Broncus Holding Corporation 堃博醫療控股有限公司 堃博醫療控股有限公司 Broncus Holding Corporation 中期報告 2024 （於開曼群島註冊成立的有限公司） 股份代號 : 2216 Interim Report 中期報告 2024 野 1 堃博醫療控股有限公司 | --- | --- | |-------|--------------------------| | | | | 目錄 | | | | | | 2 | 公司資料 | | 4 | 財務摘要 | | 5 | 業務摘要 | | 7 | 管理層討論及分析 | | 23 | 其他資料 | | 37 | 中期簡明綜合損益表 | | 38 | 中期簡明綜合全面收益表 | | 39 | 中期簡明綜合財務狀況表 | | 41 | 中期簡明綜合權益變動表 | | 43 | 中期簡明綜合現金流量表 | | 45 | 中期簡明綜合財務資料附註 | | 63 | 釋義 | 二零二四年中期報告 2 公司資料 | --- | --- | |---------------------------------|---------- ...

Financial Data and Key Metrics Changes - The overall sales of consumables increased by 29% year-on-year, primarily driven by the growth in InterVapor sales [4] - Gross margin improved from 76% to 80%, attributed to reduced production costs after localizing manufacturing [13] Business Line Data and Key Metrics Changes - The company is currently experiencing a temporary stagnation with the Interweaver Plus product, awaiting breakeven before further development [5] - The TLD product line has successfully treated over 90 patients, indicating strong market acceptance [3] Market Data and Key Metrics Changes - The company has made significant inroads in the Asian market, particularly in Thailand, Indonesia, and the Middle East, contributing to overall sales growth [16] - The market for COPD and asthma treatments is substantial, with new cases and mortality rates indicating a large potential customer base [21] Company Strategy and Development Direction - The company aims to leverage its localized production capabilities to reduce costs and expand its market reach, focusing on both domestic and international markets [11] - There is a strategic shift towards bundling new products with existing navigation products to enhance market penetration [22] Management's Comments on Operating Environment and Future Outlook - Management expressed a cautious outlook on the competitive landscape, emphasizing the need for patient and physician education to drive product adoption [9] - The company is committed to navigating regulatory challenges and is optimistic about future product approvals, which are expected to drive sales growth [17] Other Important Information - The company has identified significant issues in the market, including the need for better patient education and the impact of national healthcare regulations on product adoption [9] - The company is actively working on obtaining necessary certifications for new products to ensure compliance and market readiness [5] Q&A Session Summary Question: What is the feedback from doctors regarding the new RF2 product? - Management indicated that the feedback from clinical trials has been positive, with doctors requiring about 5 to 10 cases to become proficient in using the technology [15] Question: What is the expected market space for lung cancer treatment? - Management expects the market for lung cancer treatment to remain robust, with significant growth potential as new products are introduced [18] Question: Why did revenue decline despite an increase in consumable sales? - The decline in revenue is attributed to a strategic shift in focus from navigation products to treatment consumables, which is expected to stabilize in the future [22]

Financial Performance - Revenue for the first half of 2024 decreased by 29% to $3.704 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 $2.954 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 $7.943 million compared to $14.731 million in the same period of 2023[3] - Revenue for the first half of 2024 decreased to $3.704 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 $2.954 million, down from $4.026 million in 2023, a decrease of 26.6%[6] - Net loss for the first half of 2024 was $7.943 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 $8.290 million, compared to $16.602 million in 2023, showing a 50.1% improvement[7] - Revenue from external customers in Mainland China decreased to $2.359 million in H1 2024 from $4.251 million in H1 2023, a decline of 44.5%[17] - Total revenue from external customers dropped to $3.704 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 $3.7 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 $7.832 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 $6.491 million compared to $10.232 million in the same period of 2023[3] - R&D costs for the first half of 2024 were $6.491 million, a reduction of 36.6% compared to $10.232 million in 2023[6] - R&D costs decreased to $6.491 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 $0.8 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 $7.9 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 $178.002 million, down from $186.647 million at the end of 2023[8] - Cash and cash equivalents as of June 30, 2024, were $89.652 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 $177.191 million, down from $185.370 million at the end of 2023[10] - Cash and bank balances, including term deposits over three months, totaled $146.3 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 $15.9 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 $2.387 million in H1 2023, driven by higher bank interest income[21] - Other income and gains increased by $1.0 million to $3.5 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 $0.1 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]

