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][18] - 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 - BRUKINSA® global revenues exceeded $1 billion for the first time, growing 51% year-on-year, with U.S. volume increasing by approximately 40% [6][16] - TEVIMBRA 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-Licensed Asset Portfolio [17] Market Data and Key Metrics Changes - U.S. revenue totaled $743 million, with a year-over-year growth of 47% [17] - China revenue was $435 million, a 17% increase supported by TEVIMBRA and BRUKINSA®'s market leadership [17] - Europe contributed $167 million, with a significant year-over-year growth of 71% [17] - Rest of 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 [11][13] - BeOne Medicines is committed to a vertically integrated approach in clinical development and manufacturing, which is seen as a competitive advantage [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 sustained momentum of BRUKINSA® and the potential of Sonro, especially following its FDA breakthrough designation [6][15] - 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 - The company is preparing for a significant presentation at ASH, showcasing 47 abstracts from its Hematology Portfolio [7][23] - The company has achieved proof of concept for several innovative programs in solid tumors, including CDK4 and PRMT5 inhibitors [23][25] Q&A Session Summary Question: Update on BRUKINSA® in Europe and CDAC data expectations - Management noted that BRUKINSA® is growing in Europe, but the overall market is flattening, and CDAC data will likely be based on overall response and duration of response [44][47] Question: Insights on early-stage pipeline and new molecular entities - Management indicated that clear criteria for success are established for early programs, with some likely progressing to phase three trials [50][52] Question: Commercial dynamics in CLL and future therapy mix - Management confirmed strong new patient start share across therapy lines, with confidence in the overall CLL franchise leadership strategy [75][78] Question: Details on CDK4 phase III design and rationale for ZS vs AV study - Management provided insights on the CDK4 phase III study design and emphasized the importance of establishing ZS as the best oral fixed duration regimen [66][70]

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]

Financial Data and Key Metrics Changes - Revenue reached $1.3 billion in Q2 2025, representing a 42% year-on-year growth [5][17] - GAAP earnings per ADS grew by $2 compared to Q2 of the previous year [5] - Free cash flow generated in Q2 was $220 million, an increase of over $400 million year-on-year [5] - Gross margin improved to approximately 87% from 85% in the prior quarter [21] - Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year [23] Business Line Data and Key Metrics Changes - Brukinza global revenues were $950 million, growing 49% year-on-year, driven by strong performance across all geographies [17] - Tovembra reported a 22% increase in revenue, reflecting continued market leadership in China [19] - In-licensed products showed continued strength, growing 27% year-on-year [19] Market Data and Key Metrics Changes - The US market generated $685 million with a year-on-year growth of 43% [20] - China revenue totaled $429 million, a 23% increase [20] - Europe contributed $152 million with 87% year-on-year growth [20] - Rest of world markets grew by 168% driven by market expansions and new launches [20] Company Strategy and Development Direction - The company aims to maintain leadership in the hematology franchise and expand its solid tumor pipeline [6][15] - Plans to combine assets in multiple phase three trials to improve outcomes for CLL patients [15] - The company is focused on serial innovation in CLL and aims to build a deep pipeline across various disease areas [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in long-term market leadership for Brukinza despite competitive pricing pressures [18] - The company anticipates stable pricing for the remainder of the year [46] - Future impacts from potential US tariffs are expected to be manageable within the context of the P&L [73] Other Important Information - The company is preparing for the initial global approval of Sonro and anticipates pivotal data for its BTK CDAC by 2026 [15] - The tablet formulation of Brukinza is expected to achieve a lower cost of goods and improve patient convenience [24] Q&A Session Summary Question: Update on Brukinza's US net pricing and inventory changes - Management anticipates stable pricing for the remainder of the year and has no significant inventory levels to comment on [46][47] Question: Reaction to Bruin CLL 314 data for PERTO versus IMBRUVICA - Management noted that the OR superiority was not formally tested and emphasized the importance of PFS data [48][49] Question: Delay in starting the second line phase three trial for CDK4 - Management stated that the delay is modest and aims to let data mature for better dose level selection [53] Question: Impact of US tariffs on gross margin - Management indicated that current guidance contemplates known tariffs and that impacts have been mitigated through supply chain strategies [73] Question: Specifics on access to Brukinza and revenue mix - Management confirmed that Brukinza continues to be listed on all Medicare Part D formularies and access is strong [99][100]

