2024-05-08 10:09Financial Performance - Total revenues reached $752 million in Q1 2024, with product revenue of $747 million, marking an 82% increase from the prior year[119] - Gross profit increased to $626.7 million, a 71.2% rise from $366 million in the same quarter last year[126] - Net loss narrowed to $251.2 million, a 27.9% improvement from a loss of $348.4 million in Q1 2023[126] - Net product revenue increased by 82.0% to $746.9 million for the three months ended March 31, 2024, compared to $410.3 million in the prior-year period[130] - Global sales of BRUKINSA totaled $488.5 million in the first quarter, representing a 131.1% increase compared to the prior-year period[131] - U.S. sales of BRUKINSA grew by 153.3% to $351.5 million, while European sales increased by 242.8% to $66.8 million[131] - Sales of tislelizumab in China totaled $145.2 million, reflecting a 26.4% increase from the prior-year period[132] - Gross margin on global product sales increased to $622.0 million, with a gross margin percentage of 83.3% for the three months ended March 31, 2024[135] Expenses and Losses - Operating expenses totaled $888.1 million, up 20.5% from $737.3 million, driven by increased research and development costs[126] - Research and development expenses rose by 12.7% to $460.6 million, driven by higher development milestone fees and internal research activities[136] - Selling, general and administrative expenses increased by 30.1% to $427.4 million, primarily due to investments in commercial activities[139] - The company reported a net loss of $251.2 million for the three months ended March 31, 2024, compared to a net loss of $348.4 million for the same period in 2023, resulting in an accumulated deficit of $8.2 billion as of March 31, 2024[147] Revenue Sources - BRUKINSA generated $489 million in revenue, with growth of 153% in the U.S. and 243% in Europe compared to the prior year[119] - Collaboration revenue decreased by 87.4% to $4.7 million, primarily due to the termination of the Novartis collaborations[127] Regulatory Approvals - The European Commission approved tislelizumab for non-small cell lung cancer across three indications[120] - The FDA approved TEVIMBRA for the treatment of unresectable or metastatic esophageal squamous cell carcinoma, expected to be available in the U.S. in the second half of 2024[120] - BRUKINSA received its fifth indication in B-cell malignancies in the U.S. after FDA granted accelerated approval for relapsed or refractory follicular lymphoma[122] Cash Flow and Debt - Cash and cash equivalents decreased to $2.8 billion as of March 31, 2024, down from $3.5 billion at the end of the previous year, with net cash used in operating activities amounting to $308.6 million in Q1 2024[151] - The company utilized $209.8 million in investing activities during the three months ended March 31, 2024, primarily for capital expenditures of $156.6 million and IPR&D asset purchases of $31.8 million[155] - Financing activities generated $162.3 million in cash during Q1 2024, mainly from $142.0 million in short-term loans and $9.1 million from long-term loans[157] - Total debt increased to $1,025.99 million as of March 31, 2024, up from $885.98 million at the end of 2023[145] - The company has total debt obligations of $1.03 billion, with $827.0 million due within the next 12 months[168] Foreign Currency and Inflation - The impact of foreign currency translation negatively affected cash by $22.4 million in Q1 2024, compared to a positive impact of $11.3 million in the prior-year period[159] - The RMB depreciated approximately 1.7% against the U.S. dollar in the three months ended March 31, 2024, and approximately 2.8% in the year ended December 31, 2023[176] - The company has not used derivative financial instruments to hedge exposure to foreign exchange risk despite holding significant amounts of RMB[175] - Inflation has not had a material effect on the company's results of operations during the three months ended March 31, 2024[179] Future Outlook and Commitments - The company plans to fund its material cash requirements through existing financial resources and anticipated receipts from accounts receivable and product sales[163] - As of March 31, 2024, the company had a remaining co-development funding commitment of $457.0 million related to the Amgen collaboration[170] - The company expects to refinance its debt obligations based on historical experience, with the ability to do so influenced by prevailing interest rates and credit spreads[157] - The company expects to utilize its existing RMB cash deposits in its China operations over the next several years[175] Accounting Policies - The company continues to evaluate its critical accounting policies, with no material changes reported for the three months ended March 31, 2024[173] - The company has not reported any new accounting policies adopted during the three months ended March 31, 2024[173] - The company assesses various factors for estimating the useful lives of long-lived assets and the fair value of financial instruments, which may lead to differences from actual results[172] - The company is exposed to risks related to changes in interest rates and foreign currency exchange rates, which may impact its financial condition[174][176]