(於開曼群島註冊成立之有限公司) 股份代號: 9996 年 報 2024 2024 ANNUAL REPORT Annual Report 2024 年報 目錄 | 2 | 公司簡介 | | --- | --- | | 3 | 公司資料 | | 5 | 董事長致辭 | | 8 | 財務摘要 | | 9 | 業務摘要 | | 14 | 管理層討論及分析 | | 38 | 董事及高級管理層 | | 53 | 董事報告 | | 87 | 企業管治報告 | | 107 | 環境、社會及管治報告 | | 158 | 獨立核數師報告 | | 164 | 綜合損益及其他全面收益表 | | 165 | 綜合財務狀況表 | | 167 | 綜合權益變動表 | | 168 | 綜合現金流量表 | | 170 | 綜合財務報表附註 | | 245 | 財務概要 | | 246 | 釋義 | 公司簡介 概況 本公司是全球醫療創新產品及解決方案提供商。我們專注於中國高增長的介入手術醫療器械市場。我們的產 品及在研產品針對規模龐大、快速增長而滲透不足，且准入壁壘高的市場，包括經導管瓣膜治療醫療器械市 場及神經介入手術醫療器械市場。 我們 ...

Investment Rating - The investment rating for the company is "Buy" with a target price of 6.88 HKD [8][9]. Core Views - The company is expected to achieve a revenue of 615 million RMB in 2024, representing a year-on-year growth of 39.5%, with a significant reduction in net loss to 228 million RMB [1]. - The TAVR segment is projected to see a revenue increase of 40% year-on-year in 2024, driven by an increase in market share and product iterations [2]. - The neurointervention segment is also expected to grow by 39% year-on-year in 2024, benefiting from new product launches and import substitution opportunities [3]. - Long-term growth is anticipated from the TAVR pipeline, with new products expected to launch from late 2025 [4]. - The company is projected to achieve revenues of 818 million RMB, 1.066 billion RMB, and 1.540 billion RMB in 2025, 2026, and 2027 respectively, with a net loss of 83 million RMB in 2025 turning to a profit of 10 million RMB in 2026 [5][20]. Summary by Sections TAVR Segment - The TAVR segment is expected to generate 260 million RMB in revenue in 2024, with a 40% year-on-year growth, and a market share increase to 25% [2]. - The company plans to expand its market presence by increasing hospital partnerships and launching new products [2]. Neurointervention Segment - The neurointervention segment is projected to achieve 356 million RMB in revenue in 2024, with a 39% year-on-year growth, driven by new product launches and import substitution [3]. - The segment is expected to benefit from regional procurement policies and the introduction of new products [3]. TMV/TTV Pipeline - The TMV/TTV pipeline is progressing well, with potential sales exceeding 2 billion RMB by 2033, supported by ongoing clinical trials and product registrations [4]. Profit Forecast and Valuation - The company is expected to achieve revenues of 818 million RMB in 2025, with a net loss of 83 million RMB, improving to a profit of 10 million RMB in 2026 [5][20]. - A DCF valuation method estimates the target price at 6.88 HKD, reflecting the long-term growth potential of the company's pipeline [5][13].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 7.5 HKD, indicating that the current market price does not reflect the company's true value [1][4]. Core Insights - The company is expected to steadily reduce losses in 2024, with the neurointervention segment achieving its first annual profit. Revenue for 2024 is projected at 615 million RMB, a 40% year-over-year increase, with a gross margin of 70.5% [2][4]. - The cardiac valve segment is anticipated to generate 260 million RMB in revenue for 2024, also reflecting a 40% year-over-year growth, while the neurointervention segment is expected to reach 356 million RMB, marking a 39% increase [2][3]. - The report highlights that the market is closely monitoring the impact of centralized procurement, particularly in the neurointervention field, where risks are nearing resolution. In the cardiac valve sector, the slowdown in implant volume growth may not necessarily be negative due to potential price adjustments post-procurement [3][4]. Financial Performance Summary - Revenue projections for the company are as follows: 441 million RMB in 2023, 615 million RMB in 2024, 821 million RMB in 2025, 781 million RMB in 2026, and 1,024 million RMB in 2027, with year-over-year growth rates of 75.9%, 39.5%, 33.4%, -4.9%, and 31.2% respectively [5][12]. - The company is expected to narrow its net loss from 393 million RMB in 2023 to 228 million RMB in 2024, with further reductions anticipated in subsequent years [5][12]. - The report provides a detailed breakdown of revenue by segment, with cardiac valves and neurointervention contributing significantly to the overall growth [2][12]. Product Pipeline and Market Strategy - The company has separated three advanced products from its transcatheter valve business to prepare for independent financing and international expansion. These products are aimed at the European and American markets [4][14]. - The DCWire microguidewire is currently undergoing FDA registration and is expected to be the company's first original product to enter the international market [4][14]. - The report outlines the expected approval timelines for various products, including the TaurusNXT and TaurusTrio, which are anticipated to receive approval between late 2025 and mid-2026 [4][14].

