Core Insights - Codex Group announced that CU-40102 (topical finasteride spray) has received approval from the National Medical Products Administration for the treatment of androgenetic alopecia, marking it as the first and only approved topical finasteride for this condition globally and in China [1] Company Summary - CU-40102 is based on results from a Phase III confirmatory clinical trial, demonstrating its effectiveness in treating androgenetic alopecia, with good local tolerability reported by participants [1] - This approval will enhance Codex Group's commercialization strategy in the dermatology treatment and care sector [1]

Core Viewpoint - The clinical trial results for CU-30101, a topical anesthetic cream, have been accepted for presentation at the 30th CSD Annual Meeting, highlighting the company's influence and cutting-edge research in the dermatology field [1] Group 1: Clinical Trial Overview - The Phase III clinical trial was a multi-center, randomized, double-blind, positive drug-controlled study designed to evaluate the safety and efficacy of CU-30101 for local anesthesia in dermatological procedures [1] - The trial used Pliaglis® as a comparator, with the primary efficacy endpoint being the visual analog scale (VAS) for pain immediately after fractional laser surgery [1] Group 2: Efficacy Results - The results showed that the VAS difference between the two sides of the face (CU-30101 side vs. Pliaglis® side) fell within the predefined equivalence range, indicating comparable analgesic efficacy [2] - No statistically significant differences were found in patient evaluations regarding pain relief, likelihood of reusing the drug, and researchers' satisfaction with the efficacy of both drugs (P > 0.05) [2] Group 3: Safety Profile - CU-30101 demonstrated good overall safety with no severe adverse events reported [2] - The local tolerability assessment of CU-30101 was similar to that of Pliaglis®, consistent with known safety characteristics, and no new safety signals were identified [2] Group 4: Regulatory Progress - Based on the Phase III trial results, the company has submitted a drug marketing application for CU-30101 to the National Medical Products Administration, which is expected to be accepted by July 2024 [2]

Core Viewpoint - The recent adjustment of the Hong Kong Stock Connect list has led to a significant impact on the stock price of Kedi-B (02487), which experienced a notable decline followed by a recovery, supported by strong financial performance and market sentiment towards its new product developments [1][3][6]. Stock Performance - Kedi-B's stock price fell by 20.60% over six trading days after being removed from the Hong Kong Stock Connect [1]. - Following a brief recovery, the stock saw a dramatic drop of 26.88% on April 7 due to market volatility, creating a potential buying opportunity [1]. - The stock hit a low of 3.64 HKD on April 9 but rebounded significantly, reaching a peak of 7.62 HKD by May 20, surpassing pre-removal levels [1][3]. Financial Performance - Kedi-B reported total revenue of approximately 280 million RMB for 2024, a year-on-year increase of about 103% [6][7]. - Gross profit for the same period was around 144 million RMB, reflecting a 102% increase year-on-year, while net loss narrowed by 77.91% to approximately 434 million RMB [6][7]. - The company achieved a gross margin of 51.3%, up from 50.6% in the previous year, driven by improved product lines and cost management [8]. Product Line and Market Strategy - The revenue growth was primarily attributed to increased sales of hair care and skincare products, with hair care revenue exceeding 160 million RMB and skincare revenue surpassing 110 million RMB [8]. - Kedi-B plans to enter a second growth phase in 2025 with three significant prescription drugs, including treatments for acne and hair loss, which are expected to drive future revenue growth [9]. - The company is also involved in the development of a botulinum toxin product, CU-20101, which has received approval in South Korea, showcasing its technical capabilities [10][12]. Market Context - The domestic medical aesthetics market is under pressure, with many companies reporting declines in Q1 2025, yet Kedi-B's stock performance indicates positive market sentiment towards its product developments [11]. - The botulinum toxin market in China is projected to reach 11.4 billion RMB by 2025, with a compound annual growth rate of 23.9% from 2020 to 2025, indicating strong growth potential [12][14]. - Kedi-B's entry into the botulinum toxin market, particularly with innovative product forms, positions it well against established competitors [14].

