Product Dependence - The company reported a significant reliance on the success of filgotinib, which is approved for rheumatoid arthritis and ulcerative colitis in the EU, Great Britain, and Japan, marketed under the brand name Jyseleca[23]. - The company is heavily dependent on its global R&D collaboration with Gilead for the commercialization and development of filgotinib, with no assurance of expected benefits[20]. Financial Challenges - The company has no historical profit from product sales, making it challenging to assess future prospects and financial results[21]. - The company is prioritizing the development of certain product candidates due to limited resources and access to capital[26]. - The company may be subject to ongoing regulatory obligations and reviews, resulting in significant additional expenses if product candidates are approved[29]. Market and Competition - The company faces significant competition in drug discovery and development, which could reduce or eliminate commercial opportunities[31]. - The regulatory approval processes for product candidates are lengthy and unpredictable, which may affect commercial viability[27]. Investment and Infrastructure - The company is investing in building its marketing and sales capabilities to establish a European commercial infrastructure[22]. Market Risks - The market price of the company's American Depositary Shares (ADSs) could experience wide fluctuations[33]. - The company may face increased risks of securities class action litigation[34].
Galapagos(GLPG) - 2022 Q4 - Annual Report