Financial Performance and Prospects - Galapagos has no historical product revenues, making it difficult to assess future prospects and financial results[21]. - The company has prioritized the development of certain product candidates due to limited resources and access to capital[26]. - The COVID-19 pandemic could materially and adversely affect the company's business and future growth prospects[34]. Product Development and Regulatory Challenges - The company is heavily dependent on the success of filgotinib, which is approved for rheumatoid arthritis and ulcerative colitis in the EU and Great Britain[23]. - Regulatory approval processes for product candidates are lengthy and unpredictable, impacting commercial viability[27]. - Future clinical trials may reveal significant adverse events that could inhibit regulatory approval or market acceptance[31]. Market and Competitive Landscape - Galapagos is currently building a marketing and sales organization to establish a European commercial infrastructure[22]. - Coverage and reimbursement decisions by third-party payers may adversely affect pricing and market acceptance of approved products[32]. - The company faces significant competition in drug discovery and development efforts, which could reduce commercial opportunities[32]. - The market price of the American Depositary Shares (ADSs) could be subject to wide fluctuations[35].
Galapagos(GLPG) - 2021 Q4 - Annual Report