Financial Data and Key Metrics Changes - The company's revenue for 2023 is projected to be 9.4 billion, down from 10.4 billion in 2022, reflecting a decrease of 1 billion [10][11] - The decline in revenue is primarily attributed to the impact of centralized procurement on three key products, which saw a sales drop of approximately 1.7 billion [10][11] - Gross profit decreased by 800 million, leading to a net profit decline of 600 million [13][59] Business Line Data and Key Metrics Changes - The company has five innovative drugs that have entered the commercialization phase, with one recently approved [14][15] - The sales of non-centralized procurement products showed a growth rate of around 10%, while centralized procurement products experienced a significant decline [11][12] - The company aims to produce at least three marketable innovative drugs annually, with a focus on specialized fields such as central nervous system and dermatology [7][8] Market Data and Key Metrics Changes - The company is focusing on the Southeast Asian market, establishing a comprehensive platform for development, production, and commercialization [8][40] - The company acquired a 45% stake in a Southeast Asian CDMO factory to enhance production capabilities and meet market demands [41][42] - The overall market environment in Southeast Asia is seen as favorable, with a growing demand for high-quality innovative drugs [49][50] Company Strategy and Development Direction - The company is transitioning towards a model that emphasizes innovative drug development and commercialization, moving away from reliance on traditional products [6][7] - The strategic focus includes establishing a strong presence in specialized therapeutic areas and expanding into Southeast Asia as a key growth market [8][40] - The company has set ambitious internal KPIs for new drug approvals, aiming for 10 to 12 new drugs by 2027 [17][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges posed by centralized procurement but remains optimistic about recovery in the second half of the year [35][56] - The company expects to achieve stable revenue in 2023, with a potential for double-digit growth starting in 2025 [57][58] - Management emphasizes the importance of innovative drugs in driving future profitability and market share [60][62] Other Important Information - The company has a robust pipeline of 13 innovative drugs, with several in various stages of regulatory approval [16][17] - The company is committed to maintaining a stable sales team despite recent challenges, ensuring continued support for new product launches [12][13] Q&A Session All Questions and Answers Question: What is the current status of the recently approved innovative products? - The recently approved methylene blue sustained-release tablet has just entered the commercialization phase, while other innovative products are progressing well in clinical applications [44][45] Question: How does the company assess the Southeast Asian market's payment capacity and policy differences? - The Southeast Asian market is seen as having a significant demand for both low-cost generics and high-quality innovative drugs, with a favorable environment for market entry [48][49] Question: What are the expectations for revenue growth in the second half of the year? - The company anticipates a positive growth trajectory in the second half of the year, with expectations for revenue to stabilize compared to the previous year [56][57]

研究报告Research Report 24 Apr 2024 康哲药业 China Medical System Holdings (867 HK) 集采下业绩承压，创新管线陆续迎来转化 Earnings Under Pressure Due to VBP, Expecting Transformation of Innovative Pipeline [观Ta点bl聚e_焦yem Inevie1s] tment Focus [Tab维le_持Inf优o] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$7.10 康哲药业公布 2023 年业绩：营业额 80.1 亿元（-12.4%）；若全按 目标价 HK$9.90 药品销售收入计算，营业额 94.7 亿元（-9.8%）。毛利率 76.2% HTI ESG 2.0-2.5-4.0 （-0.7pct）；销售费用 25.1 亿元（-7.7%），销售费用率 31.3% E-S-G: 0-5, (Please refer to ...

