Core Viewpoint - The European Commission has approved the innovative drug Baiyue An (Tislelizumab) for use in neoadjuvant therapy combined with platinum-based chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence, further expanding its application in the European oncology market [1] Group 1: Market Context - Lung cancer is the most common cancer globally, with NSCLC accounting for 80%-90% of all lung cancer types, and approximately 25%-30% of NSCLC patients are eligible for surgical resection [1] - The treatment needs of this patient group represent a significant market opportunity for related drugs [1] Group 2: Product Approval and Market Expansion - Tislelizumab has received a total of 9 approvals for solid tumor indications in the EU, including 5 for lung cancer and others for gastric or gastroesophageal junction adenocarcinoma, unresectable esophageal squamous cell carcinoma, and nasopharyngeal carcinoma [2] - Tislelizumab is the first PD-(L)1 inhibitor from China to enter the global market and is a core product developed by the company following the BTK inhibitor Zebutini [2] - The global market presence of Tislelizumab has expanded to 47 countries and regions, including major markets in Europe, the United States, the United Kingdom, and Japan [2]

Group 1: Shuoshi Biotech - Shuoshi Biotech reported a significant decline in net profit for the first half of 2025, with a net profit of 3.99 million yuan, down 86.35% year-on-year [1] - The company’s non-recurring net profit was -28.05 million yuan, a staggering decrease of 1219.78% year-on-year [1] - Eight senior executives voluntarily reduced their salaries by 5% to 50% to demonstrate solidarity during challenging times, indicating a need for innovation and market expansion to find new profit growth points [1] Group 2: BeiGene - BeiGene announced that the European Commission has approved its PD-1 monoclonal antibody, Tislelizumab, for use in neoadjuvant therapy for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence [2] - This approval marks a significant step for the internationalization of domestic PD-1 therapies, benefiting patients in Europe [2] Group 3: Shenzhou Cell - Shenzhou Cell reported a revenue of 972 million yuan for the first half of 2025, a decrease of 25.5% year-on-year, with a net profit of -33.77 million yuan, down 126.87% [3] - The second quarter saw a revenue of 452 million yuan, a decline of 34.66% year-on-year, and a net profit of -97.54 million yuan, down 289.37% [3] - Despite the revenue and profit decline, the company is actively advancing its R&D pipeline and exploring international markets [3] Group 4: Sali Medical - Sali Medical reported a revenue of approximately 584 million yuan for the first half of 2025, a decrease of 40.2% year-on-year, with a net loss of approximately 56.12 million yuan [4] - The company’s revenue and gross profit declined due to the transfer of some subsidiaries and challenges in its transformation, compounded by slow accounts receivable collection and difficulties in business renewals [4] - The company needs to accelerate its transformation efforts to improve performance [4]

Group 1 - Shuoshi Biotech reported a significant decline in net profit for the first half of 2025, with a net profit of 3.99 million yuan, down 86.35% year-on-year, and a non-recurring net profit of -28.05 million yuan, down 1219.78% year-on-year [1] - Eight senior executives, including the honorary chairman and the chairman, voluntarily reduced their salaries by 5% to 50%, demonstrating a commitment to overcoming current challenges [1] - The company faces pressure from industry-wide price reductions and tax rate adjustments, leading to a decline in gross margin, necessitating a focus on innovation and market expansion for future growth [1] Group 2 - BeiGene announced that the European Commission has approved its PD-1 monoclonal antibody, Tislelizumab, for use in neoadjuvant therapy for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence [2] - This approval marks a significant step for the internationalization of domestic PD-1 therapies, benefiting patients in Europe [2] Group 3 - Shenzhou Cell reported a revenue of 972 million yuan for the first half of 2025, a decrease of 25.5% year-on-year, with a net profit of -33.77 million yuan, down 126.87% year-on-year [3] - The second quarter saw a revenue of 452 million yuan, down 34.66% year-on-year, and a net profit of -97.54 million yuan, down 289.37% year-on-year [3] - Despite the revenue decline, the company is actively advancing its R&D pipeline and exploring international markets, indicating potential for future growth [3] Group 4 - Sali Medical reported a revenue of approximately 584 million yuan for the first half of 2025, a decrease of 40.2% year-on-year, with a net loss of approximately 56.12 million yuan [4] - The company experienced a significant increase in net loss compared to the previous year, where the net loss was approximately 477,000 yuan [4] - Challenges include slow accounts receivable collection and difficulties in business renewals, necessitating a faster transformation to improve performance [4]