Financial Performance - The company's revenue for the year ended December 31, 2024, reached approximately RMB 280 million, representing a year-on-year increase of about 103%[9]. - Revenue increased approximately 103% from about RMB 138 million for the year ended December 31, 2023, to about RMB 280 million for the year ended December 31, 2024[21]. - The group reported a revenue of RMB 279.6 million for the year ended December 31, 2024, compared to RMB 137.6 million in 2023, representing a year-over-year increase of 102.5%[78]. - Gross profit increased by approximately 102.0% to about RMB 143.5 million for the year ended December 31, 2024, compared to approximately RMB 71.0 million for the year ended December 31, 2023, with a stable gross margin of around 51%[45]. - The net loss for the year narrowed to RMB 433.8 million from RMB 1,963.8 million in 2023, reflecting a significant reduction in losses[78]. - The adjusted net loss for the year ended December 31, 2024, was approximately RMB 365.2 million, a decrease from RMB 1,963.8 million in 2023, indicating improved operational performance[60]. Product Development and Approvals - The CU-10201 (4% minocycline foam) received approval from the National Medical Products Administration in November 2024, marking it as the first and only approved topical minocycline for acne treatment globally[11]. - The CU-40102 (topical finasteride spray) NDA was accepted in January 2024, with submission to the Hong Kong government in April 2024, being the first approved topical finasteride product for androgenetic alopecia[11]. - CU-20401 (recombinant mutated collagenase) completed its Phase II clinical trial in December 2024, demonstrating significant efficacy and safety[12]. - CU-40102, the first and only approved topical finasteride product for androgenetic alopecia, had its NDA accepted by the National Medical Products Administration in January 2024[18]. - CU-10201, the first and only approved topical minocycline foam for the treatment of acne, received market approval from the National Medical Products Administration in November 2024[27]. - CU-10101, a non-hormonal small molecule drug for treating mild to moderate atopic dermatitis, received IND approval in May 2024 and completed its first subject enrollment in a Phase I clinical trial in China in September 2024[31]. - CU-30101, a local anesthetic cream, completed its Phase III clinical trial in China in January 2024, with its drug registration application accepted by the National Medical Products Administration in July 2024[31]. - CU-20401, a recombinant mutated collagenase for managing local fat accumulation, completed a Phase II clinical trial in China in December 2024, showing significant efficacy and safety, with a projected commercialization approval in 2028[31]. Marketing and Sales Strategy - The company aims to enhance the commercialization of CU-10201 in China, leveraging both online and offline channels for rapid product rollout[15]. - The company aims to expand its product matrix through continuous new product launches and diversified e-commerce channels, maintaining high repurchase rates above industry averages[9]. - The company’s marketing strategy includes a strong online presence across various e-commerce and social media platforms, enhancing customer experience and brand loyalty[33]. - The company aims to enhance sales capabilities through online marketing activities and collaborations with renowned doctors to drive overall sales growth[41]. Production and Capacity - The company has established a GMP production facility in Jiangsu with an annual capacity of 5 million doses, supporting commercialization and candidate drug production needs[13]. - The company’s production facility received a drug production license from the Jiangsu Provincial Drug Administration in April 2024, expected to positively impact capacity expansion and market growth[13]. - The company has established a GMP production facility in Jiangsu with three production lines, which began operations in 2023, ensuring compliance with regulatory requirements for clinical and market approvals[36]. Financial Position and Cash Flow - The company’s cash and cash equivalents totaled approximately RMB 876 million as of December 31, 2024[21]. - As of December 31, 2024, the total cash and cash equivalents amounted to approximately RMB 385.7 million, a decrease of about 18.5% from RMB 473.1 million as of December 31, 2023, primarily due to expenditures in R&D and operations[63]. - The company's current assets were approximately RMB 1,087.1 million, with current liabilities of about RMB 323.3 million, including interest-bearing bank borrowings of RMB 213.3 million[64]. - The debt-to-asset ratio increased to 30.0% as of December 31, 2024, compared to 21.0% in 2023, mainly due to an increase in interest-bearing bank