Financial Overview - The company has utilized approximately HKD 548.9 million from the global offering proceeds, with an unutilized balance of about HKD 1,071.2 million remaining as of December 31, 2023[25]. - Revenue for the year ended December 31, 2023, was $10,255,000, representing an 8.9% increase compared to $9,413,000 in 2022[55]. - Gross profit decreased slightly to $7,227,000, down 1.2% from $7,315,000 in the previous year[55]. - The net loss for the year was $(28,092,000), a marginal increase of 0.2% from $(28,036,000) in 2022[55]. - Cash and cash equivalents decreased by 16.9% to $156,647,000 from $188,435,000[55]. - In 2023, the company’s sales and distribution expenses were $11.5 million, reflecting a growth of 2.7% compared to $11.2 million in 2022, while sales revenue increased[189]. Compliance and Governance - The company has confirmed compliance with the relevant laws and regulations, with no significant litigation or arbitration issues reported during the period[31]. - The company has not engaged in any purchases, sales, or redemptions of its listed securities during the reporting period[27]. - The company has adhered to the disclosure requirements under the Listing Rules regarding related party transactions[8]. Product Development and Innovation - The company believes that the intellectual property developed for its lung robot will play a crucial role in maintaining its competitive advantage in the lung medical robotics market[20]. - The core product, the RF-II radiofrequency ablation system for lung cancer treatment, has completed pre-market clinical trials, confirming its safety and efficacy[83]. - The innovative TLD radiofrequency ablation energy system for treating acute exacerbations of COPD completed its first clinical trial surgery in July 2023, with over 40 subjects enrolled across more than 20 research centers by December 31, 2023[87]. - The RF-II product is expected to drive the commercialization of the company's navigation platform post-launch[83]. - The company has 19 products at various stages of development, including several innovative interventional pulmonary treatment products unique to China or globally[122]. - The InterVapor® device received registration from the National Medical Products Administration in October 2023, marking a significant milestone for commercialization[119]. - The clinical trial for the TLD product is a multi-center study involving 189 patients with moderate to severe chronic obstructive pulmonary disease, expected to complete follow-ups by July 2026[141]. - The company has developed InterVapor® and InterVapor Plus for the treatment of chronic obstructive pulmonary disease and lung cancer, respectively[133]. Market Presence and Strategy - The company aims to expand sales of diagnostic consumables and focus on R&D for lung disease treatment products[62]. - The company's navigation products have achieved a market share of 40% in China[89]. - The company is expanding its market presence with its products covering multiple countries, including the US, UK, Germany, France, and India[121]. - The company aims to enhance awareness of its navigation platform among hospitals, doctors, and patients through systematic training and education, aiming to expand its sales network[181]. - The company is committed to advancing its localization strategy, which has shown significant results in 2023, further reducing operational costs[99]. Clinical Trials and Research - A government-funded clinical trial for targeted segmental vapor ablation therapy for emphysema has been initiated in Germany, expected to complete by 2025[73]. - The clinical trial data for RF-II was presented at the European Respiratory Society conference, supporting its safety and efficacy in lung cancer treatment[116]. - The clinical trial for InterVapor® was completed in March 2023, with plans to use data collected in China for registration applications in the US and EU[127][128]. - As of December 31, 2023, the clinical history of InterVapor® includes five major trials, with the NEXT-STEP trial completed in June 2020 and the VAPORIZE trial's report finalized by September 2021[135]. Future Outlook - The company plans to continue adapting to external environmental changes and optimizing its business and R&D pipelines amid industry challenges[98]. - The RF-II product is expected to be commercialized within seven years from the start of its development process[138]. - There are no significant plans for major investments or acquisitions beyond the disclosed expansion strategies[67]. - The company aims to optimize its R&D pipeline and deepen market penetration while focusing on cost reduction and efficiency improvements[85]. Customer and Market Insights - The top five customers contributed 78% of total revenue, with the largest customer accounting for 62%[47]. - The global population suffering from chronic obstructive pulmonary disease (COPD) was 233.6 million in 2022, projected to rise to 258.4 million by 2025, with China accounting for 107 million and expected to reach 109.6 million[196]. - The five-year survival rate for stage III lung cancer patients is only 12.6%, highlighting the need for early diagnosis and treatment solutions[175].

