BeOne Medicines Ltd. American Depositary Shares 2026 Q2 Earnings Call
Review the key takeaways and the transcript of this earnings call.
- B1 Medicine reported Q2 2026 total revenues of $1.7 billion, a 30% increase year over year, and GAAP earnings per ADS of $2.05, a 144% increase compared to the prior year.
- Brukinsa, the foundational BTK inhibitor, generated over $1.2 billion in global revenues in Q2, growing 31% year over year and showing strong growth across all five approved indications.
- Tevimbra achieved $229 million in global sales, up 18% versus the prior period, maintaining market leadership in China despite competition.
- The Amgen in-licensed portfolio delivered $157 million in revenue, growing 25% year over year.
- Gross profit was $1.5 billion with a gross margin just under 90%, and operating expenses totaled $1.2 billion, a 13% increase reflecting clinical program advancement and commercial investment.
- Net income was $237 million, including a $60 million tax audit settlement impact.
- Adjusted income from operations increased over 80% year over year to $503 million, with adjusted net income of $444 million and adjusted diluted EPS of $3.84.
- Free cash flow doubled year over year to $435 million.
- The FDA approved Bacall's as the first and only BCL2 inhibitor in mantle cell lymphoma.
- The phase three Mangrove study of Brukinsa showed positive results as the first chemo-free frontline treatment option for mantle cell lymphoma, with global submissions planned for H2 2026.
- B1 announced a $300 million expansion of its US manufacturing site in Hopewell, New Jersey.
- Brukinsa has the broadest label of any BTK inhibitor, approved in five B-cell malignancies and treated over 300,000 patients across 80+ markets.
- Long-term follow-up data show Brukinsa's superior progression-free survival (PFS) compared to other BTK inhibitors and fixed-duration regimens, especially in high-risk CLL patients.
- Real-world data from over 10,500 Medicare patients showed Brukinsa reduced risk of death by 24% and 36% compared to acalabrutinib and ibrutinib, respectively.
- B1 is the only company with foundational medicines across three mechanisms of action for B-cell malignancies: BTK inhibitor (Brukinsa), BCL2 inhibitor (Bacall's), and BTK degrader (Tak-020).
- The solid tumor pipeline advanced with FDA acceptance of the Her2 positive GA application and regulatory progress in China for CDK4 inhibitor and B7-H4 ADC.
- Five solid tumor programs have achieved clinical proof of concept and are advancing toward pivotal development, including CDK4 inhibitor, GPC3 form BB bispecific, B7-H4 ADC, PMT5 inhibitor, and CEA ADC.
- The CDK4 inhibitor showed a 70% objective response rate with a differentiated hematological safety profile in first-line HR positive, Her2 negative metastatic breast cancer.
- The GPC3 form BB bispecific demonstrated over 30% objective response rate in second-line plus HCC with a favorable safety profile.
- The B7-H4 ADC showed approximately 26% treatment-related grade 3 or higher adverse events, less than half the rates of other ADCs in development for first-line ovarian cancer.
- B1 plans to submit for accelerated approval of Tak-020 in relapsed refractory CLL by year-end 2026 and initiate fixed-duration combination phase three development in relapsed refractory CLL in 2027.
- The company is on track to initiate pivotal studies for GPC3 form BB bispecific in second-line plus HCC and B7-H4 ADC in first-line maintenance ovarian cancer before year-end 2026.
- B1 is advancing a CNS-penetrant Prmt5 inhibitor with initial phase one data expected at ASCO, showing clinical meaningful brain activity and plans for phase three development in 2027.
- The Ras inhibitor program will enter the clinic before year-end 2026, with a focus on non-small cell lung cancer and pancreatic cancer, including combination strategies with Prmt5 inhibitors.
- The Amgen in-licensed portfolio is expected to face biosimilar competition for Xgeva beyond 2026, which could influence future performance.
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Transcript
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안녕하세요, 여러분. BeOne Medicines 2026년 2분기 실적 발표 웨비나에 오신 것을 환영합니다. 배경 소음을 방지하기 위해 모든 전화선이 음소거 처리되었습니다. 발표가 끝난 후 질의응답 시간이 있을 예정입니다. 이제 회의를 회사 측에 넘기겠습니다.
안녕하세요, 참석해 주셔서 감사합니다. 저는 BeOne Medicines의 투자자 관계 책임자 댄 말러입니다. 시작에 앞서, 오늘 웨비나 녹화본과 발표 자료를 포함한 추가 자료는 당사 웹사이트 ir.beonemedicines.com의 투자자 관계 섹션에서 확인하실 수 있음을 알려드립니다. 이번 통화 중에 회사의 미래 전망과 사업 전략 등과 관련된 미래 예측성 발언을 할 수 있음을 모든 참석자께 상기시켜 드립니다. 실제 결과는 SEC에 제출한 최신 정기 보고서에 기재된 위험 요인을 포함한 여러 요인으로 인해 미래 예측성 발언과 실질적으로 다를 수 있습니다. 또한 이 발표에 첨부된 슬라이드 데크에 있는 미래 예측성 발언 면책 조항을 주의 깊게 검토해 주시기 바랍니다.
이번 통화에서 언급된 GAAP 및 비-GAAP 재무 지표 간 조정 내역은 당사 투자자 관계 웹사이트에 게시된 발표 자료 부록과 실적 발표 자료에 포함되어 있습니다. 이 발표의 모든 정보는 발표일 기준이며, 법률상 요구되지 않는 한 해당 정보를 업데이트할 의무는 없습니다. 3페이지에 요약된 오늘 통화 내용으로 넘어가겠습니다. 우리 공동 창립자이자 회장 겸 CEO인 존 오일러가 사업 현황을 보고할 예정입니다. 재무 책임자인 아론 로젠버그가 2분기 재무 실적과 2026년 재무 가이던스를 업데이트할 것입니다. 연구개발 총괄이자 사장인 라이 왕이 연구개발 및 파이프라인 진행 상황에 대해 설명할 예정입니다. 이후 질의응답 시간을 갖겠습니다.
질의응답 시간에는 운영 총괄이자 사장인 우 박사, 북미 총괄 매니저인 매트 술리스, 고형암 최고 의학 책임자인 마크 라나사, 혈액학 최고 의학 책임자인 아밋 아가왈이 함께 참여할 예정입니다. 이제 존에게 마이크를 넘기겠습니다.
존, 부탁드립니다. 감사합니다, 댄. 참석해 주신 모든 분들 환영합니다.
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