沛嘉医疗(09996) - 2025 - 中期业绩

Financial Summary The company's financial performance for the six months ended June 30, 2025, shows revenue growth and reduced segment loss, with overall loss stable Financial Summary for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB '000) | 2024 (RMB '000) | Period-on-period Change | | :--- | :--- | :--- | :--- | | Revenue | 353,380 | 301,203 | 17.3% | | Selling and Distribution Expenses | (145,070) | (151,565) | -4.3% | | Administrative Expenses | (62,745) | (62,625) | 0.2% | | Research and Development Expenses | (115,636) | (100,484) | 15.1% | | Segment Loss | (75,828) | (95,809) | -20.9% | | Including: Segment Profit from Neuro-Interventional Business | 40,903 | 28,716 | 42.4% | | Loss for the Period | (71,178) | (71,283) | -0.1% | | Bank Balances, Cash and Time Deposits (End of Period) | 611,769 | 707,775 | -13.6% | Business Summary The company achieved significant revenue growth from transcatheter valve therapy and neuro-interventional businesses, improving efficiency and narrowing net loss Overall Performance and Revenue Composition Revenue grew by 17.3% to RMB 353.4 million, driven by transcatheter valve therapy and neuro-interventional products, maintaining a stable revenue mix Revenue Composition and Growth | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Year-on-year Growth | | :--- | :--- | :--- | :--- | | Total Revenue | 353.4 | 301.2 | 17.3% | | TAVR-related Product Sales | 161.6 | 130.3 | 24.0% | | Neuro-interventional Product Sales | 191.8 | 170.9 | 12.2% | - TAVR-related product sales revenue increased by 24.0% year-on-year, driven by increased market share in China's transfemoral TAVR market and a shift towards newly launched high-end products, with total terminal implantations exceeding 2,050 units, a year-on-year increase of approximately 18.8%[4] - Neuro-interventional product sales revenue increased by 12.2% year-on-year, primarily due to deeper market penetration of existing products (DCwire® micro-guidewire, Tethys AS® aspiration catheter, and Fastunnel® delivery balloon dilatation catheter) and the successful launch of the newly approved YonFlow® flow diverter stent[4] Improved Operating Performance and Narrowed Net Loss The Group significantly improved operating performance and narrowed net loss through economies of scale and lean management, optimizing segment expense ratios - Segment profit from the neuro-interventional business increased by 42.4% year-on-year to RMB 40.9 million[5] - Segment loss from the transcatheter valve therapy business narrowed by 35.3% to RMB 76.1 million[5] - Excluding the impact of the frontier technology business, the Group's net loss for the period was RMB 30.7 million, a year-on-year reduction of 52.4%[5] Transcatheter Valve Therapy Business Market and Product Progress The company expanded TAVR surgery coverage to over 720 medical institutions and launched upgraded TAVR products with positive clinical feedback - TAVR products saw over 70 new hospital admissions, accumulating coverage of over 720 medical institutions in China[6] - The comprehensive commercial TAVR product portfolio includes TaurusOne®, TaurusElite®, and TaurusMax™, with the high-end product TaurusMax™ receiving positive clinical feedback[6] Transcatheter Valve Therapy Business Financial Performance and R&D Investment Improved operating efficiency significantly reduced segment loss for transcatheter valve therapy, achieving commercial profitability for the first time - The transcatheter valve therapy business segment loss significantly narrowed by 35.3% to RMB 76.1 million[7] - This segment achieved commercial profitability for the first time, reaching RMB 29.1 million[7] - Selling and distribution expenses decreased by 8.3% year-on-year, and R&D expenses decreased by 17.2% year-on-year[7] Transcatheter Valve Therapy Business Core Pipeline Product Progress Three core pipeline products (TaurusTrioTM, TaurusNXT®, GeminiOne®) completed one-year patient follow-up with excellent data, with regulatory submissions underway - TaurusTrioTM, TaurusNXT®, and GeminiOne® three pipeline products completed one-year patient follow-up, with data demonstrating excellent safety and efficacy[8] - The registration application for TaurusTrioTM was officially accepted by the NMPA in May 2025[8] - Registration applications for TaurusNXT® and GeminiOne® are expected to be submitted in the coming months, with approvals anticipated between late 2025 and mid-2026[8] Transcatheter Valve Therapy Business Other Clinical Stage Product Milestones Clinical-stage products like HighLife® TSMVR, MonarQ TTVR®, and ReachTactile™ robotic-assisted TAVR are advancing with positive early results - HighLife® TSMVR system is accelerating patient enrollment, expected to complete enrollment in 2026, making it China's most advanced TMVR product in clinical progress[9] - MonarQ TTVR® system initiated global clinical studies, with the first implantation successfully completed in the United States[9] - ReachTactile™ robotic-assisted TAVR system completed FIM studies with 5 patients and will soon initiate pivotal clinical trials[9] Neuro-Interventional Business Product Launches and Centralized Procurement Performance The neuro-interventional business achieved sustainable revenue growth through new product launches and successful centralized procurement bids, deepening market penetration - DCwire® micro-guidewire revenue increased by nearly 140% year-on-year and has submitted a US FDA 510(k) application, with approval expected by the end of 2025[10] - YonFlow® flow diverter stent was approved by the NMPA in April 2025 and has completed procurement listings in over 20 provinces[10] - SacSpeed® balloon dilatation catheter and Fastunnel® delivery balloon dilatation catheter won bids in centralized procurement led by Hebei Province, and coil products successfully renewed bids in Jiangsu Province centralized procurement[11] Neuro-Interventional Business Operating Efficiency and Profit Growth Lean production and supply chain integration partially offset centralized procurement pressure, leading to a 42.4% year-on-year increase in segment profit - The neuro-interventional business segment gross margin slightly decreased by 1.9 percentage points to 61.8% compared to full-year 2024[11] - Selling and