BeiGene(BGNE) - 2025 Q2 - Quarterly Results

Financial Performance The company reported strong Q2 2025 revenue growth, achieved GAAP profitability, and generated positive free cash flow Q2 2025 Key Financial Metrics The company's Q2 2025 featured 42% revenue growth, a return to GAAP net income, and positive free cash flow Q2 & H1 2025 Financial Highlights (vs. 2024) | | Three Months Ended June 30, | | Six Months Ended June 30, | | | :--- | :--- | :--- | :--- | :--- | | | 2025 | % Change | 2025 | % Change | | Total revenue | $1,315.3M | 42% | $2,432.6M | 45% | | GAAP income (loss) from operations | $87.9M | 182% | $99.0M | 127% | | Adjusted income (loss) from operations* | $274.9M | 467% | $414.3M | 519% | | GAAP net income (loss) | $94.3M | 178% | $95.6M | 126% | | Adjusted net income (loss)* | $252.8M | 985% | $389.0M | 417% | | GAAP diluted EPS per ADS | $0.84 | 173% | $0.85 | 124% | | Adjusted diluted EPS per ADS* | $2.25 | 923% | $3.48 | 397% | | Free Cash Flow* | $219.8M | 207% | $207.4M | 131% | - Global BRUKINSA revenues increased 49% to $950 million versus the second quarter of 2024[3] Revenue Analysis Product revenue growth was driven by strong BRUKINSA sales, with gross margin improving due to product mix and efficiencies - The increase in product revenue to $1.3 billion was primarily attributable to increased sales of BRUKINSA, with the U.S. being the largest market at $685 million[5] Q2 2025 Product Revenue Breakdown (vs. Q2 2024) | Product | Q2 2025 Revenue | YoY Growth | | :--- | :--- | :--- | | BRUKINSA (Global) | $950M | 49% | | - U.S. Sales | $684M | 43% | | - Europe Sales | $150M | 85% | | TEVIMBRA (Global) | $194M | 22% | - GAAP gross margin as a percentage of global product sales increased to 87.4% in Q2 2025 from 85.0% in Q2 2024, due to a higher sales mix of global BRUKINSA and cost productivity improvements[6] Operating Expenses Operating expenses rose due to increased R&D and SG&A investments, though operating leverage improved Q2 2025 Operating Expenses (GAAP, in thousands) | Expense Category | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $524,896 | $454,466 | 15% | | Selling, general and administrative | $537,913 | $443,729 | 21% | | Total operating expenses | $1,062,809 | $898,195 | 18% | - R&D expenses increased primarily due to advancing preclinical and early clinical programs into late-stage development[9] - SG&A expenses increased due to continued investment in global commercial expansion, while SG&A as a percentage of product sales improved to 41% for Q2 2025[10] Profitability and Cash Flow The company achieved significant GAAP net income and positive free cash flow, marking a substantial year-over-year turnaround - GAAP net income for Q2 2025 was $94 million, an increase of $215 million over the prior-year period's loss, primarily due to revenue growth and improved operating leverage[11] - Free Cash Flow for Q2 2025 was $220 million, an increase of $425 million over the prior-year period[12] Full Year 2025 Guidance The company raised its full-year revenue guidance and upgraded its cash flow outlook to positive free cash flow Updated Full Year 2025 Guidance | Metric | Prior FY 2025 Guidance | Current FY 2025 Guidance | | :--- | :--- | :--- | | Total Revenue | $4.9 - $5.3B | $5.0 - $5.3B | | GAAP Operating Expenses | $4.1 - $4.4B | $4.1 - $4.4B (Unchanged) | | GAAP Gross Margin % | Mid-80% range | Mid to high-80% range | | GAAP Operating Income | Positive FY 2025 | Positive FY 2025 (Unchanged) | | Cash Flow | Positive FY 2025 cash flow from operations | Positive FY 2025 free cash flow | - The updated guidance is driven by expectations of strong revenue growth from BRUKINSA, improved gross margin, and continued operating leverage[13] Business and Pipeline Highlights The company advanced its commercial products and clinical pipeline, anticipating over 20 R&D milestones in 18 months Core Marketed Products BRUKINSA and TEVIMBRA gained new approvals and expanded market access, strengthening their global commercial presence - BRUKINSA is now approved in 75 markets and received U.S. FDA approval and a positive CHMP opinion for a new film-coated tablet