Revenue and Financial Performance - Revenue growth of 75.9% in 2023, with a steady improvement in gross margin[6] - Revenue increased by 75.9% to RMB 441.1 million in 2023 compared to RMB 250.8 million in 2022[10] - Gross profit rose by 84.7% to RMB 325.4 million in 2023 from RMB 176.2 million in 2022[10] - Operating loss decreased by 2.7% to RMB 430.8 million in 2023 from RMB 442.5 million in 2022[10] - R&D expenses decreased by 21.4% to RMB 293.4 million in 2023 from RMB 373.1 million in 2022[10] - Revenue from transcatheter valve therapy products reached RMB 185.6 million, a 72.9% increase compared to RMB 107.3 million in the previous year[19] - Revenue from the neurovascular intervention business increased by 78.1% to RMB 255.6 million, while revenue from the transcatheter valve therapy business increased by 72.9% to RMB 185.6 million[46] - The gross profit increased by 84.7% to RMB 325.4 million in 2023, with a gross margin of 73.8%, up from 70.2% in 2022[50] - Sales and distribution expenses increased by 34.5% to RMB 325.0 million, driven by new product promotion, market education, and expansion of the sales team[51] - Administrative expenses increased by 14.7% from RMB 123.4 million in 2022 to RMB 141.6 million in 2023, primarily due to higher wages and salaries[52] - Other net losses amounted to RMB 15.8 million in 2023, compared to other net income of RMB 106.7 million in 2022, primarily due to a decrease in foreign exchange gains[55] - Financial income decreased from RMB 44.3 million in 2022 to RMB 39.3 million in 2023, mainly due to lower bank interest income[56] - The capital-to-debt ratio decreased from 25.7% in 2022 to 17.5% in 2023, primarily due to milestone payments for certain business development projects[57] - Net current assets decreased from RMB 1,429.4 million in 2022 to RMB 1,083.2 million in 2023, mainly due to milestone payments[58] - Cash, cash equivalents, and term deposits decreased by 47.5% from RMB 1,839.7 million in 2022 to RMB 965.8 million in 2023[61] - Capital expenditures totaled RMB 316.2 million in 2023, primarily used for new headquarters construction, equipment procurement, and technology[62] Market Share and Product Performance - Market share in the transfemoral TAVR market exceeded 20%, covering approximately 500 hospitals, up from nearly 300[7] - TAVR product terminal implant volume reached 2,484 units in 2023, more than double the 2022 volume, capturing over 20% market share in China's transfemoral TAVR market[12] - The company expanded its hospital coverage for TAVR products to nearly 500 hospitals, with approximately 200 new hospitals added in 2023[12] - Revenue in the neurointerventional business increased by 78.1% compared to 2022[8] - Neurointerventional business revenue grew by 78.1% to RMB 255.6 million in 2023, with gross profit increasing by 83.4% to RMB 166.4 million[13] - Revenue from hemorrhagic products grew by 44.9% to RMB 81.9 million, accounting for 32.1% of the neurointerventional business revenue[30] - Revenue from ischemic products surged by 117.3% to RMB 85.9 million, representing 33.6% of the neurointerventional business revenue[31] - Vascular access products generated revenue of RMB 87.1 million in the reporting period, an 84.6% increase from RMB 47.2 million in 2022, accounting for 34.1% of the neurointerventional business revenue[35] R&D and Clinical Trials - Completed patient enrollment for three major clinical trials: TaurusTrioTM, TaurusNXT®, and GeminiOne®[8] - Achieved early clinical data milestones for GeminiOne® and MonarQ™ at the TCT 2023 conference[8] - Expanded product pipeline with 16 commercialized products and multiple R&D projects in neurointervention[3] - The company has 6 registered products and 10 products under development in the transcatheter valve therapy business, and 16 registered products and 9 products under development in the neurointerventional business[16] - TaurusMax® has been submitted for registration approval to the National Medical Products Administration, featuring three additional radiopaque markers and an adjustable delivery system to improve coaxiality[20] - TaurusNXT®, the third-generation TAVR system, has completed patient enrollment for multicenter registration clinical trials, utilizing patented non-aldehyde tissue crosslinking technology to enhance durability and biocompatibility[20] - TaurusApex®, a fourth-generation TAVR system with polymer leaflets, is undergoing animal trials and long-term follow-up evaluations, showing promising results in durability and biocompatibility[21] - TaurusWave®, a shockwave-based calcification remodeling system, has completed its first patient treatment in October 2021 and is currently in clinical trials[21] - Trilogy™ THV system, licensed from JenaValve, has been successfully launched in Hong Kong with two commercial implants completed in May 2023, and a local production base established in Suzhou[21] - HighLife® TSMVR system, licensed from HighLife SAS, is undergoing multicenter registration clinical trials, featuring a unique "Valve-in-Ring" concept to reduce paravalvular leakage risks[22] - GeminiOne®, an edge-to-edge repair system, has completed patient enrollment for multicenter registration clinical trials in China and plans to initiate early feasibility studies in the US[23] - Sutra Hemi Valve, a transcatheter mitral valve treatment device, is currently in the animal trial stage, combining valve replacement and repair techniques[24] - MonarQ™ TTVR system has been used in Europe and the US for treating