distribution expense ratio, administrative expense ratio, and R&D expense ratio decreased by 1.3, 1.7, and 5.3 percentage points year-on-year, respectively[11] - Segment profit from the neuro-interventional business increased by 42.4% year-on-year to RMB 40.9 million[11] Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income This statement presents the Group's financial performance, showing a slight decrease in loss for the period despite revenue growth Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (For the Six Months Ended June 30, 2025) | Indicator | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Revenue | 353,380 | 301,203 | | Cost of Sales | (105,757) | (82,338) | | Gross Profit | 247,623 | 218,865 | | Other Income | 9,898 | 9,944 | | Other Gains and Losses | (2,394) | 1,091 | | Selling and Distribution Expenses | (145,070) | (151,565) | | Administrative Expenses | (62,745) | (62,625) | | Research and Development Expenses | (115,636) | (100,484) | | Net Finance (Costs) Income | (709) | 16,295 | | Loss Before Tax | (69,033) | (68,479) | | Income Tax Expense | (2,145) | (2,804) | | Loss and Total Comprehensive Expense for the Period | (71,178) | (71,283) | | Loss Attributable to Owners of the Company | (69,880) | (71,273) | | Basic and Diluted Loss Per Share (RMB) | (0.10) | (0.10) | Condensed Consolidated Statement of Financial Position This statement provides a snapshot of the Group's assets, liabilities, and equity as of June 30, 2025, showing changes in key financial positions Condensed Consolidated Statement of Financial Position (As at June 30, 2025) | Indicator | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Non-current Assets | | | | Property, Plant and Equipment | 700,531 | 650,417 | | Intangible Assets | 678,383 | 655,997 | | Financial Assets at Fair Value Through Profit or Loss | 330,666 | 316,814 | | Current Assets | | | | Bank Balances and Cash | 601,769 | 666,736 | | Trade and Other Receivables | 58,699 | 101,038 | | Current Liabilities | | | | Trade and Other Payables | 235,877 | 349,563 | | Borrowings | 224,534 | 89,775 | | Non-current Liabilities | | | | Borrowings | 91,199 | 158,312 | | Total Equity | 1,986,253 | 2,044,599 | Notes to the Condensed Consolidated Interim Financial Information This section details the preparation basis, accounting policies, segment information, and other financial disclosures for the interim period 1 General Information Peijia Medical Limited, incorporated in the Cayman Islands, primarily engages in R&D, manufacturing, and sales of transcatheter valve therapy and neuro-interventional medical devices in China - The company was incorporated in the Cayman Islands on May 30, 2012, and its shares are listed on the Main Board of the Hong Kong Stock Exchange[15] - Its principal business involves the research, development, manufacturing, and sale of transcatheter valve therapy and neuro-interventional medical devices[15] 2. Basis of Preparation The condensed consolidated financial statements are prepared according to International Accounting Standard 34 and HKEX Listing Rules - The financial statements are prepared in accordance with International Accounting Standard 34 and the HKEX Listing Rules[17] 3. Accounting Policies Financial statements are prepared on a historical cost basis, with some financial instruments at fair value, applying new share-based payment policies - The financial statements are prepared on a historical cost basis, with certain financial instruments measured at fair value[18] - The revised International Financial Reporting Standards accounting standards applied for the first time in this period had no significant impact on financial position and performance[19] - New accounting policies for share-based payments treat cancellation of share options as accelerated vesting and forfeiture as a transfer to accumulated losses[20] 4. Segments The Group's operations are divided into transcatheter valve therapy, neuro-interventional, and frontier technology businesses, primarily located in China - The Group's businesses are categorized into transcatheter valve therapy, neuro-interventional, and frontier technology businesses[21][22][23][24] - The Group's operations are primarily located in China, with both revenue and non-current assets (excluding financial assets at fair value through profit or loss) originating from China[25] Segment (Loss) Profit (For the Six Months Ended June 30, 2025) | Segment | Revenue (RMB '000) | Cost of Sales (RMB '000) | Selling and Distribution Expenses (RMB '000) | Administrative Expenses (RMB '000) | R&D Expenses (RMB '000) | Segment (Loss) Profit (RMB '000) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Transcatheter Valve Therapy Business | 161,606 | (32,492) | (100,029) | (50,982) | (54,195) | (76,092) | | Neuro-Interventional Business | 191,774 | (73,265) | (45,041) | (10,278) | (22,287) | 40,903 | | Frontier Technology Business | — | — | — | (1,485) | (39,154) | (40,639) | | Total | 353,380 | (105,757) | (145,070) | (62,745) | (115,636) | (75,828) | Major Customer Revenue Contribution (For the Six Months Ended June 30, 2025) | Customer | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Customer A | 104,292 | 48,790 | | Customer B | 76,950 | 65,922 | | Customer C | 73,922 | 62,627 | | Customer D | 41,791 | Not Applicable* | 5. Revenue The Group's medical device sales revenue for the six months ended June 30, 2025, increased by 17.3% to RMB 353,380 thousand Revenue from Medical Device Sales | Indicator | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Revenue from Medical Device Sales | 353,380 | 301,203 | 6. Other Income The Group's other income for the six months ended June 30, 2025, totaled RMB 9,898 thousand, mainly from government grants and additional VAT deductions Other Income Details | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Government Grants | 6,444 | 9,743 | | Additional VAT Deductions | 3,096 | 201 | | Others | 358 | — | | Total | 9,898 | 9,944 | 7. Other Gains and Losses The Group's net other gains and losses for the six months ended June 30, 2025, resulted in a loss of RMB 2,394 thousand, primarily due to net foreign exchange losses Other Gains and Losses Details | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Net Foreign Exchange (Losses) Gains | (3,399) | 