Financial Performance - Revenue for the six months ended June 30, 2022, reached RMB 175.3 million, a 25.1% increase compared to the same period in 2021[5] - Gross profit for the period was RMB 144.8 million, up 17.1% year-over-year[5] - The company achieved a net profit of RMB 31.1 million for the six months ended June 30, 2022, compared to a net loss of RMB 12.5 million in the same period of 2021[5] - Revenue for the six months ended June 30, 2022, was approximately RMB 175.3 million, a 25.1% increase compared to RMB 140.2 million in the same period in 2021, driven by increased sales of core products and new product launches[37] - Gross profit increased by 17.1% to RMB 144.8 million in the six months ended June 30, 2022, with a gross margin of 82.6%, down from 88.2% in the same period in 2021 due to lower-priced venous intervention and vascular access products[40] - Revenue for the six months ended June 30, 2022, was RMB 175.322 million, a significant increase from RMB 140.195 million in the same period last year[75] - Gross profit for the period was RMB 144.770 million, up from RMB 123.677 million in the previous year[75] - Net profit for the six months ended June 30, 2022, was RMB 31.096 million, compared to a net loss of RMB 12.536 million in the same period last year[75] - Basic earnings per share for the period were RMB 0.10, compared to a loss per share of RMB 0.06 in the same period last year[75] - Total comprehensive income for the period was RMB 31,189 thousand, compared to a loss of RMB 12,536 thousand in the previous period[79] - Core product revenue increased to RMB 142,898 thousand in H1 2022, up from RMB 138,300 thousand in H1 2021[92] - Venous intervention and vascular access products revenue surged to RMB 30,575 thousand in H1 2022, compared to RMB 1,863 thousand in H1 2021[92] - Total revenue from external customers in Mainland China reached RMB 171,048 thousand in H1 2022, up from RMB 136,933 thousand in H1 2021[94] - Basic earnings per share improved to RMB 0.104 in H1 2022, compared to a loss per share of RMB 0.057 in H1 2021[102] Product Development and Commercialization - The company's SFA DCB product was admitted to 1,400 hospitals as of June 30, 2022, up from 1,238 hospitals at the end of 2021[7] - BTK DCB product was admitted to 650 hospitals, a significant increase from 288 hospitals at the end of 2021[7] - The company's products have been commercialized in 12 countries globally as of June 30, 2022[8] - Other commercialized products, including AcoStream™ and PTA balloons, contributed approximately RMB 30.6 million in revenue during the reporting period[8] - Core products AcoArt Orchid® & Dhalia™ and AcoArt Tulip™ & Litos™ remained the primary revenue drivers[7] - The company's new product pipeline is progressing rapidly, with a focus on arterial diseases, venous diseases, and vascular tumor markets[10] - The company launched its peripheral thrombus aspiration system, making it the only Chinese enterprise with original technology and a comprehensive solution in this field[11] - The company has 7 commercialized products and 26 products in the pipeline, covering first, second, and third-class medical devices under the NMPA classification[12] - AcoArt Orchid® & Dhalia™ received CE marking in 2014 and NMPA approval in 2016, and has been launched in 12 countries including Germany, Italy, and Brazil[14] - The company expanded the indications of AcoArt Orchid® & Dhalia™ to treat AVF stenosis, with a 91.4% patency rate at 6 months and 66.1% at 12 months in the DCB group[14] - The company expects to receive NMPA approval for AcoArt Orchid® & Dhalia™ in the neurology field by 2024[14] - The company's peripheral support catheter and PTA balloons for above and below the knee are expected to be commercialized in 2022[13] - The company's next-generation thrombus aspiration system is expected to be commercialized in 2023[13] - The company's peripheral IVL system for vascular calcification is expected to be commercialized in 2026[13] - The company's coronary IVL system for coronary calcification is expected to be commercialized in 2026[13] - The company's intracranial PTA balloon is expected to be commercialized in 2022[13] - AcoArt Orchid® & DhaliaTM generated revenue of approximately RMB 123.8 million during the reporting period, representing a year-on-year increase of 0.9%[15] - AcoArt TulipTM & LitosTM generated revenue of approximately RMB 19.1 million during the reporting period, representing a year-on-year increase of 22.7%[16] - AcoArt TulipTM & LitosTM has been launched in 12 countries including Germany, Italy, Switzerland, and Brazil as of June 30, 2022[16] - The company submitted an IDE application to the FDA for AcoArt LitosTM in January 2022 and is currently screening business partners for clinical trials in the U.S.