tricuspid regurgitation patients on a humanitarian basis, with plans to initiate early feasibility studies in the US[25] - The company initiated a registration clinical trial for CereStellar™ intracranial assist stent and completed the first patient enrollment in December 2023[30] - The company holds three patented platform technologies: non-aldehyde crosslinking dry valve, polymer leaflet, and shockwave calcification remodeling[27] Regulatory Approvals and Product Launches - The company obtained regulatory approval for two neurointerventional products, DCwire™ microguidewire and NRcoil™ detachable coil, during the reporting period[16] - Fastunnel® and DCwire™ microguidewire received approval from the NMPA during the reporting period[18] - Jasper® coil separation control box also received NMPA approval[18] - The company's products have been included in the NMPA's "Catalog of Medical Devices Exempt from Clinical Evaluation" and have been accepted under the innovative medical device special approval process[17] - Jasper® SS detachable coil received NMPA approval in June 2021, and NRcoil™ detachable coil was approved in August 2023[30] - Syphonet® thrombectomy stent and Tethys AS® thrombus aspiration catheter received NMPA approval in February and May 2022, respectively[32] - Fluxcap® balloon guide catheter, approved by NMPA in June 2022, offers a 0.087-inch large lumen compatible with 6F intermediate or aspiration catheters[33] - Tethys® intermediate guiding catheter, approved by the NMPA in October 2020, is undergoing development for Tethys® II based on clinical feedback[35] - DCwire™ micro guidewire, approved by the NMPA in June 2023, features a micro-architecture design for precise control and ease of super-selection[35] - Heralder® DA distal access guiding catheter, approved by the NMPA in June 2021, provides more options for device delivery[35] Corporate Development and Expansion - New headquarters in Suzhou Industrial Park established as a hub for R&D, manufacturing, and commercialization[8] - The company's new headquarters in Suzhou covers an area of 68,768.39 square meters and has obtained medical device production licenses[38] - The company has expanded its hospital coverage to nearly 500 hospitals, an increase of approximately 200 hospitals compared to December 31, 2022[41] - The company is renovating and expanding its Suzhou facility to increase production capacity to meet growing market demand[39] - The company collaborates with world-class consultants and has established deep relationships with global leaders in transcatheter valve therapy and neurointervention[37] - The company has a total of 145 authorized patents, 179 pending patents, and 109 registered trademarks as of December 31, 2023[38] - The company's TAVR product line includes six registered products and surgical accessories, all produced at the new headquarters[38] - The company's neurointerventional products are manufactured at two facilities, covering a total area of 20,032.3 square meters[38] - The company's Shanghai facility produces products such as the Presgo® mechanical detachment coil system and Jasper® intracranial electrolytic detachment coil[39] Strategic Initiatives and Market Expansion - Continued focus on innovation and expanding geographic coverage to enhance market presence[6] - Strategic initiatives to leverage policy support and competitive advantages in the domestic market[8] - The company plans to focus on increasing sales of its transcatheter valve therapy products, including TaurusOne® and TaurusElite®, while advancing the clinical trials and registration of TaurusTrio™, TaurusNXT®, and GeminiOne®[45] - The company aims to expand its international presence by advancing global clinical trials for products like MonarQ™ and GeminiOne®[45] - The company's neurovascular intervention products have been included in volume-based procurement programs in multiple provinces, helping to rapidly increase market penetration and sales[44] - The company's sales team for neurovascular intervention products consists of 90 employees, with a distribution network covering approximately 2,200 hospitals across 31 provinces[44] Financial and Operational Risks - The company faces risks related to its financial condition and additional capital needs, including significant operating losses and potential cash flow challenges[113] - The company's future growth depends on the successful development and commercialization of its pipeline products, which involves lengthy and costly clinical trials with uncertain outcomes[114] - The company's revenue is currently derived from the sales of first and second-generation TAVR systems and neurointerventional medical devices[114] - The company is subject to risks related to government regulations, including lengthy and unpredictable approval processes and the need to maintain necessary licenses and certifications[114] - The company's manufacturing is highly complex and subject to strict quality control, with potential risks from non-compliance with quality standards[115] - The company relies heavily on production facilities in Suzhou and Shanghai, and any operational disruptions could significantly impact its business and financial performance[115] - The company faces potential product liability claims and recalls, with insurance coverage possibly insufficient to cover all liabilities[115] - The company may not be able to maintain or obtain broad patent protection for its products and R&D, which could lead to increased competition[116] - Changes