Financial Performance - For the fiscal year ending December 31, 2023, the company reported revenue of $10,255,000, representing an 8.9% increase compared to $9,413,000 for the previous year[3]. - The gross profit for the same period was $7,315,000, showing a slight decrease of 1.2% from $7,227,000 in the prior year[3]. - The net loss for the year was $28,092,000, which is a marginal improvement of 0.2% compared to a net loss of $28,036,000 in the previous year[3]. - The company's revenue for the fiscal year 2023 was $10,255,000, an increase from $9,413,000 in 2022, representing a growth of approximately 8.9%[9]. - The cost of goods sold for 2023 was $3,028,000, compared to $2,098,000 in 2022, indicating an increase of about 44.4%[9]. - The company's net loss for the fiscal year 2023 was $28,092,000, slightly higher than the net loss of $28,036,000 in 2022[10]. - The company reported other income and gains of $6,019,000 in 2023, up from $4,785,000 in 2022, reflecting an increase of approximately 25.8%[9]. - The company’s research and development expenses for 2023 were $20,154,000, compared to $19,167,000 in 2022, showing an increase of about 5.1%[9]. - The adjusted net loss for 2023 was $27,536 thousand, compared to $26,913 thousand in 2022, indicating an increase in losses year-over-year[135]. - The company did not declare or pay any dividends during the current year, consistent with 2022[46]. Product Development and Clinical Trials - The company completed the confirmatory clinical trial for the RF-II product, achieving a success rate of 99.35% and a complete ablation rate of 93.8% after six months[5]. - The innovative TLD radiofrequency ablation system for treating acute exacerbations of chronic obstructive pulmonary disease (COPD) has completed its first clinical trial procedure in July 2023, with over 40 patients enrolled across more than 20 research centers[5]. - The InterVapor® thermal vapor treatment system is the world's first and only medical device for treating chronic obstructive pulmonary disease without implants, with clinical trials confirming its feasibility for lung cancer treatment[64]. - The RF-II radiofrequency fusion system is the first global product for endobronchial intervention specifically for lung cancer[64]. - The company has developed a comprehensive intervention platform for respiratory diseases, addressing clinical needs for lung disease treatments[63]. - The TLD product, developed in collaboration with Sichuan University, aims to treat chronic obstructive pulmonary disease (COPD) and has completed initial clinical trials with over 40 patients enrolled by the end of 2023, expecting full enrollment by July 2026[80][82]. - InterVapor® has completed clinical trials including STEP-UP, NEXT-STEP, VAPORIZE, and BTVA Registry, with a total of 239 patients enrolled across 17 research centers by the end of 2023, reporting no serious device-related adverse events[73][74]. - The RF-II clinical trial BRONC-RF-II was completed in March 2023, with results submitted to NMPA for medical device market review[78]. - The TLD clinical trial is a prospective, randomized, single-blind, sham-controlled study involving over 20 research centers in China, with the first surgery completed in July 2023[82]. Market Expansion and Product Commercialization - As of December 31, 2023, the company has obtained various national and provincial qualifications, including recognition as a National High-tech Enterprise and a Zhejiang Province Technology-based SME[7]. - The company's market share for its navigation products in China reached 40%[8]. - The InterVapor® product has been commercialized in over 20 hospitals in China, with approximately 100 hospitals engaged in using or trialing the technology[8]. - The company has expanded its