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科笛集团(02487) - 2023 - 中期财报
2023-09-21 08:39
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]
科笛集团(02487) - 2023 - 中期业绩
2023-08-29 08:31
Financial Performance - The revenue increased by 5,119.3% from RMB 0.7 million for the six months ended June 30, 2022, to RMB 34.3 million for the six months ended June 30, 2023, primarily due to increased sales of hair disease and care products[10]. - Gross profit reached RMB 21.3 million for the six months ended June 30, 2023, up 4,593.2% from RMB 0.5 million for the same period in 2022[15]. - The company reported a loss of RMB 1,640.3 million for the six months ended June 30, 2023, compared to a loss of RMB 251.6 million for the same period in 2022, an increase of RMB 1,388.7 million[25]. - The total loss before tax for the six months ended June 30, 2023, was RMB 1.64 billion, compared to a loss of RMB 251.61 million for the same period in 2022[50]. - For the six months ended June 30, 2023, the loss attributable to ordinary shareholders was RMB 1,640,339 thousand, resulting in a basic and diluted loss per share of RMB 15.84, compared to a loss of RMB 251,613 thousand and a loss per share of RMB 3.14 for the same period in 2022[87]. - The group’s total liabilities as of June 30, 2023, were RMB 172.43 million, compared to RMB 2.69 billion as of December 31, 2022[59]. - The company does not recommend the payment of an interim dividend for the six months ended June 30, 2023, consistent with the previous year[47]. Sales and Marketing - During the "618 event," the company's hair disease and care products achieved a GMV of over RMB 9.4 million, representing a year-on-year growth of 4,348.0%[3]. - The company has established a dedicated marketing team to penetrate the extensive skin disease treatment and care market in mainland China through various e-commerce and social media platforms[3]. - Sales and distribution expenses skyrocketed by 871.1% from RMB 6.0 million for the six months ended June 30, 2022, to RMB 58.0 million for the six months ended June 30, 2023, mainly due to expanded online marketing activities[21]. Research and Development - R&D costs rose by approximately 8.0% from RMB 83.5 million for the six months ended June 30, 2022, to RMB 90.1 million for the six months ended June 30, 2023, driven by an increase in R&D personnel and stock-based payment expenses[17]. - The company aims to accelerate clinical development for CU-40102, CU-40101, CU-20401, CU-30101, and other pipeline products in the second half of 2023[9]. - The company is currently conducting a Phase III clinical trial for CU-40102 (topical finasteride spray) in mainland China, with database lock completed in May 2023[141]. - The Phase I dose escalation trial for CU-40101 (topical small molecule thyroid hormone receptor agonist) was completed in July 2023, with database lock achieved in August 2023[142]. - CU-10201 (topical 4% minocycline foam) received CDE priority review approval in August 2023 after demonstrating significant efficacy and good safety in treating acne during its Phase III clinical trial[142]. - The candidate product CU-20401 for managing submental fat is expected to enter Phase II clinical trials in Q3 2023, following successful Phase I trials demonstrating safety and tolerability[152]. - CU-40102, an external finasteride product for androgenetic alopecia, is currently in Phase III clinical trials in mainland China, with NDA submission planned for Q4 2023 and commercialization expected in 2024[154]. - CU-40103, a topical minoxidil foam, is in preclinical research with plans to submit an ANDA for alopecia treatment in Q3 2024[156]. - CU-40104, an external dutasteride formulation for androgenetic alopecia, is also in preclinical research, with IND submission planned for Q4 2024[156]. - CU-10201 is the first and only approved topical minocycline for acne treatment, currently in clinical development in China[157]. - The proprietary CATAME® technology platform has developed a competitive pipeline of formulations including creams, sprays, ointments, and aerosol foams for localized drug delivery[147]. - The pipeline includes various therapeutic areas, with multiple products at different stages of development, including preclinical, IND, and Phase I to III trials[149]. Financial Position - As of June 30, 2023, the company's current assets were approximately RMB 1,480.0 million, including cash and cash equivalents of approximately RMB 693.6 million[28]. - The debt-to-asset ratio decreased to approximately 9.6% as of June 30, 2023, down from 186.1% as of December 31, 2022, due to the conversion of all convertible redeemable preferred shares into ordinary shares[30]. - The group’s total assets as of June 30, 2023, amounted to RMB 1.79 billion, an increase from RMB 1.37 billion as of December 31, 2022[52]. - The net current assets as of June 30, 2023, were RMB 1.35 billion, compared to RMB 1.07 billion as of December 31, 2022[56]. - The total cash and cash equivalents of the group as of June 30, 2023, amounted to approximately RMB 1,399.0 million, which includes cash, term deposits over three months, and financial assets measured at fair value through profit or loss[144]. - The company reported trade payables of RMB 239 thousand as of June 30, 2023, with total other payables amounting to RMB 53,797 thousand, down from RMB 68,572 thousand at the end of 2022[91]. - The financial assets measured at fair value through profit or loss increased significantly to RMB 461,599 thousand as of June 30, 2023, compared to RMB 43,496 thousand at the end of 2022[90]. Governance and Compliance - The company has adopted the principles and provisions of the corporate governance code and has complied with all applicable code provisions since its listing date[41]. - The company has not experienced any financial impact from the adoption of new and revised International Financial Reporting Standards as of January 1, 2023[69]. - The company confirmed deferred tax assets of RMB 6,137,000 related to temporary differences arising from lease liabilities and tax losses as of January 1, 2022[74]. - The company has not recognized deferred tax assets due to the unlikely offset of taxable profits against tax losses in the foreseeable future[84]. - The company has not disclosed any significant customers contributing over 10% of total revenue for the six months ended June 30, 2023[78]. - The company anticipates that the new accounting policy disclosures will impact its annual consolidated financial statements but not the interim financial data[67]. Employee and Operational Metrics - As of June 30, 2023, the total number of employees in the group is 236, with a total salary cost of RMB 134.4 million for the six months ended June 30, 2023, compared to RMB 75.8 million for the same period in 2022, primarily due to an increase in employee numbers[35]. - The group had no significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures during the six months ended June 30, 2023[135].