Financial Performance - Revenue for the year ended December 31, 2021, was RMB 303.8 million, a 56.6% increase compared to RMB 194.0 million in 2020[7] - Gross profit for 2021 was RMB 265.9 million, up 62.4% from RMB 163.8 million in 2020[6] - The company's adjusted net profit for 2021 was RMB 42.4 million, a 141.8% increase from RMB 17.5 million in 2020[6] - Revenue for the year ended December 31, 2021, reached approximately RMB 303.8 million, a year-on-year increase of 56.6%[13] - Gross profit increased by 62.4% to RMB 265.9 million in 2021, with gross margin rising to 87.5% from 84.4% in 2020, primarily due to increased sales of DCB products[49] - R&D costs increased by 69.2% to RMB 141.3 million in 2021, driven by the acquisition of a Shenzhen R&D center, increased employee costs, and higher investment in ongoing R&D projects[55] - Sales and distribution expenses rose by 80.4% to RMB 58.8 million in 2021, mainly due to employee stock ownership plan expenses and increased sales staff costs[54] - Other income increased by 147.8% to RMB 11.4 million in 2021, attributed to higher government subsidies and increased interest income from bank deposits[50] - Administrative expenses decreased by 19.4% to RMB 58.1 million in 2021, primarily due to reduced share-based compensation[57] - The company recorded a loss of RMB 8.8 million in other gains and losses in 2021, compared to a gain of RMB 0.7 million in 2020, mainly due to foreign exchange losses[51] - The fair value change of preferred shares resulted in a loss of RMB 33.5 million in 2021, compared to a gain of RMB 0.4 million in 2020[52] - Income tax expenses decreased by 7.8% to RMB 11.8 million in 2021, primarily due to additional tax deductions from increased R&D expenses[59] - Annual loss increased to RMB 79.077 million in 2021 from RMB 44.292 million in 2020[61] - Adjusted net profit for the year was RMB 42.390 million in 2021, up from RMB 17.534 million in 2020[61] - Cash and cash equivalents increased by 673.1% to RMB 1,137.2 million in 2021 from RMB 147.1 million in 2020[64] - Bank loans decreased by 70.0% to RMB 6.0 million in 2021 from RMB 20.0 million in 2020[65] - Capital expenditure for 2021 totaled RMB 21.9 million, allocated for property, plant, equipment, rental deposits, and intangible assets[68] - Net current assets increased by 721.5% to RMB 1,155.4 million in 2021 from a net current liability of RMB 185.9 million in 2020[66] - Capital-to-debt ratio improved to 8.3% in 2021 from -197.1% in 2020[65] - The net proceeds from the global offering and the full exercise of the over-allotment option amounted to approximately RMB 1,294.0 million, which will be used in accordance with the intended purposes disclosed in the prospectus[74] - As of December 31, 2021, the company had utilized RMB 152.619 million of the net proceeds, with RMB 1,141.341 million remaining unused[75] - The company made charitable donations totaling RMB 130,000 during the year ended December 31, 2021[143] - The company paid RMB 3,500 thousand for audit services to Deloitte Touche Tohmatsu during the fiscal year 2021[175] Product Development and Pipeline - The company's core products, Orchid® & Dhalia™, and AcoArt Tulip™ & Litos™, continue to dominate revenue, with sales expected to remain the primary revenue source in the short term[7] - The peripheral thrombus aspiration system, including AcoStream™, was launched in 2021, making the company the only Chinese enterprise with proprietary technology in this field[8] - The company is expanding its product pipeline, with over 30 products expected to be launched based on its four technology platforms (drug-coated technology, aspiration platform technology, polymer material technology, and radiofrequency ablation technology)[8] - BTK DCB (below-the-knee drug-coated balloon) was admitted to 288 hospitals and completed listing in 27 provinces and autonomous regions[10][13] - ATK DCB (above-the-knee drug-coated balloon) was admitted to 1,283 hospitals[10][13] - Three drug-coated balloon products were approved for commercialization in Brazil, bringing the total number of countries with commercialized products to 12[10][14] - Five products were sent for type testing, seven products were undergoing clinical trials, two products completed clinical trials, and two products were approved by the National Medical Products Administration[13] - The company registered ten additional patents in 2021[13] - The peripheral thrombus aspiration system (AcoStream™) was launched, making the company the only Chinese enterprise with original technology and a complete solution in this field[13] - The company has developed six new products, including peripheral IVL systems, peripheral coils, and coronary IVL systems, with rapid progress in product development[17][18] - The company's peripheral IVL system was designed and implemented within seven months, showcasing strong execution capabilities[17] - The company's product pipeline includes 28 products under development, with five already commercialized[19] - The company's core product, AcoArt Orchid® & Dhalia™, has been launched in 12 countries, including Germany, Italy, and Brazil, with no major adverse events reported[22] - AcoArt Orchid® & Dhalia™ achieved a 91.4% patency rate at six months and 66.1% at 12 months in a clinical trial for AVF stenosis treatment[22] - The company expects to receive NMPA approval for AcoArt Orchid® & Dhalia™ in the nephrology field by 2022 and in the neurology field by 2024[22] - AcoArt Orchid® & Dhalia™ generated revenue of approximately RMB 275.07 million in China and overseas for the year ended December 31, 2021[23] - AcoArt Tulip™ & Litos™ generated revenue of approximately RMB 