product coverage to multiple countries, including the United States, United Kingdom, Germany, France, and India[8]. - The company plans to utilize clinical data collected in China to apply for registration in the US and EU[67]. - The company is focusing on regulatory compliance and post-market clinical research to strengthen the clinical evidence for its products[109]. - The company aims to expand its market presence and enhance its product offerings through strategic initiatives[160]. - The company is actively pursuing new strategies for market expansion and potential acquisitions[160]. Financial Position and Assets - Total assets decreased from $214,525 thousand in 2022 to $186,647 thousand in 2023, representing a decline of approximately 13%[13]. - Non-current assets increased from $19,076 thousand in 2022 to $23,153 thousand in 2023, reflecting an increase of about 21%[12]. - Current assets decreased from $202,866 thousand in 2022 to $172,652 thousand in 2023, a reduction of approximately 15%[12]. - Cash and cash equivalents decreased significantly from $106,756 thousand in 2022 to $83,564 thousand in 2023, a decline of around 22%[12]. - Total liabilities increased from $7,417 thousand in 2022 to $9,158 thousand in 2023, indicating an increase of approximately 23%[12]. - The company's equity decreased from $213,458 thousand in 2022 to $185,370 thousand in 2023, a decline of about 13%[13]. - The company reported a significant increase in intangible assets from $5,910 thousand in 2022 to $8,970 thousand in 2023, representing an increase of approximately 52%[12]. - The company's total non-current liabilities rose from $1,067 thousand in 2022 to $1,277 thousand in 2023, an increase of about 20%[13]. - The company's total current liabilities increased from $7,417 thousand in 2022 to $9,158 thousand in 2023, reflecting a rise of approximately 23%[12]. Research and Development - The company is focused on research and development, particularly in the field of chronic obstructive pulmonary disease and lung cancer treatments[160]. - The company is increasing its investment in artificial intelligence and machine learning to accumulate clinical data and enhance the performance of its navigation systems[108]. - Research and development costs amounted to approximately $20.2 million for the year ended December 31, 2023, up from $19.2 million in 2022, representing a growth of 5.1% driven by an increase in clinical trial expenses from $0.6 million to $1.5 million[120]. Corporate Governance and Compliance - The company has adhered to all applicable corporate governance codes during the reporting period, ensuring high standards of corporate governance[139]. - The board of directors includes both executive and independent non-executive members, ensuring diverse governance[162]. - The company emphasizes the importance of adhering to corporate governance guidelines as per the Listing Rules[160]. Employee and Management Information - As of December 31, 2023, the company had a total of 308 employees, with 266 located in China and 42 overseas[145]. - Total employee costs for the reporting period were approximately $22.6 million, compared to $22.4 million in the same period of 2022[146]. - The company paid a total of $681,000 in compensation to key management personnel in 2023, a decrease of 41% from $1,154,000 in 2022[61]. Future Outlook - The company anticipates commercial launch of RF-II within seven years from the start of its development process[79]. - The company plans to expand into robotic minimally invasive surgery through the development of its own flexible surgical robots[105]. - The company aims to address the significant market demand for minimally invasive solutions for lung diseases driven by aging populations and environmental factors[105].

