Financial Performance - The company's revenue increased from RMB 0 in 2020 to RMB 287.69 million in 2021, primarily due to the rise in income from designated patient medication programs[13]. - Other income and gains rose from RMB 268.34 million in 2020 to RMB 425.67 million in 2021, attributed to increased government subsidies and bank interest income[13]. - The company reported a net loss of RMB 655.53 million for 2021, compared to a net loss of RMB 2,928.92 million in 2020[10]. - The annual loss decreased from RMB 2,928.9 million for the year ended December 31, 2020, to RMB 655.5 million for the year ended December 31, 2021, primarily due to the reduction in fair value loss of convertible redeemable preferred shares[16]. - The adjusted net loss for 2021 was RMB 613.4 million, compared to RMB 454.9 million in 2020[108]. - The company reported a pre-tax loss of RMB 655.5 million for the year ended December 31, 2021, compared to a pre-tax loss of RMB 2.9 billion in the previous year[93]. Research and Development - Research and development costs for 2021 amounted to RMB 405.03 million, up from RMB 347.66 million in 2020[10]. - R&D expenses increased from RMB 347.7 million in 2020 to RMB 405.0 million in 2021, a rise of 16.5%[96]. - Employee costs for R&D staff rose from RMB 43.1 million in 2020 to RMB 60.1 million in 2021, an increase of 39.5%[98]. - The management highlighted ongoing research and development efforts aimed at new product innovations and technological advancements[10]. - The company is focusing on innovative therapies, with XPOVIO® (selinexor) being the first and only oral XPO1 inhibitor[53]. - The company is developing a clinical project pipeline with eight projects and 18 clinical studies, including five registration trials, focusing on unmet medical needs[46]. Clinical Trials and Approvals - The company received IND approval for selinexor in combination with rituximab, gemcitabine, dexamethasone, and platinum for the treatment of relapsed/refractory diffuse large B-cell lymphoma in January 2021[20]. - In May 2021, the company obtained approval to conduct a Phase III clinical trial for selinexor as a monotherapy for advanced or relapsed endometrial cancer patients[21]. - The company submitted an NDA for selinexor in Taiwan for three indications in July 2021, marking the sixth NDA submission for ATG-010 after submissions in multiple regions[24]. - In December 2021, the company announced that the total response rate (ORR) for the Ib phase Touch trial of selinexor combined with gemcitabine and oxaliplatin in Chinese patients with relapsed/refractory T-cell and NK-cell lymphoma was 46.2%, with a complete response rate (CRR) of 26.9% and a median progression-free survival (PFS) of 2.7 months[28]. - The company received conditional approval from the National Medical Products Administration (NMPA) in December 2021 for selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) who have previously received at least one treatment including an enzyme inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody[25]. Strategic Initiatives - The company plans to continue expanding its product offerings and market presence in the coming years[10]. - The company is exploring strategic partnerships and potential acquisitions to enhance its market position[10]. - The company plans to expand its commercial organization in China and the Asia-Pacific region to up to 200 full-time employees by the end of 2022, focusing on marketing, field personnel, pricing, and market access[40]. - The company has established partnerships for the development and commercialization of several drug candidates, enhancing its market reach and capabilities[57]. - The company is committed to becoming a fully integrated biopharmaceutical enterprise, focusing on innovative drug development and commercialization strategies[44]. Financial Position - The total assets as of December 31, 2021, were RMB 2,557.61 million, with current assets valued at RMB 2,412.57 million[12]. - Total liabilities as of December 31, 2021, were RMB 163.30 million, with current liabilities at RMB 159.36 million[12]. - The company's total equity as of December 31, 2021, was RMB 2,394.31 million, a decrease from RMB 3,037.81 million in 2020[12]. - As of December 31, 2021, the company's cash and bank balances were RMB 2,274.8 million, down from RMB 3,109.8 million as of December 31, 2020, primarily due to operating expenses and funds used in investment and financing activities[111]. - The current ratio as of December 31, 2021, was 1,513.9%, a decrease from 2,077.0% as of December 31, 2020[114]. Management and Governance - The company has a strong management team with diverse backgrounds in finance, investment, and pharmaceuticals, including Dr. Mei Jian Ming as Chairman and CEO, and Dr. Kevin Patrick Lynch as Chief Medical Officer[142]. - The company has seen significant leadership changes, with several directors resigning as of December 31, 2021, indicating a potential shift in strategic direction[133]. - The company is committed to maintaining a robust governance structure with independent directors overseeing strategic initiatives[140]. - The company has a diverse board composition, which is essential for navigating the complexities of the biopharmaceutical industry[139]. Market and Competitive Landscape - The company faces intense industry competition, and competitors may successfully commercialize drugs before the company does[170]. - The company has limited experience in drug production and commercialization, which may adversely affect its business if issues arise in future drug production processes[173]. - The company continues to collaborate with Karyopharm for the development and commercialization of selinexor across multiple regions[59]. Future Outlook - The company aims to commercialize its innovative therapies to improve patient outcomes and quality of life globally[51]. - The company may require additional financing to support operations, and if such financing is not obtained, it may not be able to complete the development and commercialization of candidate drugs[170]. - The expected timeline for the unutilized net proceeds of RMB 1,518.46 million is to be fully used by December 31, 2024[186].
德琪医药-B(06996) - 2021 - 年度财报