borrowings[68]. Governance and Board Structure - The board of directors held a total of 4 meetings in the fiscal year ending December 31, 2024, with all directors attending all meetings[90]. - The independent non-executive directors accounted for one-third of the board, ensuring compliance with listing rules[96]. - The company established a board independence assessment mechanism to enhance board efficiency and independent judgment[97]. - The company’s board is collectively responsible for guiding and supervising the company’s affairs, ensuring sound internal controls and risk management[92]. - The chairman and CEO roles are held by different individuals, complying with corporate governance codes[95]. Risk Management - The company has established multiple risk management procedures and guidelines to define implementation authority across key business processes and functions[130]. - The risk management committee assesses risks across various departments and subsidiaries, identifying strategic, financial, market, operational, and legal risks[130]. - The internal control system is evaluated annually, with the audit department preparing a report on the previous year's internal control management level[131]. - The company has confirmed the effectiveness of its risk management and internal control systems as of December 31, 2024[136]. Shareholder Communication - The company has established multiple communication channels with shareholders, including annual general meetings and investor relations activities[157]. - The company emphasizes effective communication with shareholders to enhance investor relations and understanding of business performance and strategy[151]. - The company has a comprehensive shareholder communication policy to encourage active participation and effective exercise of shareholder rights[152]. Employee and Diversity Initiatives - The total number of employees as of December 31, 2024, was 333, with 54.4% in sales, marketing, and management roles[75]. - The company has implemented two equity incentive plans to align employee interests with company goals[75]. - The board currently consists of 6 male directors and 3 female directors, achieving a gender diversity ratio of 33.3% female representation[112]. - The company aims to maintain at least 33.3% female directors, 42.9% female senior management, and 60.7% female employees, which have all been met[115].

Core Points - The company reported a net loss of approximately 434 million yuan for 2024, a year-on-year reduction of 77.91% [1] - Revenue reached approximately 280 million yuan, representing a year-on-year increase of about 103% [1] - Gross profit was around 143.5 million yuan, with a year-on-year increase of approximately 102% [1] Revenue Growth - The revenue growth was primarily driven by increased sales of hair disease and care products as well as daily skincare products [1] - The company achieved a GMV of over 56 million yuan during the "618 event," marking a year-on-year growth of 500% [2] - During the "Double 11 event," the GMV exceeded 110 million yuan, doubling the total achieved during the "618 event" [2] Product Performance - The company continued to launch new products and enhance the product matrix of "Qing Si Ji He®" [2] - The CUP-MNDE ("Bailleul®" Minoxidil Spray) ranked first in sales within the cross-border Minoxidil category on Tmall [2] - The revenue contribution from other hair disease and care products has been steadily increasing [2] Consumer Engagement - The company is focused on building and strengthening long-term consumer trust, with repurchase rates and customer inquiry conversion rates consistently above industry averages [2] - The "Ouma" olive oil series accounted for over 70% of sales in the skincare product category [2] - The share of revenue from other interest e-commerce channels (including Douyin and Xiaohongshu) has been expanding rapidly, significantly boosting the revenue contribution for 2024 [2]

Revenue Growth - Revenue increased approximately 103% from about RMB 138 million for the year ended December 31, 2023, to about RMB 280 million for the year ended December 31, 2024[5]. - Revenue increased approximately 103.2% from about RMB 137.6 million for the year ended December 31, 2023, to about RMB 279.6 million for the year ended December 31, 2024, primarily due to increased sales of hair disease and care products and daily skincare products[27]. - The company reported total revenue of RMB 279.6 million for the year ending December 31, 2024, compared to RMB 137.6 million in 2023, representing a growth of 102.6%[67]. Profitability and Loss - Gross profit increased approximately 102.0% to about RMB 143.5 million for the year ended December 31, 2024, with a stable gross margin of approximately 51%[29]. - The total loss for the year was RMB 433.8 million, a reduction from