百济神州(06160) - 2025 - 中期业绩

Company Announcement and Forward-Looking Statements BeiGene announced Q2 and H1 2025 unaudited financial results and updated full-year guidance, including forward-looking statements and risk disclosures Announcement Overview BeiGene, Ltd. announced unaudited condensed consolidated financial results and business updates for Q2 and H1 2025, updating its full-year 2025 financial guidance, prepared under U.S. GAAP - BeiGene announced unaudited Q2 and H1 2025 financial results and business updates, along with updated full-year financial guidance[1][2] - Financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), differing from International Financial Reporting Standards (IFRS)[2] Forward-Looking Statements and Risk Disclosures This announcement contains forward-looking statements regarding R&D milestones, clinical development, global expansion, and future financial performance, with actual results potentially differing due to various risk factors - The report includes forward-looking statements concerning R&D milestones, clinical development, global expansion, future revenue, operating profit, cash flow, and gross margin[3] - Actual results may differ materially due to risks such as drug efficacy and safety, clinical outcomes, regulatory actions, commercialization capabilities, intellectual property protection, third-party reliance, and working capital[3] - The company advises shareholders and potential investors not to over-rely on Q2 results and 2025 financial guidance, and to exercise caution when trading company securities[4] Q2 2025 Financial Results and Business Progress BeiGene reported strong Q2 2025 financial results with significant revenue growth, improved profitability, and positive free cash flow, driven by core product performance and operational efficiency CEO's Remarks and Performance Highlights CEO John Oyler highlighted the company's leadership in oncology and sustainable growth, particularly the strong performance of Brukinsa® and over 20 R&D milestones expected within 18 months - Co-founder, Chairman, and CEO John Oyler stated that the strong Q2 performance solidified the company's global leadership in oncology and demonstrated its capacity for sustainable, long-term growth[7] - Brukinsa® as a core product, set the benchmark for best-in-class BTK inhibitors, maintaining a leading position in the U.S. market[7] - Over 20 milestone advancements are anticipated in the hematology and solid tumor pipelines within the next 18 months[7] 2025 Q2 Key Financial Data | Indicator | 2025 Q2 (Million USD) | YoY Growth Rate | | :--- | :--- | :--- | | Total Revenue | 1,300 | 42% | | Brukinsa® Global Revenue | 950 | 49% | | GAAP Diluted EPS | 0.84 | - | | Non-GAAP Diluted EPS | 2.25 | - | Condensed Consolidated Financial Results BeiGene achieved total revenue of $1.315 billion in Q2 2025, a 42% year-over-year increase, with H1 total revenue of $2.433 billion, and GAAP operating and net income turning profitable 2025 Q2 and H1 Condensed Consolidated Financial Results (GAAP) | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | Change (%) | 2025 H1 (Thousand USD) | 2024 H1 (Thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue | 1,302,076 | 921,146 | 41% | 2,410,606 | 1,668,064 | 45% | | Collaboration Revenue | 13,224 | 8,020 | 65% | 21,973 | 12,754 | 72% | | Total Revenue | 1,315,300 | 929,166 | 42% | 2,432,579 | 1,680,818 | 45% | | GAAP Operating Income (Loss) | 87,885 | (107,161) | 182% | 98,987 | (368,509) | 127% | | GAAP Net Income (Loss) | 94,320 | (120,405) | 178% | 95,590 | (371,555) | 126% | | GAAP Diluted EPS | 0.84 | (1.15) | 173% | 0.85 | (3.56) | 124% | | Free Cash Flow | 219,772 | (205,538) | 207% | 207,447 | (670,688) | 131% | Revenue Analysis Q2 2025 total revenue reached $1.3 billion, primarily driven by increased Brukinsa® sales in the U.S. and Europe, with product revenue also at $1.3 billion, and the U.S. contributing $685 million - Total revenue for Q2 2025 was $1.3 billion, a 42% year-over-year increase, primarily driven by increased sales of Brukinsa® in the U.S. and Europe[9] - Product revenue was $1.3 billion, with the U.S. market contributing $685 million, a 43% year-over-year increase[9] - Sales of Amgen-licensed products and Tislelizumab also contributed to product revenue growth[9] Gross Margin Q2 2025 GAAP gross margin increased to 87.4%, mainly due to a higher proportion of Brukinsa® global sales and improved production efficiency for Brukinsa® and Tislelizumab - GAAP gross margin on global product revenue for Q2 2025 increased