24.09 million in China and overseas for the year ended December 31, 2021[24] - AcoArt Iris™ & Jasmin™ and AcoArt Lily™ & Rosmarin™ generated combined revenue of approximately RMB 4.58 million for the year ended December 31, 2021[27] - Peripheral aspiration system (AcoStream™) generated revenue of approximately RMB 35,400 for the year ended December 31, 2021[27] - The company has 14 pipeline products in vascular surgery, 10 in cardiology, 2 in nephrology, and 2 in neurology[25] - The company is expanding the indications of AcoArt Orchid® & Dhalia™ for the treatment of vasculogenic ED[25] - The company submitted an IDE application to the FDA for AcoArt Litos™ in January 2022 and is screening business partners for US clinical trials[24] - The company expects to obtain NMPA approval for peripheral support catheters in 2022[28] - The company expects to submit product registration for above-knee PTA balloons to the NMPA in 2022 and obtain approval in the same year[29] - The company expects to obtain NMPA approval for the radiofrequency ablation system in 2022[29] - Peripheral scoring balloon is in the preclinical research stage, expected to submit for NMPA registration in 2022 and obtain approval in 2023[31] - Second-generation peripheral aspiration system is under development, expected to obtain NMPA approval in 2023[31] - Peripheral IVL system is under development, expected to obtain NMPA approval in 2026[31] - Peripheral thrombectomy device is under development, expected to obtain NMPA approval in 2025[31] - Peripheral coil is under development, expected to obtain NMPA approval in 2024[31] - Carotid artery stent is under development, expected to obtain NMPA approval in 2025[31] - Coronary CTO antegrade microcatheter is under development, expected to obtain NMPA approval in 2023[32] - Coronary CTO re-entry balloon with a diameter of 0.8mm is under development, expected to obtain NMPA approval in 2023[33] - Coronary dual-lumen selective microcatheter is under development, expected to submit for NMPA registration in 2022 and obtain approval in 2023[33] - AcoArt Camellia™ for coronary small vessel disease is undergoing RCT, expected to obtain NMPA approval in 2024[33] - The company developed and launched China's first peripheral DCB product in 2016, leading the second similar product by approximately four years[94] - The second DCB product was designated as a "Breakthrough Device" by the FDA in 2019 and received NMPA approval in December 2020, becoming the first BTK DCB product globally approved based on multicenter randomized controlled clinical trial results[94] - The company has developed six new products, including peripheral IVL systems, peripheral coils, and coronary IVL systems, with rapid development progress[94] - The company's 2,400 square meter facility in Shenzhen obtained ISO13485 certification in 2021, enhancing manufacturing capabilities for balloon catheter tubing[94] - AcoArt Orchid® & DhaliaTM, a paclitaxel DCB, has been approved by the National Medical Products Administration (NMPA) and is available in 12 countries including Germany, Italy, and Brazil as of December 31, 2021[196] - AcoArt TulipTM & LitosTM, another paclitaxel DCB, received FDA "Breakthrough Device" designation in 2019 and NMPA approval in December 2020, making it the first BTK DCB product approved in China[197] - The company plans to expand its product offerings by leveraging synergies among its four core technologies and aims to increase sales of AcoArt Orchid® & DhaliaTM[198] - AcoArt LitosTM is undergoing clinical trial partner screening for the U.S. market, with plans to initiate relevant application procedures[197] - The company's DCB products are designed to address vascular diseases, with a focus on reducing restenosis and thrombosis risks compared to traditional PTA balloons and stents[195] - AcoArt Orchid® & DhaliaTM was the first peripheral DCB product launched in China, receiving CE certification in 2014 and NMPA approval in 2016[196] - The company aims to expand its geographic coverage and global strategic layout to become a global leader in the field[198] - AcoArt TulipTM & LitosTM is compatible with 0.018-inch (TulipTM) and 0.014-inch (LitosTM) guidewires, targeting chronic limb ischemia treatment[197] - The company holds multiple domestic and international core intellectual property rights, supporting its innovative medical device development[192] - AcoArt Orchid® & DhaliaTM is compatible with 0.035-inch (Orchid®) and 0.018-inch (DhaliaTM) guidewires, targeting lower extremity arterial disease (LEAD)[196] - The company's first product, AcoArt Orchid® & Dhalia™, launched in 2016, was China's first peripheral DCB product[199] - AcoArt Tulip™ & Litos™, launched in 2020, remains the world's first and only below-the-knee DCB product[199] - The company focuses on four major platform technologies and five therapeutic areas to expand its product pipeline[200] - The company aims to become a comprehensive vascular intervention technology platform company[200] - The company maintains a leading position in its niche market despite challenges such as localized COVID-19 outbreaks and economic downturns[200] - The company emphasizes strict quality control and a mature quality management system to ensure product safety[199] - The company prioritizes clinical needs, with R&D driven by unmet clinical demands[199] - The company is committed to green development and contributes to building a low-carbon society[200] - The company values talent development and has established a multi-level talent梯队 to enhance professional skills[199] - The company maintains close, mutually beneficial relationships with suppliers to ensure high-quality products