scope of our Business
Due to the large portion of our business conducted in currency other than U.S. dollars, we have significant foreign currency risk
36% rewrittenLegal and Reputational Risks
Our marketing, promotional and business practices, as well as the manner in which sales forces interact with purchasers, prescribers and patients, are subject to extensive regulation and any material failure to comply could result in significant sanctions against us
30% rewrittenRisks Relating to Our Business Strategy
Our revenues and profits could be reduced by imports from countries where our products are available at lower prices

All 48 risk factors

Headings as the filing states them, in filing order.

Risks Relating to Market and Macroeconomic Conditions

01Current market and macroeconomic conditions in one or more of our markets could impact our business, liquidity, financial condition, cash flows and results of operations56% rewritten

Risks Relating to the B+L Separation

02The B+L Separation has been subject to challenge and could be subject to further challenges in the future, any of which could delay or prevent the consummation of such transactions or cause them to occur on terms that are different or less favorable than we originally anticipated92% rewritten
03Even if the B+L Separation is completed, we may not realize all of the benefits that we originally anticipated
04We have and will continue to expend significant resources in pursuing the B+L Separation, which could have a material adverse effect on our business
05Any of the above factors could cause the B+L Separation process (or the failure to consummate the B+L Separation) to have a material adverse effect on our business61% rewritten

Legal and Reputational Risks

06We are the subject of and may become subject to additional legal and governmental proceedings, which have had and could continue to have a material adverse effect on our reputation and business, and could result in additional claims and material liabilitiesNew
07In addition, in the U.S., it has become increasingly common for patent infringement actions to prompt claims that antitrust laws have been violated during the prosecution of the patent or during litigation involving the defense of that patentNew
08We depend on third parties to meet their contractual, legal, regulatory, and other obligations, and actions by these third parties could have a material adverse effect on our businessNew
09Our marketing, promotional and business practices, as well as the manner in which sales forces interact with purchasers, prescribers and patients, are subject to extensive regulation and any material failure to comply could result in significant sanctions against us36% rewritten
10Total debt obligations $ 58 $ 701 $ 4,240 $ 1,662 $ 4,118 $ 9,453 $ 20,232New
11We have incurred significant indebtedness, which restricts the manner in which we conduct business
12We are exposed to risks related to interest rates, which could have an adverse effect on our businessNew
13Since the B+L IPO, we have experienced transition in key management positions, and the failure to successfully manage such transitions or attract and retain executives and other key employees could have a material adverse effect on our business70% rewritten

Tax-related Risks

14Our effective tax rates may increase, which could adversely affect our financial condition and results of operations51% rewritten

Risks Relating to Intellectual Property and Exclusivity

15We operate in extremely competitive industries. If competitors develop or acquire more effective or less costly pharmaceutical or OTC products or medical devices for our target indications, it could have a material adverse effect on our businessNew

Risks Relating to Our Business Strategy

16We have previously made commitments and public statements with respect to limitations on pricing increases for certain of our products. These pricing decisions, or decisions to increase prices, could have a material adverse effect on our businessNew
17We have formed a Patient Access and Pricing Team which is committed to maintaining patients’ ability to access our branded prescription pharmaceutical products. All future pricing actions will be subject to review by the Patient Access and Pricing Team41% rewritten
18We have completed a number of divestitures of our assets, products or businesses that were not considered core to our ongoing operations or the needs of our primary-customer base. We may, in the future, seek to complete additional divestituresNew
19As a result of these factors, any divestiture (whether or not completed) could have a material adverse effect on our businessNew
20Development and Regulatory Risks39% rewritten
21Our marketed products will be subject to ongoing regulatory review, the results of which could have a material adverse effect on our business and could cause the market value of our securities to decline
22Complying with existing government regulation of dietary supplements, including our eye vitamins and mineral supplements, in the U.S., Canada and elsewhere could increase our costs significantly and adversely affect our financial results
23Our revenues and profits from generic products may decline as a result of changes in regulatory policy
24Manufacturing and Supply Risks45% rewritten
25Changes in inventory levels or fluctuations in buying patterns by our large distributor and retail customers may adversely affect our sales and earnings and add to sales variability from quarter to quarter, which could have a material adverse effect on our businessNew
26Our approved products may not achieve or maintain expected levels of market acceptance, which could have a material adverse effect on our business47% rewritten
27If our products fail to gain, or lose, market acceptance, our revenues would be adversely impacted and we may be required to take material impairment charges, all of which could have a material adverse effect on our businessNew
28We have and may continue to experience pressure on the pricing of certain of our products due to pricing controls, social or government pressure to lower the cost of drugs, and consolidation across the supply chain, which may adversely affect our financial results
29Catastrophic events may disrupt our businessNew
30The illegal distribution and sale of counterfeit versions of our products may reduce demand for our products or have a negative impact on the reputation of our products, which could have a material adverse effect on our businessNew
31Our revenues and profits could be reduced by imports from countries where our products are available at lower prices30% rewritten
32Our policies regarding returns, allowances and chargebacks, and marketing programs adopted by wholesalers, may reduce our revenues in future fiscal periods62% rewritten
33We may experience declines in sales volumes or prices of certain of our products as the result of the concentration of sales to wholesalers and the continuing trend towards consolidation of such wholesalers and other customer groups and this could have a material adverse effect on our businessNew

Risks Relating to the International Scope of our Business

34Our business is subject to risks arising from the international scope of our operations, any of which could have a material adverse effect on our businessNew
35Given the international scope of our operations, any of the above factors, including sanctions, export controls, tariffs, and/or retaliatory tariffs, trade wars and other governmental actions, could have a material adverse effect on our businessNew
36Due to the large portion of our business conducted in currency other than U.S. dollars, we have significant foreign currency risk39% rewritten
37Our business could be adversely affected by disruptions in the global economy caused by the ongoing conflict in the Middle East between Israel, Hamas and other countries and militant groups in the region

Risks Relating to Information Technology

38We utilize artificial intelligence, which could expose us to liability or could have a material adverse effect on our business and financial condition53% rewritten

Risks Relating to Specific Legislation and Regulations

39Legislative or regulatory reform of the health care system may affect our ability to sell our products profitably and could have a material adverse effect on our business100% rewritten
40In the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could impact our ability to sell our products profitably, including the OBBBA and the IRANew
41The Health Care Reform Act and further changes to health care laws or regulatory framework that reduce our revenues or increase our costs could also have a material adverse effect on our businessNew
42The consequences of climate change, such as extreme weather and water scarcity, could pose risks to our facilities and disruption of our activities

Other Risks

43If we fail to maintain adequate internal controls, our business, financial condition, results of operations, cash flows and/or the market value of our securities may be adversely affected
44In recent years, shareholder activism involving corporate governance, fiduciary duties of directors and officers, strategic direction and operations has become increasingly prevalentNew
45We have significant goodwill and other intangible assets and potential impairment of goodwill and other intangibles may have a significant adverse impact on our financial condition and results of operations51% rewritten
46See Note 8, “INTANGIBLE ASSETS AND GOODWILL” to our audited Consolidated Financial Statements included elsewhere in this Form 10-K for further information on these impairment charges54% rewritten
47We have various indemnity agreements and indemnity arrangements in place, which may result in an obligation to indemnify or reimburse the relevant counterparty, which amounts may be material
48Our operating results and financial condition may fluctuate

Other Bausch Health Companies 10-Ks

FY2024 10-K risk factors
46 risks
Bausch Health faces significant risks from heavy debt obligations, ongoing legal and regulatory scrutiny of drug pricing, and uncertainties surrounding the B+L separation.
Filed Feb 20, 2025

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.