to 87.4% from 85.0% in the prior year period[10] - The increase in gross margin is primarily attributed to a higher proportion of Brukinsa® in global sales and improved production efficiency for Brukinsa® and Tislelizumab[10] - Adjusted gross margin (excluding depreciation and amortization) increased to 88.1% from 85.4% in the prior year period[10] Operating Expenses Total operating expenses for Q2 2025 increased by 18% year-over-year to $1.063 billion, with R&D expenses up 15% and SG&A expenses up 21%, driven by clinical program advancement and global commercialization 2025 Q2 Operating Expenses (GAAP) | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | Change (%) | | :--- | :--- | :--- | | R&D Expenses | 524,896 | 454,466 | 15% | | SG&A Expenses | 537,913 | 443,729 | 21% | | Total Operating Expenses | 1,062,809 | 898,195 | 18% | - The increase in R&D expenses was primarily due to higher costs associated with advancing preclinical programs into clinical stages and early-stage clinical programs into later-stage development[13] - The increase in SG&A expenses was primarily due to the company's continued investment in global commercialization expansion, particularly in the U.S. and Europe[14] - In Q2 2025, SG&A expenses as a percentage of product revenue were 41%, down from 48% in the prior year period, indicating improved operating leverage[14] Core Product Sales Performance Brukinsa® demonstrated strong performance in the U.S. and European markets, with sales increasing by 43% and 85% year-over-year respectively, maintaining its lead in new patient market share among BTK inhibitors - Brukinsa® U.S. sales reached $684 million, a 43% year-over-year increase, driven by strong demand growth across all approved indications[12] - Brukinsa® European sales reached $150 million, an 85% year-over-year increase, primarily due to market share gains in all major European markets[12] - Brukinsa® continues to maintain a leading position in new patient market share among BTK inhibitor drugs[12] - Tislelizumab sales for Q2 2025 were $194 million, a 22% year-over-year increase[12] Net Income and Free Cash Flow Q2 2025 GAAP net income was $94 million, a significant improvement from a loss in the prior year, driven by revenue growth and improved operating leverage, with free cash flow reaching $220 million - GAAP net income for Q2 2025 was $94 million, an increase of $215 million compared to a loss in the prior year period, primarily due to revenue growth and improved operating leverage[15] - Free cash flow was $220 million, an increase of $425 million compared to the prior year period[15] Updated Full-Year 2025 Financial Guidance BeiGene updated its full-year 2025 revenue guidance to $5.0 billion to $5.3 billion, maintained operating expense guidance, and expects gross margin in the mid-to-high 80-90% range, with positive GAAP operating income and free cash flow 2025 Full-Year Financial Guidance Update | Indicator | Previous 2025 FY Guidance | Current 2025 FY Guidance | | :--- | :--- | :--- | | Total Revenue | $4.9 billion to $5.3 billion | $5.0 billion to $5.3 billion | | GAAP Operating Expenses | $4.1 billion to $4.4 billion | $4.1 billion to $4.4 billion | | GAAP Gross Margin % | Mid-80-90% range | Mid-to-High 80-90% range | | GAAP Operating Income | Positive for full year | Positive for full year | | Cash Flow | Positive cash flow from operations for full year | Positive free cash flow for full year | - Total revenue guidance was raised, benefiting from Brukinsa®'s leading position in the U.S. and continued expansion in Europe and other key global markets[17] - Gross margin is expected to be in the mid-to-high 80-90% range, attributed to improved product mix and enhanced production efficiency[17] - The company's GAAP operating expense guidance includes anticipated investments to support commercialization and research growth, aiming for sustained meaningful operating leverage[17] Q2 Business Highlights Key business highlights for Q2 include significant global regulatory and reimbursement progress for core products Brukinsa® and Tislelizumab, alongside advancements in multiple clinical-stage oncology and immunology programs Core Commercial Product Progress Brukinsa® received approvals in 75 markets, expanded reimbursement in 5, and gained FDA approval for a new film-coated tablet. Tislelizumab was approved in 47 markets, expanded reimbursement in 20, and received EU Commission and FDA approvals for new indications and dosing - Brukinsa® has been approved in 75 markets globally, with new or