Financial Performance - Revenue for the six months ended June 30, 2023, was $5,234,000, representing a 62.6% increase compared to $3,218,000 in 2022[6] - Gross profit for the same period was $4,026,000, up 63.5% from $2,462,000 in the previous year[6] - The net loss for the period improved to $(14,731,000), a decrease of 8.3% from $(16,060,000) in 2022[6] - The adjusted net loss under non-IFRS was $(14,291,000), a reduction of 5.4% compared to $(15,111,000) in the prior year[6] - Other income and gains totaled approximately $2.5 million, representing a 362.6% increase from about $0.5 million in the same period last year[130] - The company reported a net loss of $14.7 million for the six months ended June 30, 2023, an improvement from a net loss of $16.1 million in the same period last year[151] - The adjusted loss for the period, excluding share-based payments, was $14.29 million, down from $15.11 million in 2022, indicating a 5.4% reduction[186] - The total employee costs for the six months ended June 30, 2023, were $5.814 million, accounting for 56.8% of total expenses, compared to $4.452 million in the same period last year[133] - The company's research and development costs for the six months ended June 30, 2023, were approximately $10.2 million, up 12.0% from $9.1 million in the same period last year, primarily due to an increase in employee costs[155] Product Development and Clinical Trials - The company completed the confirmatory clinical trial follow-up for its core product RF-II in Q1 2023, involving 126 subjects with a success rate of 99.35% and a complete ablation rate of 92.06% at 6 months post-procedure[23] - The design of InterVapor® for lung cancer treatment has been completed and submitted for type testing in July 2023[32] - The company has initiated clinical trials for its new product in China, with registration trials starting in January 2023 and expected to complete by December 2026[24] - The company reported a low incidence of common complications such as pneumothorax and bleeding in its lung cancer thermal ablation treatment[23] - The RF-II clinical trial has completed enrollment of all subjects, with 126 participants undergoing 12-month follow-up analysis, showing a technical success rate of 99.35% and a complete ablation rate of 92.06% at 6 months post-procedure[55][63] - The company completed the first clinical surgery for the lung-targeted denervation (TLD) ablation system in July 2023, with a total of 189 patients planned for the trial, expected to conclude by the end of 2025[82] - The company is conducting a pre-market clinical trial for the lung-targeted denervation (TLD) ablation system, aiming to enroll 189 patients across over 20 research centers in China, with completion expected in Q4 2024[55] Market Expansion and Strategy - The company aims to become a global leader in transforming lung disease treatment[10] - The company has expanded its product coverage to 33 countries and regions globally, including the US, UK, Germany, France, Singapore, Thailand, India, and South Korea as of H1 2023[31] - The company is addressing the growing global demand for minimally invasive solutions for chronic obstructive pulmonary disease and lung cancer due to increasing prevalence driven by aging populations and air pollution[20] - The company plans to expand the sales of LungPoint Plus and other medical consumables in China, leveraging its experience in sales and marketing[148] - The company plans to expand its sales network by providing more physician training and patient education, promoting equipment installation, and deepening hospital penetration, in response to the growing market demand for minimally invasive treatment solutions for lung diseases[124] Regulatory and Compliance - The company is subject to the requirements of maintaining a register of interests and short positions as mandated by the Securities and Futures Ordinance[199] - The report highlights the importance of compliance with regulatory requirements regarding shareholder disclosures[199] - The company continues to evaluate its performance using non-IFRS measures to provide investors with useful information for comparing operational performance across different years[184] Shareholder Information - The company's major shareholder, Mr. Kai Guo Wei, holds 2,999,396 shares, representing 0.57% of the total shares[176] - Mr. Zhao Yi Wei holds 13,021,588 shares, accounting for 2.47% of the total shares[176] - The largest shareholder, Mr. Jian Zhen Jun, has a controlled interest in 118,628,244 shares, which is 22.50% of the total shares[176] - The company reported significant shareholder interests as of June 30, 2023, in accordance with the Securities and Futures Ordinance[199] Employee and Operational Insights - The company has a total of 314 employees as of June 30, 2023, categorized by function[14] - The company has begun transferring production processes to China to leverage lower labor and material costs, with the production of H-Marker starting in June 2021[113] - The company anticipates that the localized production of InterVapor® in China will be fully operational after receiving regulatory approval in Q3 2023[113] Miscellaneous - The company did not declare or pay any dividends during the reporting period and has no plans to declare any interim dividends[167] - The company continues to explore opportunities to expand its product line, although there are no specific plans for significant investments or acquisitions at this time[173] - The document indicates that the interests and short positions of certain individuals, excluding directors and senior executives, must be disclosed to the company and the stock exchange[199] - The content lacks detailed insights into the company's strategic initiatives or future guidance[199][200]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容 概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就 因本公告全部或任何部分內容所產生或因倚賴該等內容而引致的任何損 失承擔任何責任。 Broncus Holding Corporation 堃 博醫 療控 股 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：2216） 截 至2023年6月30日 止 六 個 月 的 中 期 業 績 公 告 堃博醫 療 控股有限公司（「本公司」）之董事（「董事」）會（「董事會」）欣然公佈 本公司及其附屬公司（統稱「本集團」或「我們」）截至2023年6月30日止六個 月（「報 告 期」）之 未 經 審 核 綜 合 中 期 業 績，連 同 截 至2022年6月30日 止 六 個 月之未經審核比較數字。 財務摘要 截至6月30日止六個月 2023年 2022年 同比變動 （未經審核）（未經審核） 千美元 千美元 收入 5,234 3,218 62.6% 毛利 4,026 2,462 63.5% ...

