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堃博医疗-B(02216) - 2023 - 年度业绩
BRONCUSBRONCUS(HK:02216)2024-03-28 13:01

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].