InventisBio (SH:688382)2025-04-25 11:25Financial Performance - The net loss attributable to shareholders for the year 2024 was CNY 240.20 million, with a net loss of CNY 250.14 million after deducting non-recurring gains and losses, showing a reduction compared to the same period last year [4]. - The cumulative unabsorbed losses as of the end of the reporting period amounted to CNY 2,544.93 million [4]. - The company's revenue for 2024 was CNY 168.79 million, a decrease of 9.02% compared to CNY 185.53 million in 2023 [27]. - The net loss attributable to shareholders for 2024 was CNY 240.20 million, improving from a loss of CNY 283.98 million in 2023 [27]. - The basic earnings per share for 2024 was -CNY 0.42, compared to -CNY 0.49 in 2023 [28]. - The total assets decreased by 11.17% from CNY 216.23 million in 2023 to CNY 192.08 million in 2024 [27]. - The net assets attributable to shareholders at the end of 2024 were CNY 181.08 million, a decrease of 9.35% from CNY 199.76 million in 2023 [27]. - The cash flow from operating activities for 2024 was -CNY 241.97 million, compared to -CNY 307.75 million in 2023 [27]. - The company's total sales revenue for the year reached 168.79 million RMB, with the top five customers accounting for 100% of this total [163]. - The largest customer contributed 90.30% of the total sales, amounting to 152.41 million RMB, while the second largest customer accounted for 9.70% with sales of 1.64 million RMB [164]. Research and Development (R&D) - The company plans to maintain a high level of R&D investment to support multiple ongoing projects, despite the risk of continued losses [5]. - The company's R&D expenditure as a percentage of revenue was 227.71% in 2024, down from 238.73% in 2023, a reduction of 11.02 percentage points [28]. - The company maintained a high level of R&D investment at 384.35 million yuan in 2024 [40]. - The company has established a comprehensive R&D system covering drug discovery, preclinical research, clinical trials, and regulatory affairs, ensuring a robust pipeline of clinical candidates [63]. - The company has established R&D centers in Shanghai, Beijing, and the United States, enhancing its global competitiveness and innovation capabilities [133]. - The R&D team consists of 169 members, accounting for 91.35% of total employees, with significant expertise in drug development, including 19 PhDs and 64 Master's degrees [138]. - The company’s R&D investment as a percentage of total assets is 21.23%, indicating a strong focus on innovation [183]. - The average R&D investment among comparable companies in the industry is 68,033.73 million RMB, highlighting the company's significant commitment to R&D [183]. Product Pipeline and Clinical Trials - The company has two authorized products, Beifu Tini and Gesorase, which have been launched, and expects to receive milestone payments and sales sharing as clinical research and commercialization progress [5]. - The company has not yet established a commercial sales team, which may impact the market acceptance of its products post-approval [145]. - The company has five clinical products, with two already approved for market, while three are in clinical trial stages [176]. - The company is focusing on developing multiple preclinical pipelines in areas such as kinase, tumor driver genes, tumor immunity, and synthetic lethality pathways [176]. - The company’s clinical pipeline includes drugs targeting unmet medical needs, with a focus on oncology and autoimmune diseases [132]. - D-0502, an oral selective estrogen receptor degrader (SERD), is in Phase III clinical trials for ER-positive, HER2-negative breast cancer, with the first patient enrolled in September 2022 [42]. - D-0120, a URAT1 inhibitor for hyperuricemia and gout, has completed multiple Phase I trials and is currently in a Phase II trial in China, expected to complete by November 2024 [42]. - D-2570, a novel oral selective TYK2 inhibitor for psoriasis, started Phase II clinical trials in December 2023, showing significant efficacy compared to placebo and existing TYK2 inhibitors [43]. - The company has made significant progress in clinical research for its main products in 2024 [40]. - The product Gexorese (Anfangning®) received approval from the National Medical Products Administration (NMPA) in November 2024 [40]. - The product Beifu Tini (BPI-D0316) received NMPA approval for its second-line treatment indication in December 2023 and for its first-line treatment indication in November 2024 [41]. Market and Competitive Landscape - The global pharmaceutical market grew from $1,266.7 billion in 2018 to $1,495.0 billion in 2022, with a CAGR of 4.2% from 2018 to 2022 [70]. - In 2022, the Chinese pharmaceutical market reached ¥1,554.1 billion, with projected CAGR of 8.1% from 2022 to 2025 and 6.0% from 2025 to 2030 [73]. - The global anti-tumor drug market increased from $110.6 billion in 2017 to $181.7 billion in 2021, with a CAGR of 13.2% [79]. - China's anti-tumor drug market grew from ¥139.4 billion in 2017 to ¥231.1 billion in 2021, with a CAGR of 13.5% [79]. - The global metabolic disease market expanded from $105.0 billion in 2018 to $160.0 billion in 2022, with a CAGR of 10.9% [82]. - The global autoimmune disease drug market was approximately $132.3 billion in 2022, expected to reach $147.3 billion by 2025, with a CAGR of 3.6% from 2022 to 2025 [93]. - The Chinese autoimmune disease drug market was about $2.9 billion in 2022, projected to grow to $6.1 billion by 2025, reflecting a CAGR of 27.4% [93]. Risks and Challenges - The company faces significant risks in drug development, including long cycles and high investment requirements, which may lead to substantial performance declines or losses [5]. - The company has not established a complete commercialization and sales team, which may hinder market acceptance of its products [8]. - The company relies on third-party CMO for production, which introduces risks related to supply and quality control [8]. - The company emphasizes the uncertainty of entering the National Medical Insurance Directory, which could impact the pricing competitiveness of its products [8]. - The company is currently not profitable, with ongoing R&D investments and cumulative losses, relying on milestone payments and sales shares from its two approved products to improve financial conditions [141]. - The company faces risks related to significant financial investments in drug development, potential competition from established players, and uncertainties in market acceptance and reimbursement for its products [145]. Corporate Governance - The company held one annual and one temporary shareholders' meeting during the reporting period, ensuring compliance with relevant laws and regulations [198]. - The board of directors consists of 9 members, including 3 independent directors, and held 8 meetings during the reporting period to review all proposals [198]. - The annual general meeting held on June 21, 2024, approved 8 resolutions without any being rejected [200]. - The first extraordinary general meeting of 2024 took place on September 9, 2024, where 2 resolutions were approved without any rejections [200]. - All resolutions discussed in the shareholder meetings complied with relevant laws and regulations [200].