Core Viewpoint - The article highlights the significant achievements of Peijia Medical in the context of ongoing medical reform and centralized procurement policies, emphasizing the company's ability to emerge as a leader through strategic positioning and innovation [1][11]. Financial Performance - In 2024, Peijia Medical reported total revenue of 615 million yuan, a year-on-year increase of 39.5%, with a compound annual growth rate (CAGR) exceeding 55% from 2022 to 2024 [3]. - The sales revenue from transcatheter aortic valve replacement (TAVR) products grew by 40.1% to 260 million yuan, contributing 42.2% to total revenue, while the neurointervention segment saw a 39.1% increase to 356 million yuan, accounting for 57.8% of total revenue [3]. - The company achieved a gross profit of 434 million yuan, a 33.3% increase, with an overall gross margin of 70.5% [4]. Cost Management - Peijia Medical successfully reduced its three expense ratios in 2024, with sales expense ratio down by 20.3 percentage points to 53.3%, R&D expense ratio down by 33.4 percentage points to 33.1%, and management expense ratio down by 7.6 percentage points to 24.5% [4]. Market Position and Growth - The company’s TAVR implant volume exceeded 3,400 units in 2024, representing a 37% year-on-year growth, with a market share increase to approximately 25% [6]. - Peijia Medical's neurointervention business achieved its first annual profit, with significant growth in hemorrhagic and ischemic product lines, including a 52.3% increase in vascular access products [8]. Product Development - The company expanded its TAVR product lineup with the approval of the TaurusMax device, bringing the total to three commercialized products [7]. - Peijia Medical is advancing its pipeline with several products expected to receive regulatory approval between late 2025 and mid-2026, including TaurusNXT and TaurusTrio [12]. Industry Outlook - The Chinese TAVR market is projected to reach 11.36 billion yuan by 2030, with a CAGR of 32.4% from 2021 to 2030, indicating significant growth potential [11]. - The ongoing centralized procurement policies are seen as a double-edged sword, providing opportunities for domestic players while also posing challenges for transformation and upgrading [11]. Strategic Initiatives - Peijia Medical is implementing a strategic restructuring of its R&D framework to enhance innovation and efficiency, focusing on unmet clinical needs [13]. - The company is also exploring external technology collaborations to bolster its product offerings and market presence [12]. Valuation Perspective - Current market valuations of Peijia Medical are perceived as undervalued compared to its intrinsic value, with analysts suggesting a target price of 5.57 HKD per share based on future growth potential [14].

