Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 21

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 21
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, this insurance may not be sufficiently available in the future to cover the financial, business, or reputational losses that may result from an interruption or breach of our systems. For example, certain types of cyber-attacks could be considered as an act of war subject to insurance exclusion. The manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and financial condition, delay the launch of new products, and negatively impact our image Many of our products are manufactured using technically complex processes with production constraints, including the need for specialized facilities, trained and certified employees, and highly specific raw materials. We must ensure that all manufacturing processes comply with (i) current Good Manufacturing Practices (cGMP), (ii) other applicable regulations issued by governmental health authorities around the world, as well as (iii) our own quality standards. Third parties supply us with a portion of our raw materials, active ingredients, and medical devices, which exposes us to the risk of a supply shortage or interruption especially if these suppliers are unable to manufacture our products in line with quality standards or if they experience financial difficulties. Epidemics and other public health crises, such as the COVID-19 pandemic, expose us to risks of a slowdown or temporary suspension in the production of our active pharmaceutical ingredients, raw materials, and some of our products. Any prolonged restrictive measures put in place to control an outbreak of contagious disease or other adverse public health development, in a country, state or region in which any of our principal production sites are located, may have a material and adverse effect on our manufacturing operations. Any of these factors could adversely affect our business, operating results, or financial condition (see “Item 4. Information on the Company — B. Business Overview — B.7. Production and raw materials” for a description of these outsourcing arrangements and “A failure in our crisis and business continuity management processes in case of unpredictable events could have negative consequences for our business, operations and reputation” below). Our business may require the transformation and adaptation of our plants to ensure the continuity of production of our products in sufficient quantities to satisfy demand. This may be necessary to meet the need to produce new products, including biologics, or to ensure the scaling up production of products under development once approved. This need may also result from new regulatory requirements. Furthermore, our biological products are subject to the risk of manufacturing stoppages or the risk of loss of inventory because of the difficulties inherent in the processing of biological materials