Financial Performance - Total revenue reached $2.433 billion, a year-on-year increase of 44.7%, with product revenue at $2.411 billion, also up 44.5% [1][2] - The company achieved a net profit of $95.6 million, a significant turnaround from a net loss of $372 million in the same period last year [1] - Cash and cash equivalents stood at $2.756 billion, an increase of $129 million from the beginning of the year [1] - Gross margin improved from 84.3% in the previous year to 86.4% [1] Core Business Progress - Baiyueze continued to lead with revenue of $1.742 billion, accounting for 72% of product revenue, and a year-on-year growth of 54.7% [1][4] - The U.S. market showed strong performance with revenue of $1.249 billion, a 50.1% increase, surpassing the Chinese market for the first time [1][4] - Collaboration revenue from Amgen increased significantly to $14.55 million, compared to $840,000 in the previous year [1] - Operating expenses grew by 12.2% to $2.004 billion, significantly lower than the revenue growth rate [1] Development Strategy - The company deepened its global layout by relocating its registered office to Switzerland and adopting the new name "BeOne Medicines Ltd." [1][5] - Capital commitments for capacity construction reached $62 million, with ongoing investments in infrastructure [1][5] - R&D expenses amounted to $1.007 billion, representing 41.4% of total revenue, with a year-on-year increase of 10% [1] - The company anticipates over 20 R&D milestone events in the next 18 months [1][5] Future Focus Areas - Sustainability of growth in the U.S. market and risks associated with reliance on a single product [1][8] - Progress in establishing a second growth curve and the commercialization timeline for new products [1][8] - Challenges in cost control due to the complexities of global operations [1][5][8] - The impact of stock incentive expenses amounting to $246 million on actual cash generation capabilities [1][3][8]

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而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 截至2025年6月30日止六個月 中期業績公告 百濟神州有限公司連同其子公司（「本公司」或「百濟神州」或「我們」）謹此公佈本 公司截至2025年6月30日止六個月（「報告期」）的未經審核簡明綜合業績連同2024 年相應期間的比較數字，其乃根據美國公認會計原則（「美國公認會計原則」或 「GAAP」）編製並由本公司董事會（「董事會」）審計委員會（「審計委員會」）審閱。 財務摘要 1 • 截至2025年6月30日止六個月的收入合計較截至2024年6月30日止六個月增 加約751.8百萬美元或約44.7%至約2,432.6百萬美元。產品收入較截至2024 年6月30日止六個月增加約742.5百萬美元或約44.5%至約2,410.6百萬美元。 • 截至2025年6月30日止六個月的經營費用合計較截至 ...

Group 1: Financial Performance - The company reported a total revenue increase of approximately $751.8 million or about 44.7% to approximately $2,432.6 million for the six months ending June 30, 2025 [1] - Product revenue increased by approximately $742.5 million or about 44.5% to approximately $2,410.6 million during the same period [1] - The net profit for the period was approximately $95.6 million, a significant recovery from a net loss of approximately $371.6 million for the six months ending June 30, 2024 [1] Group 2: Research and Development Expenses - Research and development expenses increased by $91.7 million (or 10.0%) from $915.1 million in the previous year to $1,006.8 million for the six months ending June 30, 2025 [1] - Internal R&D expenses grew by $21.5 million (or 3.7%) to $606.5 million, primarily due to the expansion of global R&D facilities and an increase in clinical and preclinical candidates [1] Group 3: Gross Profit and Margin - Gross profit from product sales increased to $2,081.0 million, up from $1,405.0 million in the same period last year, driven by the increase in product revenue [2] - The gross margin improved from 84.2% in the previous year to 86.3% for the six months ending June 30, 2025, attributed to a higher sales proportion of Baiyueze compared to other products [2] Group 4: Sales Performance of Baiyueze - Global sales of Baiyueze reached $1,741.5 million, a growth of 54.7% compared to the same period last year [3] - U.S. sales of Baiyueze totaled $1,246.9 million, a 50.1% increase from $830.8 million, driven by robust demand across all indications and moderate net pricing benefits [3] - European sales of Baiyueze amounted to $266.4 million, a year-on-year increase of 79.7%, benefiting from market share growth in major European markets [3]

