Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 29

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 29
---
 laboratories or suppliers is found to be out of compliance with cGMP, we may experience delays or disruptions in manufacturing while we work with these third parties to remedy the violation(s) or while we work to identify suitable replacement vendors. The cGMP requirements govern, among other things, quality control of the manufacturing process, raw materials, containers/closures, buildings and facilities, equipment, storage and shipment, labeling, laboratory activities, data integrity, documentation policies and procedures, and returns. In complying with cGMP, we will be obligated to expend time, resources, and efforts in production, record keeping, and quality control to assure that the product meets applicable specifications and other requirements. If we fail to comply with these requirements, we would be subject to possible regulatory action that could adversely affect our business, results of operations, financial condition, and cash flows, including the inability to sell any products that we may develop.
​
Risks related to commercialization of future products
​
The commercial success of any future products will depend upon the degree of market acceptance by physicians, healthcare payers, patients, and the medical community.
​
The commercial success of any future products we may develop will depend in part on acceptance by the medical community, patients, and third-party or governmental payers as medically useful, cost-effective, and safe. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance of any future products we may develop will depend on a number of factors, including:
​
●the efficacy and safety as demonstrated in clinical trials;
●the timing of market introduction of the product as well as the timing of entry of competitive products;
●the clinical indications for which the product is approved;
●acceptance by physicians, the medical community, and patients of the product as a safe and effective treatment;
●the convenience of prescribing and initiating patients on the product;
●the potential and perceived advantages of such product over alternative treatments;
●the cost of treatment in relation to alternative treatments, including any similar generic treatments;
●the availability of coverage and adequate reimbursement and pricing by third-party payers and government authorities;
●relative convenience and ease of administration;
●the prevalence and severity of adverse side effects; and
●the effectiveness of sales and marketing efforts.
​
Even if a product displays a favorable efficacy and safety profile in preclinical and clinical studies and receives regulatory approval, market acceptance of the product will not be known until after it is launched. Our