Financial Performance - Total revenue for Q1 2024 reached $751.65 million, a 68% increase compared to $447.80 million in Q1 2023[5] - Product revenue amounted to $746.92 million, reflecting an 82% year-over-year growth from $410.29 million[5] - Collaboration revenue decreased by 87% to $4.73 million from $37.51 million year-over-year[5] - Total revenue for Q1 2024 was $752 million, compared to $448 million in the same period of 2023, primarily due to the sales growth of Baiyueze® in the US and Europe[12] - Product revenue for Q1 2024 was $747 million, an 82% increase from $410 million in Q1 2023, attributed to the sales growth of Baiyueze® and Baizean®[12] - GAAP net loss improved to $251.2 million in Q1 2024 from $348.4 million in Q1 2023, with a basic and diluted net loss per share of $0.19[18] Sales Growth - Global sales of Brukinsa® reached $489 million, with sales in the US and Europe growing by 153% and 243% respectively[3] - In Q1 2024, sales of Baiyueze® in the US reached $351 million, a year-over-year increase of 153%, driven by increased market share in treatment-naive chronic lymphocytic leukemia (CLL) and leading market share in newly diagnosed relapsed/refractory (R/R) CLL patients[6] - In Q1 2024, sales of Baizean® reached $145 million, a year-over-year increase of 26%[7] Operating Loss and Expenses - GAAP operating loss improved to $(261.35) million, a 30% reduction from $(371.26) million in the same quarter last year[5] - Adjusted operating loss decreased by 47% to $(147.34) million from $(275.86) million year-over-year[5] - Total operating expenses for Q1 2024 were $888.1 million, a 20% increase from $737.3 million in Q1 2023[13] - SG&A expenses accounted for 57% of product revenue in Q1 2024, down from 80% in the same period last year[14] - Cash used in operating activities was $309 million in Q1 2024, down from $564 million in the same quarter last year[14] Research and Development - R&D expenses for Q1 2024 were $460.6 million, a 13% increase from $408.6 million in Q1 2023, driven by advancements in clinical projects[13] - Adjusted R&D expenses for Q1 2024 were $405,440 thousand, compared to $361,696 thousand in Q1 2023, representing an increase of about 12.1%[20] Pipeline and Approvals - The company is advancing its hematology pipeline, with key studies for sonrotoclax and Brukinsa® combination therapies underway[3] - The FDA recently approved a fifth indication for Brukinsa®, making it the most broadly indicated BTK inhibitor in its class[3] - The company received FDA approval for Baiyueze® in combination with the anti-CD20 monoclonal antibody Obinutuzumab for treating adult patients with R/R follicular lymphoma[6] - The company announced the initiation of a new indication application for Baizean® for first-line treatment of gastric or gastroesophageal junction adenocarcinoma, which is currently under FDA review[7] - The company plans to submit a new drug application for Zhenidatuzumab for second-line treatment of biliary tract cancer to the National Medical Products Administration (NMPA) in China[10] Financial Position - As of March 31, 2024, total assets decreased to $5,667,681 thousand from $5,805,275 thousand as of December 31, 2023, representing a decline of approximately 2.4%[19] - Cash and cash equivalents decreased to $2,807,436 thousand from $3,188,584 thousand, a reduction of about 11.9%[19] - Net accounts receivable increased to $435,294 thousand, up from $358,027 thousand, reflecting a growth of approximately 21.6%[19] - Total liabilities increased to $2,307,320 thousand from $2,267,948 thousand, marking an increase of about 1.7%[19] - Total equity decreased to $3,360,361 thousand from $3,537,327 thousand, a decline of about 5.0%[19] Strategic Focus - The company is focused on achieving sustainable profitability while enhancing operational efficiency[4] - The company continues to invest in the global commercialization of its product, particularly in the U.S. and Europe[14] - The company is making significant progress towards sustainable profitability, driven by revenue growth and cost control[14] - The company has a strong pipeline of innovative oncology drugs and is focused on enhancing drug accessibility and affordability globally[15] - The company continues to utilize non-GAAP financial measures to provide a clearer understanding of its operational performance, which may differ from other companies' calculations[19]
百济神州(06160) - 2024 Q1 - 季度业绩