Financial Performance - For the six months ended June 30, 2023, the revenue from customer contracts for product sales at a point in time was RMB 34,343 thousand, a significant increase from RMB 658 thousand for the same period in 2022, representing a growth of approximately 5,116%[53] - The total revenue for the six months ended June 30, 2023, was RMB 53,844 thousand, compared to RMB 58,446 thousand for the same period in 2022, indicating a decrease of approximately 8.7%[54] - The company reported a net loss of RMB 134,443,000 for the six months ended June 30, 2023, compared to a loss of RMB 75,834,000 for the same period in 2022, representing an increase in losses of approximately 77.2%[84] - The total comprehensive loss for the six months ended June 30, 2023, was RMB 1,246,316,000, compared to RMB 790,509,000 for the same period in 2022, indicating an increase in losses[134] - The loss attributable to ordinary shareholders was RMB 1,640,339 thousand, compared to RMB 251,613 thousand for the same period in 2022, representing a significant increase in losses[111] - The basic and diluted loss per share for the six months ended June 30, 2023, was RMB 15.84, compared to RMB 3.14 for the same period in 2022, indicating a worsening financial performance[111] Revenue Sources - Government grants received amounted to RMB 7,855 thousand for the six months ended June 30, 2023, while no such income was recorded in the same period of 2022[54] - Bank interest income increased to RMB 12,057 thousand in the first half of 2023, compared to RMB 2,844 thousand in the same period of 2022, reflecting a growth of approximately 324%[54] Costs and Expenses - Cost of goods sold for the six months ended June 30, 2023, was RMB 9,449,000 compared to RMB 185,000 for the same period in 2022, representing a significant increase[84] - Research and development costs increased to RMB 90,139,000 for the six months ended June 30, 2023, from RMB 83,464,000 in the same period of 2022, reflecting a growth of approximately 8.5%[84] - Employee costs, including salaries, bonuses, and benefits, rose to RMB 57,523,000 in the first half of 2023, compared to RMB 34,769,000 in the same period of 2022, indicating a year-on-year increase of about 65.3%[84] - The interest expense on bank borrowings was RMB 503 thousand for the six months ended June 30, 2023, while no such expense was recorded in the same period of 2022[56] - The interest expense on lease liabilities increased to RMB 1,213 thousand in the first half of 2023, compared to RMB 608 thousand in the same period of 2022, reflecting an increase of approximately 99%[56] Assets and Liabilities - The company reported a total of RMB 461,599,000 in financial assets measured at fair value using significant observable inputs as of June 30, 2023[103] - The company’s total non-current liabilities as of June 30, 2023, were RMB 41,085,000, a decrease from RMB 2,615,719,000 as of December 31, 2022[143] - The company’s accumulated losses as of June 30, 2023, were RMB 2,626,451,000, reflecting ongoing financial challenges[134] - The company’s share premium as of June 30, 2023, was RMB 234,161,000, compared to RMB 61,445,000 as of December 31, 2022, indicating an increase in shareholder equity[134] Share Capital and Options - The total number of issued shares as of June 30, 2023, was 304,024,465, an increase from 16,009,142 shares as of December 31, 2022, following the conversion of preferred shares[92] - The company has granted unexercised options to subscribe for 33,424,310 shares under the pre-IPO equity incentive plan, representing approximately 11.0% of the total issued share capital as of June 30, 2023[25] - The total number of stock options granted as of June 30, 2023, is 33,424,310 shares[26] - The total number of stock options exercised during the reporting period was 0 shares[26] - The total number of stock options canceled during the reporting period was 0 shares[26] - The total number of stock options that expired during the reporting period was 0 shares[26] Corporate Governance - The company has complied with all applicable codes and principles of corporate governance since its listing date up to June 30, 2023[64] - The company has no outstanding obligations under the listing rules as of the report date[14] Taxation - As of June 30, 2023, the company had no tax expenses, consistent with the previous period[2] - The company has not made any provision for Hong Kong profits tax as there was no estimated taxable profit during the reporting period[57] - The company reported no estimated taxable profits in its Chinese subsidiaries for the reporting period, resulting in no provision for corporate income tax[109] Operational Developments - The company is preparing for clinical trials and has conducted preclinical research to assess the efficacy and safety of its drug candidates[134] - The GMP production facility in Jiangsu, completed in February 2023, has three production lines with an annual capacity of approximately 5 million doses[175] - The company is expanding its product pipeline with several new hair disease and care products launched in mainland China[166] Product Development - CU-10201, a topical 4% minocycline foam, has shown significant efficacy and good safety in treating acne, with the primary endpoint of the Phase III clinical trial completed in February 2023[167] - CU-40101, a topical small molecule thyroid hormone receptor agonist, completed its Phase I dose escalation trial in July 2023, assessing its safety and tolerability for promoting hair growth in androgenetic alopecia patients[174] - CU-40102 is the world's first and only approved topical finasteride product for the treatment of androgenetic alopecia, currently undergoing Phase III clinical trials in mainland China[182] - The Phase III clinical trial for CU-40102 completed database lock in May 2023 and achieved its primary endpoint in September 2023, with plans to submit an NDA to the National Medical Products Administration in Q4 2023[183] - CU-40103, a self-developed topical minoxidil foam, is in preclinical research, with plans to submit an ANDA for alopecia treatment to the National Medical Products Administration in Q3 2024[184] - CU-40104, a self-developed topical dutasteride, is in preclinical research, with an IND application planned for submission in Q4 2024[185] - CU-10201 is the world's first and only approved topical minocycline for the treatment of acne, currently in clinical development in China[186] - CU-30101, a topical lidocaine-dinoprost cream, initiated Phase III clinical trials in April 2023, with all subjects completing the trial by August 2023[188] Financial Position - The cash and cash equivalents, along with financial assets measured at fair value, totaled approximately RMB 1,399.0 million[176] - The company has recognized a deferred tax asset of RMB 6,137,000 related to lease liabilities as of January 1, 2022, indicating potential future tax benefits[154] - The company has established a broad product portfolio covering nine products and candidate products across four major therapeutic areas, including hair disease and care[198] - The proprietary CATAME® technology platform enhances drug formulation and delivery, contributing to the development of competitive product lines[199]
科笛-B(02487) - 2023 - 中期财报