expanded reimbursement in 5 markets this quarter[18] - Brukinsa® received U.S. FDA approval for a new film-coated tablet formulation and a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use[18] - Tislelizumab has been approved in 47 markets globally, with new or expanded reimbursement in 20 markets this quarter, including Japan, Europe, and Australia[19] - Tislelizumab received European Commission approval for first-line treatment of metastatic or recurrent nasopharyngeal carcinoma and extensive-stage small cell lung cancer[19] - Tislelizumab received FDA approval for alternative dosing regimens of 150mg every two weeks and 300mg every four weeks for gastric cancer and esophageal squamous cell carcinoma[19] Selected Clinical Stage Programs The company made significant progress across multiple clinical programs, including hematology (Sonrotoclax, BGB-16673), lung cancer (Tarlatamab), GI cancer (Zanidatamab), and inflammation/immunology (BGB-45035, BGB-16673) Hematology Sonrotoclax (BCL2 inhibitor) received priority review for its marketing application in China, with global Phase 3 trial enrollment initiated. BGB-16673 (BTK CDAC) received EU PRIME designation and initiated multiple Phase 3 and 2 trials - Sonrotoclax (BCL2 inhibitor) marketing applications for relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R mantle cell lymphoma (MCL) have been accepted in China and granted priority review[19] - The global Phase 3 trial of Sonrotoclax combined with an anti-CD20 antibody for R/R CLL has enrolled its first patient[19] - BGB-16673 (BTK CDAC) received Priority Medicines (PRIME) designation from the European Medicines Agency for the treatment of Waldenström's macroglobulinemia (WM) patients previously treated with a BTK inhibitor[19] - The global Phase 3 BGB-16673-302 trial and China Phase 3 BGB-16673-303 trial for BGB-16673 in R/R CLL have both enrolled their first patients[19][20] - Patient enrollment has commenced for a potential registrational Phase 2 study of BGB-16673 for R/R WM[20] Lung Cancer Tarlatamab (AMG 757) marketing applications for third-line+ and second-line small cell lung cancer treatment in China have been accepted and granted priority review - The Biologics License Application (BLA) for Tarlatamab (AMG 757) for third-line and above treatment of small cell lung cancer has been accepted in China and granted priority review[20] - The BLA for Tarlatamab for second-line treatment of small cell lung cancer has been accepted in China[20] Gastrointestinal Cancers Zanidatamab (HER2-targeted bispecific antibody) received regulatory approval in China for second-line treatment of HER2-high expressing biliary tract cancer and has been commercialized - Zanidatamab (Chinese trade name: Baihe'an®; HER2-targeted bispecific antibody) has received regulatory approval in China for second-line treatment of HER2-high expressing biliary tract cancer and has been commercialized[20] Inflammation and Immunology Phase 1b trials for BGB-45035 (IRAK4 CDAC) in atopic dermatitis and prurigo nodularis, and BGB-16673 (BTK CDAC) in chronic spontaneous urticaria, have both enrolled their first patients - The Phase 1b trial for BGB-45035 (IRAK4 CDAC) in atopic dermatitis and prurigo nodularis has enrolled its first patient[21] - The Phase 1 trial for BGB-16673 (BTK CDAC) in chronic spontaneous urticaria has also enrolled its first patient[21] Future Milestones BeiGene anticipates achieving key milestones across multiple products and therapeutic areas from H2 2025 to 2026, including Brukinsa® tablet approval, Tislelizumab subcutaneous formulation trial, Sonrotoclax data readout, and BGB-16673 head-to-head trial Expected Milestones (H2 2025 - 2026) | Product/Therapeutic Area | Expected Milestone | Expected Timeline | | :--- | :--- | :--- | | Brukinsa® | Marketing application for tablet formulation expected to receive European Commission approval | H2 2025 | | | Interim analysis of Phase 3 MANGROVE trial for first-line MCL expected to be completed | H2 2025 | | Tislelizumab | Marketing application for neoadjuvant and adjuvant treatment of early-stage NSCLC expected to receive European Commission approval | H2 2025 | | | Initiation of Phase 3 subcutaneous formulation trial expected | H2 2025 | | Hematology (Sonrotoclax) | Phase 2 data readout for R/R MCL expected, with potential for global accelerated approval submission | H2 2025 | | Hematology (BGB-16673) | Initiation of Phase 3 head-to-head trial against non-covalent BTK inhibitor pirtobrutinib for R/R CLL expected | H2 2025 | | Breast Cancer (BGB-43395) | Initiation of Phase 3 trial for second-line HR+/HER2- metastatic breast cancer expected | 2026 | | | Initiation of Phase 3 trial for first-line HR+/HER2- metastatic breast cancer expected | 2026 | | Lung Cancer (BGB-58067 & BG89894) | Completion of first patient enrollment for combination therapy trial expected | H2 2025 | | Gastrointestinal Cancers (Zanidatamab) | Primary progression-free survival data readout for Phase 3 trial in first-line HER2+ gastroesophageal adenocarcinoma, in collaboration with Zymeworks/Jazz, expected | H2 2025 | | Inflammation and Immunology (BGB-45035) | Completion of first patient enrollment for Phase 2 trial expected | H2 2025 | | | Potential proof-of-concept data for tissue IRAK4 degradation expected | H2 2025 | Other Company Information The company announced its new English name BeOne Medicines Ltd. and domicile change to Switzerland, along with details for its Q2 2025 earnings conference call and general company overview Company Name and Domicile Change The company officially adopted its new English name, BeOne Medicines Ltd., and completed its domicile transfer from Cayman to Switzerland - The company officially adopted its new English name, BeOne Medicines Ltd[25] - Completed the transfer of its domicile from Cayman to Switzerland[25] Conference Call and Webcast The company will host its Q2 2025 earnings conference call via webcast on Wednesday, August 6, 2025, at 8:00 AM ET (8:00 PM Beijing Time), accessible through its official website - The company will host its Q2 2025 earnings conference call via webcast on Wednesday, August 6, 2025, at 8:00 AM ET (8:00 PM Beijing Time)[26] - The webcast link is accessible through the investor page of BeiGene's official website (www.beonemedicines.com)[26](index=26&type=chunk) About BeiGene BeiGene is a Switzerland-domiciled global oncology innovator focused on developing novel anti-cancer drugs for patients worldwide, boasting a rich portfolio, strong R&D, and a global team dedicated to enhancing drug accessibility and affordability - BeiGene is a Switzerland-domiciled global oncology innovation company dedicated to developing novel anti-cancer drugs for cancer patients worldwide[27] - The company possesses a rich product portfolio in hematology and solid tumors, coupled with strong in-house R&D capabilities and external strategic collaborations[27] - With a team of over 11,000 people across six continents, the company is committed to comprehensively improving drug accessibility and affordability for more patients globally[27] Investor and Media Contacts Provides contact information for investor relations and media inquiries Investor and Media Contacts | Investor Contact | Media Contact | | :--- | :--- | | Mi Zhou | Yiwei Yu | | +86 10 5895 8058 | +86 21 3159 1070 | | ir@beonemed.com | media@beonemed.com | Notes to Financial Statements This section provides detailed U.S. GAAP condensed consolidated financial statements, including statements of operations, balance sheets, cash flows, and reconciliations of GAAP to non-GAAP financial measures Condensed Consolidated Statements of Operations (U.S. GAAP) Presents condensed consolidated statements of operations for the three and six months ended June 30, 2025, detailing key financial metrics including revenue, cost of sales, gross profit, operating expenses, operating income, net income, and EPS Condensed Consolidated Statements of Operations (GAAP) - Three Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Product Revenue | 1,302,076 | 921,146 | | Collaboration Revenue | 13,224 | 8,020 | | Total Revenue | 1,315,300 | 929,166 | | Cost of Sales - Product | 164,606 | 138,132 | | Gross Profit | 1,150,694 | 791,034 | | R&D Expenses | 524,896 | 454,466 | | SG&A Expenses | 537,913 | 443,729 | | Operating Income (Loss) | 87,885 | (107,161) | | Net Income (Loss) | 94,320 | (120,405) | | Diluted EPS (Loss) | 0.84 | (1.15) | Condensed Consolidated Statements of Operations (GAAP) - Six Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Product Revenue | 2,410,606 | 1,668,064 | | Collaboration Revenue | 21,973 | 12,754 | | Total Revenue | 2,432,579 | 1,680,818 | | Cost of Sales - Product | 329,608 | 263,067 | | Gross Profit | 2,102,971 | 1,417,751 | | R&D Expenses | 1,006,783 | 915,104 | | SG&A Expenses | 997,201 | 871,156 | | Operating Income (Loss) | 98,987 | (368,509) | | Net Income (Loss) | 95,590 | (371,555) | | Diluted EPS (Loss) | 0.85 | (3.56) | Condensed Consolidated Balance Sheet Summary Data (U.S. GAAP) Provides a summary of condensed consolidated balance