New Horizon Health Limited 諾輝健康2023 股份代號:6606.HK 中期報告 目 錄 2 釋義 6 技術詞彙 7 公司資料 8 財務摘要及業務摘要 11 管理層討論及分析 28 其他資料 57 簡明綜合財務報表審閱報告 58 簡明綜合損益及其他全面收益表 59 簡明綜合財務狀況表 61 簡明綜合權益變動表 62 簡明綜合現金流量表 63 簡明綜合財務報表附註 釋義 於本報告內，除文義另有所指外，以下詞彙具有下列涵義。該等詞彙及其釋義未必與任何行業標準釋義相 符，亦未必可直接與其他在本公司所屬相同行業內經營的公司所採納的同類詞彙比較。 | --- | --- | --- | |---------------------------------|-------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 New Horizon Health Limited 諾輝健康 （於開曼群島註冊成立的有限公司） （股份代號：6606） 截至2023年6月30日止六個月之 中期業績公告 諾輝健康（「本公司」）董事（「董事」）會（「董事會」）欣然公佈本公司、其附屬公司 及綜合聯屬實體（「本集團」或「我們」）截至2023年6月30日止六個月（「報告期」） 的未經審核簡明綜合中期業績，連同截至2022年6月30日止六個月的比較數字。 1 | --- | --- | |-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Product Portfolio - The company's core product, "Chang Wei Qing IVD," is a proprietary reagent approved by the National Medical Products Administration for the Chang Wei Qing test procedure[4] - The company's non-invasive fecal FIT-DNA test device, "Chang Wei Qing," is a key product in its portfolio[3] - The company's non-invasive urine-based cervical cancer home screening test, "Gong Zheng Qing," is part of its product offerings[3] - The company's non-invasive fecal FIT screening product, "Pu Pu Guan," is used to test for hemoglobin biomarkers related to colorectal cancer[5] - The company's fecal Helicobacter pylori self-test screening product, "You You Guan," is another significant product in its lineup[5] - Changweiqing IVD was approved as a Class III medical device by the National Medical Products Administration (NMPA) in November 2020[17] - Changweiqing's risk assessment algorithm was registered as a Class II medical device by the NMPA in November 2020[17] - Changweiqing sampling kit was registered as a Class I medical device by the NMPA in December 2016[17] - Pupuguan, a non-invasive colorectal cancer screening product, targets a population of 633 million in China[18] - Pupuguan received CE certification in June 2018[18] - Youyouguan, a gastric cancer screening product, completed its registration trial in November 2020 and submitted a Class III medical device registration application to the NMPA[19] - Gongzhengqing, a non-invasive urine-based cervical cancer screening test, began its registration clinical trial in June 2022[20] - Ganzhengqing, a multi-omics liquid biopsy liver cancer screening test, is expected to start registration clinical trials in 2024[21] - Yibiqing (tentative name), a non-invasive nasopharyngeal cancer screening test, is planned to undergo registration trials starting in June 2024[22] - The company's proprietary non-invasive multi-target FIT-DNA test, Changweiqing, is the first and only molecular cancer screening test approved by the National Medical Products Administration in China, targeting 120 million high-risk individuals for colorectal cancer[77] - The company has three self-developed cancer screening tests: Pupu Tube (approved in 2018), Changweiqing (approved in 2020), and Youyou Tube (approved in 2022)[27] - Changweiqing is the only screening test in China capable of detecting precancerous lesions such as advanced adenomas[28] - The company's Pupu Tube is the first and only self-administered FIT screening product approved by the NMPA for colorectal cancer screening in China[28] Financial Performance - Revenue in 2022 reached RMB 765.0 million, a significant increase from RMB 212.8 million in 2021[8] - Gross margin in 2022 improved to 84.5%, up from 72.7% in 2021[8] - Sales and marketing expenses in 2022 were RMB 539.4 million, accounting for 70.5% of revenue[8] - R&D expenses in 2022 were RMB 87.9 million, representing 11.5% of revenue[8] - Adjusted net loss in 2022 was RMB 104.6 million, a reduction from RMB 259.2 million in 2021[8] - Cash and specific financial assets as of December 31, 2022, amounted to RMB 1,572.7 million[8] - The gross margin for the product "Chang Wei Qing" in 2022 was 83.4%, while "Pu Pu Guan" and "You You Guan" had gross margins of 82.1% and 90.7%, respectively[8] - Annual revenue in 2022 was nearly 11 times that before the IPO in 2020, with a continuous two-year revenue growth exceeding 220%, and the overall gross margin increased by 32 percentage points[10] - Revenue from the colorectal cancer screening molecular test Changweiqing reached RMB 764.4 million, a 259.3% year-on-year increase, with a gross margin of 83.4%, up 7.4 percentage points year-on-year[10] - Revenue from the self-test FIT screening product Pupuguan reached RMB 200.6 million, a 73.7% year-on-year increase, with a