2024-05-08 10:06Financial Highlights BeiGene achieved significant revenue growth in Q1 2024, with total revenues reaching $751.7 million, while substantially reducing operational losses and improving efficiency Financial Performance Summary (in millions USD) | Financial Metric | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Net product revenues | $746.9 | $410.3 | 82% | | Total Revenue | $751.7 | $447.8 | 68% | | GAAP loss from operations | $(261.3) | $(371.3) | (30)% | | Adjusted loss from operations* | $(147.3) | $(275.9) | (47)% | - The company's strong global revenue growth has elevated it into the top 15 of global oncology innovators based on total oncology sales2 - BeiGene is demonstrating significantly improved operating leverage and is progressing on its path to achieving sustainable profitability12 Key Business & Pipeline Updates Key products BRUKINSA and TEVIMBRA show strong commercial growth and regulatory approvals, while the pipeline advances rapidly in hematology and solid tumors BRUKINSA (zanubrutinib) BRUKINSA revenue reached $489 million in Q1 2024 with strong U.S. and European growth, securing its fifth FDA approval for R/R follicular lymphoma BRUKINSA Revenue by Region (in millions USD) | Region | Q1 2024 Revenue | YoY Growth | | :--- | :--- | :--- | | Total | $489 | - | | U.S. | $351 | 153% | | Europe | $67 | 243% | - Received U.S. FDA approval for treating adult patients with relapsed or refractory (R/R) follicular lymphoma, establishing BRUKINSA with the broadest label in the BTKi class15 - BRUKINSA is gaining market share in treatment-naïve (TN) chronic lymphocytic leukemia (CLL) and has become the BTKi class leader in new-patient share for relapsed or refractory (R/R) CLL in the U.S.4 TEVIMBRA (tislelizumab) TEVIMBRA sales grew 26% to $145 million in Q1 2024, securing key regulatory approvals in Europe and the U.S. for NSCLC and ESCC - Sales of tislelizumab totaled $145 million in Q1 2024, representing 26% growth compared to the prior-year period5 - Key regulatory approvals were secured: - European Commission: Approved for three indications in non-small cell lung cancer (NSCLC) - U.S. FDA: Approved for second-line esophageal squamous cell carcinoma (ESCC) - U.S. FDA: Accepted Biologics License Application (BLA) for first-line gastric or gastroesophageal junction cancers5 Key Pipeline Highlights The pipeline shows strong progress in hematology with sonrotoclax and BGB-16673, and in solid tumors with multiple readouts and new assets entering the clinic in H2 2024 - Hematology Pipeline: - Sonrotoclax (BCL2 inhibitor): Received FDA fast track designation for R/R mantle cell lymphoma (MCL) and continues enrollment for registrational intent trials - BGB-16673 (BTK CDAC): Initiated expansion cohorts with potential registrational intent in R/R MCL and R/R CLL, with a Phase 3 trial in R/R CLL expected by year-end 20246 - Solid Tumor Pipeline: - Lung Cancer: Completed enrollment in a Phase 3 trial for ociperlimab (anti-TIGIT) and expects readouts for multiple tislelizumab combinations in 2024 - Breast Cancer: Progressing dose escalation for CDK4 and CDK2 inhibitors and dosed the first patient in a Phase 1 study for B7H4 ADC - New Assets: Pan-KRAS inhibitor, MTA-cooperative PRMT5 inhibitor, EGFR CDAC, CEA-ADC, and FGFR2b-ADC are on track to enter the clinic in H2 2024678 Detailed Financial Performance Q1 2024 saw an 82% product revenue increase to $747 million and improved gross margin, with operating leverage gains leading to a reduced net loss per share Revenue and Gross Margin Total Q1 2024 revenue reached $752 million, driven by an 82% increase in product revenue to $747 million, with gross margin improving to 83% - Total Q1 2024 revenue was $752 million, with product revenue contributing $747 million, an 82% increase from Q1 202310 - The U.S. was the largest market, with product revenue of $351 million, a 153% increase from the prior year period10 - Gross margin as a percentage of global product revenue increased to 83% in Q1 2024 from 80% in Q1 2023, mainly due to a higher sales mix of global BRUKINSA11 Operating Expenses and Profitability Total GAAP operating expenses rose 20% to $888.1 million, but improved operating leverage led to a 30% reduction in GAAP loss from operations and a reduced net loss per share Operating Expenses (GAAP, in millions USD) | Expense Category | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $460.6 | $408.6 | 13% | | Selling, general and administrative | $427.4 | $328.5 | 30% | | Total operating expenses | $888.1 | $737.3 | 20% | - The increase in operating expenses was due to advancing preclinical and early clinical programs (R&D) and continued investment in the global commercial launch of BRUKINSA (SG&A)1213 - Profitability metrics improved, with GAAP Net Loss decreasing to $251.2 million from $348.4 million in Q1 2023. Net loss per share improved to $(0.19) from $(0.26)131419 Financial Statements The condensed consolidated financial statements detail a net loss of $251.2 million for Q1 2024, with total assets of $5.7 billion and total equity of $3.4 billion Condensed Consolidated Statements of Operations For Q1 2024, total revenues were $751.7 million, resulting in a gross profit of $626.7 million and a net loss of $251.2 million, or $(0.19) per share Condensed Consolidated Statements of Operations (in thousands USD) | (in thousands of U.S. dollars) | Three Months Ended March 31, 2024 | | :--- | :--- | | Total revenues | $751,652 | | Gross profit | $626,717 | | Loss from operations | $(261,348) | | Net loss | $(251,150) | | Net loss per share, basic and diluted | $(0.19) | Condensed Consolidated Balance Sheet As of March 31, 2024, BeiGene reported $2.8 billion in cash and equivalents, with total assets of $5.7 billion and total equity of $3.4 billion Condensed Consolidated Balance Sheet (in thousands USD) | (in thousands of U.S. dollars) | As of March 31, 2024 | | :--- | :--- | | Cash, cash equivalents, restricted cash and short-term investments | $2,807,436 | | Total assets | $5,667,681 | | Total liabilities | $2,307,320 | | Total equity | $3,360,361 | Non-GAAP Financial Measures Non-GAAP financial measures provide additional insight into operating performance by excluding non-cash items, with adjusted loss from operations at $147.3 million for Q1 2024 - BeiGene uses non-GAAP financial measures to provide a more complete understanding of its operating performance by excluding non-cash items such as share-based compensation, depreciation, and amortization22 Reconciliation of GAAP to Adjusted Loss from Operations (in thousands USD) | Reconciliation of GAAP to Adjusted Loss from Operations (in thousands) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | GAAP loss from operations | $(261,348) | $(371,258) | | Plus: Share-based compensation expenses | $88,714 | $75,388 | | Plus: Depreciation | $24,110 | $19,025 | | Plus: Amortization of intangibles | $1,183 | $986 | | Adjusted loss from operations | $(147,341) | $(275,859) |