Financial Performance - The company's revenue for the year ended December 31, 2024, was RMB 615.5 million, representing a 39.5% increase compared to RMB 441.1 million in 2023[4] - Gross profit increased by 33.3% to RMB 433.6 million, up from RMB 325.4 million in the previous year[4] - The company reported a net loss of RMB 228.5 million, a significant decrease of 41.8% compared to 2023, with the neuro-intervention business generating a segment profit of RMB 52.1 million[14] - The company reported a segment loss of RMB 249,239,000 for the year ended December 31, 2024, compared to a loss of RMB 434,668,000 in 2023, indicating an improvement in performance[35] - The company reported a basic loss per share of RMB 0.34 for the year ended December 31, 2024, compared to RMB 0.58 in 2023, showing a reduction in loss per share[45] Expenses and Cost Management - Sales and distribution expenses rose slightly by 1.0% to RMB 328.3 million, while administrative expenses increased by 6.7% to RMB 151.1 million[4] - Research and development expenses decreased by 30.7% to RMB 203.4 million, down from RMB 293.4 million in 2023[4] - The total cost of sales, selling and distribution expenses, administrative expenses, and research and development expenses amounted to RMB 864,722,000 in 2024, slightly down from RMB 875,794,000 in 2023[38] - The gross margin remained stable at 70.5%, despite ongoing impacts from volume-based procurement in the neuro-intervention business[14] Product Development and Innovation - The new generation TAVR product TaurusMaxTM received regulatory approval, enhancing product performance and operational efficiency[8] - The company achieved significant breakthroughs in developing mitral and tricuspid regurgitation treatment solutions, alongside advancements in the Taurus series TAVR products[16] - The MonarQ TTVR® system received FDA IDE approval for early feasibility studies, with patient enrollment preparations underway[17] - The company has established a frontier technology business focused on developing innovative treatment solutions for various heart valve diseases, with three products currently in development: Shockwave Calcification Restructuring System, MonarQ TTVR® System, and ReachTactile™ Robot-Assisted TAVR System[77] Market Performance and Sales - The TAVR-related product sales revenue increased by 40.1% to RMB 259.9 million, driven by an expanded market share in China, reaching approximately 25%[5] - Neurointerventional product sales revenue grew by 39.1% to RMB 355.5 million, supported by increased surgical penetration and successful bids in volume procurement[6] - Revenue from transcatheter valve therapy products reached RMB 259.9 million, an increase of 40.1% compared to RMB 185.6 million for the year ended December 31, 2023[58] - Revenue from neurointerventional products reached RMB 355.5 million, a 39.1% increase compared to approximately RMB 255.6 million for the year ending December 2023[84] Assets and Liabilities - Total non-current assets increased to RMB 1,701,708 thousand in 2024 from RMB 1,434,472 thousand in 2023, representing a growth of approximately 18.6%[23] - Current assets decreased to RMB 986,996 thousand in 2024 from RMB 1,237,492 thousand in 2023, a decline of about 20.2%[23] - Current liabilities rose significantly to RMB 442,697 thousand in 2024 from RMB 154,249 thousand in 2023, an increase of approximately 187.5%[23] - Net assets decreased to RMB 2,044,599 thousand in 2024 from RMB 2,274,080 thousand in 2023, reflecting a decline of about 10.1%[24] Research and Development Focus - The company plans to expand its research and development activities in the catheter valve treatment product lines, indicating a strategic focus on innovation and market growth[31] - The R&D expense ratio decreased from 66.5% to 33.1%, a drop of 33.4 percentage points, due to revenue growth and products entering lower R&D spending phases[15] - The company is actively developing next-generation products based on clinical feedback to optimize current product performance[94] Strategic Partnerships and Collaborations - The company established a partnership with Jiangsu Nuanyang Medical Devices Co., Ltd. for exclusive distribution rights of the YonFlow® device in Greater China[10] - Collaboration with Sutra enhances the company's R&D capabilities in North America, with a focus on innovative medical device development[96] - Partnership with inQB8 allows the company to have exclusive rights to innovative products for structural heart disease treatment on a global scale[97] Corporate Governance and Compliance - The company emphasizes the importance of good corporate governance and has adopted relevant codes to enhance management and protect shareholder interests[144] - The audit committee has reviewed the consolidated financial statements for the reporting period and confirmed compliance with applicable accounting standards[148] Future Outlook and Growth Strategies - The company aims to become the leading TAVR brand in China and is focused on increasing sales of its existing products, including TaurusOne®, TaurusElite®, and TaurusMaxTM[108] - The company plans to accelerate the registration and follow-up of its in-development products, including TaurusTrioTM and TaurusNXT®, to address unmet clinical needs[109] - Future outlook indicates a projected revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion strategies[156]

