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]