Financial Data and Key Metrics Changes - Revenue for Q2 reached $1.3 billion, representing a 42% year-on-year growth [4][16] - GAAP earnings per ADS increased by $2 compared to Q2 of the previous year [4] - Free cash flow generated in Q2 was $220 million, an increase of over $400 million compared to last year [4] Business Line Data and Key Metrics Changes - Brukinza's global revenues were $950 million, growing 49% year-on-year, driven by strong performance across all geographies [16] - Tovembra reported a 22% increase in revenue, reflecting continued market leadership in China [18] - In-licensed products grew 27% year-on-year, with the launch of zanadatumab in China [18] Market Data and Key Metrics Changes - The US market generated $685 million with a year-on-year growth of 43% [19] - China revenue totaled $429 million, a 23% increase [19] - Europe contributed $152 million with 87% year-on-year growth [19] - Rest of the world markets grew by 168% driven by market expansions and new launches [19] Company Strategy and Development Direction - The company aims to maintain leadership in the hematology franchise and expand its solid tumor pipeline [5][14] - Plans to run over 20 phase three trials and anticipate more than 10 proof of concept data readouts by 2026 [14] - Focus on serial innovation in CLL to address unmet patient needs across all lines of therapy [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in long-term market leadership for Brukinza despite competitive pricing pressures [17] - The company is optimistic about the prospects for its pipeline and upcoming milestones [14][27] - Management noted that the current guidance reflects known factors, including potential impacts from US tariffs [72] Other Important Information - Gross margin improved to approximately 87% from 85% in the prior quarter, reflecting favorable product mix and production cost efficiencies [20] - Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year [22] Q&A Session Summary Question: Update on Brukinza's US net pricing expectations - Management anticipates stable pricing for the remainder of the year and no significant inventory changes [46] Question: Reaction to Bruin CLL 314 data - Management noted that the study did not formally test OR superiority, and emphasized the importance of PFS data [47][48] Question: CDK4 trial timeline - Management updated the timeline for the second line phase three trial to early 2026 to allow for data maturation [52] Question: Market dynamics for CELESTIAL trial - Management expressed optimism about the Xanin plus Sonro combination and its potential market impact [58] Question: Gross margin improvements - Management attributed gross margin improvements to production efficiencies and a favorable product mix [71] Question: Access to Brukinza - Management confirmed that the majority of patients have access to Brukinza, with a successful appeals process for new patients [96] Question: Revenue guidance drivers - Management indicated that the updated revenue guidance reflects confidence in execution across the portfolio [80]

Summary of the Conference Call Company Overview - The company, transitioning to B1 Medicines, was founded in February 2010 and has grown to over 11,000 employees globally, focusing on innovative medicines for patients worldwide [5][4] - The company aims to solidify its leadership in hematology, advance its pipeline, and deliver strong financial performance as it moves into 2025 [5][6] Hematology Franchise - B1 Medicines is the only company with three wholly owned, potentially best-in-class medicines for Chronic Lymphocytic Leukemia (CLL) [6] - The lead product, Brukinza, is the only BTK inhibitor to demonstrate complete and sustained BTK inhibition and has shown superiority to IMBRUVICA in head-to-head trials [6][12] - In Q1, the company achieved a revenue share lead in the CLL market just two years post-launch [6][10] - The second asset, Sonro, is a second-generation BCL2 inhibitor, with ongoing Phase III trials and a recent filing for relapsed-refractory CLL in China [7][8] - The third asset is a first-in-class BTK degrader, with over 600 patients dosed and a Phase III trial initiated [8] Financial Performance - The company reported $1.1 billion in sales for Q1, a 50% year-over-year increase, marking its first quarter of GAAP income [9][10] - The financial profile has significantly improved compared to previous years, setting a strong foundation for 2025 [11][21] Market Dynamics and Competition - The company believes in the long-term benefits of fixed-duration therapy for patients, despite competition from Akala [16] - Concerns were raised about the efficacy and safety of competing therapies, particularly regarding patient populations and outcomes [17][18] - The company sees significant opportunities in first-line Mantle Cell Lymphoma (MCL) and other B-cell malignancies, estimating over 20,000 new cases annually across these indications [19][20] Pipeline and R&D Strategy - B1 Medicines had 13 New Molecular Entities (NMEs) enter the clinic last year, the highest in the industry, with 10 proof of concept data readouts expected in 2025 [8][9] - The company is focused on a portfolio approach to manage risks associated with pricing pressures and competition [24] - Upcoming R&D Day on June 26 will highlight the company's strategy to build franchises in key disease areas, including lung cancer and breast cancer [36][39] Regulatory and Approval Insights - The company is pursuing accelerated approval opportunities for Sonro in the U.S. and is engaging with regulatory authorities regarding undetectable MRD rates as a surrogate endpoint [30][31] - The development review committee has clear go/no-go criteria for new molecules, ensuring focus on impactful investigational medicines [40] Commercial Strategy - The company is optimistic about the market potential for Tivimbra, particularly in upper GI cancers, with a global PD-1 market opportunity estimated at $50 billion [46][47] - Tivimbra has received frontline esophageal and gastric labels, with a focus on differentiation and competitive pricing [48][49] Geographic Revenue Diversity - The company has evolved to resemble a global multinational pharma, with significant growth opportunities in Europe and other markets [51][52] Conclusion - B1 Medicines is well-positioned in the hematology market with a strong pipeline and financial performance, while also preparing for future growth in solid tumors and expanding its global presence [53][54]