Core Viewpoint - Peijia Medical-B (09996) has seen a significant stock increase of over 11%, with an expected annual revenue growth of approximately 40% for the upcoming fiscal year [1] Financial Performance - The company anticipates revenue for the fiscal year 2024 to be between 610 million to 630 million, representing a year-on-year growth of approximately 38.3% to 42.8% [1] - The growth is primarily driven by the rapid expansion of the company's entire neuro-interventional product line and an increase in market share in the transcatheter aortic valve replacement (TAVR) sector in China [1] Market Position and Strategy - According to research from CICC, Peijia Medical's diverse product matrix is expected to help the company adapt to future competitive landscape changes, allowing it to maintain its leading position in the valve market [1] - Huatai Securities noted that the company is seizing industry opportunities to solidify its TAVR market share, with new TAVR/TMV products expected to be approved for commercialization by 2025 [1] - The company is also expected to improve operational efficiency, with a potential for profitability by 2026, maintaining a "buy" rating [1]

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 301,203 thousand, representing a 33.9% increase compared to RMB 224,871 thousand for the same period in 2023[8]. - Gross profit for the same period was RMB 218,865 thousand, up 26.5% from RMB 172,957 thousand year-on-year[8]. - The loss before income tax decreased by 67.6% to RMB 68,479 thousand from RMB 211,473 thousand in the previous year[8]. - The operating loss decreased to RMB 84,774 thousand for the six months ended June 30, 2024, compared to RMB 233,307 thousand for the same period in 2023, showing a significant reduction in losses[127]. - The group reported a total loss of RMB 95,809,000 for the six months ended June 30, 2024, compared to a loss of RMB 232,814,000 in the same period of 2023, showing a significant reduction in losses[138]. - The net current assets as of June 30, 2024, were RMB 1,048.3 million, down from RMB 1,083.2 million as of December 31, 2023[56]. - The company reported a net cash outflow from operating activities of RMB 41,387 thousand for the six months ended June 30, 2024, significantly improved from RMB 470,320 thousand for the same period in 2023[133]. Market Expansion and Product Development - The number of TAVR product implants reached nearly 1,750 units, with a year-on-year growth rate of approximately 40%, capturing nearly 25% market share in the Chinese TAVR market[10]. - The company expanded its hospital coverage to over 580 hospitals, with products launched in nearly 100 new hospitals during the reporting period[10]. - The company is focused on expanding its market presence in the high-growth interventional medical device market in China and globally[14]. - The company has developed thirteen innovative surgical techniques addressing unmet clinical needs in complex cases related to aneurysm embolization and intracranial atherosclerosis[12]. - The company is conducting animal trials and long-term follow-up assessments for TaurusApex®, the fourth-generation TAVR system, which aims to enhance valve durability and biocompatibility[22]. - The company has registered sixteen products in the neurointervention business and has ten products in various stages of development[15]. Research and Development - Research and development expenses decreased by 41.3% to RMB 100,484 thousand from RMB 171,295 thousand in the previous year[8]. - The core R&D team has a multidisciplinary background in medical technology and engineering, contributing to innovative product development in structural heart disease treatments[35]. - The company has established close collaborations with world-class consultants to enhance its R&D capabilities and product promotion[36]. - The company aims to enhance its R&D capabilities, allocating 8% of the proceeds (approximately HKD 207.04 million) for this purpose[121]. Regulatory Approvals and Clinical Trials - The company completed patient enrollment for multiple core registration clinical trials, with new products receiving regulatory approval[11]. - TaurusOne® received regulatory approval in April 2021 and was commercialized in May 2021, marking it as the first domestically developed TAVR product with clinical data published in an international journal[19]. - TaurusElite® was approved by the National Medical Products Administration in June 2021 and commercialized in July 2021, becoming the fastest approved domestic recyclable TAVR product in the industry[20]. - HighLife® TSMVR system has received FDA investigational device exemption (IDE) approval to initiate pivotal trials in the U.S. as of June 3, 2024[24]. - The GeminiOne® edge-to-edge repair system is currently undergoing multi-center registration clinical trials in China, with plans for early feasibility studies in the U.S.