Financial Performance - Revenue decreased by 12.4% to RMB 8,013.3 million, compared to RMB 9,150.3 million in the previous year; if calculated based on pharmaceutical sales, revenue decreased by 9.8% to RMB 9,472.2 million[6]. - Gross profit decreased by 13.2% to RMB 6,109.2 million, compared to RMB 7,035.8 million in the previous year; if calculated based on pharmaceutical sales, gross profit decreased by 12.4% to RMB 6,053.7 million[6]. - Annual profit decreased by 27.2% to RMB 2,384.4 million, compared to RMB 3,276.2 million in the previous year; normalized annual profit decreased by 18.8% to RMB 2,709.3 million[6]. - Basic earnings per share decreased by 26.3% to RMB 0.9792, compared to RMB 1.3281 in the previous year[6]. - The proposed final dividend per share is RMB 0.0783, resulting in a total dividend of RMB 0.3917 per share for the year, a decrease of 26.7% from the previous year[6]. - The group's sales revenue for the year was RMB 8,013.3 million, a decrease of 12.4% compared to RMB 9,150.3 million in 2022[34]. - The annual profit was RMB 2,384.4 million, down 27.2% from RMB 3,276.2 million in 2022[34]. - The normalized annual profit decreased by 18.8% to RMB 2,709.3 million from RMB 3,338.3 million in 2022[34]. Product Development and Innovation - The company launched three innovative drugs in China, all of which were included in the national medical insurance catalog[7][8]. - The company obtained exclusive promotion rights for a new drug Y-3 injection for ischemic stroke in August 2023, with clinical trials progressing steadily[10]. - The innovative drug Tretinoin injection has entered large-scale clinical application[14]. - Three innovative drugs, including Diazepam nasal spray, Tretinoin injection, and Methotrexate injection, were successfully approved for listing in China, significantly enhancing accessibility and affordability[19]. - The company has approximately 30 differentiated innovative pipeline products, actively promoting clinical development and commercialization[17]. - The exclusive licensing rights for the new generation iron-based non-calcium phosphate binder, Sucrose Hydroxyl Iron Chewable Tablets, were successfully obtained, marking the fourth innovative drug entering the commercialization phase[19]. - The company has established a collaborative framework with Junshi Bioscience to commercialize Tretinoin in Southeast Asia, enhancing the availability of high-quality innovative drugs for local cancer patients[14]. - The innovative medical device EyeOP1 for glaucoma treatment has completed market access work in multiple provinces and cities[14]. - The company is focusing on specialized deep development in cardiovascular, digestive, dermatology, and ophthalmology sectors to accelerate expansion and ensure sustainable growth[22]. - The company is advancing clinical development for methotrexate injection for rheumatoid arthritis, with NDA acceptance in December 2023, aiming to become the first subcutaneous treatment for RA in China[46]. - The diazepam nasal spray has been recognized in expert consensus guidelines for the treatment of Dravet syndrome, indicating its clinical significance[39]. - The Yiluqu injection has been recommended in multiple authoritative psoriasis treatment guidelines globally, enhancing its market credibility[43]. - The methotrexate injection demonstrated better gastrointestinal safety compared to oral methotrexate, improving patient compliance[48]. - The company is progressing with over ten clinical trials focused on registration-based randomized controlled trials (RCTs), creating a robust pipeline[36]. - The innovative product pipeline is expected to drive future growth and market expansion, leveraging existing product synergies[36]. Market and Business Strategy - The company is committed to developing affordable differentiated pharmaceutical products to improve accessibility for patients in China and other developing countries[27]. - The Southeast Asia business, "Kanglian Health," has rapidly introduced a diverse product portfolio, covering various countries in the region[25]. - The group is expanding its international business into the Middle East and North Africa, establishing a commercialization network in emerging markets[25]. - The company is exploring market expansion opportunities both domestically and internationally[64]. - The company is engaged in strategic collaborations to enhance its research and development capabilities[64]. - The company aims to become "China's leading ophthalmic medical device company" through continuous optimization of its ophthalmic business[24]. - The company is enhancing its international supply chain and production capacity to ensure supply chain security and stability[25]. - The