石药集团(01093) - 2025 - 中期业绩

Performance Summary Financial Highlights In H1 2025, the Group's total revenue decreased by 18.5% to RMB 13.273 billion, mainly due to a decline in the finished drug business, while profit attributable to shareholders decreased by 15.6% to RMB 2.548 billion H1 2025 Financial Highlights (RMB '000) | Indicator | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | 13,273,416 | 16,284,282 | -18.5% | | Finished Drug Revenue | 10,247,652 | 13,549,079 | -24.4% | | Raw Material Product Revenue | 2,074,708 | 1,854,794 | +11.9% | | Functional Food & Other Revenue | 951,056 | 880,409 | +8.0% | | Profit Attributable to Shareholders | 2,547,851 | 3,020,374 | -15.6% | | Basic Profit Attributable to Shareholders | 2,319,521 | 3,216,870 | -27.9% | | Basic EPS (RMB cents) | 22.29 | 25.51 | -12.6% | | Interim Dividend per Share (HK cents) | 14.00 | 16.00 | -12.5% | - The Board declared an interim dividend of HKD 14 cents per share for 2025, a decrease from HKD 16 cents in the prior year period[6] - The company repurchased and cancelled 64.3 million shares for HKD 300 million in H1 2025 to enhance EPS and shareholder returns[6] Company and Business Overview Company Overview CSPC Pharmaceutical Group is an innovation-driven, integrated pharmaceutical enterprise pursuing a 'innovation + internationalization' dual-engine strategy with a global R&D team and extensive pipeline - The Group adheres to a 'innovation + internationalization' dual-engine strategy, continuously increasing R&D investment and strengthening team building[7] - The Group has an international R&D team of over 2,000 people across multiple global centers, focusing on six core therapeutic areas including oncology, neuropsychiatry, and cardiovascular[8] - The Group has completed 4 out-licensing projects year-to-date, with cumulative contract value reaching USD 9.71 billion, and a strategic R&D collaboration with AstraZeneca on an AI platform[10] - The Group has over 200 innovative drugs and formulations in development, with over 160 clinical trials underway, and expects to file for market approval for over 50 new drugs or indications by the end of 2028[11] Finished Drug Business In H1 2025, finished drug revenue decreased by 24.4% to RMB 10.248 billion, primarily due to centralized procurement impacting core products, while out-licensing revenue provided new growth Finished Drug Business Revenue by Therapeutic Area (RMB '000) | Therapeutic Area | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Neuroscience | 3,754,814 | 5,235,700 | -28.3% | | Oncology | 1,050,606 | 2,683,139 | -60.8% | | Anti-infectives | 1,656,912 | 2,307,375 | -28.2% | | Cardiovascular | 868,336 | 1,228,902 | -29.3% | | Respiratory System | 575,441 | 756,025 | -23.9% | | Digestive & Metabolic | 528,099 | 646,697 | -18.3% | | Other | 738,777 | 691,241 | +6.9% | | Subtotal Sales of Goods | 9,172,985 | 13,549,079 | -32.3% | | Licensing Fee Income | 1,074,667 | – | Not Applicable | | Total Revenue | 10,247,652 | 13,549,079 | -24.4% | - Core products like Duomeisu and Jinyouli faced significant price adjustments due to centralized procurement policies, leading to temporary pressure on finished drug business revenue[13] - In H1 2025, the Group's licensing income reached RMB 1.075 billion, becoming a new growth driver for the finished drug business, with plans to develop it into a core source of recurring revenue[15] Neuroscience Neuroscience sales declined due to price reductions for NBP® and Shuanling® from national centralized procurement, but Mingfule® saw significant growth after entering the medical insurance catalog - NBP® sales revenue decreased due to national medical insurance negotiation price reductions, but improved product accessibility[22] - Shuanling® injection was included in the 10th batch of national centralized procurement, leading to a significant decrease in sales revenue[22] - Mingfule® sales revenue significantly increased year-on-year in H1 due to its new indication entering the medical insurance catalog[22] Oncology Oncology sales significantly declined due to Duomeisu® inclusion in national centralized procurement and Jinyouli®'s expanded centralized procurement, while new products provided growth - Duomeisu®'s inclusion in the 10th batch of national centralized procurement led to a substantial reduction in sales price, being the primary reason for the decline in this segment's revenue[29] - Jinyouli® sales revenue significantly decreased due to the expansion of the '3+N' alliance centralized drug procurement policy in Beijing-Tianjin-Hebei[29] - Duoenyi® sales revenue significantly increased year-on-year, and newly launched product Enshuxing® also provided new growth momentum for the business[29] Anti-infectives Anti-infectives business saw reduced sales for key products like Anfulike®, Weihong®, and Nuomoling® in H1 2025 due to weakened market demand, with only Shuluoke® showing growth - Sales revenue for products such as Anfulike®, Weihong®, and Nuomoling® all decreased