sheet data as of June 30, 2025, and December 31, 2024, showing key items such as cash, accounts receivable, inventory, property, plant, and equipment, total assets, liabilities, and shareholders' equity Condensed Consolidated Balance Sheet Summary Data (GAAP) | Indicator | 2025-06-30 (Thousand USD) | 2024-12-31 (Thousand USD) | | :--- | :--- | :--- | | Cash, Cash Equivalents & Restricted Cash | 2,786,086 | 2,638,747 | | Accounts Receivable, Net | 770,776 | 676,278 | | Inventory | 502,867 | 494,986 | | Property, Plant & Equipment, Net | 1,615,792 | 1,578,423 | | Total Assets | 6,298,394 | 5,920,910 | | Total Liabilities | 2,527,919 | 2,588,688 | | Total Shareholders' Equity | 3,770,475 | 3,332,222 | Unaudited Condensed Consolidated Statements of Cash Flows Summary Data (U.S. GAAP) Presents unaudited condensed consolidated statements of cash flows for the three and six months ended June 30, 2025, including net cash from operating, investing, and financing activities, and cash and cash equivalents at period-end Condensed Consolidated Statements of Cash Flows Summary Data (GAAP) - Three Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Cash from Operating Activities | 263,598 | (95,588) | | Net Cash Used in Investing Activities | (66,605) | (111,032) | | Net Cash Provided by Financing Activities | 35,025 | 23,017 | | Cash, Cash Equivalents & Restricted Cash at Period End | 2,786,086 | 2,617,931 | Condensed Consolidated Statements of Cash Flows Summary Data (GAAP) - Six Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Cash from Operating Activities | 307,680 | (404,160) | | Net Cash Used in Investing Activities | (188,546) | (320,863) | | Net Cash Provided by Financing Activities | 1,248 | 185,310 | | Cash, Cash Equivalents & Restricted Cash at Period End | 2,786,086 | 2,617,931 | Explanation Regarding the Use of Non-GAAP Financial Measures The company provides non-GAAP financial measures to offer a more comprehensive view of operating performance by excluding non-cash and special items, supplementing but not replacing GAAP metrics for investor understanding and comparison - The company provides non-GAAP financial measures, including adjusted operating expenses, operating loss, net income, and EPS, to offer additional information on its operating performance[37] - Non-GAAP measures adjust GAAP data by excluding non-cash items such as share-based compensation expense, depreciation, and amortization, as well as certain unusual or significant items[37] - These non-GAAP financial measures should be considered supplementary to, and not as a substitute for or superior to, financial measures prepared in accordance with U.S. GAAP[37] Reconciliation of Selected GAAP to Non-GAAP Financial Measures This section provides detailed reconciliation tables between GAAP and non-GAAP financial measures, covering cost of sales, R&D, SG&A, operating expenses, operating income, net income, EPS, and free cash flow, to clearly illustrate specific adjustments and their impact GAAP to Adjusted Cost of Sales - Product Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | GAAP Cost of Sales - Product | 164,606 | 138,132 | | Less: Depreciation | 3,321 | 2,684 | | Less: Amortization of Intangible Assets | 5,749 | 1,177 | | Adjusted Cost of Sales - Product | 154,643 | 134,271 | GAAP to Adjusted R&D Expenses Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | GAAP R&D Expenses | 524,896 | 454,466 | | Less: Share-based Compensation Expense | 64,392 | 55,406 | | Less: Depreciation | 16,447 | 16,551 | | Adjusted R&D Expenses | 444,057 | 382,509 | GAAP to Adjusted Operating Income (Loss) Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | GAAP Operating Income (Loss) | 87,885 | (107,161) | | Add: Share-based Compensation Expense | 150,553 | 130,694 | | Add: Depreciation | 29,854 | 23,754 | | Add: Amortization of Intangible Assets | 5,760 | 1,177 | | Adjusted Operating Income (Loss) | 274,945 | 48,464 | GAAP to Adjusted Diluted EPS (Loss) Reconciliation | Indicator | 2025 Q2 (USD) | 2024 Q2 (USD) | | :--- | :--- | :--- | | GAAP Diluted EPS (Loss) | 0.84 | (1.13) | | Add: Share-based Compensation Expense | 1.34 | 1.23 | | Add: Depreciation | 0.27 | 0.22 | | Add: Amortization of Intangible Assets | 0.05 | 0.01 | | Adjusted Diluted EPS (Loss) | 2.25 | 0.22 | Free Cash Flow (Non-GAAP) Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | Net Cash from Operating Activities (GAAP) | 263,598 | (95,588) | | Less: Purchases of Property, Plant & Equipment | (43,826) | (109,950) | | Free Cash Flow (Non-GAAP) | 219,772 | (205,538) |