B1 Medicines (ONC) Q2 2025: Brukinsa Drives 49% Global Growth as Margin Expands to 87%
B1 Medicines’ Q2 results highlight Brukinsa’s dominant US market share and accelerating global expansion, powering broad-based revenue and margin gains. Margin expansion and robust pipeline execution signal a business model built for durable growth, even as leadership eyes further global launches and next-generation R&D milestones. Guidance raise cements confidence in execution, with investors now watching for pivotal data and new product launches to sustain momentum into 2026.
Summary
- Brukinsa’s Market Leadership: US and global adoption outpaces rivals, reinforcing franchise durability.
- Margin Expansion: Operational leverage and mix improvements drive gross margin to record highs.
- Pipeline Execution: Multiple late-stage and early-stage catalysts set up significant data flow through 2026.
Performance Analysis
B1 Medicines delivered a standout quarter, with total revenue climbing sharply on the back of sustained Brukinsa, BTK inhibitor, uptake. Brukinsa’s global revenue grew 49% YoY, now representing the clear market leader in the US and gaining ground internationally, including rapid launches in Japan and Europe. Tevimbra, PD-1 inhibitor, and in-licensed products also contributed to diversified growth across China, Europe, and Rest of World, supporting a balanced revenue mix.
Gross margin expanded to 87%, up from 85% in the prior quarter, propelled by product mix, pricing discipline, and manufacturing efficiencies, notably in Tevimbra. Operating expenses rose 18% YoY as the company invests in commercial expansion and R&D, but margin expansion and improved net income signal operational leverage. Free cash flow generation exceeded $220 million in Q2, a $400 million YoY improvement, underscoring the business’s cash conversion strength even as it scales globally.
- US Revenue Mix Shifts: US revenues now lead, with $685 million and 43% YoY growth, reflecting Brukinsa’s dominance.
- Geographic Diversity: China grew 23%, Europe 87%, and Rest of World 168%, highlighting broad market penetration and launch execution.
- Tablet Formulation Rollout: New Brukinsa tablet reduces cost of goods and enhances patient experience, supporting future margin gains.
Management raised full-year revenue guidance, reflecting confidence in execution and the durability of core franchises. The company’s ability to maintain pricing and access despite competitive discounting and regulatory changes further supports the financial outlook.
Executive Commentary
"Brukinsa has cemented itself as the number one BTK inhibitor in the U.S. market... The gap between us and the competition continues to widen. Brukinsa is both the market share leader and it's the fastest growing brand and it's the only BTK to be approved in five indications."
John Euler, Co-Founder, Chairman and CEO
"Gross margin improved to approximately 87% from 85% in the prior quarter. This improvement reflects the benefits from favorable product mix, price, and production efficiencies... We remain committed to achieving positive GAAP operating income and we expect to generate positive free cash flow for the year."
Aaron Rosenberg, Chief Financial Officer
Strategic Positioning
1. Brukinsa as Franchise Cornerstone
Brukinsa’s best-in-class clinical profile and multi-indication approvals have propelled it to the top of the US BTK inhibitor market, displacing entrenched incumbents despite a later launch. Head-to-head trial data and real-world evidence reinforce its superior efficacy and safety, particularly in challenging patient subpopulations. The franchise is now expanding globally, with launches in Japan and Europe fueling further volume growth.
2. Global Diversification and Access Strategy
B1’s revenue base is increasingly diversified, with China, Europe, and Rest of World all posting strong double- and triple-digit growth. The company’s open access strategy and protected class status in the US ensure broad patient reach, while ongoing launches in new markets and indications extend the runway. Tablet formulation and local manufacturing investments mitigate tariff risks and support margin resilience.
3. Pipeline Depth and Serial Innovation
Beyond CLL, B1 is advancing a robust late- and early-stage pipeline, including the upcoming global filing for Sonro, a next-generation BCL-2 inhibitor, and pivotal studies for BTK CDAC, a BTK degrader. Solid tumor programs are being rapidly scaled, with multiple assets entering or progressing through clinical trials, and a focus on portfolio synergies across disease areas. More than 20 Phase III trials and over 10 proof-of-concept readouts are expected by the end of 2026, setting the stage for sustained innovation-led growth.
