Product Development Risks - The company is heavily dependent on the success of its clinical-stage product candidates, including oncology candidates GLPG5101 and GLPG5301, and immunology candidates GLPG3667[21] - Clinical development is lengthy and expensive, with uncertain outcomes, and earlier study results may not predict future trial results[22] - The regulatory approval processes in the US and Europe are lengthy and unpredictable, potentially affecting the commercial viability of products in development[24] - The company may not be successful in expanding its oncology portfolio and building a pipeline of product candidates due to limited resources[23] Financial Performance and Market Conditions - The company has limited historical profit from product sales, making it difficult to assess future prospects and financial results[30] - The market price of the American Depositary Shares (ADSs) could be subject to wide fluctuations[31] Competition and Market Dynamics - The company faces significant competition in drug discovery and development, which could reduce or eliminate commercial opportunities[28] - Legislative and regulatory activity may exert downward pressure on potential pricing and reimbursement for approved product candidates[28] Collaboration and Legal Risks - The company relies on a global R&D collaboration with Gilead, with no assurance that it will deliver expected benefits[29] - The company may face increased risks of securities class action litigation and shareholder activism[32]
Galapagos(GLPG) - 2024 Q4 - Annual Report