[25]. Financial Position and Investments - The total assets of the company were RMB 2,613,974 thousand, down from RMB 2,671,964 thousand as of December 31, 2023[128]. - The total equity amounted to RMB 2,181,253 thousand, a decrease of 4.1% from RMB 2,274,080 thousand as of December 31, 2023[129]. - The company has long-term borrowings of RMB 248.4 million as of June 30, 2024, up from RMB 217.4 million as of December 31, 2023[57]. - The fair value of the group's investment in inQB8, a medical device incubator, is RMB 163.9 million, representing 6.3% of total assets as of June 30, 2024[60]. - The company has extended the lock-up period for its investment in a private fund until December 31, 2024, with an expected fixed annual return of 6.191%[175]. Shareholder and Governance Matters - The audit committee, which includes one non-executive director and three independent non-executive directors, reviewed the unaudited interim financial statements and found them compliant with applicable accounting standards and regulations[68]. - The company has established an audit committee in accordance with listing rules, ensuring proper governance and oversight of financial reporting[68]. - The company’s board of directors has not undergone any changes that require disclosure since the last annual report[69]. - The company has no significant contingent liabilities as of June 30, 2024[61]. Employee Compensation and Stock Options - The company has a stock option plan approved on December 27, 2019[82]. - The stock option plan allows the company to grant options to a maximum of 2,911,989 shares, which can be adjusted to 58,239,780 shares after capitalization, representing approximately 12.7% of the total issued share capital before the global offering[83]. - The total number of unexercised stock options granted as of January 1, 2024, is 33,166,381 shares[89]. - The company has established a trust agreement with a trustee to manage the stock option plan and hold shares granted under the plan[87]. - The total number of restricted share units granted to employees (excluding directors) is 7,000,000, with a fair value of HKD 24.4 per share[102]. Risks and Challenges - The company acknowledges the technical challenges in the TMVR field, including risks associated with anchoring and paravalvular leaks[24]. - A comprehensive risk management control program has been established to ensure compliance with quality control systems throughout the product lifecycle[39]. - The quality management system complies with relevant laws and international standards, including GMP standards and ISO 13485:2016 for medical device quality management systems[39].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 7.50, indicating a potential upside of 156% from the current price of HKD 2.93 [2][3]. Core Insights - The company's value is considered undervalued by the market, primarily due to concerns over the TAVI (Transcatheter Aortic Valve Implantation) business and the impact of being removed from the Hong Kong Stock Connect list. The report suggests that these concerns have already been reflected in the stock price decline [3]. - The report highlights that the market is overly focused on the TAVI business while underestimating the growth potential of the neurointervention segment, which has shown strong performance [3]. - Potential catalysts for a stock price turnaround include the resolution of the "out of connect" issue, the implementation of price-volume exchange in valve procurement, achieving profitability by 2026, and the launch of new products like TaurusTrio [3]. Financial Performance Summary - For 1H24, the company reported revenue of RMB 300 million, a year-on-year increase of 34%. The cardiac valve segment generated RMB 130 million (up 21% YoY), while the neurointervention segment saw revenue of RMB 170 million (up 46% YoY) [3][10]. - The company reduced its net loss to RMB 71.28 million in 1H24, a 66% improvement compared to a loss of RMB 210 million in 1H23 [3][10]. - The report projects revenue growth to RMB 600 million in 2024, with a CAGR of 28% from 2024 to 2026 [4][5]. Market Position and Valuation - The company has a market capitalization of HKD 1.861 billion and a current price-to-sales (P/S) ratio of 2.8 based on 2024 estimates [2][12]. - The report indicates that the company’s cardiac valve and neurointervention businesses are valued at HKD 23 billion and HKD 28 billion, respectively, contributing to the target market value of HKD 51 billion [3]. Product Pipeline and Development - The report outlines the company's product pipeline, including various cardiac valve products and neurointervention devices, with several products expected to receive regulatory approval in the coming years [13].