4,660 | | Net Fair Value Change of Financial Assets at Fair Value Through Profit or Loss | — | 2,002 | | Gains (Losses) on Disposal of Property, Plant and Equipment | 76 | (307) | | Loss on Forward Foreign Exchange Contracts | — | (4,826) | | Others | 929 | (438) | | Total | (2,394) | 1,091 | 8. Expense Analysis Total expenses for the six months ended June 30, 2025, increased to RMB 429,208 thousand, driven by higher employee benefits, raw materials, R&D services, and professional fees Expense Analysis (For the Six Months Ended June 30, 2025) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Employee Benefit Expenses | 171,142 | 162,235 | | Raw Materials and Consumables Used | 83,505 | 66,798 | | R&D Service Expenses | 28,330 | 21,467 | | Professional Service Fees | 34,325 | 20,458 | | Depreciation of Property, Plant and Equipment | 24,616 | 16,538 | | Total Cost of Sales, Selling and Distribution Expenses, Administrative Expenses and R&D Expenses | 429,208 | 397,012 | 9. Net Finance (Costs) Income Net finance income for the six months ended June 30, 2025, became a net cost of RMB 709 thousand, driven by reduced bank interest income and increased borrowing interest expense Net Finance (Costs) Income Details | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Bank Interest Income | 5,106 | 16,427 | | Interest on Lease Liabilities | (208) | (132) | | Interest Expense on Borrowings | (5,607) | — | | Net Finance Income | (709) | 16,295 | 10. Income Tax Expense Income tax expense for the six months ended June 30, 2025, was RMB 2,145 thousand, with PRC entities benefiting from preferential tax rates and R&D deductions Income Tax Expense Details | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Current Income Tax: PRC Enterprise Income Tax | (1,699) | (2,380) | | Current Income Tax: Other Jurisdictions | (2,727) | (424) | | Deferred Tax Credit | 2,281 | — | | Total | (2,145) | (2,804) | - PRC entities are subject to Enterprise Income Tax rates of 25% or 15% (for high-tech enterprises)[34] - Enterprises engaged in R&D activities are entitled to claim 200% of their incurred R&D expenses as deductible expenses for tax purposes[34] 11. Loss Per Share Basic and diluted loss per share for the six months ended June 30, 2025, remained at RMB 0.10, with potential ordinary shares excluded due to anti-dilutive effect Loss Per Share (For the Six Months Ended June 30, 2025) | Indicator | 2025 | 2024 | | :--- | :--- | :--- | | Loss for the Period Attributable to Owners of the Company (RMB '000) | (69,880) | (71,273) | | Weighted Average Number of Ordinary Shares for Basic Loss Per Share (in thousands) | 665,991 | 679,375 | | Basic Loss Per Share (RMB) | (0.10) | (0.10) | | Diluted Loss Per Share (RMB) | (0.10) | (0.10) | - Due to the Group incurring a loss, potential ordinary shares (share options granted to employees) are not included in the calculation of diluted loss per share as they would have an anti-dilutive effect[37] 12. Trade and Other Receivables Total trade and other receivables decreased to RMB 65,568 thousand as of June 30, 2025, with trade receivables typically due within 60 days Trade and Other Receivables Details | Item | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Trade Receivables | 30,674 | 22,336 | | Loans to Employees | 10,312 | 11,186 | | Recoverable VAT | 15,173 | 8,463 | | Deposits | 6,735 | 4,634 | | Interest Receivable | 1,141 | 722 | | Other Receivables | 1,533 | 57,621 | | Total | 65,568 | 104,962 | - The credit period for trade receivables is generally around 60 days[38] - Unsecured, interest-free loans provided to certain key management personnel are repayable between March 2026 and January 2027[38] 13. Trade and Other Payables Total trade and other payables decreased to RMB 257,897 thousand as of June 30, 2025, with an average credit period of 30 days for goods purchased Trade and Other Payables Details | Item | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Trade Payables | 38,717 | 25,722 | | Other Payables | 151,973 | 262,340 | | Other Tax Payables | 22,548 | 13,170 | | Accrued Staff Salaries and Welfare | 33,958 | 40,465 | | Liabilities Arising from Share-based Payments with Cash Alternatives | 10,701 | 10,186 | | Total | 257,897 | 351,883 | - The average credit period for the purchase of goods is 30 days[39] - An investment of RMB 20,000,000 by an independent investor in a subsidiary is classified as a non-current liability due to a repurchase obligation under specific conditions[40] 14. Dividends No dividends were paid, declared, or proposed by the company or its existing subsidiaries for the six months ended June 30, 2025 - No dividends were paid or declared by the company or its existing subsidiaries for the six months ended June 30, 2025[41] I. Business Review This section reviews the company's business operations, product lines, R&D, intellectual property, manufacturing, commercialization strategies, and future outlook Overview Peijia Medical established a leading medical technology platform focused on high-growth, underserved, and high-barrier interventional medical device markets globally - The company is committed to addressing high-growth interventional medical device market challenges in China and globally[42] - Key markets include transcatheter valve therapy medical device market and neuro-interventional surgery medical device market[42] Products and Product Pipeline As of the announcement date, the company boasts a comprehensive product portfolio across transcatheter valve therapy, frontier technology, and neuro-interventional businesses - Transcatheter valve therapy business: eight registered products and multiple pipeline products under development[43] - Frontier technology business: three pipeline products under development[43] - Neuro-interventional business: seventeen registered products and multiple pipeline products under development[43] Transcatheter Valve Therapy Products and Pipeline Products The transcatheter valve therapy business generated RMB 161.6 million in revenue, growing by 24.0% year-on-year, with a comprehensive portfolio covering TAVR, TMVR, and TTVR - Transcatheter valve therapy product sales revenue reached RMB 161.6 million, a year-on-year increase of 24.0%[47] Transcatheter Aortic Valve Replacement and Repair Products and Pipeline