Company: BLCO
Filing Date: 2025-02-19
Form Type: 10-K
Source: 0001860742-25-000004
Chunk: 204

Company: Bausch & Lomb Corp
Filing Date: 2025-02-19
Form: 10-K
Item: Item 1A
Chunk 204
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 expensive and unpredictable. The commercial launch of a product takes significant time, resources, personnel and expertise, which we may not have in sufficient levels to achieve success, and is subject to various market conditions, some of which may be beyond our control. There can be no assurance that we will be able to, either by ourselves or in collaboration with our partners or through our licensees or distributors, successfully launch and commercialize new products or gain market acceptance for such products. New product candidates that appear promising in development may fail to reach the market or may have only limited or no commercial success. While we have been successful in launching some of our products, we may not achieve the same level of success with respect to all of our new products, and we may face additional challenges associated with operating as an independent company following the 

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completion of the Separation. Our inability to successfully launch our new products may negatively impact the commercial success of such products, 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. Our inability to successfully launch our new products could also lead to material impairment charges.Levels of market acceptance for our new products could be impacted by several factors, some of which are not within our control, including but not limited to the following:•safety, efficacy, convenience and cost-effectiveness of our products compared to the products of our competitors;•scope of approved uses and marketing approval;•availability of patent or regulatory exclusivity;•timing of market approvals and market entry;•ongoing regulatory obligations following approval, such as the requirement to conduct Risk Evaluation and Mitigation Strategy (“REMS”) programs;•any restrictions or “black box” warnings required on the labeling of such products;•availability of alternative products from our competitors;•acceptance of the price of our products;•effectiveness of our sales forces and promotional efforts;•the level of reimbursement of our products;•acceptance of our products on government and private formularies;•ability to market our products effectively at the retail level or in the appropriate setting of care; and•the reputation of our products.Further, the market perception and reputation of our products and their safety and efficacy are important to our business and the continued acceptance of our products. Any negative publicity about our products, such as the discovery of safety issues with our products, adverse events involving our products, or even public rumors about such events, could have a material adverse effect