BRONCUS(02216)

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堃博医疗-B(02216) - 2024 - 年度业绩
2025-03-31 10:59
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2024年12月31日止年度的年度業績公告 及 更改所得款項淨額用途 董事會欣然公佈本公司及其附屬公司報告期之經審核綜合業績,連同截至2023年 12月31日止年度之經審核比較數字。 | 財務摘要 | | | | | --- | --- | --- | --- | | | 截至2024年 | 截至2023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 | 8,131 | 10,255 | -21% | | 毛利 | 6,139 | 7,227 | -15% | | 年內虧損 | (15,303) | (28,092) | -46% | | 加: | | | | ...
堃博医疗-B(02216) - 2024 - 中期财报
2024-09-24 08:30
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 | --- | --- | |---------------------------------|---------- ...
堃博医疗-B(02216) - 2024 Q2 - 业绩电话会
2024-08-30 02:00
各位投资人各位分析师大家早上好我是公共医疗董事长徐鸿这里我代表公司给各位汇报一下上半年的一个业绩的一个总体的情况概览这些情况分为四个部分第一个部分是我们的整体耗材的这些销售同比增长是29%主要来源于我们InterVapor的销售的增量 目前为止在中国已经覆盖了180家医院这180家医院主要还是大部分的目前还是以试用的阶段进入禁区的大概有10家医院开始在常规化的开展相关的手术 同时呢这个物权这个vapor和物权呢是在28个省市呢已经获得了阳光挂网突阔是我们最近这个拿证的一个产品大概在23个省市有阳光挂网的这个情况 物权和图库开始实现一些多用途的场景的一个临床的应用物权主要是在我们的化痰和抗炎药物的注入图库是在比如像冷冻活检配合冷冻活检以及我们简化版的BT-BNA术师上有了比较好的应用的场景 第二个方面是我们的国产化的效益国产化截止到目前为止我们之前在美国所开发和生产的产品目前只剩下LAMPRO这款产品还没有完成最后的国产化预计我们应该是在9月初也就是下个月月初的时候我们应该可能会拿到国家局的产品注册证 截至9月拿到证之后我们应该会也就是全面的已经完成了我们的进口产品的国产化由于国产化的调整我们整个毛利率是提升至 ...
堃博医疗-B(02216) - 2024 - 中期业绩
2024-08-29 13:21
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]
堃博医疗-B(02216) - 2023 - 年度财报
2024-04-26 08:34
單位日期间 受限制股份單位計劃將自2021年5月9日(即受限制股份單位計劃獲董事會首次採納之日)超計10 年期間有效及生效,此後將不會授出任何獎勵,但受限制股份單位計劃的條文應在所有方面維持 十足效力及作用。因此·於本年報日期·受限制股份單位計劃的剩餘年限約為7年1個月。 申請或接納獎勵時的應付款項 វេ 董事會報告 報告期內根據受限制股份計劃進行了以下授出: 3. 購買價為(i) 0:或(i)相等於本公司於每個餘屬日期前一年1月1日之前最後五個交易日的平均收市價*乘以 80%之價格。 購買價為(i) 0;或(il)相等於本公司於每個歸屬日期前五個藝業日的平均收市價 * 乘以 50%之價格。 8. 有關購股權計劃及受限制股份單位計劃的進一步詳情·請參閱招股章程附錄四|法定及一般資料 一D.股 權激勵計劃」一節及本公司於2023年10月4日刊發的通函。 董事會報告 有開本集團於報告期內的開聯方交易詳情戴於本年報所載綜合財務報表附註 32。除本年報所披露者外。該 等開聯方交易概無構成《上市規則》所界定的關連交易或持續開連交易·且本公司已遵守《上市規則》第14A 章項下的披露規定並於本年報內披露。 於 2023年 ...
堃博医疗-B(02216) - 2023 - 年度业绩
2024-03-28 13:01
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 (於開曼群島註冊成立的有限公司) 堃 博 醫 療 控股有限公司 (股份代號:2216) (I) 截 至2023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2023年12月31日 止 年 度 (「報 告 期」)之 經 審 核 綜 合 業 績,連 ...
堃博医疗-B(02216) - 2023 - 中期财报
2023-09-21 08:36
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |------------------------------------------------------|-------------|------------------------|-----------------------------|-------|-----------------|---------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | 參與者名稱或類別(按適用者) | 授出日期 | 웹尚未行偿 | | 失效 | | | | 行使 末尚未行使 (視情況而定) | 購買價(港元) | | 董事或最高行政人員及其聯繫人 | | | | | | | | | | | 趨 ...
堃博医疗-B(02216) - 2023 - 中期业绩
2023-08-29 13:00
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% ...
堃博医疗-B(02216) - 2022 - 年度财报
2023-04-21 08:30
堃博醫療控股有限公司 Broncus Holding Corporation (於開曼群島註冊成立的有限公司) 股份代號 : 2216 Broncus Holding Corporation 堃博 醫療 控股有限公司 Annual Report 年報 目錄 | 公司資料 | 2 | | --- | --- | | 財務摘要 | 4 | | 主席報告 | 5 | | 管理層討論及分析 | 7 | | 董事及高級管理層 | 25 | | 董事會報告 | 31 | | 企業管治報告 | 55 | | 環境、社會及管治報告 | 74 | | 獨立核數師報告 | 112 | | 綜合損益表 | 117 | | 綜合全面收益表 | 118 | | 綜合財務狀況表 | 119 | | 綜合權益變動表 | 121 | | 綜合現金流量表 | 123 | | 綜合財務報表附註 | 125 | | 釋義 | 202 | | 財務概要 | 204 | 二零二二年年度報告 2 公司資料 公司名稱 堃博醫療控股有限公司 董事 執行董事 湛國威先生 (首席執行官) 徐宏先生 年報 2022 2022 非執行董事 趙亦偉先生 (主席) 訾 ...
堃博医疗-B(02216) - 2022 - 年度业绩
2023-03-29 14:14
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 ...