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堃博医疗-B(02216) - 2024 - 中期业绩
02216BRONCUS(02216)2024-08-29 13:21

Financial Performance - Revenue for the first half of 2024 decreased by 29% to 3.704millioncomparedto3.704 million compared to 5.234 million in the same period of 2023[3] - Gross profit for the first half of 2024 decreased by 27% to 2.954millioncomparedto2.954 million compared to 4.026 million in the same period of 2023[3] - Net loss for the first half of 2024 narrowed by 46% to 7.943millioncomparedto7.943 million compared to 14.731 million in the same period of 2023[3] - Revenue for the first half of 2024 decreased to 3.704million,comparedto3.704 million, compared to 5.234 million in the same period of 2023, reflecting a decline of 29.2%[6] - Gross profit for the first half of 2024 was 2.954million,downfrom2.954 million, down from 4.026 million in 2023, a decrease of 26.6%[6] - Net loss for the first half of 2024 was 7.943million,animprovementfromthe7.943 million, an improvement from the 14.731 million loss in 2023, reflecting a 46.1% reduction in losses[6] - Total comprehensive loss for the first half of 2024 was 8.290million,comparedto8.290 million, compared to 16.602 million in 2023, showing a 50.1% improvement[7] - Revenue from external customers in Mainland China decreased to 2.359millioninH12024from2.359 million in H1 2024 from 4.251 million in H1 2023, a decline of 44.5%[17] - Total revenue from external customers dropped to 3.704millioninH12024from3.704 million in H1 2024 from 5.234 million in H1 2023, a decrease of 29.2%[17] - Revenue for the six months ended June 30, 2024, was 3.7million,adecreasefrom3.7 million, a decrease from 5.2 million in the same period last year[52] - Adjusted net loss for the six months ended June 30, 2024 was 7.832million,comparedto7.832 million, compared to 14.291 million in the same period in 2023[67] R&D and Product Development - R&D expenses for the first half of 2024 decreased by 37% to 6.491millioncomparedto6.491 million compared to 10.232 million in the same period of 2023[3] - R&D costs for the first half of 2024 were 6.491million,areductionof36.66.491 million, a reduction of 36.6% compared to 10.232 million in 2023[6] - R&D costs decreased to 6.491millioninH12024from6.491 million in H1 2024 from 10.232 million in H1 2023, a reduction of 36.6%[23] - R&D expenses decreased by 37% to 6.5 million, reflecting cost optimization and focus on core product development[59] - The company's lung cancer intervention product, the Zhiheng RF-II radiofrequency ablation system, is the world's first bronchoscopic intervention product with an indication for lung cancer and has submitted for regulatory review in China[5] - The key clinical study for the Targeted Lung Denervation (TLD) system for acute COPD treatment has enrolled over 80 subjects across multiple medical centers in China[5] - The company's TLD radiofrequency ablation system, developed in collaboration with West China Hospital, is in a key clinical trial phase with over 80 subjects enrolled across 20 research centers as of June 30, 2024[34] - The TLD system is expected to complete all subject follow-ups by July 2026, with clinical trial reports and data to be released no earlier than that date[34] - The company's product pipeline includes InterVapor® and TLD, targeting severe and acute COPD, with InterVapor® already holding CE and NMPA certifications[32] - The Zhihang RF-II radiofrequency ablation system, developed in collaboration with Guangzhou Medical University, is the world's first bronchoscopic intervention product for lung cancer treatment[36] - The Zhihang RF-II completed its clinical trial BRONC-RF-II in March 2023, demonstrating safety and efficacy, and has been submitted for regulatory approval[37] - The company has three navigation products: LungPoint, LungPoint Plus/Archimedes Lite, and LungPro/Archimedes system, covering different hospital needs[39] - The LungPro/Archimedes system, approved in the US, EU, and China, represents an upgrade to the LungPoint VBN system, enabling precise navigation for peripheral lesions[40] - The company focuses on developing innovative technologies for lung disease navigation, diagnosis, and treatment, leveraging international technology and local R&D cost advantages[41] Product Commercialization and Market Penetration - The InterVapor® thermal vapor therapy system has been commercially applied in over 60 hospitals in China, with approximately 180 hospitals having access to or trialing the technology[4] - The disposable thermal vapor therapy catheter for InterVapor® has obtained sunshine procurement prices in 28 provinces and cities, with gradual implementation of local medical insurance coverage[4] - The BroncTru® disposable bronchoscopic puncture dilation catheter has been clinically applied in multiple medical centers across China since its launch in September 2023[4] - The company's InterVapor® thermal vapor treatment system is the world's first and only non-implantable medical device for treating chronic obstructive pulmonary disease (COPD) and has been commercialized in over 60 hospitals in China[33] - The InterVapor® system has been approved for commercialization in multiple regions including Europe, China, and Australia, with over 180 hospitals in China having used or trialed the technology[33] - The company's InterVapor® system has been listed on the centralized procurement platforms in 28 provinces in China, facilitating hospital procurement and pricing negotiations[33] - The Woquan® disposable endoscope nebulization microcatheter has been used in over 1,000 surgeries in the first half of 2024, primarily for airway anesthesia and nebulized drug delivery[37] - The BroncTru® disposable bronchoscopic puncture dilation catheter was approved by Zhejiang Medical Products Administration in September 2023 and has been widely adopted in top medical centers[38] - Sales of medical consumables increased by 29% to 2.3 million, driven by higher market penetration of products like InterVapor® and BroncTru in China[53] Operational Efficiency and Cost Management - The company has improved production efficiency and optimized production processes, steadily increasing capacity to meet growing