RMB 1,963.8 million in 2023, showing an improvement in financial performance[67]. - The company reported a net loss of RMB 433.8 million for 2024, a significant improvement from a loss of RMB 1,963.8 million in 2023[45]. - Non-IFRS adjusted net loss for 2024 was RMB 365.2 million, compared to RMB 351.9 million in 2023, representing a loss margin of 1.31% of revenue[45]. - The basic and diluted loss per share for 2024 was RMB 1.41, compared to RMB 9.60 in 2023, reflecting a reduction in losses[90]. Expenses and Costs - Sales and distribution expenses as a percentage of revenue significantly decreased compared to the previous year, while R&D costs decreased by approximately RMB 17 million or 8%, and administrative expenses decreased by approximately RMB 44 million or 24%[5]. - Cost of sales rose by approximately RMB 69.6 million to about RMB 136.2 million for the year ended December 31, 2024, compared to about RMB 66.6 million for the year ended December 31, 2023, consistent with business growth[28]. - Selling and distribution expenses increased approximately 26.6% to about RMB 263.7 million for the year ended December 31, 2024, compared to about RMB 208.3 million for the year ended December 31, 2023, driven by expanded online marketing activities[32]. - Research and development costs decreased approximately 7.7% to about RMB 199.0 million for the year ended December 31, 2024, from about RMB 215.7 million for the year ended December 31, 2023[33]. - Administrative expenses decreased approximately 23.7% to about RMB 141.9 million for the year ended December 31, 2024, compared to about RMB 185.9 million for the year ended December 31, 2023[35]. Cash and Financial Position - The total cash and cash equivalents, along with financial assets at fair value, amounted to approximately RMB 876 million as of December 31, 2024[5]. - Cash and cash equivalents decreased by approximately 18.5% to RMB 385.7 million as of December 31, 2024, down from RMB 473.1 million in 2023[46]. - The company's current assets totaled approximately RMB 1,087.1 million, with current liabilities of about RMB 323.3 million, including interest-bearing bank loans of RMB 213.3 million[46]. - The debt-to-asset ratio increased to 30.0% as of December 31, 2024, up from 21.0% in 2023, primarily due to increased interest-bearing bank loans[49]. - The company held financial assets at fair value of approximately RMB 480.0 million as of December 31, 2024, an increase of about 2.3% from RMB 469.3 million in 2023[46]. Product Development and Approvals - CU-10201, a topical 4% minocycline foam, received approval from the National Medical Products Administration in November 2024, marking it as the first and only approved topical minocycline for acne treatment globally[6]. - CU-40102, a topical finasteride spray, had its NDA accepted by the National Medical Products Administration in January 2024, and it is the first and only approved topical finasteride product for androgenetic alopecia[6]. - CU-30101, a topical lidocaine-prilocaine cream, had its drug registration application accepted in July 2024, demonstrating comparable analgesic efficacy to the reference product Pliaglis®[6]. - The company completed the Phase II clinical trial for CU-20401, a recombinant mutated collagenase for treating submental fat accumulation, showing significant efficacy and good safety profile[6]. - CU-20401 is expected to accelerate into Phase III clinical trials following positive Phase II results, showcasing good safety and efficacy[24]. Market Performance - During the "618 event," the company's products recorded GMV exceeding RMB 56 million, a year-on-year increase of 500%, and during the "Double 11 event," GMV exceeded RMB 110 million, doubling the performance from the "618 event"[6]. - The company has developed a tailored commercialization strategy to penetrate the extensive skin disease treatment market in China, leveraging online and offline marketing channels[18]. - The self-operated customer service team enhances customer experience, contributing to higher repurchase rates and brand loyalty[20]. Governance and Corporate Structure - The company has adhered to all applicable corporate governance codes throughout the year ending December 31, 2024[58]. - The board of directors includes both executive and independent non-executive members, ensuring diverse governance[109]. - The company has established independent investment funds, such as Oriental Kylin Fund SPC and Summit View Fund SPC, to enhance its investment strategies[110]. Shareholder Actions - The company did not recommend a final dividend for the year ending December 31, 2024, consistent with the previous year[64]. - The company has repurchased a total of 1,362,600 shares at a total cost of approximately HKD 15.1 million, representing about 0.44714% of the issued shares[60].