[16] - The company has 5 commercialized products and 12 pipeline products in the vascular surgery field, 10 pipeline products in cardiology, 2 in nephrology, and 2 in neurology[17] - AcoArt IrisTM & JasminTM and AcoArt LilyTM & RosmarinTM are among the 5 commercialized products in the vascular surgery field[18][19] - Revenue from venous intervention and vascular access products, including AcoArt IrisTM & JasminTM, AcoArt LilyTM & RosmarinTM, AcoStreamTM, and AcoArt CedarTM, was approximately RMB 30.6 million during the reporting period[20] - The company expects to submit product registration applications for the above-knee PTA balloon and below-knee PTA balloon to the NMPA in 2022[21] - The company plans to submit a product registration application for the peripheral three-wire balloon to the NMPA in 2022 and expects approval in 2023[21] - Peripheral Rotational Atherectomy Device is in the preclinical research stage, with expected submission for product registration to the National Medical Products Administration (NMPA) in 2023 and approval expected in 2025[22] - Peripheral Spot Stent is undergoing clinical trials, with NMPA approval expected in 2024[22] - Lower Limb Rapamycin DCB is currently enrolling patients, with NMPA approval expected in 2025[22] - Peripheral Scoring Balloon is in the preclinical research stage, with product registration submission expected in 2022 and NMPA approval expected in 2023[22] - Second-generation Peripheral Aspiration System is under development, with NMPA approval expected in 2023[22] - Peripheral IVL System is under development, with NMPA approval expected in 2026[22] - Coronary CTO Antegrade Microcatheter is under development, with NMPA approval expected in 2023[24] - Coronary CTO Re-entry Balloon, with a diameter of 0.8mm, is under development and expected to receive NMPA approval in 2023[24] - Coronary Dual Lumen Selective Microcatheter is under development, with product registration submission expected in 2022 and NMPA approval expected in 2023[24] - Coronary Retrograde Microcatheter is under development, with product registration submission and NMPA approval expected in 2023[24] - AcoArt DaisyTM, a rapid exchange system DCB for treating intracranial atherosclerotic stenosis (ICAS), has recruited 10 patients for RCT as of June 30, 2022, with expected completion in 2022 and anticipated NMPA approval by 2024[28] - The company's intracranial PTA balloon, optimized for navigating tortuous and narrow vascular environments, has been submitted for type testing with expected NMPA approval in 2022[28] - AcoArt Orchid® & DhaliaTM and AcoArt TulipTM & LitosTM are being expanded for treating vasculogenic ED, with clinical trials expected to begin and NMPA approval anticipated by 2025[29] R&D and Innovation - The company's total number of employees reached 534 as of June 30, 2022, with expanded technical expertise in electronics, automation, and computer programming[9] - R&D costs increased by 25.6% to RMB 77.1 million in the six months ended June 30, 2022, driven by the integration of new R&D centers and increased investment in ongoing projects[44] - R&D expenses increased to RMB 77.070 million from RMB 61.375 million in the previous year, reflecting continued investment in innovation[75] - The company aims to expand its product offerings across five therapeutic areas (vascular surgery, cardiology, nephrology, neurology, and andrology) and increase investment in technological innovation to enhance R&D capabilities[36] - The company has a robust intellectual property portfolio, including 35 registered patents and 26 pending patent applications as of June 30, 2022[30] - The company has 35 registered patents, 50 registered trademarks, 26 pending patent applications, and 43 pending trademark applications as of June 30, 2022[34] - The company plans to expand its product pipeline through internal development, mergers and acquisitions, and other financing channels, with sufficient bank credit lines currently available[55] Sales and Distribution - Sales of DCB products accounted for 81.5% of total revenue in the six months ended June 30, 2022, down from 98.6% in the same period in 2021, reflecting diversification into venous intervention and vascular access products[37] - The company plans to expand sales of AcoArt Orchid® & DhaliaTM, deepen hospital penetration, and increase awareness of DCB among hospitals, doctors, and patients in China[36] - Sales and distribution costs decreased by 13.3% to RMB 24.7 million in the six months ended June 30, 2022, due to reduced share-based compensation and lower business travel expenses[43] Financial Position and Cash Flow - Cash and cash equivalents decreased by 6.6% to RMB 1,062.6 million as of June 30, 2022, compared to RMB 1,137.2 million as of December 31, 2021, primarily due to increased operating expenses[51] - The company's capital expenditure totaled RMB 18.2 million during the reporting period, allocated for purchasing plant and equipment, rental deposits, and intangible assets[54] - The company's capital-to-debt ratio decreased from 8.3% as of December 31, 2021, to 7.7% as of June 30, 2022[52] - Net proceeds from the global offering and the full exercise of the over-allotment option amounted to RMB 1,294.0 million, with RMB 273.1 million utilized as of