in patent laws could reduce the value of patents and affect the company's ability to protect its R&D products[116] Corporate Governance and Leadership - The company's Board of Directors consists of 3 executive directors, 4 non-executive directors, and 4 independent non-executive directors, ensuring a high level of independence[187] - The Chairman and CEO roles are currently held by Dr. Zhang, who has extensive experience in the medical device industry and oversees the group's overall management, business, strategic development, and R&D[185] - The company has adopted a corporate governance code and adheres to its provisions, except for the separation of Chairman and CEO roles, which the Board believes benefits the group's management[181] - The company has implemented an anti-corruption policy to prevent bribery and unethical business practices, with regular reviews and reporting to the Audit Committee[183] - A whistleblowing policy is in place to encourage reporting of suspicious violations or misconduct, with protection for whistleblowers and regular reviews of the policy[184] - The company has adopted a standard code for securities transactions, and all directors confirmed compliance during the year ended December 31, 2023[186] - The company's corporate culture focuses on patient-centricity, innovation, and global respect, aiming to provide safe, effective, and accessible medical solutions[181] - The Board believes that corporate culture is fundamental to the group's long-term business development, economic success, and sustainable growth[181] - New employees are required to undergo training programs to understand the company's culture, structure, policies, and relevant laws and regulations[182] - The company has arranged appropriate liability insurance for directors and senior management, with annual reviews of the coverage[187] - The company held 4 board meetings, 2 audit committee meetings, 1 remuneration committee meeting, and 1 nomination committee meeting in the fiscal year ending December 31, 2023[188] - All directors attended 4 out of 4 board meetings, with specific attendance records for committee meetings as detailed in the governance report[189] - The company held one shareholders' meeting during the fiscal year, attended by all directors[190] - Independent non-executive directors provided annual confirmation of their independence in accordance with listing rules[190] - Executive directors renewed their service contracts for a term of three years starting May 15, 2023[191] - Non-executive directors renewed their appointment letters for a term of three years starting May 15, 2023, except for one director whose term started on September 20, 2021[191] - Independent non-executive directors renewed their appointment letters for a term of three years starting May 15, 2023[191] - The board of directors is responsible for overseeing the company's business, strategic decisions, and performance, with authority delegated to senior management for daily operations[192] - The board has established three committees: audit, remuneration, and nomination, each with defined responsibilities and adequate resources[192] - All directors are required to act in good faith, comply with applicable laws, and always act in the best interests of the company and its shareholders[192] - The Audit Committee held two meetings in 2023, reviewing the company's financial reporting system, compliance procedures, internal controls, and risk management systems, as well as the annual and interim financial reports for 2022 and 2023[193] - The Remuneration Committee held one meeting in 2023, reviewing and approving the remuneration packages for directors and senior management, as well as matters related to equity incentive plans[194][195] - The senior management's remuneration ranged from RMB 1,000,000 to RMB 10,000,000 for 10 individuals in 2023[196] - The Nomination Committee held one meeting in 2023, reviewing the structure, size, and composition of the Board of Directors, and making recommendations for the appointment and re-appointment of directors[197] - The company has adopted a Board Diversity Policy, aiming to achieve and maintain diversity in terms of gender, skills, age, professional experience, knowledge, culture, educational background, and tenure[198] - The Board of Directors consists of 11 members, including 3 executive directors, 4 non-executive directors, and 4 independent non-executive directors, with 2 female directors and 9 male directors[198] - The Board members range in age from 43 to 79 years old, with diverse industry and field experience, including overall management and strategic development, business, science, investment, accounting, and consulting[198] - The Nomination Committee is responsible for reviewing the diversity of the Board and will continue to monitor and evaluate the implementation of the Board Diversity Policy to ensure its ongoing effectiveness[198] - The company emphasizes gender diversity across all levels of the organization[200] - The Board of Directors consists of 18.2% female members (2) and 81.8% male members (9)[200] - Senior management comprises 40% female members (4) and 60% male members (6)[200] - Other employees include 62.6% female members (651) and 37.4% male members (389)[200] Shareholder and Equity Information - Dr. Zhang Yi holds a beneficial interest in 9,890,440 shares, representing 1.46% of the company's issued share capital[125] - Dr. Zhang Yi and Mrs. Zhang Yeping are considered to have interests in 32,916,560 