company has implemented organizational restructuring to enhance execution capabilities throughout the product lifecycle, ensuring a more agile modern organization[20]. Financial Management and Operations - Cash generated from operating activities was RMB 2,502.9 million, a decrease of 29.6% from RMB 3,553.2 million in the previous year[129]. - Cash used in investing activities decreased by 62.5% to RMB 442.3 million, compared to RMB 1,178.2 million in the previous year[130]. - Total bank borrowings decreased to RMB 1,269.7 million from RMB 1,783.3 million, with the debt-to-asset ratio declining to 7.2% from 10.0%[135]. - The company plans to utilize long-term bank loans and other financing tools to meet liquidity needs based on its development strategy and cash flow from operations[132]. - The group closely monitors interest rates and foreign exchange market fluctuations to mitigate risks[137]. - The group has signed several foreign exchange forward contracts to hedge foreign exchange risks as of December 31, 2023[136]. - The company has received clinical trial approval for the innovative drug TYK2 inhibitor (CMS-D001) from China's NMPA in January 2024[65]. - The company has also obtained clinical trial approval for the GnRH receptor antagonist (CMS-D002) from China's NMPA in February 2024[65]. Corporate Governance and Management - The company has implemented a share incentive plan on January 17, 2024, to motivate and retain key employees[188]. - The management team includes experienced professionals with over 10 years in marketing, operations, and finance, enhancing the company's strategic capabilities[165][166][180]. - The board of directors will present resolutions for the re-election of three directors at the upcoming annual general meeting[181]. - The company has confirmed the independence of all non-executive directors in accordance with listing rules[182]. - The company has approved the addition of five employees to its core employee benefits plan during the reporting period[186]. - The company has implemented a share incentive plan aimed at encouraging core management and key personnel to contribute to the launch and sales of new products[189]. - The total number of shares that can be purchased under the share incentive plan is capped at 100,000,000 shares, representing approximately 4% of the company's issued share capital as of the report date[192]. - The maximum number of shares that can be granted to any selected employee within any 12-month period shall not exceed 1% of the company's issued share capital at any time[193]. - The share incentive plan is set to be effective from January 17, 2024, and will last for ten years, with a remaining duration of 9 years and 9 months as of the report date[197]. - The board of directors sets performance targets based on the number of new products launched and their sales revenue[196]. Research and Development - Research and development expenses increased by 11.7% to RMB 815.9 million, representing 10.2% of revenue, up from 8.0% in the previous year, with R&D expenses alone rising by 55.6% to RMB 195.1 million[113]. - The company is focused on accelerating the clinical development and registration process of innovative products to continuously meet clinical demands[104]. - The company emphasizes its commitment to innovation and research in the pharmaceutical sector[65]. - The company is actively pursuing clinical trials for new treatments for conditions like acute ischemic stroke and non-alcoholic fatty liver disease[65]. - The company has a pipeline of products in various stages of clinical trials, including those for glaucoma and skin diseases[65].

CHINA MEDICAL SYSTEM HOLDINGS LIMITED 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，並表明概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔 任何責任。 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （股份代號：867） 截至二零二三年十二月三十一日止之年度業績公告 及建議修訂現有組織章程大綱及細則以及採納新組織章程大綱及細則 China Medical System Holdings Limited（「本公司」）之董事會（「董事會」）欣然公佈本公司及其附 屬公司（「本集團」或「康哲藥業」）截至二零二三年十二月三十一日止年度(「報告期」)之經審核合 併業績。 財務摘要 *正常化年度溢利是指剔除相關資產減值損失計提之後的年度溢利。 *僅供識別 - 1 - l 營業額下降 12.4%至人民幣 8,013.3 百萬元（二零二二年：人民幣 9,150.3 百萬元）；若全按藥品 銷售收入計算則營業額下降 9.8%至人民幣 9,472.2 百萬元（二零二二年：人民幣 10,497.5 ...

康智药业 2023 中期報告 康哲薬業控股有限公司 (股份代號:867) 康 哲® 執行董事 林剛先生 陳洪兵先生 陳燕玲女士 OH HN HS NH2 NH OH 目錄 | 公司資料 . | T | | --- | --- | | 財務摘要 | 2 | | 業務摘要 | 3 | | 管理層討論與分析 | ব | | 其他資料 . | ····· 25 | | 簡明合併損益及其他全面收益表 | | | 簡明合併財務狀況表 . | | | 簡明合併權益變動表 . | | | 簡明合併現金流量表 … | | | 簡明合併財務報表附注 | …… 35 | 公司資料 董事會 獨立非執行董事 梁創順先生 羅瑩女士 馮征先生 公司秘書 吳三燕女士 授權代表 吳三燕女士 林剛先生 審核委員會 馮征先生(主席) 梁創順先生 羅瑩女士 薪酬委員會 梁創順先生(主席) 羅瑩女士 馮征先生 提名委員會 羅瑩女士 (主席) 林剛先生 梁創順先生 馮征先生 環境、社會及管治委員會 陳燕玲女士 (主席) 梁創順先生 馮征先生 核數師 德勤 • 關黃陳方會計師行 註冊公眾利益實體核數師 主要往來銀行 招商銀行股份有限公司 渣打銀行（香港） ...