Core Insights - The company reported a total revenue of 2.433 billion RMB for the six months ending June 30, 2025, representing a year-on-year increase of 44.73% [1] - Gross profit reached 2.103 billion USD, up 48.33% compared to the previous year [1] - The net profit was 95.59 million USD, a turnaround from a net loss of 372 million USD in the same period last year, with basic earnings per share of 0.07 USD [1] Revenue Breakdown - The increase in total revenue was primarily driven by sales growth of the company's self-developed products, Baiyueze and Trelatuzumab, as well as an increase in sales from licensed products, mainly from Amgen [1] - Product revenue net increased by 44.5% to 2.4106 billion USD, compared to 1.6681 billion USD in the same period last year, largely due to significant sales growth of Baiyueze in the US and Europe [1] - Baiyueze's global sales reached 1.7415 billion USD, a 54.7% increase year-on-year, with US sales totaling 1.2469 billion USD, up 50.1% from 830.8 million USD last year [2] Market Position - Baiyueze continues to maintain a leading market share among new patients in the BTK inhibitor class, supported by robust demand across all indications and moderate gains from net pricing [2]

Group 1 - The core viewpoint of the articles highlights the significant financial performance of BeiGene, with a total revenue of 2.433 billion RMB for the six months ending June 30, 2025, representing a year-on-year increase of 44.73% [1] - Gross profit reached 2.103 billion USD, an increase of 48.33% compared to the previous year [1] - The net profit for the period was 95.59 million USD, a turnaround from a net loss of 372 million USD in the same period last year, with basic earnings per share of 0.07 USD [1] Group 2 - The increase in total revenue is primarily attributed to the sales growth of the company's self-developed products, including Baiyueze® and Tislelizumab, as well as the sales of licensed products, mainly from Amgen [1] - For the six months ending June 30, 2025, product revenue net increased by 44.5% to 2.4106 billion USD, up from 1.6681 billion USD in the same period last year [1] - Baiyueze® global sales reached 1.7415 billion USD, a 54.7% increase year-on-year, with U.S. sales totaling 1.2469 billion USD, up 50.1% from 830.8 million USD in the previous year [2] Group 3 - The robust growth in Baiyueze® sales is attributed to strong demand across all indications and moderate gains from net pricing [2] - Baiyueze® continues to maintain a leading market share among new patients in the BTK inhibitor class due to its differentiated and best-in-class clinical characteristics [2]