gross margin of 82.1%, up 10.6 percentage points year-on-year[11] - Revenue from the Helicobacter pylori self-test product Youyouguan reached RMB 207.8 million with a gross margin of 90.7%[11] - Revenue for the year ended December 31, 2022, reached RMB 765.0 million, a 259.5% increase compared to RMB 212.8 million in 2021, driven by growth in product sales (Chang Wei Qing, Pu Pu Guan) and the launch of You You Guan in January 2022[32] - Chang Wei Qing revenue recognition units surged to 361,400 in 2022, a 150.1% year-over-year increase, driven by higher customer acceptance and product awareness among doctors[29] - Pu Pu Guan revenue recognition units reached 7,962,600 in 2022, a 37% year-over-year increase, supported by strong market demand and increased sales through key customer partnerships[29] - You You Guan, launched in January 2022, achieved revenue recognition units of 3,550,900 in 2022, driven by consumer interest in non-invasive Helicobacter pylori testing[29] - Gross profit for 2022 was RMB 646.2 million, a 317.8% increase from RMB 154.6 million in 2021, with gross margin rising to 84.5% from 72.7% in 2021[39] - Chang Wei Qing contributed RMB 356.6 million in revenue in 2022, up from RMB 97.2 million in 2021, with hospital channels becoming the largest and fastest-growing revenue source[33] - Pu Pu Guan revenue reached RMB 200.6 million in 2022, up from RMB 115.5 million in 2021, driven by increased sales and higher unit revenue from direct-to-consumer and physical examination center channels[34] - You You Guan generated RMB 207.8 million in revenue in 2022, its first year of launch, supported by strong sales and unit revenue growth in direct-to-consumer and physical examination center channels[34] - Sales costs increased to RMB 118.8 million in 2022, up 104.4% from RMB 58.1 million in 2021, primarily due to higher sales volumes[35] - Inventory write-downs rose to RMB 3.7 million in 2022, a 153.0% increase from RMB 1.5 million in 2021, driven by higher revenue and channel shipments[38] - Gross profit of Chang Wei Qing in 2022 reached RMB 296.987 million with a gross margin of 83.4%, up from RMB 73.914 million and 76.0% in 2021, driven by economies of scale, higher revenue per test in hospital and direct-to-consumer channels, and optimized channel mix[40][41] - Pu Pu Guan's gross profit in 2022 was RMB 164.642 million with a gross margin of 82.1%, compared to RMB 82.600 million and 71.5% in 2021, due to increased revenue per test and reduced unit production costs[40][42] - You You Guan, launched in January 2022, achieved a gross margin of 90.7% for the year[40][42] - Other income decreased by 29.5% to RMB 16.0 million in 2022 from RMB 22.7 million in 2021, primarily due to reduced monetary funds[44] - Sales and marketing expenses increased by 104.5% to RMB 555.1 million in 2022 from RMB 271.4 million in 2021, mainly due to higher employee costs and promotional expenses[45] - R&D expenses rose by 60.6% to RMB 94.6 million in 2022 from RMB 58.9 million in 2021, driven by increased employee costs and R&D material costs[46] - Administrative expenses increased by 46.0% to RMB 159.6 million in 2022 from RMB 109.3 million in 2021, primarily due to higher employee costs[48] - Trade and other receivables impairment losses surged by 223.1% to RMB 21.4 million in 2022 from RMB 6.6 million in 2021, mainly due to deteriorating cash flows of customers affected by COVID-19[49] - Financial costs decreased by 5.1% to RMB 7.4 million in 2022 from RMB 7.8 million in 2021, primarily due to lower bank loan interest rates[50] - Income tax expense for the year ended December 31, 2022, was RMB 0.7 million, compared to zero in the same period of 2021[51] - Adjusted net loss for 2022 was RMB 104.575 million, compared to RMB 259.221 million in 2021[52][53] - Cash and cash equivalents, including time deposits and pledged bank deposits, decreased by 16.4% to RMB 1,572.7 million as of December 31, 2022, from RMB 1,882.1 million in 2021[55] - Secured bank borrowings increased to RMB 180 million as of December 31, 2022, from RMB 79.5 million in 2021[55] - Asset-liability ratio increased to 18% as of December 31, 2022, up from 10% in 2021[56] - The company received net proceeds of RMB 670 million from a subscription in January 2023[9] - The company did not recommend the payment of a final dividend for the year ended December 31, 2022[79] - The company has not issued any equity securities or debt for cash during the reporting period[86] - The