Core Insights - The company reported a revenue of 616 million yuan for 2024, representing a year-on-year growth of 39.5%, while operating losses narrowed by 44.4% to 239 million yuan [1][2] - The neurointervention segment became the first profitable business unit, contributing a profit of 52.1 million yuan [1] Revenue Composition - Revenue composition remained stable, with 42.2% from TAVR-related product sales and 57.8% from neurointervention product sales [1] - TAVR-related product sales increased by 40.1% year-on-year to 260 million yuan, while neurointervention product sales rose by 39.1% to 356 million yuan [1] Growth Drivers - Revenue growth was primarily driven by high sales growth in the transcatheter valve therapy and neurointervention businesses [2] - TAVR-related product revenue growth was attributed to an increase in market share in China's transcatheter aortic valve replacement market, with total implantations exceeding 3,400 units, a year-on-year increase of approximately 37% [2] - The neurointervention product revenue growth was supported by improved surgical penetration rates, successful bids in volume-based procurement, and a comprehensive product pipeline with effective marketing strategies [2] Cost Management - Research and development expenditure ratio decreased from 66.5% to 33.1%, a decline of 33.4 percentage points, due to revenue growth and products entering a lower expenditure phase [2] - The sales and distribution expense ratio fell by 20.3 percentage points to 53.5%, resulting in a commercial profit of 105 million yuan [2] - Administrative expenses remained stable over the past few years, with the administrative expense ratio decreasing from 32.1% to 24.5%, a year-on-year decline of 7.6 percentage points [2]

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]

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

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 10.20, indicating a potential upside of 182% from the current price of HKD 3.62 [4][5]. Core Insights - The audit results from PwC, which provided a standard unqualified opinion, are expected to enhance investor confidence in the company's financials and internal controls [2]. - The company has shown significant growth in its core business segments, with a notable increase in market share and revenue from its heart valve and neurointervention products [2][3]. - Key new products, such as TaurusTrio, are anticipated to be catalysts for stock price appreciation, with expected domestic approvals in 2025/26 [2][3]. Financial Performance Summary - In 2023, the company reported revenue of RMB 441 million, a year-on-year increase of 76%, with heart valve and neurointervention revenues growing by 73% and 78%, respectively [2][3]. - The gross margin improved to 73.8%, up 3.5 percentage points year-on-year, with heart valve gross margin at 85.7% and neurointervention at 65.1% [2][3]. - The net loss attributable to shareholders narrowed to RMB 393 million in 2023, compared to a loss of RMB 408 million in 2022 [2][3]. Market Position and Growth Potential - The heart valve segment achieved a revenue of RMB 186 million in 2023, with an implantation volume of 2,484 cases, reflecting a 106% year-on-year increase and a market share increase of 4 percentage points to 20% [2][3]. - The neurointervention segment generated RMB 256 million in revenue, with significant growth in ischemic products, particularly the Syphonet thrombectomy stent, which saw a revenue increase of 339% [2][3]. - The company expects to achieve profitability in the neurointervention segment in 2024, with projected profits of RMB 10-20 million [2][3]. Future Projections - Revenue forecasts for 2024, 2025, and 2026 are RMB 648 million, RMB 892 million, and RMB 897 million, respectively, with expected growth rates of 47%, 38%, and 1% [3][9]. - The company anticipates that the introduction of three major new products will mitigate potential impacts from future centralized procurement [2][3]. Product Pipeline - The company has a robust product pipeline, with several key products expected to receive domestic approval by 2025/26, including TaurusTrio, GeminiOne, and TaurusNXT [12][13].

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]