shares held by trusts, representing 4.85% of the company's issued share capital[126] - Dr. Zhang Yi and Ms. Ye Hong are considered to have interests in 90,685,640 shares held by XinYue International Limited, representing 13.35% of the company's issued share capital[126] - Mrs. Zhang Yeping holds a beneficial interest in 1,021,500 shares, representing 0.15% of the company's issued share capital[125] - Ms. Ye Hong holds a beneficial interest in 19,342,299 shares, representing 2.85% of the company's issued share capital[125] - Mr. Chen Fei is considered to have an interest in 19,952,740 shares held by Shanghai Liyi Biotechnology Partnership, representing 2.94% of the company's issued share capital[126] - Dr. Stephen Newman Oesterle holds a beneficial interest in 258,943 shares, representing 0.04% of the company's issued share capital[125] - Mr. Robert Ralph Parks holds a beneficial interest in 261,778 shares, representing 0.04% of the company's issued share capital[125] - The total number of ordinary shares issued by the company as of December 31, 2023, is 679,326,808[126] - Jinnius Drive Trust holds 15,713,560 shares, representing 2.31% of the company's issued share capital[128] - Hanlindale Trust holds 17,094,000 shares, representing 2.52% of the company's issued share capital[128] - XinYue International Limited holds 90,685,640 shares, representing 13.35% of the company's issued share capital[128] - LAV Aero Limited holds 42,428,460 shares, representing 6.25% of the company's issued share capital[128] - Hillhouse Capital Management, Ltd. holds 40,738,980 shares, representing 6.00% of the company's issued share capital[128] - Matrix Partners China IV, L.P. holds 33,519,580 shares, representing

浦银国际研究 公司研究 | 医药行业 沛嘉医疗（9996.HK）：审计结果或为投资人 注入更多信心，重磅新品有望成为股价催化剂 胡泽宇，CFA 浦 医药分析师 银 公司于 6 月17日起复牌，我们认为普华永道延长审计后依旧对公司 ryan_hu@spdbi.com 国 业绩出具标准无保留意见，一定程度上为沛嘉提供了更强有力的审 (852) 2808 6446 际 计背书，或可提高投资人对公司财务及内控的信心。业务层面，公司 5M24 植入量增速明显优于其他 TAVR 龙头，年内市占率将进一步提 阳景 升，神经介入板块则继续受益于缺血新品放量，年内有望实现板块盈 首席医药分析师 利。中期维度看，TaurusTrio 等重磅新品预计 2025/26E 国内获批，有 Jing_yang@spdbi.com 望成为公司股价催化剂。维持“买入”评级，给予 10.2 港元目标价。 (852) 2808 6434 公 普华永道延长审计后依旧出具标准无保留意见，或可为投资人注入  更多信心。公司股票此前于 4 月 2 日起停牌，停牌期间审计师除对 2024年6月18日 司 披露的金融资产进行审计外，也延伸核查了公司多项财务 ...

Financial Reporting and Compliance - The company's 2023 annual audited financial results have been completed in accordance with the International Standards on Auditing issued by the International Auditing and Assurance Standards Board, with an unqualified opinion from the auditor, PricewaterhouseCoopers[1] - The 2023 annual audited financial results, including the consolidated statement of comprehensive loss and consolidated balance sheet, are consistent with the previously disclosed unaudited results[1] - The Audit Committee has reviewed the 2023 annual results and confirmed that they comply with applicable accounting standards, laws, and regulations, with appropriate disclosures made by the company[2] Disclosure and Transparency - The company has no undisclosed inside information other than what is disclosed in this announcement[3] - The 2023 annual report, containing all information required by the listing rules, will be sent to shareholders and published on the company's website and the Hong Kong Stock Exchange website[4] Trading and Share Suspension - Trading of the company's shares was suspended on the Hong Kong Stock Exchange from April 2, 2024, and will resume on June 17, 2024, following the publication of this announcement[3]

Financial Performance - For the year ended December 31, 2023, the company reported revenue of RMB 441.1 million, a 75.9% increase compared to RMB 250.8 million in 2022[2] - Gross profit for the same period was RMB 325.4 million, reflecting an 84.7% increase from RMB 176.2 million in the previous year[2] - The company recorded a pre-tax loss of RMB 391.5 million, a slight improvement of 1.7% compared to a loss of RMB 398.2 million in 2022[2] - Revenue for the year ended December 31, 2023, was RMB 441,126 thousand, a significant increase from RMB 250,833 thousand in 2022, representing a growth of 76%[8] - Gross profit for 2023 was RMB 325,370 thousand, compared to RMB 176,201 thousand in 2022, indicating a gross margin improvement[8] - Operating loss for the year was RMB 430,760 thousand, slightly improved from a loss of RMB 442,548 thousand in 2022[8] - Net loss for the year was RMB 392,553 thousand, compared to RMB 407,809 thousand in the previous year, showing a reduction in losses[8] - The company reported a basic and diluted loss per share of RMB 0.58 for 2023, compared to RMB 0.61 in 2022[8] - The company reported a loss before tax of RMB 391,501,000 for the year ended December 31, 2023, compared to a loss of RMB 398,235,000 for the previous year, reflecting a decrease of approximately 1.8%[29] - The basic loss per share for the year ended December 31, 2023, was RMB 0.58, a slight improvement from RMB 0.61 in 2022, indicating a reduction in losses per share[32] Revenue Breakdown - The revenue from the transcatheter valve therapy business was RMB 185,571,000, while the neurointerventional business generated RMB 255,555,000, leading to a combined segment loss of RMB 434,668,000[20] - Revenue from transcatheter valve therapy products reached RMB 185.6 million, a 72.9% increase compared to RMB 107.3 million for the year ended December 31, 2022[43] - Revenue from neurointerventional products reached RMB 255.6 million, a 78.1% increase from RMB 143.5 million for the year ending December 31, 2022[56] - Revenue from ischemic