company has not purchased, sold, or redeemed any of its listed securities during the reporting period[85] - The company's shares were listed on the Hong Kong Stock Exchange on February 18, 2021, with net proceeds from the global offering amounting to approximately 2,190.5 million HKD[87] - As of December 31, 2022, the company had utilized 54.7% (1,197,896 HKD) of the net proceeds from its global offering, with the remaining funds to be used according to the plans outlined in the prospectus[87] - 40% of the funds (HK$876.2 million) will be used for the commercialization and further development of Changweiqing (as a medical service or standalone product), expected to be fully utilized by the second half of 2025[89] - 5% of the funds (HK$109.525 million) will be allocated to enhance colorectal cancer screening awareness and market penetration for Pupuguan, expected to be fully utilized by the second half of 2025[89] - 30% of the funds (HK$657.15 million) will be used for ongoing and planned R&D to further develop Youyouguan, Gongzhengqing, and other early-stage pipeline products, expected to be fully utilized by the second half of 2025[89] - 15% of the funds (HK$328.575 million) will be used for potential acquisitions or external introductions of cancer screening candidate products to diversify the product portfolio, expected to be fully utilized by the second half of 2025[89] - 10% of the funds (HK$219.05 million) will be used for working capital and other general corporate purposes, expected to be fully utilized by the second half of 2025[89] - The total funds allocated amount to HK$2,190.5 million, with HK$1,565.801 million already utilized and HK$573.197 million remaining[89] Corporate Governance and Leadership - The company's annual general meeting of shareholders is scheduled for June 9, 2023[3] - The company's restricted share unit plan and share option plan were approved and adopted on June 24, 2022[3] - The company's co-founder and CEO, Mr. Zhu, has extensive experience in the biotech and healthcare sectors, including roles at Samsung and General Electric[68] - Dr. Chen, the company's co-founder and Chief Scientific Officer, has over 20 years of experience in oncology R&D and holds multiple patents[70] - Mr. Yao, a non-executive director, has a background in technology and investment management, with experience in various industries including biotech[71] - Yu Danke was appointed as an Independent Non-Executive Director on February 5, 2021, and currently serves as the Chairman of the Audit Committee and a member of the Remuneration and Nomination Committees[72] - Yu Danke led a restructuring business with revenue of $50 million during his tenure as CFO and General Manager at Lightway Australia Pty Ltd[72] - Wu Hong was appointed as an Independent Non-Executive Director on February 5, 2021, and serves as the Chairman of the Remuneration Committee and a member of the Nomination Committee[73] - Dr. Li Kwok-tung was appointed as an Independent Non-Executive Director on February 5, 2021, and is a member of the Audit Committee[74] - Dr. Chen Yiyou, a co-founder of the group, was appointed as Chief Scientific Officer on June 7, 2018, and as an Executive Director on October 9, 2020[75] - Zhu Yeqing, a co-founder of the group, was appointed as CEO on June 7, 2018, and as an Executive Director on October 9, 2020[75] - Gao Yu joined the group as CFO on June 1, 2020, and has over 15 years of experience in the healthcare industry[75] - Dr. Lü Ning has been serving as the Chief Technology Officer since November 19, 2015, and has played a significant role in product development and regulatory approvals[75] - The Board consists of 6 members, including 2 executive directors, 1 non-executive director, and 3 independent non-executive directors[189] - Mr. Zhu Yeqing serves as both Chairman and CEO, a dual role deemed beneficial for the company's operational focus and strategic planning[190] - The company complies with the requirement of having at least three independent non-executive directors, with one possessing appropriate professional qualifications in accounting or financial management[191] - Non-executive directors, including independent non-executive directors, have a designated term of three years and are eligible for re-election[192] - The Board is responsible for leading and monitoring the company, overseeing operations, and ensuring robust internal control and risk management systems[193] - Mechanisms are in