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].

Financial Performance - Revenue for 2021 reached $10.891 million, a 234.2% increase compared to $3.259 million in 2020[11] - Gross profit for 2021 was $8.742 million, reflecting a 248.8% increase from $2.506 million in 2020[11] - The net loss for the year was $(236.178) million, which is a 384.1% increase from $(48.786) million in 2020[11] - The adjusted net loss for the year, according to non-IFRS measures, was $(23.654) million, a 24.1% increase from $(19.058) million in 2020[11] - Other income and gains totaled approximately $3.1 million, up 181.8% from about $1.1 million in the previous year, primarily due to increased government grants and compensation from licensing agreements[71] - Research and development costs rose to approximately $16.8 million, a 78.7% increase from $9.4 million in the previous year, driven by expanded R&D team and clinical trial expenses[72] - Sales and distribution expenses increased by 98.4%, reaching $12.7 million compared to $6.4 million in the previous year, attributed to increased marketing activities and an expanded sales team[74] - The company reported a net loss of $236.2 million for the fiscal year ended December 31, 2021, compared to a net loss of $48.8 million in the previous year[68] - Administrative expenses increased from approximately $7.7 million in 2020 to about $18.5 million in 2021, primarily due to professional service fees related to the global offering rising from $1.6 million to $4.6 million and share-based payment expenses increasing from $0.2 million to $6.3 million[75] Product Development and Clinical Trials - The company has commercialized 12 products and marketed them in 33 countries, including major markets like the USA, UK, Germany, France, and Japan[12] - The RF-II product successfully initiated its pre-market clinical trials in China, completing case enrollment at top medical centers[12] - The Targeted Lung Denervation (TLD) system completed its first clinical application at Sichuan University Huaxi Hospital, marking a significant milestone[13] - The company has over 5 products in various stages of development for lung cancer and chronic obstructive pulmonary disease treatment[12] - The core product, InterVapor, received approval for market launch in China in March 2022, targeting the large population of patients with chronic obstructive pulmonary disease (COPD)[16] - InterVapor received approval from the National Medical Products Administration in China in March 2022[23] - The company has developed a three-in-one pulmonary platform with multiple products in various stages, including InterVapor for chronic obstructive pulmonary disease and lung cancer, with clinical trials ongoing[30] - The clinical trial for the lung-targeted denervation (TLD) radiofrequency ablation system is expected to be completed in Q2 2022, which is crucial for COPD treatment[39] - RF-II, a radiofrequency ablation system for lung tumors, completed patient enrollment for its clinical trial in December 2021 and is preparing for FDA 510k approval[40] - The company plans to conduct a prospective, multi-center, randomized controlled study for the InterVapor system in treating middle and/or lower lobe emphysema, expected to start in Q3 2022 and complete by 2023[65] - The company anticipates conducting a series of clinical studies focused on lung cancer indications in various regions, with trials planned in China and Europe from 2023 to 2025[65] Market Expansion and Strategic Partnerships - The company is actively pursuing strategic partnerships with leading private hospitals and innovative companies to enhance its core capabilities in precision intervention for lung diseases[16] - A strategic partnership was established with United Family Healthcare, a leading private healthcare provider in China, in December 2021[32] - The company plans to enhance its sales network through increased physician training and patient education, as well as deeper penetration in hospitals[61] - The company is focusing on expanding its market presence, particularly in Asia, with plans to increase sales and marketing efforts by 30% in the next fiscal year[124] - The company has established partnerships with leading healthcare institutions to enhance its research capabilities and product development[124] Research and Development - The company aims to expand its R&D team globally to ensure continuous technological and product innovation, with a focus on artificial intelligence and machine learning[64] - The company has obtained 658 patents and patent applications as of December 31, 2021, including 71 related to InterVapor and 23 related to RF-II[58] - The company is committed to addressing unmet medical needs in lung disease treatment through innovative minimally invasive solutions[18] - The company has allocated $50 million for research and development of new medical technologies in the upcoming year[124] Financial