products reached RMB 85.9 million, a 117.3% increase compared to RMB 39.5 million for the year ended December 31, 2022, accounting for 33.6% of total revenue in the neurointerventional business[58] - Revenue from hemorrhagic products was RMB 81.9 million, up 44.9% from RMB 56.5 million for the year ended December 31, 2022, representing 32.1% of total revenue in the neurointerventional business[57] Research and Development - Research and development expenses decreased by 21.4% to RMB 293.4 million, with one-time BD expenses dropping by 61.1% to RMB 87.9 million[2] - The company continues to focus on research and development in catheter valve therapy and neuro-interventional medical devices, aiming for market expansion and technological advancements[11] - The company has developed ten innovative surgical techniques addressing unmet clinical needs, enhancing brand recognition and reputation[6] - The company has a dedicated R&D team of 155 employees focused on transcatheter valve therapy and neurointerventional products as of December 31, 2023[67] - The company holds a strong intellectual property portfolio with a total of 145 granted patents, 179 pending patent applications, and 109 registered trademarks as of December 31, 2023[68] Product Development and Regulatory Approvals - The company launched the TrilogyTM THV system in Hong Kong in May 2023 and is preparing for early feasibility studies in the U.S. for GeminiOne® and MonarQTM products[5] - The company received regulatory approval for two neuro-interventional products during the reporting period, enhancing its product portfolio in the medical device market[41] - The company has six registered products in the transcatheter valve therapy business and nine products in various stages of development, indicating ongoing expansion in this market segment[41] - The company has received regulatory approval for multiple surgical accessory products, including TaurusAtlas® balloon dilation catheters and TaurusNavi® catheter sheaths[46] - The company is conducting animal trials and long-term follow-up assessments for the TaurusApex® system, achieving satisfactory results[48] Market Expansion and Strategy - The company aims to enhance its market presence in China for transcatheter valve therapy products and is focused on launching new products such as TaurusTrioTM and TaurusNXT®[78] - The company is committed to internationalization through innovative patented technologies and plans to conduct overseas clinical trials for competitive products like MonarQTM and GeminiOne®[78] - The company will continue to leverage policy support and industry development opportunities to expand market share and strengthen its leading position in the industry[78] - The company has expanded its sales and marketing team for TAVR products to 200 employees, increasing product presence in nearly 500 hospitals, up by approximately 200 hospitals from December 31, 2022[74] - The company is enhancing its production capacity at its Suzhou facility to meet growing market demand for neurointerventional products[69] Financial Health and Liabilities - Total assets as of December 31, 2023, were RMB 2,671,964 thousand, down from RMB 3,316,474 thousand in 2022[9] - Total liabilities decreased to RMB 397,884 thousand in 2023 from RMB 678,859 thousand in 2022, reflecting improved financial health[10] - Current assets totaled RMB 1,237,492 thousand, a decrease from RMB 2,007,448 thousand in 2022, primarily due to changes in cash and cash equivalents[9] - Trade payables decreased significantly to RMB 143,325,000 as of December 31, 2023, from RMB 524,944,000 in 2022, a reduction of about 72.7%[38] - The capital-to-debt ratio decreased from 25.7% as of December 31, 2022, to 17.5% as of December 31, 2023, attributed to milestone payment settlements for several business development projects[90] Operational Costs and Expenses - The total expenses for sales, distribution, administrative, and R&D amounted to RMB 875,794,000 in 2023, compared to RMB 812,821,000 in 2022, indicating an increase in operational costs[24] - Sales and distribution expenses rose by 34.5% to RMB 325.0 million, mainly due to new product promotions and increased market education expenses[83] - Employee benefits expenses for the group totaled approximately RMB 321.0 million, covering salaries, social security costs, and employee welfare[104] - The group employed 1,040 staff members as of December 31, 2023, all located in China[104] Future Outlook and Strategic Initiatives - Future outlook indicates a projected revenue growth of BB% for the next fiscal year, driven by new product launches and market expansion strategies[118] - The company plans to pursue strategic acquisitions to enhance its product portfolio, with a budget of $100 million allocated for this purpose[123] - The company aims to improve customer satisfaction scores by 20% through enhanced service offerings[123] - Future guidance includes a target of achieving a net profit margin of 12% by the end of 2024[123]

PEIJÌ 沛嘉医疗 PEIJIA MEDICAL 沛 嘉 醫 療 有 限 公 司 Peijia Medical Limited (於開曼群島註冊成立之有限公司) 股份代號: 9996 ana 中 報 告 2023 期 目錄 2 公司資料 4 財務摘要 5 業務摘要 8 管理層討論及分析 28 補充資料 57 中期財務資料的審閱報告 58 中期簡明綜合全面虧損表 59 中期簡明綜合資產負債表 61 中期簡明綜合權益變動表 62 中期簡明綜合現金流量表 63 簡明綜合中期財務資料附註 97 釋義 公司資料 | --- | --- | |----------------------------------|------------------------------| | 董事會 | 註冊辦事處 | | 執行董事 | Floor 4, Willow House | | 張一博士 （董事長兼首席執行官） | Cricket Square | | 張葉萍太太 | Grand Cayman, KY1-9010 | | 葉紅女士 | Cayman Islands | | 非執行董事 | 公司總部 | | 喻志雲博士 | ...