and services[200] R&D and Innovation - The company established Acotec Technologies Limited in California, focusing on forward-looking and innovative product development[9][14] - Four global top medical experts joined the Scientific Advisory Committee to guide clinical research and product launches in the US and Europe[9][14] - The company's employee count reached approximately 400, with the R&D team growing to 86 members[16] - The company has obtained ISO 13485 certification for its 2,400 square meter facility in Shenzhen, enhancing its manufacturing capabilities[18] - The company has a strong internal R&D team of 86 members, led by experienced professionals including Ms. Li Weijia, Ms. Yaze Li, Mr. Ruijie Zhang, Mr. Lu Lizhong, and Mr. Scott Wilson[39] - The company owns 27 registered patents and has 13 pending patent applications as of December 31, 2021[39] - The company established a new R&D team in a 600-square-meter laboratory in Shenzhen, focusing on active medical devices[39] - The company set up Acotec Technologies Limited in California, USA, as its R&D center, led by Mr. Scott Wilson, who has over 25 years of experience in medical device development[39] - The company expanded its Scientific Advisory Board with four top doctors to guide global studies for FDA registration and new product development in peripheral intervention[41] - The company's main production facility in Beijing covers 6,000 square meters, and it expanded production capacity with a 2,400-square-meter facility in Shenzhen, achieving ISO 13485 certification[42] - The company has a comprehensive intellectual property portfolio, including 27 registered patents, 26 registered trademarks, and 13 pending patent applications as of December 31, 2021[44] - The company's clinical trials and product sales were not significantly impacted by COVID-19, with no confirmed or suspected cases reported among employees as of December 31, 2021[45] - The company's future growth heavily depends on the successful development and commercialization of its pipeline products[99] - The company's clinical product development involves a lengthy and costly process with uncertain outcomes[99] - The company has a total of 313,389,171 issued shares as of December 31, 2021[112] - Li Jing holds 55,291,087 shares, representing approximately 17.64% of the company's equity[112] - Silvio Rudolf Schaffner holds 4,272,065 shares, representing approximately 1.36% of the company's equity[112] - CA Medtech Investment (Cayman) Limited holds 158,614,642 shares, representing approximately 50.61% of the company's equity[115] - CPEChina Fund III, L.P. holds 161,877,642 shares, representing approximately 51.65% of the company's equity[115] - Cosmic Elite Holdings Limited holds 43,062,647 shares, representing approximately 13.74% of the company's equity[115] - The company's executive directors have service agreements with an initial term of three years from the listing date[109] - The company's non-executive directors have service agreements with an initial term of three years from the listing date[109] - The company's independent non-executive directors have appointment letters with a term of three years from the listing date[109] - The company confirms that all independent non-executive directors are independent as of the date of the annual report[110] - The company had a total of 313,389,171 shares issued as of December 31, 2021[116] - CPE Investment Wu Limited holds 3,263,000 shares of the company, with 85.61% owned by CPEChina Fund III and 14.39% by CPE Global Opportunities Fund[116] - Cosmic Elite, a subsidiary of Nexus Partners Group Limited, holds 43,062,647 shares, with 95.31% ownership by Nexus Partners Group Limited[116] - No warrants were issued by the company during the year ended December 31, 2021[119] - No significant legal proceedings or claims were pending or threatened against the company as of December 31, 2021[123] - The company has established a Remuneration Committee to review and establish transparent procedures for the remuneration policies of directors and senior management[125] - One senior management member received remuneration between HKD 1,000,001 and HKD 1,500,000, while two others received between HKD 8,500,001 and HKD 9,500,000 for the year ended December 31, 2021[126] - The Restricted Share Unit Plan was approved on January 8, 2021, with 12,228,440 ordinary shares issued to Sino Fame Ventures Limited[127] - No Restricted Share Units were granted, vested, canceled, or lapsed under the Restricted Share Unit Plan during the year ended December 31, 2021[127] - The Restricted Share Unit Plan is effective for ten years from its adoption date, with no further awards to be granted after the expiration[128] - The total number of shares available for issuance under the Restricted Share Unit Plan is 12,228,440 shares, held by the trustee nominee shareholder Sino Fame Ventures Limited[129] - The Restricted Share Unit Plan includes participants such as employees, officers, consultants, and other individuals or entities providing services to the company[129] - The Restricted Share Unit Plan has a vesting period, and if conditions are not met, the vesting date is postponed by one year, with unvested units automatically forfeited if conditions remain unmet[130] - The company adopted a Share Award Plan on December 31, 2021, managed by Hengtai Trust (Hong Kong) Limited, with awards granted in the form of shares or cash based on the actual sale price of the shares[131] - The Share Award Plan aims to recognize contributions and incentivize selected participants to remain with the company, promoting its continuous operation and development[132
先瑞达医疗-B(06669) - 2021 - 年度财报