Products The company's TAVR product line includes commercialized and upgraded systems, with advanced pipeline products like TaurusNXT® and TaurusTrioTM progressing towards regulatory approval - TaurusOne® (first-generation TAVR system) was commercialized in May 2021, with AV21 specifications approved in April 2024 and delivery system performance optimization approved in December 2024[48] - TaurusElite® (second-generation retrievable TAVR system) was commercialized in July 2021, with AV21 specifications approved in April 2024, making it the fastest-approved domestic retrievable TAVR product in the industry[50] - TaurusMax™ (new iteration steerable TAVR system) was approved by the NMPA in August 2024, commercialized in February 2025, and has received positive clinical feedback[51] - TaurusNXT® (third-generation "non-aldehyde cross-linked" dry valve TAVR system) is preparing for NMPA registration application submission, expected to significantly enhance artificial valve durability[53] - TaurusTrioTM (exclusively licensed JenaValve TrilogyTM THV system) has been implanted in Hong Kong and Taiwan, China, and its NMPA registration application was accepted in April 2025[57] Transcatheter Mitral Valve Replacement and Repair Pipeline Products The company's TMVR and TTVR pipeline includes HighLife® TSMVR, GeminiOne®, and Sutra Hemi Valve, all advancing in clinical development - HighLife® TSMVR system has received FDA IDE approval and Breakthrough Device Designation, and is undergoing multi-center pivotal clinical trials[60] - GeminiOne® (edge-to-edge repair system) is preparing for NMPA registration application submission and has received FDA IDE approval for an early feasibility study[61] - Sutra Hemi Valve (transcatheter mitral valve coaptation enhancement system) is preparing for FIM study[63] Frontier Technology Pipeline Products The frontier technology business focuses on global cutting-edge treatment solutions for heart valve diseases, with three pipeline products addressing unmet clinical needs - The frontier technology business focuses on providing global cutting-edge treatment solutions for various heart valve diseases, with all projects addressing unmet clinical needs in markets lacking mature treatment options[64] - Currently, there are three pipeline products: shockwave calcification remodeling system, MonarQ TTVR® system, and ReachTactile™ robotic-assisted TAVR system[64] - Two of these projects have independently secured external financing[64] Shockwave Calcification Remodeling System The shockwave calcification remodeling system uses shockwave technology to reshape calcified valve structures, showing positive early safety and efficacy data in FIM studies - The shockwave calcification remodeling system applies shockwave technology to reshape calcified structures on heart valves, usable as a standalone transcatheter aortic valve treatment or pre-TAVR procedure[65] - FIM studies for aortic valve stenosis and calcific mitral valve stenosis have been completed, showing positive early safety and efficacy data[65] MonarQ TTVR® System The MonarQ TTVR® system, an innovative technology for tricuspid regurgitation, initiated global clinical studies following FDA IDE approval for EFS - The MonarQ TTVR® system is an innovative technology for treating tricuspid regurgitation, featuring a unique bio-dynamically compatible attachment system[67] - It has received FDA IDE approval for EFS, with global clinical studies underway, and the first implantation successfully completed in June 2025[67] ReachTactile™ Robotic-Assisted TAVR System ReachTactile™ is a self-developed robotic-assisted TAVR system addressing surgical challenges and physician shortages, with modular design, haptic feedback, and remote control - ReachTactile™ is a self-developed robotic-assisted TAVR system aimed at addressing technical challenges during surgery and the shortage of experienced interventional cardiologists capable of performing transcatheter valve replacement or repair procedures[68] - The system features a modular mobile design, force-sensing mechanisms providing immediate haptic feedback, and remote control capabilities[68] - FIM studies have been completed, and pivotal clinical trials are being prepared for initiation soon[69] Platform Technologies The company possesses three patented platform technologies: "non-aldehyde cross-linked" dry valve, polymer leaflet, and shockwave calcification remodeling, applied in TAVR pipeline products - The company holds three patented platform technologies: "non-aldehyde cross-linked" dry valve technology, polymer leaflet technology, and shockwave calcification remodeling technology[70] - "Non-aldehyde cross-linked" dry valve technology and polymer leaflet technology are currently used in the third-generation TAVR product TaurusNXT® and fourth-generation TAVR product TaurusApex®, and can also be applied to other TAVR, TMVR, or TTVR pipeline products[70] - Shockwave calcification remodeling technology is currently used in the shockwave calcification remodeling system, applicable independently or as a pre-treatment step before transcatheter valve replacement surgery[70] Neuro-Interventional Products and Pipeline Products The neuro-interventional business achieved RMB 191.8 million in revenue, a 12.2% year-on-year increase, with a comprehensive product portfolio for hemorrhagic and ischemic stroke markets - Neuro-interventional product sales revenue reached RMB 191.8 million, a year-on-year increase of 12.2%[71] Hemorrhagic Products Total revenue from hemorrhagic products was RMB 59.9 million, growing by 8.7% year-on-year, with four registered detachable coil products and the newly approved YonFlow® flow diverter stent - Total revenue from hemorrhagic products was RMB 59.9 million, an increase of 8.7% compared to approximately RMB 55.1 million for the six months ended June 30, 2024, accounting for 31.3% of total neuro-interventional business revenue[72] - The company possesses four registered detachable coil products, including the latest generation NRcoilTM detachable coil[72] - YonFlow® flow diverter stent received NMPA registration approval in April 2025 and is exclusively distributed by the company[73] Ischemic Products Total revenue from ischemic products was RMB 56.8 million, a 3.3% year-on-year