June 30, 2022[56] - The company's net current assets increased by 0.3% to RMB 1,159.1 million as of June 30, 2022, compared to RMB 1,155.4 million as of December 31, 2021[52] - The company has no contingent liabilities or asset mortgages as of June 30, 2022[54] - Non-current assets increased to RMB 90,067 thousand as of June 30, 2022, up from RMB 63,841 thousand as of December 31, 2021[80] - Current assets stood at RMB 1,229,015 thousand as of June 30, 2022, slightly down from RMB 1,243,525 thousand as of December 31, 2021[80] - Cash and cash equivalents decreased to RMB 1,062,621 thousand as of June 30, 2022, from RMB 1,137,184 thousand as of December 31, 2021[80] - Net current assets increased to RMB 1,159,111 thousand as of June 30, 2022, compared to RMB 1,155,413 thousand as of December 31, 2021[80] - Total assets minus current liabilities rose to RMB 1,249,178 thousand as of June 30, 2022, from RMB 1,219,254 thousand as of December 31, 2021[80] - Non-current liabilities increased to RMB 23,869 thousand as of June 30, 2022, up from RMB 12,060 thousand as of December 31, 2021[81] - Total equity attributable to equity shareholders of the company was RMB 1,225,309 thousand as of June 30, 2022, compared to RMB 1,207,194 thousand as of December 31, 2021[81] - Accumulated losses increased to RMB 268,835 thousand as of June 30, 2022, from RMB 202,294 thousand as of December 31, 2021[84] - Total equity increased to RMB 1,225,309 thousand, up from RMB 1,207,194 thousand[86] - Accumulated losses decreased to RMB (237,739) thousand from RMB (268,835) thousand[86] - Cash and cash equivalents decreased by RMB 74,656 thousand to RMB 1,062,621 thousand[88] - Operating activities used RMB 36,707 thousand in cash, compared to generating RMB 21,033 thousand in the same period last year[87] - Investment activities used RMB 10,418 thousand in cash, a decrease from RMB 13,161 thousand in the previous year[87] - Financing activities used RMB 27,531 thousand in cash, a significant reduction from RMB 131,103 thousand in the prior year[87] - The company issued shares under the employee incentive platform, raising RMB 72,746 thousand in the previous year[87] - The company paid RMB 16,560 thousand for repurchasing shares under the share incentive plan[87] - The company's cash flow from operating activities was negatively impacted by a tax payment of RMB 5,072 thousand[87] - The company's cash flow from investment activities was affected by payments for property, plant, and equipment amounting to RMB 17,335 thousand[87] Corporate Governance and Shareholding - The company's Chairman and CEO positions are both held by Ms. Li Jing, with the Board believing this structure does not weaken the balance of power between the Board and management[59] - The company expects to retain all future profits for business operations and expansion, with no immediate plans to adopt a dividend policy[59] - As of June 30, 2022, Ms. Li Jing holds 55,291,087 shares, representing approximately 17.64% of the company's total issued shares[63] - CA Medtech Investment (Cayman) Limited holds 158,614,642 shares, representing approximately 50.61% of the company's total issued shares[66] - CPEChina Fund III, L.P. holds 161,877,642 shares, representing approximately 51.65% of the company's total issued shares[66] - Cosmic Elite Holdings Limited holds 43,062,647 shares, representing approximately 13.74% of the company's total issued shares[66] - The company's total issued shares as of June 30, 2022, were 313,389,171[67] - CPE Investment Wu Limited holds 3,263,000 shares, representing 85.61% ownership by CPEChina Fund III and 14.39% by CPE Global Opportunities Fund[67] - The company's financial statements for the six months ended June 30, 2022, were reviewed by KPMG, with no significant issues identified[74] - The company did not engage in any significant purchases, sales, or redemptions of listed securities during the reporting period[70] - The company's IPO was successfully completed on August 24, 2021, with shares listed and traded on the Hong Kong Stock Exchange[126] - The reporting period for the interim report is the six months ended June 30, 2022[127] - The company's shares have a par value of 0.00001 per share[127] Employee and Incentive Programs - The company employs a total of 534 employees, with the majority based in China, and offers competitive compensation and incentive programs[54] - The company repurchased 2,004,000 shares at an average price of HKD 9.94 per share (approximately RMB 8.26) under the share incentive plan[70] - The company issued 1,540,000 restricted shares to 55 eligible employees under the Restricted Share Unit Plan, with 50% vesting on the first anniversary and the remaining 50% on the second anniversary of the grant date[118] - The expected retention rate for employees under the Restricted Share Unit Plan was assessed to be between 82% and 84% as of June 30, 2022[118] - The company deducted RMB 3,486,000 from its income statement for the six months ended June 30, 2022, related
先瑞达医疗-B(06669) - 2022 - 中期财报