business demands[5] - Cost of sales decreased by 38% to 0.8million,primarilyduetocostoptimizationandlocalizationofproductionprocesses[54]−Grossmarginimprovedto800.8 million, primarily due to cost optimization and localization of production processes[54] - Gross margin improved to 80% from 77%, attributed to reduced production costs following the localization of InterVapor® and navigation products[55] - Administrative expenses decreased by 22% to 3.6 million, driven by cost control measures[61] - Total employee costs (excluding share-based compensation) for the reporting period were 7.9million,downfrom7.9 million, down from 12.6 million in the same period in 2023[74] Financial Position and Liquidity - Total assets minus current liabilities as of June 30, 2024, were 178.002million,downfrom178.002 million, down from 186.647 million at the end of 2023[8] - Cash and cash equivalents as of June 30, 2024, were 89.652million,anincreasefrom89.652 million, an increase from 72.845 million at the end of 2023[8] - Total equity attributable to owners of the parent company as of June 30, 2024, was 177.191million,downfrom177.191 million, down from 185.370 million at the end of 2023[10] - Cash and bank balances, including term deposits over three months, totaled 146.3millionasofJune30,2024,ensuringsufficientliquidityforoperationsanddevelopment[62]−Netcashusedinoperatingactivitieswas146.3 million as of June 30, 2024, ensuring sufficient liquidity for operations and development[62] - Net cash used in operating activities was 8.8 million, a reduction from 15.9millioninthesameperiodlastyear[63]−Thecompany′scapital−to−debtratiodecreasedto1.0615.9 million in the same period last year[63] - The company's capital-to-debt ratio decreased to 1.06% as of June 30, 2024, from 1.27% at the end of 2023[64] Market and Industry Trends - The global and Chinese COPD patient populations are projected to increase to 258.4 million and 109.6 million respectively by 2025[32] - Lung cancer is the most common cancer globally in 2022, with nearly 2.5 million new cases (12.4% of all cancers) and 1.8 million deaths (18.7% of all cancer deaths)[35] - China has the highest lung cancer incidence globally, with 1.06 million new cases in 2022 (22% of global cases) and 733,300 deaths (28.4% of all cancer deaths in China)[35] - The five-year survival rate for stage III lung cancer patients is 12.6%, while for stage IV patients it is only 2.9%[35] Corporate Governance and Compliance - The company complied with the Corporate Governance Code, except for the separation of Chairman and CEO roles, which are currently held by Mr. Xu Hong[68] - The company has established a high-standard quality management system in compliance with ISO13485, NMPA GMP, FDA OSR, and EU MDR regulations[43] - No significant contingent liabilities as of June 30, 2024[65] - No significant litigation or arbitration involving the company during the reporting period[73] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[70] - The company did not issue any equity securities or sell treasury shares for cash during the reporting period[71] - The company has no specific plans for major investments or acquisitions of significant capital assets or other businesses beyond the expansion strategy disclosed in the prospectus dated September 13, 2021[75] Use of Proceeds and Capital Allocation - The net proceeds from the global offering amounted to approximately HKD 1,620.1 million, with HKD 642.3 million utilized as of June 30, 2024, and an unused balance of HKD 977.8 million[76] - The company plans to allocate 29.0% of the net proceeds (HKD 469.2 million) for the development and commercialization of InterVapor®, with HKD 256.0 million remaining unused as of the reporting period[76] - 20.9% of the net proceeds (HKD 339.4 million) are allocated for the development and commercialization of RF-II, with HKD 274.2 million remaining unused as of the reporting period[76] - 18.5% of the net proceeds (HKD 299.9 million) are allocated for the R&D of other candidate products, with HKD 81.1 million remaining unused as of the reporting period[76] - 9.2% of the net proceeds (HKD 149.2 million) are allocated for the expansion of production lines at the company's manufacturing plant, with the full amount remaining unused as of the reporting period[76] - 13.2% of the net proceeds (HKD 213.2 million) are allocated for mergers, acquisitions, or investments in new product lines, with HKD 194.0 million remaining unused as of the reporting period[76] - 9.2% of the net proceeds (HKD 149.2 million) are allocated for working capital and other general corporate purposes, with HKD 23.3 million remaining unused as of the reporting period[76] Other Income and Expenses - Total other income increased to 3.333 million in H1 2024 from 2.387millioninH12023,drivenbyhigherbankinterestincome[21]−Otherincomeandgainsincreasedby2.387 million in H1 2023, driven by higher bank interest income[21] - Other income and gains increased by 1.0 million to 3.5million,mainlyduetohigherinterestincome[56]−Taxexpenseremainedstableat3.5 million, mainly due to higher interest income[56] - Tax expense remained stable at 2 thousand in both H1 2024 and H1 2023[24] - The company received 0.1millioningovernmentsubsidiesduringthereportingperiod,comparedto0.1 million in government subsidies during the reporting period, compared to 0.05 million in the same period last year[50] Employee and Organizational Structure - The company had 208 employees as of June 30, 2024, with 183 in China and 25 overseas[74] - No significant investments, acquisitions, or disposals in subsidiaries, associates, or joint ventures during the reporting period[72] Dividends and Shareholder Returns - No interim dividends were declared or paid in H1 2024, consistent with H1 2023[25] - The company has not declared or paid any interim dividend for the six months ended June 30, 2024[79] Post-Reporting Period Events - The company is not aware of any significant post-reporting period events from June 30, 2024, to the date of the announcement[79] Non-IFRS Financial Measures - The company has adopted non-IFRS financial measures to provide useful information for comparing operating performance across different periods[66]