decrease, offering comprehensive solutions for acute ischemic stroke and intracranial atherosclerotic disease - Total revenue from ischemic products was RMB 56.8 million, a decrease of 3.3% compared to approximately RMB 58.8 million for the six months ended June 30, 2023, accounting for 29.6% of total neuro-interventional business revenue[74] - Syphonet® thrombectomy stent, Tethys AS® aspiration catheter, and Fluxcap® balloon guide catheter have received NMPA approval, providing a one-stop solution for mechanical thrombectomy procedures[75][76][77] - Fastunnel® delivery balloon dilatation catheter is the first domestic medical device capable of simultaneous balloon dilatation and stent delivery, utilizing an innovative "zero-exchange" technology[78] Vascular Access Products Total revenue from vascular access products increased by 32.3% to RMB 75.0 million, driven by approved products and the DCwire® micro-guidewire with US FDA 510(k) application - Total revenue from vascular access products was RMB 75.0 million, an increase of 32.3% compared to approximately RMB 56.7 million for the six months ended June 30, 2024, accounting for 39.1% of total neuro-interventional business revenue[79] - Tethys® intermediate guiding catheter and Heralder® DA distal access guiding catheter have received NMPA approval[79][80] - DCwire® micro-guidewire has received NMPA approval, and has submitted a 510(k) application to the US FDA[80] Research and Development The company's R&D, led by Dr. Zhang Yi and Dr. Chen Jianfeng, focuses on internal innovation, BD opportunities, global collaborations, and establishing overseas R&D capabilities - The core R&D team is led by Dr. Zhang Yi, Chairman and CEO, and Dr. Chen Jianfeng, CTO, with Mr. Pan Kongrong transitioning to company advisor for R&D projects[81] - Overseas R&D capabilities are being established through collaborations with Sutra, inQB8, and others, alongside close cooperation with world-class advisors such as Dr. Nicolo PIAZZA, Dr. Saibal KAR, and Dr. Gilbert Tang[82][83][84] - Suzhou Institute of Interventional Medical Technology (IMI) was established to provide opportunities for acquiring emerging medical device technologies with significant global impact[84] - As of June 30, 2025, the internal R&D team consisted of 169 employees[84] Intellectual Property The company is committed to independent innovation, enhancing its IP architecture to an offensive-defensive strategy, strengthening trademark compliance, and establishing trade secret management - The company has upgraded its intellectual property architecture from a defensive stance to an offensive-defensive strategy, marked by strengthened trademark usage compliance, the establishment of a preliminary framework for trade secret management, and more comprehensive protection of core technologies[85] - It has obtained GB/T 29490-2013 Intellectual Property Management System certification and is upgrading to meet the requirements of GB/T 29490-2023 Enterprise Intellectual Property Compliance Management System[85] - The company possesses a strong intellectual property portfolio, including a total of 228 granted and valid patents, 155 pending patent applications, and 137 registered trademarks[85] Manufacturing The transcatheter valve therapy business's new headquarters boasts expanded production capacity, while the neuro-interventional business expands its Suzhou factory, supported by an advanced quality management system - The new headquarters for the transcatheter valve therapy business has approximately 10,000 square meters of production area and an annual production capacity of approximately 30,000 sets, both more than three times the original capacity, and has passed NMPA inspection and obtained a medical device production license[86] - The neuro-interventional business is renovating and expanding its factory in Zhongtian Lane, Suzhou, to increase production capacity[86] - An advanced quality management system has been established, complying with GMP standards and ISO 13485:2016 Medical Devices — Quality Management Systems[87] Commercialization The company focuses on becoming a trusted partner for physicians through precise product positioning, comprehensive sales and marketing, and end-to-end engagement, achieving market penetration and successful centralized procurement bids - Transcatheter valve therapy products saw over 70 new hospital admissions, covering approximately 720 medical institutions as of June 30, 2025, with total terminal implantations exceeding 2,050 units, a year-on-year increase of approximately 18.8%[89] - The neuro-interventional business's YonFlow® flow diverter stent was successfully launched, completing procurement listings in over 20 provinces and winning bids in Guangdong Province's centralized procurement for flow diverter stents[91] - The neuro-interventional product distributor network covers approximately 2,300 hospitals across 31 provinces and cities nationwide[91] - The company actively participates in centralized procurement for neuro-interventional products and has won multiple bids, with coil products covering over 90% of provinces nationwide[93] Future Outlook The company aims to lead innovative interventional therapies for structural heart and neurovascular diseases, focusing on market penetration, R&D advancement, and profitability - The transcatheter valve therapy business will steadfastly pursue the goal of becoming the number one TAVR brand in China, focusing on expanding market penetration of approved products and accelerating the regulatory process for pipeline products[94] - The frontier technology business will continuously advance subsidiary financing plans and R&D of cutting-edge therapeutic products, accelerating the translation of technological innovation into clinical application[95] - The neuro-interventional business will maintain its revenue growth momentum while implementing cost control measures to enhance profitability and maximize shareholder value[95] II. Financial Review This section provides a detailed review of the Group's financial performance, including revenue, costs, profitability, and financial position Revenue The Group's revenue for the six months ended June 30, 2025, increased by 17.3% to RMB 353.4 million, driven by strong performance in transcatheter