Financial Data and Key Metrics Changes - The company achieved GAAP profitability for the first time in Q1 2025, with revenue of $1.1 billion, representing a 49% increase from $752 million in Q1 2024 [37][38] - Non-GAAP net income totaled $136 million in Q1 2025, an increase of $282 million compared to the prior year, equating to non-GAAP earnings of $1.22 per ADS [41][42] - Product gross margin increased to 85% in Q1 2025 from 83% in Q1 2024, driven by favorable mix and cost of sales productivity [40] Business Line Data and Key Metrics Changes - Brukinza sales reached $792 million in Q1 2025, representing a 62% growth compared to Q1 2024, establishing it as the market leader in the U.S. BTK market [38][39] - Tivenbra sales were $171 million, resulting in 18% revenue growth year-over-year, primarily driven by its leading market position in China [39] - The U.S. market grew 60% due to strong demand for Brukinza, while China sales grew by 26% compared to the prior year [16][17] Market Data and Key Metrics Changes - Global sales reached $1.1 billion, with the U.S. being the largest market, growing 60% [16][17] - European sales experienced a 75% growth, driven by the launch of Brukinza and Tivenbra [18] - Sales in the rest of the world totaled $32 million, growing 146% compared to the prior year, primarily due to expansion in new markets [19] Company Strategy and Development Direction - The company focuses on solidifying its hematology franchise leadership, advancing its pipeline of internally developed assets, and driving superior financial performance [6][12] - The company is committed to regional manufacturing to mitigate risks associated with trade policies and tariffs, including an $800 million investment in its New Jersey manufacturing facility [13][14] - The company plans to submit its first global filing for Sonro in the second half of 2025, marking a significant step in its oncology portfolio [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's unique model to succeed despite challenges in the global environment, emphasizing a technology-enabled and vertically integrated organization [12][13] - The company anticipates more than 10 proof of concept readouts across its solid tumor pipeline this year, representing potential near-term value inflection points [11] - Management remains optimistic about the growth prospects in Europe and the rest of the world, expecting these markets to contribute significantly to future revenue growth [18][19] Other Important Information - The company has received approval for redomiciling to Switzerland and changing its name to B1 Medicines, reflecting its evolution into a globally diversified oncology leader [14] - The company has a robust pipeline with 19 new molecules in the clinic across major tumor types, focusing on targeted therapies [34][35] Q&A Session Summary Question: Can you remind us how 4395 differs from Pfizer's Otermo and the potential role of Rekinza in autoimmune diseases? - The company’s CDK4 molecule is designed to be more potent and selective than Pfizer's Otermo, with plans to initiate phase three trials in second-line settings [48][49] Question: Can you provide a sense of Kinza's Q1 performance and split sales by region? - The company noted that the Part D redesign had some impact on pricing, but overall, they experienced a stable net pricing environment [56][58] Question: What are the expectations for the interim analysis of the Mangrove trial? - The Mangrove trial is event-driven, and the company hopes to see results in the second half of the year [78] Question: How does the company view the competitive landscape for Brukinza with upcoming data from competitors? - The company believes that Brukinza will maintain and expand its market share, emphasizing its superior safety and efficacy profile compared to competitors [86][92] Question: What is the company's strategy regarding R&D spending amid a wave of approved concept data? - The company is committed to investing significantly in its pipeline while maintaining a focus on sustainable growth and profitability [93][96]