What the changes say
- New risks emphasize workforce shortages, contact-lens channel disruption, and environmental compliance costs.
What changed since the prior 10-K
New
- NewRisks Relating to the Separation
In addition, we may experience challenges in building and retaining our workforce in certain markets, where pressure from inflation and competition have exacerbated turnover. Labor shortages and competition for qualified personnel could cause disruptions in our business operations
Inflation, labor shortages, turnover, and executive departures could disrupt operations, increase recruitment costs, and complicate strategic transitions.
- NewRisks Relating to Information Technology
companies, OTC companies and generic manufacturers, in the United States, Canada, Europe, Asia, Latin America, the Middle East, Africa and in other countries in which we market our products
Asian entrants, direct-to-consumer sales, and demand for daily lenses could intensify competition and cannibalize reusable-lens and care-product sales.
- NewRisks Relating to Specific Legislation and Regulations
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, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
Environmental, safety, chemical, and product regulations could require significant spending, remediation, or restrictions on manufacturing and operations.
Dropped
- DroppedRisks Relating to the Separation
We have limited history of operating as an independent company, and our historical financial information prior to the B+L IPO is not necessarily representative of the results that we would have achieved as an independent or standalone company and may not be a reliable indicator of our future results
- DroppedRisks Relating to the Separation
Certain requirements of the public company “butterfly reorganization” rules in Section 55 of the Tax Act depend on events that may not be within our control
- DroppedRisks Relating to the Separation
The services that BHC provides to us may not be sufficient to meet our needs, which may result in increased costs and otherwise adversely affect our business
- DroppedRisks Relating to the Separation
devices for which they are responsible for placing on the market in the UK, whether in Great Britain or Northern Ireland, as required by the UM MDR 2002. This may create added expense and challenges as explained below
- DroppedRisks Relating to the Separation
have the ability to increase the supply price payable by us for the manufacture and supply of our products, in some cases without our consent
- DroppedLegal and Reputational Risks
proceedings will remain with BHC and will be controlled by BHC, but the Company will share in applicable future liabilities, should any result from these proceedings
Limited standalone operating history made pre-IPO financial results potentially unreliable indicators of future performance.
- DroppedRisks Relating to Specific Legislation and Regulations
fines and penalties, exclusion from federal health care programs or other sanctions, including consent orders or corporate integrity agreements
Reworded
- 99% rewrittenRisks Relating to Specific Legislation and Regulations
prevail in any litigation or investigation related to noncompliance 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
The risk changed from self-insured product-liability losses exceeding reserves to False Claims Act, Anti-Kickback Statute, and health-care fraud litigation or investigations.
Was: 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
- 96% rewrittenRisks Relating to the Separation
they could have an adverse impact on results of operations and could cause the market value of our common shares and/or debt securities to decline
The risk changed from unfavorable managed-care formularies to shortages of components, raw materials, or finished products from limited suppliers.
Was: impact on the utilization of our products and, as a result, 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
- 88% rewrittenLegal and Reputational Risks
We are or may become subject to legal and governmental proceedings that are uncertain, costly and time-consuming 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
The risk now specifies BHC-controlled legacy proceedings, shared future liabilities, management distraction, damages, and potentially unfavorable settlements.
- 76% 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, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline
The health-care reform risk is substantially unchanged, with minor wording changes to the PPACA and Health Care Reform Act references.
- 70% 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 AI risk now expressly identifies operational inefficiency, competitive harm, legal liability, reputational damage, and financial impacts from deficient solutions.
- 61% rewrittenRisks Relating to Our Business and our Business Strategy
Our indebtedness could adversely affect our business and our ability to meet our obligations
Debt increased to $3,695 million variable-rate and $1,412 million fixed-rate principal, with January 2031 Secured Notes added to covenant coverage.
- 60% rewrittenRisks Relating to the Separation
The loss of the services of, or our inability to recruit, retain, 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
The executive-retention risk now adds potential disruption and instability affecting management, employees, customers, credit agencies, third parties, and securityholders.
- 60% rewrittenRisks Relating to the Separation
The 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 worse terms than we currently expect
The Separation risk now emphasizes ongoing proceedings, possible government inquiries, costs, sanctions, and management distraction, rather than a specific investor lawsuit.
Was: The 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 worse terms than we currently expect
- 45% rewrittenRisks Relating to the International Scope of our Business
Our business, financial condition, cash flows and results of operations are subject to risks arising from the international scope of our operations
- 35% rewrittenRisks Relating to the Separation
Manufacturing and Supply Risks
- 32% rewrittenRisks Relating to Economic and Market Conditions
Inflation and other macroeconomic factors could materially adversely affect our business and operations
- 27% rewrittenRisks Relating to the Separation
Our marketed products will be subject to ongoing regulatory review
- 25% rewrittenRisks Relating to the Separation
We may not realize the anticipated benefits from the Separation, and the Separation could harm our business
- 25% rewrittenRisks Relating to the Separation
Our approved products may not achieve or maintain expected levels of market acceptance
- 23% rewrittenRisks Relating to the Separation
Until the completion of the Separation, BHC will control the direction of our business, and the concentrated ownership of our common shares will prevent you and other shareholders from influencing significant decisions
- 20% rewrittenTax- and Accounting-related Risks
Our effective tax rates may increase
All 42 risk factors
Headings as the filing states them, in filing order.