Financial Performance - Revenue for 2022 was $9.413 million, a decrease of 13.57% compared to $10.891 million in 2021[10] - Gross profit for 2022 was $7.315 million, down 16.32% from $8.742 million in 2021[10] - The net loss for the year was $28.036 million, an improvement of 88.13% compared to a loss of $236.178 million in 2021[10] - The non-IFRS adjusted net loss for 2022 was $26.913 million, a 13.78% increase from $23.654 million in 2021[10] - Revenue from direct sales to hospitals was approximately $2.3 million in 2022, a decrease from $4.9 million in 2021, while revenue from distributors increased to about $7.1 million from $6.0 million[53] - Other income and gains totaled approximately $4.8 million for the year ended December 31, 2022, an increase of about $1.7 million from the previous year, primarily due to interest income rising from $0.1 million to $2.6 million[65] - The company reported a net cash outflow from operating activities of $(30.954) million for the year ended December 31, 2022[72] - The company reported a comprehensive loss for the fiscal year ending December 31, 2022, with no dividends declared during the reporting period[116] Product Development and Clinical Trials - The InterVapor® thermal vapor treatment system was commercialized in March 2022, with clinical applications in nearly 20 hospitals across over 10 provinces[12] - The innovative TLD radiofrequency ablation energy system completed its first human clinical trial in July 2022, enrolling 9 patients[13] - The RF-II radiofrequency ablation system for lung cancer has completed data collection for all primary endpoints in its registration clinical trial[13] - The company is conducting clinical trials for the InterVapor® system for lung cancer treatment, with registration trials initiated in January 2023 and expected market entry by September 2025[20] - The TLD clinical trial will involve 189 moderate to severe COPD patients across 26 research centers in China, with an expected enrollment period of 28 months and a follow-up period of 12 months[37] - The clinical trial for the TLD radiofrequency ablation system completed patient enrollment in July 2022, with follow-up expected to finish by July 2023, and the clinical trial report anticipated to be published by the end of 2023[37] - The company plans to conduct a series of post-market clinical studies focused on lung cancer indications in China and Europe from 2023 to 2025[60] Market Position and Strategy - The company maintained a market share of approximately 40% in the domestic market for lung navigation platforms[12] - The company achieved a market share leadership position in China for its navigation products in 2022[24] - The company plans to accelerate R&D processes, deepen market penetration, and enhance cost efficiency in 2023, aiming to strengthen its leadership in the global pulmonary intervention field[15] - The company aims to collaborate with clinical experts and biopharmaceutical companies to explore new applications for its nebulization microcatheter in various medical fields[15] - The company plans to expand its sales network by enhancing doctor training and patient education, and increasing equipment installation in hospitals[58] - The company anticipates more global sales as its current and candidate products receive additional market approvals[48] Research and Development - Over 5 products targeting lung cancer and COPD are in various stages of research and clinical trials[11] - Research and development costs increased by 14.4% to approximately $19.2 million in 2022, up from $16.8 million in 2021, driven by an expansion of the R&D team and increased technical service fees[66] - The company aims to enhance its research and development team globally to ensure continuous technological and product innovation[59] - The company plans to increase spending on artificial intelligence and machine learning to accumulate clinical data and improve treatment procedures guided by its navigation systems[59] Corporate Governance and Management - The company is committed to enhancing corporate governance and pursuing strategic partnerships with top global business partners to drive growth[15] - The management team includes independent directors with extensive backgrounds in finance and healthcare, ensuring robust governance and oversight[102][104] - The board of directors consists of eight members, including both executive and independent non-executive directors[122] - The company has established a remuneration committee to