Financial Performance - In Q4 2024, total global revenue reached $1.1 billion, a 78% year-over-year increase, while total global revenue for the year reached $3.8 billion, a 55% year-over-year increase[9]. - In Q4 2024, product revenue reached $1,118,035, a 77% increase from $630,526 in Q4 2023[40]. - Total revenue for the year 2024 was $3,810,241, compared to $2,458,779 in 2023, reflecting a 55% year-over-year growth[40]. - Adjusted operating profit for Q4 2024 was $78,603, compared to a loss of $267,224 in Q4 2023, marking a 129% improvement; annual adjusted operating profit was $45,356, up from a loss of $752,473 in 2023[10]. - Net loss for Q4 2024 was $(151,881), compared to $(367,553) in Q4 2023, indicating a reduction in losses[40]. - For the full year 2024, GAAP net loss was $0.47 per share for common stock and $6.12 per ADS, an improvement from $0.65 and $8.45 in the previous year[32]. - Operating cash flow in Q4 2024 was $75 million, an increase of $297 million year-over-year, while the full year cash used in operations was $141 million, a decrease of $1 billion compared to the previous year[32]. Product Sales - Sales of Baiyueze® in Q4 2024 amounted to $828 million, a 100% year-over-year increase, with total sales for the year reaching $2.6 billion, a 105% year-over-year increase[9]. - Sales of Baiyueze® in the US for Q4 2024 were $616 million, a 97% year-over-year increase, with annual sales reaching $2 billion, up 106%[12]. - Baiyueze® sales in Europe for Q4 2024 were $113 million, a 148% increase year-over-year, with annual sales of $359 million, up 194%[12]. - Bai Ze An® sales for Q4 2024 were $154 million, a 20% increase year-over-year, with annual sales of $621 million, up 16%[15]. - Baiyueze® has been approved in over 70 markets globally, with more than 180,000 patients treated[11]. Research and Development - Six new molecular entities (NMEs) entered clinical development in Q4 2024, with a total of 13 for the year; multiple innovative solid tumor projects are expected to have data readouts in the first half of 2025[9]. - The company is leveraging its research and development platforms, including multispecific antibodies and antibody-drug conjugates, to accelerate future treatments in breast cancer, lung cancer, and gastrointestinal cancer[9]. - The company has a robust pipeline with over 1,800 patients enrolled in clinical trials for various indications, including R/R CLL and R/R MCL[17]. - The company plans to read out data from a Phase 3 study of Tarlatamab for small cell lung cancer in H1 2025[20]. - The company expects to enter clinical development for BG-60366 in Q4 2024, targeting EGFR mutations with strong efficacy[20]. Operational Expenses - R&D expenses for Q4 2024 were $542 million, a 10% increase from $494 million in Q4 2023, while annual R&D expenses reached $1.95 billion, up 10% from $1.78 billion[28][30]. - SG&A expenses for Q4 2024 were $505 million, a 21% increase from $418 million in Q4 2023, with annual SG&A expenses totaling $1.83 billion, also up 21% from $1.51 billion[28][30]. - Total GAAP operating expenses for 2024 reached $3,784,351, up from $3,286,595 in 2023, representing a 15.1% increase[49]. - Adjusted sales and marketing expenses for 2024 were $1,549,864, compared to $1,284,689 in 2023, reflecting a 20.7% increase[49]. Future Outlook - The company expects full-year 2025 revenue guidance to be between $4.9 billion and $5.3 billion, while reaffirming expectations for positive GAAP operating profit and positive cash flow from operations[9]. - The company anticipates strong growth in 2025, positioning it as a pivotal year for its operations[9]. - The company projects total revenue for 2025 to be between $4.9 billion and $5.3 billion, driven by strong growth from the product 百悦泽® in the U.S. and continued expansion in Europe and other key markets[33]. - GAAP operating expenses for 2025 are expected to be between $4.1 billion and $4.4 billion, with a projected gross margin in the range of 80% to 90%[33]. - The earnings call for Q4 2024 and full year results will be held on February 27, 2025, at 8 AM EST[34]. Corporate Developments - The company plans to utilize its new English name "BeOne" and has activated the new stock code ONC on NASDAQ[9]. - The company will change its NASDAQ ticker from "BGNE" to "ONC" pending shareholder approval[25]. - The company plans to submit a marketing application for Baiyueze® tablet formulation to the FDA and EU in the second half of 2025[16]. - The company has signed a settlement agreement with MSN Pharmaceuticals, allowing them to sell a generic version of Baiyueze® in the US no earlier than June 15, 2037[12]. - The company plans to present key data at the 2024 ASH annual meeting and the 2025 J.P. Morgan Healthcare Conference[25]. Strategic Focus - The company emphasizes its leadership position in the chronic lymphocytic leukemia (CLL) treatment market with Baiyueze®[9]. - The company emphasizes a data-driven strategy to maximize resource utilization and prioritize promising clinical candidates[14]. - 百济神州 is focused on developing innovative oncology drugs and enhancing drug accessibility and affordability globally[35]. - The company plans to utilize various social media platforms for significant disclosures in compliance with U.S. fair disclosure regulations[36]. - Forward-looking statements include expectations for future revenue, operating profit, cash flow, and gross margin, with actual results subject to various risks and uncertainties[37].
百济神州(06160) - 2024 - 年度业绩