due to weakened market demand[31] Cardiovascular Cardiovascular sales declined as Xuanning® was impacted by centralized procurement volume-based tasks in public medical institutions, while only Daxinning® achieved steady growth - Xuanning® sales in public medical institutions were affected by the implementation of volume-based tasks for centralized procurement products, leading to a year-on-year revenue decrease[36] Respiratory System Respiratory system sales decreased overall, as market impacts on Qixin®, Nuoyian®, and Qixiao® offset stable growth from Yiluoda® and new contributions from Ennitan® - Yiluoda® sales revenue achieved steady growth, and new product Ennitan® contributed new growth points to this segment[40] - Sales revenue for products such as Qixin®, Nuoyian®, and Qixiao® all decreased due to market impact, leading to an overall revenue reduction in this segment[40] Digestive & Metabolic Digestive and metabolic sales declined overall, as competitive market conditions and a pricing strategy adjustment for Debixin® led to a decrease in average selling price - Debixin®'s sales strategy adjustment led to a decrease in its unit price, which was the main reason for the overall decline in sales revenue for this segment[43] Raw Material Product Business In H1 2025, raw material product sales increased by 11.9% to RMB 2.075 billion, driven by a 21.6% rise in Vitamin C revenue from strong overseas demand, while antibiotic sales remained flat Raw Material Product Business Revenue (RMB Billion) | Product Category | H1 2025 Revenue | Year-on-Year Growth | | :--- | :--- | :--- | | Total | 2.075 | +11.9% | | Vitamin C | 1.196 | +21.6% | | Antibiotics | 0.879 | Flat | - Vitamin C product revenue growth was primarily driven by significantly increased overseas market demand[46] Functional Food and Other Businesses In H1 2025, functional food and other businesses generated RMB 951.056 million in sales revenue, an 8.0% increase, primarily due to higher caffeine sales volume - Functional food and other businesses revenue was RMB 951.056 million, a year-on-year increase of 8.0%, mainly due to increased caffeine sales volume[48] R&D Progress R&D Investment and Pipeline Overview In H1 2025, R&D expenses increased by 5.5% to RMB 2.683 billion, representing 26.2% of finished drug revenue, with nearly 90 products in clinical stages and 12 submitted for market approval R&D Expenses | Indicator | Amount (RMB) | Year-on-Year Change | % of Finished Drug Revenue | | :--- | :--- | :--- | :--- | | R&D Expenses | 2.683 billion | +5.5% | 26.2% | - Currently, nearly 90 products are in different stages of clinical trials, with 12 submitted for market approval and over 30 key products in registration clinical stages[49] Registration and Approval Progress Year-to-date, the Group achieved significant regulatory milestones in China with 3 innovative product approvals and 5 marketing application acceptances, alongside 9 IND approvals and 1 Fast Track designation in North America - Year-to-date, the Group obtained approval for 3 innovative products in China, accepted 5 marketing applications, and received 4 breakthrough therapy designations[50] Products Approved for Marketing in H1 2025 | Month | Drug Name | Indication | | :--- | :--- | :--- | | January 2025 | Sanzeping® (Pluoglitin Tablets) | Improving glycemic control in adults with type 2 diabetes | | February 2025 | Ennitan® (Omalizumab for Injection) | Treatment of moderate to severe persistent allergic asthma | | June 2025 | Meiluotai® (Meloxicam Injection (III)) | Moderate to severe pain in adults | Products with Marketing Applications Accepted in H1 2025 | Month | Investigational Drug | Indication | | :--- | :--- | :--- | | March 2025 | Aprepitant Injection | Prevention of postoperative nausea and vomiting | | March 2025 | Irinotecan Liposome Injection | First-line metastatic pancreatic cancer | | March 2025 | Paliperidone Palmitate Injection (1M) | Schizophrenia | | June 2025 | Pregabalin Extended-Release Tablets | Diabetic peripheral neuropathic pain and postherpetic neuralgia | | August 2025 | Semaglutide Injection | Glycemic control in adults with type 2 diabetes | Key Clinical Research Progress During the period, the Group initiated or completed first patient enrollment for multiple pivotal clinical trials across oncology, depression, and hypertension, with key studies reaching top-line results and findings published in international conferences - First patient enrollment achieved for Phase III clinical trials of multiple drugs including JSKN003, Amcitine Hydrochloride Enteric-coated Tablets, and SYS6010[60][61] - TG103 Injection (GLP-1) Phase III clinical trial for the treatment of overweight and obesity completed its clinical study report[64] - Semaglutide Injection Phase III clinical trial for the treatment of type 2 diabetes completed its clinical study report[66] - Multiple research findings were presented as oral reports or posters at international conferences such as AACR, ASCO, and ESMO, gaining