Key Considerations
This quarter showcased B1 Medicines’ ability to execute simultaneously on commercial, operational, and R&D fronts, while navigating competitive and regulatory headwinds. Investors should assess how these levers interact to shape future growth and resilience.
Key Considerations:
- Access and Pricing Stability: Brukinsa’s protected class status and open access policy underpin US leadership, even amid aggressive competitor discounting.
- Operational Leverage: Margin gains stem from manufacturing scale, product mix, and cost discipline, with the new tablet formulation promising further efficiency.
- Pipeline Catalysts: Multiple late-stage readouts and filings, especially for Sonro and BTK CDAC, could reshape the competitive landscape in CLL and beyond.
- Geographic Expansion: Rapid uptake in new markets and indications diversifies risk and supports top-line durability, but requires sustained investment and local execution.
- Tariff and Regulatory Preparedness: Supply chain localization and inventory strategy reduce tariff exposure, but ongoing vigilance is needed as US policy evolves.
Risks
Tariff escalation and regulatory shifts in the US could pressure margins, though B1’s regional manufacturing mitigates near-term impact. Competitive intensity remains high, with rivals discounting and launching new BTK and BCL-2 agents, potentially challenging Brukinsa’s share and pricing. Pipeline execution risk exists, as pivotal trial outcomes and regulatory timelines will determine the next leg of growth. Management’s raised guidance assumes continued operational and commercial momentum, which could be disrupted by macro or clinical setbacks.
Forward Outlook
For Q3 2025, B1 Medicines guided to:
- Continued revenue growth across all regions, led by Brukinsa and new launches
- Gross margin in the mid-to-high 80% range, reflecting mix and cost efficiencies
For full-year 2025, management raised guidance:
- Total revenue of $5.0 to $5.3 billion
- Operating expenses of $4.1 to $4.4 billion (unchanged)
Management highlighted several factors that underpin the outlook:
- Strong first-half execution and broad-based demand support the higher range
- Upcoming pivotal data and product launches could further accelerate growth
Takeaways
B1 Medicines’ Q2 results underscore the power of a differentiated clinical franchise, global execution, and pipeline momentum. Margin expansion and cash flow gains suggest operational discipline is keeping pace with topline growth, while the breadth of late-stage R&D sets the company apart from less diversified biotech peers.
- Brukinsa’s Dominance: Clinical and commercial leadership in BTK inhibitors is translating into global market share and margin strength, with new launches extending the lead.
- Operational Discipline: Manufacturing efficiencies, supply chain localization, and a patient-centric access model support margin durability and risk mitigation.
- Pipeline Watch: Investors should monitor pivotal trial readouts (Sonro, BTK CDAC), global filings, and the pace of solid tumor asset advancement for signs of the next growth wave.
Conclusion
B1 Medicines enters the second half of 2025 with robust momentum, driven by Brukinsa’s US and global strength, expanding margin profile, and a pipeline stacked with late-stage catalysts. Execution across commercial, operational, and R&D fronts positions the company for continued outperformance, though investors should remain vigilant around competitive and regulatory risks.
Industry Read-Through
B1’s results reinforce the critical importance of clinical differentiation and real-world evidence in crowded oncology markets, particularly as payers and prescribers increasingly reward best-in-class efficacy and safety. Operational leverage and geographic expansion are proving essential for scaling biopharma franchises globally, with local manufacturing and product innovation (such as tablet reformulations) serving as key margin levers. Pipeline breadth and speed to pivotal data are now table stakes for oncology leaders, with serial innovation required to sustain growth as legacy assets mature. Competitors in BTK, BCL-2, and solid tumor spaces face a high bar for clinical and commercial adoption, making trial design, access strategy, and global execution critical differentiators going forward.