Position and Cash Flow - As of December 31, 2021, cash and bank balances totaled $227.2 million, a significant increase from $18.8 million on December 31, 2020, mainly due to the completion of Series D financing and proceeds from the global offering[76] - Net cash used in operating activities was $(31,494) thousand in 2021, compared to $(15,588) thousand in 2020, indicating a worsening cash flow situation[78] - The net cash flow from financing activities was $241,822 thousand in 2021, up from $32,225 thousand in 2020, reflecting strong financing support[78] - The company reported no significant contingent liabilities as of December 31, 2021, indicating a stable risk profile[81] - The capital debt ratio remained negative as of December 31, 2021, indicating that total debt minus cash and cash equivalents was less than equity[79] Governance and Management - The management team has extensive experience in the medical device industry, with key executives having over 22 years and 11 years of relevant experience respectively[96][97] - The company is led by a board chairman with approximately 24 years of experience in the medical device and healthcare sectors[101] - The management team includes individuals with advanced degrees in relevant fields, enhancing the company's strategic capabilities[97][102] - The company has a diverse management team with backgrounds in finance, engineering, and healthcare investment[107][109] - Dr. Liu Yuny's appointment as an independent non-executive director on September 13, 2021, emphasizes the company's commitment to strong governance and oversight[113] Shareholder Information - As of December 31, 2021, the total number of shares issued by the company was 526,560,828[149] - The company’s major shareholder, QM12 Limited, holds 81,412,808 shares, representing approximately 15.46% of the total shares[153] - The director, Zi Zhenjun, has a controlled interest in 118,628,244 shares, accounting for 22.53% of the total shares[149] - The beneficial owner, Zhao Yiwei, holds 13,021,588 shares, which is about 2.47% of the total shares[149] - The company has not granted any rights to directors or their immediate family members to acquire shares or bonds during the reporting period[145] Environmental and Social Responsibility - The company has established detailed internal environmental protection rules and effective measures for resource efficiency, waste reduction, and energy saving[132] - The company actively communicates with stakeholders, including customers, employees, investors, and regulatory bodies, to enhance operational management and sustainability[133] - The company has not reported any significant violations of relevant laws and regulations regarding environmental protection, health, and safety[132]

Product Development and Innovation - As of June 30, 2021, Broncus Holding Corporation has 17 products and major candidates at various stages of development[7] - The core products include the InterVapor system, the world's first and only thermal vapor energy ablation system for treating COPD and lung cancer, and the RF-II system, specifically designed for lung cancer[7] - InterVapor system is the world's first and only thermal steam energy ablation system for treating chronic obstructive pulmonary disease (COPD) and lung cancer[18] - The company has completed site initiation for 20 sites in the BTVA registration study, with 17 sites currently enrolling patients, totaling 124 patients treated with 194 procedures[21] - The targeted lung denervation system has been in clinical trials since August 2021, with expected registration in September 2025 and December 2026[18] - The InterVapor for lung cancer is designed to continuously release thermal steam energy to ablate lung lesions, with a focus on low energy doses to adequately cover the lesion area[19] - The company has developed a new generation navigation platform, currently in the design phase, with expected registration in December 2025 and March 2027[18] - H-Marker, a self-developed surgical marker for lung nodules, completed patient enrollment and follow-up in a prospective, multi-center clinical study with 76 qualified participants[26] - The company has three navigation products: LungPoint, LungPoint Plus, and Archimedes system, all classified as Class II or III medical devices in various regions[27][28][29] - The company plans to conduct several clinical studies for InterVapor targeting lung cancer indications in various regions, with trials expected to take place from 2022 to 2024[47] Regulatory and Market Approvals - The company expects the National Medical Products Administration to complete the technical review for InterVapor for COPD by the end of September 2021, and is preparing for FDA 510(k) application in the US[22] - The company plans to utilize clinical data collected in China to apply for registration in the US and EU[14] - The company has received CE certification for InterVapor in 2018, allowing