valve therapy and neuro-interventional businesses Revenue Details | Business | H1 2025 (RMB million) | H1 2024 (RMB million) | Year-on-year Growth | | :--- | :--- | :--- | :--- | | Total Revenue | 353.4 | 301.2 | 17.3% | | Neuro-Interventional Business | 191.8 | 170.9 | 12.2% | | Transcatheter Valve Therapy Business | 161.6 | 130.3 | 24.0% | - Revenue growth is primarily attributable to further market share growth in China's TAVR market and a shift in product portfolio towards newly launched high-end products[96] - Strong performance of key neuro-interventional products (including DCwire® micro-guidewire, Tethys AS® aspiration catheter, Fastunnel® delivery balloon dilatation catheter, and YonFlow® flow diverter stent) also contributed to revenue growth[96] Neuro-Interventional Business Revenue Details | Product Category | 2025 (RMB '000) | Share (%) | 2024 (RMB '000) | Share (%) | | :--- | :--- | :--- | :--- | :--- | | Vascular Access Products | 74,978 | 39.1 | 56,665 | 33.2 | | Ischemic Products | 59,920 | 31.3 | 55,138 | 32.3 | | Hemorrhagic Products | 56,813 | 29.6 | 58,763 | 34.3 | | Others | 63 | —* | 320 | 0.2 | | Total | 191,774 | 100.0 | 170,886 | 100.0 | Cost of Sales Cost of sales increased by 28.4% to RMB 105.8 million for the six months ended June 30, 2025, mainly due to higher sales volumes in both transcatheter valve therapy and neuro-interventional businesses - Cost of sales was RMB 105.8 million, a year-on-year increase of 28.4%[97] - The increase was primarily due to higher sales volumes in both the transcatheter valve therapy business and the neuro-interventional business, leading to increased material costs, labor costs, and overheads[97] Gross Profit and Gross Margin Gross profit increased by 13.1% to RMB 247.6 million, but gross margin decreased from 72.7% to 70.1%, primarily impacted by centralized procurement for neuro-interventional products - Gross profit increased by 13.1% from RMB 218.9 million for the six months ended June 30, 2024, to RMB 247.6 million for the six months ended June 30, 2025[98] - Gross margin was 70.1% for the six months ended June 30, 2025, compared to 72.7% for the six months ended June 30, 2024, with the decrease primarily due to the impact of centralized procurement for neuro-interventional products[98] Selling and Distribution Expenses Selling and distribution expenses decreased by 4.3% to RMB 145.1 million, mainly due to savings from refined management of conference, promotion, and travel expenses - Selling and distribution expenses decreased by 4.3% from RMB 151.6 million for the six months ended June 30, 2024, to RMB 145.1 million during the reporting period[99] - The decrease was primarily due to savings achieved through refined management of conference expenses, promotion expenses, travel costs, and other expenses[99] Administrative Expenses Administrative expenses slightly increased by 0.2% to RMB 62.7 million, mainly due to higher depreciation expenses partially offset by cost control - Administrative expenses increased by 0.2% from RMB 62.6 million for the six months ended June 30, 2024, to RMB 62.7 million for the six months ended June 30, 2025[100] - The increase was primarily due to higher depreciation expenses, partially offset by cost control measures[100] Research and Development Expenses R&D expenses increased by 15.1% to RMB 115.6 million, primarily due to higher service expenses for frontier technology product development - R&D expenses increased by 15.1% from RMB 100.5 million for the six months ended June 30, 2024, to RMB 115.6 million during the reporting period[101] - The increase was primarily due to service expenses paid for the development of frontier technology products[101] R&D Expense Components | Item | 2025 (RMB '000) | Share (%) | 2024 (RMB '000) | Share (%) | | :--- | :--- | :--- | :--- | :--- | | R&D Service Expenses | 23,571 | 20.4 | 21,467 | 21.4 | | Employee Benefit Expenses | 43,967 | 38.0 | 43,477 | 43.3 | | Professional Service Fees | 17,613 | 15.2 | 2,695 | 2.7 | | Cost of Raw Materials and Consumables Used | 21,116 | 18.3 | 22,527 | 22.4 | | Depreciation and Amortization | 6,125 | 5.3 | 5,628 | 5.6 | | Others | 3,244 | 2.8 | 4,690 | 4.6 | | Total | 115,636 | 100.0 | 100,484 | 100.0 | Net Other Gains and Losses Net other gains and losses shifted from a gain of RMB 1.1 million to a loss of RMB 2.4 million, primarily due to changes in foreign exchange gains and losses - Net other gains and losses decreased from a net gain of RMB 1.1 million for the six months ended June 30, 2024, to a net loss of RMB 2.4 million for the six months ended June 30, 2025[103] - This decrease was primarily due to changes in foreign exchange gains and losses, shifting from a foreign exchange gain of RMB 4.6 million in the prior year to a foreign exchange loss of RMB 3.4 million[103] Net Finance (Costs) Income Net finance income decreased significantly from RMB 16.3 million to a net cost of RMB 0.7 million, mainly due to reduced bank interest income from lower bank balances - Net finance income decreased from RMB 16.3 million for the six months ended June 30, 2024, to a net finance cost of RMB 0.7 million during the reporting period[104] - This decrease was primarily due to reduced bank balances (especially large-denomination time deposits), leading to lower interest income[104] Capital Gearing Ratio The Group's capital gearing ratio decreased from 31.5% as of December 31, 2024, to 30.9% as of June 30, 2025 - As of June 30, 2025, the Group's capital gearing ratio decreased from 31.5% as of December 31, 2024, to 30.9%[105] Net Current Assets The Group's net current assets decreased by RMB 180.0 million to RMB 364.3 million as of June 30, 2025, due to reduced trade and other receivables and lower short-term deposit balances - The Group's net current assets as of June 30, 2025, were RMB 364.3 million, a decrease of RMB 180.0 million compared to RMB 544.3 million as of December 31, 2024[106] - This decrease was primarily attributable to reduced trade and other receivables, and lower short-term deposit balances driven by investments in property and plant[106] Borrowings Total borrowings increased to RMB 315.7 million as of June 30, 2025, primarily for new headquarters construction financing and managing funding costs - As of June 30, 2025, the