Risks Relating to Economic and Market Conditions
- 01Current market and economic conditions in one or more of our markets could impact our ability to grow our business
- 02Inflation and other macroeconomic factors could materially adversely affect our business and operations32% rewritten
Risks Relating to the Separation
- 03We may not realize the anticipated benefits from the Separation, and the Separation could harm our business25% rewritten
- 04The Separation is subject to certain uncertainties. Furthermore, the Distribution or the Sale Transaction may not occur
- 05The 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 worse terms than we currently expect60% rewritten
- 06Until the completion of the Separation, BHC will control the direction of our business, and the concentrated ownership of our common shares will prevent you and other shareholders from influencing significant decisions23% rewritten
- 07Some of our directors and officers may have actual or potential conflicts of interest because of their equity ownership in BHC, and some of our directors may have actual or potential conflicts of interest because they also serve as directors of BHC
- 08To preserve the tax-free treatment of certain transactions related to the Distribution, we may not be able to engage in certain transactions. We could incur significant tax liabilities, or be liable to BHC, if certain transactions occur which result in these transactions or the Distribution being subject to tax
- 09We potentially could have received better terms from unaffiliated third parties than the terms we received in our agreements with BHC
- 10As long as BHC owns a majority of our common shares, we may rely on certain exemptions from the corporate governance requirements of the NYSE available to “controlled companies” and of the TSX available to “majority controlled” companies
- 11The Distribution or future sales by BHC or others of our common shares, or the perception that the Distribution or such sales may occur, could depress our common share price
- 12Development and Regulatory Risks
- 13Our marketed products will be subject to ongoing regulatory review27% rewritten
- 14Complying 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
- 15Manufacturing and Supply Risks35% rewritten
- 16they could have an adverse impact on results of operations and could cause the market value of our common shares and/or debt securities to decline96% rewritten
- 17Changes 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
- 18Our approved products may not achieve or maintain expected levels of market acceptance25% rewritten
- 19Catastrophic events may disrupt our business
- 20The loss of the services of, or our inability to recruit, retain, 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 decline60% rewritten
- 21In addition, we may experience challenges in building and retaining our workforce in certain markets, where pressure from inflation and competition have exacerbated turnover. Labor shortages and competition for qualified personnel could cause disruptions in our business operationsNew
Risks Relating to Our Business and our Business Strategy
- 22Our policies regarding returns, allowances and chargebacks, and marketing programs adopted by wholesalers, may reduce our revenues in future fiscal periods
- 23We 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
- 24Our indebtedness could adversely affect our business and our ability to meet our obligations61% rewritten
Risks Relating to the International Scope of our Business
- 25Our business, financial condition, cash flows and results of operations are subject to risks arising from the international scope of our operations45% rewritten
- 26Due to the large portion of our business conducted in currency other than U.S. dollars, we have significant foreign currency risk
Risks Relating to Intellectual Property and Exclusivity
- 27Intellectual property litigation could cause us to spend substantial resources, distract our personnel from their normal responsibilities and cause the value of our common shares and/or debt securities to decline
Risks Relating to Information Technology
- 28We utilize artificial intelligence, which could expose us to liability or could have a material adverse effect on our business and financial condition70% rewritten
- 29companies, OTC companies and generic manufacturers, in the United States, Canada, Europe, Asia, Latin America, the Middle East, Africa and in other countries in which we market our productsNew
Tax- and Accounting-related Risks
- 30Our effective tax rates may increase20% rewritten
- 31We have significant goodwill and other intangible assets and potential impairment of goodwill and other intangibles may have a significant adverse impact on our profitability
- 32For example, in 2024 and 2023, we recognized impairments to finite-lived and indefinite-lived intangible assets of $5 million and less than $1 million, respectively. These asset impairments were primarily attributable to the discontinuance of certain product lines
- 33See Note 5, “FAIR VALUE MEASUREMENTS” and 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
Legal and Reputational Risks
- 34We are or may become subject to legal and governmental proceedings that are uncertain, costly and time-consuming 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 decline88% rewritten
- 35We depend on third parties to meet their contractual, legal, regulatory and other obligations
- 36Our 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
Risks Relating to Specific Legislation and Regulations
- 37prevail in any litigation or investigation related to noncompliance 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 decline99% rewritten
- 38Legislative 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 decline76% rewritten
- 39Changes 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, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to declineNew
- 40We are currently governed by the corporate laws of Canada that in some cases have a different effect on shareholders than the corporate laws of Delaware
Risks Relating to our Common Shares
- 41Our by-laws designate specific courts in Canada and the federal district courts of the United States as the exclusive forum for certain litigation that may be initiated by our shareholders, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us
- 42Our operating results and financial condition may fluctuate
Other Bausch & Lomb 10-Ks
- Filed Feb 19, 2025
About this page
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.