Company Performance - In the first half of 2024, Everest Medicines achieved significant milestones, including the successful commercialization of the only approved treatment for IgA nephropathy in China, Nanfukang®[7]. - The company reported a strong performance despite the biotechnology sector facing challenges, outperforming the Hang Seng Hong Kong-listed biotech index, which fell nearly 30% in the same period[7]. - Revenue growth is driven by deepening hospital penetration and expanding clinical applications of its product Yijia® in more hospitals[7]. - The company remains committed to efficiently executing its strategy to deliver innovative therapies to more patients globally[7]. - Everest Medicines is confident in its development as a leading biopharmaceutical company in the Asia-Pacific region, supported by increasing policy backing and its robust performance[7]. Product Development and Approvals - NEFECON® is the first drug globally for the treatment of IgA nephropathy, showing a 50% reduction in kidney function decline and a 66% delay in kidney function deterioration in the Chinese population, extending the time to dialysis or kidney transplant by 12.8 years[8]. - NEFECON® received approval from the Chinese National Medical Products Administration in November 2023 and is expected to be commercially launched in mainland China in May 2024[8]. - The company plans to announce topline results from the open-label study of NEFECON® in China in the second half of 2024[11]. - Zetomipzomib, a novel selective immunoproteasome inhibitor, has shown good safety and tolerability in treating severe chronic autoimmune diseases, with clinical trials approved in China for lupus nephritis[11]. - The company plans to submit a new drug application for cefepime-tazobactam for complicated urinary tract infections in mainland China by 2025[16]. Financial Performance - Revenue increased from RMB 89 million for the six months ended June 30, 2023, to RMB 301.5 million for the six months ending June 30, 2024, primarily due to the expansion of sales in mainland China and Hong Kong[22]. - Gross margin improved from 62.7% for the six months ended June 30, 2023, to 76.6% for the six months ending June 30, 2024, driven by the launch of new products[22]. - Net loss increased from RMB 423.6 million for the six months ended June 30, 2023, to RMB 632.4 million for the six months ending June 30, 2024, primarily due to a one-time impairment loss related to mRNA COVID-19 vaccine intangible assets[22]. - The company aims to achieve revenue guidance of RMB 700 million for the current year, reflecting confidence in meeting the clinical needs of patients in Asia[24]. - The company reported a net loss of RMB 632,413 thousand for the six months ended June 30, 2024, compared to a loss of RMB 423,612 thousand for the same period in 2023[111]. Research and Development - The company is developing multiple mRNA therapeutic drugs and has established an end-to-end capability for mRNA drug development and manufacturing[33]. - The company has terminated its collaboration with Providence Therapeutics to focus on developing proprietary mRNA therapeutic vaccines, shifting its strategy towards owning all intellectual property and global rights[19]. - The company plans to submit a new drug application for Etrasimod in China in 2024, following the announcement of positive top-line results from a Phase 3 clinical trial in July[28]. - The company expects to announce the topline results of the Phase 1b clinical study for EVER001 in membranous nephropathy in the second half of 2024[13]. - The company has initiated a partnership to develop an integrated ecosystem for kidney disease diagnosis and treatment, aiming to launch a commercially valuable IgA nephropathy testing kit[29]. Market Strategy and Collaborations - The company is actively seeking external collaborations in key therapeutic areas such as renal, infectious, and autoimmune diseases to maximize synergies across its clinical and commercialization platforms[7]. - The commercialization team has expanded to support the launch of new products and growth in existing product sales, with selling expenses increasing from RMB 64.1 million to RMB 200.4 million[22]. - The sales team for NEFECON® has been established with over 100 representatives, targeting 400 to 600 core hospitals, covering more than 60% of the IgA nephropathy patient population in China[29]. - The company is collaborating with contract sales organizations to expand access to Etrasimod beyond its internal commercialization team, targeting additional patients[29]. - The company has published several articles in medical journals regarding Etrasimod's efficacy and safety in treating various infections, enhancing its clinical profile[30]. Governance and Compliance - The audit committee consists of three independent non-executive directors, ensuring compliance with corporate governance standards[67]. - The company has implemented training for directors regarding compliance with the standard code of conduct to prevent future violations[66]. - The company has established a special resolution to amend its articles of association to comply with updated listing rules[69]. - The company maintains a strong governance structure with significant shareholding by key stakeholders, ensuring alignment of interests[81]. - The company plans to continue compliance with the new Chapter 17 of the listing rules effective from January 1, 2023[84]. Shareholder Information - As of June 30, 2024, Mr. Bo Wei holds 129,265,877 shares, representing 39.75% of the company's equity[76]. - Major shareholders include Vistra Trust (Singapore) Pte. Limited and Nova Aqua Limited, both holding 129,265,877 shares (39.75%)[80]. - C-Bridge Healthcare Fund II, L.P. and its affiliates collectively hold 52,777,778 shares, accounting for 16.23% of the equity[80]. - The total number of shares issued as of June 30, 2024, is 325,164,793[78]. - The company has not disclosed any additional interests or short positions held by directors or senior management as of June 30, 2024[78].
云顶新耀(01952) - 2024 - 中期业绩