it to be listed as a Class II medical device in the European Economic Area[18] - RF-II is the only RFA system specifically designed for lung cancer treatment globally, classified as a Class III medical device in China and Class II in the EU and the US[23] - The company completed the first human clinical trial for RF-II in December 2020, with a registration clinical trial currently ongoing and an FDA 510k application expected to be submitted by November 2022[23] Financial Performance - The company reported a revenue of $2,853,000 for the six months ended June 30, 2021, compared to $833,000 for the same period in 2020, representing a significant increase of 243%[129] - Gross profit for the six months ended June 30, 2021, was $2,203,000, up from $555,000 in the previous year, indicating a growth of 296%[129] - The company reported a net loss of $43,118,000 for the six months ended June 30, 2021, compared to a net loss of $15,109,000 for the same period in 2020[67] - The adjusted net loss for the same period was $10,267,000, slightly higher than the adjusted net loss of $9,218,000 in 2020[67] - Basic and diluted loss per share for the six months ended June 30, 2021, was $0.19, compared to $0.07 for the same period in 2020[76] - The company reported a pre-tax loss of $43,117 million for the six months ended June 30, 2021, compared to a loss of $15,108 million for the same period in 2020[148] Research and Development - The company has incurred approximately $2.67 million in research and development expenses for InterVapor and RF-II during the reporting period[37] - Research and development costs for the six months ended June 30, 2021, were approximately $7.8 million, a 74.3% increase from $4.4 million for the same period in 2020[54] - The company plans to expand its R&D team globally to ensure continuous technological and product innovation, with increased spending on artificial intelligence and machine learning[46] Sales and Marketing - The company aims to expand its sales and marketing efforts in the US, Europe, and Asia as more products receive market approvals[38] - Direct sales to hospitals reached $50 million in 2021, up from $23 million in 2020, with significant contributions from Europe ($25 million) and the U.S. ($16 million)[39] - The number of distributors increased to 34 as of June 30, 2021, compared to 29 in the previous year, with notable growth in China from 11 to 16 distributors[42] - The company is collaborating with key opinion leaders to promote RF-II and conduct training courses for doctors[23] Funding and Capital Structure - The net proceeds from the global offering amounted to HKD 1,552.4 million, with approximately 29.0% allocated for funding ongoing and planned R&D and commercial launch of InterVapor[116] - Approximately 21.0% of the proceeds will be used for funding ongoing and planned R&D and commercial launch of RF-II[116] - About 18.5% of the proceeds is designated for other products and candidate products[116] - Approximately 9.2% will be invested in expanding production lines, including the construction of assembly, textile, and purification workshops[116] - About 13.2% of the proceeds will be used for potential acquisitions to continue expanding the product portfolio[116] Employee and Corporate Governance - The company had a total of 245 employees as of June 30, 2021, with the majority in research and development (108 employees)[125] - The company reported employee costs of approximately $15.8 million for the six months ended June 30, 2021, compared to $6.0 million for the same period in 2020, an increase of 163%[126] - The company has adopted stock option plans and restricted share unit plans as part of its employee incentive programs[127] - The company has complied with all applicable provisions of the Corporate Governance Code since its listing date[122] Assets and Liabilities - Total assets less current liabilities increased to $52,276 million as of June 30, 2021, compared to $25,650 million as of December 31, 2020[141] - Current assets rose significantly to $46,876 million from $26,682 million, driven by an increase in cash and cash equivalents to $37,617 million from $18,788 million[141] - Non-current liabilities totaled $209,555 million as of June 30, 2021, up from $148,091 million as of December 31, 2020[141] - The total current liabilities decreased to $7,476 million from $14,227 million, indicating improved liquidity management[141] Shareholder Information - The company completed the acquisition of minority shares in Broncus Medical, making it a wholly-owned subsidiary[70] - The company issued a total of 3,168,375 shares to various shareholders as part of its restructuring on May 12, 2021[71] - The total number of shares held by major shareholders is disclosed, with specific percentages outlined for each entity[88] - The report indicates that no other directors or senior executives hold any interests in the company or its affiliates[86]