Group's interest-bearing borrowings at rates of 2.7%-3.6% amounted to RMB 315.7 million, compared to RMB 248.1 million as of December 31, 2024[107] - Long-term borrowings are for financing the construction of the new headquarters, while short-term borrowings aim to better manage funding costs by securing more favorable interest rates[107] Liquidity and Financial Resources The Group's total cash, cash equivalents, and time deposits decreased by 13.6% to RMB 611.8 million, but the company maintains a strong financial position and expects increased cash inflows - As of June 30, 2025, the Group's total cash, cash equivalents, and time deposits were approximately RMB 611.8 million, a decrease of 13.6% compared to RMB 707.8 million as of December 31, 2024[109] - The Group relies on capital contributions from shareholders as its primary source of liquidity and generates cash from sales of existing commercialized products[109] - With business development and expansion, the Group expects to generate more net cash inflows from operating activities through increasing sales of existing commercialized products and launching new products[109] Capital Expenditure Total capital expenditure for the six months ended June 30, 2025, was approximately RMB 188.1 million, primarily for pipeline products, property, plant, and equipment - Total capital expenditure for the six months ended June 30, 2025, was approximately RMB 188.1 million[110] - Primarily used for ongoing investments in TaurusTrioTM and TaurusNXT®, construction of property and plant, and equipment procurement[110] Significant Investments As of June 30, 2025, the Group held RMB 330.7 million in non-current financial assets at fair value through profit or loss, comprising nine unlisted equity investments, including a 50% stake in inQB8 - As of June 30, 2025, the balance of non-current financial assets at fair value through profit or loss was RMB 330.7 million, representing nine unlisted equity investments[111] - The Group holds a 50% equity interest in inQB8, with the fair value of the Group's interest being RMB 164.6 million, accounting for 6.3% of total assets as of June 30, 2025[112] - inQB8 is strategically collaborating with the Group to develop the innovative MonarQ TTVR® system for tricuspid regurgitation, with global clinical studies currently underway[112] Contingent Liabilities As of June 30, 2025, the Group had no significant contingent liabilities - As of June 30, 2025, the Group had no significant contingent liabilities[113] Significant Acquisitions and Disposals As of June 30, 2025, the Group had no significant acquisitions or disposals of subsidiaries, associates, or joint ventures - As of June 30, 2025, the Group had no significant acquisitions or disposals of subsidiaries, associates, or joint ventures[114] Future Plans for Material Investments or Capital Assets As of the announcement date, the Group has no authorized or specific plans for any material investments or acquisitions of capital assets - As of the date of this announcement, the Group has no authorized or specific plans for any material investments or acquisitions of capital assets[115] Pledge of Assets As of June 30, 2025, land use rights and property, plant, and equipment with carrying values of RMB 8.7 million and RMB 346.0 million were pledged for long-term bank borrowings - As of June 30, 2025, land use rights and property, plant and equipment with carrying values of RMB 8.7 million and RMB 346.0 million, respectively, were pledged for long-term bank borrowings[116] Foreign Exchange Risk The Group is exposed to transactional currency risk, with certain cash, cash equivalents, and financial assets at fair value through profit or loss denominated in foreign currencies - The Group is exposed to transactional currency risk, with certain cash and cash equivalents and financial assets at fair value through profit or loss denominated in foreign currencies[117] Use of Proceeds from Global Offering Net proceeds from the global offering, approximately HKD 2,587.98 million, are utilized consistent with the intended purposes disclosed in the prospectus - Net proceeds from the global offering were approximately HKD 2,587.98 million and will be utilized in a manner consistent with the intended purposes disclosed in the prospectus[118] Use of Net Proceeds from Global Offering (As of June 30, 2025) | Business Objective | Percentage of Total (%) | Net Proceeds (HKD million) | Unutilized Amount as at December 31, 2024 (HKD million) | Amount Utilized During the Reporting Period (HKD million) | Unutilized Amount as at June 30, 2025 (HKD million) | Expected Timeline for Utilizing Unutilized Amount | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Development and Commercialization of Core Products and Other Key Pipeline Products | 65 | 1,682.18 | 399.44 | 81.65 | 317.79 | 2028(2) | | Ongoing Pre-clinical Studies and Proposed Clinical Trials, Preparation for Registration Filings, and Potential Commercial Launch (including Sales and Marketing) for Other Pipeline Products | 10 | 258.80 | 0 | 0 | 0 | — | | Strengthening R&D Capabilities to Enrich Our Product Pipeline | 8 | 207.04 | 30.45 | 18.30 | 12.15 | 2025 | | Expanding Our Product Portfolio or Intellectual Property Portfolio Through Potential Strategic Acquisitions, Investments, Partnerships, and Licensing Opportunities | 10 | 258.80 | 0 | 0 | 0 | — | | Working Capital and Other General Corporate Purposes | 7 | 181.16 | 0 | 0 | 0 | — | | Total | 100 | 2,587.98 | 429.89 | 99.95 | 329.94 | | - The expected timeline for the development and commercialization of core products and other key pipeline products has been extended from 2025 to 2028[122] Use of Proceeds from Placing Net proceeds from the placing, approximately HKD 971.48 million, are used to strengthen the Group's financial position and fund its business, expansion, and growth plans - Net proceeds from the placing were approximately HKD 971.48 million, used to strengthen the Group's financial position and long-term fund its business, expansion, and growth plans[121] Use of Net Proceeds from Placing (As of June 30, 2025) | Business Objective | Percentage of Total (%) | Net Proceeds (HKD million) | Unutilized Amount as at December 31, 2024 (HKD million) | Amount Utilized During the Reporting