Group 1 - Some Hong Kong Stock Connect stocks experienced declines despite market trends, with Codi-B leading the drop at 5.43% [1] - Following Codi-B, Hai Feng International fell by 4.04%, China Traditional Chinese Medicine decreased by 3.90%, Zhixing Automotive Technology dropped by 3.74%, and Tehai International declined by 3.03% [1] - Other companies such as COSCO Shipping Energy, Quan Feng Holdings, Chunli Medical, Nongfu Spring, and Fuyao Glass also saw declines exceeding 2% [1]

Revenue and Financial Performance - Revenue increased by approximately 178.3% from about RMB 343 million for the six months ended June 30, 2023, to about RMB 956 million for the six months ended June 30, 2024[4]. - The company reported a revenue increase of 178.3%, from RMB 34.3 million for the six months ended June 30, 2023, to RMB 95.6 million for the six months ended June 30, 2024, primarily due to increased sales of hair disease and skincare products[21]. - Revenue for the six months ended June 30, 2024, was RMB 95,575 thousand, a significant increase from RMB 34,343 thousand in the same period of 2023, representing an increase of 178%[102]. - Gross profit for the same period was RMB 50,335 thousand, compared to RMB 21,260 thousand in 2023, indicating a growth of 136%[102]. - The total loss for the period was RMB 200,926 thousand, a reduction from a loss of RMB 1,640,339 thousand in the previous year, showing an improvement of 87%[102]. - Basic and diluted loss per share was RMB (0.66), compared to RMB (15.84) in the prior year, reflecting a significant reduction in loss per share[102]. - The adjusted net loss for the six months ended June 30, 2024, was approximately RMB 1.61 billion, with the adjusted net loss as a percentage of revenue further narrowing[4]. Product Performance and Development - During the "618 event," the combined GMV of hair disease and care products and skin care products grew nearly fivefold year-on-year[5]. - The revenue of the "Qing Si Ji He" selenium disulfide shampoo increased by 12,100% year-on-year in the first half of 2024[5]. - CU-40102, the world's first and only approved topical finasteride for androgenetic alopecia, had its NDA accepted by the National Medical Products Administration in January 2024[5]. - CU-10201, the world's first and only approved topical minocycline for acne treatment, received NDA acceptance in September 2023[6]. - CU-30101, a topical lidocaine-dinoprost cream for skin surface surgeries, had its drug listing application accepted in July 2024[6]. - CU-40102 is the world's first and only approved topical finasteride spray for androgenetic alopecia, with its NDA accepted by the National Medical Products Administration (NMPA) in January 2024[10]. - CU-10201 is the first and only approved topical minocycline foam for the treatment of acne, with its NDA accepted by the NMPA in September 2023[11]. - CU-30101 completed its Phase III clinical trial in January 2024, with its drug registration application accepted by the NMPA in July 2024[13]. - CU-20401 is currently undergoing a Phase II clinical trial for submental fat accumulation, expected to complete by 2025 and aims for regulatory approval in 2028[14]. Marketing and Sales Strategy - The company is focused on expanding its online marketing strategy and enhancing sales capabilities across various e-commerce and social media platforms[20]. - The "Qing Si Ji He®" flagship store on e-commerce platforms has a repurchase rate and customer inquiry conversion rate consistently above industry averages[16]. - The company is expanding its interest e-commerce channels, with significant year-on-year revenue growth in the first half of 2024[16]. - The "Ouma" olive oil series products account for over 70% of skin care product sales[16]. - The online sales performance during the "618 event" saw a nearly fivefold year-on-year increase in GMV for hair and skin care products[16]. Expenses and Cost Management - The cost of sales rose from RMB 13.1 million to RMB 45.2 million, an increase of RMB 32.1 million, consistent with business growth[22]. - Sales and distribution expenses increased by 78.3% from RMB 58.0 million to RMB 103.5 million, driven by expanded online marketing activities[26]. - Research and development costs rose by 9.8% from RMB 90.1 million to RMB 99.0 million, attributed to an increase in R&D personnel and milestone-related expenses[27]. - Administrative expenses decreased by 23.1% from RMB 87.9 million to RMB 67.6 million, primarily due to reduced share-based payment expenses[29]. - Financial costs increased by 182.4% from RMB 1.7 million to RMB 4.8 million, mainly due to