Stock Options - The company clarified that no stock options or rewards were granted under the stock option plan after the listing date, and during the reporting period, 2,113,900 stock options were not granted[1] - The calculated percentage of shares that could be issued under all stock option plans during the reporting period is 0.3112%[1]

Revenue Growth - Revenue for the six months ended June 30, 2024, was RMB 301,203 thousand, representing a 33.9% increase compared to RMB 224,871 thousand for the same period in 2023[2] - Revenue from transcatheter valve treatment products reached RMB 130.3 million, an increase of 21.0% compared to approximately RMB 107.7 million for the six months ended June 30, 2023[10] - Revenue from neurointerventional products reached RMB 170.9 million, a 45.9% increase compared to RMB 117.1 million for the six months ended June 30, 2023[24] - Total revenue from hemorrhagic products was RMB 55.1 million, a 72.5% increase from approximately RMB 32.0 million for the six months ended June 30, 2023, accounting for 32.3% of total neurointerventional revenue[25] - Revenue from ischemic products reached RMB 58.8 million, a 28.1% increase from approximately RMB 45.9 million for the six months ended June 30, 2023, representing 34.4% of total neurointerventional revenue[27] Product Development and Innovation - The company has developed thirteen innovative surgical techniques targeting complex cases in areas such as aneurysm embolization and intracranial atherosclerosis[5] - The registration application for the new generation product TaurusMaxTM was approved by the National Medical Products Administration in August 2024[4] - The TaurusMaxTM TAVR system received approval from the National Medical Products Administration in August 2024, representing a new iteration of the TAVR system[14] - TaurusNXT® is a third-generation TAVR system that utilizes a non-glutaraldehyde cross-linking technology, aiming to significantly enhance the durability and biocompatibility of artificial aortic valves[16] - TaurusApex®, a fourth-generation TAVR system, replaces biological materials with high-strength polymer leaflets, improving durability and biocompatibility, with satisfactory results from ongoing animal trials[17] Financial Performance - Gross profit increased by 26.5% to RMB 218.9 million, with a gross margin of 72.7%, down from 76.9% in the previous period[52] - Operating loss decreased significantly to RMB 84,774 thousand from RMB 233,307 thousand year-over-year, reflecting improved operational efficiency[78] - The net loss for the period was RMB 71,283 thousand, a reduction from RMB 212,075 thousand in the previous year, showing a decrease of approximately 66%[79] - R&D expenses decreased by 41.3% to RMB 100.5 million, mainly due to reduced service fees for TAVR product development[54] - The total cost of sales, distribution expenses, administrative expenses, and R&D expenses amounted to RMB 397,012 thousand, down from RMB 457,685 thousand in 2023, indicating a decrease of 13%[89] Market Expansion and Strategy - The company aims to enhance its market presence in China for transcatheter valve therapy products, including TaurusOne®, TaurusElite®, and TaurusMaxTM, while focusing on the follow-up and registration of in-development products[48] - The company plans to continue expanding its product offerings in neurointerventional surgery and maintain revenue growth while implementing cost control measures[48] - The company is focused on expanding its market presence in China and other countries through the development of new medical devices[82] - The company is committed to internationalization through patented innovative technologies and products, with ongoing overseas clinical trials for competitive products like MonarQTM and GeminiOne®[48] - The company is exploring new strategies for market expansion and product development in the cardiovascular sector[113] Regulatory and Compliance - The company is actively monitoring regulatory developments from the National Medical Products Administration of China[111] - The company emphasizes the importance of compliance with listing rules and corporate governance standards[110] - The audit committee has reviewed the unaudited interim financial statements and believes that the interim performance is in compliance with applicable accounting standards and regulations[104] Employee and Operational Insights - As of June 30, 2024, the company has 198 employees dedicated to the sales and marketing of transcatheter aortic valve replacement (TAVR) products, with products now in over 580 hospitals, an increase of about 100 hospitals since December 31, 2023[42] - The internal R&D team consists of 184 employees focused on transcatheter valve therapy and neurointervention product development as of June 30, 2024[37] - The company has established subsidiaries in Shanghai and Suzhou, enhancing its operational capabilities in China[112] - The company has agreed to acquire JenaValve for a total consideration of up to USD 445 million, with an initial payment of USD 500 million upon completion of the merger[73] Cash Flow and Capital Management - Cash and cash equivalents decreased by 13.9% to RMB 831,326 thousand from RMB 965,768 thousand as of December 31, 2023[2] - The capital debt ratio increased from 17.5% as of December 31, 2023, to 19.8% as of June 30, 2024[57] - Total cash, cash equivalents, and time deposits amounted to RMB 831.3 million, a decrease of 13.9% from RMB 965.8 million as of December 31, 2023[61] - The company maintains its unutilized net proceeds in licensed banks in Hong Kong or China as of June 30, 2024[71] Corporate Governance - The company emphasizes good corporate governance practices and has adopted a code of corporate governance to enhance management and protect shareholder interests[75] - The board expresses gratitude to all employees and stakeholders for their support and trust in the company[106]