formulate salary policies for directors and senior management, considering factors such as comparable company salaries and responsibilities[128] Intellectual Property and Licensing - The company holds a total of 748 patents and patent applications, including 117 related to InterVapor® and 50 related to RF-II as of December 31, 2022[54] - The company has a licensing agreement with Norcon, which requires an annual payment of $250,000 for ten years, starting from September 7, 2021[165] - The licensing agreement is expected to provide stable additional income over the next ten years, aligning with the company's business goals[166] - The company has established a pricing policy for the licensing fees based on market rates for similar intellectual property[167] Risks and Challenges - The company faces risks related to product development, including the potential for clinical trial failures and regulatory approval delays, which could severely impact business operations[196][198] - The company has incurred net losses since its inception and may continue to do so in the foreseeable future[198] - The company is subject to strict regulatory oversight in all significant aspects of product development and commercialization[198] Environmental and Social Responsibility - The company has established a detailed environmental protection policy and has not found any significant violations of relevant laws and regulations[120] - The company emphasizes communication with stakeholders, including customers, employees, and investors, to enhance operational management and sustainability[121] - The company has implemented effective measures for resource efficiency, waste reduction, and energy conservation[120]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Broncus Holding Corporation 堃 博 醫 療 控 股 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：2216） (I)截至2022年12月31日止年度的年度業績公告；及 (II)建議修訂現有組織章程大綱及細則及採納新組織章程大綱及細則 堃博醫療控股有限公司（「本公司」）之董事（「董事」）會（「董事會」）欣然公佈本公 司及其附屬公司（統稱「本集團」或「我們」）截至2022年12月31日止年度（「報告 期」）之經審核綜合業績，連同截至2021年12月31日止年度之經審核比較數字。 財務摘要 截至2022年 截至2021年 12月31日 12月31日 止年度 止年度 同比變動 千美元 千美元 收入 9,413 10,891 -13.57% 出售醫療設備╱耗材及其他收入 9,413 8,739 ...

Financial Performance - Revenue for the six months ended June 30, 2022, was $3,218 million, representing a 12.8% increase compared to $2,853 million in the same period of 2021[7]. - Gross profit for the same period was $2,462 million, up 11.8% from $2,203 million year-over-year[7]. - The net loss for the period was $(16,060) million, a significant improvement of 62.8% compared to $(43,118) million in the prior year[7]. - The adjusted net loss under non-IFRS measures for the period was $(15,111) million, an increase of 47.2% from $(10,267) million in the previous year[7]. - Other income and gains totaled approximately $0.5 million, a decrease of 76.5% from approximately $2.3 million in the prior year, primarily due to a reduction in government grants from $1.2 million to $0.2 million[64]. - Research and development costs increased by 17.8% to approximately $9.1 million for the six months ended June 30, 2022, compared to $7.8 million for the same period in 2021, driven by higher employee costs and technical service fees[65]. - For the six months ended June 30, 2022, total operating expenses amounted to $9.138 million, an increase from $7.755 million for the same period in 2021, representing a 17.7% increase[67]. - Employee costs rose significantly to $4.452 million, accounting for 48.7% of total expenses, compared to $2.950 million or 38.0% in the previous year[67]. - The company reported a net loss of $16,060,000 for the six months ended June 30, 2022, compared to a net loss of $43,118,000 for the same period in 2021, representing a significant improvement[79]. - The company reported a decrease in selling and distribution expenses to $5,300,000 in the first half of 2022 from $5,638,000 in 2021, a reduction of approximately 6%[147]. Product Development and Clinical Trials - The company has 17 products and several major candidates at different stages of development as of June 30, 2022[9]. - The core products include the InterVapor system, the first and only thermal vapor treatment system for COPD and lung cancer, and the RF-II system, specifically designed for lung cancer[9]. - The company completed the first human clinical trial of the lung-targeted denervation (TLD) radiofrequency ablation energy system in Q2 2022, which is expected to be crucial for treating COPD by reducing airway tension and mucus production[12]. - The InterVapor® system, approved