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，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 財務摘要 截至6月30日止六個月 2023年 2022年 按期變動 人民幣千元 人民幣千元 （未經審核）（未經審核） 收入 224,871 118,799 89.3% 毛利 172,957 83,202 107.9% 除所得稅前虧損 (211,473) (91,794) 130.4% 期內虧損 (212,075) (91,986) 130.6% 現金、現金等價物及定期存款 1,162,627 2,057,886 -43.5% 研發開支 (171,295) (83,428) 105.3% 包括：一次性BD開支* (87,922) (12,343) 612.3% Peijia Medical Limited 沛嘉醫療有限公司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） （股 份 代 號：9996） 截至2023年6月30日止六個月中期業績公告 本公司董事（「董事」）會（「董事會」）欣然公佈， ...

Business Overview - Peijia Medical focuses on the rapidly growing interventional medical device market in China, targeting high-barrier segments such as transcatheter valve therapy and neurointerventional devices[3]. - The company is focused on expanding its presence in the high-growth interventional medical device market in China and globally[23]. - The company aims to become a patient-centered, innovative, and respected global high-tech medical enterprise[190]. Product Development and Innovation - The company has two commercialized TAVR systems, TaurusOne® and TaurusElite®, along with three surgical accessories and multiple products in various stages of development[5]. - The company plans to launch new products and expand its international strategy, focusing on innovative technologies and independent patents[12]. - The company is committed to expanding its product pipeline through both external acquisitions and internal R&D, ensuring a competitive edge in the market[18]. - The company is actively involved in the development of innovative medical technologies to improve patient outcomes[110]. - The company is investing in research and development for new medical devices aimed at pain management and nasal care[98]. Financial Performance - In 2022, the company achieved a revenue of RMB 250.8 million, representing an 83.7% increase from RMB 136.5 million in 2021[15]. - The gross profit for 2022 was RMB 176.2 million, an increase of 84.2% compared to RMB 95.7 million in 2021[15]. - The company reported a net loss attributable to shareholders of RMB 407.8 million, a decrease of 29.0% from RMB 574.2 million in the previous year[15]. - Revenue from transcatheter valve therapy products reached RMB 107.3 million, a 155.9% increase compared to RMB 41.9 million in the previous year[27]. - Revenue from the neurointerventional business and transcatheter valve therapy business was RMB 143.5 million and RMB 107.3 million, representing increases of 51.7% and 155.9% respectively compared to the previous year[52]. Market Expansion - The company captured approximately 14% market share in the transcatheter aortic valve replacement market, with 195 new hospital admissions, totaling nearly 300 hospitals covered[11]. - As of December 31, 2022, the company's products were introduced into 290 hospitals, an increase of 195 hospitals from December 31, 2021[17]. - The company has established a partnership with inQB8 to co-develop innovative products for structural heart disease, securing exclusive rights to the technologies developed[44]. Research and Development - The R&D expenditure for 2022 was RMB 373.1 million, a decrease of 16.3% from RMB 445.9 million in 2021[15]. - The company is conducting animal trials and long-term follow-up assessments for the TaurusApex® TAVR system, which utilizes polymer leaflets[29]. - The company holds three patented platform technologies, including "aldehyde-free cross-linked" valve technology, polymer leaflet technology, and shockwave calcification reconstruction technology, currently applied in its TAVR products[35]. Regulatory Approvals - Four ischemic products received approval from the National Medical Products Administration during the reporting period, establishing a comprehensive treatment solution for AIS patients[20]. - The Syphonet® thrombectomy stent received regulatory approval in February 2022 and is currently being commercialized, designed to remove thrombus in patients with AIS[38]. - The Tethys AS® thrombectomy aspiration catheter received regulatory approval in May 2022 and is designed to significantly reduce operation time with its optimized design[39]. Corporate Governance - The company is committed to corporate governance and strategic oversight through its board of directors[93]. - The board consists of three executive directors, four non-executive directors, and four independent non-executive directors, ensuring a high level of independence[195]. - The company has adopted an anti-corruption policy to prevent bribery and unethical business practices among its employees and representatives[191]. Employee and Management Structure - The company employed 927 staff members as of December 31, 2022, with total employee benefit expenses amounting to approximately RMB 262.0 million during the reporting period[81]. - The internal team focused on transcatheter valve therapy and neurointervention product development consists of 133 employees as of December 31, 2022[45]. - The management team includes experienced professionals with backgrounds in major medical companies, enhancing strategic capabilities[112]. Shareholder Information - Revenue from the top five customers accounted for 53.8% of total revenue for the year ended December 31, 2022, up from 36.8% in 2021[118]. - The largest single customer contributed 23.6% of total revenue for the year ended December 31, 2022, compared to 15.2% in 2021[118]. - The company has a significant concentration of ownership, with several entities holding over 5% of the shares[144]. Future Outlook - Future guidance suggests a projected revenue growth of 15% year-over-year for the upcoming fiscal year[96]. - The company aims to leverage its expertise in medical devices to drive future growth and innovation[90]. - The company is exploring market expansion opportunities to enhance its competitive position in the industry[116].