place to ensure the Board's independence, including evaluating candidates' ability to provide independent opinions[194] - The company ensures that independent non-executive directors can provide independent opinions and has channels for obtaining external independent professional advice[195] - Directors are required to participate in continuous professional development to stay updated on regulatory changes and enhance their knowledge and skills[196] - All directors have participated in training related to their duties and responsibilities during the reporting period[197] - The Board has adopted a diversity policy aimed at achieving a balanced mix of knowledge and skills, including expertise in business management, finance, and life sciences[198] - The company has achieved a gender diversity target of at least 10% or 1 female director on the board, with current female representation at 16.7% (1 out of 6)[200] - Senior management gender diversity stands at 41.7% female (10 out of 24), exceeding the 30% target[200] - Overall employee gender distribution is nearly balanced, with 50.8% female (446 out of 878) and 49.2% male (432 out of 878)[200] - The company has met its target of at least 40% female representation among other employees, currently at 51.1% (436 out of 854)[200] - Male representation in the board remains high at 83.3% (5 out of 6), indicating room for improvement in top-level gender diversity[200] - The company has implemented measures to support gender diversity in recruitment and prohibits gender discrimination[199] - The company reports no known factors or circumstances that would make achieving gender diversity more challenging or less relevant[200] Research and Development - The company established a research center in Hong Kong in January 2023, focusing on cancer screening pipeline development and international market expansion[11] - The urine-based cervical cancer screening test Gongzhengqing began registration trials in June 2022 and recruited its first participant in November 2022[11] - The PANDA project, a pan-cancer early detection clinical project targeting over 22 types of cancer, was launched in China in November 2022[11] - Gongzhengqing obtained CE certification in February 2023[11] - The company's proprietary DNA extraction technology has a success rate of approximately 99.4% in purifying evaluable DNA from highly complex stool samples[24] - The company has developed a clinically validated risk assessment algorithm, the first of its kind approved by the National Medical Products Administration (NMPA) for cancer screening[24] - The company's R&D team consists of over 74.6% members holding master's or doctoral degrees, led by Chief Scientific Officer Dr. Chen Yiyou and Chief Technology Officer Dr. Lü Ning[24] - The company operates three laboratories in Beijing, Hangzhou, and Guangzhou, with a total area of approximately 7,000 square meters, all certified for clinical use[25] - The company's main production facility in Hangzhou spans approximately 11,300 square meters and utilizes advanced automation to enhance efficiency and reduce costs[26] - The company plans to enhance its R&D capabilities by recruiting more experts and collaborating with academic and medical institutions, focusing on developing screening tests for other cancer types[64] - The company aims to launch Gong Zheng Qing, a cervical cancer screening product, and has submitted a registration application for You You Tube to the National Medical Products Administration[64] - The company plans to selectively expand geographically, pursue strategic partnerships, and explore acquisition opportunities to maximize the global value of its products[66] - The company intends to acquire or collaborate with candidates that have significant market potential or cutting-edge technologies to complement its existing product portfolio[66] Market and Strategic Partnerships - The company has strategic partnerships with AstraZeneca, JD Health, Ping An Good Doctor, and others to promote colorectal cancer screening awareness and product penetration[27] - The colorectal cancer screening market in China is expected to grow rapidly due to aging population, increased public awareness, and government support[28] - The company plans to expand market penetration for its colorectal cancer screening products, Chang Wei Qing and Poop Tube, leveraging its leading position in the Chinese market[62] - The company aims to increase awareness of cancer screening