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，並表明概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失 承擔任何責任。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康 哲 藥 業 控 股 有 限 公 司 * （於開曼群島註冊成立的有限公司） （股份代號：867） 截至二零二三年六月三十日止六個月之中期業績公告 China Medical System Holdings Limited（「本公司」）之董事（「董事」）會（「董事會」）欣然公佈本公 司及其附屬公司（「本集團」或「康哲藥業」）截至二零二三年六月三十日止六個月（「報告期」） 之未經審計簡明合併業績。 財務摘要 ⚫ 營業額增長 3.6%至人民幣 4,610.1 百萬元（二零二二年中期：人民幣 4,447.8 百萬元）；若全 按藥品銷售收入計算則營業額增長 7.1%至人民幣 5,536.6 百萬元（二零二二年中期：人民幣 5,170.0百萬元） ⚫ 毛利增長 4.9%至人民幣 3,605.9 百萬元（二零二二年中期：人民幣 3,436.2 百 ...

Financial Performance - Revenue increased by 9.8% to RMB 9,150.3 million, with pharmaceutical sales revenue growth of 13.7% to RMB 10,497.5 million[6] - Gross profit grew by 12.6% to RMB 7,035.8 million, with pharmaceutical sales gross profit growth of 14.4% to RMB 6,910.5 million[6] - Annual profit increased by 8.3% to RMB 3,276.2 million, with basic earnings per share rising by 8.6% to RMB 1.3281[6] - Total assets increased to RMB 17,753.5 million in 2022, while total liabilities rose to RMB 3,016.5 million[7] - The group’s revenue increased by 9.8% to RMB 9,150.3 million, compared to RMB 8,337.2 million in the previous year[68] - Gross profit grew by 12.6% to RMB 7,035.8 million, with a gross margin of 76.9%, up from 74.9% in the previous year[69] - Annual profit grew by 8.3% to RMB 3,276.2 million, driven by continuous revenue growth[80] - The company reported a pre-tax profit of RMB 3,762,850 thousand, up from RMB 3,456,589 thousand in the previous year, indicating an increase of 8.8%[200] - Net profit attributable to the owners of the company for 2022 was RMB 3,258,992 thousand, compared to RMB 3,017,402 thousand in 2021, marking a growth of 8.0%[200] - Basic earnings per share for 2022 was RMB 1.3281, an increase from RMB 1.2228 in 2021, representing a rise of 8.6%[200] Product Development and Innovation - The company plans to launch three innovative products that are currently in the clinical development and registration phase[8] - The company has secured exclusive rights for the commercialization of a topical JAK inhibitor and a glaucoma treatment device in China and Southeast Asia[9] - The company is advancing the clinical and registration processes for several innovative drugs, including a nasal spray and an injection for psoriasis[9] - The company has successfully developed a pipeline of 30 innovative products, with 3 products expected to be approved for market launch in China soon[22] - The company emphasizes innovation as a core strategy, transitioning from mature products to innovative patented products since 2018, establishing itself as an open platform for pharmaceutical innovation and commercialization[14] - The company aims to accelerate clinical development and commercialization of innovative products, with expectations of annual approvals for new products[16] - The company is actively developing new products such as CF101 for psoriasis and CMS-D001 for autoimmune diseases, which are in the preclinical or clinical trial phases[42] - The diazepam nasal spray NDA is under review in China, demonstrating a bioavailability of 77.55% to 86.21% in different dosage groups, indicating rapid absorption and good safety tolerance[33] - The innovative oral HIF-PHI drug, intended for treating anemia in chronic kidney disease (CKD), has completed its first subject dosing in a Phase III clinical trial with 150 subjects planned for enrollment[39] Market Expansion and Strategic Partnerships - The company is expanding its operations into Southeast Asia, aiming to broaden its business scope and depth[23] - The company has entered into an exclusive licensing agreement for a series of affordable insulin products in Southeast Asia, marking a significant entry into this market[12] - The company views Southeast Asia as a key growth market, leveraging its global investment and commercialization experience to meet the demand for high-quality pharmaceutical products[18] - The company has secured exclusive rights to register, market, and distribute insulin products in eleven Southeast Asian countries, marking a significant entry into this market[62] - The company has established a strategic partnership with Incyte for the development and commercialization of ruxolitinib cream, enhancing its dermatology product