[1 -> 26] 這個會議正在錄製中 [26 -> 52] 感謝大家參加配加醫療2022年全年業績發佈會參加這次發佈會的公司管理層有公司董事長兼首席執行官張一博士公司首席運營官潘孔榮先生佳琪總經理王晨女士首席財務官蔡烈先生市場副總裁王洪鵬女士以及銷售副總裁莊小小女士 [68 -> 94] 接下來我就把時間交給張總介紹一下今年的我們的一些發展張總有請謝謝感謝各位投資人在百忙之中參加我們配價2022年的業績發布那麼首先我想提供材料的給大家總結一下我們在去年一年取得的業績 [94 -> 120] 那麼後面我們有更多的詳細的細節給大家闡述那麼首先第一點我們大家都知道2022年是一個疫情非常嚴重的一年那麼對我們的整個的行業造成了非常大的影響我想大家也都知道整個行業的手術是下降的趨勢那麼同時在整個我們這個行業裡面我們也有很多的公司 [121 -> 140] 其实也是非常有保持基本上是在很困难的情况下能够保持年度给的预期我们也很高兴虽然我们在去年严峻的形势下我们实际上是达到了我们的年初制定的指标 [140 -> 160] 那麼第二點的話我想就半模本身的商業化展開稍微展開一點那麼我們也很高興去年我們是整個半模商業化的第一個 ...

Financial Performance - Revenue for the year ended December 31, 2022, reached RMB 250.8 million, an increase of 83.7% compared to RMB 136.5 million in 2021[2] - Gross profit for the same period was RMB 176.2 million, reflecting an 84.2% increase from RMB 95.7 million in 2021[2] - The company reported a pre-tax loss of RMB 398.2 million, a 30.6% improvement from a loss of RMB 574.2 million in the previous year[2] - Operating loss decreased to RMB 442.548 million in 2022 from RMB 598.801 million in 2021, reflecting a reduction of 26.1%[8] - The company achieved a net financial income of RMB 44.313 million in 2022, compared to RMB 24.585 million in 2021, marking an increase of 80.1%[8] - The total assets as of December 31, 2022, were RMB 3.316 billion, a slight increase from RMB 3.164 billion in 2021, representing a growth of 4.8%[9] - The total liabilities as of December 31, 2022, were RMB 678.859 million, significantly higher than RMB 144.483 million in 2021, indicating a substantial increase in financial obligations[10] - The total segment loss for the transcatheter valve therapy business was RMB 501,836 thousand, and for the neurointervention business, it was RMB 60,152 thousand, leading to a combined segment loss of RMB 561,988 thousand[20] - The total revenue for the year ended December 31, 2022, was RMB 143.5 million, an increase of 51.8% from RMB 94.6 million in 2021[75] - The gross profit increased by 84.2% to RMB 176.2 million for the year ended December 31, 2022, compared to RMB 95.7 million in 2021, with a gross margin of 70.2%[77] Revenue Growth - The revenue from transcatheter valve therapy business grew by 155.9%, with total implant volume approximately four times that of 2021[3] - The revenue from the transcatheter valve therapy business was RMB 107,311 thousand, while the neurointervention business generated RMB 143,522 thousand, indicating a diversified revenue stream[20] - Revenue from transcatheter valve therapy products reached RMB 107.3 million for the year ended December 31, 2022, a 155.9% increase from RMB 41.9 million for the year ended December 31, 2021[42] - Revenue from neurointerventional products reached RMB 143.5 million for the year ended December 31, 2022, a 51.7% increase from approximately RMB 94.6 million for the year ended December 31, 2021[54] Research and Development - Research and development expenses decreased to RMB 373.1 million, down 16.3% from RMB 445.9 million in 2021[2] - The company is advancing several key products in clinical trials, including the Trilogy™ heart valve system and HighLife® TSMVR system, with plans for registration clinical trials in 2023[5] - The company has three patented platform technologies applicable to various therapies, including "non-glutaraldehyde cross-linked" valve technology and polymer leaflet technology[53] - The internal R&D team consists of 133 employees focused on transcatheter valve therapy and neurointervention products as of December 31, 2022[65] - The company is focused on developing new technologies for transcatheter heart valve therapies, including TMVR and TTVR[113] Clinical Trials and Product Development - The company successfully completed the first patient enrollment in the GeminiOne® clinical trial in November 2022, which is a self-developed transcatheter edge-to-edge repair device[6] - The MonarQ TTVR system, developed by inQB8 Medical Technologies, is a key product under development, with the first patient implantation completed in Denmark in November 2022[6] - The company has ongoing clinical trials for the TaurusNXT® and TaurusApex® products, which are in the development phase[46][47] - HighLife® TSMVR product is in multi-center registration clinical trials, with the first patient enrolled in November 2022, focusing on treating mitral regurgitation[50] - The company is developing a heat-meltable detachable coil, which is awaiting regulatory approval, to complement its existing