Company Overview and Strategy - In 2020, Zai Lab achieved significant milestones, including the successful launch of new products and submission of new drug applications, with a strong focus on innovation despite the global COVID-19 pandemic [2]. - The company aims to become a leading global biopharmaceutical company by 2023, focusing on innovative therapies for patients in China and worldwide [5]. - Zai Lab focuses on developing and commercializing therapies for unmet medical needs, particularly in oncology, autoimmune diseases, and infectious diseases [37]. - The company has established partnerships with leading biopharmaceutical and healthcare companies such as GSK, Novocure, and Incyte Corporation to position itself as a preferred partner for new therapies in the Greater China region [138]. - The company aims to leverage global collaborations and business development activities to expand its candidate product pipeline and capture commercial opportunities for approved products [139]. Product Development and Pipeline - The company has 21 products in clinical development targeting over 60 indications, with 11 in late-stage clinical development and 5 products already approved by the FDA [2]. - Zai Lab's strong product pipeline is expected to significantly address unmet medical needs and improve patient outcomes globally [3]. - The company has expanded its candidate product pipeline from four in 2015 to twenty-one, including eleven in late-stage clinical development [16]. - The company has commercialized two products, Zejula and Aipudun, and has expanded its pipeline from 4 to 21 candidate products since 2015, including 11 clinical projects in late-stage development [138]. - The company is focused on expanding its oncology drug pipeline, including potential combinations with immunotherapy and targeted therapies [155]. Financial Performance - Total revenue for the fiscal year 2020 was $48.96 million, a significant increase from $12.99 million in 2019, representing a growth of approximately 276% [12]. - The company reported a net loss of $268.91 million for the fiscal year 2020, compared to a net loss of $195.07 million in 2019, reflecting an increase in losses of approximately 37.8% [12]. - Research and development expenses rose to $222.71 million in 2020, compared to $142.22 million in 2019, indicating a year-over-year increase of about 56.5% [12]. - Cash and cash equivalents, along with restricted cash, totaled $442.86 million at the end of 2020, up from $76.44 million in 2019, marking an increase of about 479% [11]. - Total assets reached $1.30 billion in 2020, a substantial rise from $355.15 million in 2019, representing an increase of approximately 265% [11]. Research and Development - The company has incurred significant R&D expenses amounting to approximately $223 million, primarily paid to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) for outsourced services [20]. - The company has implemented strategies since 2014 to enhance its R&D and commercialization capabilities [16]. - Research and development expenses include employee wages, patent fees, and costs related to clinical trials, with all R&D expenditures recognized as incurred [60]. Regulatory and Compliance - The company has received priority review status for its new drug applications, indicating strong regulatory support for its products [2]. - The company has received priority review designation from the National Medical Products Administration for certain candidate products [16]. - The company is responsible for preparing consolidated financial statements in accordance with U.S. GAAP, ensuring no material misstatements due to fraud or error [23]. Collaborations and Licensing Agreements - The company entered into a collaboration and licensing agreement with GSK, involving an upfront payment of $15,000 and potential milestone payments totaling up to $36,000 [116]. - The company has a licensing agreement with NovoCure Limited, with an upfront payment of $15,000 and milestone payments totaling $10,000, along with potential milestone payments up to $68,000 [120]. - The company has entered into a licensing and collaboration agreement with Five Prime, acquiring exclusive rights to develop and commercialize bemarituzumab (FPA144) in Greater China, with an upfront payment of $5 million and a milestone payment of $2 million [196]. Market Presence and Growth - As of December 31, 2020, Zai Lab has significant market shares in Greater China and the United States, with 100% ownership in its subsidiaries across various regions [38]. - The company has opened a new 20,000 square foot research facility in the San Francisco Bay Area and established a new office in Cambridge, Massachusetts, to expand its presence in the U.S. [138]. - The company is actively working to attract, retain, and motivate key personnel to support its growth strategy [137]. Risks and Challenges - Significant risks include the ability to commercialize products and candidates successfully, as well as the expected amounts and timing of revenue [136]. - The ongoing COVID-19 pandemic may have direct and indirect effects on the company's operations and growth capabilities [137]. - The company acknowledges the potential impact of new laws, regulations, and accounting standards on its operations [137].