Product Portfolio and Development - Zai Ding Pharma has established a product portfolio of 28 products, including 11 internally developed products with global rights and 4 already marketed products[4]. - The company aims to have at least 15 marketed products covering over 30 indications by 2025, leveraging favorable policy environments[7]. - The first non-oncology product, New Zai Le, has been approved, enhancing the company's registration achievements[5]. - The company's four marketed products, including Ze Le and Ai Pu Dun, continue to drive commercialization efforts[5]. - Zai Ding Pharma's leading product portfolio addresses significant unmet medical needs in China, particularly in oncology and autoimmune diseases[4]. - The company has expanded its candidate product pipeline from 4 in 2015 to 28 as of the report date, including 12 in late-stage clinical development[18]. - The company aims to become a leading global biopharmaceutical company focused on developing and commercializing innovative therapies for unmet medical needs[18]. - The company is focused on addressing medical needs in oncology, autoimmune diseases, infectious diseases, and central nervous system disorders[18]. Financial Performance - Total revenue for the fiscal year 2021 reached $144.312 million, a significant increase from $48.958 million in 2020, representing a growth of 195%[14]. - Product revenue net amounted to $144.105 million in 2021, compared to $48.958 million in 2020, indicating a growth of 194%[14]. - The company reported a net loss of $704.471 million for the fiscal year 2021, compared to a net loss of $268.905 million in 2020, which is an increase in losses of 162%[14]. - Cash and cash equivalents, along with restricted cash, totaled $964.903 million in 2021, a substantial increase from $442.859 million in 2020, marking a growth of 118%[13]. - Total assets increased to $1.609956 billion in 2021 from $1.297638 billion in 2020, representing a growth of 24%[13]. - Shareholders' equity rose to $1.379956 billion in 2021, compared to $1.169345 billion in 2020, indicating an increase of 18%[13]. - The company has a strong cash position with total cash and short-term investments amounting to $1.409 billion in 2021, compared to $1.187 billion in 2020, an increase of 18.6%[13]. - The company incurred significant R&D expenses amounting to approximately $573 million, primarily paid to contract research organizations (CROs) and contract manufacturing organizations (CMOs) for outsourced services[23]. Research and Development - The company has made important R&D progress, with ZL-1102 achieving proof of concept for treating chronic plaque psoriasis[5]. - Research and development expenses for 2021 were $573.306 million, up from $222.711 million in 2020, reflecting an increase of 157%[14]. - R&D expenses include costs related to employee wages, patent fees, clinical trials, and materials, with all expenses recognized as incurred if they lack alternative future use[70]. - The company assesses its collaborative arrangements under ASC Topic 808, determining the appropriate recognition method for each component[69]. Strategic Collaborations and Partnerships - The company has established strategic collaborations with leading global biopharmaceutical companies to enhance its product pipeline[18]. - The company has entered into a global exclusive licensing agreement with Crescendo Biologics Ltd., with upfront payments totaling $4,500 and milestone payments of $6,000, plus potential milestone payments up to $298,075[135]. - The company has secured exclusive rights to develop and commercialize multiple products in the Greater China region through various licensing agreements with different partners[137][139][140]. - The company has a collaboration agreement with Regeneron, with an upfront payment of $30,000 and potential milestone payments up to $160,000 based on regulatory and sales milestones[140]. Market Presence and Operations - The company has a significant market presence in Greater China and the United States, focusing on innovative therapies for unmet medical needs in oncology and autoimmune diseases[44]. - The company has built a factory in China to support its operations across the Greater China region and the United States[175]. - The company has opened a new research facility in the San Francisco Bay Area and established a new office in Cambridge, Massachusetts to expand its presence in the U.S.[175]. - Zai Lab's operational subsidiaries include various entities registered in Hong Kong and mainland China, indicating a broad operational footprint in the Greater China region[167]. Risks and Compliance - Zai Lab reported significant operational risks associated with conducting business in mainland China, including potential changes in laws and regulations that could adversely affect the company's market value[169]. - The company is subject to significant legal and operational risks due to the political and economic policies of the Chinese government, which could adversely impact its business and financial performance[169]. - The company must obtain several approvals from relevant Chinese authorities to operate and issue securities to foreign investors[170]. - Compliance with various Chinese laws, including the Data Security Law and Personal Information Protection Law, may pose additional challenges for the company[172]. Stock and Equity - The weighted average shares used to calculate basic and diluted loss per share increased to 92,992,112 in 2021 from 77,667,743 in 2020[14]. - Basic and diluted loss per share for 2021 was $(7.58), compared to $(3.46) in 2020, reflecting a deterioration in per-share performance[14]. - The company has a total of 8,101,559 unexercised stock options as of December 31, 2021, with a weighted average remaining contractual life of 5.98 years[124]. - The company has granted stock options with a weighted average grant date fair value of $20.98, $40.60, and $126.02 for the years 2019, 2020, and 2021, respectively[124][125]. Product Commercialization - Niraparib (Zelboraf) is a PARP 1/2 inhibitor approved for maintenance treatment in adult patients with recurrent epithelial ovarian cancer, tubal cancer, or primary peritoneal cancer after platinum-based chemotherapy, with FDA approval received in March 2017[182]. - The drug has been launched in Hong Kong and Macau for the treatment of platinum-sensitive recurrent high-grade serous ovarian cancer, with regulatory approvals in December 2018 and August 2021 respectively[183]. - Tumor Treating Fields (TTFields) therapy, delivered through the Optune Lua device, is approved for use in combination with temozolomide for newly diagnosed GBM patients and for recurrent GBM patients[185]. - The company has an exclusive licensing agreement with Novocure for the development and commercialization of Optune Lua in the Greater China region[185].
再鼎医药(09688) - 2021 - 年度财报