increased bank loans for operational funding[30]. - Other income decreased by 44.6% from RMB 21.5 million to RMB 11.9 million, mainly due to reduced government subsidies and lower bank interest income[24]. Shareholder and Equity Information - As of June 30, 2024, the beneficial ownership of shares includes Zhang Lele with 27,524,275 shares (9.03%) and Huang Yuqing with 4,750,000 shares (1.56%) in the company[50]. - As of June 30, 2024, 6 Dimensions Capital, L.P. holds 61,771,710 shares, representing approximately 20.27% of the total shares[51]. - 6 Dimensions Capital GP, LLC controls 65,022,855 shares, accounting for about 21.34% of the total shares[51]. - The total shareholding structure indicates significant concentration among a few major shareholders, with the top three shareholders holding over 60% of the total shares[51]. - The company has a diverse shareholder base, including various investment partnerships and funds, indicating strong institutional interest[51]. - The company repurchased a total of 585,800 shares at a total cost of approximately HKD 4.2 million, representing about 0.19223% of the issued shares as of the date of the repurchase resolution[56]. - The total number of issued shares remains unchanged at 304,738,625 shares after the repurchase[56]. Cash Flow and Financial Position - As of June 30, 2024, cash and cash equivalents totaled RMB 276.0 million, a decrease of 41.7% from RMB 473.1 million as of December 31, 2023, primarily due to expenditures in R&D and operations[36]. - The company's current assets amounted to RMB 1,210.1 million, including cash and cash equivalents of RMB 276.0 million, while current liabilities were RMB 237.8 million[36]. - The debt-to-asset ratio as of June 30, 2024, was 21.2%, slightly up from 21.0% as of December 31, 2023[38]. - The total equity of Cutia Therapeutics is RMB 1,188,333,000, down from RMB 1,349,039,000 as of December 31, 2023, representing a decrease of approximately 11.93%[104]. - The company’s cash and cash equivalents decreased to RMB 276,047,000 as of June 30, 2024, down from RMB 693,557,000 as of June 30, 2023, a decline of approximately 60.19%[109]. - The total amount of loans payable within one year increased to RMB 170,332,000 as of June 30, 2024, compared to RMB 129,411,000 as of December 31, 2023[131]. Corporate Governance and Compliance - The company has adopted the principles and code provisions of the corporate governance code and has complied with all applicable code provisions for the six months ending June 30, 2024[90]. - The company has complied with the standard code of conduct for securities trading, with no violations reported by employees who may possess inside information[58]. - The company did not declare an interim dividend for the six months ended June 30, 2024, consistent with the previous year[95]. - There were no significant breaches of loan agreements during the reporting period[93]. - The company did not issue any equity securities or sell treasury shares for cash during the reporting period[94].

Fund Allocation and Utilization - Global offering net proceeds amounted to approximately HKD 392.7 million (equivalent to approximately RMB 356.8 million)[1] - 42% of the net proceeds (HKD 164.9 million) allocated for CU-20401 R&D personnel costs and ongoing R&D activities[1] - 11% of the net proceeds (HKD 43.2 million) allocated for CU-40102 and CU-10201 R&D personnel costs and ongoing R&D activities[1] - 10% of the net proceeds (HKD 39.3 million) allocated for technology and business development for pipeline expansion[1] - 5% of the net proceeds (HKD 19.6 million) allocated for working capital and general corporate purposes[1] - As of December 31, 2023, HKD 130.2 million of the net proceeds had been utilized, with HKD 262.5 million remaining unused[1] Equity Incentive Plan - 30,402,446 shares were available for issuance under the post-IPO equity incentive plan, representing 9.98% of the company's issued shares[2] - The post-IPO equity incentive plan allows for the granting of options or share awards with a minimum holding period of 12 months from the grant date[2]

f 源证券 医药生物/生物制品 公 司 研 究 科笛-B（02487.HK） 2024 年 08 月 31 日 上半年营收维持较快增长，各重磅管线进展顺利 ——港股公司信息更新报告 投资评级：买入（维持） 黄泽鹏（分析师） 杨柏炜（分析师） huangzepeng@kysec.cn 证书编号：S0790519110001 yangbowei@kysec.cn 证书编号：S0790524050001 事件：2024H1 营收同增 178%，维持较快增长 公司发布半年报：2024H1 实现营收 0.96 亿元（同比+178.3%，下同）、归母净利 润-2.01 亿元、经调净利润-1.61 亿元，经营层面亏损占收入的比例进一步收窄。 公司是泛皮肤病治疗领域新星，毛发产品全面布局，研发+消费双管齐下共筑壁 垒，外用米诺环素/外用非那雄胺/利丁双卡因麻膏获批后有望贡献增量。我们维 持盈利预测不变，预计公司 2024-2026 年归母净利润为-4.97/-3.41/-1.70 亿元，对 应 EPS 为-1.63/-1.12/-0.56 元，营业收入为 2.79/5.49/10.09 亿元，当前股价对应 PS 为 12.8 ...