by the National Medical Products Administration in March 2022, is the first thermal steam ablation system for treating COPD in China, marking a new era in interventional respiratory disease treatment[13]. - The lung-targeted denervation system is currently in clinical trials in China, with registration expected by December 2027[14]. - The company has completed enrollment for all subjects in its clinical trials, with data from China expected to support registration applications in the US and EU[19]. - The LungPro augmented reality optical navigation system's clinical study results were published in Respirology, confirming its safety and effectiveness for diagnosing peripheral lung lesions[12]. - The company launched a multidisciplinary joint diagnosis for pulmonary nodules in collaboration with Shanghai United Family Hospital in July 2022, aiming to improve early detection and treatment of lung cancer[25]. - The RF-II system, the only radiofrequency ablation system specifically for lung cancer treatment, completed patient enrollment for its registration clinical trial in December 2021, with primary efficacy endpoint assessment expected in Q1 2023[34]. Market and Strategic Initiatives - The company aims to become a global leader in transforming lung disease treatment[10]. - The company has identified a significant market demand for minimally invasive solutions for lung diseases driven by aging populations, air pollution, and smoking habits[8]. - The company sold products in 33 countries and regions globally, including the US, UK, Germany, France, and Japan in the first half of 2022[24]. - A strategic partnership was established with Healium Medical Ltd. in February 2022 to integrate energy ablation and ultrasound technology for real-time monitoring of ablated tissue, enhancing treatment safety and predictability[24]. - The company plans to expand its sales network by enhancing physician training and patient education, and increasing hospital penetration through its proprietary BTPNA technology[56]. - The company anticipates conducting a prospective, multi-center, randomized controlled study on the use of the InterVapor system, aiming for completion in 2024[58]. Shareholder and Corporate Governance - The company did not declare or pay any dividends during the reporting period and has no plans to declare any interim dividends[82]. - The company has undergone changes in its board and senior management, with several appointments and resignations effective from August 30, 2022[93]. - Major shareholders include QM12 Limited with 81,412,808 shares, representing approximately 15.46% of the company[104]. - The company has a stock option plan with a total of 11,714,220 options available for issuance, which represents about 2.22% of the total issued share capital[111]. - The company has adopted a share option plan on May 9, 2021, and issued 9,877,197 shares under the restricted share unit plan, equivalent to 39,508,788 shares post-split[124]. - The company has complied with all applicable provisions of the Corporate Governance Code during the reporting period[139]. Cash Flow and Financial Position - As of June 30, 2022, cash and bank balances totaled $205.1 million, down from $227.2 million at the end of 2021, primarily due to operating expenses incurred[70]. - The net cash flow used in operating activities was $(16.855) million for the six months ended June 30, 2022, compared to $(14.348) million in the same period of 2021[71]. - The group had outstanding borrowings of $31,000 as of June 30, 2022, up from $13,000 at the end of 2021[72]. - The company’s total liabilities increased significantly, leading to a cumulative loss of $424,784,000 as of June 30, 2022[154]. - The company’s cash and cash equivalents at the end of June 30, 2022, were $56,651,000, an increase from $37,617,000 at the end of June 30, 2021[159]. - The company experienced a foreign exchange loss of $1,364,000 during the first half of 2022, compared to a gain of $94,000 in the same period of 2021[157]. Research and Development Focus - The company is developing a comprehensive solution for interventional respiratory diseases, supported by government initiatives[13]. - The company plans to increase spending on artificial intelligence and machine learning to accumulate clinical data and cases during procedures guided by its navigation system[57]. - The company’s operational focus remains on the research, development, manufacturing, and commercialization of medical devices and consumables[161].