Period (HKD million) | Unutilized Amount as at June 30, 2025 (HKD million) | Expected Timeline for Utilizing Unutilized Amount | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Funding Potential Product Licensing and M&A Opportunities in the Mitral Valve Replacement and Repair Treatment Field | 30 | 291.44 | 25.31 | 0 | 25.31 | 2028(2) | | Funding Potential Product Licensing and M&A Opportunities in Other Fields, including Tricuspid Valve Replacement and Repair Treatment | 40 | 388.59 | 0 | 0 | 0 | — | | Funding the Group's Ongoing Technology Transfer, Product Development, and R&D | 25 | 242.87 | 0 | 0 | 0 | — | | For Other General Corporate Purposes | 5 | 48.58 | 48.58 | 37.60 | 10.98 | 2025 | | Total | 100 | 971.48 | 73.89 | 37.60 | 36.29 | | - The company has extended the timeline for utilizing placing proceeds for the execution of the licensing agreement with HighLife SAS from 2025 to 2028, aligning with expected outcomes of key milestones around 2028[125] Employees and Remuneration Policy As of June 30, 2025, the Group had 1,035 employees in China, with total employee benefit expenses of approximately RMB 171.1 million, and a policy of continuous education and performance-based remuneration - As of June 30, 2025, the Group had 1,035 employees, all located in China[126] - During the reporting period, the Group's total employee benefit expenses were approximately RMB 171.1 million, including wages, salaries and bonuses, social security costs and housing benefits, employee welfare, and share-based compensation expenses[126] - The company provides employees with continuous education programs, regular feedback, and internal and external training, and evaluates their performance to determine salaries, promotion opportunities, and career development[126] Events After Reporting Period No significant events occurred after the reporting period and up to the date of this announcement, other than those disclosed herein - Except as disclosed in this announcement, no significant events occurred after the reporting period and up to the date of this announcement for the company or the Group[127] Interim Dividend The Board of Directors resolved not to declare any interim dividend for the reporting period - The Board of Directors has resolved not to declare any interim dividend for the reporting period (for the six months ended June 30, 2024: nil)[128] Corporate Governance Practices The company adopted and complied with the Corporate Governance Code, maintaining a highly independent Board of Directors despite the Chairman and CEO being the same person - The company has adopted the code provisions of the Corporate Governance Code as the code governing its corporate governance practices and has complied with the relevant code provisions during the reporting period[129][130] - The Board Chairman and CEO are held by the same person (Dr. Zhang), which the Board believes is beneficial to the Group's management, and the Board currently comprises three executive directors, three non-executive directors, and four independent non-executive directors, demonstrating a high degree of independence[130] Standard Code for Securities Transactions The company adopted the Standard Code for securities transactions by directors and senior management, with all directors confirming compliance during the reporting period - The company has adopted the Standard Code as the code of conduct for directors and senior management of the company in dealing in the company's securities[132] - Following specific inquiries with all directors, each confirmed compliance with the Standard Code for the six months ended June 30, 2025, and the company is unaware of any non-compliance by the Group's senior management during the reporting period[132] Purchase, Sale or Redemption of the Company's Listed Securities or Sale of Treasury Shares From September 1, 2020, to June 30, 2025, the RSU trustee purchased 5,859,000 shares under the Restricted Share Unit Scheme, with no other significant transactions by the company or its subsidiaries - From September 1, 2020, to June 30, 2025, the Restricted Share Unit Scheme trustee purchased a total of 5,859,000 shares (approximately 0.8751% of the company's total issued share capital as of June 30, 2025) under the Restricted Share Unit Scheme[133] - Except as disclosed above, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities or sold any treasury shares during the reporting period[133] Review of Financial Information The Audit Committee reviewed the Group's unaudited interim financial statements, confirming compliance with applicable accounting standards, laws, and regulations - The Audit Committee discussed with the company's management and reviewed the Group's unaudited interim financial statements for the reporting period, deeming them compliant with applicable accounting standards, laws, and regulations, with appropriate disclosures made by the company[134] Publication of Results Announcement and Interim Report This announcement is published on the HKEX and company websites, with the full interim report to be dispatched to shareholders and published online - This announcement is published on the HKEX website (www.hkexnews.hk) and the company's website (www.peijiamedical.com)[135](index=135&type=chunk) - The company's interim report for the reporting period, containing all information required by the Listing Rules, will be dispatched to shareholders and published on the aforementioned websites in due course, in accordance with the company's corporate communication arrangements[135] Acknowledgements The Board expresses gratitude to all colleagues for their dedication and integrity, and to shareholders, customers, banks, and business partners for their trust and support - The Board extends its sincere gratitude to all colleagues for their hard work, dedication, loyalty, and integrity, and expresses deep appreciation to shareholders, customers, banks, and other business partners for their trust and support[136] Definitions This section provides key terms and their meanings used in this interim results announcement to ensure clear understanding of the report content - This section provides key terms and their meanings used in this interim results announcement to ensure clear understanding of the report content[137]