Financial Performance - Revenue for the six months ended June 30, 2021, was RMB 140,195 thousand, representing a 106.0% increase compared to RMB 68,066 thousand for the same period in 2020[7] - Gross profit for the same period was RMB 123,677 thousand, up 118.6% from RMB 56,580 thousand year-over-year[7] - The company reported a loss before tax of RMB (6,590) thousand, compared to a profit of RMB 18,195 thousand in the previous year, indicating a significant shift in financial performance[7] - The net loss attributable to the owners of the company for the period was RMB (12,536) thousand, compared to a profit of RMB 17,308 thousand in the prior year[7] - Adjusted net profit for the period was RMB 37.966 million, a 120.0% increase compared to RMB 17.260 million for the same period in 2020[57] - The company reported a net cash inflow from operating activities of RMB 21,033,000 for the six months ended June 30, 2021, compared to RMB 15,931,000 for the same period in 2020, representing a year-over-year increase of approximately 32.9%[92] - The company experienced a decrease in cash and cash equivalents of RMB 123,231,000 for the six months ended June 30, 2021, compared to a decrease of RMB 2,373,000 in the same period of 2020[93] - The company’s total liabilities as of June 30, 2021, amounted to RMB 290,976,000, with net current liabilities of RMB 101,433,000[97] Product Development and Pipeline - The product pipeline includes 4 commercialized products and 24 products under development, all classified as Class III medical devices by the National Medical Products Administration[9] - The company is a pioneer in expanding the indications for DCB products, targeting various vascular diseases including peripheral artery disease (PAD) and coronary artery disease (CAD)[8] - The company also develops other therapeutic and surgical medical devices, such as thrombectomy devices and radiofrequency ablation systems[8] - The company is expanding its pipeline with 11 products in development across various medical fields[15] - The coronary CTO recanalization balloon, with a diameter of 0.8mm, is under development and is expected to be the smallest balloon on the market, with product registration submission planned for Q1 2022 and NMPA approval expected in Q3 2022[26] - AcoArt CamelliaTM, a paclitaxel DCB for treating small vessel disease, has recruited 46 patients as of August 3, 2021, with a target of completing recruitment of 230 patients by Q1 2022 and NMPA submission expected in Q1 2023[30] Market Presence and Expansion - The company aims to enhance its market presence and product offerings through continuous innovation and expansion strategies[8] - AcoArt Orchid® & DhaliaTM generated revenue of RMB 122.7 million in sales in China and overseas for the six months ended June 30, 2021[13] - As of August 3, 2021, AcoArt Orchid® & DhaliaTM was available in 1,056 hospitals in China for peripheral vascular intervention[12] - The company has launched AcoArt Orchid® in 12 other countries including Germany, Italy, and Spain as of August 3, 2021[12] - The company plans to continue expanding in both the Chinese and global markets, focusing on product development and growth through internal development, mergers, and acquisitions[67] Research and Development - Research and development costs for the six months ended June 30, 2021, were RMB 61.4 million, an increase of 327.9% from RMB 14.3 million for the same period in 2020, driven by acquisitions and increased employee costs[50] - The company has a strong internal R&D team of 62 members and holds 25 registered patents and 15 pending patent applications as of August 3, 2021[36] - The company plans to continue investing in research and development to enhance its product offerings and market position[87] Regulatory and Compliance - AcoArt Orchid® received CE marking in 2014 and regulatory approval from the National Medical Products Administration in 2016[12] - The company plans to submit a product registration application to the National Medical Products Administration by the end of 2021[12] - The company has adopted a corporate governance code and has complied with all applicable provisions since the listing date, with a commitment to maintaining high standards of corporate governance[70] Financial Position and Liabilities - Cash and cash equivalents as of June 30, 2021, were RMB 20.7 million, a decrease of 85.9% from RMB 147.1 million as of December 31, 2020, mainly due to operating expenses and dividend payments[60] - Total borrowings as of June 30, 2021, amounted to RMB 142.7 million, an increase of 613.7% from RMB 20.0 million as of December 31, 2020, primarily due to a loan of USD 19 million obtained from Silicon Valley Bank[61] - The capital to debt ratio as of June 30, 2021, decreased to -159.9% from -197.1% as of December 31, 2020[61] - The company’s total equity (deficit) as of June 30, 2021, was RMB (290,976) thousand, compared to RMB (281,009) thousand at the end of 2020[89] Shareholder Information - CA Medtech Investment (Cayman) Limited holds 50.61% of the company's shares, totaling 158,614,642 shares[77] - CPEChina Fund III, L.P. has a 51.65% stake in the company, with 161,877,642 shares[77] - Cosmic Elite Holdings Limited owns 13.63% of the company, amounting to 42,720,647 shares[77] - Morgan Stanley & Co. International plc holds 5.88% of the company's shares, totaling 18,455,000 shares[78] - The total number of shares issued by the company as of the listing date is 313,389,171 shares[78] Employee and Management - As of August 3, 2021, the company employed a total of 287 staff, primarily based in China[66] - Total employee costs increased to RMB 75,505,000, up from RMB 21,592,000 in the previous year, reflecting a rise of approximately 250%[1] - Total short-term employee benefits for key management personnel increased to RMB 5,109,000 for the six months ended June 30, 2021, up from RMB 3,913,000 in 2020, reflecting a 30.5% growth[147]
先瑞达医疗(06669) - 2021 - 中期财报