formulation[16] - TEVIMBRA is now approved in 47 markets, receiving European Commission approval for new indications and a positive CHMP opinion for resectable NSCLC[16] Clinical-Stage Programs The pipeline advanced with key trial initiations and positive regulatory designations in hematology, oncology, and immunology - Hematology program advancements: - Sonrotoclax (BCL2 inhibitor): Submissions accepted in China for R/R CLL and R/R MCL; first patient enrolled in a global Phase 3 trial for R/R CLL[20] - BGB-16673 (BTK CDAC): Received EMA PRIME designation for Waldenstrom's macroglobulinemia (WM); initiated global and China Phase 3 trials for R/R CLL[20] - Zanidatamab (HER2-targeting bispecific antibody): Received regulatory approval and launched commercially in China for second-line HER2-high-expression biliary tract cancer[18] - Tarlatamab (AMG 757): Achieved acceptance of BLA and priority review in China for 3L+ small cell lung cancer (SCLC)[20] Anticipated R&D Milestones Over 20 R&D milestones are expected in the next 18 months, including key approvals and data readouts in 2H 2025 - The company anticipates more than 20 R&D milestones in the next 18 months across its hematology and solid tumor pipeline[2][3] Selected Upcoming Milestones | Program | Milestone | Timing | | :--- | :--- | :--- | | BRUKINSA | EC approval of tablet formulation | 2H 2025 | | TEVIMBRA | EU approval for neoadjuvant/adjuvant early stage NSCLC | 2H 2025 | | Sonrotoclax | Data readout of Phase 2 trial and potential global accelerated approval submissions for R/R MCL | 2H 2025 | | BGB-16673 | Initiate Phase 3 head-to-head trial vs. pirtobrutinib for R/R CLL | 2H 2025 | | Zanidatamab | Readout of primary PFS data from Phase 3 trial for 1L HER2+ gastroesophageal adenocarcinoma | 2H 2025 | Appendix: Financial Statements This section provides detailed unaudited financial statements and a reconciliation of GAAP to non-GAAP measures Condensed Consolidated Statements of Operations The statement shows a significant turnaround to a net income of $94.3 million for Q2 2025 from a loss in Q2 2024 Q2 2025 Statement of Operations Highlights (in thousands) | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total revenues | $1,315,300 | $929,166 | | Gross profit | $1,150,694 | $791,034 | | Income (loss) from operations | $87,885 | $(107,161) | | Net income (loss) | $94,320 | $(120,405) | Condensed Consolidated Balance Sheet Total assets grew to $6.3 billion and total equity increased to $3.8 billion as of June 30, 2025 Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $2,786,086 | $2,638,747 | | Total assets | $6,298,394 | $5,920,910 | | Total liabilities | $2,527,919 | $2,588,688 | | Total equity | $3,770,475 | $3,332,222 | Condensed Consolidated Statements of Cash Flows The company generated $263.6 million in net cash from operating activities in Q2 2025, a strong year-over-year improvement Cash Flow Highlights (in thousands) | Cash Flow Activity | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $263,598 | $307,680 | | Net cash used in investing activities | $(66,605) | $(188,546) | | Net cash provided by financing activities | $35,025 | $1,248 | | Net increase in cash | $255,495 | $147,339 | Reconciliation of GAAP to Non-GAAP Measures This section details adjustments for non-cash items, reconciling GAAP net income to an adjusted net income of $252.8 million - The company provides non-GAAP measures to offer additional insight into operating performance, excluding non-cash items like share-based compensation, depreciation, and amortization[36] Q2 2025 GAAP to Non-GAAP Net Income Reconciliation (in thousands) | | Amount | | :--- | :--- | | GAAP net income | $94,320 | | Plus: Share-based compensation expenses | $150,553 | | Plus: Depreciation | $29,854 | | Plus: Amortization of intangibles | $5,760 | | Other adjustments | $(17,072) | | Adjusted net income | $252,822 | Q2 2025 Free Cash Flow Reconciliation (in thousands) | | Amount | | :--- | :--- | | Net cash provided by operating activities (GAAP) | $263,598 | | Less: Purchases of property, plant and equipment | $(43,826) | | Free Cash Flow (Non-GAAP) | $219,772 |