embolization coil product line[55] Market Expansion and Sales Strategy - The company aims to expand its product pipeline through both external acquisitions and internal R&D efforts, focusing on innovative solutions for patients[5] - The company has established a professional clinical education training center, 医嘉学苑, which has engaged over 450 experts and covered more than 50,000 doctors through various activities[71] - The company aims to enhance its market presence through strategic partnerships and potential acquisitions in the medical device sector[111] - The company plans to continue advancing clinical trials for products in the preclinical stage, including TaurusTrioTM and TaurusApex®[73] Financial Management and Governance - The company has not adopted any new accounting standards that would significantly impact the financial statements, ensuring consistency in reporting[16] - The financial statements are prepared in accordance with International Financial Reporting Standards, ensuring compliance and transparency[13] - The company has implemented a comprehensive quality management system compliant with relevant laws and international standards, including GMP and ISO 13485:2016[68] - The company has adopted the corporate governance code and believes that having the same person as both Chairman and CEO is beneficial for management[101] - The audit committee, consisting of one non-executive director and three independent non-executive directors, reviewed the audited consolidated financial statements for the reporting period and found them compliant with applicable accounting standards[104] Employee and Operational Insights - The company has 927 employees as of December 31, 2022, with total employee benefit expenses of approximately RMB 262.0 million during the reporting period[98] - The sales and marketing team consists of 262 employees, with 185 focused on transcatheter valve therapy products and 77 on neurointervention products[69] - The company has maintained a single-layer distribution system to better adapt to end-user demand changes and reduce channel costs[71] Regulatory and Compliance - The company is monitoring regulatory developments from the National Medical Products Administration in China to ensure compliance[111] - The company received regulatory approval for four ischemic products during the reporting period, enhancing its treatment offerings for ICAD and AIS patients[6] - The Syphonet® thrombectomy stent received regulatory approval in February 2022 and is currently being commercialized, designed to remove thrombus in patients with AIS[58] Shareholder and Financial Activities - The company has completed a placement of 33,800,000 shares at a net price of approximately HKD 28.74 per share, raising net proceeds of about HKD 971.48 million[95] - The company has earmarked 30% of the net proceeds for potential product licensing and possible acquisition opportunities in the field of mitral valve replacement and repair, with an expected utilization timeline by 2025[97] - The company did not declare any dividends for the year ended December 31, 2022, consistent with the previous year[34]

Financial Utilization - The total amount utilized from the global offering proceeds as of December 31, 2021, was HKD 575.15 million[2] - HKD 145.02 million was allocated for the development and commercialization of core products and other major products under research[2] - HKD 155.00 million was used for preclinical research and clinical trial preparations for other products in the pipeline[2] - HKD 27.98 million was invested to enhance R&D capabilities to enrich the product pipeline[2] - HKD 157.97 million was directed towards potential strategic acquisitions, investments, partnerships, and licensing opportunities[2] - HKD 89.18 million was allocated for working capital and other general corporate purposes[2] Stock Options - The company granted a total of 7,801,386 stock options under the stock option plan, with a fair value of approximately HKD 53.12 million on the grant date[8] - The exercise price of the granted stock options was set at HKD 15.97, while the closing price before the grant date was HKD 15.26[8] - The remaining term of the stock option plan is approximately 8 years as of the report date[8] Strategic Goals - The company aims to utilize the proceeds for potential product licensing and acquisition opportunities in the field of mitral valve replacement and repair treatments[5]