Investment Rating - Buy (首次评级) [1] Core Views - The company's flagship product, Nefecon, has successfully commercialized, marking a significant milestone in the treatment of IgA nephropathy [1][2] - Revenue is expected to grow steadily as products like Eravacycline and Nefecon continue to contribute to sales, with potential for further expansion in 2024 [1][2] - The company is actively preparing for医保谈判, which could significantly boost Nefecon's revenue if successful [2] - The mRNA platform, focusing on tumor therapeutic vaccines, is expected to become a cornerstone for sustainable growth in the medium to long term [4] Financial Performance - Revenue for 2023 was RMB 125.93 million, a significant increase from RMB 12.79 million in 2022, driven by the commercialization of Eravacycline and Nefecon [1] - Net loss for 2023 widened to RMB 844.46 million, compared to RMB 247.28 million in 2022, primarily due to increased expenses and the absence of a one-time gain from the Trodelvy® transaction [1] - Revenue is projected to grow to RMB 702.70 million in 2024, RMB 1,749.72 million in 2025, and RMB 2,817.06 million in 2026 [1] Product Pipeline - **Nephrology**: Nefecon, the first innovative drug for IgA nephropathy, has shown significant clinical benefits in reducing proteinuria and slowing eGFR decline [2][38] - **Infectious Diseases**: Eravacycline, a broad-spectrum antibiotic, has been successfully commercialized, while Cefepime-Taniborbactam is expected to launch by 2025-2026 [2][53] - **Autoimmune Diseases**: Etrasimod, approved in Macau, is expected to contribute to revenue starting in 2024-2025 [2] - **mRNA Platform**: The company is focusing on developing tumor therapeutic vaccines, with clinical trials expected to begin in the second half of 2024 [4] Market Potential - The global market for chronic kidney disease (CKD) is substantial, with an estimated 700 million patients worldwide, and China accounts for approximately 18% of this population [28][30] - IgA nephropathy, the most common primary glomerular disease, has a higher prevalence in Asian populations, particularly in China, where it accounts for about 53% of primary glomerular diseases [31][32] - The market for multi-drug resistant Gram-negative bacteria (MDR-GNB) antibiotics is expected to grow, with projections indicating a market size of RMB 19.3 billion by 2027 [59] Strategic Developments - The company has built a robust commercialization team to accelerate the market penetration of its products in Greater China and other Asia-Pacific markets [1][19] - The company is leveraging the "Greater Bay Area Drug and Device Access" policy to expand the reach of its products, such as Etrasimod, in the region [2] - The mRNA platform is being developed with full industrial chain capabilities, positioning the company for long-term growth in the oncology space [4]