Financial Performance - Total revenue for the six months ended June 30, 2025, increased by approximately $751.8 million or 44.7% to about $2,432.6 million compared to the same period in 2024[3]. - Product revenue for the same period rose by approximately $742.5 million or 44.5% to about $2,410.6 million[3]. - Net profit for the six months ended June 30, 2025, was approximately $95.6 million, a significant improvement from a net loss of approximately $371.6 million in the same period of 2024[3]. - Basic and diluted earnings per share for the six months ended June 30, 2025, were $0.07, compared to a loss of $0.27 per share in the prior year[3]. - The company reported a comprehensive income of approximately $130.9 million for the six months ended June 30, 2025, compared to a comprehensive loss of approximately $412.6 million in the same period of 2024[5]. - The company reported a net loss of $371,555 thousand for the six months ended June 30, 2024, compared to a net loss of $95,590 thousand in 2025, showing a positive trend in financial performance[10]. - For the six months ended June 30, 2025, the company reported a net profit of $95,590,000, compared to a net loss of $371,555,000 for the same period in 2024[59]. - The diluted earnings per share (EPS) for the six months ended June 30, 2025, was $0.07, a significant improvement from a diluted loss per share of $(0.27) in 2024[59]. Cash and Liquidity - Cash and cash equivalents as of June 30, 2025, were $2,756.1 million, an increase from $2,627.4 million as of December 31, 2024[6]. - Cash generated from operating activities was $307,680 thousand, a turnaround from cash used of $404,160 thousand in the previous year[8]. - Cash used in investing activities decreased to $188,546 thousand in 2025 from $320,863 thousand in 2024, indicating a 41% reduction[9]. - Cash and cash equivalents increased to $2,786,086 thousand at the end of June 2025, up from $2,617,931 thousand at the end of June 2024[9]. - Cash, cash equivalents, and restricted cash totaled approximately $1.1 billion as of June 30, 2025, including about $1.4 billion in RMB and $281.1 million in other currencies[114]. - The company plans to utilize available cash to meet significant short-term and long-term cash needs, including operational, capital, and production expenditures[132]. Assets and Liabilities - Total assets as of June 30, 2025, amounted to $6,298.4 million, compared to $5,920.9 million as of December 31, 2024[7]. - Total liabilities as of June 30, 2025, were $2,527.9 million, a decrease from $2,588.7 million as of December 31, 2024[7]. - Shareholders' equity as of June 30, 2025, increased to $3,770.5 million from $3,332.2 million as of December 31, 2024[7]. - The total carrying amount of intangible assets as of June 30, 2025, was $64,890,000, up from $51,095,000 as of December 31, 2024[39]. - The total debt obligations as of June 30, 2025, amounted to $1,000,000, with various loans from banks, including a significant loan of $380,000,000 due in January 2026[48]. - Total liabilities for accrued expenses and other payables increased to $908,882,000 as of June 30, 2025, from $803,713,000 as of December 31, 2024, marking an increase of about 13.1%[46]. Research and Development - Research and development costs for the six months ended June 30, 2025, amounted to $1,006,783,000, up from $915,104,000 in the same period of 2024, indicating an increase of approximately 10%[57]. - The company has established a highly efficient and cost-effective oncology research team with over 1,200 scientists, leading to continuous innovation and market leadership[93]. - The company anticipates over 20 research milestones within the next 18 months, including advancements in solid tumor pipelines targeting various high-incidence cancers[88]. Product Sales and Market Performance - The leading product, Baiyueze®, generated $1.7415 billion in revenue, a 54.7% increase from $1.1259 billion in the previous year[99]. - U.S. sales of Baiyueze® totaled $1.2469 billion, up 50.1% from $830.8 million in the same period last year, driven by robust demand across all indications and moderate net pricing gains[100]. - Total collaboration revenue for the six months ended June 30, 2025, was $21,973,000, a 72% increase from $12,754,000 in 2024[26]. - The company’s total revenue from China for the six months ended June 30, 2025, was $832,516 thousand, up 24% from $672,446 thousand in 2024[77]. Corporate Governance and Compliance - The audit committee is composed of four independent non-executive directors, with Shalini Sharp serving as the chair, ensuring compliance with the Hong Kong Listing Rules and NASDAQ regulations[159]. - The company has adhered to all provisions of the corporate governance code during the reporting period, with ongoing reviews to maintain high standards[162]. - The company has implemented its own insider trading policy, which meets or exceeds the standards set by the Hong Kong Listing Rules[163]. Future Plans and Commitments - The company plans to relocate its registered address to Switzerland in the second quarter of 2025, which will not affect its financial performance under GAAP[12]. - The company plans to expand the global reach of its PD-1 inhibitor, Bai Ze An®, which has been approved in major markets including the US, EU, China, and Japan[95]. - The company has irrevocable purchase commitments totaling $130,087,000 as of June 30, 2025, with $97,496,000 related to binding purchase obligations from Amgen[70]. - The company plans to fully utilize the remaining net proceeds within five years from the completion of the Sci-Tech Innovation Board issuance[169].

Core Viewpoint - BeiGene, a leading innovative drug company, has entered the innovative drug business development (BD) wave by selling a portion of the royalty rights for a cancer drug for up to $950 million, marking a significant transaction in the Chinese innovative drug sector [1] Group 1: Transaction Details - BeiGene announced the sale of royalty rights for a cancer drug, receiving an upfront payment of $885 million, which accounts for 36% of its revenue for the first half of the year [1] - The drug, Talazoparib, is set to launch in the U.S. in May 2024 for small cell lung cancer treatment, with the overseas sales managed by Amgen [2] - Royalty Pharma, the buyer, expects a return on investment of 10%-15% from this transaction, with total sales of Talazoparib projected to reach $19.6 billion from 2025 to 2035 [3] Group 2: Market Impact and Analysis - The transaction is significant as it is BeiGene's first drug rights sale in four years and introduces a new BD model in the Chinese innovative drug industry, focusing solely on royalty rights [1][5] - Despite the substantial upfront payment, BeiGene's stock did not rise post-announcement, contrasting with other companies that saw stock increases following similar transactions [6] - Analysts suggest that the transaction may not create long-term value for BeiGene, as it resembles a debt financing rather than a value-generating deal [6] Group 3: Financial Position and Future Outlook - BeiGene's CFO emphasized the importance of a robust balance sheet, stating that the transaction enhances operational and strategic flexibility [7] - The company has over 30 drug candidates in its pipeline, with more than 10 in Phase III clinical trials, necessitating significant R&D investment [7] - As of June 30, 2025, BeiGene had approximately $2.8 billion in cash, down $170 million year-over-year, with liabilities around $2.5 billion [7]