FibroGen(FGEN) - 2023 Q4 - Annual Report

Product Dependence - The company is heavily reliant on the success of its lead products, pamrevlumab and roxadustat, for future growth[22] - The company faces substantial competition in the discovery, development, and commercialization of product candidates[22] Regulatory Environment - The regulatory approval process for product candidates is highly uncertain, and the company may not obtain necessary approvals in various jurisdictions[26] - The pharmaceutical industry in China is highly regulated, and changes in regulations could materially affect the company's operations[26] International Operations - The company operates in China through FibroGen Beijing, which holds regulatory licenses for roxadustat and has a drug product manufacturing facility[25] - The company has established operations in China and is seeking to commercialize product candidates outside the U.S., facing various international operational risks[26] Financial Management - As of December 31, 2023, the company reported no material financial assets and liabilities denominated in foreign currencies, indicating low foreign currency risk[596] - The company aims to preserve capital while maximizing income from cash and cash equivalents, primarily investing in commercial paper and money market funds[597] - The company has not entered into any hedging arrangements regarding foreign currency risk or other derivative financial instruments[598] - The company’s future financial condition and results of operations may be adversely affected by fluctuations in foreign currency exchange rates[595]