portfolio[26] - The company acquired a 60% stake in the dermatological skincare R&D platform Hezero Pharmaceuticals, enhancing its product lineup for sensitive skin[11] Financial Management and Governance - The company has a robust financial management structure, with experienced professionals overseeing financial and tax compliance[108] - The company has a strong management team with extensive experience in the pharmaceutical industry, including Mr. Lin Gang, who has been the executive director since December 18, 2006[96] - The board consists of six directors, including three executive directors and three independent non-executive directors[156] - The company emphasizes compliance and governance, with a dedicated legal and compliance team led by the company secretary[109] - The company has committed to high standards of corporate governance to enhance accountability and transparency, thereby increasing long-term shareholder value[151] - The company has established a whistleblowing system to ensure proper handling of reports related to fraud management[182] Research and Development - The company has implemented a systematic management mechanism for the entire process of innovative product development, ensuring efficient clinical research and commercialization[25] - The company is continuously working on enhancing its research and development capabilities to support the launch of new therapies and maintain a competitive edge in the market[43] - Research and development expenses for the year were RMB 125,431 thousand, compared to RMB 114,761 thousand in 2021, reflecting an increase of 9.2%[200] Regulatory and Compliance - The company has established a robust quality management system to comply with GMP and GSP standards, ensuring ongoing regulatory compliance[133] - The company has not obtained product liability insurance in China, which poses a risk of significant costs and damage to customer relationships in the event of product-related claims[134] - The Chinese healthcare system is undergoing significant reforms, with frequent changes in laws and regulations that could adversely affect the company's operations if strategies are not timely adjusted[135] - The company must participate in government-led bidding processes, and failure to win bids could impact product sales capabilities in specific provinces[136] Community Engagement and ESG Initiatives - The company made donations totaling approximately RMB 2.7 million for community welfare during the reporting period[142] - The company emphasizes environmental, social, and governance (ESG) initiatives as part of its long-term strategy[102] - The company has implemented environmental management measures in compliance with applicable laws, including the establishment of an environmental management committee[131] Operational Efficiency - The company has a robust commercialization system, focusing on specialized disease areas, which has been developed over 30 years, ensuring sustainable business growth and maximizing economic benefits[43] - The company has over 4,300 professional marketing and promotion personnel, covering more than 50,000 hospitals and medical institutions, and over 200,000 retail pharmacies in China[45] - The company is focused on academic promotion and market strategy formulation for innovative products post-launch, aiming to establish a strong academic influence quickly[44]

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，並表明概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔 任何責任。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （股份代號：867） 截至二零二二年十二月三十一日止之年度業績公告 及 建議修訂現有組織章程大綱及細則 以及採納新組織章程大綱及細則 China Medical System Holdings Limited（「本公司」）之董事會（「董事會」）欣然公佈本公司及其附 屬公司（「本集團」或「康哲藥業」）截至二零二二年十二月三十一日止年度(「報告期」)之經審核合 併業績。 財務摘要 ⚫ 營業額增長 9.8%至人民幣 9,150.3百萬元（二零二一年：人民幣 8,337.2百萬元）；若全按藥品銷 售收入計算則營業額增長13.7%至人民幣10,497.5百萬元（二零二一年：人民幣9,230.2百萬元） ⚫ 毛利增長 12.6%至人民幣 7,035.8 百萬元（二零二一年：人民幣 6,24 ...

康 哲° CMS 康哲药业 2021年度報告 庚哲薬業控股有限公司 (服務代號:867) 目錄 | --- | --- | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | | | | | | | 公司資料 ..............................................................................................................................................1 | | | 財務摘要 .............................................................................................................. ...