Financial Data and Key Metrics Changes - Revenue reached $1.4 billion, representing a 41% year-on-year growth [5][16] - GAAP earnings per ADS were $1.09, an increase of over $2 compared to Q3 of the previous year [5][16] - Free cash flow generated during the quarter was over $350 million, with ending cash and cash equivalents totaling $4.1 billion, an increase of $1.3 billion from Q2 [5][20] - Non-GAAP net income reached $304 million, reflecting an increase of $252 million compared to the previous year, translating to diluted non-GAAP earnings per ADS of $2.65 [19] Business Line Data and Key Metrics Changes - Rukinza, the leading BTK inhibitor, generated over $1 billion in quarterly global revenue for the first time, growing 51% [6][7] - Tivimra reported a 17% increase in revenue, reflecting continued market leadership in China [16] - In-license products grew 17% year-over-year, driven by a 31% increase from the Amgen in-license asset portfolio [16] Market Data and Key Metrics Changes - U.S. revenue totaled $743 million, with year-over-year growth of 47% [17] - China revenue was $435 million, a 17% increase supported by Tivimra and Rukinza's market leadership [17] - Europe contributed $167 million, with 71% year-over-year growth [17] - Rest of the world markets grew 133%, driven by market expansions and new launches [17] Company Strategy and Development Direction - The company aims to develop innovative medicines that deliver long-term outcomes for patients, focusing on Rukinza, Sonro, and BTK CDAC as core elements in B cell malignancies [6][13] - A global superhighway strategy has been established, integrating clinical development and manufacturing to enhance R&D investment returns [14] - The company plans to run more than 20 phase three trials and anticipates over 10 proof of concept data readouts by the end of 2026 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial success of Rukinza, citing strong clinical data and market leadership [8][9] - The company is focused on achieving positive GAAP operating income and generating positive free cash flow for the year [20] - Management highlighted the importance of long-term data in CLL treatment and the competitive landscape for fixed-duration therapies [10][11] Other Important Information - Sonro received FDA breakthrough designation for relapsed refractory mantle cell lymphoma, with plans for global filing [23] - The company has achieved proof of concept for several innovative programs in solid tumors, including CDK4 and PRMT5 inhibitors [24][26] Q&A Session Summary Question: Update on Bakensa's performance in Europe - Management noted significant growth for Bakensa in Europe, but prescription levels have not been extremely high, leading to flattening total ACALA numbers [45] Question: Expectations for CDAC data in CLL - Management indicated that the CDAC data will likely be based on overall response rates and duration of response, with further discussions with the agency ongoing [46] Question: Insights on earlier stage pipeline and new molecular entities - Management emphasized that clear criteria for success have been established for early programs, with some likely progressing to phase three trials [52] Question: Commercial dynamics in relapsed refractory CLL - Management confirmed strong new patient start share for Rukinza across therapy lines, with confidence in the overall CLL franchise leadership strategy [78] Question: Details on CDK4 phase three design - Management shared that three dose levels are being explored, with a head-to-head study planned against currently available CDK4/6 inhibitors [67] Question: Rationale for additional investment in ZS versus AV study - Management stated the importance of establishing ZS as the best oral fixed duration regimen, despite existing long-term data supporting its efficacy [70][72]

Financial Data and Key Metrics Changes - Revenue reached $1.4 billion, representing a 41% year-on-year growth [4][16] - GAAP earnings per ADS were $1.09, an increase of over $2 compared to Q3 of the previous year [4] - Free cash flow generated during the quarter was over $350 million, with ending cash and cash equivalents totaling $4.1 billion, an increase of $1.3 billion from Q2 [4][20] - Non-GAAP net income reached $304 million, reflecting an increase of $252 million compared to the previous year, translating to diluted non-GAAP earnings per ADS of $2.65 [19] Business Line Data and Key Metrics Changes - Rukinza, the leading BTK inhibitor, grew 51% and exceeded $1 billion in quarterly global revenue for the first time [5][16] - Tivimra reported a 17% increase in revenue, reflecting continued market leadership in China [16] - In-license products grew 17% year-over-year, driven by a 31% increase from the Amgen in-license asset portfolio [16] Market Data and Key Metrics Changes - U.S. revenue totaled $743 million, with year-over-year growth of 47% [17] - China revenue was $435 million, a 17% increase supported by Tivimra and Rukinza's market leadership [17] - Europe contributed $167 million, with 71% year-over-year growth [17] - Rest of the world markets grew 133%, driven by market expansions and new launches [17] Company Strategy and Development Direction - The company aims to develop a more efficacious, time-limited regimen that does not come with caveats or accommodations, focusing on the combination of Zanu and Sonro [10][12] - The company is committed to advancing its innovative pipeline, with plans for over 20 phase three trials and more than 10 proof of concept data readouts by the end of 2026 [14][15] - The company emphasizes a vertically integrated approach to clinical development and manufacturing as a competitive advantage [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term data for Rukinza, stating it sets a high standard for BTK inhibitors in CLL treatment [8][9] - The company anticipates continued strong performance in the BTK market, with a focus on maintaining leadership in B cell malignancies [5][12] - Management highlighted the importance of long-term follow-up data in understanding treatment efficacy in CLL [9] Other Important Information - The company has received FDA breakthrough designation for Sonro in relapsed refractory mantle cell lymphoma [24] - The company plans to present 47 abstracts from its heme portfolio at the upcoming ASH conference [5][24] Q&A Session Summary Question: What is the status of Bakensa in Europe? - The company has seen close to 70% growth for Bakensa in Europe, but excitement among healthcare professionals has been limited [40] Question: Can you provide more details on the CDAC data expected in the first half of next year? - The CDAC data will likely be based on overall response rates and duration of response, with further discussions with regulatory agencies ongoing [40] Question: What is the outlook for the earlier stage pipeline? - The company has established clear criteria for success based on preclinical data, with some programs actively planning acceleration to phase three studies [42][44] Question: What is the rationale for the CDK4 phase three study design? - The study aims to establish the CDK4 inhibitor as superior to currently available CDK4/6 inhibitors, with final decisions on study size and powering pending [50] Question: How is Rukinza's share holding up in the relapsed refractory setting? - The company continues to see strong new patient start share across therapy lines, including in the relapsed setting [54]