Financial Performance - Everest Medicines reported revenue of RMB 125.9 million from its first product, Yiga®, within five months of launch, significantly exceeding the initial forecast of RMB 70 million to RMB 100 million[5]. - Revenue increased by RMB 113.1 million or 884% to RMB 125.9 million for the year ended December 31, 2023, primarily due to the commercialization of products in mainland China and Hong Kong[9]. - The company achieved revenue of RMB 125.9 million in 2023, significantly exceeding the previous guidance of RMB 70 million to RMB 100 million[34]. - The combined revenue from Iqmod and Iqia is projected to reach RMB 700 million in 2024[36]. - The company anticipates revenue exceeding the initial guidance of RMB 700 million to RMB 1 billion during its commercialization year in 2023[29]. Product Development and Commercialization - The company received NDA approval for its primary IgA nephropathy treatment, Nanfukang®, in Macau and mainland China, with plans for commercialization in mainland China in the first half of 2024[5]. - Everest Medicines plans to launch Nanfukang® in Singapore and Hong Kong in 2024, following its commercialization in Macau[5]. - The company plans to commercialize the nephrology product, Naimu, in mainland China in 2024, supported by a new sales team of approximately 120 employees[8]. - TARPEYO® received approval from the National Medical Products Administration in China for the treatment of primary IgA nephropathy in November 2023, with plans for market launch in 2024[13]. - The company plans to submit a new drug application for the combination of cefepime and tanibartin for treating complex urinary tract infections in 2024[22]. Clinical Trials and Research - The company is advancing the global Phase 2b PALIZADE clinical study for zetomipzomib in collaboration with Kezar Life Sciences, targeting autoimmune diseases[6]. - The mRNA platform is expected to advance therapeutic vaccine development into clinical trials in 2024, enhancing the company's R&D product portfolio[12]. - In a Phase 3 clinical trial (NeflgArd), TARPEYO® demonstrated a statistically significant improvement in estimated glomerular filtration rate (eGFR) compared to placebo, with an average increase of 5.05 mL/min/1.73 m² over two years (P<0.0001)[13]. - The company completed patient recruitment for the open-label extension study of TARPEYO® in August 2023, aimed at assessing long-term efficacy and safety in Chinese patients[15]. - The company plans to advance the global, placebo-controlled Phase 2b clinical trial PALIZADE for Zetomipzomib in patients with active lupus nephritis[26]. Financial Position and Expenses - Cash and cash equivalents as of December 31, 2023, amounted to RMB 2,349.7 million[10]. - R&D expenses decreased by RMB 269.6 million to RMB 540.1 million for the year ended December 31, 2023, due to several candidate drugs completing clinical trials and entering registration or commercialization stages[9]. - The company reported a loss of RMB 844.5 million for the year ended December 31, 2023, compared to a loss of RMB 247.3 million for the previous year, marking a significant increase in losses[39]. - The net cash used in operating activities for the year ended December 31, 2023, was RMB 769.2 million, compared to RMB 1,155.8 million for the year ended December 31, 2022[60]. - The current ratio improved from 3.92 in 2022 to 8.36 in 2023, indicating a stronger liquidity position[61]. Strategic Partnerships and Collaborations - Everest Medicines partnered with Pfizer for the approval of Iqmod (VELSIPITY®) for treating moderate to severe ulcerative colitis, with plans to submit a new drug application in China[6]. - The company entered into a collaboration and licensing agreement with Kezar Life Sciences for the development and commercialization of Zetomipzomib (澤托佐米) in Greater China, Korea, and parts of Southeast Asia, with Kezar entitled to receive an upfront payment of $7 million and up to $125.5 million in future milestone payments[25]. - The company has terminated its collaboration with Providence in February 2023, retaining full rights to develop mRNA products independently[8]. - The company has entered into a collaboration agreement with Kezar Life Sciences to develop the drug Zetomipzomib for autoimmune diseases in Greater China and Southeast Asia[37]. - The company is collaborating with Venatorx Pharmaceuticals on the development of cefepime-tanibartin, with positive results from a global Phase 3 trial expected to be submitted in 2024[22]. Governance and Corporate Structure - The board of directors has undergone several changes, with new appointments and resignations noted for 2024[69]. - The company is committed to maintaining high ethical standards and transparency in its operations to maximize long-term shareholder returns[165]. - The board emphasizes the importance of managing overall business risks and providing high-quality products and services to customers[165]. - The company has adopted the corporate governance code as a benchmark for its governance practices, emphasizing the importance of high standards in protecting shareholder interests[166]. - The company has established appropriate insurance arrangements for directors and senior management against legal claims arising from corporate activities[181]. Employee and Shareholder Engagement - The company has a total employee count of 432 as of December 31, 2023, an increase from 365 in 2022, with 416 located in China[77]. - The total compensation for directors, including basic salary, housing allowance, and discretionary bonuses, amounted to approximately RMB 24.7 million, with discretionary bonuses totaling RMB 9.1 million for the year ending December 31, 2023[138]. - The company has made charitable donations of approximately RMB 15.8 million for the year ended December 31, 2023, compared to zero in 2022[84]. - The company emphasizes the importance of gender diversity at all levels and aims to increase female representation in senior management and the board[193]. - The company aims to align the interests of eligible participants with the group's interests through the post-IPO share incentive plan[129]. Market Expansion and Future Outlook - Everest Medicines aims to establish a sales team of 120 representatives by the end of 2024, targeting 600 core hospitals to cover at least 60% of market potential[5]. - The company aims to achieve cash breakeven by 2025, focusing on high-value therapeutic areas such as kidney diseases, anti-infection, and autoimmune diseases[8]. - The company aims to expand the market for Iqmod to approximately 5 million IgA nephropathy patients in mainland China in 2024[34]. - The company is focused on developing innovative therapies to meet unmet medical needs in Greater China and other emerging markets in the Asia-Pacific region[71]. - The company is dedicated to fostering a culture of compliance and ethical business practices across all levels of the organization[165].