international recognition[67][68][69] Clinical Pipeline Overview The Group maintains a robust clinical pipeline with multiple products submitted for market approval in China and the US, alongside dozens of ongoing pivotal clinical trials utilizing advanced technologies - Submitted marketing applications for 10 drugs in China, including Semaglutide Injection (for type 2 diabetes) and Irinotecan Liposome Injection (for first-line pancreatic cancer)[70] - Submitted marketing applications for 2 drugs in the United States, namely Amphotericin B Liposome for Injection and Irinotecan Hydrochloride Liposome Injection[70] - Over 20 pivotal clinical trials are ongoing in China, covering high-demand therapeutic areas such as breast cancer, gastric cancer, obesity, diabetes, and depression[71][72][73] Business Development and Financial Review Business Development In H1 2025, the Group achieved significant business development breakthroughs through out-licensing, completing four major agreements with substantial potential transaction values, including a strategic AI platform collaboration with AstraZeneca - Reached an exclusive licensing agreement with Radiance Biopharma for ADC drug SYS6005, with a potential total value of up to USD 1.24 billion[76] - Reached an exclusive licensing agreement with Cipla USA for the commercialization rights of Irinotecan Liposome Injection in the US, with a potential total value of up to USD 1.065 billion[77] - Reached a strategic R&D collaboration with AstraZeneca on an AI drug discovery platform, with a potential total value of up to USD 5.33 billion[78] - Reached a global exclusive licensing agreement with Madrigal Pharmaceuticals for small molecule GLP-1 agonist SYH2086, with a potential total value of up to USD 2.075 billion[79] Financial Review In H1 2025, revenue decreased by 18.5% and gross margin by 6 percentage points to 65.6% due to centralized procurement, while operating expenses significantly decreased, and R&D investment continued to grow, maintaining a robust financial position - Revenue decreased by 18.5% to RMB 13.273 billion, and gross margin decreased by 6.0 percentage points to 65.6%, primarily due to the inclusion of Duomeisu® and Jinyouli® in centralized procurement and a reduced proportion of finished drug business revenue[80] - Sales and distribution expenses decreased by 36.2% year-on-year to RMB 3.049 billion, mainly due to significantly lower sales expenses for products winning centralized procurement bids[83] - R&D expenses increased by 5.5% year-on-year to RMB 2.683 billion, primarily for ongoing and newly initiated clinical studies[84] - Cash inflow from operating activities was RMB 3.187 billion, significantly higher than RMB 1.425 billion in the prior year period[88] - As of June 30, 2025, the Group's bank deposits, balances, and cash reached RMB 10.291 billion, with a debt-to-asset ratio of only 0.7%, indicating a robust financial position[89] Condensed Consolidated Financial Statements Condensed Consolidated Statement of Profit or Loss For the six months ended June 30, 2025, the Group reported revenue of RMB 13.273 billion, a 18.5% decrease, and profit for the period of RMB 2.574 billion, a 15.6% decrease, despite reduced operating expenses Condensed Consolidated Statement of Profit or Loss (RMB '000) | Item | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Revenue | 13,273,416 | 16,284,282 | | Gross Profit | 8,710,192 | 11,654,547 | | Sales and Distribution Expenses | (3,049,160) | (4,777,410) | | R&D Expenses | (2,682,631) | (2,541,991) | | Profit Before Tax | 3,117,667 | 3,801,130 | | Profit for the Period | 2,574,050 | 3,051,466 | | Profit Attributable to Owners of the Company | 2,547,851 | 3,020,374 | Condensed Consolidated Statement of Financial Position As of June 30, 2025, total assets were RMB 46.002 billion, total liabilities RMB 11.138 billion, and net assets RMB 34.864 billion, all showing slight increases from year-end 2024, with improved net current assets Condensed Consolidated Statement of Financial Position Summary (RMB '000) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Assets | 46,002,354 | 44,388,991 | | Non-current Assets | 23,392,266 | 22,500,847 | | Current Assets | 22,610,088 | 21,888,144 | | Total Liabilities | 11,138,478 | 10,522,701 | | Current Liabilities | 10,112,501 | 9,634,027 | | Non-current Liabilities | 1,025,977 | 888,674 | | Net Assets/Total Equity | 34,863,876 | 33,866,290 | Other Information Share Repurchase As of June 30, 2025, the company repurchased and cancelled 64.3 million shares for approximately HKD 300 million, aiming to enhance earnings per share and shareholder value Share Repurchase Details | Month | Number of Shares Repurchased | Highest Price (HKD) | Lowest Price (HKD) | Total Consideration (HKD) | | :--- | :--- | :--- | :--- | :--- | | January | 38,850,000 | 4.72 | 4.38 | 176,597,000 | | March | 3,000,000 | 4.95 | 4.88 | 14,763,000 | | April | 22,450,000 | 4.95 | 4.66 | 108,155,000 | | Total | 64,300,000 | | | 299,515,000 |