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 對 因 本 公 告 全 部 或 任 何 部 份 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。 Everest Medicines Limited 雲頂新耀有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1952） 截 至2023年12月31日 止 年 度 全 年 業 績 公 告 雲 頂 新 耀 有 限 公 司（「本 公 司」）董 事 會（「董 事 會」）宣 佈 本 公 司 及 其 附 屬 公 司 截 至2023年12月31日 止 年 度 的 經 審 計 全 年 業 績。本 公 告 載 有 本 公 司2023年 度 報 告 全 文，符 合 香 港 聯 合 交 易 所 有 限 公 司（「聯 交 所」）證 券 上 市 規 則 中 有 關 年 度 業 績 初 步 公 告 附 載 資 料 的 相 關 要 求。 本 全 ...

雲頂新耀有限公司 | --- | --- | --- | |-------|-------|-------------------| | | | | | | | | | | | | | | | EVEREST MEDICINES | | 六 | 100 | | Everest Medicines Limited (Incorporated in the Cayman Islands with limited liability) (於開曼群島註冊成立的有限公司) Stock Code 股份代號：1952 引領新藥,光耀生命 Better Medicines Better Life 2025 ERIM REPORT 中期報告 目錄 公司資料 2 業務摘要 4 | --- | --- | --- | --- | --- | --- | |--------------------------|-------|-------|-------|-------|-------| | 財務摘要 | | | | | | | 管理層討論及分析 | | | | | | | 企業管治及其他資料 | | | | | | | 中期財務 ...

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 對 因 本 公 告 全 部 或 任 何 部 份 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。 Everest Medicines Limited 雲頂新耀有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1952） 截 至2023年6月30日 止 六 個 月 中 期 業 績 公 告 雲 頂 新 耀 有 限 公 司（「本 公 司」）董 事 會（「董 事 會」）宣 佈 本 公 司 及 其 附 屬 公 司 截 至2023年6月30日 止 六 個 月 的 未 經 審 計 中 期 業 績。本 公 告 載 有 本 公 司2023中 期 報 告 全 文，符 合 香 港 聯 合 交 易 所 有 限 公 司（「聯 交 所」）證 券 上 市 規 則 中 有 關 中 期 業 績 初 步 公 告 附 載 資 料 的 相 關 要 求 ...

EVEREST MEDICINES 14 顶 新 耀 Everest Medicines Limited 婴頂新耀有限公司 (於開曼群島註冊成立的有限公司) 股份代號 : 1952 引 領 新 बहु 光耀生命 2022 年度報告 | --- | --- | |--------------------|-------| | 目 錄 | | | 公司資料 | 2 | | 主席報告 | 4 | | 財務摘要 | 7 | | 業務摘要 | 8 | | 管理層討論及分析 | 14 | | 董事會報告 | 26 | | 董事會及高級管理層 | 61 | | 企業管治報告 | 68 | | 獨立核數師報告 | 90 | | 綜合全面虧損表 | 98 | | 綜合財務狀況表 | 99 | | 綜合權益變動表 | 101 | | 綜合現金流量表 | 103 | | 綜合財務報表附註 | 105 | | 五年財務概要 | 204 | | 釋義 | 205 | 公司資料 | --- | --- | |----------------------------------------------------------------- ...

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 對 因 本 公 告 全 部 或 任 何 部 份 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。 | --- | --- | |----------------------------------|-------| | | | | | | | | | | | | | | | | Everest Medicines Limited | | | 雲頂新耀有限公司 | | | （於開曼群島註冊成立的有限公司） | | | （股份代號： 1952） | | 截 至2022年12月31日 止 年 度 全 年 業 績 公 告 雲 頂 新 耀 有 限 公 司（「本 公 司」）董 事 會（「董 事 會」）謹 此 宣 佈 本 公 司 及 其 附 屬 公 司 截 至2022年12月31日 止 年 度 的 經 審 計 全 年 業 績。本 公 ...